Neurology

This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome back to The Curbsiders. I’m Dr. Matthew Watto, here with my very good friend, Dr. Paul Williams. It’s time to talk about headaches. We did a great recent podcast on migraines, Headache Update: Making Migraines Less Painful with Dr. Kevin Weber. One of the quotes from that episode that stayed with me was when he said, “I tell my patients to think about migraine as an irritable old miser set in their ways, and your brain is set in its ways. It doesn’t like changes in routine. It doesn’t like lack of sleep, it doesn’t like being hungry, it doesn’t like being thirsty, and it doesn’t like changes in the weather.” That’s a reminder of the good, old-fashioned primary care tips for taking care of headache.

Paul N. Williams, MD: That’s right. Conservative supportive management goes by the wayside because we focus on the medications. But I thought that was a really nice way to start the episode.

Dr. Watto: I asked him about cervicogenic headaches, which I guess you have to diagnose by giving a cervical steroid injection and see if the patient feels better, but he said he doesn’t do this. This is expert opinion territory. He asks his patients with chronic headache about cervical neck pain, because if they have it, he goes after it with physical therapy, which can help with the headaches. I thought that was a great pearl that I hadn’t heard before.

Give the audience a pearl from this great episode.

Dr. Williams: We talked about foundational treatments. We reviewed some of the abortive therapies and over-the-counter products. Some patients do quite well with acetaminophen or NSAIDs. We also talked about triptans, which are the standard medicines that we all know about. You can use those in combination, by the way. Patients can take their triptan with the NSAID that works best for them. They don’t have to be used one at a time, trying one and then trying the other one if the first one doesn’t help. Dr. Weber gave us practical guides in terms of which triptans he favors. He mentioned rizatriptan and naratriptan, which is one that I had not used with any frequency. I’ve seen rizatriptan a fair amount and that one seems to be covered by most insurances. He favors those two triptans.

He also reminded us that even though there is theoretical concern for serotonin toxicity because these are serotonergic and you’ll see these scary pop-ups in your electronic health record, that concern is almost purely theoretical. It hasn’t been borne out. They are really safe medications to use. But do use caution if you have a patient with known cardiovascular disease or cerebrovascular disease. We spent a fair amount of time talking about chest pressure as a common side effect. We also talked about some of the newer agents.

Dr. Watto: I wanted to add something about the triptans. Part of the reason he favors rizatriptan and naratriptan is that they are newer. He thinks they tend to have fewer side effects. But he did mention sumatriptan because it comes in the most different formulations. If patients have severe nausea, there is a subcutaneous version of sumatriptan and also an intranasal version.

The new kids on the block are the CGRP receptor antagonists, and they are available for preventive and abortive therapy. The abortive therapies are probably what people will be seeing most often in primary care – ubrogepant and rimegepant. Patients can take ubrogepant for abortive therapy and then repeat it if necessary. That’s similar to what patients are used to with the triptans. Rimegepant is taken once daily for abortive therapy or every other day as a preventive agent. Those are two of the agents that you might see patients taking. I’ve certainly started to see them.

There are also a whole bunch of monoclonal antibodies that affect the CGRP pathway. Those are given either once a month by subcutaneous injection or once every 3 months, and one is an infusion. They are pretty safe, and the big appeal is that they can be used in patients with cardiovascular disease. He also said that he has some patients who take them because triptans can cause the medication overuse side effect, but the CGRP receptor antagonists don’t. It’s an option for some patients to take the CGRP receptor antagonists on certain days for abortive therapy and then they can take the triptans the rest of the month.

Dr. Weber said that in his practice, these new drugs have really been great, which I can imagine, if you’re a specialist, patients have exhausted many of the typical therapies we offer in primary care.

Paul, bring us home here. What else should we tell the audience about? In primary care, what can we offer these patients?

Dr. Williams: A lot of the stuff we can offer works, by the way. It’s exciting to have fancy new medications to use, but you don’t even necessarily need to get to that point. We have a lot of medications that we can use for migraine prophylaxis, such as the beta-blockers and antihypertensives. Candesartan was a new one to me, an angiotensin receptor blocker that apparently has good evidence for migraine prophylaxis and Dr. Weber swears by it. We talked about some of the antiseizure medications, such as topiramate, which is probably the one with the most comfort in primary care. Some older folks may be using valproic acid or the tricyclic antidepressants (amitriptyline and nortriptyline) because people with migraine often will have comorbid anxiety or trouble sleeping, so I find that can sometimes be an effective medication or if they have comorbid neuropathic pain.

Another one that was new to me was venlafaxine as migraine prophylaxis. It’s not something I’d heard about before this episode. Certainly, for someone with chronic pain or a mood disorder that’s comorbid with migraines, it may be worth a shot. So there are options that we can exhaust first, and we may actually be doing our specialist friends a favor by trying one or two of these in advance, because then by the time the patient gets to the neurologist, it makes the prior authorization process much easier for the newer, fancier-pants medications that we’re all very excited about.

Dr. Watto: Paul, we’ve teased this fantastic podcast episode filled with so much more great stuff, so people should check out Headache Update: Making Migraines Less Painful with Dr. Kevin Weber.

Until next time, this has been another episode of The Curbsiders, bringing you a little knowledge food for your brain hole.

The Curbsiders is an internal medicine podcast, in which three board-certified internists interview experts on clinically important topics. In a collaboration with Medscape, the Curbsiders share clinical pearls and practice-changing knowledge from selected podcasts.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome back to The Curbsiders. I’m Dr. Matthew Watto, here with my very good friend, Dr. Paul Williams. It’s time to talk about headaches. We did a great recent podcast on migraines, Headache Update: Making Migraines Less Painful with Dr. Kevin Weber. One of the quotes from that episode that stayed with me was when he said, “I tell my patients to think about migraine as an irritable old miser set in their ways, and your brain is set in its ways. It doesn’t like changes in routine. It doesn’t like lack of sleep, it doesn’t like being hungry, it doesn’t like being thirsty, and it doesn’t like changes in the weather.” That’s a reminder of the good, old-fashioned primary care tips for taking care of headache.

Paul N. Williams, MD: That’s right. Conservative supportive management goes by the wayside because we focus on the medications. But I thought that was a really nice way to start the episode.

Dr. Watto: I asked him about cervicogenic headaches, which I guess you have to diagnose by giving a cervical steroid injection and see if the patient feels better, but he said he doesn’t do this. This is expert opinion territory. He asks his patients with chronic headache about cervical neck pain, because if they have it, he goes after it with physical therapy, which can help with the headaches. I thought that was a great pearl that I hadn’t heard before.

Give the audience a pearl from this great episode.

Dr. Williams: We talked about foundational treatments. We reviewed some of the abortive therapies and over-the-counter products. Some patients do quite well with acetaminophen or NSAIDs. We also talked about triptans, which are the standard medicines that we all know about. You can use those in combination, by the way. Patients can take their triptan with the NSAID that works best for them. They don’t have to be used one at a time, trying one and then trying the other one if the first one doesn’t help. Dr. Weber gave us practical guides in terms of which triptans he favors. He mentioned rizatriptan and naratriptan, which is one that I had not used with any frequency. I’ve seen rizatriptan a fair amount and that one seems to be covered by most insurances. He favors those two triptans.

He also reminded us that even though there is theoretical concern for serotonin toxicity because these are serotonergic and you’ll see these scary pop-ups in your electronic health record, that concern is almost purely theoretical. It hasn’t been borne out. They are really safe medications to use. But do use caution if you have a patient with known cardiovascular disease or cerebrovascular disease. We spent a fair amount of time talking about chest pressure as a common side effect. We also talked about some of the newer agents.

Dr. Watto: I wanted to add something about the triptans. Part of the reason he favors rizatriptan and naratriptan is that they are newer. He thinks they tend to have fewer side effects. But he did mention sumatriptan because it comes in the most different formulations. If patients have severe nausea, there is a subcutaneous version of sumatriptan and also an intranasal version.

The new kids on the block are the CGRP receptor antagonists, and they are available for preventive and abortive therapy. The abortive therapies are probably what people will be seeing most often in primary care – ubrogepant and rimegepant. Patients can take ubrogepant for abortive therapy and then repeat it if necessary. That’s similar to what patients are used to with the triptans. Rimegepant is taken once daily for abortive therapy or every other day as a preventive agent. Those are two of the agents that you might see patients taking. I’ve certainly started to see them.

There are also a whole bunch of monoclonal antibodies that affect the CGRP pathway. Those are given either once a month by subcutaneous injection or once every 3 months, and one is an infusion. They are pretty safe, and the big appeal is that they can be used in patients with cardiovascular disease. He also said that he has some patients who take them because triptans can cause the medication overuse side effect, but the CGRP receptor antagonists don’t. It’s an option for some patients to take the CGRP receptor antagonists on certain days for abortive therapy and then they can take the triptans the rest of the month.

Dr. Weber said that in his practice, these new drugs have really been great, which I can imagine, if you’re a specialist, patients have exhausted many of the typical therapies we offer in primary care.

Paul, bring us home here. What else should we tell the audience about? In primary care, what can we offer these patients?

Dr. Williams: A lot of the stuff we can offer works, by the way. It’s exciting to have fancy new medications to use, but you don’t even necessarily need to get to that point. We have a lot of medications that we can use for migraine prophylaxis, such as the beta-blockers and antihypertensives. Candesartan was a new one to me, an angiotensin receptor blocker that apparently has good evidence for migraine prophylaxis and Dr. Weber swears by it. We talked about some of the antiseizure medications, such as topiramate, which is probably the one with the most comfort in primary care. Some older folks may be using valproic acid or the tricyclic antidepressants (amitriptyline and nortriptyline) because people with migraine often will have comorbid anxiety or trouble sleeping, so I find that can sometimes be an effective medication or if they have comorbid neuropathic pain.

Another one that was new to me was venlafaxine as migraine prophylaxis. It’s not something I’d heard about before this episode. Certainly, for someone with chronic pain or a mood disorder that’s comorbid with migraines, it may be worth a shot. So there are options that we can exhaust first, and we may actually be doing our specialist friends a favor by trying one or two of these in advance, because then by the time the patient gets to the neurologist, it makes the prior authorization process much easier for the newer, fancier-pants medications that we’re all very excited about.

Dr. Watto: Paul, we’ve teased this fantastic podcast episode filled with so much more great stuff, so people should check out Headache Update: Making Migraines Less Painful with Dr. Kevin Weber.

Until next time, this has been another episode of The Curbsiders, bringing you a little knowledge food for your brain hole.

The Curbsiders is an internal medicine podcast, in which three board-certified internists interview experts on clinically important topics. In a collaboration with Medscape, the Curbsiders share clinical pearls and practice-changing knowledge from selected podcasts.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome back to The Curbsiders. I’m Dr. Matthew Watto, here with my very good friend, Dr. Paul Williams. It’s time to talk about headaches. We did a great recent podcast on migraines, Headache Update: Making Migraines Less Painful with Dr. Kevin Weber. One of the quotes from that episode that stayed with me was when he said, “I tell my patients to think about migraine as an irritable old miser set in their ways, and your brain is set in its ways. It doesn’t like changes in routine. It doesn’t like lack of sleep, it doesn’t like being hungry, it doesn’t like being thirsty, and it doesn’t like changes in the weather.” That’s a reminder of the good, old-fashioned primary care tips for taking care of headache.

Paul N. Williams, MD: That’s right. Conservative supportive management goes by the wayside because we focus on the medications. But I thought that was a really nice way to start the episode.

Dr. Watto: I asked him about cervicogenic headaches, which I guess you have to diagnose by giving a cervical steroid injection and see if the patient feels better, but he said he doesn’t do this. This is expert opinion territory. He asks his patients with chronic headache about cervical neck pain, because if they have it, he goes after it with physical therapy, which can help with the headaches. I thought that was a great pearl that I hadn’t heard before.

Give the audience a pearl from this great episode.

Dr. Williams: We talked about foundational treatments. We reviewed some of the abortive therapies and over-the-counter products. Some patients do quite well with acetaminophen or NSAIDs. We also talked about triptans, which are the standard medicines that we all know about. You can use those in combination, by the way. Patients can take their triptan with the NSAID that works best for them. They don’t have to be used one at a time, trying one and then trying the other one if the first one doesn’t help. Dr. Weber gave us practical guides in terms of which triptans he favors. He mentioned rizatriptan and naratriptan, which is one that I had not used with any frequency. I’ve seen rizatriptan a fair amount and that one seems to be covered by most insurances. He favors those two triptans.

He also reminded us that even though there is theoretical concern for serotonin toxicity because these are serotonergic and you’ll see these scary pop-ups in your electronic health record, that concern is almost purely theoretical. It hasn’t been borne out. They are really safe medications to use. But do use caution if you have a patient with known cardiovascular disease or cerebrovascular disease. We spent a fair amount of time talking about chest pressure as a common side effect. We also talked about some of the newer agents.

Dr. Watto: I wanted to add something about the triptans. Part of the reason he favors rizatriptan and naratriptan is that they are newer. He thinks they tend to have fewer side effects. But he did mention sumatriptan because it comes in the most different formulations. If patients have severe nausea, there is a subcutaneous version of sumatriptan and also an intranasal version.

The new kids on the block are the CGRP receptor antagonists, and they are available for preventive and abortive therapy. The abortive therapies are probably what people will be seeing most often in primary care – ubrogepant and rimegepant. Patients can take ubrogepant for abortive therapy and then repeat it if necessary. That’s similar to what patients are used to with the triptans. Rimegepant is taken once daily for abortive therapy or every other day as a preventive agent. Those are two of the agents that you might see patients taking. I’ve certainly started to see them.

There are also a whole bunch of monoclonal antibodies that affect the CGRP pathway. Those are given either once a month by subcutaneous injection or once every 3 months, and one is an infusion. They are pretty safe, and the big appeal is that they can be used in patients with cardiovascular disease. He also said that he has some patients who take them because triptans can cause the medication overuse side effect, but the CGRP receptor antagonists don’t. It’s an option for some patients to take the CGRP receptor antagonists on certain days for abortive therapy and then they can take the triptans the rest of the month.

Dr. Weber said that in his practice, these new drugs have really been great, which I can imagine, if you’re a specialist, patients have exhausted many of the typical therapies we offer in primary care.

Paul, bring us home here. What else should we tell the audience about? In primary care, what can we offer these patients?

Dr. Williams: A lot of the stuff we can offer works, by the way. It’s exciting to have fancy new medications to use, but you don’t even necessarily need to get to that point. We have a lot of medications that we can use for migraine prophylaxis, such as the beta-blockers and antihypertensives. Candesartan was a new one to me, an angiotensin receptor blocker that apparently has good evidence for migraine prophylaxis and Dr. Weber swears by it. We talked about some of the antiseizure medications, such as topiramate, which is probably the one with the most comfort in primary care. Some older folks may be using valproic acid or the tricyclic antidepressants (amitriptyline and nortriptyline) because people with migraine often will have comorbid anxiety or trouble sleeping, so I find that can sometimes be an effective medication or if they have comorbid neuropathic pain.

Another one that was new to me was venlafaxine as migraine prophylaxis. It’s not something I’d heard about before this episode. Certainly, for someone with chronic pain or a mood disorder that’s comorbid with migraines, it may be worth a shot. So there are options that we can exhaust first, and we may actually be doing our specialist friends a favor by trying one or two of these in advance, because then by the time the patient gets to the neurologist, it makes the prior authorization process much easier for the newer, fancier-pants medications that we’re all very excited about.

Dr. Watto: Paul, we’ve teased this fantastic podcast episode filled with so much more great stuff, so people should check out Headache Update: Making Migraines Less Painful with Dr. Kevin Weber.

Until next time, this has been another episode of The Curbsiders, bringing you a little knowledge food for your brain hole.

The Curbsiders is an internal medicine podcast, in which three board-certified internists interview experts on clinically important topics. In a collaboration with Medscape, the Curbsiders share clinical pearls and practice-changing knowledge from selected podcasts.

A version of this article first appeared on Medscape.com.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

The authors of a new evidence review recommend the Canadian TIA Risk Score for managing patients who present to the emergency department or physician’s office with an apparent transient ischemic attack (TIA) or minor stroke.

“Many hospitals do not have enough stroke neurologists to see every patient with TIA or minor stroke within 24 hours. Likewise, many emergency departments around the world are stretched beyond capacity,” study author Jeffery J. Perry, MD, senior scientist at the Ottawa Hospital Research Institute, said in an interview.

“This review corresponds to most of the recommendations by the American Heart Association and the Canadian Stroke Best Practice Recommendations,” he said. “It does, however, go further to differentiate high-risk versus low-risk patients for subsequent stroke using the Canadian TIA Score and offers practical suggestions for how to provide high-quality care in environments without the capacity to provide immediate vascular imaging, immediate MRI scanning, and immediate stroke specialist assessments.”

Most patients at low risk of a subsequent stroke (that is, patients with < 1% risk for a subsequent stroke at 7 days) can be managed safely as outpatients without causing delays in their departure for vascular imaging or neurology consultation during their initial emergency department visits, Dr. Perry added. “The Canadian TIA Score can be used to determine the urgency for an assessment by a stroke neurologist.”

The study was published  in CMAJ.
 

Score stratifies risk

Dr. Perry, lead author of the Canadian TIA Score validation study, said that the CMAJ editorial board approached him to write the review and to incorporate the new score into the latest recommendations. To include the latest evidence, Dr. Perry and colleagues reviewed the most recent position statements on TIA and minor stroke management and searched the literature for relevant articles. They note that the nomenclature related to TIA and minor stroke is inconsistent, that it’s not necessary to differentiate between the two from a clinical standpoint, and that the term “acute ischemic cerebrovascular syndrome” has been proposed to include both.

Broadly, the team’s recommended strategy for the diagnosis and management of the condition includes the following steps:

• Diagnosis: Sudden loss of motor function and impaired speech are strong indicators; symptoms tend to be negative (for example, loss of vision rather than flashing lights).
• Risk assessment: Use of the Canadian TIA Score to stratify 7-day stroke risk (low risk: < 1%, medium risk: 1%-5%, high risk: > 5%).
• Investigations: Urgent CT within 48 hours; vascular imaging to identify acutely symptomatic carotid stenosis in medium- to high-risk patients, as determined on the basis of the TIA score; ECG to identify atrial fibrillation or flutter and to optimize anticoagulant use; if the index of suspicion is high, echocardiography should be employed to look for cardioembolic sources.
• Management: Dual antiplatelet therapy for 21 days in medium- and high-risk patients; hypertension should be managed; patients should be referred for stroke clinic assessment; aggressive lifestyle changes should be initiated to lower lipid levels.

“I believe that our recommendations should be incorporated with the clinical guidelines,” said Dr. Perry.
 

Caveats and concerns

Commenting on the article, Steven M. Greenberg, MD, PhD, vice chair for faculty development of the department of neurology at Massachusetts General Hospital and a professor of neurology at Harvard Medical School, both in Boston, said, “Although the proposed guidelines are broadly evidence-based and consistent with standard of care, there are several areas where stroke specialists might disagree and suggest alternative strategies.” Dr. Greenberg was not involved in the study.

While some lower-risk features, such as repetitive or stereotyped symptoms or vertigo, can be more suggestive of TIA mimics, he said that “these features need to be scrutinized quite carefully. Critical carotid stenosis, for example, can give rise to brief, repetitive, stereotyped low-flow TIAs that require urgent revascularization.”

Vertigo might be a feature of brainstem or cerebellar TIA or minor stroke, said Dr. Greenberg, especially in the setting of other posterior circulation symptoms. Validated guidelines for differentiating peripheral vertigo and CNS vertigo are available, he noted.

“Another caveat is that the studies demonstrating benefit of brief dual antiplatelet therapy following acute TIA or minor stroke were based on ABCD2 rather than the Canadian TIA score,” he said. “It is therefore important for any score-based recommendations to be applied in the overall context of existing stroke prevention guidelines.”

In addition to the recommendation for urgent vascular imaging of patients whose presentations suggest bona fide TIA or minor stroke, most guidelines also recommend extended cardiac monitoring and transthoracic ECG to identify potential sources of embolism, Dr. Greenberg added. “Users of these guidelines should also be aware of the limited yield of head CT, which is able to detect some old strokes, large acute strokes – presumably not relevant to patients presenting with TIA or minor stroke – and acute intracranial hemorrhages.”

Louis R. Caplan, MD, founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center, Boston, and a professor of neurology at Harvard Medical School, also commented on the study.

While the review “is okay for care by nonstroke specialists, ideally, major referral centers could have a TIA or stroke clinic, as is present in much of Western Europe,” he said. This would allow the stroke etiology to be investigated for each patient.

“Many patients can be treated with the regimen outlined by the authors, but some with other conditions, such as atrial cardiopathy, patent foramen ovale, atrial myxoma, thrombus within the cardiac ventricle or atrium, will require anticoagulants,” he noted. “Thrombolysis and mechanical thrombectomy would be considered in some. Each stroke patient is different, and management cannot be homogenized into one remedy. One size does not fit all.”

In an accompanying commentary, Shelagh B. Coutts, MD, and Michael D. Hill, MD, both of the University of Calgary (Alta.), presented their team’s approach to the acute management of patients with likely cerebral ischemia. Such management includes risk assessment and stratification by clinical symptoms, rather than a particular score. They also typically conduct CT angiography. “If the CTA is completely normal (that is, no occlusion, no atherosclerosis or arterial dissection and no other vascular abnormality), we rely on the high negative predictive value of this result and discharge the patient home on antiplatelet treatment with outpatient follow-up, including MRI of the brain (since CT cannot reliably rule out minor ischemia) within the first week,” they write.

The review was conducted without commercial funding. Dr. Perry, Dr. Greenberg, Dr. Caplan, Dr. Coutts, and Dr. Hill have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The authors of a new evidence review recommend the Canadian TIA Risk Score for managing patients who present to the emergency department or physician’s office with an apparent transient ischemic attack (TIA) or minor stroke.

“Many hospitals do not have enough stroke neurologists to see every patient with TIA or minor stroke within 24 hours. Likewise, many emergency departments around the world are stretched beyond capacity,” study author Jeffery J. Perry, MD, senior scientist at the Ottawa Hospital Research Institute, said in an interview.

“This review corresponds to most of the recommendations by the American Heart Association and the Canadian Stroke Best Practice Recommendations,” he said. “It does, however, go further to differentiate high-risk versus low-risk patients for subsequent stroke using the Canadian TIA Score and offers practical suggestions for how to provide high-quality care in environments without the capacity to provide immediate vascular imaging, immediate MRI scanning, and immediate stroke specialist assessments.”

Most patients at low risk of a subsequent stroke (that is, patients with < 1% risk for a subsequent stroke at 7 days) can be managed safely as outpatients without causing delays in their departure for vascular imaging or neurology consultation during their initial emergency department visits, Dr. Perry added. “The Canadian TIA Score can be used to determine the urgency for an assessment by a stroke neurologist.”

The study was published  in CMAJ.
 

Score stratifies risk

Dr. Perry, lead author of the Canadian TIA Score validation study, said that the CMAJ editorial board approached him to write the review and to incorporate the new score into the latest recommendations. To include the latest evidence, Dr. Perry and colleagues reviewed the most recent position statements on TIA and minor stroke management and searched the literature for relevant articles. They note that the nomenclature related to TIA and minor stroke is inconsistent, that it’s not necessary to differentiate between the two from a clinical standpoint, and that the term “acute ischemic cerebrovascular syndrome” has been proposed to include both.

Broadly, the team’s recommended strategy for the diagnosis and management of the condition includes the following steps:

• Diagnosis: Sudden loss of motor function and impaired speech are strong indicators; symptoms tend to be negative (for example, loss of vision rather than flashing lights).
• Risk assessment: Use of the Canadian TIA Score to stratify 7-day stroke risk (low risk: < 1%, medium risk: 1%-5%, high risk: > 5%).
• Investigations: Urgent CT within 48 hours; vascular imaging to identify acutely symptomatic carotid stenosis in medium- to high-risk patients, as determined on the basis of the TIA score; ECG to identify atrial fibrillation or flutter and to optimize anticoagulant use; if the index of suspicion is high, echocardiography should be employed to look for cardioembolic sources.
• Management: Dual antiplatelet therapy for 21 days in medium- and high-risk patients; hypertension should be managed; patients should be referred for stroke clinic assessment; aggressive lifestyle changes should be initiated to lower lipid levels.

“I believe that our recommendations should be incorporated with the clinical guidelines,” said Dr. Perry.
 

Caveats and concerns

Commenting on the article, Steven M. Greenberg, MD, PhD, vice chair for faculty development of the department of neurology at Massachusetts General Hospital and a professor of neurology at Harvard Medical School, both in Boston, said, “Although the proposed guidelines are broadly evidence-based and consistent with standard of care, there are several areas where stroke specialists might disagree and suggest alternative strategies.” Dr. Greenberg was not involved in the study.

While some lower-risk features, such as repetitive or stereotyped symptoms or vertigo, can be more suggestive of TIA mimics, he said that “these features need to be scrutinized quite carefully. Critical carotid stenosis, for example, can give rise to brief, repetitive, stereotyped low-flow TIAs that require urgent revascularization.”

Vertigo might be a feature of brainstem or cerebellar TIA or minor stroke, said Dr. Greenberg, especially in the setting of other posterior circulation symptoms. Validated guidelines for differentiating peripheral vertigo and CNS vertigo are available, he noted.

“Another caveat is that the studies demonstrating benefit of brief dual antiplatelet therapy following acute TIA or minor stroke were based on ABCD2 rather than the Canadian TIA score,” he said. “It is therefore important for any score-based recommendations to be applied in the overall context of existing stroke prevention guidelines.”

In addition to the recommendation for urgent vascular imaging of patients whose presentations suggest bona fide TIA or minor stroke, most guidelines also recommend extended cardiac monitoring and transthoracic ECG to identify potential sources of embolism, Dr. Greenberg added. “Users of these guidelines should also be aware of the limited yield of head CT, which is able to detect some old strokes, large acute strokes – presumably not relevant to patients presenting with TIA or minor stroke – and acute intracranial hemorrhages.”

Louis R. Caplan, MD, founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center, Boston, and a professor of neurology at Harvard Medical School, also commented on the study.

While the review “is okay for care by nonstroke specialists, ideally, major referral centers could have a TIA or stroke clinic, as is present in much of Western Europe,” he said. This would allow the stroke etiology to be investigated for each patient.

“Many patients can be treated with the regimen outlined by the authors, but some with other conditions, such as atrial cardiopathy, patent foramen ovale, atrial myxoma, thrombus within the cardiac ventricle or atrium, will require anticoagulants,” he noted. “Thrombolysis and mechanical thrombectomy would be considered in some. Each stroke patient is different, and management cannot be homogenized into one remedy. One size does not fit all.”

In an accompanying commentary, Shelagh B. Coutts, MD, and Michael D. Hill, MD, both of the University of Calgary (Alta.), presented their team’s approach to the acute management of patients with likely cerebral ischemia. Such management includes risk assessment and stratification by clinical symptoms, rather than a particular score. They also typically conduct CT angiography. “If the CTA is completely normal (that is, no occlusion, no atherosclerosis or arterial dissection and no other vascular abnormality), we rely on the high negative predictive value of this result and discharge the patient home on antiplatelet treatment with outpatient follow-up, including MRI of the brain (since CT cannot reliably rule out minor ischemia) within the first week,” they write.

The review was conducted without commercial funding. Dr. Perry, Dr. Greenberg, Dr. Caplan, Dr. Coutts, and Dr. Hill have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The authors of a new evidence review recommend the Canadian TIA Risk Score for managing patients who present to the emergency department or physician’s office with an apparent transient ischemic attack (TIA) or minor stroke.

“Many hospitals do not have enough stroke neurologists to see every patient with TIA or minor stroke within 24 hours. Likewise, many emergency departments around the world are stretched beyond capacity,” study author Jeffery J. Perry, MD, senior scientist at the Ottawa Hospital Research Institute, said in an interview.

“This review corresponds to most of the recommendations by the American Heart Association and the Canadian Stroke Best Practice Recommendations,” he said. “It does, however, go further to differentiate high-risk versus low-risk patients for subsequent stroke using the Canadian TIA Score and offers practical suggestions for how to provide high-quality care in environments without the capacity to provide immediate vascular imaging, immediate MRI scanning, and immediate stroke specialist assessments.”

Most patients at low risk of a subsequent stroke (that is, patients with < 1% risk for a subsequent stroke at 7 days) can be managed safely as outpatients without causing delays in their departure for vascular imaging or neurology consultation during their initial emergency department visits, Dr. Perry added. “The Canadian TIA Score can be used to determine the urgency for an assessment by a stroke neurologist.”

The study was published  in CMAJ.
 

Score stratifies risk

Dr. Perry, lead author of the Canadian TIA Score validation study, said that the CMAJ editorial board approached him to write the review and to incorporate the new score into the latest recommendations. To include the latest evidence, Dr. Perry and colleagues reviewed the most recent position statements on TIA and minor stroke management and searched the literature for relevant articles. They note that the nomenclature related to TIA and minor stroke is inconsistent, that it’s not necessary to differentiate between the two from a clinical standpoint, and that the term “acute ischemic cerebrovascular syndrome” has been proposed to include both.

Broadly, the team’s recommended strategy for the diagnosis and management of the condition includes the following steps:

• Diagnosis: Sudden loss of motor function and impaired speech are strong indicators; symptoms tend to be negative (for example, loss of vision rather than flashing lights).
• Risk assessment: Use of the Canadian TIA Score to stratify 7-day stroke risk (low risk: < 1%, medium risk: 1%-5%, high risk: > 5%).
• Investigations: Urgent CT within 48 hours; vascular imaging to identify acutely symptomatic carotid stenosis in medium- to high-risk patients, as determined on the basis of the TIA score; ECG to identify atrial fibrillation or flutter and to optimize anticoagulant use; if the index of suspicion is high, echocardiography should be employed to look for cardioembolic sources.
• Management: Dual antiplatelet therapy for 21 days in medium- and high-risk patients; hypertension should be managed; patients should be referred for stroke clinic assessment; aggressive lifestyle changes should be initiated to lower lipid levels.

“I believe that our recommendations should be incorporated with the clinical guidelines,” said Dr. Perry.
 

Caveats and concerns

Commenting on the article, Steven M. Greenberg, MD, PhD, vice chair for faculty development of the department of neurology at Massachusetts General Hospital and a professor of neurology at Harvard Medical School, both in Boston, said, “Although the proposed guidelines are broadly evidence-based and consistent with standard of care, there are several areas where stroke specialists might disagree and suggest alternative strategies.” Dr. Greenberg was not involved in the study.

While some lower-risk features, such as repetitive or stereotyped symptoms or vertigo, can be more suggestive of TIA mimics, he said that “these features need to be scrutinized quite carefully. Critical carotid stenosis, for example, can give rise to brief, repetitive, stereotyped low-flow TIAs that require urgent revascularization.”

Vertigo might be a feature of brainstem or cerebellar TIA or minor stroke, said Dr. Greenberg, especially in the setting of other posterior circulation symptoms. Validated guidelines for differentiating peripheral vertigo and CNS vertigo are available, he noted.

“Another caveat is that the studies demonstrating benefit of brief dual antiplatelet therapy following acute TIA or minor stroke were based on ABCD2 rather than the Canadian TIA score,” he said. “It is therefore important for any score-based recommendations to be applied in the overall context of existing stroke prevention guidelines.”

In addition to the recommendation for urgent vascular imaging of patients whose presentations suggest bona fide TIA or minor stroke, most guidelines also recommend extended cardiac monitoring and transthoracic ECG to identify potential sources of embolism, Dr. Greenberg added. “Users of these guidelines should also be aware of the limited yield of head CT, which is able to detect some old strokes, large acute strokes – presumably not relevant to patients presenting with TIA or minor stroke – and acute intracranial hemorrhages.”

Louis R. Caplan, MD, founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center, Boston, and a professor of neurology at Harvard Medical School, also commented on the study.

While the review “is okay for care by nonstroke specialists, ideally, major referral centers could have a TIA or stroke clinic, as is present in much of Western Europe,” he said. This would allow the stroke etiology to be investigated for each patient.

“Many patients can be treated with the regimen outlined by the authors, but some with other conditions, such as atrial cardiopathy, patent foramen ovale, atrial myxoma, thrombus within the cardiac ventricle or atrium, will require anticoagulants,” he noted. “Thrombolysis and mechanical thrombectomy would be considered in some. Each stroke patient is different, and management cannot be homogenized into one remedy. One size does not fit all.”

In an accompanying commentary, Shelagh B. Coutts, MD, and Michael D. Hill, MD, both of the University of Calgary (Alta.), presented their team’s approach to the acute management of patients with likely cerebral ischemia. Such management includes risk assessment and stratification by clinical symptoms, rather than a particular score. They also typically conduct CT angiography. “If the CTA is completely normal (that is, no occlusion, no atherosclerosis or arterial dissection and no other vascular abnormality), we rely on the high negative predictive value of this result and discharge the patient home on antiplatelet treatment with outpatient follow-up, including MRI of the brain (since CT cannot reliably rule out minor ischemia) within the first week,” they write.

The review was conducted without commercial funding. Dr. Perry, Dr. Greenberg, Dr. Caplan, Dr. Coutts, and Dr. Hill have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Pediatric patients with epilepsy have an increased risk of cardiovascular complications later in life, but little is known about how they progress. A new study finds that abnormalities in electrocardiograms are linked to an earlier age of diagnosis and longer epilepsy duration.

The findings could help researchers in the search for biomarkers that could predict later problems in children with epilepsy. “In pediatric neurology I think we’re a little bit removed from some of the cardiovascular complications that can happen within epilepsy, but cardiovascular complications are well established, especially in adults that have epilepsy. Adults with epilepsy are more likely to have coronary artery disease, atherosclerosis, arrhythmias, heart attacks, and sudden cardiac death. It’s a pretty substantial difference compared with their nonepileptic peers. So knowing that, the big question is, how do these changes develop, and how do we really counsel our patients in regards to these complications?” said Brittnie Bartlett, MD, during her presentation of the research at the 2022 annual meeting of the Child Neurology Society.

Identifying factors that increase cardiac complications

Previous studies suggested that epilepsy duration might be linked to cardiovascular complications. In children with Dravet syndrome, epilepsy duration has been shown to be associated with cardiac complications. Pathological T wave alternans, which indicates ventricular instability, has been observed in adults with longstanding epilepsy but not adults with newly diagnosed epilepsy.

“So our question in this preliminary report of our data is: What factors in our general pediatric epilepsy cohort can we identify that put them at a greater risk for having EKG changes, and specifically, we wanted to verify these findings from the other studies that epilepsy duration is, in fact, a risk factor for these EKG changes in general [among children] with epilepsy aside from channelopathies,” said Dr. Bartlett, who is an assistant professor at Baylor College of Medicine and a child neurologist at Texas Children’s Hospital, both in Houston.

She presented a striking finding that cardiovascular changes appear early. “The most important thing I want you all to make note of is the fact that, in this baseline study that we got on these kids, 47% already had changes that we were seeing on their EKGs,” said Dr. Bartlett.

The researchers also looked for factors associated with EKG changes, and found that duration of epilepsy and age at diagnosis were the two salient factors. “Our kids that did have EKG changes present had an average epilepsy duration of 73 months, as opposed to [the children] that did not have EKG changes and had an average epilepsy duration of 46 months,” said Dr. Bartlett.

Other factors, such epilepsy type, etiology, refractory epilepsy, and seizure frequency had no statistically significant association with EKG changes. They also saw no associations with high-risk seizure medications, even though some antiseizure drugs have been shown to be linked to EKG changes.

“We were able to confirm our hypothesis that EKG changes were more prevalent with longer duration of epilepsy. Unfortunately, we weren’t able to find any other clues that would help us counsel our patients, but this is part of a longitudinal prospective study that we’ll be following these kids over a couple of years’ time, so maybe we’ll be able to tease out some of these differences. Ideally, we’d be able to find some kind of a biomarker for future cardiovascular complications, and right now we’re working with some multivariable models to verify some of these findings,” said Dr. Bartlett.

Implications for clinical practice

During the Q&A, Dr. Bartlett was asked if all kids with epilepsy should undergo an EKG. She recommended against it for now. “At this point, I don’t think we have enough clear data to support getting an EKG on every kid with epilepsy. I do think it’s good practice to do them on all kids with channelopathies. As a general practice, I tend to have a low threshold towards many kids with epilepsy, but a lot of these cardiovascular risk factors tend to pop up more in adulthood, so it’s more preventative,” she said.

Grace Gombolay, MD, who moderated the session where the poster was presented, was asked for comment on the study. “What’s surprising about it is that up to half of patients actually had EKG changes, different what from what we see in normal population, and it’s interesting to think about the implications. One of the things that our epilepsy patients are at risk for is SUDEP – sudden, unexplained death in epilepsy. It’s interesting to think about what these EKG changes mean for clinical care. I think it’s too early to say at this time, but this might be one of those markers for SUDEP,” said Dr. Gombolay, who is an assistant professor at Emory University, Atlanta, and director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Children’s Healthcare of Atlanta.

The researchers prospectively studied 213 patients who were recruited. 46% were female, 42% were white, 41% were Hispanic, and 13% were African American. The mean age at enrollment was 116 months, and mean age of seizure onset was 45 months.

The researchers found that 47% had abnormal EKG readings. None of the changes were pathologic, but they may reflect changes to cardiac electrophysiology, according to Dr. Bartlett. Those with abnormal readings were older on average (11.6 vs. 8.3 years; P < .005) and had a longer epilepsy duration (73 vs. 46 months; P = .004).

Dr. Gombolay has no relevant financial disclosures.

Pediatric patients with epilepsy have an increased risk of cardiovascular complications later in life, but little is known about how they progress. A new study finds that abnormalities in electrocardiograms are linked to an earlier age of diagnosis and longer epilepsy duration.

The findings could help researchers in the search for biomarkers that could predict later problems in children with epilepsy. “In pediatric neurology I think we’re a little bit removed from some of the cardiovascular complications that can happen within epilepsy, but cardiovascular complications are well established, especially in adults that have epilepsy. Adults with epilepsy are more likely to have coronary artery disease, atherosclerosis, arrhythmias, heart attacks, and sudden cardiac death. It’s a pretty substantial difference compared with their nonepileptic peers. So knowing that, the big question is, how do these changes develop, and how do we really counsel our patients in regards to these complications?” said Brittnie Bartlett, MD, during her presentation of the research at the 2022 annual meeting of the Child Neurology Society.

Identifying factors that increase cardiac complications

Previous studies suggested that epilepsy duration might be linked to cardiovascular complications. In children with Dravet syndrome, epilepsy duration has been shown to be associated with cardiac complications. Pathological T wave alternans, which indicates ventricular instability, has been observed in adults with longstanding epilepsy but not adults with newly diagnosed epilepsy.

“So our question in this preliminary report of our data is: What factors in our general pediatric epilepsy cohort can we identify that put them at a greater risk for having EKG changes, and specifically, we wanted to verify these findings from the other studies that epilepsy duration is, in fact, a risk factor for these EKG changes in general [among children] with epilepsy aside from channelopathies,” said Dr. Bartlett, who is an assistant professor at Baylor College of Medicine and a child neurologist at Texas Children’s Hospital, both in Houston.

She presented a striking finding that cardiovascular changes appear early. “The most important thing I want you all to make note of is the fact that, in this baseline study that we got on these kids, 47% already had changes that we were seeing on their EKGs,” said Dr. Bartlett.

The researchers also looked for factors associated with EKG changes, and found that duration of epilepsy and age at diagnosis were the two salient factors. “Our kids that did have EKG changes present had an average epilepsy duration of 73 months, as opposed to [the children] that did not have EKG changes and had an average epilepsy duration of 46 months,” said Dr. Bartlett.

Other factors, such epilepsy type, etiology, refractory epilepsy, and seizure frequency had no statistically significant association with EKG changes. They also saw no associations with high-risk seizure medications, even though some antiseizure drugs have been shown to be linked to EKG changes.

“We were able to confirm our hypothesis that EKG changes were more prevalent with longer duration of epilepsy. Unfortunately, we weren’t able to find any other clues that would help us counsel our patients, but this is part of a longitudinal prospective study that we’ll be following these kids over a couple of years’ time, so maybe we’ll be able to tease out some of these differences. Ideally, we’d be able to find some kind of a biomarker for future cardiovascular complications, and right now we’re working with some multivariable models to verify some of these findings,” said Dr. Bartlett.

Implications for clinical practice

During the Q&A, Dr. Bartlett was asked if all kids with epilepsy should undergo an EKG. She recommended against it for now. “At this point, I don’t think we have enough clear data to support getting an EKG on every kid with epilepsy. I do think it’s good practice to do them on all kids with channelopathies. As a general practice, I tend to have a low threshold towards many kids with epilepsy, but a lot of these cardiovascular risk factors tend to pop up more in adulthood, so it’s more preventative,” she said.

Grace Gombolay, MD, who moderated the session where the poster was presented, was asked for comment on the study. “What’s surprising about it is that up to half of patients actually had EKG changes, different what from what we see in normal population, and it’s interesting to think about the implications. One of the things that our epilepsy patients are at risk for is SUDEP – sudden, unexplained death in epilepsy. It’s interesting to think about what these EKG changes mean for clinical care. I think it’s too early to say at this time, but this might be one of those markers for SUDEP,” said Dr. Gombolay, who is an assistant professor at Emory University, Atlanta, and director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Children’s Healthcare of Atlanta.

The researchers prospectively studied 213 patients who were recruited. 46% were female, 42% were white, 41% were Hispanic, and 13% were African American. The mean age at enrollment was 116 months, and mean age of seizure onset was 45 months.

The researchers found that 47% had abnormal EKG readings. None of the changes were pathologic, but they may reflect changes to cardiac electrophysiology, according to Dr. Bartlett. Those with abnormal readings were older on average (11.6 vs. 8.3 years; P < .005) and had a longer epilepsy duration (73 vs. 46 months; P = .004).

Dr. Gombolay has no relevant financial disclosures.

Pediatric patients with epilepsy have an increased risk of cardiovascular complications later in life, but little is known about how they progress. A new study finds that abnormalities in electrocardiograms are linked to an earlier age of diagnosis and longer epilepsy duration.

The findings could help researchers in the search for biomarkers that could predict later problems in children with epilepsy. “In pediatric neurology I think we’re a little bit removed from some of the cardiovascular complications that can happen within epilepsy, but cardiovascular complications are well established, especially in adults that have epilepsy. Adults with epilepsy are more likely to have coronary artery disease, atherosclerosis, arrhythmias, heart attacks, and sudden cardiac death. It’s a pretty substantial difference compared with their nonepileptic peers. So knowing that, the big question is, how do these changes develop, and how do we really counsel our patients in regards to these complications?” said Brittnie Bartlett, MD, during her presentation of the research at the 2022 annual meeting of the Child Neurology Society.

Identifying factors that increase cardiac complications

Previous studies suggested that epilepsy duration might be linked to cardiovascular complications. In children with Dravet syndrome, epilepsy duration has been shown to be associated with cardiac complications. Pathological T wave alternans, which indicates ventricular instability, has been observed in adults with longstanding epilepsy but not adults with newly diagnosed epilepsy.

“So our question in this preliminary report of our data is: What factors in our general pediatric epilepsy cohort can we identify that put them at a greater risk for having EKG changes, and specifically, we wanted to verify these findings from the other studies that epilepsy duration is, in fact, a risk factor for these EKG changes in general [among children] with epilepsy aside from channelopathies,” said Dr. Bartlett, who is an assistant professor at Baylor College of Medicine and a child neurologist at Texas Children’s Hospital, both in Houston.

She presented a striking finding that cardiovascular changes appear early. “The most important thing I want you all to make note of is the fact that, in this baseline study that we got on these kids, 47% already had changes that we were seeing on their EKGs,” said Dr. Bartlett.

The researchers also looked for factors associated with EKG changes, and found that duration of epilepsy and age at diagnosis were the two salient factors. “Our kids that did have EKG changes present had an average epilepsy duration of 73 months, as opposed to [the children] that did not have EKG changes and had an average epilepsy duration of 46 months,” said Dr. Bartlett.

Other factors, such epilepsy type, etiology, refractory epilepsy, and seizure frequency had no statistically significant association with EKG changes. They also saw no associations with high-risk seizure medications, even though some antiseizure drugs have been shown to be linked to EKG changes.

“We were able to confirm our hypothesis that EKG changes were more prevalent with longer duration of epilepsy. Unfortunately, we weren’t able to find any other clues that would help us counsel our patients, but this is part of a longitudinal prospective study that we’ll be following these kids over a couple of years’ time, so maybe we’ll be able to tease out some of these differences. Ideally, we’d be able to find some kind of a biomarker for future cardiovascular complications, and right now we’re working with some multivariable models to verify some of these findings,” said Dr. Bartlett.

Implications for clinical practice

During the Q&A, Dr. Bartlett was asked if all kids with epilepsy should undergo an EKG. She recommended against it for now. “At this point, I don’t think we have enough clear data to support getting an EKG on every kid with epilepsy. I do think it’s good practice to do them on all kids with channelopathies. As a general practice, I tend to have a low threshold towards many kids with epilepsy, but a lot of these cardiovascular risk factors tend to pop up more in adulthood, so it’s more preventative,” she said.

Grace Gombolay, MD, who moderated the session where the poster was presented, was asked for comment on the study. “What’s surprising about it is that up to half of patients actually had EKG changes, different what from what we see in normal population, and it’s interesting to think about the implications. One of the things that our epilepsy patients are at risk for is SUDEP – sudden, unexplained death in epilepsy. It’s interesting to think about what these EKG changes mean for clinical care. I think it’s too early to say at this time, but this might be one of those markers for SUDEP,” said Dr. Gombolay, who is an assistant professor at Emory University, Atlanta, and director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Children’s Healthcare of Atlanta.

The researchers prospectively studied 213 patients who were recruited. 46% were female, 42% were white, 41% were Hispanic, and 13% were African American. The mean age at enrollment was 116 months, and mean age of seizure onset was 45 months.

The researchers found that 47% had abnormal EKG readings. None of the changes were pathologic, but they may reflect changes to cardiac electrophysiology, according to Dr. Bartlett. Those with abnormal readings were older on average (11.6 vs. 8.3 years; P < .005) and had a longer epilepsy duration (73 vs. 46 months; P = .004).

Dr. Gombolay has no relevant financial disclosures.

CINCINNATI – Cerebral palsy affects about 3 in every 1,000 children, but there is usually little sign of the condition at birth. Instead, it usually shows clinical manifestation between ages 2 and 5, and a diagnosis can trigger early interventions that can improve long-term outcomes.

Physicians and patients would benefit from a screening method for cerebral palsy at birth, but that has so far eluded researchers.

At the 2022 annual meeting of the Child Neurology Society, researchers presented evidence that respiratory rate measured in the last 24 hours of residence in the neonate intensive care unit (NICU) predicts later onset of cerebral palsy, with higher variability associated with increased cerebral palsy risk.

The study results were promising, according to Marc Patterson, MD, who comoderated the session. “It gives us more confidence in predicting the children at risk and making sure that they’re going to be followed closely to get the interventions they need to help them,” said Dr. Patterson, who is a professor of neurology, pediatrics, and medical genetics at Mayo Medical School in Rochester, Minn.

“By the time a child is 5 or 6, the symptoms are usually very obvious, but you really want to intervene as soon as possible before their brain’s plasticity decreases over time, so the earlier you can intervene in general, the better your results are going to be,” said Dr. Patterson.

There are tools available to diagnose cerebral palsy at an earlier age, including the Prechtl General Movements Assessment (GMA), which can be done up to 5 months of corrected age. It has 97% sensitivity and 89% specificity for cerebral palsy. The Hammersmith Infant Neurological Examination (HINE), which can be used in the same age range, and has 72-91% sensitivity and 100% specificity.

Both of the available tools are resource intensive and require trained clinicians, and may be unavailable in many areas. Despite these tools, early diagnosis of cerebral palsy is still underemployed, according to Arohi Saxena, a third-year medical student at Washington University in St. Louis, who presented the study results.
 

Respiratory rate variability may indicate increased risk

The researchers set out to identify objective metrics that correlated with HINE and GMA scores. They looked at kinematic data from practical assessments carried out by their physical therapists, as well as vital sign instability obtained at NICU discharge, which was based on suggestions that hemodynamic instability may be linked to later risk of cerebral palsy, according to Ms. Saxena.

They analyzed data from 31 infants with a corrected age of 8-25 weeks at a tertiary NICU follow-up clinic. Of these, 18 displayed fidgety movements on their Prechtl assessment, and 13 did not.

They used DeepLabCut software to analyze data from videos of the Prechtl assessment, with a focus on range and variance of hand and foot movements normalized to nose-to-umbilicus distance. They also analyzed pulse and respiratory data from the final 24 hours before NICU discharge.

They found that infants without fidgety movements had decreased hand and foot movement ranges (P = .04). There was no significant difference between the two groups with respect to pulse measurements. However, the respiratory rate range and variance was significantly higher in infants without fidgety movements. “Infants who are at higher risk for developing cerebral palsy had more respiratory instability early on in life,” said Ms. Saxena during her talk.

When they compared values to HINE scores, they found a correlation with less foot movement and a predisposition to develop cerebral palsy, but no correlation with hand movement. A lower HINE sore also correlated to larger respiratory rate range and variance (P < .01 for both).

“Our hypothesis to explain this link is that respiratory rate variability is likely driven by neonatal injury in the brainstem, where the respiratory centers are located. In some infants, this may correlate with more extensive cerebral injury that could predict the development of cerebral palsy,” said Ms. Saxena.

The group plans to increase its sample size as well as to conduct long-term follow-up on the infants to see how many receive formal diagnoses of cerebral palsy.

After her talk, asked by a moderator why motor assessments were not a reliable predictor in their study, Ms. Saxena pointed to the inexperience of assessors at the institution, where Prechtl testing had only recently begun.

“I think a lot of it is to do with the more subjective nature of the motor assessment. We definitely saw kind of a trend where in the earlier data that was collected, right when our institutions started doing these Prechtls, it was even less of a reliable effect. So I think possibly as clinicians continue to get more familiar with this assessment and there’s more like a validated and robust scoring system, maybe we’ll see a stronger correlation,” she said.

Ms. Saxena had no relevant disclosures. Coauthor Boomah Aravamuthan, MD, DPhil, is a consultant for Neurocrine Biosciences and has received royalties from UpToDate and funding from the National Institute of Neurological Disorders and Stroke.

CINCINNATI – Cerebral palsy affects about 3 in every 1,000 children, but there is usually little sign of the condition at birth. Instead, it usually shows clinical manifestation between ages 2 and 5, and a diagnosis can trigger early interventions that can improve long-term outcomes.

Physicians and patients would benefit from a screening method for cerebral palsy at birth, but that has so far eluded researchers.

At the 2022 annual meeting of the Child Neurology Society, researchers presented evidence that respiratory rate measured in the last 24 hours of residence in the neonate intensive care unit (NICU) predicts later onset of cerebral palsy, with higher variability associated with increased cerebral palsy risk.

The study results were promising, according to Marc Patterson, MD, who comoderated the session. “It gives us more confidence in predicting the children at risk and making sure that they’re going to be followed closely to get the interventions they need to help them,” said Dr. Patterson, who is a professor of neurology, pediatrics, and medical genetics at Mayo Medical School in Rochester, Minn.

“By the time a child is 5 or 6, the symptoms are usually very obvious, but you really want to intervene as soon as possible before their brain’s plasticity decreases over time, so the earlier you can intervene in general, the better your results are going to be,” said Dr. Patterson.

There are tools available to diagnose cerebral palsy at an earlier age, including the Prechtl General Movements Assessment (GMA), which can be done up to 5 months of corrected age. It has 97% sensitivity and 89% specificity for cerebral palsy. The Hammersmith Infant Neurological Examination (HINE), which can be used in the same age range, and has 72-91% sensitivity and 100% specificity.

Both of the available tools are resource intensive and require trained clinicians, and may be unavailable in many areas. Despite these tools, early diagnosis of cerebral palsy is still underemployed, according to Arohi Saxena, a third-year medical student at Washington University in St. Louis, who presented the study results.
 

Respiratory rate variability may indicate increased risk

The researchers set out to identify objective metrics that correlated with HINE and GMA scores. They looked at kinematic data from practical assessments carried out by their physical therapists, as well as vital sign instability obtained at NICU discharge, which was based on suggestions that hemodynamic instability may be linked to later risk of cerebral palsy, according to Ms. Saxena.

They analyzed data from 31 infants with a corrected age of 8-25 weeks at a tertiary NICU follow-up clinic. Of these, 18 displayed fidgety movements on their Prechtl assessment, and 13 did not.

They used DeepLabCut software to analyze data from videos of the Prechtl assessment, with a focus on range and variance of hand and foot movements normalized to nose-to-umbilicus distance. They also analyzed pulse and respiratory data from the final 24 hours before NICU discharge.

They found that infants without fidgety movements had decreased hand and foot movement ranges (P = .04). There was no significant difference between the two groups with respect to pulse measurements. However, the respiratory rate range and variance was significantly higher in infants without fidgety movements. “Infants who are at higher risk for developing cerebral palsy had more respiratory instability early on in life,” said Ms. Saxena during her talk.

When they compared values to HINE scores, they found a correlation with less foot movement and a predisposition to develop cerebral palsy, but no correlation with hand movement. A lower HINE sore also correlated to larger respiratory rate range and variance (P < .01 for both).

“Our hypothesis to explain this link is that respiratory rate variability is likely driven by neonatal injury in the brainstem, where the respiratory centers are located. In some infants, this may correlate with more extensive cerebral injury that could predict the development of cerebral palsy,” said Ms. Saxena.

The group plans to increase its sample size as well as to conduct long-term follow-up on the infants to see how many receive formal diagnoses of cerebral palsy.

After her talk, asked by a moderator why motor assessments were not a reliable predictor in their study, Ms. Saxena pointed to the inexperience of assessors at the institution, where Prechtl testing had only recently begun.

“I think a lot of it is to do with the more subjective nature of the motor assessment. We definitely saw kind of a trend where in the earlier data that was collected, right when our institutions started doing these Prechtls, it was even less of a reliable effect. So I think possibly as clinicians continue to get more familiar with this assessment and there’s more like a validated and robust scoring system, maybe we’ll see a stronger correlation,” she said.

Ms. Saxena had no relevant disclosures. Coauthor Boomah Aravamuthan, MD, DPhil, is a consultant for Neurocrine Biosciences and has received royalties from UpToDate and funding from the National Institute of Neurological Disorders and Stroke.

CINCINNATI – Cerebral palsy affects about 3 in every 1,000 children, but there is usually little sign of the condition at birth. Instead, it usually shows clinical manifestation between ages 2 and 5, and a diagnosis can trigger early interventions that can improve long-term outcomes.

Physicians and patients would benefit from a screening method for cerebral palsy at birth, but that has so far eluded researchers.

At the 2022 annual meeting of the Child Neurology Society, researchers presented evidence that respiratory rate measured in the last 24 hours of residence in the neonate intensive care unit (NICU) predicts later onset of cerebral palsy, with higher variability associated with increased cerebral palsy risk.

The study results were promising, according to Marc Patterson, MD, who comoderated the session. “It gives us more confidence in predicting the children at risk and making sure that they’re going to be followed closely to get the interventions they need to help them,” said Dr. Patterson, who is a professor of neurology, pediatrics, and medical genetics at Mayo Medical School in Rochester, Minn.

“By the time a child is 5 or 6, the symptoms are usually very obvious, but you really want to intervene as soon as possible before their brain’s plasticity decreases over time, so the earlier you can intervene in general, the better your results are going to be,” said Dr. Patterson.

There are tools available to diagnose cerebral palsy at an earlier age, including the Prechtl General Movements Assessment (GMA), which can be done up to 5 months of corrected age. It has 97% sensitivity and 89% specificity for cerebral palsy. The Hammersmith Infant Neurological Examination (HINE), which can be used in the same age range, and has 72-91% sensitivity and 100% specificity.

Both of the available tools are resource intensive and require trained clinicians, and may be unavailable in many areas. Despite these tools, early diagnosis of cerebral palsy is still underemployed, according to Arohi Saxena, a third-year medical student at Washington University in St. Louis, who presented the study results.
 

Respiratory rate variability may indicate increased risk

The researchers set out to identify objective metrics that correlated with HINE and GMA scores. They looked at kinematic data from practical assessments carried out by their physical therapists, as well as vital sign instability obtained at NICU discharge, which was based on suggestions that hemodynamic instability may be linked to later risk of cerebral palsy, according to Ms. Saxena.

They analyzed data from 31 infants with a corrected age of 8-25 weeks at a tertiary NICU follow-up clinic. Of these, 18 displayed fidgety movements on their Prechtl assessment, and 13 did not.

They used DeepLabCut software to analyze data from videos of the Prechtl assessment, with a focus on range and variance of hand and foot movements normalized to nose-to-umbilicus distance. They also analyzed pulse and respiratory data from the final 24 hours before NICU discharge.

They found that infants without fidgety movements had decreased hand and foot movement ranges (P = .04). There was no significant difference between the two groups with respect to pulse measurements. However, the respiratory rate range and variance was significantly higher in infants without fidgety movements. “Infants who are at higher risk for developing cerebral palsy had more respiratory instability early on in life,” said Ms. Saxena during her talk.

When they compared values to HINE scores, they found a correlation with less foot movement and a predisposition to develop cerebral palsy, but no correlation with hand movement. A lower HINE sore also correlated to larger respiratory rate range and variance (P < .01 for both).

“Our hypothesis to explain this link is that respiratory rate variability is likely driven by neonatal injury in the brainstem, where the respiratory centers are located. In some infants, this may correlate with more extensive cerebral injury that could predict the development of cerebral palsy,” said Ms. Saxena.

The group plans to increase its sample size as well as to conduct long-term follow-up on the infants to see how many receive formal diagnoses of cerebral palsy.

After her talk, asked by a moderator why motor assessments were not a reliable predictor in their study, Ms. Saxena pointed to the inexperience of assessors at the institution, where Prechtl testing had only recently begun.

“I think a lot of it is to do with the more subjective nature of the motor assessment. We definitely saw kind of a trend where in the earlier data that was collected, right when our institutions started doing these Prechtls, it was even less of a reliable effect. So I think possibly as clinicians continue to get more familiar with this assessment and there’s more like a validated and robust scoring system, maybe we’ll see a stronger correlation,” she said.

Ms. Saxena had no relevant disclosures. Coauthor Boomah Aravamuthan, MD, DPhil, is a consultant for Neurocrine Biosciences and has received royalties from UpToDate and funding from the National Institute of Neurological Disorders and Stroke.

Apixaban offers greater protection than rivaroxaban against ischemic stroke, systemic embolism, and bleeding in patients with both atrial fibrillation (AFib) and valvular heart disease (VHD), a new study finds.

Compared with rivaroxaban, apixaban cut risks nearly in half, suggesting that clinicians should consider these new data when choosing an anticoagulant, reported lead author Ghadeer K. Dawwas, PhD, of the University of Pennsylvania, Philadelphia, and colleagues.

In the new retrospective study involving almost 20,000 patients, Dr. Dawwas and her colleagues “emulated a target trial” using private insurance claims from Optum’s deidentified Clinformatics Data Mart Database. The cohort was narrowed from a screened population of 58,210 patients with concurrent AFib and VHD to 9,947 new apixaban users who could be closely matched with 9,947 new rivaroxaban users. Covariates included provider specialty, type of VHD, demographic characteristics, measures of health care use, baseline use of medications, and baseline comorbidities.

The primary effectiveness outcome was a composite of systemic embolism and ischemic stroke, while the primary safety outcome was a composite of intracranial or gastrointestinal bleeding.

“Although several ongoing trials aim to compare apixaban with warfarin in patients with AFib and VHD, none of these trials will directly compare apixaban and rivaroxaban,” the investigators wrote. Their report is in Annals of Internal Medicine.

Dr. Dawwas and colleagues previously showed that direct oral anticoagulants (DOACs) were safer and more effective than warfarin in the same patient population. Comparing apixaban and rivaroxaban – the two most common DOACs – was the next logical step, Dr. Dawwas said in an interview.
 

Study results

Compared with rivaroxaban, patients who received apixaban had a 43% reduced risk of stroke or embolism (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.40-0.80). Apixaban’s ability to protect against bleeding appeared even more pronounced, with a 49% reduced risk over rivaroxaban (HR, 0.51; 95% CI, 0.41-0.62).

Comparing the two agents on an absolute basis, apixaban reduced risk of embolism or stroke by 0.2% within the first 6 months of treatment initiation, and 1.1% within the first year of initiation. At the same time points, absolute risk reductions for bleeding were 1.2% and 1.9%, respectively.

The investigators noted that their results held consistent in an alternative analysis that considered separate types of VHD.

“Based on the results from our analysis, we showed that apixaban is effective and safe in patients with atrial fibrillation and valvular heart diseases,” Dr. Dawwas said.
 

Head-to-head trial needed to change practice

Christopher M. Bianco, DO, associate professor of medicine at West Virginia University Heart and Vascular Institute, Morgantown, said the findings “add to the growing body of literature,” but “a head-to-head trial would be necessary to make a definitive change to clinical practice.”

Dr. Bianco, who recently conducted a retrospective analysis of apixaban and rivaroxaban that found no difference in safety and efficacy among a different patient population, said these kinds of studies are helpful in generating hypotheses, but they can’t account for all relevant clinical factors.

“There are just so many things that go into the decision-making process of [prescribing] apixaban and rivaroxaban,” he said. “Even though [Dr. Dawwas and colleagues] used propensity matching, you’re never going to be able to sort that out with a retrospective analysis.”

Specifically, Dr. Bianco noted that the findings did not include dose data. This is a key gap, he said, considering how often real-world datasets have shown that providers underdose DOACs for a number of unaccountable reasons, and how frequently patients exhibit poor adherence.

The study also lacked detail concerning the degree of renal dysfunction, which can determine drug eligibility, Dr. Bianco said. Furthermore, attempts to stratify patients based on thrombosis and bleeding risk were likely “insufficient,” he added.

Dr. Bianco also cautioned that the investigators defined valvular heart disease as any valve-related disease of any severity. In contrast, previous studies have generally restricted valvular heart disease to patients with mitral stenosis or prosthetic valves.

“This is definitely not the traditional definition of valvular heart disease, so the title is a little bit misleading in that sense, although they certainly do disclose that in the methods,” Dr. Bianco said.

On a more positive note, he highlighted the size of the patient population, and the real-world data, which included many patients who would be excluded from clinical trials.

More broadly, the study helps drive research forward, Dr. Bianco concluded; namely, by attracting financial support for a more powerful head-to-head trial that drug makers are unlikely to fund due to inherent market risk.

This study was supported by the National Institutes of Health. The investigators disclosed additional relationships with Takeda, Spark, Sanofi, and others. Dr. Bianco disclosed no conflicts of interest.

Apixaban offers greater protection than rivaroxaban against ischemic stroke, systemic embolism, and bleeding in patients with both atrial fibrillation (AFib) and valvular heart disease (VHD), a new study finds.

Compared with rivaroxaban, apixaban cut risks nearly in half, suggesting that clinicians should consider these new data when choosing an anticoagulant, reported lead author Ghadeer K. Dawwas, PhD, of the University of Pennsylvania, Philadelphia, and colleagues.

In the new retrospective study involving almost 20,000 patients, Dr. Dawwas and her colleagues “emulated a target trial” using private insurance claims from Optum’s deidentified Clinformatics Data Mart Database. The cohort was narrowed from a screened population of 58,210 patients with concurrent AFib and VHD to 9,947 new apixaban users who could be closely matched with 9,947 new rivaroxaban users. Covariates included provider specialty, type of VHD, demographic characteristics, measures of health care use, baseline use of medications, and baseline comorbidities.

The primary effectiveness outcome was a composite of systemic embolism and ischemic stroke, while the primary safety outcome was a composite of intracranial or gastrointestinal bleeding.

“Although several ongoing trials aim to compare apixaban with warfarin in patients with AFib and VHD, none of these trials will directly compare apixaban and rivaroxaban,” the investigators wrote. Their report is in Annals of Internal Medicine.

Dr. Dawwas and colleagues previously showed that direct oral anticoagulants (DOACs) were safer and more effective than warfarin in the same patient population. Comparing apixaban and rivaroxaban – the two most common DOACs – was the next logical step, Dr. Dawwas said in an interview.
 

Study results

Compared with rivaroxaban, patients who received apixaban had a 43% reduced risk of stroke or embolism (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.40-0.80). Apixaban’s ability to protect against bleeding appeared even more pronounced, with a 49% reduced risk over rivaroxaban (HR, 0.51; 95% CI, 0.41-0.62).

Comparing the two agents on an absolute basis, apixaban reduced risk of embolism or stroke by 0.2% within the first 6 months of treatment initiation, and 1.1% within the first year of initiation. At the same time points, absolute risk reductions for bleeding were 1.2% and 1.9%, respectively.

The investigators noted that their results held consistent in an alternative analysis that considered separate types of VHD.

“Based on the results from our analysis, we showed that apixaban is effective and safe in patients with atrial fibrillation and valvular heart diseases,” Dr. Dawwas said.
 

Head-to-head trial needed to change practice

Christopher M. Bianco, DO, associate professor of medicine at West Virginia University Heart and Vascular Institute, Morgantown, said the findings “add to the growing body of literature,” but “a head-to-head trial would be necessary to make a definitive change to clinical practice.”

Dr. Bianco, who recently conducted a retrospective analysis of apixaban and rivaroxaban that found no difference in safety and efficacy among a different patient population, said these kinds of studies are helpful in generating hypotheses, but they can’t account for all relevant clinical factors.

“There are just so many things that go into the decision-making process of [prescribing] apixaban and rivaroxaban,” he said. “Even though [Dr. Dawwas and colleagues] used propensity matching, you’re never going to be able to sort that out with a retrospective analysis.”

Specifically, Dr. Bianco noted that the findings did not include dose data. This is a key gap, he said, considering how often real-world datasets have shown that providers underdose DOACs for a number of unaccountable reasons, and how frequently patients exhibit poor adherence.

The study also lacked detail concerning the degree of renal dysfunction, which can determine drug eligibility, Dr. Bianco said. Furthermore, attempts to stratify patients based on thrombosis and bleeding risk were likely “insufficient,” he added.

Dr. Bianco also cautioned that the investigators defined valvular heart disease as any valve-related disease of any severity. In contrast, previous studies have generally restricted valvular heart disease to patients with mitral stenosis or prosthetic valves.

“This is definitely not the traditional definition of valvular heart disease, so the title is a little bit misleading in that sense, although they certainly do disclose that in the methods,” Dr. Bianco said.

On a more positive note, he highlighted the size of the patient population, and the real-world data, which included many patients who would be excluded from clinical trials.

More broadly, the study helps drive research forward, Dr. Bianco concluded; namely, by attracting financial support for a more powerful head-to-head trial that drug makers are unlikely to fund due to inherent market risk.

This study was supported by the National Institutes of Health. The investigators disclosed additional relationships with Takeda, Spark, Sanofi, and others. Dr. Bianco disclosed no conflicts of interest.

Apixaban offers greater protection than rivaroxaban against ischemic stroke, systemic embolism, and bleeding in patients with both atrial fibrillation (AFib) and valvular heart disease (VHD), a new study finds.

Compared with rivaroxaban, apixaban cut risks nearly in half, suggesting that clinicians should consider these new data when choosing an anticoagulant, reported lead author Ghadeer K. Dawwas, PhD, of the University of Pennsylvania, Philadelphia, and colleagues.

In the new retrospective study involving almost 20,000 patients, Dr. Dawwas and her colleagues “emulated a target trial” using private insurance claims from Optum’s deidentified Clinformatics Data Mart Database. The cohort was narrowed from a screened population of 58,210 patients with concurrent AFib and VHD to 9,947 new apixaban users who could be closely matched with 9,947 new rivaroxaban users. Covariates included provider specialty, type of VHD, demographic characteristics, measures of health care use, baseline use of medications, and baseline comorbidities.

The primary effectiveness outcome was a composite of systemic embolism and ischemic stroke, while the primary safety outcome was a composite of intracranial or gastrointestinal bleeding.

“Although several ongoing trials aim to compare apixaban with warfarin in patients with AFib and VHD, none of these trials will directly compare apixaban and rivaroxaban,” the investigators wrote. Their report is in Annals of Internal Medicine.

Dr. Dawwas and colleagues previously showed that direct oral anticoagulants (DOACs) were safer and more effective than warfarin in the same patient population. Comparing apixaban and rivaroxaban – the two most common DOACs – was the next logical step, Dr. Dawwas said in an interview.
 

Study results

Compared with rivaroxaban, patients who received apixaban had a 43% reduced risk of stroke or embolism (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.40-0.80). Apixaban’s ability to protect against bleeding appeared even more pronounced, with a 49% reduced risk over rivaroxaban (HR, 0.51; 95% CI, 0.41-0.62).

Comparing the two agents on an absolute basis, apixaban reduced risk of embolism or stroke by 0.2% within the first 6 months of treatment initiation, and 1.1% within the first year of initiation. At the same time points, absolute risk reductions for bleeding were 1.2% and 1.9%, respectively.

The investigators noted that their results held consistent in an alternative analysis that considered separate types of VHD.

“Based on the results from our analysis, we showed that apixaban is effective and safe in patients with atrial fibrillation and valvular heart diseases,” Dr. Dawwas said.
 

Head-to-head trial needed to change practice

Christopher M. Bianco, DO, associate professor of medicine at West Virginia University Heart and Vascular Institute, Morgantown, said the findings “add to the growing body of literature,” but “a head-to-head trial would be necessary to make a definitive change to clinical practice.”

Dr. Bianco, who recently conducted a retrospective analysis of apixaban and rivaroxaban that found no difference in safety and efficacy among a different patient population, said these kinds of studies are helpful in generating hypotheses, but they can’t account for all relevant clinical factors.

“There are just so many things that go into the decision-making process of [prescribing] apixaban and rivaroxaban,” he said. “Even though [Dr. Dawwas and colleagues] used propensity matching, you’re never going to be able to sort that out with a retrospective analysis.”

Specifically, Dr. Bianco noted that the findings did not include dose data. This is a key gap, he said, considering how often real-world datasets have shown that providers underdose DOACs for a number of unaccountable reasons, and how frequently patients exhibit poor adherence.

The study also lacked detail concerning the degree of renal dysfunction, which can determine drug eligibility, Dr. Bianco said. Furthermore, attempts to stratify patients based on thrombosis and bleeding risk were likely “insufficient,” he added.

Dr. Bianco also cautioned that the investigators defined valvular heart disease as any valve-related disease of any severity. In contrast, previous studies have generally restricted valvular heart disease to patients with mitral stenosis or prosthetic valves.

“This is definitely not the traditional definition of valvular heart disease, so the title is a little bit misleading in that sense, although they certainly do disclose that in the methods,” Dr. Bianco said.

On a more positive note, he highlighted the size of the patient population, and the real-world data, which included many patients who would be excluded from clinical trials.

More broadly, the study helps drive research forward, Dr. Bianco concluded; namely, by attracting financial support for a more powerful head-to-head trial that drug makers are unlikely to fund due to inherent market risk.

This study was supported by the National Institutes of Health. The investigators disclosed additional relationships with Takeda, Spark, Sanofi, and others. Dr. Bianco disclosed no conflicts of interest.

Martha Welch, MD, spent the better part of three decades in private practice treating children with emotional, behavioral, and developmental disorders before accepting a job on the faculty of Columbia University, New York, in 1997.

She took the position, she said, with a mission: to find evidence to support what she’d observed in her practice – that parents could, by making stronger emotional connections, change the trajectory of development for preemie infants.

With that understanding, Dr. Welch created Family Nurture Intervention (FNI), which has been shown to improve the development of premature babies.

“We saw that no matter what happened to the baby, no matter how avoidant the baby might be, we’re able to overcome this with emotional expression,” Dr. Welch said.

Over the course of the intervention, families work with a specialist who helps bring mother and baby together – both physically and emotionally – until both are calm, which can initially take several hours and over time, minutes.

FNI appears to help families – especially mothers – re-establish an emotional connection often interrupted by their babies’ stressful and uncertain stay in a neonatal intensive care unit (NICU). In turn, both the infant and maternal nervous systems become better regulated, according to researchers.
 

Early challenges

Babies born preterm can face a range of short-term and long-term challenges, such as breathing problems due to an underdeveloped respiratory system, an increased risk of infection from an underdeveloped immune system, and learning difficulties, according to the Mayo Clinic.

Many aspects of FNI are not new: The neonatal intensive care unit has long incorporated activities such as scent cloth exchanges, talking to the baby, and skin-to-skin contact. But the approach Dr. Welch and her colleagues advocate emphasizes building a bond between the mother and the infant.

Mounting evidence shows that FNI can improve a wide range of outcomes for premature babies. In a 2021 study, for example, Dr. Welch’s group showed that FNI was associated with lower heart rates among preemies in the NICU. A 2016 study linked the intervention to reduced depression and anxiety symptoms in mothers of preterm infants. And a 2015 randomized controlled trial showed FNI improved development and behavioral outcomes in infants up to 18 months.

A new study published in Science Translational Medicine showed that the intervention led to a greater likelihood that babies had improved cognitive development later on, narrowing the developmental gap between healthy, full-term babies.

Dr. Welch and her colleagues tested to see if FNI measurably changed brain development in preterm infants who were born at 26-34 weeks of a pregnancy.

“We were blown away by the strength of the effect,” said Pauliina Yrjölä, MSc, a doctoral student and medical physicist at the University of Helsinki, who led the study on which Dr. Welch is a co-author.

Mothers in the intervention group made as much eye contact with the infants as possible and spoke with infants about their feelings.

Intimate sensory interactions between mothers and infants physically altered infants’ cortical networks in the brain and was later correlated to improved neurocognitive performance, according to the researchers.

“I was convinced there were physiological changes; I knew that from my clinical work,” Dr. Welch said. “I wanted to show it in this concrete, scientific way.”
 

Preterm babies face many hurdles

“If we can prevent problems in brain network organization to the extent that’s shown in this study and improve their outcomes, this is worth millions of dollars in terms of cost to society, schooling, health care, especially education, and families,” said Ruth Grunau, PhD, a professor in the Division of Neonatology in the department of pediatrics at the University of British Columbia, Vancouver, who was not involved with the most recent study but has worked with Dr. Welch previously.

Babies born too early, especially before 32 weeks, have higher rates of death and disability, according to the Centers for Disease Control and Prevention.

And preterm babies overall may experience breathing problems and feeding difficulties almost immediately following birth. They may also experience long-term problems such as developmental delays, vision problems, and hearing problems.

Dr. Grunau said that while many other programs and interventions have been used in the neonatal intensive care unit to help infants and mothers, the results from FNI stand out.

Ms. Yrjölä said she was surprised by the strength of the correlation as the infants continued to develop. The infants receiving the Family Nurture Intervention showed brain development close to the control group, which was infants born at full-term.

“Emotional connection is a state, not a trait – and a state can be changed,” said Dr. Welch. “And in this case, it can be changed by the parent through emotional expression.”
 

Steps clinicians can take

Dr. Welch said the approach is highly scalable, and two NICUs that participated in the FNI studies have implemented the program as standard care.

The approach is also gaining interest outside of the clinical setting, as preschool partners have expressed interest in implementing some of the methods to promote development.

Parents, family members, and teachers can use many of the FNI techniques – such as eye contact and emotional expression – to continue to develop and strengthen connection.

For clinicians who want to implement parts of the intervention on their own, Dr. Welch said doctors can observe if the baby looks at or turns toward their mother.

Clinicians can encourage mothers to express deep, emotional feelings toward the infant. Dr. Welch stressed that feelings don’t have to be positive, as many mothers with babies in the NICU have a hard time expressing positive emotions. Crying or talking about the difficulties of their childbirth experience count as expressing emotion. The important part is that the baby hears emotion, of any kind, in the mother’s voice, Dr. Welch said.

As the connection develops, it will eventually take less time for the mother and the baby to form a bond, and eventually the pair will become autonomically regulated.

“This is what gives us hope,” she said. “We affect each other in our autonomic nervous systems. It’s why this treatment works.”

The study was funded by the Finnish Pediatric Foundation, The Finnish Academy, the Juselius Foundation, Aivosäätiö, Neuroscience Center at University of Helsinki and Helsinki University Central Hospital, gifts from the Einhorn Family Charitable Trust, the Fleur Fairman Family, M. D. Stephenson, and The National Health and Medical Research Council of Australia. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Martha Welch, MD, spent the better part of three decades in private practice treating children with emotional, behavioral, and developmental disorders before accepting a job on the faculty of Columbia University, New York, in 1997.

She took the position, she said, with a mission: to find evidence to support what she’d observed in her practice – that parents could, by making stronger emotional connections, change the trajectory of development for preemie infants.

With that understanding, Dr. Welch created Family Nurture Intervention (FNI), which has been shown to improve the development of premature babies.

“We saw that no matter what happened to the baby, no matter how avoidant the baby might be, we’re able to overcome this with emotional expression,” Dr. Welch said.

Over the course of the intervention, families work with a specialist who helps bring mother and baby together – both physically and emotionally – until both are calm, which can initially take several hours and over time, minutes.

FNI appears to help families – especially mothers – re-establish an emotional connection often interrupted by their babies’ stressful and uncertain stay in a neonatal intensive care unit (NICU). In turn, both the infant and maternal nervous systems become better regulated, according to researchers.
 

Early challenges

Babies born preterm can face a range of short-term and long-term challenges, such as breathing problems due to an underdeveloped respiratory system, an increased risk of infection from an underdeveloped immune system, and learning difficulties, according to the Mayo Clinic.

Many aspects of FNI are not new: The neonatal intensive care unit has long incorporated activities such as scent cloth exchanges, talking to the baby, and skin-to-skin contact. But the approach Dr. Welch and her colleagues advocate emphasizes building a bond between the mother and the infant.

Mounting evidence shows that FNI can improve a wide range of outcomes for premature babies. In a 2021 study, for example, Dr. Welch’s group showed that FNI was associated with lower heart rates among preemies in the NICU. A 2016 study linked the intervention to reduced depression and anxiety symptoms in mothers of preterm infants. And a 2015 randomized controlled trial showed FNI improved development and behavioral outcomes in infants up to 18 months.

A new study published in Science Translational Medicine showed that the intervention led to a greater likelihood that babies had improved cognitive development later on, narrowing the developmental gap between healthy, full-term babies.

Dr. Welch and her colleagues tested to see if FNI measurably changed brain development in preterm infants who were born at 26-34 weeks of a pregnancy.

“We were blown away by the strength of the effect,” said Pauliina Yrjölä, MSc, a doctoral student and medical physicist at the University of Helsinki, who led the study on which Dr. Welch is a co-author.

Mothers in the intervention group made as much eye contact with the infants as possible and spoke with infants about their feelings.

Intimate sensory interactions between mothers and infants physically altered infants’ cortical networks in the brain and was later correlated to improved neurocognitive performance, according to the researchers.

“I was convinced there were physiological changes; I knew that from my clinical work,” Dr. Welch said. “I wanted to show it in this concrete, scientific way.”
 

Preterm babies face many hurdles

“If we can prevent problems in brain network organization to the extent that’s shown in this study and improve their outcomes, this is worth millions of dollars in terms of cost to society, schooling, health care, especially education, and families,” said Ruth Grunau, PhD, a professor in the Division of Neonatology in the department of pediatrics at the University of British Columbia, Vancouver, who was not involved with the most recent study but has worked with Dr. Welch previously.

Babies born too early, especially before 32 weeks, have higher rates of death and disability, according to the Centers for Disease Control and Prevention.

And preterm babies overall may experience breathing problems and feeding difficulties almost immediately following birth. They may also experience long-term problems such as developmental delays, vision problems, and hearing problems.

Dr. Grunau said that while many other programs and interventions have been used in the neonatal intensive care unit to help infants and mothers, the results from FNI stand out.

Ms. Yrjölä said she was surprised by the strength of the correlation as the infants continued to develop. The infants receiving the Family Nurture Intervention showed brain development close to the control group, which was infants born at full-term.

“Emotional connection is a state, not a trait – and a state can be changed,” said Dr. Welch. “And in this case, it can be changed by the parent through emotional expression.”
 

Steps clinicians can take

Dr. Welch said the approach is highly scalable, and two NICUs that participated in the FNI studies have implemented the program as standard care.

The approach is also gaining interest outside of the clinical setting, as preschool partners have expressed interest in implementing some of the methods to promote development.

Parents, family members, and teachers can use many of the FNI techniques – such as eye contact and emotional expression – to continue to develop and strengthen connection.

For clinicians who want to implement parts of the intervention on their own, Dr. Welch said doctors can observe if the baby looks at or turns toward their mother.

Clinicians can encourage mothers to express deep, emotional feelings toward the infant. Dr. Welch stressed that feelings don’t have to be positive, as many mothers with babies in the NICU have a hard time expressing positive emotions. Crying or talking about the difficulties of their childbirth experience count as expressing emotion. The important part is that the baby hears emotion, of any kind, in the mother’s voice, Dr. Welch said.

As the connection develops, it will eventually take less time for the mother and the baby to form a bond, and eventually the pair will become autonomically regulated.

“This is what gives us hope,” she said. “We affect each other in our autonomic nervous systems. It’s why this treatment works.”

The study was funded by the Finnish Pediatric Foundation, The Finnish Academy, the Juselius Foundation, Aivosäätiö, Neuroscience Center at University of Helsinki and Helsinki University Central Hospital, gifts from the Einhorn Family Charitable Trust, the Fleur Fairman Family, M. D. Stephenson, and The National Health and Medical Research Council of Australia. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Martha Welch, MD, spent the better part of three decades in private practice treating children with emotional, behavioral, and developmental disorders before accepting a job on the faculty of Columbia University, New York, in 1997.

She took the position, she said, with a mission: to find evidence to support what she’d observed in her practice – that parents could, by making stronger emotional connections, change the trajectory of development for preemie infants.

With that understanding, Dr. Welch created Family Nurture Intervention (FNI), which has been shown to improve the development of premature babies.

“We saw that no matter what happened to the baby, no matter how avoidant the baby might be, we’re able to overcome this with emotional expression,” Dr. Welch said.

Over the course of the intervention, families work with a specialist who helps bring mother and baby together – both physically and emotionally – until both are calm, which can initially take several hours and over time, minutes.

FNI appears to help families – especially mothers – re-establish an emotional connection often interrupted by their babies’ stressful and uncertain stay in a neonatal intensive care unit (NICU). In turn, both the infant and maternal nervous systems become better regulated, according to researchers.
 

Early challenges

Babies born preterm can face a range of short-term and long-term challenges, such as breathing problems due to an underdeveloped respiratory system, an increased risk of infection from an underdeveloped immune system, and learning difficulties, according to the Mayo Clinic.

Many aspects of FNI are not new: The neonatal intensive care unit has long incorporated activities such as scent cloth exchanges, talking to the baby, and skin-to-skin contact. But the approach Dr. Welch and her colleagues advocate emphasizes building a bond between the mother and the infant.

Mounting evidence shows that FNI can improve a wide range of outcomes for premature babies. In a 2021 study, for example, Dr. Welch’s group showed that FNI was associated with lower heart rates among preemies in the NICU. A 2016 study linked the intervention to reduced depression and anxiety symptoms in mothers of preterm infants. And a 2015 randomized controlled trial showed FNI improved development and behavioral outcomes in infants up to 18 months.

A new study published in Science Translational Medicine showed that the intervention led to a greater likelihood that babies had improved cognitive development later on, narrowing the developmental gap between healthy, full-term babies.

Dr. Welch and her colleagues tested to see if FNI measurably changed brain development in preterm infants who were born at 26-34 weeks of a pregnancy.

“We were blown away by the strength of the effect,” said Pauliina Yrjölä, MSc, a doctoral student and medical physicist at the University of Helsinki, who led the study on which Dr. Welch is a co-author.

Mothers in the intervention group made as much eye contact with the infants as possible and spoke with infants about their feelings.

Intimate sensory interactions between mothers and infants physically altered infants’ cortical networks in the brain and was later correlated to improved neurocognitive performance, according to the researchers.

“I was convinced there were physiological changes; I knew that from my clinical work,” Dr. Welch said. “I wanted to show it in this concrete, scientific way.”
 

Preterm babies face many hurdles

“If we can prevent problems in brain network organization to the extent that’s shown in this study and improve their outcomes, this is worth millions of dollars in terms of cost to society, schooling, health care, especially education, and families,” said Ruth Grunau, PhD, a professor in the Division of Neonatology in the department of pediatrics at the University of British Columbia, Vancouver, who was not involved with the most recent study but has worked with Dr. Welch previously.

Babies born too early, especially before 32 weeks, have higher rates of death and disability, according to the Centers for Disease Control and Prevention.

And preterm babies overall may experience breathing problems and feeding difficulties almost immediately following birth. They may also experience long-term problems such as developmental delays, vision problems, and hearing problems.

Dr. Grunau said that while many other programs and interventions have been used in the neonatal intensive care unit to help infants and mothers, the results from FNI stand out.

Ms. Yrjölä said she was surprised by the strength of the correlation as the infants continued to develop. The infants receiving the Family Nurture Intervention showed brain development close to the control group, which was infants born at full-term.

“Emotional connection is a state, not a trait – and a state can be changed,” said Dr. Welch. “And in this case, it can be changed by the parent through emotional expression.”
 

Steps clinicians can take

Dr. Welch said the approach is highly scalable, and two NICUs that participated in the FNI studies have implemented the program as standard care.

The approach is also gaining interest outside of the clinical setting, as preschool partners have expressed interest in implementing some of the methods to promote development.

Parents, family members, and teachers can use many of the FNI techniques – such as eye contact and emotional expression – to continue to develop and strengthen connection.

For clinicians who want to implement parts of the intervention on their own, Dr. Welch said doctors can observe if the baby looks at or turns toward their mother.

Clinicians can encourage mothers to express deep, emotional feelings toward the infant. Dr. Welch stressed that feelings don’t have to be positive, as many mothers with babies in the NICU have a hard time expressing positive emotions. Crying or talking about the difficulties of their childbirth experience count as expressing emotion. The important part is that the baby hears emotion, of any kind, in the mother’s voice, Dr. Welch said.

As the connection develops, it will eventually take less time for the mother and the baby to form a bond, and eventually the pair will become autonomically regulated.

“This is what gives us hope,” she said. “We affect each other in our autonomic nervous systems. It’s why this treatment works.”

The study was funded by the Finnish Pediatric Foundation, The Finnish Academy, the Juselius Foundation, Aivosäätiö, Neuroscience Center at University of Helsinki and Helsinki University Central Hospital, gifts from the Einhorn Family Charitable Trust, the Fleur Fairman Family, M. D. Stephenson, and The National Health and Medical Research Council of Australia. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Contrary to some prior studies, new research suggests that a healthy diet, including the Mediterranean diet, does not reduce dementia risk.

After adjusting for relevant demographic and other lifestyle measures, there was no association between adherence to healthy dietary advice or the Mediterranean diet on the future risk of dementia or amyloid-beta (Abeta) accumulation.

OksanaKiian/Getty Images

“While our study does not rule out a possible association between diet and dementia, we did not find a link in our study, which had a long follow-up period, included younger participants than some other studies and did not require people to remember what foods they had eaten regularly years before,” study investigator Isabelle Glans, MD, of Lund (Sweden) University, said in a news release.

The findings were published online in Neurology.
 

No risk reduction

Several studies have investigated how dietary habits affect dementia risk, with inconsistent results.

The new findings are based on 28,025 adults (61% women; mean age, 58 years at baseline) who were free of dementia at baseline and were followed over a 20-year period as part of the Swedish Malmö Diet and Cancer Study. Dietary habits were assessed with a 7-day food diary, detailed food frequency questionnaire, and in-person interview.

During follow-up, 1,943 individuals (6.9%) developed dementia.

Compared with those who did not develop dementia, those who did develop dementia during follow-up were older and had a lower level of education and more cardiovascular risk factors and comorbidities at baseline.

Individuals who adhered to conventional healthy dietary recommendations did not have a lower risk of developing all-cause dementia (hazard ratio comparing worst with best adherence, 0.93; 95% confidence interval, 0.81-1.08), Alzheimer’s disease (HR, 1.03; 95% CI, 0.85-1.23) or vascular dementia (HR, 0.93; 95% CI, 0.69-1.26).

Adherence to the modified Mediterranean diet also did not appear to lower the risk of all-cause dementia (HR, 0.93; 95% CI, 0.75-1.15), Alzheimer’s disease (HR, 0.90; 95% CI, 0.68-1.19), or vascular dementia (HR, 1.00; 95% CI, 0.65-1.55).

There was also no significant association between diet and Alzheimer’s disease–related pathology, as measured by cerebrospinal fluid analysis of Abeta42 in a subgroup of 738 participants. Various sensitivity analyses yielded similar results.
 

Diet still matters

The authors of an accompanying editorial noted that diet as a “singular factor may not have a strong enough effect on cognition, but is more likely to be considered as one factor embedded with various others, the sum of which may influence the course of cognitive function (diet, regular exercise, vascular risk factor control, avoiding cigarette smoking, drinking alcohol in moderation, etc).

“Diet should not be forgotten and it still matters” but should be regarded as “one part of a multidomain intervention with respect to cognitive performance,” wrote Nils Peters, MD, with the University of Basel (Switzerland), and Benedetta Nacmias, PhD, with the University of Florence (Italy)).

“Key questions that remain include how to provide evidence for promoting the implications of dietary habits on cognition? Overall, dietary strategies will most likely be implicated either in order to reduce the increasing number of older subjects with dementia, or to extend healthy life expectancy, or both,” Dr. Peters and Dr. Nacmias said.

The study had no commercial funding. Dr. Glans, Dr. Peters, and Dr. Nacmias disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Contrary to some prior studies, new research suggests that a healthy diet, including the Mediterranean diet, does not reduce dementia risk.

After adjusting for relevant demographic and other lifestyle measures, there was no association between adherence to healthy dietary advice or the Mediterranean diet on the future risk of dementia or amyloid-beta (Abeta) accumulation.

OksanaKiian/Getty Images

“While our study does not rule out a possible association between diet and dementia, we did not find a link in our study, which had a long follow-up period, included younger participants than some other studies and did not require people to remember what foods they had eaten regularly years before,” study investigator Isabelle Glans, MD, of Lund (Sweden) University, said in a news release.

The findings were published online in Neurology.
 

No risk reduction

Several studies have investigated how dietary habits affect dementia risk, with inconsistent results.

The new findings are based on 28,025 adults (61% women; mean age, 58 years at baseline) who were free of dementia at baseline and were followed over a 20-year period as part of the Swedish Malmö Diet and Cancer Study. Dietary habits were assessed with a 7-day food diary, detailed food frequency questionnaire, and in-person interview.

During follow-up, 1,943 individuals (6.9%) developed dementia.

Compared with those who did not develop dementia, those who did develop dementia during follow-up were older and had a lower level of education and more cardiovascular risk factors and comorbidities at baseline.

Individuals who adhered to conventional healthy dietary recommendations did not have a lower risk of developing all-cause dementia (hazard ratio comparing worst with best adherence, 0.93; 95% confidence interval, 0.81-1.08), Alzheimer’s disease (HR, 1.03; 95% CI, 0.85-1.23) or vascular dementia (HR, 0.93; 95% CI, 0.69-1.26).

Adherence to the modified Mediterranean diet also did not appear to lower the risk of all-cause dementia (HR, 0.93; 95% CI, 0.75-1.15), Alzheimer’s disease (HR, 0.90; 95% CI, 0.68-1.19), or vascular dementia (HR, 1.00; 95% CI, 0.65-1.55).

There was also no significant association between diet and Alzheimer’s disease–related pathology, as measured by cerebrospinal fluid analysis of Abeta42 in a subgroup of 738 participants. Various sensitivity analyses yielded similar results.
 

Diet still matters

The authors of an accompanying editorial noted that diet as a “singular factor may not have a strong enough effect on cognition, but is more likely to be considered as one factor embedded with various others, the sum of which may influence the course of cognitive function (diet, regular exercise, vascular risk factor control, avoiding cigarette smoking, drinking alcohol in moderation, etc).

“Diet should not be forgotten and it still matters” but should be regarded as “one part of a multidomain intervention with respect to cognitive performance,” wrote Nils Peters, MD, with the University of Basel (Switzerland), and Benedetta Nacmias, PhD, with the University of Florence (Italy)).

“Key questions that remain include how to provide evidence for promoting the implications of dietary habits on cognition? Overall, dietary strategies will most likely be implicated either in order to reduce the increasing number of older subjects with dementia, or to extend healthy life expectancy, or both,” Dr. Peters and Dr. Nacmias said.

The study had no commercial funding. Dr. Glans, Dr. Peters, and Dr. Nacmias disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Contrary to some prior studies, new research suggests that a healthy diet, including the Mediterranean diet, does not reduce dementia risk.

After adjusting for relevant demographic and other lifestyle measures, there was no association between adherence to healthy dietary advice or the Mediterranean diet on the future risk of dementia or amyloid-beta (Abeta) accumulation.

OksanaKiian/Getty Images

“While our study does not rule out a possible association between diet and dementia, we did not find a link in our study, which had a long follow-up period, included younger participants than some other studies and did not require people to remember what foods they had eaten regularly years before,” study investigator Isabelle Glans, MD, of Lund (Sweden) University, said in a news release.

The findings were published online in Neurology.
 

No risk reduction

Several studies have investigated how dietary habits affect dementia risk, with inconsistent results.

The new findings are based on 28,025 adults (61% women; mean age, 58 years at baseline) who were free of dementia at baseline and were followed over a 20-year period as part of the Swedish Malmö Diet and Cancer Study. Dietary habits were assessed with a 7-day food diary, detailed food frequency questionnaire, and in-person interview.

During follow-up, 1,943 individuals (6.9%) developed dementia.

Compared with those who did not develop dementia, those who did develop dementia during follow-up were older and had a lower level of education and more cardiovascular risk factors and comorbidities at baseline.

Individuals who adhered to conventional healthy dietary recommendations did not have a lower risk of developing all-cause dementia (hazard ratio comparing worst with best adherence, 0.93; 95% confidence interval, 0.81-1.08), Alzheimer’s disease (HR, 1.03; 95% CI, 0.85-1.23) or vascular dementia (HR, 0.93; 95% CI, 0.69-1.26).

Adherence to the modified Mediterranean diet also did not appear to lower the risk of all-cause dementia (HR, 0.93; 95% CI, 0.75-1.15), Alzheimer’s disease (HR, 0.90; 95% CI, 0.68-1.19), or vascular dementia (HR, 1.00; 95% CI, 0.65-1.55).

There was also no significant association between diet and Alzheimer’s disease–related pathology, as measured by cerebrospinal fluid analysis of Abeta42 in a subgroup of 738 participants. Various sensitivity analyses yielded similar results.
 

Diet still matters

The authors of an accompanying editorial noted that diet as a “singular factor may not have a strong enough effect on cognition, but is more likely to be considered as one factor embedded with various others, the sum of which may influence the course of cognitive function (diet, regular exercise, vascular risk factor control, avoiding cigarette smoking, drinking alcohol in moderation, etc).

“Diet should not be forgotten and it still matters” but should be regarded as “one part of a multidomain intervention with respect to cognitive performance,” wrote Nils Peters, MD, with the University of Basel (Switzerland), and Benedetta Nacmias, PhD, with the University of Florence (Italy)).

“Key questions that remain include how to provide evidence for promoting the implications of dietary habits on cognition? Overall, dietary strategies will most likely be implicated either in order to reduce the increasing number of older subjects with dementia, or to extend healthy life expectancy, or both,” Dr. Peters and Dr. Nacmias said.

The study had no commercial funding. Dr. Glans, Dr. Peters, and Dr. Nacmias disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

CINCINNATI – Dystonia is a frequent complication seen in cerebral palsy, but it often goes undiagnosed. Using a unique video analysis, researchers have identified some movement features that have the potential to simplify diagnosis.

“[We have] previously demonstrated that by the age of 5 years, only 30% of children seen in a clinical setting have had their predominant motor phenotype identified, including dystonia. This helps demonstrate a broad diagnostic gap and the need for novel solutions,” said Laura Gilbert, DO, during her presentation of the results at the 2022 annual meeting of the Child Neurology Society.

Diagnosis of dystonia is challenging because of its clinical variability, and diagnostic tools often require a trained physician, which limits access to diagnoses. Expert clinician consensus therefore remains the gold standard for diagnosis of dystonia.

Another clinical need is that specific features of dystonia have not been well described in the upper extremities, and the research suggests there could be differences in brain injuries contributing to dystonia in the two domains.

The researchers set out to discover expert-identified features of patient videos that could be used to allow nonexperts to make a diagnosis of dystonia.

The researchers analyzed 26 videos with upper extremity exam maneuvers performed on children with periventricular leukomalacia at St. Louis Children’s Hospital Cerebral Palsy Center from 2005 to 2018. Among the study cohort, 65% of patients were male, 77% were White, and 11% were Black; 24% of patients were Gross Motor Function Classification Scale I, 24% were GMFCS II, 24% were GMFCS III, 16% were GMFCS IV, and 12% were GMFCS V. A total of 12% of patients were older than 20, 11% were aged 15-20, 38% were aged 10-15, 31% were aged 5-10, and 8% were age 5 or younger.
 

Video clues aid diagnosis

Three pediatric movement disorder specialists independently reviewed each video and assessed severity of dystonia. They then met over Zoom to reach a diagnostic consensus for each case.

The research team performed a content analysis of the experts’ discussions and identified specific statement fragments. The frequency of these fragments was then linked to severity of dystonia.

A total of 45% of the statement fragments referenced movement codes, which in turn comprised five content areas: 33% referenced a body part, 24% focused on laterality, 22% described movement features, 18% an action, and 3% described exam maneuvers. Examples included shoulder as a body part, flexion as an action descriptor, brisk as a movement feature, unilateral, and finger-nose-finger for exam maneuver.

With increasing dystonia severity, the shoulder was more often cited and hand was cited less often. Mirror movements, defined as involuntary, contralateral movements that are similar to the voluntary action, occurred more often in patients with no dystonia or only mild dystonia. Variability of movement over time, which is a distinguishing feature found in lower extremities, was not significantly associated with dystonia severity.

Within the category of exam maneuver, hand opening and closing was the most commonly cited, and it was cited more frequently among individuals with mild dystonia (70% vs. about 10% for both no dystonia and moderate to severe dystonia; P < .005).

“So how can we adopt this clinically? First, we can add in a very brief exam maneuver of hand opening and closing that can help assess for mild dystonia. Shoulder involvement may suggest more severe dystonia, and we must recognize the dystonia features seem to differ by body region and the triggering task. Overall, to help improve dystonia diagnosis, we must continue to work towards understanding these salient features to fully grasp the breadth of dystonia manifestations in people with [cerebral palsy],” said Dr. Gilbert, who is a pediatric movements disorder fellow at Washington University in St. Louis.
 

Key features help determine dystonia severity

The study is particularly interesting for its different findings in upper extremities versus lower extremities, according to Keith Coffman, MD, who comoderated the session where the study was presented. “That same group showed that there are very clear differences in lower-extremity function, but when they looked at upper extremity, there really weren’t robust differences. What it may show is that the features of cerebral palsy regarding dystonia may be very dependent on what type of injury you have to your brain. Because when you think about where the motor fibers that provide leg function, they live along the medial walls of the brain right along the midline, whereas the representation of the hand and arm are more out on the lateral side of the brain. So it may be that those regional anatomy differences and where the injury occurred could be at the baseline of why they had such differences in motor function,” said Dr. Coffman, who is a professor of pediatrics at University of Missouri–Kansas City and director of the movement disorders program at Children’s Mercy Hospital, also in Kansas City, Mo.

He suggested that the researchers might also do kinematic analysis of the videos to make predictions using quantitative differences in movement.

The research has the potential to improve dystonia diagnosis, according to comoderator Marc Patterson, MD, professor of neurology, pediatrics, and medical genetics at Mayo Clinic in Rochester, Minn. “I think they really pointed to some key features that can help clinicians distinguish [dystonia severity]. Something like the speed of opening and closing the hands [is a] fairly simple thing. That was to me the chief value of that study,” Dr. Patterson said.

Dr. Gilbert reported no relevant disclosures.

CINCINNATI – Dystonia is a frequent complication seen in cerebral palsy, but it often goes undiagnosed. Using a unique video analysis, researchers have identified some movement features that have the potential to simplify diagnosis.

“[We have] previously demonstrated that by the age of 5 years, only 30% of children seen in a clinical setting have had their predominant motor phenotype identified, including dystonia. This helps demonstrate a broad diagnostic gap and the need for novel solutions,” said Laura Gilbert, DO, during her presentation of the results at the 2022 annual meeting of the Child Neurology Society.

Diagnosis of dystonia is challenging because of its clinical variability, and diagnostic tools often require a trained physician, which limits access to diagnoses. Expert clinician consensus therefore remains the gold standard for diagnosis of dystonia.

Another clinical need is that specific features of dystonia have not been well described in the upper extremities, and the research suggests there could be differences in brain injuries contributing to dystonia in the two domains.

The researchers set out to discover expert-identified features of patient videos that could be used to allow nonexperts to make a diagnosis of dystonia.

The researchers analyzed 26 videos with upper extremity exam maneuvers performed on children with periventricular leukomalacia at St. Louis Children’s Hospital Cerebral Palsy Center from 2005 to 2018. Among the study cohort, 65% of patients were male, 77% were White, and 11% were Black; 24% of patients were Gross Motor Function Classification Scale I, 24% were GMFCS II, 24% were GMFCS III, 16% were GMFCS IV, and 12% were GMFCS V. A total of 12% of patients were older than 20, 11% were aged 15-20, 38% were aged 10-15, 31% were aged 5-10, and 8% were age 5 or younger.
 

Video clues aid diagnosis

Three pediatric movement disorder specialists independently reviewed each video and assessed severity of dystonia. They then met over Zoom to reach a diagnostic consensus for each case.

The research team performed a content analysis of the experts’ discussions and identified specific statement fragments. The frequency of these fragments was then linked to severity of dystonia.

A total of 45% of the statement fragments referenced movement codes, which in turn comprised five content areas: 33% referenced a body part, 24% focused on laterality, 22% described movement features, 18% an action, and 3% described exam maneuvers. Examples included shoulder as a body part, flexion as an action descriptor, brisk as a movement feature, unilateral, and finger-nose-finger for exam maneuver.

With increasing dystonia severity, the shoulder was more often cited and hand was cited less often. Mirror movements, defined as involuntary, contralateral movements that are similar to the voluntary action, occurred more often in patients with no dystonia or only mild dystonia. Variability of movement over time, which is a distinguishing feature found in lower extremities, was not significantly associated with dystonia severity.

Within the category of exam maneuver, hand opening and closing was the most commonly cited, and it was cited more frequently among individuals with mild dystonia (70% vs. about 10% for both no dystonia and moderate to severe dystonia; P < .005).

“So how can we adopt this clinically? First, we can add in a very brief exam maneuver of hand opening and closing that can help assess for mild dystonia. Shoulder involvement may suggest more severe dystonia, and we must recognize the dystonia features seem to differ by body region and the triggering task. Overall, to help improve dystonia diagnosis, we must continue to work towards understanding these salient features to fully grasp the breadth of dystonia manifestations in people with [cerebral palsy],” said Dr. Gilbert, who is a pediatric movements disorder fellow at Washington University in St. Louis.
 

Key features help determine dystonia severity

The study is particularly interesting for its different findings in upper extremities versus lower extremities, according to Keith Coffman, MD, who comoderated the session where the study was presented. “That same group showed that there are very clear differences in lower-extremity function, but when they looked at upper extremity, there really weren’t robust differences. What it may show is that the features of cerebral palsy regarding dystonia may be very dependent on what type of injury you have to your brain. Because when you think about where the motor fibers that provide leg function, they live along the medial walls of the brain right along the midline, whereas the representation of the hand and arm are more out on the lateral side of the brain. So it may be that those regional anatomy differences and where the injury occurred could be at the baseline of why they had such differences in motor function,” said Dr. Coffman, who is a professor of pediatrics at University of Missouri–Kansas City and director of the movement disorders program at Children’s Mercy Hospital, also in Kansas City, Mo.

He suggested that the researchers might also do kinematic analysis of the videos to make predictions using quantitative differences in movement.

The research has the potential to improve dystonia diagnosis, according to comoderator Marc Patterson, MD, professor of neurology, pediatrics, and medical genetics at Mayo Clinic in Rochester, Minn. “I think they really pointed to some key features that can help clinicians distinguish [dystonia severity]. Something like the speed of opening and closing the hands [is a] fairly simple thing. That was to me the chief value of that study,” Dr. Patterson said.

Dr. Gilbert reported no relevant disclosures.

CINCINNATI – Dystonia is a frequent complication seen in cerebral palsy, but it often goes undiagnosed. Using a unique video analysis, researchers have identified some movement features that have the potential to simplify diagnosis.

“[We have] previously demonstrated that by the age of 5 years, only 30% of children seen in a clinical setting have had their predominant motor phenotype identified, including dystonia. This helps demonstrate a broad diagnostic gap and the need for novel solutions,” said Laura Gilbert, DO, during her presentation of the results at the 2022 annual meeting of the Child Neurology Society.

Diagnosis of dystonia is challenging because of its clinical variability, and diagnostic tools often require a trained physician, which limits access to diagnoses. Expert clinician consensus therefore remains the gold standard for diagnosis of dystonia.

Another clinical need is that specific features of dystonia have not been well described in the upper extremities, and the research suggests there could be differences in brain injuries contributing to dystonia in the two domains.

The researchers set out to discover expert-identified features of patient videos that could be used to allow nonexperts to make a diagnosis of dystonia.

The researchers analyzed 26 videos with upper extremity exam maneuvers performed on children with periventricular leukomalacia at St. Louis Children’s Hospital Cerebral Palsy Center from 2005 to 2018. Among the study cohort, 65% of patients were male, 77% were White, and 11% were Black; 24% of patients were Gross Motor Function Classification Scale I, 24% were GMFCS II, 24% were GMFCS III, 16% were GMFCS IV, and 12% were GMFCS V. A total of 12% of patients were older than 20, 11% were aged 15-20, 38% were aged 10-15, 31% were aged 5-10, and 8% were age 5 or younger.
 

Video clues aid diagnosis

Three pediatric movement disorder specialists independently reviewed each video and assessed severity of dystonia. They then met over Zoom to reach a diagnostic consensus for each case.

The research team performed a content analysis of the experts’ discussions and identified specific statement fragments. The frequency of these fragments was then linked to severity of dystonia.

A total of 45% of the statement fragments referenced movement codes, which in turn comprised five content areas: 33% referenced a body part, 24% focused on laterality, 22% described movement features, 18% an action, and 3% described exam maneuvers. Examples included shoulder as a body part, flexion as an action descriptor, brisk as a movement feature, unilateral, and finger-nose-finger for exam maneuver.

With increasing dystonia severity, the shoulder was more often cited and hand was cited less often. Mirror movements, defined as involuntary, contralateral movements that are similar to the voluntary action, occurred more often in patients with no dystonia or only mild dystonia. Variability of movement over time, which is a distinguishing feature found in lower extremities, was not significantly associated with dystonia severity.

Within the category of exam maneuver, hand opening and closing was the most commonly cited, and it was cited more frequently among individuals with mild dystonia (70% vs. about 10% for both no dystonia and moderate to severe dystonia; P < .005).

“So how can we adopt this clinically? First, we can add in a very brief exam maneuver of hand opening and closing that can help assess for mild dystonia. Shoulder involvement may suggest more severe dystonia, and we must recognize the dystonia features seem to differ by body region and the triggering task. Overall, to help improve dystonia diagnosis, we must continue to work towards understanding these salient features to fully grasp the breadth of dystonia manifestations in people with [cerebral palsy],” said Dr. Gilbert, who is a pediatric movements disorder fellow at Washington University in St. Louis.
 

Key features help determine dystonia severity

The study is particularly interesting for its different findings in upper extremities versus lower extremities, according to Keith Coffman, MD, who comoderated the session where the study was presented. “That same group showed that there are very clear differences in lower-extremity function, but when they looked at upper extremity, there really weren’t robust differences. What it may show is that the features of cerebral palsy regarding dystonia may be very dependent on what type of injury you have to your brain. Because when you think about where the motor fibers that provide leg function, they live along the medial walls of the brain right along the midline, whereas the representation of the hand and arm are more out on the lateral side of the brain. So it may be that those regional anatomy differences and where the injury occurred could be at the baseline of why they had such differences in motor function,” said Dr. Coffman, who is a professor of pediatrics at University of Missouri–Kansas City and director of the movement disorders program at Children’s Mercy Hospital, also in Kansas City, Mo.

He suggested that the researchers might also do kinematic analysis of the videos to make predictions using quantitative differences in movement.

The research has the potential to improve dystonia diagnosis, according to comoderator Marc Patterson, MD, professor of neurology, pediatrics, and medical genetics at Mayo Clinic in Rochester, Minn. “I think they really pointed to some key features that can help clinicians distinguish [dystonia severity]. Something like the speed of opening and closing the hands [is a] fairly simple thing. That was to me the chief value of that study,” Dr. Patterson said.

Dr. Gilbert reported no relevant disclosures.

Teens diagnosed with attention-deficit/hyperactivity disorder in childhood reported similar overall quality of life compared with teens with ADHD behaviors but no childhood diagnosis, a new study finds.

The results align with findings from other studies suggesting lower quality of life (QOL) in teens with ADHD, but the current study is the first known to focus on the association between ADHD diagnosis itself vs. ADHD symptoms, and QOL, the researchers wrote. The findings show that at least some of the reduced QOL is associated with the diagnosis itself, they explained.

The researchers directly compared 393 teens with a childhood ADHD diagnosis to 393 matched teens with no ADHD diagnosis but who had hyperactive/inattentive behaviors.

The researchers reviewed self-reports from individuals who were enrolled in a population-based prospective study in Australia. The primary outcome was quality of life at age 14-15, which was measured with Child Health Utility 9D (CHU9D), a validated quality of life measure.
 

Study results

Overall, teens with and without an ADHD diagnosis reported similar levels of overall quality of life; the mean difference in the primary outcome CHU9D score was –0.03 (P = .10). Teens with and without an ADHD diagnosis also showed similar scores on measures of general health, happiness, and peer trust, the researchers noted.

The researchers also reviewed eight other prespecified, self-reported measures: academic self-concept, global health, negative social behaviors, overall happiness, peer trust, psychological sense of school membership, self-efficacy, and self-harm.

Teens diagnosed with ADHD in childhood were more than twice as likely to report self-harm (odds ratio 2.53, P less than .001) and displayed significantly more negative social behaviors (mean difference 1.56, P = .002), compared with teens without an ADHD diagnosis.

Teens diagnosed with ADHD in childhood also scored significantly worse on measures of sense of school membership (mean difference −2.58, P less than .001), academic self-concept (mean difference, −0.14; P = .02), and self-efficacy (mean difference −0.20; P = .007), compared to teens without an ADHD diagnosis.

The average age at ADHD diagnosis was 10 years, and 72% of the ADHD-diagnosed group were boys. No significant differences were noted for levels of hyperactive/inattentive behaviors and between girls and boys, but girls overall and children with the highest levels of hyperactive and inattentive behaviors reported generally worse outcomes, regardless of ADHD diagnosis, the researchers noted.
 

Don’t rush to diagnosis

Although rates of ADHD diagnosis in children continue to rise, the prevalence of hyperactivity and inattentive behaviors appears stable, which suggests a problem with diagnosis, senior author Alexandra Barratt, MBBS, MPH, PhD, professor of public health at the University of Sydney, Australia, said in an interview.

“Our hypothesis was that children who had been diagnosed, and we assume treated for, ADHD would have better outcomes, compared to children matched for hyperactivity/inattention behaviors who were left undiagnosed and untreated, but we were surprised to find that, at best, outcomes were unchanged, and for some outcomes, worse,” Dr. Barratt said.

“Our study provides evidence that diagnosing ADHD may lead, inadvertently, to long-term harms, particularly for children with mild or borderline hyperactivity and inattention behaviors,” she emphasized.

“We can’t say from this study what to do instead, but previously one of our team has looked at stepped diagnosis as an alternative option for children with mild or borderline hyperactivity and inattention behaviors,” she said.

The stepped diagnosis includes such actions as gathering behavior data from multiple sources, and conducting a period of watchful waiting without presumption of a diagnosis or active treatment.

Given the findings of the new study, “I would ask that health professionals considering a child who may have ADHD be aware that there is an evidence gap around the long-term impact of an ADHD diagnosis on children, and to proceed cautiously,” Dr. Barratt said. As for additional research, independent, high-quality, randomized controlled trials of ADHD diagnosis in children with mild or borderline hyperactivity/inattention behaviors are urgently needed, with long-term, patient-centered outcomes including quality of life she noted.

ADHD screening needs improvement

The incidence and prevalence of ADHD is on the rise, but much of the perceived increase in ADHD may be due to overdiagnosis, “and a lack of robust thorough psychological testing as standard of care for diagnosis,” Peter Loper, MD, a pediatrician and psychiatrist at the University of South Carolina, Columbia, said in an interview.

The current study “reinforces the necessity of consistent screening for comorbid mental health problems, and specifically for thoughts of self-harm, in those children who are diagnosed with ADHD,” he said.

Expressing his lack of astonishment about the study findings, Dr. Loper said: “Previous data indicates that while following initial diagnosis of a medical or mental health problem, patients may experience a sense of relief; however, this is followed shortly thereafter by feelings of insufficiency or anxiety related to their specific diagnosis.”

“As it stands now, ADHD is often diagnosed in children and adolescents using basic screening questionnaires,” said Dr. Loper. “The findings of this study may bolster calls for more robust and thorough psychological testing for supporting the diagnosis of ADHD,” he said.

Individuals diagnosed with ADHD can sometimes have difficulty with social skills and relating to others, said Dr. Loper. “They may be more prone to internalize their poor school performance as due to being ‘stupid’ or ‘dumb,’ ” he said. Children and teens with ADHD should, whenever possible, be involved in extracurricular activities that support the development of social skills, he said. Parents’ praise of the process/effort, rather than focusing only on outcomes such as grades, is very important for the esteem of children and teens with ADHD, he added.

The study limitations included the use of observational data vs. data from randomized trials, and the potential for confounding factors in propensity scoring, the researchers wrote. Additional limitations include the size of the sample, which may have been too small to detect additional differences between diagnosed teens and matched controls, they noted.

“As the study authors appropriately cite, a large, randomized trial would be very helpful in supporting additional understanding of this issue,” Dr. Loper added.

The study was supported by the National Health and Medical Research Council The researchers and Dr. Loper had no financial conflicts to disclose.

Teens diagnosed with attention-deficit/hyperactivity disorder in childhood reported similar overall quality of life compared with teens with ADHD behaviors but no childhood diagnosis, a new study finds.

The results align with findings from other studies suggesting lower quality of life (QOL) in teens with ADHD, but the current study is the first known to focus on the association between ADHD diagnosis itself vs. ADHD symptoms, and QOL, the researchers wrote. The findings show that at least some of the reduced QOL is associated with the diagnosis itself, they explained.

The researchers directly compared 393 teens with a childhood ADHD diagnosis to 393 matched teens with no ADHD diagnosis but who had hyperactive/inattentive behaviors.

The researchers reviewed self-reports from individuals who were enrolled in a population-based prospective study in Australia. The primary outcome was quality of life at age 14-15, which was measured with Child Health Utility 9D (CHU9D), a validated quality of life measure.
 

Study results

Overall, teens with and without an ADHD diagnosis reported similar levels of overall quality of life; the mean difference in the primary outcome CHU9D score was –0.03 (P = .10). Teens with and without an ADHD diagnosis also showed similar scores on measures of general health, happiness, and peer trust, the researchers noted.

The researchers also reviewed eight other prespecified, self-reported measures: academic self-concept, global health, negative social behaviors, overall happiness, peer trust, psychological sense of school membership, self-efficacy, and self-harm.

Teens diagnosed with ADHD in childhood were more than twice as likely to report self-harm (odds ratio 2.53, P less than .001) and displayed significantly more negative social behaviors (mean difference 1.56, P = .002), compared with teens without an ADHD diagnosis.

Teens diagnosed with ADHD in childhood also scored significantly worse on measures of sense of school membership (mean difference −2.58, P less than .001), academic self-concept (mean difference, −0.14; P = .02), and self-efficacy (mean difference −0.20; P = .007), compared to teens without an ADHD diagnosis.

The average age at ADHD diagnosis was 10 years, and 72% of the ADHD-diagnosed group were boys. No significant differences were noted for levels of hyperactive/inattentive behaviors and between girls and boys, but girls overall and children with the highest levels of hyperactive and inattentive behaviors reported generally worse outcomes, regardless of ADHD diagnosis, the researchers noted.
 

Don’t rush to diagnosis

Although rates of ADHD diagnosis in children continue to rise, the prevalence of hyperactivity and inattentive behaviors appears stable, which suggests a problem with diagnosis, senior author Alexandra Barratt, MBBS, MPH, PhD, professor of public health at the University of Sydney, Australia, said in an interview.

“Our hypothesis was that children who had been diagnosed, and we assume treated for, ADHD would have better outcomes, compared to children matched for hyperactivity/inattention behaviors who were left undiagnosed and untreated, but we were surprised to find that, at best, outcomes were unchanged, and for some outcomes, worse,” Dr. Barratt said.

“Our study provides evidence that diagnosing ADHD may lead, inadvertently, to long-term harms, particularly for children with mild or borderline hyperactivity and inattention behaviors,” she emphasized.

“We can’t say from this study what to do instead, but previously one of our team has looked at stepped diagnosis as an alternative option for children with mild or borderline hyperactivity and inattention behaviors,” she said.

The stepped diagnosis includes such actions as gathering behavior data from multiple sources, and conducting a period of watchful waiting without presumption of a diagnosis or active treatment.

Given the findings of the new study, “I would ask that health professionals considering a child who may have ADHD be aware that there is an evidence gap around the long-term impact of an ADHD diagnosis on children, and to proceed cautiously,” Dr. Barratt said. As for additional research, independent, high-quality, randomized controlled trials of ADHD diagnosis in children with mild or borderline hyperactivity/inattention behaviors are urgently needed, with long-term, patient-centered outcomes including quality of life she noted.

ADHD screening needs improvement

The incidence and prevalence of ADHD is on the rise, but much of the perceived increase in ADHD may be due to overdiagnosis, “and a lack of robust thorough psychological testing as standard of care for diagnosis,” Peter Loper, MD, a pediatrician and psychiatrist at the University of South Carolina, Columbia, said in an interview.

The current study “reinforces the necessity of consistent screening for comorbid mental health problems, and specifically for thoughts of self-harm, in those children who are diagnosed with ADHD,” he said.

Expressing his lack of astonishment about the study findings, Dr. Loper said: “Previous data indicates that while following initial diagnosis of a medical or mental health problem, patients may experience a sense of relief; however, this is followed shortly thereafter by feelings of insufficiency or anxiety related to their specific diagnosis.”

“As it stands now, ADHD is often diagnosed in children and adolescents using basic screening questionnaires,” said Dr. Loper. “The findings of this study may bolster calls for more robust and thorough psychological testing for supporting the diagnosis of ADHD,” he said.

Individuals diagnosed with ADHD can sometimes have difficulty with social skills and relating to others, said Dr. Loper. “They may be more prone to internalize their poor school performance as due to being ‘stupid’ or ‘dumb,’ ” he said. Children and teens with ADHD should, whenever possible, be involved in extracurricular activities that support the development of social skills, he said. Parents’ praise of the process/effort, rather than focusing only on outcomes such as grades, is very important for the esteem of children and teens with ADHD, he added.

The study limitations included the use of observational data vs. data from randomized trials, and the potential for confounding factors in propensity scoring, the researchers wrote. Additional limitations include the size of the sample, which may have been too small to detect additional differences between diagnosed teens and matched controls, they noted.

“As the study authors appropriately cite, a large, randomized trial would be very helpful in supporting additional understanding of this issue,” Dr. Loper added.

The study was supported by the National Health and Medical Research Council The researchers and Dr. Loper had no financial conflicts to disclose.

Teens diagnosed with attention-deficit/hyperactivity disorder in childhood reported similar overall quality of life compared with teens with ADHD behaviors but no childhood diagnosis, a new study finds.

The results align with findings from other studies suggesting lower quality of life (QOL) in teens with ADHD, but the current study is the first known to focus on the association between ADHD diagnosis itself vs. ADHD symptoms, and QOL, the researchers wrote. The findings show that at least some of the reduced QOL is associated with the diagnosis itself, they explained.

The researchers directly compared 393 teens with a childhood ADHD diagnosis to 393 matched teens with no ADHD diagnosis but who had hyperactive/inattentive behaviors.

The researchers reviewed self-reports from individuals who were enrolled in a population-based prospective study in Australia. The primary outcome was quality of life at age 14-15, which was measured with Child Health Utility 9D (CHU9D), a validated quality of life measure.
 

Study results

Overall, teens with and without an ADHD diagnosis reported similar levels of overall quality of life; the mean difference in the primary outcome CHU9D score was –0.03 (P = .10). Teens with and without an ADHD diagnosis also showed similar scores on measures of general health, happiness, and peer trust, the researchers noted.

The researchers also reviewed eight other prespecified, self-reported measures: academic self-concept, global health, negative social behaviors, overall happiness, peer trust, psychological sense of school membership, self-efficacy, and self-harm.

Teens diagnosed with ADHD in childhood were more than twice as likely to report self-harm (odds ratio 2.53, P less than .001) and displayed significantly more negative social behaviors (mean difference 1.56, P = .002), compared with teens without an ADHD diagnosis.

Teens diagnosed with ADHD in childhood also scored significantly worse on measures of sense of school membership (mean difference −2.58, P less than .001), academic self-concept (mean difference, −0.14; P = .02), and self-efficacy (mean difference −0.20; P = .007), compared to teens without an ADHD diagnosis.

The average age at ADHD diagnosis was 10 years, and 72% of the ADHD-diagnosed group were boys. No significant differences were noted for levels of hyperactive/inattentive behaviors and between girls and boys, but girls overall and children with the highest levels of hyperactive and inattentive behaviors reported generally worse outcomes, regardless of ADHD diagnosis, the researchers noted.
 

Don’t rush to diagnosis

Although rates of ADHD diagnosis in children continue to rise, the prevalence of hyperactivity and inattentive behaviors appears stable, which suggests a problem with diagnosis, senior author Alexandra Barratt, MBBS, MPH, PhD, professor of public health at the University of Sydney, Australia, said in an interview.

“Our hypothesis was that children who had been diagnosed, and we assume treated for, ADHD would have better outcomes, compared to children matched for hyperactivity/inattention behaviors who were left undiagnosed and untreated, but we were surprised to find that, at best, outcomes were unchanged, and for some outcomes, worse,” Dr. Barratt said.

“Our study provides evidence that diagnosing ADHD may lead, inadvertently, to long-term harms, particularly for children with mild or borderline hyperactivity and inattention behaviors,” she emphasized.

“We can’t say from this study what to do instead, but previously one of our team has looked at stepped diagnosis as an alternative option for children with mild or borderline hyperactivity and inattention behaviors,” she said.

The stepped diagnosis includes such actions as gathering behavior data from multiple sources, and conducting a period of watchful waiting without presumption of a diagnosis or active treatment.

Given the findings of the new study, “I would ask that health professionals considering a child who may have ADHD be aware that there is an evidence gap around the long-term impact of an ADHD diagnosis on children, and to proceed cautiously,” Dr. Barratt said. As for additional research, independent, high-quality, randomized controlled trials of ADHD diagnosis in children with mild or borderline hyperactivity/inattention behaviors are urgently needed, with long-term, patient-centered outcomes including quality of life she noted.

ADHD screening needs improvement

The incidence and prevalence of ADHD is on the rise, but much of the perceived increase in ADHD may be due to overdiagnosis, “and a lack of robust thorough psychological testing as standard of care for diagnosis,” Peter Loper, MD, a pediatrician and psychiatrist at the University of South Carolina, Columbia, said in an interview.

The current study “reinforces the necessity of consistent screening for comorbid mental health problems, and specifically for thoughts of self-harm, in those children who are diagnosed with ADHD,” he said.

Expressing his lack of astonishment about the study findings, Dr. Loper said: “Previous data indicates that while following initial diagnosis of a medical or mental health problem, patients may experience a sense of relief; however, this is followed shortly thereafter by feelings of insufficiency or anxiety related to their specific diagnosis.”

“As it stands now, ADHD is often diagnosed in children and adolescents using basic screening questionnaires,” said Dr. Loper. “The findings of this study may bolster calls for more robust and thorough psychological testing for supporting the diagnosis of ADHD,” he said.

Individuals diagnosed with ADHD can sometimes have difficulty with social skills and relating to others, said Dr. Loper. “They may be more prone to internalize their poor school performance as due to being ‘stupid’ or ‘dumb,’ ” he said. Children and teens with ADHD should, whenever possible, be involved in extracurricular activities that support the development of social skills, he said. Parents’ praise of the process/effort, rather than focusing only on outcomes such as grades, is very important for the esteem of children and teens with ADHD, he added.

The study limitations included the use of observational data vs. data from randomized trials, and the potential for confounding factors in propensity scoring, the researchers wrote. Additional limitations include the size of the sample, which may have been too small to detect additional differences between diagnosed teens and matched controls, they noted.

“As the study authors appropriately cite, a large, randomized trial would be very helpful in supporting additional understanding of this issue,” Dr. Loper added.

The study was supported by the National Health and Medical Research Council The researchers and Dr. Loper had no financial conflicts to disclose.