Randy Dotinga

SEATTLE – While several dozen studies have been conducted into cannabis-based treatments for symptoms of multiple sclerosis (MS), a new systematic review deems most to be of fair to poor quality. Reviewers found modest evidence of benefit and plenty of room for more research.

“Cannabis-based medicine may be useful for refractory MS symptoms, especially spasticity and pain, and side effects are usually well tolerated,” study lead author Natasha Breward, a graduate student at the College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, said in an interview. Ms. Breward spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

For the review, Ms. Breward and colleagues focused on 60 studies - 26 randomized controlled trials and 34 trials with other designs. Forty of the studies used nabiximols (Sativex), an oromucosal spray that is derived from the cannabis sativa plant and approved for use in multiple countries but not yet in the United States.

According to Ms. Breward, some of the other treatments included dried cannabis that is smoked or eaten and cannabidiol that’s typically delivered with tetrahydrocannabinol (THC) either oromucosally or as an oral capsule.

MS symptoms treated in the studies included spasticity (n = 29), pain (n = 8) and cognition (n = 6).

The researchers considered 22 studies to be poor quality, 14 to be fair quality, and 24 to be good/excellent quality.

As for results, the researchers found that the cannabis-based medicine “significantly reduced spasticity and pain in several individual good-quality studies,” Ms. Breward said. The drugs seem to work by inhibiting neurotransmitter release via cannabinoids, she said.

“However,” she added, “the variability in study quality – and in the products and regimens studied – make it hard to draw any conclusions about specific products and doses that may have the most potential benefit.”

As for adverse effects, dried cannabis was linked to decreased long-term cognitive function, which is distinct from being temporarily high, Ms. Breward said.

“Further research should focus on the use of different products and formulations of cannabis-based medicine such as cannabis oil and cannabidiol-prominent products, as no studies have focused on this area,” she said. “Research should also look at the potential of cannabis-based medicine for the treatment of disease progression, as cannabinoids are anti-inflammatory and immunomodulatory. Finally, more research regarding the potentially synergistic effects of cannabis-based medicine administered with current MS medications would also be useful.”

No study funding is reported and the authors report no relevant disclosures.

SEATTLE – While several dozen studies have been conducted into cannabis-based treatments for symptoms of multiple sclerosis (MS), a new systematic review deems most to be of fair to poor quality. Reviewers found modest evidence of benefit and plenty of room for more research.

“Cannabis-based medicine may be useful for refractory MS symptoms, especially spasticity and pain, and side effects are usually well tolerated,” study lead author Natasha Breward, a graduate student at the College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, said in an interview. Ms. Breward spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

For the review, Ms. Breward and colleagues focused on 60 studies - 26 randomized controlled trials and 34 trials with other designs. Forty of the studies used nabiximols (Sativex), an oromucosal spray that is derived from the cannabis sativa plant and approved for use in multiple countries but not yet in the United States.

According to Ms. Breward, some of the other treatments included dried cannabis that is smoked or eaten and cannabidiol that’s typically delivered with tetrahydrocannabinol (THC) either oromucosally or as an oral capsule.

MS symptoms treated in the studies included spasticity (n = 29), pain (n = 8) and cognition (n = 6).

The researchers considered 22 studies to be poor quality, 14 to be fair quality, and 24 to be good/excellent quality.

As for results, the researchers found that the cannabis-based medicine “significantly reduced spasticity and pain in several individual good-quality studies,” Ms. Breward said. The drugs seem to work by inhibiting neurotransmitter release via cannabinoids, she said.

“However,” she added, “the variability in study quality – and in the products and regimens studied – make it hard to draw any conclusions about specific products and doses that may have the most potential benefit.”

As for adverse effects, dried cannabis was linked to decreased long-term cognitive function, which is distinct from being temporarily high, Ms. Breward said.

“Further research should focus on the use of different products and formulations of cannabis-based medicine such as cannabis oil and cannabidiol-prominent products, as no studies have focused on this area,” she said. “Research should also look at the potential of cannabis-based medicine for the treatment of disease progression, as cannabinoids are anti-inflammatory and immunomodulatory. Finally, more research regarding the potentially synergistic effects of cannabis-based medicine administered with current MS medications would also be useful.”

No study funding is reported and the authors report no relevant disclosures.

SEATTLE – While several dozen studies have been conducted into cannabis-based treatments for symptoms of multiple sclerosis (MS), a new systematic review deems most to be of fair to poor quality. Reviewers found modest evidence of benefit and plenty of room for more research.

“Cannabis-based medicine may be useful for refractory MS symptoms, especially spasticity and pain, and side effects are usually well tolerated,” study lead author Natasha Breward, a graduate student at the College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, said in an interview. Ms. Breward spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

For the review, Ms. Breward and colleagues focused on 60 studies - 26 randomized controlled trials and 34 trials with other designs. Forty of the studies used nabiximols (Sativex), an oromucosal spray that is derived from the cannabis sativa plant and approved for use in multiple countries but not yet in the United States.

According to Ms. Breward, some of the other treatments included dried cannabis that is smoked or eaten and cannabidiol that’s typically delivered with tetrahydrocannabinol (THC) either oromucosally or as an oral capsule.

MS symptoms treated in the studies included spasticity (n = 29), pain (n = 8) and cognition (n = 6).

The researchers considered 22 studies to be poor quality, 14 to be fair quality, and 24 to be good/excellent quality.

As for results, the researchers found that the cannabis-based medicine “significantly reduced spasticity and pain in several individual good-quality studies,” Ms. Breward said. The drugs seem to work by inhibiting neurotransmitter release via cannabinoids, she said.

“However,” she added, “the variability in study quality – and in the products and regimens studied – make it hard to draw any conclusions about specific products and doses that may have the most potential benefit.”

As for adverse effects, dried cannabis was linked to decreased long-term cognitive function, which is distinct from being temporarily high, Ms. Breward said.

“Further research should focus on the use of different products and formulations of cannabis-based medicine such as cannabis oil and cannabidiol-prominent products, as no studies have focused on this area,” she said. “Research should also look at the potential of cannabis-based medicine for the treatment of disease progression, as cannabinoids are anti-inflammatory and immunomodulatory. Finally, more research regarding the potentially synergistic effects of cannabis-based medicine administered with current MS medications would also be useful.”

No study funding is reported and the authors report no relevant disclosures.

SEATTLE – Neurologists who subspecialize in multiple sclerosis (MS) are more likely than are general neurologists to prescribe three out of five high-efficacy medications for patients with the condition, according to the findings from a single-system study. It is not clear if the greater reluctance among general neurologists to prescribe the drugs is hurting the health of patients, and the study does not examine whether general neurologists are referring their toughest patients to their subspecialist colleagues.

Still, the findings raise questions because “starting highly effective drugs early can prevent long-term disability,” said study lead author and neurologist Casey V. Farin, MD, a clinical fellow in the department of neurology at Duke University, Durham, N.C., who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers. “A lot of our general neurologists are prescribing the traditional platform therapies that have fallen a bit out of favor in the MS community,” she said.

Dr. Farin and colleagues launched their study to better understand whether “therapeutic inertia” is affecting how general neurologists treat MS. The term refers to “staying with one drug just because it is easier not to rock the boat,” she said. For the purposes of their study, the term encompasses reluctance of neurologists to escalate therapy or prescribe high-efficacy drugs.

“There have been small studies comparing subspecialists and general neurologists using surveys of theoretical cases,” she said. “No studies have looked at how people are prescribing disease-modifying therapy.”

In the new age of high-efficacy treatment, guidelines about early MS treatment are lacking. As the study abstract notes, “in the absence of robust head-to-head clinical data, neurologists do not have an accepted algorithm for initiation and escalation of therapy, although recent research indicates a benefit in initiating highly effective therapies early in the disease course.”

For the study, researchers tracked 4,753 patients with MS who were treated at the Duke University Health System from 2016 to 2018.

General neurologists prescribed platform therapies – interferons, glatiramer acetate (Copaxone) and dimethyl fumarate (Tecfidera) more often than did MS subspecialists (16% vs. 5%, P less than .0001, 12% vs. 6%, P = .001 and 31% vs. 11%, P less than .0001, respectively).

In regard to high-efficacy MS drugs, there was no significant difference in prescription rates of fingolimod (Gilenya) and natalizumab (Tysabri). But general neurologists were less likely to prescribe three other types than were general neurologists: Alemtuzumab (Lemtrada), ocrelizumab (Ocrevus) and rituximab (Rituxan) (0 vs. 8%, P = .0001, 3% vs. 27%, P less than .0001, and 2% vs. 7%, P = .0001, respectively).

Why might general neurologists be more resistant to embrace high-efficacy MS drugs? “They are newer and seen as more aggressive, and riskier,” Dr. Farin said. If general neurologists are not seeing many patients with MS and not prescribing these newer drugs very often, they may be more familiar with the older platform drugs, she said. “They may start with the ones that seem safer and are easier to start with.”

It is possible, she cautioned, that the study results may be confounded by general neurologists who refer patients to MS subspecialists when initial disease-modifying therapies fail.

No study funding was reported. Dr. Farin and two of the other four authors disclosed consulting fees from Biogen. No other disclosures were reported.

SOURCE: Farin CV et al. CMSC 2019. Abstract DXT44.

SEATTLE – Neurologists who subspecialize in multiple sclerosis (MS) are more likely than are general neurologists to prescribe three out of five high-efficacy medications for patients with the condition, according to the findings from a single-system study. It is not clear if the greater reluctance among general neurologists to prescribe the drugs is hurting the health of patients, and the study does not examine whether general neurologists are referring their toughest patients to their subspecialist colleagues.

Still, the findings raise questions because “starting highly effective drugs early can prevent long-term disability,” said study lead author and neurologist Casey V. Farin, MD, a clinical fellow in the department of neurology at Duke University, Durham, N.C., who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers. “A lot of our general neurologists are prescribing the traditional platform therapies that have fallen a bit out of favor in the MS community,” she said.

Dr. Farin and colleagues launched their study to better understand whether “therapeutic inertia” is affecting how general neurologists treat MS. The term refers to “staying with one drug just because it is easier not to rock the boat,” she said. For the purposes of their study, the term encompasses reluctance of neurologists to escalate therapy or prescribe high-efficacy drugs.

“There have been small studies comparing subspecialists and general neurologists using surveys of theoretical cases,” she said. “No studies have looked at how people are prescribing disease-modifying therapy.”

In the new age of high-efficacy treatment, guidelines about early MS treatment are lacking. As the study abstract notes, “in the absence of robust head-to-head clinical data, neurologists do not have an accepted algorithm for initiation and escalation of therapy, although recent research indicates a benefit in initiating highly effective therapies early in the disease course.”

For the study, researchers tracked 4,753 patients with MS who were treated at the Duke University Health System from 2016 to 2018.

General neurologists prescribed platform therapies – interferons, glatiramer acetate (Copaxone) and dimethyl fumarate (Tecfidera) more often than did MS subspecialists (16% vs. 5%, P less than .0001, 12% vs. 6%, P = .001 and 31% vs. 11%, P less than .0001, respectively).

In regard to high-efficacy MS drugs, there was no significant difference in prescription rates of fingolimod (Gilenya) and natalizumab (Tysabri). But general neurologists were less likely to prescribe three other types than were general neurologists: Alemtuzumab (Lemtrada), ocrelizumab (Ocrevus) and rituximab (Rituxan) (0 vs. 8%, P = .0001, 3% vs. 27%, P less than .0001, and 2% vs. 7%, P = .0001, respectively).

Why might general neurologists be more resistant to embrace high-efficacy MS drugs? “They are newer and seen as more aggressive, and riskier,” Dr. Farin said. If general neurologists are not seeing many patients with MS and not prescribing these newer drugs very often, they may be more familiar with the older platform drugs, she said. “They may start with the ones that seem safer and are easier to start with.”

It is possible, she cautioned, that the study results may be confounded by general neurologists who refer patients to MS subspecialists when initial disease-modifying therapies fail.

No study funding was reported. Dr. Farin and two of the other four authors disclosed consulting fees from Biogen. No other disclosures were reported.

SOURCE: Farin CV et al. CMSC 2019. Abstract DXT44.

SEATTLE – Neurologists who subspecialize in multiple sclerosis (MS) are more likely than are general neurologists to prescribe three out of five high-efficacy medications for patients with the condition, according to the findings from a single-system study. It is not clear if the greater reluctance among general neurologists to prescribe the drugs is hurting the health of patients, and the study does not examine whether general neurologists are referring their toughest patients to their subspecialist colleagues.

Still, the findings raise questions because “starting highly effective drugs early can prevent long-term disability,” said study lead author and neurologist Casey V. Farin, MD, a clinical fellow in the department of neurology at Duke University, Durham, N.C., who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers. “A lot of our general neurologists are prescribing the traditional platform therapies that have fallen a bit out of favor in the MS community,” she said.

Dr. Farin and colleagues launched their study to better understand whether “therapeutic inertia” is affecting how general neurologists treat MS. The term refers to “staying with one drug just because it is easier not to rock the boat,” she said. For the purposes of their study, the term encompasses reluctance of neurologists to escalate therapy or prescribe high-efficacy drugs.

“There have been small studies comparing subspecialists and general neurologists using surveys of theoretical cases,” she said. “No studies have looked at how people are prescribing disease-modifying therapy.”

In the new age of high-efficacy treatment, guidelines about early MS treatment are lacking. As the study abstract notes, “in the absence of robust head-to-head clinical data, neurologists do not have an accepted algorithm for initiation and escalation of therapy, although recent research indicates a benefit in initiating highly effective therapies early in the disease course.”

For the study, researchers tracked 4,753 patients with MS who were treated at the Duke University Health System from 2016 to 2018.

General neurologists prescribed platform therapies – interferons, glatiramer acetate (Copaxone) and dimethyl fumarate (Tecfidera) more often than did MS subspecialists (16% vs. 5%, P less than .0001, 12% vs. 6%, P = .001 and 31% vs. 11%, P less than .0001, respectively).

In regard to high-efficacy MS drugs, there was no significant difference in prescription rates of fingolimod (Gilenya) and natalizumab (Tysabri). But general neurologists were less likely to prescribe three other types than were general neurologists: Alemtuzumab (Lemtrada), ocrelizumab (Ocrevus) and rituximab (Rituxan) (0 vs. 8%, P = .0001, 3% vs. 27%, P less than .0001, and 2% vs. 7%, P = .0001, respectively).

Why might general neurologists be more resistant to embrace high-efficacy MS drugs? “They are newer and seen as more aggressive, and riskier,” Dr. Farin said. If general neurologists are not seeing many patients with MS and not prescribing these newer drugs very often, they may be more familiar with the older platform drugs, she said. “They may start with the ones that seem safer and are easier to start with.”

It is possible, she cautioned, that the study results may be confounded by general neurologists who refer patients to MS subspecialists when initial disease-modifying therapies fail.

No study funding was reported. Dr. Farin and two of the other four authors disclosed consulting fees from Biogen. No other disclosures were reported.

SOURCE: Farin CV et al. CMSC 2019. Abstract DXT44.

SEATTLE – Patients with multiple sclerosis (MS) are more than twice as likely as the general population to engage in significant hoarding behaviors, according to a small study that appears to be the first of its kind. It is not clear how MS and hoarding may be linked, but study author Joshua Bacon, PhD, an MS researcher and associate professor at New York University, and coauthors suspect that physical limitations are an important factor.

“It is important for clinicians to identify patients who might be hoarders and/or clutterers. It is very likely that this has an impact on the trajectory of their activities of daily living,” he said in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Dr. Bacon said the study was inspired by his observation that hoarding and cluttering behavior appear to be common among patients with MS. “As I became more interested in it, it became clear there hasn’t been any work on this in the MS population.”

For the new study, Dr. Bacon and colleagues surveyed 139 consecutive patients with MS at the New York University MS Center. The patients had a mean age of 45 years and mean disease duration of 14 years; 71% were female, and 48% were non white. The researchers measured the patients on scales of hoarding behavior (Activities of Daily Living for Hoarding and the Hoarding Rating Scale) and disability (Patient-Determined Disability Steps).

The researchers found that nearly 12% showed signs of clinically significant hoarding behavior, compared with an estimated 5% of the general population (P = .0008). Researchers linked disability and Hoarding Rating Scale to the variability in degree of difficulty in performing activities of daily living (P less than .0001).

Dr. Bacon and colleagues do not believe MS is the direct cause of hoarding behaviors. “There has been no literature on this, and we do not know whether this is connected to the neurological condition,” he said. “I think it has more to do with physical capabilities.”

Patients with MS may have mobility problems that disrupt their ability to organize their homes, he said. “You can’t move things the way you can when you have normal mobility,” he said. “Things can start building up, and it is harder to get yourself out of the mess because you don’t have the wherewithal to move things out of that way.”

As a result, he said, patients may become more isolated if they become embarrassed about inviting people into their homes. To make matters worse, some patients with MS already suffer from social isolation, he said.

He added that some patients with MS may be “clutterers” who do not fit the definition of hoarders but are still affected. “Even cluttering can have an impact on quality of life. You do not have to have the disorder,” he said.

What can be done to help patients who are hoarders or clutterers? Dr. Bacon acknowledged that hoarding behavior is very difficult to treat successfully, but cluttering – a step below hoarding – may be easier to address.

“As therapists, we try to help MS patients confront the debilitating emotional distress that inevitably emerges from the loss of control as disability progresses,” he said. “A central emphasis in therapy is to turn the focus away from the neurological changes and their sequelae that cannot be changed to those facets of their lives over which they can have control and that can be nurtured and strengthened.”

No study funding was reported, and the study authors reported no relevant disclosures.

SEATTLE – Patients with multiple sclerosis (MS) are more than twice as likely as the general population to engage in significant hoarding behaviors, according to a small study that appears to be the first of its kind. It is not clear how MS and hoarding may be linked, but study author Joshua Bacon, PhD, an MS researcher and associate professor at New York University, and coauthors suspect that physical limitations are an important factor.

“It is important for clinicians to identify patients who might be hoarders and/or clutterers. It is very likely that this has an impact on the trajectory of their activities of daily living,” he said in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Dr. Bacon said the study was inspired by his observation that hoarding and cluttering behavior appear to be common among patients with MS. “As I became more interested in it, it became clear there hasn’t been any work on this in the MS population.”

For the new study, Dr. Bacon and colleagues surveyed 139 consecutive patients with MS at the New York University MS Center. The patients had a mean age of 45 years and mean disease duration of 14 years; 71% were female, and 48% were non white. The researchers measured the patients on scales of hoarding behavior (Activities of Daily Living for Hoarding and the Hoarding Rating Scale) and disability (Patient-Determined Disability Steps).

The researchers found that nearly 12% showed signs of clinically significant hoarding behavior, compared with an estimated 5% of the general population (P = .0008). Researchers linked disability and Hoarding Rating Scale to the variability in degree of difficulty in performing activities of daily living (P less than .0001).

Dr. Bacon and colleagues do not believe MS is the direct cause of hoarding behaviors. “There has been no literature on this, and we do not know whether this is connected to the neurological condition,” he said. “I think it has more to do with physical capabilities.”

Patients with MS may have mobility problems that disrupt their ability to organize their homes, he said. “You can’t move things the way you can when you have normal mobility,” he said. “Things can start building up, and it is harder to get yourself out of the mess because you don’t have the wherewithal to move things out of that way.”

As a result, he said, patients may become more isolated if they become embarrassed about inviting people into their homes. To make matters worse, some patients with MS already suffer from social isolation, he said.

He added that some patients with MS may be “clutterers” who do not fit the definition of hoarders but are still affected. “Even cluttering can have an impact on quality of life. You do not have to have the disorder,” he said.

What can be done to help patients who are hoarders or clutterers? Dr. Bacon acknowledged that hoarding behavior is very difficult to treat successfully, but cluttering – a step below hoarding – may be easier to address.

“As therapists, we try to help MS patients confront the debilitating emotional distress that inevitably emerges from the loss of control as disability progresses,” he said. “A central emphasis in therapy is to turn the focus away from the neurological changes and their sequelae that cannot be changed to those facets of their lives over which they can have control and that can be nurtured and strengthened.”

No study funding was reported, and the study authors reported no relevant disclosures.

SEATTLE – Patients with multiple sclerosis (MS) are more than twice as likely as the general population to engage in significant hoarding behaviors, according to a small study that appears to be the first of its kind. It is not clear how MS and hoarding may be linked, but study author Joshua Bacon, PhD, an MS researcher and associate professor at New York University, and coauthors suspect that physical limitations are an important factor.

“It is important for clinicians to identify patients who might be hoarders and/or clutterers. It is very likely that this has an impact on the trajectory of their activities of daily living,” he said in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Dr. Bacon said the study was inspired by his observation that hoarding and cluttering behavior appear to be common among patients with MS. “As I became more interested in it, it became clear there hasn’t been any work on this in the MS population.”

For the new study, Dr. Bacon and colleagues surveyed 139 consecutive patients with MS at the New York University MS Center. The patients had a mean age of 45 years and mean disease duration of 14 years; 71% were female, and 48% were non white. The researchers measured the patients on scales of hoarding behavior (Activities of Daily Living for Hoarding and the Hoarding Rating Scale) and disability (Patient-Determined Disability Steps).

The researchers found that nearly 12% showed signs of clinically significant hoarding behavior, compared with an estimated 5% of the general population (P = .0008). Researchers linked disability and Hoarding Rating Scale to the variability in degree of difficulty in performing activities of daily living (P less than .0001).

Dr. Bacon and colleagues do not believe MS is the direct cause of hoarding behaviors. “There has been no literature on this, and we do not know whether this is connected to the neurological condition,” he said. “I think it has more to do with physical capabilities.”

Patients with MS may have mobility problems that disrupt their ability to organize their homes, he said. “You can’t move things the way you can when you have normal mobility,” he said. “Things can start building up, and it is harder to get yourself out of the mess because you don’t have the wherewithal to move things out of that way.”

As a result, he said, patients may become more isolated if they become embarrassed about inviting people into their homes. To make matters worse, some patients with MS already suffer from social isolation, he said.

He added that some patients with MS may be “clutterers” who do not fit the definition of hoarders but are still affected. “Even cluttering can have an impact on quality of life. You do not have to have the disorder,” he said.

What can be done to help patients who are hoarders or clutterers? Dr. Bacon acknowledged that hoarding behavior is very difficult to treat successfully, but cluttering – a step below hoarding – may be easier to address.

“As therapists, we try to help MS patients confront the debilitating emotional distress that inevitably emerges from the loss of control as disability progresses,” he said. “A central emphasis in therapy is to turn the focus away from the neurological changes and their sequelae that cannot be changed to those facets of their lives over which they can have control and that can be nurtured and strengthened.”

No study funding was reported, and the study authors reported no relevant disclosures.

Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – older age, smoking, history of cardiovascular disease, and longer duration of diabetes – seem to indicate increased risk only in type 1 disease, according to the new study findings.

The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.

DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.

For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.

Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.

Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.

Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).

The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.

The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.

SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.

Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – older age, smoking, history of cardiovascular disease, and longer duration of diabetes – seem to indicate increased risk only in type 1 disease, according to the new study findings.

The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.

DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.

For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.

Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.

Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.

Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).

The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.

The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.

SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.

Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – older age, smoking, history of cardiovascular disease, and longer duration of diabetes – seem to indicate increased risk only in type 1 disease, according to the new study findings.

The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.

DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.

For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.

Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.

Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.

Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).

The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.

The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.

SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.

LOS ANGELES – Recent research, a new test, and upcoming guidelines are providing insight into the diagnosis of adult growth hormone deficiency and the importance of treatment, Kevin C.J. Yuen, MD, FRCP(UK), FACE, told colleagues at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE).

“The data show that growth hormone replacement is safe and may improve survival,” said Dr Yuen, professor of medicine and medical director at Barrow Neurological Institute Pituitary Center in Phoenix.

Dr. Yuen is chair of the AACE’s growth hormone task force and coauthored both the 2009 and soon-to-be-published 2019 AACE guidelines for the treatment of adult growth hormone deficiency (AGHD).

Updated AGHD guidelines were needed for a variety of reasons, including a greater awareness of the benefits of hormone replacement in these patients and new developments in areas such as testing, he said. The guidelines also are also necessary because of the skepticism about the cost and benefits of AGHD therapy, concerns about the safety of long-term therapy, and the misuse of treatment in certain patients, he added.

On the treatment front, Dr. Yuen said it has become more clear over recent years that patients with AGHD benefit from hormone replacement. Findings from two studies have linked treatment to improvements in exercise capacity (Clin Endocrinol [Oxf]. 2016;85[4]:660-8) and patient quality of life (Eur J Endocrinol. 2017;176:99-109). “Even just after 6 months there’s an improvement in aerobic power,” he said.

And, he continued, other findings have suggested that treatment could lower mortality in men and reduce the number of deaths from malignant neoplasms in all patients (Eur J Endocrinol. 2017;176[1]:67-75).

However, Dr. Yuen cautioned that the confirmation of a survival benefit from hormone replacement will be speculative as long as there are no prospective data available.

He offered five tips about diagnosing and treating AGHD:

First, be aware that a number of conditions other than AGHD can cause low levels of insulin-like growth factor 1, including malnutrition, diabetes, untreated hypothyroidism, liver disease, and kidney failure.

Second, follow recommended algorithms for testing adult patients and transition those pediatric patients who seem to be at risk of having the condition. (Those moving from pediatric to adult care are known as transition patients.) The algorithms suggest that three diagnostic tests can be helpful, depending on the situation: the macimorelin test, the insulin tolerance test, and the glucagon stimulation test.

In 2017, the Food and Drug Administration approved the macimorelin (Macrilen) test, which requires the administration of an oral medication before a blood test. Dr. Yuen cited a phase 3 study that demonstrated that the test was “highly reproducible” and has a “good safety profile” (J Clin Endocrinol Metab. 2018;103[8]:3083-93). Dr. Yuen believes the test will become the preferred alternative to the insulin tolerance test.

Third, transition patients require special care as they move from pediatric care. “The handover is still very challenging,” Dr. Yuen said. “There’s still much to be done to improve the quality of treatment for these patients.” Challenges during the transition can include the patient’s reluctance to continue taking hormones in adulthood, he said. “Encourage pediatricians to start educating patients from early on that they’ll need to remain on hormones,” he advised, and help patients take accountability for their health in areas such as self-injection.

Patients may suffer from “injection fatigue,” they may be concerned about the side effects of the therapy, and/or they may be overwhelmed by the cost of care, he said. They may not understand how to manage their care and lack insight into the consequences of treatment cessation.

He advised endocrinologists to monitor transition patients who aren’t growth-hormone deficient because their status may change in the future.

Fourth, start treatment in adults with recommended doses of growth hormone. For those younger than 30 years, use 0.4-0.5 mg/day (higher for transition patients); for those aged between 30 and 60 years, use 0.2-0.3 mg/day; and for those who are older than 60 years, use 0.1-0.2 mg/day. Doses should be adjusted to 0.1-0.2 mg/day in patients with diabetes, obesity, and/or previous gestational diabetes.

Fifth, treat patients with growth hormone indefinitely if benefits are seen, but consider stopping treatment after a year if there doesn’t seem to be a benefit, Dr. Yuen advised. Follow up at 6 months, he recommended.

Dr. Yuen disclosed receiving research grants from and consulting for Pfizer, Novo Nordisk, and Aeterna Zentaris. He has also consulted for Strongbridge.

LOS ANGELES – Recent research, a new test, and upcoming guidelines are providing insight into the diagnosis of adult growth hormone deficiency and the importance of treatment, Kevin C.J. Yuen, MD, FRCP(UK), FACE, told colleagues at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE).

“The data show that growth hormone replacement is safe and may improve survival,” said Dr Yuen, professor of medicine and medical director at Barrow Neurological Institute Pituitary Center in Phoenix.

Dr. Yuen is chair of the AACE’s growth hormone task force and coauthored both the 2009 and soon-to-be-published 2019 AACE guidelines for the treatment of adult growth hormone deficiency (AGHD).

Updated AGHD guidelines were needed for a variety of reasons, including a greater awareness of the benefits of hormone replacement in these patients and new developments in areas such as testing, he said. The guidelines also are also necessary because of the skepticism about the cost and benefits of AGHD therapy, concerns about the safety of long-term therapy, and the misuse of treatment in certain patients, he added.

On the treatment front, Dr. Yuen said it has become more clear over recent years that patients with AGHD benefit from hormone replacement. Findings from two studies have linked treatment to improvements in exercise capacity (Clin Endocrinol [Oxf]. 2016;85[4]:660-8) and patient quality of life (Eur J Endocrinol. 2017;176:99-109). “Even just after 6 months there’s an improvement in aerobic power,” he said.

And, he continued, other findings have suggested that treatment could lower mortality in men and reduce the number of deaths from malignant neoplasms in all patients (Eur J Endocrinol. 2017;176[1]:67-75).

However, Dr. Yuen cautioned that the confirmation of a survival benefit from hormone replacement will be speculative as long as there are no prospective data available.

He offered five tips about diagnosing and treating AGHD:

First, be aware that a number of conditions other than AGHD can cause low levels of insulin-like growth factor 1, including malnutrition, diabetes, untreated hypothyroidism, liver disease, and kidney failure.

Second, follow recommended algorithms for testing adult patients and transition those pediatric patients who seem to be at risk of having the condition. (Those moving from pediatric to adult care are known as transition patients.) The algorithms suggest that three diagnostic tests can be helpful, depending on the situation: the macimorelin test, the insulin tolerance test, and the glucagon stimulation test.

In 2017, the Food and Drug Administration approved the macimorelin (Macrilen) test, which requires the administration of an oral medication before a blood test. Dr. Yuen cited a phase 3 study that demonstrated that the test was “highly reproducible” and has a “good safety profile” (J Clin Endocrinol Metab. 2018;103[8]:3083-93). Dr. Yuen believes the test will become the preferred alternative to the insulin tolerance test.

Third, transition patients require special care as they move from pediatric care. “The handover is still very challenging,” Dr. Yuen said. “There’s still much to be done to improve the quality of treatment for these patients.” Challenges during the transition can include the patient’s reluctance to continue taking hormones in adulthood, he said. “Encourage pediatricians to start educating patients from early on that they’ll need to remain on hormones,” he advised, and help patients take accountability for their health in areas such as self-injection.

Patients may suffer from “injection fatigue,” they may be concerned about the side effects of the therapy, and/or they may be overwhelmed by the cost of care, he said. They may not understand how to manage their care and lack insight into the consequences of treatment cessation.

He advised endocrinologists to monitor transition patients who aren’t growth-hormone deficient because their status may change in the future.

Fourth, start treatment in adults with recommended doses of growth hormone. For those younger than 30 years, use 0.4-0.5 mg/day (higher for transition patients); for those aged between 30 and 60 years, use 0.2-0.3 mg/day; and for those who are older than 60 years, use 0.1-0.2 mg/day. Doses should be adjusted to 0.1-0.2 mg/day in patients with diabetes, obesity, and/or previous gestational diabetes.

Fifth, treat patients with growth hormone indefinitely if benefits are seen, but consider stopping treatment after a year if there doesn’t seem to be a benefit, Dr. Yuen advised. Follow up at 6 months, he recommended.

Dr. Yuen disclosed receiving research grants from and consulting for Pfizer, Novo Nordisk, and Aeterna Zentaris. He has also consulted for Strongbridge.

LOS ANGELES – Recent research, a new test, and upcoming guidelines are providing insight into the diagnosis of adult growth hormone deficiency and the importance of treatment, Kevin C.J. Yuen, MD, FRCP(UK), FACE, told colleagues at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE).

“The data show that growth hormone replacement is safe and may improve survival,” said Dr Yuen, professor of medicine and medical director at Barrow Neurological Institute Pituitary Center in Phoenix.

Dr. Yuen is chair of the AACE’s growth hormone task force and coauthored both the 2009 and soon-to-be-published 2019 AACE guidelines for the treatment of adult growth hormone deficiency (AGHD).

Updated AGHD guidelines were needed for a variety of reasons, including a greater awareness of the benefits of hormone replacement in these patients and new developments in areas such as testing, he said. The guidelines also are also necessary because of the skepticism about the cost and benefits of AGHD therapy, concerns about the safety of long-term therapy, and the misuse of treatment in certain patients, he added.

On the treatment front, Dr. Yuen said it has become more clear over recent years that patients with AGHD benefit from hormone replacement. Findings from two studies have linked treatment to improvements in exercise capacity (Clin Endocrinol [Oxf]. 2016;85[4]:660-8) and patient quality of life (Eur J Endocrinol. 2017;176:99-109). “Even just after 6 months there’s an improvement in aerobic power,” he said.

And, he continued, other findings have suggested that treatment could lower mortality in men and reduce the number of deaths from malignant neoplasms in all patients (Eur J Endocrinol. 2017;176[1]:67-75).

However, Dr. Yuen cautioned that the confirmation of a survival benefit from hormone replacement will be speculative as long as there are no prospective data available.

He offered five tips about diagnosing and treating AGHD:

First, be aware that a number of conditions other than AGHD can cause low levels of insulin-like growth factor 1, including malnutrition, diabetes, untreated hypothyroidism, liver disease, and kidney failure.

Second, follow recommended algorithms for testing adult patients and transition those pediatric patients who seem to be at risk of having the condition. (Those moving from pediatric to adult care are known as transition patients.) The algorithms suggest that three diagnostic tests can be helpful, depending on the situation: the macimorelin test, the insulin tolerance test, and the glucagon stimulation test.

In 2017, the Food and Drug Administration approved the macimorelin (Macrilen) test, which requires the administration of an oral medication before a blood test. Dr. Yuen cited a phase 3 study that demonstrated that the test was “highly reproducible” and has a “good safety profile” (J Clin Endocrinol Metab. 2018;103[8]:3083-93). Dr. Yuen believes the test will become the preferred alternative to the insulin tolerance test.

Third, transition patients require special care as they move from pediatric care. “The handover is still very challenging,” Dr. Yuen said. “There’s still much to be done to improve the quality of treatment for these patients.” Challenges during the transition can include the patient’s reluctance to continue taking hormones in adulthood, he said. “Encourage pediatricians to start educating patients from early on that they’ll need to remain on hormones,” he advised, and help patients take accountability for their health in areas such as self-injection.

Patients may suffer from “injection fatigue,” they may be concerned about the side effects of the therapy, and/or they may be overwhelmed by the cost of care, he said. They may not understand how to manage their care and lack insight into the consequences of treatment cessation.

He advised endocrinologists to monitor transition patients who aren’t growth-hormone deficient because their status may change in the future.

Fourth, start treatment in adults with recommended doses of growth hormone. For those younger than 30 years, use 0.4-0.5 mg/day (higher for transition patients); for those aged between 30 and 60 years, use 0.2-0.3 mg/day; and for those who are older than 60 years, use 0.1-0.2 mg/day. Doses should be adjusted to 0.1-0.2 mg/day in patients with diabetes, obesity, and/or previous gestational diabetes.

Fifth, treat patients with growth hormone indefinitely if benefits are seen, but consider stopping treatment after a year if there doesn’t seem to be a benefit, Dr. Yuen advised. Follow up at 6 months, he recommended.

Dr. Yuen disclosed receiving research grants from and consulting for Pfizer, Novo Nordisk, and Aeterna Zentaris. He has also consulted for Strongbridge.

LOS ANGELES – A phase 3 clinical trial shows promising results for an experimental drug called teprotumumab, which treats thyroid eye disease, researchers reported at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

“For the first time, there appears to be a medicine that can be given during the active phase of the disease and can actually reverse not just the eyelid swelling and the clinical activity score, but also reduce the eye bulging and double vision and [improve] the [patient’s] quality of life. It could be a watershed moment in the treatment of the disease,” said ophthalmologist Raymond Douglas, MD, PhD, professor of surgery at Cedar-Sinai Medical Center Los Angeles and the study’s coprincipal investigator, in an interview at the meeting.

According to Dr. Douglas, thyroid eye disease, which is also known as Graves’ eye disease, is a severely disabling condition that causes swelling, pain, discomfort, and blindness. “The burden really is quite significant,” he said, with an impact that’s been compared with that of breast cancer in quality-of-life studies.

“Current treatments for thyroid eye disease are rather limited,” he said. “They really encompass just reducing the swelling and the short-term manifestations of the disease. Treatments such as IV steroids and radiation have been shown to not have any effect on long-term manifestations such as eye bulging and double vision.”

Teprotumumab is a fully human monoclonal antibody that targets the insulinlike growth factor I receptor (IGF-IR). It seems to downregulate thyroid eye disease, Dr. Douglas said.

Researchers studied the drug in a randomized, placebo-controlled study: 41 patients were designated to receive eight intravenous infusions of the drug over 21 weeks (10 mg/kg for the first infusion, then 20 mg/kg thereafter). At week 24, 83% of the study group (34 of 41 patients) reached the endpoint of a reduction of eye bulging by at least 2 mm, compared with 10% of patients (4 of 42) in the placebo group, which received infusions of saline solution.

Two millimeters is significant, Dr. Douglas said. “If you noticed someone’s eye was bulging 2 millimeters, you’d say, ‘Hey, I think something is wrong with your eye.’ ”

Initial study results were released in February 2019. New data about secondary endpoints were released at the AACE meeting: Researchers reported that the average reduction in proptosis (eye bulging) was 2.82 mm in the study group, compared with 0.54 mm in the placebo group (P less than .001).

Dr. Douglas said he can “achieve 3 mm of reduction through surgery to drill out the bone between the eye and the brain. [The patients in the study group] were able to achieve almost 3 millimeters of reduction by the drug alone. It’s a rather significant improvement.”

The new data also provided some insight into the timing of clinical improvements. According to Dr. Douglas, “most of the endpoints were met as early as 6 weeks or [after] two infusions of this drug.”

The adverse effects were relatively mild and included muscle spasms, said Dr. Douglas. The side effects seem to be “well tolerated,” he noted, and none led to cessation of therapy.

Participants with potential for motherhood or fatherhood during the trial had to agree to take precautions to avoid becoming pregnant or impregnating a partner.

Dr. Douglas didn’t provide cost information about the drug. However, it seems likely to be expensive. A writer with Seeking Alpha, a stock market analysis site, estimated that the cost could reach “$250,000 or $300,000 per patient per year, which translates to a $3.7 billion to $6 billion market in the United States alone (based on the estimated patient population in the 15,000-20,000 range).”

The drug’s manufacturer, Horizon Therapeutics, expects to apply to the Food and Drug Administration later this year for approval of the drug.

If it is approved, endocrinologists will have an opportunity to partner with eye surgeons to treat thyroid eye disease, Dr. Douglas said. “The crux will be the comanagement with the endocrinologist helping to control the thyroid function and manage some of the side effects of this medication, and the oculoplastic surgeon [working on] diagnosis, appropriate use, and management.”

Horizon Therapeutics funded the study. Dr. Douglas disclosed that he is a consultant with the company.
 

LOS ANGELES – A phase 3 clinical trial shows promising results for an experimental drug called teprotumumab, which treats thyroid eye disease, researchers reported at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

“For the first time, there appears to be a medicine that can be given during the active phase of the disease and can actually reverse not just the eyelid swelling and the clinical activity score, but also reduce the eye bulging and double vision and [improve] the [patient’s] quality of life. It could be a watershed moment in the treatment of the disease,” said ophthalmologist Raymond Douglas, MD, PhD, professor of surgery at Cedar-Sinai Medical Center Los Angeles and the study’s coprincipal investigator, in an interview at the meeting.

According to Dr. Douglas, thyroid eye disease, which is also known as Graves’ eye disease, is a severely disabling condition that causes swelling, pain, discomfort, and blindness. “The burden really is quite significant,” he said, with an impact that’s been compared with that of breast cancer in quality-of-life studies.

“Current treatments for thyroid eye disease are rather limited,” he said. “They really encompass just reducing the swelling and the short-term manifestations of the disease. Treatments such as IV steroids and radiation have been shown to not have any effect on long-term manifestations such as eye bulging and double vision.”

Teprotumumab is a fully human monoclonal antibody that targets the insulinlike growth factor I receptor (IGF-IR). It seems to downregulate thyroid eye disease, Dr. Douglas said.

Researchers studied the drug in a randomized, placebo-controlled study: 41 patients were designated to receive eight intravenous infusions of the drug over 21 weeks (10 mg/kg for the first infusion, then 20 mg/kg thereafter). At week 24, 83% of the study group (34 of 41 patients) reached the endpoint of a reduction of eye bulging by at least 2 mm, compared with 10% of patients (4 of 42) in the placebo group, which received infusions of saline solution.

Two millimeters is significant, Dr. Douglas said. “If you noticed someone’s eye was bulging 2 millimeters, you’d say, ‘Hey, I think something is wrong with your eye.’ ”

Initial study results were released in February 2019. New data about secondary endpoints were released at the AACE meeting: Researchers reported that the average reduction in proptosis (eye bulging) was 2.82 mm in the study group, compared with 0.54 mm in the placebo group (P less than .001).

Dr. Douglas said he can “achieve 3 mm of reduction through surgery to drill out the bone between the eye and the brain. [The patients in the study group] were able to achieve almost 3 millimeters of reduction by the drug alone. It’s a rather significant improvement.”

The new data also provided some insight into the timing of clinical improvements. According to Dr. Douglas, “most of the endpoints were met as early as 6 weeks or [after] two infusions of this drug.”

The adverse effects were relatively mild and included muscle spasms, said Dr. Douglas. The side effects seem to be “well tolerated,” he noted, and none led to cessation of therapy.

Participants with potential for motherhood or fatherhood during the trial had to agree to take precautions to avoid becoming pregnant or impregnating a partner.

Dr. Douglas didn’t provide cost information about the drug. However, it seems likely to be expensive. A writer with Seeking Alpha, a stock market analysis site, estimated that the cost could reach “$250,000 or $300,000 per patient per year, which translates to a $3.7 billion to $6 billion market in the United States alone (based on the estimated patient population in the 15,000-20,000 range).”

The drug’s manufacturer, Horizon Therapeutics, expects to apply to the Food and Drug Administration later this year for approval of the drug.

If it is approved, endocrinologists will have an opportunity to partner with eye surgeons to treat thyroid eye disease, Dr. Douglas said. “The crux will be the comanagement with the endocrinologist helping to control the thyroid function and manage some of the side effects of this medication, and the oculoplastic surgeon [working on] diagnosis, appropriate use, and management.”

Horizon Therapeutics funded the study. Dr. Douglas disclosed that he is a consultant with the company.
 

LOS ANGELES – A phase 3 clinical trial shows promising results for an experimental drug called teprotumumab, which treats thyroid eye disease, researchers reported at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

“For the first time, there appears to be a medicine that can be given during the active phase of the disease and can actually reverse not just the eyelid swelling and the clinical activity score, but also reduce the eye bulging and double vision and [improve] the [patient’s] quality of life. It could be a watershed moment in the treatment of the disease,” said ophthalmologist Raymond Douglas, MD, PhD, professor of surgery at Cedar-Sinai Medical Center Los Angeles and the study’s coprincipal investigator, in an interview at the meeting.

According to Dr. Douglas, thyroid eye disease, which is also known as Graves’ eye disease, is a severely disabling condition that causes swelling, pain, discomfort, and blindness. “The burden really is quite significant,” he said, with an impact that’s been compared with that of breast cancer in quality-of-life studies.

“Current treatments for thyroid eye disease are rather limited,” he said. “They really encompass just reducing the swelling and the short-term manifestations of the disease. Treatments such as IV steroids and radiation have been shown to not have any effect on long-term manifestations such as eye bulging and double vision.”

Teprotumumab is a fully human monoclonal antibody that targets the insulinlike growth factor I receptor (IGF-IR). It seems to downregulate thyroid eye disease, Dr. Douglas said.

Researchers studied the drug in a randomized, placebo-controlled study: 41 patients were designated to receive eight intravenous infusions of the drug over 21 weeks (10 mg/kg for the first infusion, then 20 mg/kg thereafter). At week 24, 83% of the study group (34 of 41 patients) reached the endpoint of a reduction of eye bulging by at least 2 mm, compared with 10% of patients (4 of 42) in the placebo group, which received infusions of saline solution.

Two millimeters is significant, Dr. Douglas said. “If you noticed someone’s eye was bulging 2 millimeters, you’d say, ‘Hey, I think something is wrong with your eye.’ ”

Initial study results were released in February 2019. New data about secondary endpoints were released at the AACE meeting: Researchers reported that the average reduction in proptosis (eye bulging) was 2.82 mm in the study group, compared with 0.54 mm in the placebo group (P less than .001).

Dr. Douglas said he can “achieve 3 mm of reduction through surgery to drill out the bone between the eye and the brain. [The patients in the study group] were able to achieve almost 3 millimeters of reduction by the drug alone. It’s a rather significant improvement.”

The new data also provided some insight into the timing of clinical improvements. According to Dr. Douglas, “most of the endpoints were met as early as 6 weeks or [after] two infusions of this drug.”

The adverse effects were relatively mild and included muscle spasms, said Dr. Douglas. The side effects seem to be “well tolerated,” he noted, and none led to cessation of therapy.

Participants with potential for motherhood or fatherhood during the trial had to agree to take precautions to avoid becoming pregnant or impregnating a partner.

Dr. Douglas didn’t provide cost information about the drug. However, it seems likely to be expensive. A writer with Seeking Alpha, a stock market analysis site, estimated that the cost could reach “$250,000 or $300,000 per patient per year, which translates to a $3.7 billion to $6 billion market in the United States alone (based on the estimated patient population in the 15,000-20,000 range).”

The drug’s manufacturer, Horizon Therapeutics, expects to apply to the Food and Drug Administration later this year for approval of the drug.

If it is approved, endocrinologists will have an opportunity to partner with eye surgeons to treat thyroid eye disease, Dr. Douglas said. “The crux will be the comanagement with the endocrinologist helping to control the thyroid function and manage some of the side effects of this medication, and the oculoplastic surgeon [working on] diagnosis, appropriate use, and management.”

Horizon Therapeutics funded the study. Dr. Douglas disclosed that he is a consultant with the company.
 

LOS ANGELES – The 69-year-old woman with a history of type 2 diabetes had persistent hypoglycemia despite treatment with hydrocortisone, dextrose, and glucagon. Doctors in South Carolina worried about insulinoma and planned to launch an intra-arterial calcium stimulation test. But the medical team wasn’t quite certain it had the correct diagnosis.

Then along came a suspicious nurse who uncovered the truth: The patient had used syringes and vials of insulin socked away in a cosmetics bag. The diagnosis? An unusual, but not entirely rare, case of factitious hypoglycemia. That doesn’t mean her condition was fictional. Instead, it means she created it herself.

Randy Dotinga/MDedge News

• In any case of hypoglycemia, consider the possibility that the patient has factitious hypoglycemia. In every patient, he said, do a drug screen for sulfonylureas. “Now that we have multiple classes of diabetes drugs, most of which have a risk for hypoglycemia, one has to have a lab capable of measuring all of them. And that is not easy. It’s not just ‘draw the blood and send to your corner lab.’ ”
• Patients with factitious hypoglycemia don’t tend to have predictable dips in blood sugar during fasting or after meals. Instead, their symptoms are chaotic. “It all depends on when they’re taking [insulin],” he said.
• Patients with factitious hypoglycemia don’t seem ill, but those with insulinomas do. “Patients with insulinomas are totally incapable of living normal lives. They’re incapacitated. Their lives are so disrupted that some of them need ‘babysitters’,” Dr. Service said. If they “get the tumor removed, they are cured. Then they are back to the normal life.”
• Beware that patients may not realize they’re taking a medication that causes factitious hypoglycemia. It’s common, Dr. Service said, for a patient to accidentally take his or her spouse’s medication because of a mix-up.

Ultimately, the goal is to catch factitious hypoglycemia in time. Some physicians haven’t been so fortunate. “They only get to the right answer,” he said, “after the patient has recovered from surgery.”

LOS ANGELES – The 69-year-old woman with a history of type 2 diabetes had persistent hypoglycemia despite treatment with hydrocortisone, dextrose, and glucagon. Doctors in South Carolina worried about insulinoma and planned to launch an intra-arterial calcium stimulation test. But the medical team wasn’t quite certain it had the correct diagnosis.

Then along came a suspicious nurse who uncovered the truth: The patient had used syringes and vials of insulin socked away in a cosmetics bag. The diagnosis? An unusual, but not entirely rare, case of factitious hypoglycemia. That doesn’t mean her condition was fictional. Instead, it means she created it herself.

Randy Dotinga/MDedge News

• In any case of hypoglycemia, consider the possibility that the patient has factitious hypoglycemia. In every patient, he said, do a drug screen for sulfonylureas. “Now that we have multiple classes of diabetes drugs, most of which have a risk for hypoglycemia, one has to have a lab capable of measuring all of them. And that is not easy. It’s not just ‘draw the blood and send to your corner lab.’ ”
• Patients with factitious hypoglycemia don’t tend to have predictable dips in blood sugar during fasting or after meals. Instead, their symptoms are chaotic. “It all depends on when they’re taking [insulin],” he said.
• Patients with factitious hypoglycemia don’t seem ill, but those with insulinomas do. “Patients with insulinomas are totally incapable of living normal lives. They’re incapacitated. Their lives are so disrupted that some of them need ‘babysitters’,” Dr. Service said. If they “get the tumor removed, they are cured. Then they are back to the normal life.”
• Beware that patients may not realize they’re taking a medication that causes factitious hypoglycemia. It’s common, Dr. Service said, for a patient to accidentally take his or her spouse’s medication because of a mix-up.

Ultimately, the goal is to catch factitious hypoglycemia in time. Some physicians haven’t been so fortunate. “They only get to the right answer,” he said, “after the patient has recovered from surgery.”

LOS ANGELES – The 69-year-old woman with a history of type 2 diabetes had persistent hypoglycemia despite treatment with hydrocortisone, dextrose, and glucagon. Doctors in South Carolina worried about insulinoma and planned to launch an intra-arterial calcium stimulation test. But the medical team wasn’t quite certain it had the correct diagnosis.

Then along came a suspicious nurse who uncovered the truth: The patient had used syringes and vials of insulin socked away in a cosmetics bag. The diagnosis? An unusual, but not entirely rare, case of factitious hypoglycemia. That doesn’t mean her condition was fictional. Instead, it means she created it herself.

Randy Dotinga/MDedge News

• In any case of hypoglycemia, consider the possibility that the patient has factitious hypoglycemia. In every patient, he said, do a drug screen for sulfonylureas. “Now that we have multiple classes of diabetes drugs, most of which have a risk for hypoglycemia, one has to have a lab capable of measuring all of them. And that is not easy. It’s not just ‘draw the blood and send to your corner lab.’ ”
• Patients with factitious hypoglycemia don’t tend to have predictable dips in blood sugar during fasting or after meals. Instead, their symptoms are chaotic. “It all depends on when they’re taking [insulin],” he said.
• Patients with factitious hypoglycemia don’t seem ill, but those with insulinomas do. “Patients with insulinomas are totally incapable of living normal lives. They’re incapacitated. Their lives are so disrupted that some of them need ‘babysitters’,” Dr. Service said. If they “get the tumor removed, they are cured. Then they are back to the normal life.”
• Beware that patients may not realize they’re taking a medication that causes factitious hypoglycemia. It’s common, Dr. Service said, for a patient to accidentally take his or her spouse’s medication because of a mix-up.

Ultimately, the goal is to catch factitious hypoglycemia in time. Some physicians haven’t been so fortunate. “They only get to the right answer,” he said, “after the patient has recovered from surgery.”

LOS ANGELES – On the male fertility front, obesity seems to hurt semen quality. So does weight-loss surgery reverse the trend? A new review of existing research suggests that there may be an effect, but the findings aren’t conclusive.

“We found something,” said Sikarin Upala, MD, a second-year endocrinology fellow at the University of Chicago, who pointed out that three of the four reports he and his colleagues reviewed suggested improvement in semen motility. “But we still need to study more about whether bariatric surgery will affect infertility,” he continued.

Dr. Upala, who led the systematic review and meta-analysis of research into bariatric surgery and semen quality, spoke in an interview after his presentation at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

Researchers have linked obesity to infertility in men, but it’s not entirely clear how excess weight and sperm deficiencies are connected. As researchers explained in a 2018 report, “conflicting results have been observed in studies evaluating the correlation between [body mass index] and sperm parameters, such as sperm concentration and total sperm count.” However, they noted that it is “generally accepted” that men with obesity seem to be at higher risk of having a low sperm count or having azoospermia, which is the total lack of sperm in semen.

It’s also not clear whether weight loss directly improves male fertility. “We do know that androgen levels improve after weight-loss surgery, and that might be one factor among several that may contribute to improved male fertility,” Edward Lin, DO, MBA, FACS, professor of surgery and chief of gastrointestinal and general surgery at Emory University, Atlanta, said in an interview.

In their review, Dr. Upala and his colleagues analyzed four studies published between 2012 and 2018 that evaluated the effect of bariatric surgery on semen quality. All of the studies examined semen volume and sperm morphology and motility, and three examined sperm concentration.

A meta-analysis found that motility and volume improved after surgery; however, some of the studies (two for volume, one for motility) failed to show a statistically significant change.

There was no statistically significant difference in sperm morphology or concentration overall, although one study showed a statistically significant improvement in both categories.

Overall, “there might be a little bit of positive effect, but we couldn’t reach a good conclusion because there were too few studies,” Dr. Upala said.

Dr. Lin, director of the Emory Bariatrics Center, agreed that the review findings are limited. He said that although the findings hint at a positive effect on semen quality, “the jury is still out” when it comes to a link between bariatric surgery and male infertility.

“Multiple factors contribute to semen quality,” he added, pointing to vitamin deficiencies, micronutrient levels in the body, enzyme signaling pathways, and sperm chromatin integrity. “In fact, surgically or diet-induced weight loss may be associated with permissive malnutrition, which further exacerbates these deficiencies. Deficiencies in these areas can sometimes take months, if not years, to correct by taking vitamin D or copper or zinc, for example.”

Dr. Lin referred to a small study in which reporters observed semen abnormalities and subfertility after weight-loss surgery despite improvements in androgenic and quality of life levels.

Dr. Upala reported having no relevant disclosures.

LOS ANGELES – On the male fertility front, obesity seems to hurt semen quality. So does weight-loss surgery reverse the trend? A new review of existing research suggests that there may be an effect, but the findings aren’t conclusive.

“We found something,” said Sikarin Upala, MD, a second-year endocrinology fellow at the University of Chicago, who pointed out that three of the four reports he and his colleagues reviewed suggested improvement in semen motility. “But we still need to study more about whether bariatric surgery will affect infertility,” he continued.

Dr. Upala, who led the systematic review and meta-analysis of research into bariatric surgery and semen quality, spoke in an interview after his presentation at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

Researchers have linked obesity to infertility in men, but it’s not entirely clear how excess weight and sperm deficiencies are connected. As researchers explained in a 2018 report, “conflicting results have been observed in studies evaluating the correlation between [body mass index] and sperm parameters, such as sperm concentration and total sperm count.” However, they noted that it is “generally accepted” that men with obesity seem to be at higher risk of having a low sperm count or having azoospermia, which is the total lack of sperm in semen.

It’s also not clear whether weight loss directly improves male fertility. “We do know that androgen levels improve after weight-loss surgery, and that might be one factor among several that may contribute to improved male fertility,” Edward Lin, DO, MBA, FACS, professor of surgery and chief of gastrointestinal and general surgery at Emory University, Atlanta, said in an interview.

In their review, Dr. Upala and his colleagues analyzed four studies published between 2012 and 2018 that evaluated the effect of bariatric surgery on semen quality. All of the studies examined semen volume and sperm morphology and motility, and three examined sperm concentration.

A meta-analysis found that motility and volume improved after surgery; however, some of the studies (two for volume, one for motility) failed to show a statistically significant change.

There was no statistically significant difference in sperm morphology or concentration overall, although one study showed a statistically significant improvement in both categories.

Overall, “there might be a little bit of positive effect, but we couldn’t reach a good conclusion because there were too few studies,” Dr. Upala said.

Dr. Lin, director of the Emory Bariatrics Center, agreed that the review findings are limited. He said that although the findings hint at a positive effect on semen quality, “the jury is still out” when it comes to a link between bariatric surgery and male infertility.

“Multiple factors contribute to semen quality,” he added, pointing to vitamin deficiencies, micronutrient levels in the body, enzyme signaling pathways, and sperm chromatin integrity. “In fact, surgically or diet-induced weight loss may be associated with permissive malnutrition, which further exacerbates these deficiencies. Deficiencies in these areas can sometimes take months, if not years, to correct by taking vitamin D or copper or zinc, for example.”

Dr. Lin referred to a small study in which reporters observed semen abnormalities and subfertility after weight-loss surgery despite improvements in androgenic and quality of life levels.

Dr. Upala reported having no relevant disclosures.

LOS ANGELES – On the male fertility front, obesity seems to hurt semen quality. So does weight-loss surgery reverse the trend? A new review of existing research suggests that there may be an effect, but the findings aren’t conclusive.

“We found something,” said Sikarin Upala, MD, a second-year endocrinology fellow at the University of Chicago, who pointed out that three of the four reports he and his colleagues reviewed suggested improvement in semen motility. “But we still need to study more about whether bariatric surgery will affect infertility,” he continued.

Dr. Upala, who led the systematic review and meta-analysis of research into bariatric surgery and semen quality, spoke in an interview after his presentation at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

Researchers have linked obesity to infertility in men, but it’s not entirely clear how excess weight and sperm deficiencies are connected. As researchers explained in a 2018 report, “conflicting results have been observed in studies evaluating the correlation between [body mass index] and sperm parameters, such as sperm concentration and total sperm count.” However, they noted that it is “generally accepted” that men with obesity seem to be at higher risk of having a low sperm count or having azoospermia, which is the total lack of sperm in semen.

It’s also not clear whether weight loss directly improves male fertility. “We do know that androgen levels improve after weight-loss surgery, and that might be one factor among several that may contribute to improved male fertility,” Edward Lin, DO, MBA, FACS, professor of surgery and chief of gastrointestinal and general surgery at Emory University, Atlanta, said in an interview.

In their review, Dr. Upala and his colleagues analyzed four studies published between 2012 and 2018 that evaluated the effect of bariatric surgery on semen quality. All of the studies examined semen volume and sperm morphology and motility, and three examined sperm concentration.

A meta-analysis found that motility and volume improved after surgery; however, some of the studies (two for volume, one for motility) failed to show a statistically significant change.

There was no statistically significant difference in sperm morphology or concentration overall, although one study showed a statistically significant improvement in both categories.

Overall, “there might be a little bit of positive effect, but we couldn’t reach a good conclusion because there were too few studies,” Dr. Upala said.

Dr. Lin, director of the Emory Bariatrics Center, agreed that the review findings are limited. He said that although the findings hint at a positive effect on semen quality, “the jury is still out” when it comes to a link between bariatric surgery and male infertility.

“Multiple factors contribute to semen quality,” he added, pointing to vitamin deficiencies, micronutrient levels in the body, enzyme signaling pathways, and sperm chromatin integrity. “In fact, surgically or diet-induced weight loss may be associated with permissive malnutrition, which further exacerbates these deficiencies. Deficiencies in these areas can sometimes take months, if not years, to correct by taking vitamin D or copper or zinc, for example.”

Dr. Lin referred to a small study in which reporters observed semen abnormalities and subfertility after weight-loss surgery despite improvements in androgenic and quality of life levels.

Dr. Upala reported having no relevant disclosures.

LOS ANGELES – Cardiology patients can strap on a Holter monitor for a day or two to track their heart activity and get a brief but helpful glimpse at their cardiac health. Could patients with type 2 diabetes benefit by monitoring their blood sugar for a short period? Absolutely, according to an endocrinologist who says he’s had tremendous success with the temporary use of continuous glucose monitors (CGMs) in appropriate patients.

“There’s an actionable surprise with almost every patient,” said Daniel Einhorn, MD, FACP, FACE, medical director of Scripps Whittier Diabetes Institute and clinical professor of medicine at the University of California, San Diego.

The key is to use CGM data to pinpoint glucose spikes and then quickly make adjustments, typically over a period of 2 weeks. “This is about pattern recognition. We can do [CGM] over a week, see what the pattern is, and then try to fix something. Then they come back after the second week or send [the monitor] in, and they have the problem fixed. You have a happy patient and a happy family,” said Dr. Einhorn, who spoke in a presentation at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

He highlighted how CGM data allow patients to track their blood sugar over extended periods of time and detect patterns. The data can uncover hidden hypoglycemia and hyperglycemia, he said, and is much more useful to patients than the self-monitoring of glucose levels or hemoglobin A_1c (HbA_1c) data.

Reading the patterns, adjusting behavior

Dr. Einhorn discussed several specific cases of patients who had changed their behavior in regard to food or medicine after CGM data disclosed certain blood sugar patterns.

Often, he said, patients say they’re surprised to find their well-being improves after they make adjustments, saying something along the lines of “I didn’t feel badly, but I feel better now.” According to Dr. Einhorn, “You hear that all the time.”

For example, he said, one patient knew his blood sugar occasionally topped 200 mg/dL, but he felt all right and didn’t want to take insulin. CGM monitoring over 6 days showed the patient had continuous glucose levels well over 200 mg/dL, especially at night. The patient accepted insulin, and a few months later his HbA_1c dropped from 10.4% to 6.6%, and his blood sugar level stayed near or below the target range of 154 mg/dL.

Dr. Einhorn said the CGM data can reveal a range of problems, including:

• The “breakfast bump” after carbohydrate-heavy breakfasts of cereal, toast, and juice. “Breakfast cereal is diabolical,” he said.
• Hypoglycemia hours after exercise.
• Nocturnal hypoglycemia.
• Hypoglycemia unawareness.

Insurance coverage of the CGM device varies widely, he said, and insurers may not cover it at all in type 2 diabetes or only pay if the patient takes insulin. Fortunately, he said, the devices can be inexpensive.
 

Temporary use is not for everyone

Dr. Einhorn cautioned that temporary use of CGM is not appropriate for every patient with type 2 diabetes. “There’s absolutely a place for [permanent] monitoring for those people who have to make decisions throughout the day, especially if they are taking insulin,” he said.

And anyone with type 1 diabetes should use CGM on an ongoing basis, he emphasized. “Type 1 is a different world, a different universe,” he said.

He also noted that some patients don’t fare well on CGM, even on a temporary basis. That would include patients who hate to wear devices (possibly out of embarrassment), those who can’t manage to switch over from self-monitoring, and those who can’t manage to understand the data.

Dr. Einhorn disclosed various types of relationships with a number of drug makers, including Abbott, Boehringer Ingelheim, Novo, Sanofi, Janssen, and others.

LOS ANGELES – Cardiology patients can strap on a Holter monitor for a day or two to track their heart activity and get a brief but helpful glimpse at their cardiac health. Could patients with type 2 diabetes benefit by monitoring their blood sugar for a short period? Absolutely, according to an endocrinologist who says he’s had tremendous success with the temporary use of continuous glucose monitors (CGMs) in appropriate patients.

“There’s an actionable surprise with almost every patient,” said Daniel Einhorn, MD, FACP, FACE, medical director of Scripps Whittier Diabetes Institute and clinical professor of medicine at the University of California, San Diego.

The key is to use CGM data to pinpoint glucose spikes and then quickly make adjustments, typically over a period of 2 weeks. “This is about pattern recognition. We can do [CGM] over a week, see what the pattern is, and then try to fix something. Then they come back after the second week or send [the monitor] in, and they have the problem fixed. You have a happy patient and a happy family,” said Dr. Einhorn, who spoke in a presentation at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

He highlighted how CGM data allow patients to track their blood sugar over extended periods of time and detect patterns. The data can uncover hidden hypoglycemia and hyperglycemia, he said, and is much more useful to patients than the self-monitoring of glucose levels or hemoglobin A_1c (HbA_1c) data.

Reading the patterns, adjusting behavior

Dr. Einhorn discussed several specific cases of patients who had changed their behavior in regard to food or medicine after CGM data disclosed certain blood sugar patterns.

Often, he said, patients say they’re surprised to find their well-being improves after they make adjustments, saying something along the lines of “I didn’t feel badly, but I feel better now.” According to Dr. Einhorn, “You hear that all the time.”

For example, he said, one patient knew his blood sugar occasionally topped 200 mg/dL, but he felt all right and didn’t want to take insulin. CGM monitoring over 6 days showed the patient had continuous glucose levels well over 200 mg/dL, especially at night. The patient accepted insulin, and a few months later his HbA_1c dropped from 10.4% to 6.6%, and his blood sugar level stayed near or below the target range of 154 mg/dL.

Dr. Einhorn said the CGM data can reveal a range of problems, including:

• The “breakfast bump” after carbohydrate-heavy breakfasts of cereal, toast, and juice. “Breakfast cereal is diabolical,” he said.
• Hypoglycemia hours after exercise.
• Nocturnal hypoglycemia.
• Hypoglycemia unawareness.

Insurance coverage of the CGM device varies widely, he said, and insurers may not cover it at all in type 2 diabetes or only pay if the patient takes insulin. Fortunately, he said, the devices can be inexpensive.
 

Temporary use is not for everyone

Dr. Einhorn cautioned that temporary use of CGM is not appropriate for every patient with type 2 diabetes. “There’s absolutely a place for [permanent] monitoring for those people who have to make decisions throughout the day, especially if they are taking insulin,” he said.

And anyone with type 1 diabetes should use CGM on an ongoing basis, he emphasized. “Type 1 is a different world, a different universe,” he said.

He also noted that some patients don’t fare well on CGM, even on a temporary basis. That would include patients who hate to wear devices (possibly out of embarrassment), those who can’t manage to switch over from self-monitoring, and those who can’t manage to understand the data.

Dr. Einhorn disclosed various types of relationships with a number of drug makers, including Abbott, Boehringer Ingelheim, Novo, Sanofi, Janssen, and others.

LOS ANGELES – Cardiology patients can strap on a Holter monitor for a day or two to track their heart activity and get a brief but helpful glimpse at their cardiac health. Could patients with type 2 diabetes benefit by monitoring their blood sugar for a short period? Absolutely, according to an endocrinologist who says he’s had tremendous success with the temporary use of continuous glucose monitors (CGMs) in appropriate patients.

“There’s an actionable surprise with almost every patient,” said Daniel Einhorn, MD, FACP, FACE, medical director of Scripps Whittier Diabetes Institute and clinical professor of medicine at the University of California, San Diego.

The key is to use CGM data to pinpoint glucose spikes and then quickly make adjustments, typically over a period of 2 weeks. “This is about pattern recognition. We can do [CGM] over a week, see what the pattern is, and then try to fix something. Then they come back after the second week or send [the monitor] in, and they have the problem fixed. You have a happy patient and a happy family,” said Dr. Einhorn, who spoke in a presentation at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

He highlighted how CGM data allow patients to track their blood sugar over extended periods of time and detect patterns. The data can uncover hidden hypoglycemia and hyperglycemia, he said, and is much more useful to patients than the self-monitoring of glucose levels or hemoglobin A_1c (HbA_1c) data.

Reading the patterns, adjusting behavior

Dr. Einhorn discussed several specific cases of patients who had changed their behavior in regard to food or medicine after CGM data disclosed certain blood sugar patterns.

Often, he said, patients say they’re surprised to find their well-being improves after they make adjustments, saying something along the lines of “I didn’t feel badly, but I feel better now.” According to Dr. Einhorn, “You hear that all the time.”

For example, he said, one patient knew his blood sugar occasionally topped 200 mg/dL, but he felt all right and didn’t want to take insulin. CGM monitoring over 6 days showed the patient had continuous glucose levels well over 200 mg/dL, especially at night. The patient accepted insulin, and a few months later his HbA_1c dropped from 10.4% to 6.6%, and his blood sugar level stayed near or below the target range of 154 mg/dL.

Dr. Einhorn said the CGM data can reveal a range of problems, including:

• The “breakfast bump” after carbohydrate-heavy breakfasts of cereal, toast, and juice. “Breakfast cereal is diabolical,” he said.
• Hypoglycemia hours after exercise.
• Nocturnal hypoglycemia.
• Hypoglycemia unawareness.

Insurance coverage of the CGM device varies widely, he said, and insurers may not cover it at all in type 2 diabetes or only pay if the patient takes insulin. Fortunately, he said, the devices can be inexpensive.
 

Temporary use is not for everyone

Dr. Einhorn cautioned that temporary use of CGM is not appropriate for every patient with type 2 diabetes. “There’s absolutely a place for [permanent] monitoring for those people who have to make decisions throughout the day, especially if they are taking insulin,” he said.

And anyone with type 1 diabetes should use CGM on an ongoing basis, he emphasized. “Type 1 is a different world, a different universe,” he said.

He also noted that some patients don’t fare well on CGM, even on a temporary basis. That would include patients who hate to wear devices (possibly out of embarrassment), those who can’t manage to switch over from self-monitoring, and those who can’t manage to understand the data.

Dr. Einhorn disclosed various types of relationships with a number of drug makers, including Abbott, Boehringer Ingelheim, Novo, Sanofi, Janssen, and others.

LAS VEGAS – Two-thirds of colon resections in the United States are open procedures, but a colorectal surgeon told colleagues that evidence shows minimally invasive surgery deserves a wider place in his field.

Why? Because minimally invasive surgery – despite its limited utilization – is linked to multiple improved outcomes in colorectal surgery, said Matthew G. Mutch, MD, chief of colon and rectal surgery at Washington University, St. Louis, in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

“Our goal should be to offer minimally invasive surgery to as many patients as possible by as many different methods as needed,” Dr. Mutch said. “If you’re willing to take this on and do this over a regular basis, you’ll get over that learning curve and expand the number of patients you can offer laparoscopy to.”

According to Dr. Mutch, benefits of minimally invasive colorectal surgery include:

• Improved short-term outcomes – length of stay and return of bowel function, and morbidity and mortality. A 2012 retrospective study of 85,712 colon resections that found laparoscopic resections, when feasible, “had better outcomes than open colectomy in the immediate perioperative period.” (Ann Surg. 2012 Sep;256[3]462-8).
• Improved long-term outcomes: faster recovery, fewer hernias, and fewer bowel obstructions.
• Lower overall costs.
• Fewer complications in the elderly.

When it comes to laparoscopic colorectal surgery, Dr. Mutch cautioned that the robotic technology has unclear benefit in rectal cancer, and the cost in colorectal cancer is unclear.

Another alternative is to perform laparoscopic colorectal surgery through alternative extraction sites such as the rectum, vagina, stomach, and even a stoma site or perineal wound. Both transanal and transvaginal extraction are feasible and safe, he said, adding that transvaginal procedures are best performed in conjunction with a hysterectomy. One benefit of these procedures is that they avoid abdominal wall trauma. However, he cautioned that colorectal surgery is unique because a cancerous specimen cannot be morcellated and must instead be removed whole.

Dr. Mutch also discussed laparoendoscopic resection of colon polyps. Benefits include shorter length of stay and faster recovery, he said, but complications can include perforation and bleeding. And, he said, there’s currently no code for the procedure.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Mutch has no relevant disclosures.

LAS VEGAS – Two-thirds of colon resections in the United States are open procedures, but a colorectal surgeon told colleagues that evidence shows minimally invasive surgery deserves a wider place in his field.

Why? Because minimally invasive surgery – despite its limited utilization – is linked to multiple improved outcomes in colorectal surgery, said Matthew G. Mutch, MD, chief of colon and rectal surgery at Washington University, St. Louis, in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

“Our goal should be to offer minimally invasive surgery to as many patients as possible by as many different methods as needed,” Dr. Mutch said. “If you’re willing to take this on and do this over a regular basis, you’ll get over that learning curve and expand the number of patients you can offer laparoscopy to.”

According to Dr. Mutch, benefits of minimally invasive colorectal surgery include:

• Improved short-term outcomes – length of stay and return of bowel function, and morbidity and mortality. A 2012 retrospective study of 85,712 colon resections that found laparoscopic resections, when feasible, “had better outcomes than open colectomy in the immediate perioperative period.” (Ann Surg. 2012 Sep;256[3]462-8).
• Improved long-term outcomes: faster recovery, fewer hernias, and fewer bowel obstructions.
• Lower overall costs.
• Fewer complications in the elderly.

When it comes to laparoscopic colorectal surgery, Dr. Mutch cautioned that the robotic technology has unclear benefit in rectal cancer, and the cost in colorectal cancer is unclear.

Another alternative is to perform laparoscopic colorectal surgery through alternative extraction sites such as the rectum, vagina, stomach, and even a stoma site or perineal wound. Both transanal and transvaginal extraction are feasible and safe, he said, adding that transvaginal procedures are best performed in conjunction with a hysterectomy. One benefit of these procedures is that they avoid abdominal wall trauma. However, he cautioned that colorectal surgery is unique because a cancerous specimen cannot be morcellated and must instead be removed whole.

Dr. Mutch also discussed laparoendoscopic resection of colon polyps. Benefits include shorter length of stay and faster recovery, he said, but complications can include perforation and bleeding. And, he said, there’s currently no code for the procedure.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Mutch has no relevant disclosures.

LAS VEGAS – Two-thirds of colon resections in the United States are open procedures, but a colorectal surgeon told colleagues that evidence shows minimally invasive surgery deserves a wider place in his field.

Why? Because minimally invasive surgery – despite its limited utilization – is linked to multiple improved outcomes in colorectal surgery, said Matthew G. Mutch, MD, chief of colon and rectal surgery at Washington University, St. Louis, in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

“Our goal should be to offer minimally invasive surgery to as many patients as possible by as many different methods as needed,” Dr. Mutch said. “If you’re willing to take this on and do this over a regular basis, you’ll get over that learning curve and expand the number of patients you can offer laparoscopy to.”

According to Dr. Mutch, benefits of minimally invasive colorectal surgery include:

• Improved short-term outcomes – length of stay and return of bowel function, and morbidity and mortality. A 2012 retrospective study of 85,712 colon resections that found laparoscopic resections, when feasible, “had better outcomes than open colectomy in the immediate perioperative period.” (Ann Surg. 2012 Sep;256[3]462-8).
• Improved long-term outcomes: faster recovery, fewer hernias, and fewer bowel obstructions.
• Lower overall costs.
• Fewer complications in the elderly.

When it comes to laparoscopic colorectal surgery, Dr. Mutch cautioned that the robotic technology has unclear benefit in rectal cancer, and the cost in colorectal cancer is unclear.

Another alternative is to perform laparoscopic colorectal surgery through alternative extraction sites such as the rectum, vagina, stomach, and even a stoma site or perineal wound. Both transanal and transvaginal extraction are feasible and safe, he said, adding that transvaginal procedures are best performed in conjunction with a hysterectomy. One benefit of these procedures is that they avoid abdominal wall trauma. However, he cautioned that colorectal surgery is unique because a cancerous specimen cannot be morcellated and must instead be removed whole.

Dr. Mutch also discussed laparoendoscopic resection of colon polyps. Benefits include shorter length of stay and faster recovery, he said, but complications can include perforation and bleeding. And, he said, there’s currently no code for the procedure.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Mutch has no relevant disclosures.