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‘Soak-and-smear’ AD protocol backed by evidence
The most effective initial step for clearing atopic dermatitis in infants and young children involves daily bathing, followed by immediate application of a moisturizer, topical steroid, or both, according to an expert speaking at the virtual annual Coastal Dermatology Symposium.
“If they are really severe, you can do it twice-daily, but there are several studies that show there is not a huge benefit of twice-daily over once-daily,” said Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland.
He called this technique “soak-and-smear.” The “smear” is performed immediately after the bath when the skin is still damp, he said. When clearing is the goal, and the child has moderate to severe atopic dermatitis (AD), 0.1% triamcinolone or a similar medium potency topical steroid can be applied, and after clearing, the steroid can be switched for a moisturizer, according to Dr. Simpson.
Rather than restricting application to areas of greatest skin involvement, “put it all over,” he advised.
The clearing regimen should be continued “for a couple of more days” after the lesions have resolved, with a return visit in about a week to confirm clearing and reinforce the next steps for keeping patients clear, he added.
The next steps depend on severity. According to Dr. Simpson, severity is defined less by the extent of skin involvement at the baseline examination than the speed at which symptoms return.
For those with only mild symptoms after an extended period of clearing, moisturizer might be sufficient to prevent a significant relapse. For children with a more rapid relapse, it will be necessary to reintroduce topical steroid either every day, every other day, or twice per week.
Whether with moisturizer or with topical steroids, the soak-and-smear technique has now been validated in a recently published crossover randomized trial.
In the trial, children aged 6 months to 11 years, with moderate to severe AD, were randomized to a twice-daily bath, called the “wet method,” versus a twice-weekly bath, called the “dry method.” Both groups received a cleanser and moisturizer along with a low-potency topical steroid as needed.
After 2 weeks, the 40 evaluable patients were crossed over to the opposite bathing technique. The wet, or soak-and-smear approach, was associated with a highly significant reduction in the primary endpoint of SCORing Atopic Dermatitis (SCORAD) index, compared with the dry method (95% confidence interval, 14.9-27.6; P less than .0001). In a secondary analysis, this translated into a 30% relative reduction in favor of the wet method.
In addition, there was improvement in a caregiver assessment of the Atopic Dermatitis Quickscore (ADQ). These data show that “twice-daily baths with topical steroids and moisturizer can help in more moderate to severe population,” said Dr. Simpson, who noted that he has participated in open-label studies with the same soak-and-smear technique that have produced similar results.
Once children are clear, Dr. Simpson recommends a maintenance strategy individualized for severity. In many cases, this will involve moisturizers applied after the bath, supplemented intermittently, such as once or twice per week, with topical steroids. However, if parents find themselves resorting to daily steroids to maintain control, “that’s when you incorporate the TCIs [topical calcineurin inhibitors].”
TCIs “can help you stay at twice-per-week topical steroids,” Dr. Simpson said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
TCIs also help patients avoid steroid withdrawal, a particularly common phenomenon when topical steroids are applied repeatedly to the face. He recommended a proactive approach. By applying TCIs to areas where skin lesions frequently recur, such as the eyelids, flares can often be prevented.
Repeated applications of TCIs “is perfectly safe and effective, and there are many studies that show proactive treatment is very effective and can prevent you from having to use too much topical steroids” or move to a systemic steroid, Dr. Simpson said.
These steps have been highly effective for sustained control even in challenging cases of AD, but he emphasized the importance of explaining the rationale to parents and eliciting their adherence to these treatment steps. Writing out the instructions will reduce confusion and help parents keep their children clear, he added.
Lawrence F. Eichenfield, MD, professor of pediatrics and dermatology at the University of California, San Diego, agreed that this recently published crossover trial has been helpful in counseling parents about how to manage AD in their children.
“Many times, pediatricians tell parents to avoid bathing because they feel that bathing will dry out the skin,” he said. The crossover study, by showing better control of AD with frequent bathing, dispels that notion, although he is not convinced that bathing at this frequency is necessary.
“I have not advised anyone to do twice-daily bathing, with rare exceptions, on the basis on this study, but, basically, I think that whether people do daily bathing or every other day bathing, it is pretty reasonable that bathing might help as long as they are applying moisturizer immediately afterward,” he said.
Dr. Simpson reports financial relationships with AbbVie, Celgene Dermira, Genentech, GlaxoSmithKline, Incyte, Lilly, Medimmune, Pfizer, Regeneron/Sanofi, and Tioga.
This publication and Global Academy for Medical Education are owned by the same parent company.
The most effective initial step for clearing atopic dermatitis in infants and young children involves daily bathing, followed by immediate application of a moisturizer, topical steroid, or both, according to an expert speaking at the virtual annual Coastal Dermatology Symposium.
“If they are really severe, you can do it twice-daily, but there are several studies that show there is not a huge benefit of twice-daily over once-daily,” said Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland.
He called this technique “soak-and-smear.” The “smear” is performed immediately after the bath when the skin is still damp, he said. When clearing is the goal, and the child has moderate to severe atopic dermatitis (AD), 0.1% triamcinolone or a similar medium potency topical steroid can be applied, and after clearing, the steroid can be switched for a moisturizer, according to Dr. Simpson.
Rather than restricting application to areas of greatest skin involvement, “put it all over,” he advised.
The clearing regimen should be continued “for a couple of more days” after the lesions have resolved, with a return visit in about a week to confirm clearing and reinforce the next steps for keeping patients clear, he added.
The next steps depend on severity. According to Dr. Simpson, severity is defined less by the extent of skin involvement at the baseline examination than the speed at which symptoms return.
For those with only mild symptoms after an extended period of clearing, moisturizer might be sufficient to prevent a significant relapse. For children with a more rapid relapse, it will be necessary to reintroduce topical steroid either every day, every other day, or twice per week.
Whether with moisturizer or with topical steroids, the soak-and-smear technique has now been validated in a recently published crossover randomized trial.
In the trial, children aged 6 months to 11 years, with moderate to severe AD, were randomized to a twice-daily bath, called the “wet method,” versus a twice-weekly bath, called the “dry method.” Both groups received a cleanser and moisturizer along with a low-potency topical steroid as needed.
After 2 weeks, the 40 evaluable patients were crossed over to the opposite bathing technique. The wet, or soak-and-smear approach, was associated with a highly significant reduction in the primary endpoint of SCORing Atopic Dermatitis (SCORAD) index, compared with the dry method (95% confidence interval, 14.9-27.6; P less than .0001). In a secondary analysis, this translated into a 30% relative reduction in favor of the wet method.
In addition, there was improvement in a caregiver assessment of the Atopic Dermatitis Quickscore (ADQ). These data show that “twice-daily baths with topical steroids and moisturizer can help in more moderate to severe population,” said Dr. Simpson, who noted that he has participated in open-label studies with the same soak-and-smear technique that have produced similar results.
Once children are clear, Dr. Simpson recommends a maintenance strategy individualized for severity. In many cases, this will involve moisturizers applied after the bath, supplemented intermittently, such as once or twice per week, with topical steroids. However, if parents find themselves resorting to daily steroids to maintain control, “that’s when you incorporate the TCIs [topical calcineurin inhibitors].”
TCIs “can help you stay at twice-per-week topical steroids,” Dr. Simpson said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
TCIs also help patients avoid steroid withdrawal, a particularly common phenomenon when topical steroids are applied repeatedly to the face. He recommended a proactive approach. By applying TCIs to areas where skin lesions frequently recur, such as the eyelids, flares can often be prevented.
Repeated applications of TCIs “is perfectly safe and effective, and there are many studies that show proactive treatment is very effective and can prevent you from having to use too much topical steroids” or move to a systemic steroid, Dr. Simpson said.
These steps have been highly effective for sustained control even in challenging cases of AD, but he emphasized the importance of explaining the rationale to parents and eliciting their adherence to these treatment steps. Writing out the instructions will reduce confusion and help parents keep their children clear, he added.
Lawrence F. Eichenfield, MD, professor of pediatrics and dermatology at the University of California, San Diego, agreed that this recently published crossover trial has been helpful in counseling parents about how to manage AD in their children.
“Many times, pediatricians tell parents to avoid bathing because they feel that bathing will dry out the skin,” he said. The crossover study, by showing better control of AD with frequent bathing, dispels that notion, although he is not convinced that bathing at this frequency is necessary.
“I have not advised anyone to do twice-daily bathing, with rare exceptions, on the basis on this study, but, basically, I think that whether people do daily bathing or every other day bathing, it is pretty reasonable that bathing might help as long as they are applying moisturizer immediately afterward,” he said.
Dr. Simpson reports financial relationships with AbbVie, Celgene Dermira, Genentech, GlaxoSmithKline, Incyte, Lilly, Medimmune, Pfizer, Regeneron/Sanofi, and Tioga.
This publication and Global Academy for Medical Education are owned by the same parent company.
The most effective initial step for clearing atopic dermatitis in infants and young children involves daily bathing, followed by immediate application of a moisturizer, topical steroid, or both, according to an expert speaking at the virtual annual Coastal Dermatology Symposium.
“If they are really severe, you can do it twice-daily, but there are several studies that show there is not a huge benefit of twice-daily over once-daily,” said Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland.
He called this technique “soak-and-smear.” The “smear” is performed immediately after the bath when the skin is still damp, he said. When clearing is the goal, and the child has moderate to severe atopic dermatitis (AD), 0.1% triamcinolone or a similar medium potency topical steroid can be applied, and after clearing, the steroid can be switched for a moisturizer, according to Dr. Simpson.
Rather than restricting application to areas of greatest skin involvement, “put it all over,” he advised.
The clearing regimen should be continued “for a couple of more days” after the lesions have resolved, with a return visit in about a week to confirm clearing and reinforce the next steps for keeping patients clear, he added.
The next steps depend on severity. According to Dr. Simpson, severity is defined less by the extent of skin involvement at the baseline examination than the speed at which symptoms return.
For those with only mild symptoms after an extended period of clearing, moisturizer might be sufficient to prevent a significant relapse. For children with a more rapid relapse, it will be necessary to reintroduce topical steroid either every day, every other day, or twice per week.
Whether with moisturizer or with topical steroids, the soak-and-smear technique has now been validated in a recently published crossover randomized trial.
In the trial, children aged 6 months to 11 years, with moderate to severe AD, were randomized to a twice-daily bath, called the “wet method,” versus a twice-weekly bath, called the “dry method.” Both groups received a cleanser and moisturizer along with a low-potency topical steroid as needed.
After 2 weeks, the 40 evaluable patients were crossed over to the opposite bathing technique. The wet, or soak-and-smear approach, was associated with a highly significant reduction in the primary endpoint of SCORing Atopic Dermatitis (SCORAD) index, compared with the dry method (95% confidence interval, 14.9-27.6; P less than .0001). In a secondary analysis, this translated into a 30% relative reduction in favor of the wet method.
In addition, there was improvement in a caregiver assessment of the Atopic Dermatitis Quickscore (ADQ). These data show that “twice-daily baths with topical steroids and moisturizer can help in more moderate to severe population,” said Dr. Simpson, who noted that he has participated in open-label studies with the same soak-and-smear technique that have produced similar results.
Once children are clear, Dr. Simpson recommends a maintenance strategy individualized for severity. In many cases, this will involve moisturizers applied after the bath, supplemented intermittently, such as once or twice per week, with topical steroids. However, if parents find themselves resorting to daily steroids to maintain control, “that’s when you incorporate the TCIs [topical calcineurin inhibitors].”
TCIs “can help you stay at twice-per-week topical steroids,” Dr. Simpson said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
TCIs also help patients avoid steroid withdrawal, a particularly common phenomenon when topical steroids are applied repeatedly to the face. He recommended a proactive approach. By applying TCIs to areas where skin lesions frequently recur, such as the eyelids, flares can often be prevented.
Repeated applications of TCIs “is perfectly safe and effective, and there are many studies that show proactive treatment is very effective and can prevent you from having to use too much topical steroids” or move to a systemic steroid, Dr. Simpson said.
These steps have been highly effective for sustained control even in challenging cases of AD, but he emphasized the importance of explaining the rationale to parents and eliciting their adherence to these treatment steps. Writing out the instructions will reduce confusion and help parents keep their children clear, he added.
Lawrence F. Eichenfield, MD, professor of pediatrics and dermatology at the University of California, San Diego, agreed that this recently published crossover trial has been helpful in counseling parents about how to manage AD in their children.
“Many times, pediatricians tell parents to avoid bathing because they feel that bathing will dry out the skin,” he said. The crossover study, by showing better control of AD with frequent bathing, dispels that notion, although he is not convinced that bathing at this frequency is necessary.
“I have not advised anyone to do twice-daily bathing, with rare exceptions, on the basis on this study, but, basically, I think that whether people do daily bathing or every other day bathing, it is pretty reasonable that bathing might help as long as they are applying moisturizer immediately afterward,” he said.
Dr. Simpson reports financial relationships with AbbVie, Celgene Dermira, Genentech, GlaxoSmithKline, Incyte, Lilly, Medimmune, Pfizer, Regeneron/Sanofi, and Tioga.
This publication and Global Academy for Medical Education are owned by the same parent company.
FROM COASTAL DERM
Sublingual apomorphine alleviates off episodes in Parkinson’s disease
, long-term follow-up of a phase 3 study has shown. Besides the usual adverse effects with apomorphine, the sublingual film was associated with more oral adverse effects than seen with the injectable drug. However, it may have some advantages over subcutaneous apomorphine injections in terms of administration during off episodes.
The study was presented at the Movement Disorder Society 23rd International Congress of Parkinson’s Disease and Movement Disorders (Virtual) 2020.
For example, the new formulation is more convenient than carrying an injection. It comes in a small, tear-open packet that contains a medication strip patients place under their tongues.
“When a patient is in the off state, depending on how off they are, they could have a little difficulty opening the strip [packet], but anyone can open the strip for them,” said lead author Rajesh Pahwa, MD, professor of neurology and chief of the Parkinson and Movement Disorder Division at the University of Kansas Medical Center in Kansas City. “On the other hand with the subcutaneous, they have to give the injection themselves and a stranger or someone is not going to help them with that.”
Open-label safety and efficacy study
The aims of this open-label, 48-week follow-up were to add new patients to assess safety and tolerability over the long term and to see if continued benefit from a previous 12-week double-blind study was still present at 1 year for patients in the earlier study.
This multicenter study (NCT02542696) included “rollover” patients (n = 78 for safety; n = 70 for efficacy) from the previous phase 2/3 double-blind trial, as well as new patients with no prior exposure to apomorphine sublingual film (n = 347 for safety; n = 275 for efficacy).
New patients experienced one or more off episodes per day with a daily off time of 2 hours or more per day while on stable doses of levodopa/carbidopa. All had clinically meaningful responses to levodopa/carbidopa and were judged by the investigator to be Stage 1-3 by modified Hoehn and Yahr scale rating during ON periods.
Rollover patients completed the prior study and had no major changes in their anti-Parkinson’s medications since then. Mouth cankers or sores were exclusion criteria for either group. New subjects could not have received subcutaneous apomorphine within 7 days of a screening visit.
The demographics and baseline characteristics of the new and rollover groups were similar (approximately 64 years; 65%-71% male; 96% White; 8.3-9.6 years since diagnosis; 3.9 to 4.1 off episodes/day, and total mean daily levodopa dose of 1120 to 1478 mg).
Assessing only the group of new patients, the investigators reported that 80% had a Hoehn and Yahr score of 2 or 2.5 when in the ON state and a Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III predose score of 41.8.
At the beginning of this study, patients in an off period received titrated doses of 10-35 mg of sublingual apomorphine in 5 mg increments during sequential office visits until they achieved a tolerable full ON within 45 minutes of a dose. They then entered a 48-week safety and efficacy phase, during which they self-administered the drug at home up to five times daily for off episodes with a minimum of 2 hours between doses. The investigators could adjust the doses for safety or lack of efficacy.
Two-thirds of new patients and three-quarters of rollovers received doses in the 10-20 mg range. The highest dose in the study of 35 mg was used by only 8%-9% of patients, but the highest approved and marketed dose is 30 mg.
Long-term benefits
Onset of efficacy was achieved by 15 minutes after dose for both new and rollover patients, and maximal efficacy occurred by 30 minutes. Results were very similar at 24, 36, and 48 weeks. The investigators did not perform statistical analyses.
Across study weeks 1, 12, 24, 36, and 48, between 77% and 92% of new patients and between 65% and 77% of rollover patients self-reported full ON within 30 minutes. “The long-term benefits are maintained over a year as far as the speed of onset and the duration,” Dr. Pahwa said.
Treatment-emergent adverse events occurred in about half of the new and the rollover patient groups in the titration phase and in 71%-81% of patients during the long-term safety phase. Nearly all were mild to moderate in severity.
A large number of participants withdrew from this long-term safety phase because of adverse events – 90 (33%) of new enrollees and 16 (23%) of rollover patients. Only 4% dropped out for lack of efficacy, all in the new enrollee group. Because the sublingual formulation is delivered under the tongue, patients in that group had more oral side effects, Dr. Pahwa said. Otherwise, “the side effects were very similar to the subcutaneous delivery.”
Treatment-emergent adverse events specific to sublingual apomorphine included oral mucosal erythema, lip or tongue swelling, and mouth ulceration (6% to 7% of patients each). Occurring less often were glossodynia, oral candidiasis, stomatitis, and tongue ulceration (2% each).
These were in addition to adverse events typically occurring with subcutaneous apomorphine, which are nausea, falls, dizziness, somnolence, dyskinesia, syncope, and yawning.
There are no head-to-head comparisons of sublingual versus subcutaneous delivery of apomorphine. But based on experience, Dr. Pahwa said, “With the subcutaneous, you have a slightly faster onset of action compared to the sublingual. However, sublingual has a slightly longer duration of benefit.”
He predicted that patients may prefer using an injection for a faster benefit or a sublingual for a slightly longer benefit.
More therapeutic options are welcome
Commenting on the study, Ray Dorsey, MD, professor of neurology at the University of Rochester (N.Y.), said that, for people with more advanced Parkinson’s disease “there’s usually a caregiver who’s injecting someone with an off period, as opposed to sublingual, which seems like a much easier way of administering a drug, especially for people with motor fluctuations.”
He noted that adverse events that led to premature discontinuation from the study “are concerning about the overall tolerability of the drug, which also will be determined in clinical practice, and will likely influence its overall utility.”
However, more therapeutic options are welcome because “the number of people with advanced Parkinson’s disease is going to grow and grow substantially,” he said. “So having therapies that help people with more advanced Parkinson’s disease ... many of whom don’t reach the clinic ... are going to be increasingly important.”
The study was supported by Sunovion. Dr. Pahwa and Dr. Dorsey reported conflicts of interest with numerous sources in industry.
A version of this article originally appeared on Medscape.com.
, long-term follow-up of a phase 3 study has shown. Besides the usual adverse effects with apomorphine, the sublingual film was associated with more oral adverse effects than seen with the injectable drug. However, it may have some advantages over subcutaneous apomorphine injections in terms of administration during off episodes.
The study was presented at the Movement Disorder Society 23rd International Congress of Parkinson’s Disease and Movement Disorders (Virtual) 2020.
For example, the new formulation is more convenient than carrying an injection. It comes in a small, tear-open packet that contains a medication strip patients place under their tongues.
“When a patient is in the off state, depending on how off they are, they could have a little difficulty opening the strip [packet], but anyone can open the strip for them,” said lead author Rajesh Pahwa, MD, professor of neurology and chief of the Parkinson and Movement Disorder Division at the University of Kansas Medical Center in Kansas City. “On the other hand with the subcutaneous, they have to give the injection themselves and a stranger or someone is not going to help them with that.”
Open-label safety and efficacy study
The aims of this open-label, 48-week follow-up were to add new patients to assess safety and tolerability over the long term and to see if continued benefit from a previous 12-week double-blind study was still present at 1 year for patients in the earlier study.
This multicenter study (NCT02542696) included “rollover” patients (n = 78 for safety; n = 70 for efficacy) from the previous phase 2/3 double-blind trial, as well as new patients with no prior exposure to apomorphine sublingual film (n = 347 for safety; n = 275 for efficacy).
New patients experienced one or more off episodes per day with a daily off time of 2 hours or more per day while on stable doses of levodopa/carbidopa. All had clinically meaningful responses to levodopa/carbidopa and were judged by the investigator to be Stage 1-3 by modified Hoehn and Yahr scale rating during ON periods.
Rollover patients completed the prior study and had no major changes in their anti-Parkinson’s medications since then. Mouth cankers or sores were exclusion criteria for either group. New subjects could not have received subcutaneous apomorphine within 7 days of a screening visit.
The demographics and baseline characteristics of the new and rollover groups were similar (approximately 64 years; 65%-71% male; 96% White; 8.3-9.6 years since diagnosis; 3.9 to 4.1 off episodes/day, and total mean daily levodopa dose of 1120 to 1478 mg).
Assessing only the group of new patients, the investigators reported that 80% had a Hoehn and Yahr score of 2 or 2.5 when in the ON state and a Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III predose score of 41.8.
At the beginning of this study, patients in an off period received titrated doses of 10-35 mg of sublingual apomorphine in 5 mg increments during sequential office visits until they achieved a tolerable full ON within 45 minutes of a dose. They then entered a 48-week safety and efficacy phase, during which they self-administered the drug at home up to five times daily for off episodes with a minimum of 2 hours between doses. The investigators could adjust the doses for safety or lack of efficacy.
Two-thirds of new patients and three-quarters of rollovers received doses in the 10-20 mg range. The highest dose in the study of 35 mg was used by only 8%-9% of patients, but the highest approved and marketed dose is 30 mg.
Long-term benefits
Onset of efficacy was achieved by 15 minutes after dose for both new and rollover patients, and maximal efficacy occurred by 30 minutes. Results were very similar at 24, 36, and 48 weeks. The investigators did not perform statistical analyses.
Across study weeks 1, 12, 24, 36, and 48, between 77% and 92% of new patients and between 65% and 77% of rollover patients self-reported full ON within 30 minutes. “The long-term benefits are maintained over a year as far as the speed of onset and the duration,” Dr. Pahwa said.
Treatment-emergent adverse events occurred in about half of the new and the rollover patient groups in the titration phase and in 71%-81% of patients during the long-term safety phase. Nearly all were mild to moderate in severity.
A large number of participants withdrew from this long-term safety phase because of adverse events – 90 (33%) of new enrollees and 16 (23%) of rollover patients. Only 4% dropped out for lack of efficacy, all in the new enrollee group. Because the sublingual formulation is delivered under the tongue, patients in that group had more oral side effects, Dr. Pahwa said. Otherwise, “the side effects were very similar to the subcutaneous delivery.”
Treatment-emergent adverse events specific to sublingual apomorphine included oral mucosal erythema, lip or tongue swelling, and mouth ulceration (6% to 7% of patients each). Occurring less often were glossodynia, oral candidiasis, stomatitis, and tongue ulceration (2% each).
These were in addition to adverse events typically occurring with subcutaneous apomorphine, which are nausea, falls, dizziness, somnolence, dyskinesia, syncope, and yawning.
There are no head-to-head comparisons of sublingual versus subcutaneous delivery of apomorphine. But based on experience, Dr. Pahwa said, “With the subcutaneous, you have a slightly faster onset of action compared to the sublingual. However, sublingual has a slightly longer duration of benefit.”
He predicted that patients may prefer using an injection for a faster benefit or a sublingual for a slightly longer benefit.
More therapeutic options are welcome
Commenting on the study, Ray Dorsey, MD, professor of neurology at the University of Rochester (N.Y.), said that, for people with more advanced Parkinson’s disease “there’s usually a caregiver who’s injecting someone with an off period, as opposed to sublingual, which seems like a much easier way of administering a drug, especially for people with motor fluctuations.”
He noted that adverse events that led to premature discontinuation from the study “are concerning about the overall tolerability of the drug, which also will be determined in clinical practice, and will likely influence its overall utility.”
However, more therapeutic options are welcome because “the number of people with advanced Parkinson’s disease is going to grow and grow substantially,” he said. “So having therapies that help people with more advanced Parkinson’s disease ... many of whom don’t reach the clinic ... are going to be increasingly important.”
The study was supported by Sunovion. Dr. Pahwa and Dr. Dorsey reported conflicts of interest with numerous sources in industry.
A version of this article originally appeared on Medscape.com.
, long-term follow-up of a phase 3 study has shown. Besides the usual adverse effects with apomorphine, the sublingual film was associated with more oral adverse effects than seen with the injectable drug. However, it may have some advantages over subcutaneous apomorphine injections in terms of administration during off episodes.
The study was presented at the Movement Disorder Society 23rd International Congress of Parkinson’s Disease and Movement Disorders (Virtual) 2020.
For example, the new formulation is more convenient than carrying an injection. It comes in a small, tear-open packet that contains a medication strip patients place under their tongues.
“When a patient is in the off state, depending on how off they are, they could have a little difficulty opening the strip [packet], but anyone can open the strip for them,” said lead author Rajesh Pahwa, MD, professor of neurology and chief of the Parkinson and Movement Disorder Division at the University of Kansas Medical Center in Kansas City. “On the other hand with the subcutaneous, they have to give the injection themselves and a stranger or someone is not going to help them with that.”
Open-label safety and efficacy study
The aims of this open-label, 48-week follow-up were to add new patients to assess safety and tolerability over the long term and to see if continued benefit from a previous 12-week double-blind study was still present at 1 year for patients in the earlier study.
This multicenter study (NCT02542696) included “rollover” patients (n = 78 for safety; n = 70 for efficacy) from the previous phase 2/3 double-blind trial, as well as new patients with no prior exposure to apomorphine sublingual film (n = 347 for safety; n = 275 for efficacy).
New patients experienced one or more off episodes per day with a daily off time of 2 hours or more per day while on stable doses of levodopa/carbidopa. All had clinically meaningful responses to levodopa/carbidopa and were judged by the investigator to be Stage 1-3 by modified Hoehn and Yahr scale rating during ON periods.
Rollover patients completed the prior study and had no major changes in their anti-Parkinson’s medications since then. Mouth cankers or sores were exclusion criteria for either group. New subjects could not have received subcutaneous apomorphine within 7 days of a screening visit.
The demographics and baseline characteristics of the new and rollover groups were similar (approximately 64 years; 65%-71% male; 96% White; 8.3-9.6 years since diagnosis; 3.9 to 4.1 off episodes/day, and total mean daily levodopa dose of 1120 to 1478 mg).
Assessing only the group of new patients, the investigators reported that 80% had a Hoehn and Yahr score of 2 or 2.5 when in the ON state and a Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III predose score of 41.8.
At the beginning of this study, patients in an off period received titrated doses of 10-35 mg of sublingual apomorphine in 5 mg increments during sequential office visits until they achieved a tolerable full ON within 45 minutes of a dose. They then entered a 48-week safety and efficacy phase, during which they self-administered the drug at home up to five times daily for off episodes with a minimum of 2 hours between doses. The investigators could adjust the doses for safety or lack of efficacy.
Two-thirds of new patients and three-quarters of rollovers received doses in the 10-20 mg range. The highest dose in the study of 35 mg was used by only 8%-9% of patients, but the highest approved and marketed dose is 30 mg.
Long-term benefits
Onset of efficacy was achieved by 15 minutes after dose for both new and rollover patients, and maximal efficacy occurred by 30 minutes. Results were very similar at 24, 36, and 48 weeks. The investigators did not perform statistical analyses.
Across study weeks 1, 12, 24, 36, and 48, between 77% and 92% of new patients and between 65% and 77% of rollover patients self-reported full ON within 30 minutes. “The long-term benefits are maintained over a year as far as the speed of onset and the duration,” Dr. Pahwa said.
Treatment-emergent adverse events occurred in about half of the new and the rollover patient groups in the titration phase and in 71%-81% of patients during the long-term safety phase. Nearly all were mild to moderate in severity.
A large number of participants withdrew from this long-term safety phase because of adverse events – 90 (33%) of new enrollees and 16 (23%) of rollover patients. Only 4% dropped out for lack of efficacy, all in the new enrollee group. Because the sublingual formulation is delivered under the tongue, patients in that group had more oral side effects, Dr. Pahwa said. Otherwise, “the side effects were very similar to the subcutaneous delivery.”
Treatment-emergent adverse events specific to sublingual apomorphine included oral mucosal erythema, lip or tongue swelling, and mouth ulceration (6% to 7% of patients each). Occurring less often were glossodynia, oral candidiasis, stomatitis, and tongue ulceration (2% each).
These were in addition to adverse events typically occurring with subcutaneous apomorphine, which are nausea, falls, dizziness, somnolence, dyskinesia, syncope, and yawning.
There are no head-to-head comparisons of sublingual versus subcutaneous delivery of apomorphine. But based on experience, Dr. Pahwa said, “With the subcutaneous, you have a slightly faster onset of action compared to the sublingual. However, sublingual has a slightly longer duration of benefit.”
He predicted that patients may prefer using an injection for a faster benefit or a sublingual for a slightly longer benefit.
More therapeutic options are welcome
Commenting on the study, Ray Dorsey, MD, professor of neurology at the University of Rochester (N.Y.), said that, for people with more advanced Parkinson’s disease “there’s usually a caregiver who’s injecting someone with an off period, as opposed to sublingual, which seems like a much easier way of administering a drug, especially for people with motor fluctuations.”
He noted that adverse events that led to premature discontinuation from the study “are concerning about the overall tolerability of the drug, which also will be determined in clinical practice, and will likely influence its overall utility.”
However, more therapeutic options are welcome because “the number of people with advanced Parkinson’s disease is going to grow and grow substantially,” he said. “So having therapies that help people with more advanced Parkinson’s disease ... many of whom don’t reach the clinic ... are going to be increasingly important.”
The study was supported by Sunovion. Dr. Pahwa and Dr. Dorsey reported conflicts of interest with numerous sources in industry.
A version of this article originally appeared on Medscape.com.
FROM MOVEMENT DISORDERS SOCIETY 2020
PARTNER registry valve-in-valve outcomes reassuring at 5 years
Transcatheter replacement of a failing surgical bioprosthetic valve showed durably favorable valve hemodynamics coupled with markedly improved patient functional status and excellent quality of life benefits at 5 years of follow-up in the prospective multicenter PARTNER 2 ViV Registry, Rebecca T. Hahn, MD, reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
She provided an update on previously reported 3-year outcomes in 365 patients at high to extreme surgical risk who underwent transcatheter aortic valve replacement (TAVR) with a 23-mm or 26-mm Sapien XT valve to address a failing surgical aortic bioprosthesis. The ViV (valve-in-valve) results are quite encouraging, she said at the meeting sponsored by the Cardiovascular Research Foundation.
“I think that this information is changing our algorithm for how we initially make treatment decisions in our patients,” according to the cardiologist.
“We now know that we can salvage a surgical bioprosthetic valve failure with a transcatheter procedure that is relatively safe and has good outcomes out to 5 years – and that’s with a second-generation TAVR valve, not even the third-generation valve,” observed Dr. Hahn, director of interventional echocardiography at New York–Presbyterian/Columbia University Medical Center and professor of clinical medicine at Columbia University, both in New York.
Interventionalists consider the third-generation valve, the Sapien 3, a superior platform compared to the Sapien 2 in use when the PARTNERS 2 ViV Registry started, she added.
At 5 years of follow-up since TAVR valve implantation, the all-cause mortality rate was 50.6%, up significantly from 32.7% at 3 years. However, this high mortality comes as no surprise given that registry participants had a profound comorbidity burden, as reflected in their mean Society of Thoracic Surgeons risk score of 9.1% at the time of TAVR. Of note, the 5-year mortality in surgically high- to extreme-risk patients in the ViV registry was comparable with the 45.9% rate at 5 years following TAVR of a native valve in intermediate-risk patients in the PARTNER 2b trial and superior to the 73% rate with TAVR of a native aortic valve in inoperable patients in PARTNER 2a, the cardiologist said.
The 5-year stroke rate in the ViV registry was 10.1%, up from 6.2% at 3 years. The cumulative incidence of death or stroke through 5 years was 53.8%.
Mortality was significantly lower in recipients of a 26-mm Sapien 2 valve than with the 23-mm version, at 40% at 5 years versus 53%. Recipients of the smaller valve were more often male, had a higher prevalence of coronary artery disease, a higher surgical risk score, a significantly smaller baseline aortic valve area, and a higher mean gradient. Dr. Hahn and her coinvestigators are now examining their data to determine if surgical valve size/patient mismatch was a major driver of adverse outcomes, as has been reported in some other datasets.
At 5 years, the rate of structural valve deterioration–related hemodynamic valve deterioration (SVD-HVD) or bioprosthetic valve failure (BVF) using the soon-to-be-published Valve Academic Research Consortium–3 definitions was 6.6%. The rates of each class of valve deterioration at 5 years in this high- to extreme-risk population were 1.2 per 100 patient-years for SVD-HVD, 0.88 per 100 patient-years for all BVF, and 0.4 per 100 patient-years for SVD-related BVF.
Fully 51% of 5-year survivors were NYHA functional class I, whereas more than 90% of patients were class III or IV at baseline. The mean gradient was 16.8 mm Hg at 5 years, the Doppler velocity index was 0.35, and the mean Kansas City Cardiomyopathy Questionnaire overall summary score was 74.2, all closely similar to the values at 3 years. That dramatic and sustained improvement in the Kansas City Cardiomyopathy Questionnaire from a baseline of 43.1 points is larger than ever seen in any clinical trial of native valve TAVR, Dr. Hahn noted.
For discussant Vinayak N. Bapat, MD a cardiothoracic surgeon at the Minneapolis Heart Institute Foundation, the 5-year PARTNER 2 follow-up data contains a clear take-home message: “These data show that, when we as surgeons are putting in small valves, we ought to put in valves that are expandable.”
Discussant Jeroen J. Bax, MD, had one major caveat regarding the PARTNER 2 ViV Registry findings: They focused on high-surgical-risk patients.
“I think we would all agree that in high-risk patients, valve-in-valve is a better option than redo surgery. But in young, low-risk patients who are getting a bioprosthetic valve – and we’re going to be seeing more and more of them because over 90% of patients in Europe getting aortic valve surgery now are getting a bioprosthetic valve – we really don’t know what the best option is,” said Dr. Bax, professor of cardiology at the University of Leiden (the Netherlands).
He suggested a randomized trial of TAVR versus redo surgery in low-risk patients with failing bioprosthetic valves is in order, particularly in light of concerns raised by a recent report from a French national patient registry. These were “high-quality, real-world data,” Dr. Bax said, and while they showed better early outcomes for TAVR ViV than with redo surgery, there was a crossing of the curves for heart failure hospitalization already by 2 years.
“We need to look closely at younger, low-risk patients,” he concluded.
The PARTNER 2 ViV Registry is funded by Edwards Lifesciences. Dr. Hahn reported receiving research support from Philips Healthcare and 3Mensio and honoraria from Boston Scientific, Edwards Lifesciences, and Philips Healthcare.
SOURCE: Hahn RT. TCT 2020, Late breaker.
Transcatheter replacement of a failing surgical bioprosthetic valve showed durably favorable valve hemodynamics coupled with markedly improved patient functional status and excellent quality of life benefits at 5 years of follow-up in the prospective multicenter PARTNER 2 ViV Registry, Rebecca T. Hahn, MD, reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
She provided an update on previously reported 3-year outcomes in 365 patients at high to extreme surgical risk who underwent transcatheter aortic valve replacement (TAVR) with a 23-mm or 26-mm Sapien XT valve to address a failing surgical aortic bioprosthesis. The ViV (valve-in-valve) results are quite encouraging, she said at the meeting sponsored by the Cardiovascular Research Foundation.
“I think that this information is changing our algorithm for how we initially make treatment decisions in our patients,” according to the cardiologist.
“We now know that we can salvage a surgical bioprosthetic valve failure with a transcatheter procedure that is relatively safe and has good outcomes out to 5 years – and that’s with a second-generation TAVR valve, not even the third-generation valve,” observed Dr. Hahn, director of interventional echocardiography at New York–Presbyterian/Columbia University Medical Center and professor of clinical medicine at Columbia University, both in New York.
Interventionalists consider the third-generation valve, the Sapien 3, a superior platform compared to the Sapien 2 in use when the PARTNERS 2 ViV Registry started, she added.
At 5 years of follow-up since TAVR valve implantation, the all-cause mortality rate was 50.6%, up significantly from 32.7% at 3 years. However, this high mortality comes as no surprise given that registry participants had a profound comorbidity burden, as reflected in their mean Society of Thoracic Surgeons risk score of 9.1% at the time of TAVR. Of note, the 5-year mortality in surgically high- to extreme-risk patients in the ViV registry was comparable with the 45.9% rate at 5 years following TAVR of a native valve in intermediate-risk patients in the PARTNER 2b trial and superior to the 73% rate with TAVR of a native aortic valve in inoperable patients in PARTNER 2a, the cardiologist said.
The 5-year stroke rate in the ViV registry was 10.1%, up from 6.2% at 3 years. The cumulative incidence of death or stroke through 5 years was 53.8%.
Mortality was significantly lower in recipients of a 26-mm Sapien 2 valve than with the 23-mm version, at 40% at 5 years versus 53%. Recipients of the smaller valve were more often male, had a higher prevalence of coronary artery disease, a higher surgical risk score, a significantly smaller baseline aortic valve area, and a higher mean gradient. Dr. Hahn and her coinvestigators are now examining their data to determine if surgical valve size/patient mismatch was a major driver of adverse outcomes, as has been reported in some other datasets.
At 5 years, the rate of structural valve deterioration–related hemodynamic valve deterioration (SVD-HVD) or bioprosthetic valve failure (BVF) using the soon-to-be-published Valve Academic Research Consortium–3 definitions was 6.6%. The rates of each class of valve deterioration at 5 years in this high- to extreme-risk population were 1.2 per 100 patient-years for SVD-HVD, 0.88 per 100 patient-years for all BVF, and 0.4 per 100 patient-years for SVD-related BVF.
Fully 51% of 5-year survivors were NYHA functional class I, whereas more than 90% of patients were class III or IV at baseline. The mean gradient was 16.8 mm Hg at 5 years, the Doppler velocity index was 0.35, and the mean Kansas City Cardiomyopathy Questionnaire overall summary score was 74.2, all closely similar to the values at 3 years. That dramatic and sustained improvement in the Kansas City Cardiomyopathy Questionnaire from a baseline of 43.1 points is larger than ever seen in any clinical trial of native valve TAVR, Dr. Hahn noted.
For discussant Vinayak N. Bapat, MD a cardiothoracic surgeon at the Minneapolis Heart Institute Foundation, the 5-year PARTNER 2 follow-up data contains a clear take-home message: “These data show that, when we as surgeons are putting in small valves, we ought to put in valves that are expandable.”
Discussant Jeroen J. Bax, MD, had one major caveat regarding the PARTNER 2 ViV Registry findings: They focused on high-surgical-risk patients.
“I think we would all agree that in high-risk patients, valve-in-valve is a better option than redo surgery. But in young, low-risk patients who are getting a bioprosthetic valve – and we’re going to be seeing more and more of them because over 90% of patients in Europe getting aortic valve surgery now are getting a bioprosthetic valve – we really don’t know what the best option is,” said Dr. Bax, professor of cardiology at the University of Leiden (the Netherlands).
He suggested a randomized trial of TAVR versus redo surgery in low-risk patients with failing bioprosthetic valves is in order, particularly in light of concerns raised by a recent report from a French national patient registry. These were “high-quality, real-world data,” Dr. Bax said, and while they showed better early outcomes for TAVR ViV than with redo surgery, there was a crossing of the curves for heart failure hospitalization already by 2 years.
“We need to look closely at younger, low-risk patients,” he concluded.
The PARTNER 2 ViV Registry is funded by Edwards Lifesciences. Dr. Hahn reported receiving research support from Philips Healthcare and 3Mensio and honoraria from Boston Scientific, Edwards Lifesciences, and Philips Healthcare.
SOURCE: Hahn RT. TCT 2020, Late breaker.
Transcatheter replacement of a failing surgical bioprosthetic valve showed durably favorable valve hemodynamics coupled with markedly improved patient functional status and excellent quality of life benefits at 5 years of follow-up in the prospective multicenter PARTNER 2 ViV Registry, Rebecca T. Hahn, MD, reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
She provided an update on previously reported 3-year outcomes in 365 patients at high to extreme surgical risk who underwent transcatheter aortic valve replacement (TAVR) with a 23-mm or 26-mm Sapien XT valve to address a failing surgical aortic bioprosthesis. The ViV (valve-in-valve) results are quite encouraging, she said at the meeting sponsored by the Cardiovascular Research Foundation.
“I think that this information is changing our algorithm for how we initially make treatment decisions in our patients,” according to the cardiologist.
“We now know that we can salvage a surgical bioprosthetic valve failure with a transcatheter procedure that is relatively safe and has good outcomes out to 5 years – and that’s with a second-generation TAVR valve, not even the third-generation valve,” observed Dr. Hahn, director of interventional echocardiography at New York–Presbyterian/Columbia University Medical Center and professor of clinical medicine at Columbia University, both in New York.
Interventionalists consider the third-generation valve, the Sapien 3, a superior platform compared to the Sapien 2 in use when the PARTNERS 2 ViV Registry started, she added.
At 5 years of follow-up since TAVR valve implantation, the all-cause mortality rate was 50.6%, up significantly from 32.7% at 3 years. However, this high mortality comes as no surprise given that registry participants had a profound comorbidity burden, as reflected in their mean Society of Thoracic Surgeons risk score of 9.1% at the time of TAVR. Of note, the 5-year mortality in surgically high- to extreme-risk patients in the ViV registry was comparable with the 45.9% rate at 5 years following TAVR of a native valve in intermediate-risk patients in the PARTNER 2b trial and superior to the 73% rate with TAVR of a native aortic valve in inoperable patients in PARTNER 2a, the cardiologist said.
The 5-year stroke rate in the ViV registry was 10.1%, up from 6.2% at 3 years. The cumulative incidence of death or stroke through 5 years was 53.8%.
Mortality was significantly lower in recipients of a 26-mm Sapien 2 valve than with the 23-mm version, at 40% at 5 years versus 53%. Recipients of the smaller valve were more often male, had a higher prevalence of coronary artery disease, a higher surgical risk score, a significantly smaller baseline aortic valve area, and a higher mean gradient. Dr. Hahn and her coinvestigators are now examining their data to determine if surgical valve size/patient mismatch was a major driver of adverse outcomes, as has been reported in some other datasets.
At 5 years, the rate of structural valve deterioration–related hemodynamic valve deterioration (SVD-HVD) or bioprosthetic valve failure (BVF) using the soon-to-be-published Valve Academic Research Consortium–3 definitions was 6.6%. The rates of each class of valve deterioration at 5 years in this high- to extreme-risk population were 1.2 per 100 patient-years for SVD-HVD, 0.88 per 100 patient-years for all BVF, and 0.4 per 100 patient-years for SVD-related BVF.
Fully 51% of 5-year survivors were NYHA functional class I, whereas more than 90% of patients were class III or IV at baseline. The mean gradient was 16.8 mm Hg at 5 years, the Doppler velocity index was 0.35, and the mean Kansas City Cardiomyopathy Questionnaire overall summary score was 74.2, all closely similar to the values at 3 years. That dramatic and sustained improvement in the Kansas City Cardiomyopathy Questionnaire from a baseline of 43.1 points is larger than ever seen in any clinical trial of native valve TAVR, Dr. Hahn noted.
For discussant Vinayak N. Bapat, MD a cardiothoracic surgeon at the Minneapolis Heart Institute Foundation, the 5-year PARTNER 2 follow-up data contains a clear take-home message: “These data show that, when we as surgeons are putting in small valves, we ought to put in valves that are expandable.”
Discussant Jeroen J. Bax, MD, had one major caveat regarding the PARTNER 2 ViV Registry findings: They focused on high-surgical-risk patients.
“I think we would all agree that in high-risk patients, valve-in-valve is a better option than redo surgery. But in young, low-risk patients who are getting a bioprosthetic valve – and we’re going to be seeing more and more of them because over 90% of patients in Europe getting aortic valve surgery now are getting a bioprosthetic valve – we really don’t know what the best option is,” said Dr. Bax, professor of cardiology at the University of Leiden (the Netherlands).
He suggested a randomized trial of TAVR versus redo surgery in low-risk patients with failing bioprosthetic valves is in order, particularly in light of concerns raised by a recent report from a French national patient registry. These were “high-quality, real-world data,” Dr. Bax said, and while they showed better early outcomes for TAVR ViV than with redo surgery, there was a crossing of the curves for heart failure hospitalization already by 2 years.
“We need to look closely at younger, low-risk patients,” he concluded.
The PARTNER 2 ViV Registry is funded by Edwards Lifesciences. Dr. Hahn reported receiving research support from Philips Healthcare and 3Mensio and honoraria from Boston Scientific, Edwards Lifesciences, and Philips Healthcare.
SOURCE: Hahn RT. TCT 2020, Late breaker.
FROM TCT 2020
MADIT-CRT: Resynchronization linked to fewer heart failure hospitalizations
Patients with mild heart failure who received a cardiac resynchronization device had significantly reduced rates of hospitalizations for heart failure during follow-up of 1,820 patients for an average of 5.6 years, identifying in this post hoc analysis another benefit from this device that patients potentially receive in addition to an established survival advantage.
Extended follow-up of patients enrolled in the MADIT-CRT trial showed that patients with either New York Heart Association (NYHA) class I or II cardiomyopathy who received a cardiac resynchronization device with a defibrillator (CRT-D) had a significant reduction in all-cause hospitalization during follow-up, compared with control patients randomized to receive an implantable cardioverter defibrillator (ICD) device. This reduction in all hospitalizations was specifically driven by a significant reduction in cardiovascular hospitalizations, and the drop in cardiovascular hospitalizations was specifically driven by a cut in hospitalizations for heart failure (HHF), Sabu Thomas, MD, said at the annual scientific meeting of the Heart Failure Society of America.
The data showed that during follow-up all-cause hospitalizations occurred in 73% of the CRT-D patients and 83% of those who received an ICD; cardiovascular hospitalizations happened in 29% of the CRT-D patients and in 43% of those with an ICD; and HHF occurred in 12% of the CRT-D patients and in 22% of those with an ICD, reported Dr. Thomas, a heart failure cardiologist at the University of Rochester (N.Y.) Medical Center. All three between-group differences were statistically significant for these post hoc endpoints.
These reduced hospitalizations also linked with better survival. Patients in the trial database with cardiovascular hospitalizations had a nearly fourfold higher rate of death, compared with nonhospitalized patients, Dr. Thomas said.
The findings “suggest that this device [CRT-D] has sustained benefit in these patients for up to 7 years,” said Dr. Thomas and his collaborator, Valentina Kutyifa, MD, in an interview. “However, this was only seen in patients with left bundle branch block [LBBB].” In patients with non-LBBB, CRT-D was not associated with a reduction in [cardiovascular] hospitalizations.
The LBBB connection
In a multivariate analysis, the 1,281 patients with LBBB (70% of the study cohort) who were more than 6 months out from device placement had a significant 43% relative cut in their incidence of cardiovascular hospitalizations, compared with that of control patients who received an ICD, while the 537 patients with non-LBBB showed no benefit from CRT-D treatment, compared with those who received an ICD, for reducing cardiovascular hospitalizations. (Data from two enrolled patients weren’t available for the analyses.) This finding that the HHF benefit focused in patients with LBBB was consistent with many prior observations that CRT-D was most effective in this patient subgroup.
The researchers also highlighted that their findings apply only to patients with NYHA functional class I or II heart failure with reduced ejection fraction (HFrEF), the only types of patients enrolled in the MADIT-CRT trial (15% had class I disease).
The results also showed that, during the first 6 months on CRT-D treatment, patients with a LBBB showed a significant 43% increase in their cardiovascular hospitalizations, compared with control patients, which may have been driven by device-related events. “We did not investigate this in detail, and it needs more study,” said Dr. Thomas and Dr. Kutyifa, a cardiac electrophysiologist at the University of Rochester.Their new findings extend the initial, prespecified results of the MADIT-CRT (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy) trial, which was designed to examine a primary endpoint of death from any cause or a nonfatal heart failure event. During the initial average follow-up of 2.4 years, patients who received a CRT-D device had a significant relative reduction in this endpoint of 34%, compared with patients on ICD treatment, exclusively in patients with LBBB. Extended follow-up for as long as 7 years of the same cohort showed a continued significant reduction of all-cause death compared with controls, a 41% relative risk reduction, that again was only apparent in patients with LBBB.
The MADIT-CRT findings are generally consistent with prevailing CRT-D recommendations from the American College of Cardiology and American Heart Association from 2013 that give a class I indication (“is indicated”) for using the device in heart failure patients with LBBB, a QRS interval of at least 150 msec, NYHA class II-IV function, and a left ventricular ejection fraction no greater than 35%. A lesser, class IIa recommendation (“can be useful”) exists for patients with a narrower QRS of 120-149 msec with the other class I criteria, and for patients with non-LBBB the recommendation drops to class IIb (“may be considered”).
CRT-D ‘is mysterious,’ especially for non-LBBB patients
“Every time researchers have tried to move beyond the [existing] paradigm of who benefits from CRT-D, it’s never panned out,” commented Jeffrey J. Goldberger, MD, an electrophysiologist, professor, and chief of the cardiovascular division at the University of Miami. “The guidelines are pretty correct on who should get CRT-D. I wouldn’t say that no patients with non-LBBB should get it, but they are less likely to benefit,” although he conceded that responses to CRT-D are highly individualized and hard to predict.
“CRT is mysterious. I’ve had patients who did incredibly well on it,” but “once you start getting outside of where the benefits are proven, you start to run into issues,” Dr. Goldberger said in an interview. “The only solid predictor of a CRT-D response is in patients with LBBB.”
The hospitalizations for heart failure that the University of Rochester investigators assessed as an additional study outcome represent an “important endpoint, but one that is much more subjective than survival,” making its reliability “a bit of a gray area,” he said. The analyses are also limited by being post hoc and, hence, just hypothesis generating.
A recently published analysis of the same dataset by many of the same investigators hinted that CRT-D might reduce HHF in non-LBBB patients when the focus is on recurrent hospitalizations.
Despite the evidence of a survival benefit from CRT-D placement in selected patients, especially those with LBBB, “registry data have shown that use of CRT-D varies widely and has been as low as 27% of eligible patients,” noted Dr. Thomas and Dr. Kutyifa. “There is an opportunity here to understand the barriers to more widespread adoption of CRT-D in appropriate patients,” they said. It is also “possible that CRT-D is overused in non-LBBB patients” given that this subgroup receives about a third of CRT-D devices now. “Future studies should carefully investigate the role of CRT-D in non-LBBB patients.”
MADIT-CRT was funded by Boston Scientific, which markets several CRT-D devices. Dr. Thomas had no disclosures. Dr. Kutyifa has been a consultant to Biotronik and Zoll and has received research funding from Biotronik, Boston Scientific, Spire, and Zoll. Dr Goldberger is director of a not-for-profit think tank on risk stratification for sudden cardiac death that has received unrestricted educational grants from Abbott, Biotronik, Boston Scientific, and Medtronic.
SOURCE: Thomas S et al. HFSA 2020, Abstract 019.
Patients with mild heart failure who received a cardiac resynchronization device had significantly reduced rates of hospitalizations for heart failure during follow-up of 1,820 patients for an average of 5.6 years, identifying in this post hoc analysis another benefit from this device that patients potentially receive in addition to an established survival advantage.
Extended follow-up of patients enrolled in the MADIT-CRT trial showed that patients with either New York Heart Association (NYHA) class I or II cardiomyopathy who received a cardiac resynchronization device with a defibrillator (CRT-D) had a significant reduction in all-cause hospitalization during follow-up, compared with control patients randomized to receive an implantable cardioverter defibrillator (ICD) device. This reduction in all hospitalizations was specifically driven by a significant reduction in cardiovascular hospitalizations, and the drop in cardiovascular hospitalizations was specifically driven by a cut in hospitalizations for heart failure (HHF), Sabu Thomas, MD, said at the annual scientific meeting of the Heart Failure Society of America.
The data showed that during follow-up all-cause hospitalizations occurred in 73% of the CRT-D patients and 83% of those who received an ICD; cardiovascular hospitalizations happened in 29% of the CRT-D patients and in 43% of those with an ICD; and HHF occurred in 12% of the CRT-D patients and in 22% of those with an ICD, reported Dr. Thomas, a heart failure cardiologist at the University of Rochester (N.Y.) Medical Center. All three between-group differences were statistically significant for these post hoc endpoints.
These reduced hospitalizations also linked with better survival. Patients in the trial database with cardiovascular hospitalizations had a nearly fourfold higher rate of death, compared with nonhospitalized patients, Dr. Thomas said.
The findings “suggest that this device [CRT-D] has sustained benefit in these patients for up to 7 years,” said Dr. Thomas and his collaborator, Valentina Kutyifa, MD, in an interview. “However, this was only seen in patients with left bundle branch block [LBBB].” In patients with non-LBBB, CRT-D was not associated with a reduction in [cardiovascular] hospitalizations.
The LBBB connection
In a multivariate analysis, the 1,281 patients with LBBB (70% of the study cohort) who were more than 6 months out from device placement had a significant 43% relative cut in their incidence of cardiovascular hospitalizations, compared with that of control patients who received an ICD, while the 537 patients with non-LBBB showed no benefit from CRT-D treatment, compared with those who received an ICD, for reducing cardiovascular hospitalizations. (Data from two enrolled patients weren’t available for the analyses.) This finding that the HHF benefit focused in patients with LBBB was consistent with many prior observations that CRT-D was most effective in this patient subgroup.
The researchers also highlighted that their findings apply only to patients with NYHA functional class I or II heart failure with reduced ejection fraction (HFrEF), the only types of patients enrolled in the MADIT-CRT trial (15% had class I disease).
The results also showed that, during the first 6 months on CRT-D treatment, patients with a LBBB showed a significant 43% increase in their cardiovascular hospitalizations, compared with control patients, which may have been driven by device-related events. “We did not investigate this in detail, and it needs more study,” said Dr. Thomas and Dr. Kutyifa, a cardiac electrophysiologist at the University of Rochester.Their new findings extend the initial, prespecified results of the MADIT-CRT (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy) trial, which was designed to examine a primary endpoint of death from any cause or a nonfatal heart failure event. During the initial average follow-up of 2.4 years, patients who received a CRT-D device had a significant relative reduction in this endpoint of 34%, compared with patients on ICD treatment, exclusively in patients with LBBB. Extended follow-up for as long as 7 years of the same cohort showed a continued significant reduction of all-cause death compared with controls, a 41% relative risk reduction, that again was only apparent in patients with LBBB.
The MADIT-CRT findings are generally consistent with prevailing CRT-D recommendations from the American College of Cardiology and American Heart Association from 2013 that give a class I indication (“is indicated”) for using the device in heart failure patients with LBBB, a QRS interval of at least 150 msec, NYHA class II-IV function, and a left ventricular ejection fraction no greater than 35%. A lesser, class IIa recommendation (“can be useful”) exists for patients with a narrower QRS of 120-149 msec with the other class I criteria, and for patients with non-LBBB the recommendation drops to class IIb (“may be considered”).
CRT-D ‘is mysterious,’ especially for non-LBBB patients
“Every time researchers have tried to move beyond the [existing] paradigm of who benefits from CRT-D, it’s never panned out,” commented Jeffrey J. Goldberger, MD, an electrophysiologist, professor, and chief of the cardiovascular division at the University of Miami. “The guidelines are pretty correct on who should get CRT-D. I wouldn’t say that no patients with non-LBBB should get it, but they are less likely to benefit,” although he conceded that responses to CRT-D are highly individualized and hard to predict.
“CRT is mysterious. I’ve had patients who did incredibly well on it,” but “once you start getting outside of where the benefits are proven, you start to run into issues,” Dr. Goldberger said in an interview. “The only solid predictor of a CRT-D response is in patients with LBBB.”
The hospitalizations for heart failure that the University of Rochester investigators assessed as an additional study outcome represent an “important endpoint, but one that is much more subjective than survival,” making its reliability “a bit of a gray area,” he said. The analyses are also limited by being post hoc and, hence, just hypothesis generating.
A recently published analysis of the same dataset by many of the same investigators hinted that CRT-D might reduce HHF in non-LBBB patients when the focus is on recurrent hospitalizations.
Despite the evidence of a survival benefit from CRT-D placement in selected patients, especially those with LBBB, “registry data have shown that use of CRT-D varies widely and has been as low as 27% of eligible patients,” noted Dr. Thomas and Dr. Kutyifa. “There is an opportunity here to understand the barriers to more widespread adoption of CRT-D in appropriate patients,” they said. It is also “possible that CRT-D is overused in non-LBBB patients” given that this subgroup receives about a third of CRT-D devices now. “Future studies should carefully investigate the role of CRT-D in non-LBBB patients.”
MADIT-CRT was funded by Boston Scientific, which markets several CRT-D devices. Dr. Thomas had no disclosures. Dr. Kutyifa has been a consultant to Biotronik and Zoll and has received research funding from Biotronik, Boston Scientific, Spire, and Zoll. Dr Goldberger is director of a not-for-profit think tank on risk stratification for sudden cardiac death that has received unrestricted educational grants from Abbott, Biotronik, Boston Scientific, and Medtronic.
SOURCE: Thomas S et al. HFSA 2020, Abstract 019.
Patients with mild heart failure who received a cardiac resynchronization device had significantly reduced rates of hospitalizations for heart failure during follow-up of 1,820 patients for an average of 5.6 years, identifying in this post hoc analysis another benefit from this device that patients potentially receive in addition to an established survival advantage.
Extended follow-up of patients enrolled in the MADIT-CRT trial showed that patients with either New York Heart Association (NYHA) class I or II cardiomyopathy who received a cardiac resynchronization device with a defibrillator (CRT-D) had a significant reduction in all-cause hospitalization during follow-up, compared with control patients randomized to receive an implantable cardioverter defibrillator (ICD) device. This reduction in all hospitalizations was specifically driven by a significant reduction in cardiovascular hospitalizations, and the drop in cardiovascular hospitalizations was specifically driven by a cut in hospitalizations for heart failure (HHF), Sabu Thomas, MD, said at the annual scientific meeting of the Heart Failure Society of America.
The data showed that during follow-up all-cause hospitalizations occurred in 73% of the CRT-D patients and 83% of those who received an ICD; cardiovascular hospitalizations happened in 29% of the CRT-D patients and in 43% of those with an ICD; and HHF occurred in 12% of the CRT-D patients and in 22% of those with an ICD, reported Dr. Thomas, a heart failure cardiologist at the University of Rochester (N.Y.) Medical Center. All three between-group differences were statistically significant for these post hoc endpoints.
These reduced hospitalizations also linked with better survival. Patients in the trial database with cardiovascular hospitalizations had a nearly fourfold higher rate of death, compared with nonhospitalized patients, Dr. Thomas said.
The findings “suggest that this device [CRT-D] has sustained benefit in these patients for up to 7 years,” said Dr. Thomas and his collaborator, Valentina Kutyifa, MD, in an interview. “However, this was only seen in patients with left bundle branch block [LBBB].” In patients with non-LBBB, CRT-D was not associated with a reduction in [cardiovascular] hospitalizations.
The LBBB connection
In a multivariate analysis, the 1,281 patients with LBBB (70% of the study cohort) who were more than 6 months out from device placement had a significant 43% relative cut in their incidence of cardiovascular hospitalizations, compared with that of control patients who received an ICD, while the 537 patients with non-LBBB showed no benefit from CRT-D treatment, compared with those who received an ICD, for reducing cardiovascular hospitalizations. (Data from two enrolled patients weren’t available for the analyses.) This finding that the HHF benefit focused in patients with LBBB was consistent with many prior observations that CRT-D was most effective in this patient subgroup.
The researchers also highlighted that their findings apply only to patients with NYHA functional class I or II heart failure with reduced ejection fraction (HFrEF), the only types of patients enrolled in the MADIT-CRT trial (15% had class I disease).
The results also showed that, during the first 6 months on CRT-D treatment, patients with a LBBB showed a significant 43% increase in their cardiovascular hospitalizations, compared with control patients, which may have been driven by device-related events. “We did not investigate this in detail, and it needs more study,” said Dr. Thomas and Dr. Kutyifa, a cardiac electrophysiologist at the University of Rochester.Their new findings extend the initial, prespecified results of the MADIT-CRT (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy) trial, which was designed to examine a primary endpoint of death from any cause or a nonfatal heart failure event. During the initial average follow-up of 2.4 years, patients who received a CRT-D device had a significant relative reduction in this endpoint of 34%, compared with patients on ICD treatment, exclusively in patients with LBBB. Extended follow-up for as long as 7 years of the same cohort showed a continued significant reduction of all-cause death compared with controls, a 41% relative risk reduction, that again was only apparent in patients with LBBB.
The MADIT-CRT findings are generally consistent with prevailing CRT-D recommendations from the American College of Cardiology and American Heart Association from 2013 that give a class I indication (“is indicated”) for using the device in heart failure patients with LBBB, a QRS interval of at least 150 msec, NYHA class II-IV function, and a left ventricular ejection fraction no greater than 35%. A lesser, class IIa recommendation (“can be useful”) exists for patients with a narrower QRS of 120-149 msec with the other class I criteria, and for patients with non-LBBB the recommendation drops to class IIb (“may be considered”).
CRT-D ‘is mysterious,’ especially for non-LBBB patients
“Every time researchers have tried to move beyond the [existing] paradigm of who benefits from CRT-D, it’s never panned out,” commented Jeffrey J. Goldberger, MD, an electrophysiologist, professor, and chief of the cardiovascular division at the University of Miami. “The guidelines are pretty correct on who should get CRT-D. I wouldn’t say that no patients with non-LBBB should get it, but they are less likely to benefit,” although he conceded that responses to CRT-D are highly individualized and hard to predict.
“CRT is mysterious. I’ve had patients who did incredibly well on it,” but “once you start getting outside of where the benefits are proven, you start to run into issues,” Dr. Goldberger said in an interview. “The only solid predictor of a CRT-D response is in patients with LBBB.”
The hospitalizations for heart failure that the University of Rochester investigators assessed as an additional study outcome represent an “important endpoint, but one that is much more subjective than survival,” making its reliability “a bit of a gray area,” he said. The analyses are also limited by being post hoc and, hence, just hypothesis generating.
A recently published analysis of the same dataset by many of the same investigators hinted that CRT-D might reduce HHF in non-LBBB patients when the focus is on recurrent hospitalizations.
Despite the evidence of a survival benefit from CRT-D placement in selected patients, especially those with LBBB, “registry data have shown that use of CRT-D varies widely and has been as low as 27% of eligible patients,” noted Dr. Thomas and Dr. Kutyifa. “There is an opportunity here to understand the barriers to more widespread adoption of CRT-D in appropriate patients,” they said. It is also “possible that CRT-D is overused in non-LBBB patients” given that this subgroup receives about a third of CRT-D devices now. “Future studies should carefully investigate the role of CRT-D in non-LBBB patients.”
MADIT-CRT was funded by Boston Scientific, which markets several CRT-D devices. Dr. Thomas had no disclosures. Dr. Kutyifa has been a consultant to Biotronik and Zoll and has received research funding from Biotronik, Boston Scientific, Spire, and Zoll. Dr Goldberger is director of a not-for-profit think tank on risk stratification for sudden cardiac death that has received unrestricted educational grants from Abbott, Biotronik, Boston Scientific, and Medtronic.
SOURCE: Thomas S et al. HFSA 2020, Abstract 019.
FROM HFSA 2020
Survey finds European dermatologists unhappy with pandemic teledermatology experience
intensely, according to the findings of a survey presented at the virtual annual congress of the European Academy of Dermatology and Venereology.
“The results of our survey clearly show 7 out of 10 participating dermatologists declared that they were not happy with teledermatology, and most of them declared that they were not at all happy,” according to Mariano Suppa, MD, PhD, of the department of dermatology and venereology, Free University of Brussels.
“It was very interesting: it was not just about the lack of a good quality of consultation, but was also related to some extent to a lack of respect from some patients, and also a lack of empathy. The majority of survey respondents felt [attacked] by their own patients because they were proposing teledermatology. So, yes, we were forced to go to teledermatology, and I think we will be again to some extent, but clearly we’re not happy about it,” he elaborated in response to a question from session chair Brigitte Dreno, MD, professor of dermatology and vice dean of the faculty of medicine at the University of Nantes (France).
The survey, conducted by the EADV communication committee, assessed the pandemic’s impact on European dermatologists’ professional practices and personal lives through 30 brief questions, with space at the end for additional open-ended comments. In the comments section, many dermatologists vented about their income loss, the disorganized response to round one of the pandemic, and most of all about teledermatology. Common complaints were that teledermatology required a huge consumption of energy and constituted a major intrusion upon the physicians’ personal lives. And then there was the common theme of unkind treatment by some patients.
The survey was sent twice in June 2020 to more than 4,800 EADV members. It was completed by 490 dermatologists from 39 countries. Dr. Suppa attributed the low response rate to physician weariness of the topic due to saturation news media coverage of the pandemic.
Sixty-nine percent of responding dermatologists were women. Fifty-two percent of participants were over age 50, 81% lived in a city, and 53% worked in a university or public hospital or clinic. Twelve percent lived alone.
Impact on professional practice
Many European dermatologists were on the front lines in dealing with the first wave of COVID-19. Twenty-eight percent worked in a COVID-19 unit. Forty-eight percent of dermatologists performed COVID-19 tests, and those who didn’t either had no patient contact or couldn’t get test kits. Thirty-five percent of dermatologists saw patients who presented with skin signs of COVID-19. Four percent of survey respondents became infected.
Seventy percent rescheduled or canceled all or most patient appointments. Clinical care was prioritized: during the peak of the pandemic, 76% of dermatologists saw only urgent cases – mostly potentially serious rashes – and dermato-oncology patients. Seventy-six percent of dermatologists performed teledermatology, although by June 60% of respondents reported seeing at least three-quarters of their patients face-to-face.
Twenty-three percent of dermatologists reported having lost most or all of their income during March through June, and another 26% lost about half.
Impact on dermatologists’ personal lives
About half of survey respondents reported feeling stressed, and a similar percentage checked the box marked ‘anxiety.’ Nine percent reported depressive symptoms, 15% mentioned feeling anger, 17% uselessness, and 2% admitted suicidal ideation. But 30% of dermatologists reported experiencing no negative psychological effects whatsoever stemming from the pandemic.
Sixteen percent of dermatologists reported drinking more alcohol during sequestration.
But respondents cited positive effects as well: a renewed appreciation of the importance of time, and enjoyment of the additional time spent with family and alone. Many dermatologists relished the opportunity to spend more time cooking, reading literature, doing research, listening to or playing music, and practicing yoga or meditation. And dermatologists took solace and pride in being members of the vital medical community.
Dr. Dreno asked if the survey revealed evidence of underdiagnosis and undertreatment of dermatologic diseases during the pandemic. Dr. Suppa replied that the survey didn’t address that issue, but it’s his personal opinion that this was no doubt the case. Roughly one-quarter of dermatologists canceled all appointments, and when dermatology clinics became filled beginning in June, he and his colleagues saw a number of cases of delayed-diagnosis advanced skin cancer.
“I think that the diseases that were really penalized were the chronic inflammatory diseases, such as psoriasis, hidradenitis suppurativa, and also atopic dermatitis. We were doing a lot of telephone consultations for those patients at that time, and we saw in June that for those particular patients there was an unmet need in the pandemic because some of them really needed to have been seen. I think this is a lesson we should learn for the second wave that we’re unfortunately facing right now: We need to adopt restrictive measures to avoid spreading the pandemic, yes, for sure, but we need to keep in mind that there is not just COVID-19, but also other important diseases,” Dr. Suppa said.
A second EADV survey will be performed during the fall/winter wave of the pandemic.
Dr. Suppa reported having no financial conflicts regarding the EADV-funded survey.
SOURCE: Suppa M. EADV 2020. Presentation D3T03.4D
intensely, according to the findings of a survey presented at the virtual annual congress of the European Academy of Dermatology and Venereology.
“The results of our survey clearly show 7 out of 10 participating dermatologists declared that they were not happy with teledermatology, and most of them declared that they were not at all happy,” according to Mariano Suppa, MD, PhD, of the department of dermatology and venereology, Free University of Brussels.
“It was very interesting: it was not just about the lack of a good quality of consultation, but was also related to some extent to a lack of respect from some patients, and also a lack of empathy. The majority of survey respondents felt [attacked] by their own patients because they were proposing teledermatology. So, yes, we were forced to go to teledermatology, and I think we will be again to some extent, but clearly we’re not happy about it,” he elaborated in response to a question from session chair Brigitte Dreno, MD, professor of dermatology and vice dean of the faculty of medicine at the University of Nantes (France).
The survey, conducted by the EADV communication committee, assessed the pandemic’s impact on European dermatologists’ professional practices and personal lives through 30 brief questions, with space at the end for additional open-ended comments. In the comments section, many dermatologists vented about their income loss, the disorganized response to round one of the pandemic, and most of all about teledermatology. Common complaints were that teledermatology required a huge consumption of energy and constituted a major intrusion upon the physicians’ personal lives. And then there was the common theme of unkind treatment by some patients.
The survey was sent twice in June 2020 to more than 4,800 EADV members. It was completed by 490 dermatologists from 39 countries. Dr. Suppa attributed the low response rate to physician weariness of the topic due to saturation news media coverage of the pandemic.
Sixty-nine percent of responding dermatologists were women. Fifty-two percent of participants were over age 50, 81% lived in a city, and 53% worked in a university or public hospital or clinic. Twelve percent lived alone.
Impact on professional practice
Many European dermatologists were on the front lines in dealing with the first wave of COVID-19. Twenty-eight percent worked in a COVID-19 unit. Forty-eight percent of dermatologists performed COVID-19 tests, and those who didn’t either had no patient contact or couldn’t get test kits. Thirty-five percent of dermatologists saw patients who presented with skin signs of COVID-19. Four percent of survey respondents became infected.
Seventy percent rescheduled or canceled all or most patient appointments. Clinical care was prioritized: during the peak of the pandemic, 76% of dermatologists saw only urgent cases – mostly potentially serious rashes – and dermato-oncology patients. Seventy-six percent of dermatologists performed teledermatology, although by June 60% of respondents reported seeing at least three-quarters of their patients face-to-face.
Twenty-three percent of dermatologists reported having lost most or all of their income during March through June, and another 26% lost about half.
Impact on dermatologists’ personal lives
About half of survey respondents reported feeling stressed, and a similar percentage checked the box marked ‘anxiety.’ Nine percent reported depressive symptoms, 15% mentioned feeling anger, 17% uselessness, and 2% admitted suicidal ideation. But 30% of dermatologists reported experiencing no negative psychological effects whatsoever stemming from the pandemic.
Sixteen percent of dermatologists reported drinking more alcohol during sequestration.
But respondents cited positive effects as well: a renewed appreciation of the importance of time, and enjoyment of the additional time spent with family and alone. Many dermatologists relished the opportunity to spend more time cooking, reading literature, doing research, listening to or playing music, and practicing yoga or meditation. And dermatologists took solace and pride in being members of the vital medical community.
Dr. Dreno asked if the survey revealed evidence of underdiagnosis and undertreatment of dermatologic diseases during the pandemic. Dr. Suppa replied that the survey didn’t address that issue, but it’s his personal opinion that this was no doubt the case. Roughly one-quarter of dermatologists canceled all appointments, and when dermatology clinics became filled beginning in June, he and his colleagues saw a number of cases of delayed-diagnosis advanced skin cancer.
“I think that the diseases that were really penalized were the chronic inflammatory diseases, such as psoriasis, hidradenitis suppurativa, and also atopic dermatitis. We were doing a lot of telephone consultations for those patients at that time, and we saw in June that for those particular patients there was an unmet need in the pandemic because some of them really needed to have been seen. I think this is a lesson we should learn for the second wave that we’re unfortunately facing right now: We need to adopt restrictive measures to avoid spreading the pandemic, yes, for sure, but we need to keep in mind that there is not just COVID-19, but also other important diseases,” Dr. Suppa said.
A second EADV survey will be performed during the fall/winter wave of the pandemic.
Dr. Suppa reported having no financial conflicts regarding the EADV-funded survey.
SOURCE: Suppa M. EADV 2020. Presentation D3T03.4D
intensely, according to the findings of a survey presented at the virtual annual congress of the European Academy of Dermatology and Venereology.
“The results of our survey clearly show 7 out of 10 participating dermatologists declared that they were not happy with teledermatology, and most of them declared that they were not at all happy,” according to Mariano Suppa, MD, PhD, of the department of dermatology and venereology, Free University of Brussels.
“It was very interesting: it was not just about the lack of a good quality of consultation, but was also related to some extent to a lack of respect from some patients, and also a lack of empathy. The majority of survey respondents felt [attacked] by their own patients because they were proposing teledermatology. So, yes, we were forced to go to teledermatology, and I think we will be again to some extent, but clearly we’re not happy about it,” he elaborated in response to a question from session chair Brigitte Dreno, MD, professor of dermatology and vice dean of the faculty of medicine at the University of Nantes (France).
The survey, conducted by the EADV communication committee, assessed the pandemic’s impact on European dermatologists’ professional practices and personal lives through 30 brief questions, with space at the end for additional open-ended comments. In the comments section, many dermatologists vented about their income loss, the disorganized response to round one of the pandemic, and most of all about teledermatology. Common complaints were that teledermatology required a huge consumption of energy and constituted a major intrusion upon the physicians’ personal lives. And then there was the common theme of unkind treatment by some patients.
The survey was sent twice in June 2020 to more than 4,800 EADV members. It was completed by 490 dermatologists from 39 countries. Dr. Suppa attributed the low response rate to physician weariness of the topic due to saturation news media coverage of the pandemic.
Sixty-nine percent of responding dermatologists were women. Fifty-two percent of participants were over age 50, 81% lived in a city, and 53% worked in a university or public hospital or clinic. Twelve percent lived alone.
Impact on professional practice
Many European dermatologists were on the front lines in dealing with the first wave of COVID-19. Twenty-eight percent worked in a COVID-19 unit. Forty-eight percent of dermatologists performed COVID-19 tests, and those who didn’t either had no patient contact or couldn’t get test kits. Thirty-five percent of dermatologists saw patients who presented with skin signs of COVID-19. Four percent of survey respondents became infected.
Seventy percent rescheduled or canceled all or most patient appointments. Clinical care was prioritized: during the peak of the pandemic, 76% of dermatologists saw only urgent cases – mostly potentially serious rashes – and dermato-oncology patients. Seventy-six percent of dermatologists performed teledermatology, although by June 60% of respondents reported seeing at least three-quarters of their patients face-to-face.
Twenty-three percent of dermatologists reported having lost most or all of their income during March through June, and another 26% lost about half.
Impact on dermatologists’ personal lives
About half of survey respondents reported feeling stressed, and a similar percentage checked the box marked ‘anxiety.’ Nine percent reported depressive symptoms, 15% mentioned feeling anger, 17% uselessness, and 2% admitted suicidal ideation. But 30% of dermatologists reported experiencing no negative psychological effects whatsoever stemming from the pandemic.
Sixteen percent of dermatologists reported drinking more alcohol during sequestration.
But respondents cited positive effects as well: a renewed appreciation of the importance of time, and enjoyment of the additional time spent with family and alone. Many dermatologists relished the opportunity to spend more time cooking, reading literature, doing research, listening to or playing music, and practicing yoga or meditation. And dermatologists took solace and pride in being members of the vital medical community.
Dr. Dreno asked if the survey revealed evidence of underdiagnosis and undertreatment of dermatologic diseases during the pandemic. Dr. Suppa replied that the survey didn’t address that issue, but it’s his personal opinion that this was no doubt the case. Roughly one-quarter of dermatologists canceled all appointments, and when dermatology clinics became filled beginning in June, he and his colleagues saw a number of cases of delayed-diagnosis advanced skin cancer.
“I think that the diseases that were really penalized were the chronic inflammatory diseases, such as psoriasis, hidradenitis suppurativa, and also atopic dermatitis. We were doing a lot of telephone consultations for those patients at that time, and we saw in June that for those particular patients there was an unmet need in the pandemic because some of them really needed to have been seen. I think this is a lesson we should learn for the second wave that we’re unfortunately facing right now: We need to adopt restrictive measures to avoid spreading the pandemic, yes, for sure, but we need to keep in mind that there is not just COVID-19, but also other important diseases,” Dr. Suppa said.
A second EADV survey will be performed during the fall/winter wave of the pandemic.
Dr. Suppa reported having no financial conflicts regarding the EADV-funded survey.
SOURCE: Suppa M. EADV 2020. Presentation D3T03.4D
FROM THE EADV CONGRESS
IMRT new standard of care for high-risk cervical cancer
“IG-IMRT should represent the new standard of care for postoperative pelvic radiation therapy in women with gynecological cancers,” said study lead author Supriya Chopra, MD, of the Tata Memorial Center in Mumbai, India.
She noted that the study, known as PARCER, is the first in gynecologic cancer to show the impact of advanced technology in reducing long-term morbidity and thus improving the experience of survivors.
At 4 years, rates of late GI toxicity of grade 2 or higher in the IG-IMRT and 3D-CRT arms were 19.2% and 36.2%, respectively (P = .005). Rates of toxicity of grade 3 or higher were 2.0% and 8.7%, respectively (P < .01).
Chopra presented the results at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online.
Postoperative radiotherapy is indicated for women with cervical and endometrial cancers who have high-risk features, but long-term follow-up has shown an increase in GI symptom burden and toxicity in long-term survivors after adjuvant radiotherapy.
“The uptake of IMRT has been relatively slow in gynecological cancers,” said Chopra. She explained that previous data suggested a benefit with the use of IMRT, but long-term postoperative effects were unclear.
The new data amount to a “practice-change use” of IMRT for this indication, said Sue Yom, MD, PhD, of the University of California, San Francisco, who was not involved with the study. “I see this as having potentially important future impacts on clinical practice.”
Yom explained that, although there have been studies in the United States on the use of postoperative IMRT for pelvic cancer, “this is the first phase 3 study that has shown definite long-term advantages with the use of IMRT, and I would consider it confirmatory.”
In 2015, the preliminary results of PARCER were presented at the plenary session at ASTRO. The results showed that patients treated with IG-IMRT had fewer late GI toxicities at a median follow-up of 20 months. However, the difference between groups was not statistically significant in this earlier analysis.
Now at 49 months’ follow-up
The study was conducted in three clinical sites of Tata Memorial Center and included a total of 300 patients with cervical cancer. The patients had undergone type III hysterectomy and had intermediate- or high-risk features, or they had undergone type I/II hysterectomy necessitating adjuvant chemoradiotherapy. They were randomly assigned to IG-IMRT (n = 151) or 3D-CRT (n = 149). Most patients (117 in the IG-IMRT arm and 114 in the 3D-CRT arm) received concurrent chemotherapy.
The primary endpoint was late GI toxicity of grade 2 or higher. Follow-up included clinical and quality-of-life evaluations, which were conducted every 3 months for 2 years and then every 6 months for years 2 to 5.
Chopra and colleagues evaluated 11 different GI-related side effects. Differences emerged over time between the two groups. Among the group that received IG-IMRT, significantly fewer patients reported moderate to severe acute diarrhea (17% in the IG-IMRT arm vs 27% in the 3D-CRT arm), late abdominal bloating (14% vs 28%), bowel obstruction (1% vs 7%), and anorexia/appetite loss (1% vs 7%).
Overall, for patients treated with IG-IMRT, grade 2 toxicity–free survival rates were significantly higher (78% with IG-IMRT vs 57% with 3D-CRT; P = .0009), as were grade 3 toxicity–free survival rates (97.6% vs 81.6%; P = .001).
As noted above, rates of disease-free survival were similar for both groups (73% with image-guided IMRT vs 68% with 3D-CRT; P = .30).
Funding for the study was provided by the Department of Science and Technology and the Department of Atomic Energy, Clinical Trials Center, in India, and by Varian International and the Terry Fox Foundation. Chopra and Yom have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
“IG-IMRT should represent the new standard of care for postoperative pelvic radiation therapy in women with gynecological cancers,” said study lead author Supriya Chopra, MD, of the Tata Memorial Center in Mumbai, India.
She noted that the study, known as PARCER, is the first in gynecologic cancer to show the impact of advanced technology in reducing long-term morbidity and thus improving the experience of survivors.
At 4 years, rates of late GI toxicity of grade 2 or higher in the IG-IMRT and 3D-CRT arms were 19.2% and 36.2%, respectively (P = .005). Rates of toxicity of grade 3 or higher were 2.0% and 8.7%, respectively (P < .01).
Chopra presented the results at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online.
Postoperative radiotherapy is indicated for women with cervical and endometrial cancers who have high-risk features, but long-term follow-up has shown an increase in GI symptom burden and toxicity in long-term survivors after adjuvant radiotherapy.
“The uptake of IMRT has been relatively slow in gynecological cancers,” said Chopra. She explained that previous data suggested a benefit with the use of IMRT, but long-term postoperative effects were unclear.
The new data amount to a “practice-change use” of IMRT for this indication, said Sue Yom, MD, PhD, of the University of California, San Francisco, who was not involved with the study. “I see this as having potentially important future impacts on clinical practice.”
Yom explained that, although there have been studies in the United States on the use of postoperative IMRT for pelvic cancer, “this is the first phase 3 study that has shown definite long-term advantages with the use of IMRT, and I would consider it confirmatory.”
In 2015, the preliminary results of PARCER were presented at the plenary session at ASTRO. The results showed that patients treated with IG-IMRT had fewer late GI toxicities at a median follow-up of 20 months. However, the difference between groups was not statistically significant in this earlier analysis.
Now at 49 months’ follow-up
The study was conducted in three clinical sites of Tata Memorial Center and included a total of 300 patients with cervical cancer. The patients had undergone type III hysterectomy and had intermediate- or high-risk features, or they had undergone type I/II hysterectomy necessitating adjuvant chemoradiotherapy. They were randomly assigned to IG-IMRT (n = 151) or 3D-CRT (n = 149). Most patients (117 in the IG-IMRT arm and 114 in the 3D-CRT arm) received concurrent chemotherapy.
The primary endpoint was late GI toxicity of grade 2 or higher. Follow-up included clinical and quality-of-life evaluations, which were conducted every 3 months for 2 years and then every 6 months for years 2 to 5.
Chopra and colleagues evaluated 11 different GI-related side effects. Differences emerged over time between the two groups. Among the group that received IG-IMRT, significantly fewer patients reported moderate to severe acute diarrhea (17% in the IG-IMRT arm vs 27% in the 3D-CRT arm), late abdominal bloating (14% vs 28%), bowel obstruction (1% vs 7%), and anorexia/appetite loss (1% vs 7%).
Overall, for patients treated with IG-IMRT, grade 2 toxicity–free survival rates were significantly higher (78% with IG-IMRT vs 57% with 3D-CRT; P = .0009), as were grade 3 toxicity–free survival rates (97.6% vs 81.6%; P = .001).
As noted above, rates of disease-free survival were similar for both groups (73% with image-guided IMRT vs 68% with 3D-CRT; P = .30).
Funding for the study was provided by the Department of Science and Technology and the Department of Atomic Energy, Clinical Trials Center, in India, and by Varian International and the Terry Fox Foundation. Chopra and Yom have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
“IG-IMRT should represent the new standard of care for postoperative pelvic radiation therapy in women with gynecological cancers,” said study lead author Supriya Chopra, MD, of the Tata Memorial Center in Mumbai, India.
She noted that the study, known as PARCER, is the first in gynecologic cancer to show the impact of advanced technology in reducing long-term morbidity and thus improving the experience of survivors.
At 4 years, rates of late GI toxicity of grade 2 or higher in the IG-IMRT and 3D-CRT arms were 19.2% and 36.2%, respectively (P = .005). Rates of toxicity of grade 3 or higher were 2.0% and 8.7%, respectively (P < .01).
Chopra presented the results at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online.
Postoperative radiotherapy is indicated for women with cervical and endometrial cancers who have high-risk features, but long-term follow-up has shown an increase in GI symptom burden and toxicity in long-term survivors after adjuvant radiotherapy.
“The uptake of IMRT has been relatively slow in gynecological cancers,” said Chopra. She explained that previous data suggested a benefit with the use of IMRT, but long-term postoperative effects were unclear.
The new data amount to a “practice-change use” of IMRT for this indication, said Sue Yom, MD, PhD, of the University of California, San Francisco, who was not involved with the study. “I see this as having potentially important future impacts on clinical practice.”
Yom explained that, although there have been studies in the United States on the use of postoperative IMRT for pelvic cancer, “this is the first phase 3 study that has shown definite long-term advantages with the use of IMRT, and I would consider it confirmatory.”
In 2015, the preliminary results of PARCER were presented at the plenary session at ASTRO. The results showed that patients treated with IG-IMRT had fewer late GI toxicities at a median follow-up of 20 months. However, the difference between groups was not statistically significant in this earlier analysis.
Now at 49 months’ follow-up
The study was conducted in three clinical sites of Tata Memorial Center and included a total of 300 patients with cervical cancer. The patients had undergone type III hysterectomy and had intermediate- or high-risk features, or they had undergone type I/II hysterectomy necessitating adjuvant chemoradiotherapy. They were randomly assigned to IG-IMRT (n = 151) or 3D-CRT (n = 149). Most patients (117 in the IG-IMRT arm and 114 in the 3D-CRT arm) received concurrent chemotherapy.
The primary endpoint was late GI toxicity of grade 2 or higher. Follow-up included clinical and quality-of-life evaluations, which were conducted every 3 months for 2 years and then every 6 months for years 2 to 5.
Chopra and colleagues evaluated 11 different GI-related side effects. Differences emerged over time between the two groups. Among the group that received IG-IMRT, significantly fewer patients reported moderate to severe acute diarrhea (17% in the IG-IMRT arm vs 27% in the 3D-CRT arm), late abdominal bloating (14% vs 28%), bowel obstruction (1% vs 7%), and anorexia/appetite loss (1% vs 7%).
Overall, for patients treated with IG-IMRT, grade 2 toxicity–free survival rates were significantly higher (78% with IG-IMRT vs 57% with 3D-CRT; P = .0009), as were grade 3 toxicity–free survival rates (97.6% vs 81.6%; P = .001).
As noted above, rates of disease-free survival were similar for both groups (73% with image-guided IMRT vs 68% with 3D-CRT; P = .30).
Funding for the study was provided by the Department of Science and Technology and the Department of Atomic Energy, Clinical Trials Center, in India, and by Varian International and the Terry Fox Foundation. Chopra and Yom have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Birch bark derivative gel found effective for EB, in phase 3 study
A . The results come from the largest double-blind, randomized trial performed in this patient population.
More than 41% of EB target wounds that were treated with Oleogel-S10 healed within 45 days, compared with about 29% of target wounds treated with placebo, in the EASE phase 3 trial, conducted at 58 sites in 28 countries.
A group of rare genetic disorders, EB “is described as the worst disease you’ve never heard of,” explained lead investigator Dedee Murrell, MD, director of dermatology, St. George Hospital at the University of New South Wales, Sydney. “It starts in children and is like having burns that heal with scars, and no treatment has been approved for it” by the Food and Drug Administration.
“This is the first large clinical trial with placebo of a topical treatment that’s worked for this terrible disease,” Dr. Murrell said in an interview. She noted that standard EB treatment currently consists of applying nonstick dressings to wounds to protect skin from trauma and infection.
Dr. Murrell, who has focused her work on EB patients since 1990, presented the findings at the virtual annual Congress of the European Academy of Dermatology and Venereology.
The trial enrolled 223 patients (average age, 12 years, but ages ranged to 81 years) with three types of EB, including dystrophic and junctional EB and Kindler syndrome. For each participant, a target wound was selected for use as the primary efficacy endpoint. Those wounds had a partial thickness of between 10 cm2 and 50 cm2 and lasted between 21 days and 9 months. Patients were stratified into groups depending on type of EB and size of target wound.
Participants were randomly assigned to receive either Oleogel-S10 (n = 109) or placebo (n = 114). All applied the blinded-study gel to all their wounds at least every 4 days at the time dressings were changed.
The primary endpoint was the percentage of patients whose target wounds completely closed within 45 days. Key secondary endpoints included time to wound healing and percentage of target wounds that healed within 90 days of treatment; incidence and severity of target wound infection; change in total body wound burden, as measured by the Epidermolysis Bullosa Disease Activity and Scarring Index skin activity subscore; change in itching, as measured by the Itch Man Scale and the Leuven Itch Scale; and adverse events.
Nearly 92% of patients who were treated with Oleogel-S10 completed the double-blind phase of the trial, compared with nearly 87% who received placebo. As noted, the primary endpoint was met, with 41.3% of Oleogel-S10 patients achieving target wound closure within 45 days, compared with 28.9% of the patients who received placebo (P = .013).
But the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of Oleogel-S10 patients achieving wound closure vs. 43.9% of control patients.
Target-wound infection occurred in eight participants, including three who used Oleogel-S10 and five who received placebo; all moderate or severe infections occurred in patients who received placebo. Total wound burden was reduced to a greater extent among Oleogel-S10 patients by day 60, but there was no apparent difference at day 90.
Both treatment groups reported qualitative improvements in itch, with no significant differences between groups. The prevalence of adverse events was also similar between groups (Oleogel-S10, 81.7%; placebo, 80.7%). The most frequently reported adverse events among Oleogel-S10 patients, compared with patients who received placebo, were wound complications, pyrexia, wound infection, pruritus, and anemia; only 4.5% of adverse events were deemed severe.
Dr. Murrell said that, on the basis of the trial results, she expects the FDA to fast-track approval of Oleogel-S10, which contains triterpene extract and sunflower oil.
The gel is “a treatment patients will be able to put under their dressings, added to normal treatment, which will accelerate their wound healing, with no significant increase in any side effects,” she added.
Jemima Mellerio, MD, of St. Thomas’ Hospital in London who sees about 400 EB patients each year, agreed with Dr. Murrell that the results are “very exciting.” Dr. Mellerio was not involved in the study.
“Practicing dermatologists seeing people with EB will have something to offer that appears to speed up wound healing in chronic wounds,” Dr. Mellerio said in an interview. “It’s a positive option rather than just supportive treatment, something that makes a difference to the natural history of wounds.”
She said the trial’s biggest strength was including “such a large cohort of patients.
“It’s extremely difficult to do that kind of study, especially with a placebo-controlled arm and especially in a rare disease,” Dr. Mellerio said. “If you think about the product itself, it’s easy to apply, so it’s not particularly onerous for people to add to their daily regimen of dressings.”
The study was funded by Amryt Pharma. Dr. Murrell is an advisory board member for Amryt Pharma. Dr. Mellerio is a consultant for Amryt Pharma.
A version of this article originally appeared on Medscape.com.
A . The results come from the largest double-blind, randomized trial performed in this patient population.
More than 41% of EB target wounds that were treated with Oleogel-S10 healed within 45 days, compared with about 29% of target wounds treated with placebo, in the EASE phase 3 trial, conducted at 58 sites in 28 countries.
A group of rare genetic disorders, EB “is described as the worst disease you’ve never heard of,” explained lead investigator Dedee Murrell, MD, director of dermatology, St. George Hospital at the University of New South Wales, Sydney. “It starts in children and is like having burns that heal with scars, and no treatment has been approved for it” by the Food and Drug Administration.
“This is the first large clinical trial with placebo of a topical treatment that’s worked for this terrible disease,” Dr. Murrell said in an interview. She noted that standard EB treatment currently consists of applying nonstick dressings to wounds to protect skin from trauma and infection.
Dr. Murrell, who has focused her work on EB patients since 1990, presented the findings at the virtual annual Congress of the European Academy of Dermatology and Venereology.
The trial enrolled 223 patients (average age, 12 years, but ages ranged to 81 years) with three types of EB, including dystrophic and junctional EB and Kindler syndrome. For each participant, a target wound was selected for use as the primary efficacy endpoint. Those wounds had a partial thickness of between 10 cm2 and 50 cm2 and lasted between 21 days and 9 months. Patients were stratified into groups depending on type of EB and size of target wound.
Participants were randomly assigned to receive either Oleogel-S10 (n = 109) or placebo (n = 114). All applied the blinded-study gel to all their wounds at least every 4 days at the time dressings were changed.
The primary endpoint was the percentage of patients whose target wounds completely closed within 45 days. Key secondary endpoints included time to wound healing and percentage of target wounds that healed within 90 days of treatment; incidence and severity of target wound infection; change in total body wound burden, as measured by the Epidermolysis Bullosa Disease Activity and Scarring Index skin activity subscore; change in itching, as measured by the Itch Man Scale and the Leuven Itch Scale; and adverse events.
Nearly 92% of patients who were treated with Oleogel-S10 completed the double-blind phase of the trial, compared with nearly 87% who received placebo. As noted, the primary endpoint was met, with 41.3% of Oleogel-S10 patients achieving target wound closure within 45 days, compared with 28.9% of the patients who received placebo (P = .013).
But the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of Oleogel-S10 patients achieving wound closure vs. 43.9% of control patients.
Target-wound infection occurred in eight participants, including three who used Oleogel-S10 and five who received placebo; all moderate or severe infections occurred in patients who received placebo. Total wound burden was reduced to a greater extent among Oleogel-S10 patients by day 60, but there was no apparent difference at day 90.
Both treatment groups reported qualitative improvements in itch, with no significant differences between groups. The prevalence of adverse events was also similar between groups (Oleogel-S10, 81.7%; placebo, 80.7%). The most frequently reported adverse events among Oleogel-S10 patients, compared with patients who received placebo, were wound complications, pyrexia, wound infection, pruritus, and anemia; only 4.5% of adverse events were deemed severe.
Dr. Murrell said that, on the basis of the trial results, she expects the FDA to fast-track approval of Oleogel-S10, which contains triterpene extract and sunflower oil.
The gel is “a treatment patients will be able to put under their dressings, added to normal treatment, which will accelerate their wound healing, with no significant increase in any side effects,” she added.
Jemima Mellerio, MD, of St. Thomas’ Hospital in London who sees about 400 EB patients each year, agreed with Dr. Murrell that the results are “very exciting.” Dr. Mellerio was not involved in the study.
“Practicing dermatologists seeing people with EB will have something to offer that appears to speed up wound healing in chronic wounds,” Dr. Mellerio said in an interview. “It’s a positive option rather than just supportive treatment, something that makes a difference to the natural history of wounds.”
She said the trial’s biggest strength was including “such a large cohort of patients.
“It’s extremely difficult to do that kind of study, especially with a placebo-controlled arm and especially in a rare disease,” Dr. Mellerio said. “If you think about the product itself, it’s easy to apply, so it’s not particularly onerous for people to add to their daily regimen of dressings.”
The study was funded by Amryt Pharma. Dr. Murrell is an advisory board member for Amryt Pharma. Dr. Mellerio is a consultant for Amryt Pharma.
A version of this article originally appeared on Medscape.com.
A . The results come from the largest double-blind, randomized trial performed in this patient population.
More than 41% of EB target wounds that were treated with Oleogel-S10 healed within 45 days, compared with about 29% of target wounds treated with placebo, in the EASE phase 3 trial, conducted at 58 sites in 28 countries.
A group of rare genetic disorders, EB “is described as the worst disease you’ve never heard of,” explained lead investigator Dedee Murrell, MD, director of dermatology, St. George Hospital at the University of New South Wales, Sydney. “It starts in children and is like having burns that heal with scars, and no treatment has been approved for it” by the Food and Drug Administration.
“This is the first large clinical trial with placebo of a topical treatment that’s worked for this terrible disease,” Dr. Murrell said in an interview. She noted that standard EB treatment currently consists of applying nonstick dressings to wounds to protect skin from trauma and infection.
Dr. Murrell, who has focused her work on EB patients since 1990, presented the findings at the virtual annual Congress of the European Academy of Dermatology and Venereology.
The trial enrolled 223 patients (average age, 12 years, but ages ranged to 81 years) with three types of EB, including dystrophic and junctional EB and Kindler syndrome. For each participant, a target wound was selected for use as the primary efficacy endpoint. Those wounds had a partial thickness of between 10 cm2 and 50 cm2 and lasted between 21 days and 9 months. Patients were stratified into groups depending on type of EB and size of target wound.
Participants were randomly assigned to receive either Oleogel-S10 (n = 109) or placebo (n = 114). All applied the blinded-study gel to all their wounds at least every 4 days at the time dressings were changed.
The primary endpoint was the percentage of patients whose target wounds completely closed within 45 days. Key secondary endpoints included time to wound healing and percentage of target wounds that healed within 90 days of treatment; incidence and severity of target wound infection; change in total body wound burden, as measured by the Epidermolysis Bullosa Disease Activity and Scarring Index skin activity subscore; change in itching, as measured by the Itch Man Scale and the Leuven Itch Scale; and adverse events.
Nearly 92% of patients who were treated with Oleogel-S10 completed the double-blind phase of the trial, compared with nearly 87% who received placebo. As noted, the primary endpoint was met, with 41.3% of Oleogel-S10 patients achieving target wound closure within 45 days, compared with 28.9% of the patients who received placebo (P = .013).
But the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of Oleogel-S10 patients achieving wound closure vs. 43.9% of control patients.
Target-wound infection occurred in eight participants, including three who used Oleogel-S10 and five who received placebo; all moderate or severe infections occurred in patients who received placebo. Total wound burden was reduced to a greater extent among Oleogel-S10 patients by day 60, but there was no apparent difference at day 90.
Both treatment groups reported qualitative improvements in itch, with no significant differences between groups. The prevalence of adverse events was also similar between groups (Oleogel-S10, 81.7%; placebo, 80.7%). The most frequently reported adverse events among Oleogel-S10 patients, compared with patients who received placebo, were wound complications, pyrexia, wound infection, pruritus, and anemia; only 4.5% of adverse events were deemed severe.
Dr. Murrell said that, on the basis of the trial results, she expects the FDA to fast-track approval of Oleogel-S10, which contains triterpene extract and sunflower oil.
The gel is “a treatment patients will be able to put under their dressings, added to normal treatment, which will accelerate their wound healing, with no significant increase in any side effects,” she added.
Jemima Mellerio, MD, of St. Thomas’ Hospital in London who sees about 400 EB patients each year, agreed with Dr. Murrell that the results are “very exciting.” Dr. Mellerio was not involved in the study.
“Practicing dermatologists seeing people with EB will have something to offer that appears to speed up wound healing in chronic wounds,” Dr. Mellerio said in an interview. “It’s a positive option rather than just supportive treatment, something that makes a difference to the natural history of wounds.”
She said the trial’s biggest strength was including “such a large cohort of patients.
“It’s extremely difficult to do that kind of study, especially with a placebo-controlled arm and especially in a rare disease,” Dr. Mellerio said. “If you think about the product itself, it’s easy to apply, so it’s not particularly onerous for people to add to their daily regimen of dressings.”
The study was funded by Amryt Pharma. Dr. Murrell is an advisory board member for Amryt Pharma. Dr. Mellerio is a consultant for Amryt Pharma.
A version of this article originally appeared on Medscape.com.
Antibiotics fail to improve colon ischemia outcomes
Antibiotics may not significantly improve clinical outcomes in patients with colon ischemia (CI), regardless of severity level, based on a retrospective study involving more than 800 patients.
Given these findings, clinicians “should consider not giving antibiotics to patients with CI,” reported lead author Paul Feuerstadt, MD, of Yale University, New Haven , Conn., and colleagues.
“CI is the most common ischemic injury to the GI tract,” the investigators wrote in their abstract, which was presented at the annual meeting of the American College of Gastroenterology. “The clinical utility of antibiotic treatment in CI is unclear and the literature is limited.”
Dr. Feuerstadt and colleagues analyzed data from 838 patients with biopsy-proven CI who were hospitalized between 2005 and 2017, of whom 413 and 425 had moderate and severe disease, respectively.
Across all patients, 67.7% received antibiotics. While there were no significant intergroup differences in age, Charlson Comorbidity Index, or sex, patients who received antibiotics were more likely to have severe CI (54.4% vs. 42.2%; P = .001), small-bowel involvement (12.0% vs. 5.7%; P = .04), and peritonitis (11.3% vs. 4.5%; P = 002), as well as require intensive care (26.1% vs. 19.9%; P = .04).
After adjusting for severity of CI, small-bowel involvement, and comorbidities, analysis revealed no significant associations between antibiotic use and 30-day mortality, 90-day mortality, 30-day colectomy, 90-day recurrence, 90-day readmission, or length of stay. The primary outcome, 30-day mortality, remained insignificant in subgroup analyses based on CI severity and age.
Patients were most frequently prescribed ciprofloxacin-metronidazole (57.1%), followed by piperacillin-tazobactam (13.2%), ceftriaxone-metronidazole (11.1%), and other antibiotics (18.5%).
When each of these antimicrobials was compared with no antibiotic usage, only piperacillin-tazobactam correlated with a higher rate of 30-day mortality, based on an adjusted odds ratio of 3.4 (95% CI, 1.5-8.0; P = .0003). But most patients who received piperacillin-tazobactam underwent colectomy, which prompted independent analyses of patients who underwent colectomy and those who did not undergo colectomy. These findings showed no difference in 30-day mortality based on the type of antibiotic used.
During an oral presentation at the meeting, coauthor Karthik Gnanapandithan, MD, of the Mayo Clinic in Jacksonville, Fla, said, “In practice, it is reasonable to still use antibiotics in patients with small bowel ischemia and those with severe CI with a high risk of poor outcomes pending prospective studies.”
According to John F. Valentine, MD, of the University of Utah, Salt Lake City, the present study “adds to the literature that questions the role of antibiotics in CI.”
Dr. Valentine noted that, even among patients with CI who have severe inflammation, “sepsis rarely occurs without frank perforation.”
Still, like Dr. Gnanapandithan, Dr. Valentine concluded that antibiotics are still a reasonable treatment option for certain patients with CI.
“The risks and potential benefits of antibiotics must be considered,” he said. “Until prospective studies are available, use of antibiotics in colon ischemia is reasonable in the setting of severe disease with peritoneal signs, signs of sepsis, pneumatosis, or portal venous gas.”
Dr. Feuerstadt disclosed relationships with Ferring/Rebiotix, Merck, and Roche. Dr. Valentine reported no relevant conflicts of interest.
Antibiotics may not significantly improve clinical outcomes in patients with colon ischemia (CI), regardless of severity level, based on a retrospective study involving more than 800 patients.
Given these findings, clinicians “should consider not giving antibiotics to patients with CI,” reported lead author Paul Feuerstadt, MD, of Yale University, New Haven , Conn., and colleagues.
“CI is the most common ischemic injury to the GI tract,” the investigators wrote in their abstract, which was presented at the annual meeting of the American College of Gastroenterology. “The clinical utility of antibiotic treatment in CI is unclear and the literature is limited.”
Dr. Feuerstadt and colleagues analyzed data from 838 patients with biopsy-proven CI who were hospitalized between 2005 and 2017, of whom 413 and 425 had moderate and severe disease, respectively.
Across all patients, 67.7% received antibiotics. While there were no significant intergroup differences in age, Charlson Comorbidity Index, or sex, patients who received antibiotics were more likely to have severe CI (54.4% vs. 42.2%; P = .001), small-bowel involvement (12.0% vs. 5.7%; P = .04), and peritonitis (11.3% vs. 4.5%; P = 002), as well as require intensive care (26.1% vs. 19.9%; P = .04).
After adjusting for severity of CI, small-bowel involvement, and comorbidities, analysis revealed no significant associations between antibiotic use and 30-day mortality, 90-day mortality, 30-day colectomy, 90-day recurrence, 90-day readmission, or length of stay. The primary outcome, 30-day mortality, remained insignificant in subgroup analyses based on CI severity and age.
Patients were most frequently prescribed ciprofloxacin-metronidazole (57.1%), followed by piperacillin-tazobactam (13.2%), ceftriaxone-metronidazole (11.1%), and other antibiotics (18.5%).
When each of these antimicrobials was compared with no antibiotic usage, only piperacillin-tazobactam correlated with a higher rate of 30-day mortality, based on an adjusted odds ratio of 3.4 (95% CI, 1.5-8.0; P = .0003). But most patients who received piperacillin-tazobactam underwent colectomy, which prompted independent analyses of patients who underwent colectomy and those who did not undergo colectomy. These findings showed no difference in 30-day mortality based on the type of antibiotic used.
During an oral presentation at the meeting, coauthor Karthik Gnanapandithan, MD, of the Mayo Clinic in Jacksonville, Fla, said, “In practice, it is reasonable to still use antibiotics in patients with small bowel ischemia and those with severe CI with a high risk of poor outcomes pending prospective studies.”
According to John F. Valentine, MD, of the University of Utah, Salt Lake City, the present study “adds to the literature that questions the role of antibiotics in CI.”
Dr. Valentine noted that, even among patients with CI who have severe inflammation, “sepsis rarely occurs without frank perforation.”
Still, like Dr. Gnanapandithan, Dr. Valentine concluded that antibiotics are still a reasonable treatment option for certain patients with CI.
“The risks and potential benefits of antibiotics must be considered,” he said. “Until prospective studies are available, use of antibiotics in colon ischemia is reasonable in the setting of severe disease with peritoneal signs, signs of sepsis, pneumatosis, or portal venous gas.”
Dr. Feuerstadt disclosed relationships with Ferring/Rebiotix, Merck, and Roche. Dr. Valentine reported no relevant conflicts of interest.
Antibiotics may not significantly improve clinical outcomes in patients with colon ischemia (CI), regardless of severity level, based on a retrospective study involving more than 800 patients.
Given these findings, clinicians “should consider not giving antibiotics to patients with CI,” reported lead author Paul Feuerstadt, MD, of Yale University, New Haven , Conn., and colleagues.
“CI is the most common ischemic injury to the GI tract,” the investigators wrote in their abstract, which was presented at the annual meeting of the American College of Gastroenterology. “The clinical utility of antibiotic treatment in CI is unclear and the literature is limited.”
Dr. Feuerstadt and colleagues analyzed data from 838 patients with biopsy-proven CI who were hospitalized between 2005 and 2017, of whom 413 and 425 had moderate and severe disease, respectively.
Across all patients, 67.7% received antibiotics. While there were no significant intergroup differences in age, Charlson Comorbidity Index, or sex, patients who received antibiotics were more likely to have severe CI (54.4% vs. 42.2%; P = .001), small-bowel involvement (12.0% vs. 5.7%; P = .04), and peritonitis (11.3% vs. 4.5%; P = 002), as well as require intensive care (26.1% vs. 19.9%; P = .04).
After adjusting for severity of CI, small-bowel involvement, and comorbidities, analysis revealed no significant associations between antibiotic use and 30-day mortality, 90-day mortality, 30-day colectomy, 90-day recurrence, 90-day readmission, or length of stay. The primary outcome, 30-day mortality, remained insignificant in subgroup analyses based on CI severity and age.
Patients were most frequently prescribed ciprofloxacin-metronidazole (57.1%), followed by piperacillin-tazobactam (13.2%), ceftriaxone-metronidazole (11.1%), and other antibiotics (18.5%).
When each of these antimicrobials was compared with no antibiotic usage, only piperacillin-tazobactam correlated with a higher rate of 30-day mortality, based on an adjusted odds ratio of 3.4 (95% CI, 1.5-8.0; P = .0003). But most patients who received piperacillin-tazobactam underwent colectomy, which prompted independent analyses of patients who underwent colectomy and those who did not undergo colectomy. These findings showed no difference in 30-day mortality based on the type of antibiotic used.
During an oral presentation at the meeting, coauthor Karthik Gnanapandithan, MD, of the Mayo Clinic in Jacksonville, Fla, said, “In practice, it is reasonable to still use antibiotics in patients with small bowel ischemia and those with severe CI with a high risk of poor outcomes pending prospective studies.”
According to John F. Valentine, MD, of the University of Utah, Salt Lake City, the present study “adds to the literature that questions the role of antibiotics in CI.”
Dr. Valentine noted that, even among patients with CI who have severe inflammation, “sepsis rarely occurs without frank perforation.”
Still, like Dr. Gnanapandithan, Dr. Valentine concluded that antibiotics are still a reasonable treatment option for certain patients with CI.
“The risks and potential benefits of antibiotics must be considered,” he said. “Until prospective studies are available, use of antibiotics in colon ischemia is reasonable in the setting of severe disease with peritoneal signs, signs of sepsis, pneumatosis, or portal venous gas.”
Dr. Feuerstadt disclosed relationships with Ferring/Rebiotix, Merck, and Roche. Dr. Valentine reported no relevant conflicts of interest.
FROM ACG 2020
Family planning issues loom large for female radiation oncologists
Results from the survey were reported at the American Society for Radiation Oncology Annual Meeting 2020.
“Female radiation oncologists often spend their childbearing years in training and establishing careers,” commented lead investigator Anna Lee, MD, of the University of Texas MD Anderson Cancer Center in Houston.
“Currently, physician fertility and family planning are rarely discussed or taught in medical school or postgraduate training,” Dr. Lee said.
Dr. Lee and colleagues conducted a national anonymous cross-sectional online survey of female oncologists of all types and all career levels (including trainees). The team circulated a 39-item questionnaire exploring attitudes toward and experiences related to family planning and assisted reproductive technology (ART) by email and social media channels.
A total of 351 radiation oncologists participated, representing one-fifth of the specialty’s entire female workforce nationally and making this study the largest to date on family planning among these physicians.
Most respondents were aged 31-40 years (60%) and married (79%), had children (68%), and were in training (26%) or academic practice (48%).
Survey results
Fully 74% of respondents reported that their career plans strongly influenced the timing of when to start a family, and 29% said family planning considerations influenced their decision regarding their choice of academia versus private practice, Dr. Lee reported.
Overall, 24% of respondents indicated that they had difficulty with infertility or required fertility counseling/treatment, 66% said they wished fertility preservation was discussed at some point during their training, and 22% said either that ART would have benefited them if it had been available or that they were planning to or had already used fertility preservation.
On the topic of maternity leave, some respondents reported that their institution either had no formal leave policy during training or provided less than 1 month of leave (23%) and that they felt pressure to take less time off than was policy (15%).
“Of note, 32 women in our survey were not offered non–radiation-exposing assignments during pregnancy, and an additional 57 had to specifically ask for them,” Dr. Lee remarked.
About one-third of respondents each reported that they did not feel supported during training for issues related to fertility and/or pregnancy (33%) and that they experienced discrimination for being pregnant (32%) and taking maternity leave (30%).
“Systemic changes are necessary early in medical education and training to ensure women are supported and able to advance equitably in the field. As less than a third of the current radiation oncology workforce are women, improvement upon these issues will be necessary to draw more women into the field,” Dr. Lee commented. “Education on ART risks, benefits, and success rates can help physicians and those in training in their family planning, while the lack of education and structured policy can exacerbate the emotional, physical, and financial impact of infertility.
“Until recently, there has been a dearth of policy at the programmatic, institutional, and national level allowing time and protection for pregnancy and maternity leave,” she added. “Thankfully, this summer, the American Board of Medical Specialties announced a progressive leave policy for residents and fellows.”
The new policy, which goes into effect July 2021, allows a minimum of 6 weeks away without exhausting time allowed for vacation or sick leave and without requiring an extension in training.
When career and biology collide
“The collision of professional and biological clocks for women in medicine is an important issue highlighted by this study,” Reshma Jagsi, MD, DPhil, of the University of Michigan in Ann Arbor, said in an interview.
“Prior work focused on women in medicine more generally. A deeper dive into the experiences of women in a specific field may be even more compelling to drive change on the part of professional societies and organizations,” Dr. Jagsi added.
The infertility rate observed in the study could have potentially been skewed by the preponderance of younger respondents (resulting in underestimation) or by greater participation of those interested in the subject (resulting in overestimation), she noted. However, it aligns well with the rate in a study Dr. Jagsi and colleagues conducted among female physicians generally using somewhat different methods. That study was published in the Journal of Women’s Health.
Concern about radiation exposure and its potential reproductive health effects should not deter women from choosing radiation oncology as a specialty, according to Dr. Jagsi.
“Radiation exposure is actually very low in radiation oncology, much lower than in specialties like interventional cardiology, where physicians are in the room where fluoroscopy is being used. It is actually an important misconception about this field that merits correction,” she stressed. “Rather, the fertility concerns are related to the expectations of training and demands of work during the prime childbearing years more generally that can lead women to delay pregnancy, which is an issue common to all medical specialties.”
“The investigators’ conclusions are very reasonable,” Dr. Jagsi said. “Although one might quibble whether the exact proportions reflect the experiences of all women in the field perfectly due to the possibility of selection bias, one cannot question whether a substantial number of women are experiencing these challenges and that they merit intervention.”
The study did not receive specific funding. Dr. Lee and Dr. Jagsi disclosed no relevant conflicts of interest.
SOURCE: Lee A et al. ASTRO 2020, Abstract LBA 6.
Results from the survey were reported at the American Society for Radiation Oncology Annual Meeting 2020.
“Female radiation oncologists often spend their childbearing years in training and establishing careers,” commented lead investigator Anna Lee, MD, of the University of Texas MD Anderson Cancer Center in Houston.
“Currently, physician fertility and family planning are rarely discussed or taught in medical school or postgraduate training,” Dr. Lee said.
Dr. Lee and colleagues conducted a national anonymous cross-sectional online survey of female oncologists of all types and all career levels (including trainees). The team circulated a 39-item questionnaire exploring attitudes toward and experiences related to family planning and assisted reproductive technology (ART) by email and social media channels.
A total of 351 radiation oncologists participated, representing one-fifth of the specialty’s entire female workforce nationally and making this study the largest to date on family planning among these physicians.
Most respondents were aged 31-40 years (60%) and married (79%), had children (68%), and were in training (26%) or academic practice (48%).
Survey results
Fully 74% of respondents reported that their career plans strongly influenced the timing of when to start a family, and 29% said family planning considerations influenced their decision regarding their choice of academia versus private practice, Dr. Lee reported.
Overall, 24% of respondents indicated that they had difficulty with infertility or required fertility counseling/treatment, 66% said they wished fertility preservation was discussed at some point during their training, and 22% said either that ART would have benefited them if it had been available or that they were planning to or had already used fertility preservation.
On the topic of maternity leave, some respondents reported that their institution either had no formal leave policy during training or provided less than 1 month of leave (23%) and that they felt pressure to take less time off than was policy (15%).
“Of note, 32 women in our survey were not offered non–radiation-exposing assignments during pregnancy, and an additional 57 had to specifically ask for them,” Dr. Lee remarked.
About one-third of respondents each reported that they did not feel supported during training for issues related to fertility and/or pregnancy (33%) and that they experienced discrimination for being pregnant (32%) and taking maternity leave (30%).
“Systemic changes are necessary early in medical education and training to ensure women are supported and able to advance equitably in the field. As less than a third of the current radiation oncology workforce are women, improvement upon these issues will be necessary to draw more women into the field,” Dr. Lee commented. “Education on ART risks, benefits, and success rates can help physicians and those in training in their family planning, while the lack of education and structured policy can exacerbate the emotional, physical, and financial impact of infertility.
“Until recently, there has been a dearth of policy at the programmatic, institutional, and national level allowing time and protection for pregnancy and maternity leave,” she added. “Thankfully, this summer, the American Board of Medical Specialties announced a progressive leave policy for residents and fellows.”
The new policy, which goes into effect July 2021, allows a minimum of 6 weeks away without exhausting time allowed for vacation or sick leave and without requiring an extension in training.
When career and biology collide
“The collision of professional and biological clocks for women in medicine is an important issue highlighted by this study,” Reshma Jagsi, MD, DPhil, of the University of Michigan in Ann Arbor, said in an interview.
“Prior work focused on women in medicine more generally. A deeper dive into the experiences of women in a specific field may be even more compelling to drive change on the part of professional societies and organizations,” Dr. Jagsi added.
The infertility rate observed in the study could have potentially been skewed by the preponderance of younger respondents (resulting in underestimation) or by greater participation of those interested in the subject (resulting in overestimation), she noted. However, it aligns well with the rate in a study Dr. Jagsi and colleagues conducted among female physicians generally using somewhat different methods. That study was published in the Journal of Women’s Health.
Concern about radiation exposure and its potential reproductive health effects should not deter women from choosing radiation oncology as a specialty, according to Dr. Jagsi.
“Radiation exposure is actually very low in radiation oncology, much lower than in specialties like interventional cardiology, where physicians are in the room where fluoroscopy is being used. It is actually an important misconception about this field that merits correction,” she stressed. “Rather, the fertility concerns are related to the expectations of training and demands of work during the prime childbearing years more generally that can lead women to delay pregnancy, which is an issue common to all medical specialties.”
“The investigators’ conclusions are very reasonable,” Dr. Jagsi said. “Although one might quibble whether the exact proportions reflect the experiences of all women in the field perfectly due to the possibility of selection bias, one cannot question whether a substantial number of women are experiencing these challenges and that they merit intervention.”
The study did not receive specific funding. Dr. Lee and Dr. Jagsi disclosed no relevant conflicts of interest.
SOURCE: Lee A et al. ASTRO 2020, Abstract LBA 6.
Results from the survey were reported at the American Society for Radiation Oncology Annual Meeting 2020.
“Female radiation oncologists often spend their childbearing years in training and establishing careers,” commented lead investigator Anna Lee, MD, of the University of Texas MD Anderson Cancer Center in Houston.
“Currently, physician fertility and family planning are rarely discussed or taught in medical school or postgraduate training,” Dr. Lee said.
Dr. Lee and colleagues conducted a national anonymous cross-sectional online survey of female oncologists of all types and all career levels (including trainees). The team circulated a 39-item questionnaire exploring attitudes toward and experiences related to family planning and assisted reproductive technology (ART) by email and social media channels.
A total of 351 radiation oncologists participated, representing one-fifth of the specialty’s entire female workforce nationally and making this study the largest to date on family planning among these physicians.
Most respondents were aged 31-40 years (60%) and married (79%), had children (68%), and were in training (26%) or academic practice (48%).
Survey results
Fully 74% of respondents reported that their career plans strongly influenced the timing of when to start a family, and 29% said family planning considerations influenced their decision regarding their choice of academia versus private practice, Dr. Lee reported.
Overall, 24% of respondents indicated that they had difficulty with infertility or required fertility counseling/treatment, 66% said they wished fertility preservation was discussed at some point during their training, and 22% said either that ART would have benefited them if it had been available or that they were planning to or had already used fertility preservation.
On the topic of maternity leave, some respondents reported that their institution either had no formal leave policy during training or provided less than 1 month of leave (23%) and that they felt pressure to take less time off than was policy (15%).
“Of note, 32 women in our survey were not offered non–radiation-exposing assignments during pregnancy, and an additional 57 had to specifically ask for them,” Dr. Lee remarked.
About one-third of respondents each reported that they did not feel supported during training for issues related to fertility and/or pregnancy (33%) and that they experienced discrimination for being pregnant (32%) and taking maternity leave (30%).
“Systemic changes are necessary early in medical education and training to ensure women are supported and able to advance equitably in the field. As less than a third of the current radiation oncology workforce are women, improvement upon these issues will be necessary to draw more women into the field,” Dr. Lee commented. “Education on ART risks, benefits, and success rates can help physicians and those in training in their family planning, while the lack of education and structured policy can exacerbate the emotional, physical, and financial impact of infertility.
“Until recently, there has been a dearth of policy at the programmatic, institutional, and national level allowing time and protection for pregnancy and maternity leave,” she added. “Thankfully, this summer, the American Board of Medical Specialties announced a progressive leave policy for residents and fellows.”
The new policy, which goes into effect July 2021, allows a minimum of 6 weeks away without exhausting time allowed for vacation or sick leave and without requiring an extension in training.
When career and biology collide
“The collision of professional and biological clocks for women in medicine is an important issue highlighted by this study,” Reshma Jagsi, MD, DPhil, of the University of Michigan in Ann Arbor, said in an interview.
“Prior work focused on women in medicine more generally. A deeper dive into the experiences of women in a specific field may be even more compelling to drive change on the part of professional societies and organizations,” Dr. Jagsi added.
The infertility rate observed in the study could have potentially been skewed by the preponderance of younger respondents (resulting in underestimation) or by greater participation of those interested in the subject (resulting in overestimation), she noted. However, it aligns well with the rate in a study Dr. Jagsi and colleagues conducted among female physicians generally using somewhat different methods. That study was published in the Journal of Women’s Health.
Concern about radiation exposure and its potential reproductive health effects should not deter women from choosing radiation oncology as a specialty, according to Dr. Jagsi.
“Radiation exposure is actually very low in radiation oncology, much lower than in specialties like interventional cardiology, where physicians are in the room where fluoroscopy is being used. It is actually an important misconception about this field that merits correction,” she stressed. “Rather, the fertility concerns are related to the expectations of training and demands of work during the prime childbearing years more generally that can lead women to delay pregnancy, which is an issue common to all medical specialties.”
“The investigators’ conclusions are very reasonable,” Dr. Jagsi said. “Although one might quibble whether the exact proportions reflect the experiences of all women in the field perfectly due to the possibility of selection bias, one cannot question whether a substantial number of women are experiencing these challenges and that they merit intervention.”
The study did not receive specific funding. Dr. Lee and Dr. Jagsi disclosed no relevant conflicts of interest.
SOURCE: Lee A et al. ASTRO 2020, Abstract LBA 6.
FROM ASTRO 2020
Let side effects guide treatment choice for refractory OCD
Choosing the most effective treatment for patients with obsessive-compulsive disorder requires flexibility and agility on the part of clinicians, according to Wayne K. Goodman, MD.
“There are no data at this point to suggest that one SSRI is superior to another. It’s really dealer’s choice, and it has to do with really picking medications based upon side effects,” Dr. Goodman said at the Psychopharmacology Update, presented by Current Psychiatry and Global Academy for Medical Education. Clinicians can use family history as a guide, he noted, but pharmacogenetic testing has not been helpful in his experience for selection or dosing of an SSRI.
SSRIs, such as fluvoxamine, are one of two mainstays of treatment for patients with obsessive-compulsive disorder (OCD). The other drug class is serotonin reuptake inhibitors, which include medications such clomipramine. Cognitive-behavioral therapy options, such as Exposure and Response Prevention therapy, also has some, albeit limited, efficacy.
Meanwhile, Dr. Goodman said, antidepressant classes other than SRIs and SSRIs have not been effective in treating obsessive-compulsive symptoms, and some patients do not adhere well to cognitive-behavioral therapy, said Dr. Goodman, who is the D.C. and Irene Ellwood Professor in the department of psychiatry and behavioral sciences at Baylor College of Medicine, Houston.
Choosing the most effective treatment for patients with obsessive-compulsive disorder requires flexibility and agility on the part of clinicians, according to Wayne K. Goodman, MD.
“There are no data at this point to suggest that one SSRI is superior to another. It’s really dealer’s choice, and it has to do with really picking medications based upon side effects,” Dr. Goodman said at the Psychopharmacology Update, presented by Current Psychiatry and Global Academy for Medical Education. Clinicians can use family history as a guide, he noted, but pharmacogenetic testing has not been helpful in his experience for selection or dosing of an SSRI.
SSRIs, such as fluvoxamine, are one of two mainstays of treatment for patients with obsessive-compulsive disorder (OCD). The other drug class is serotonin reuptake inhibitors, which include medications such clomipramine. Cognitive-behavioral therapy options, such as Exposure and Response Prevention therapy, also has some, albeit limited, efficacy.
Meanwhile, Dr. Goodman said, antidepressant classes other than SRIs and SSRIs have not been effective in treating obsessive-compulsive symptoms, and some patients do not adhere well to cognitive-behavioral therapy, said Dr. Goodman, who is the D.C. and Irene Ellwood Professor in the department of psychiatry and behavioral sciences at Baylor College of Medicine, Houston.
Choosing the most effective treatment for patients with obsessive-compulsive disorder requires flexibility and agility on the part of clinicians, according to Wayne K. Goodman, MD.
“There are no data at this point to suggest that one SSRI is superior to another. It’s really dealer’s choice, and it has to do with really picking medications based upon side effects,” Dr. Goodman said at the Psychopharmacology Update, presented by Current Psychiatry and Global Academy for Medical Education. Clinicians can use family history as a guide, he noted, but pharmacogenetic testing has not been helpful in his experience for selection or dosing of an SSRI.
SSRIs, such as fluvoxamine, are one of two mainstays of treatment for patients with obsessive-compulsive disorder (OCD). The other drug class is serotonin reuptake inhibitors, which include medications such clomipramine. Cognitive-behavioral therapy options, such as Exposure and Response Prevention therapy, also has some, albeit limited, efficacy.
Meanwhile, Dr. Goodman said, antidepressant classes other than SRIs and SSRIs have not been effective in treating obsessive-compulsive symptoms, and some patients do not adhere well to cognitive-behavioral therapy, said Dr. Goodman, who is the D.C. and Irene Ellwood Professor in the department of psychiatry and behavioral sciences at Baylor College of Medicine, Houston.
FROM PSYCHOPHARMACOLOGY UPDATE