Neurology

An epilepsy drug sold in Europe as Ospolot and also known as sulthiame showed promise in reducing sleep disordered breathing and other symptoms of obstructive sleep apnea (OSA), based on data from nearly 300 individuals presented in a late-breaking study at the annual congress of the European Respiratory Society.

“Current therapies are mechanical and based on the notion of an airway splint,” presenting author Jan Hedner, MD, professor of respiratory medicine at Sahlgrenska University Hospital and the University of Gothenburg, both in Sweden, said in an interview. “In other words, applying an airflow at elevated pressure [continuous positive airway pressure] or advancing the jaw with a dental device. Adherence to this type of therapy is limited. In the case of continuous positive airway pressure [CPAP], it is < 50% after 3-4 years of therapy.” Therefore, there is a need for a better-tolerated therapy, such as a drug, and possibly a combination of mechanical and pharmaceutical therapies.

The use of medication has emerged as a viable option for OSA, with a high rate of compliance and acceptable safety profile, Dr. Hedner said in his presentation.

“Modified carbonic anhydrase activity may be a pathophysiological mechanism in OSA,” said Dr. Hedner. Sulthiame, a carbonic anhydrase inhibitor, showed safety and effectiveness for improving OSA in a previous phase 2b trial.

In the current study, the researchers sought to determine the most effective dose of sulthiame for patients with OSA. They randomized 298 adults with OSA who could not accept or tolerate oral splints or CPAP to 100 mg, 200 mg, or 300 mg of sulthiame daily (74, 74, and 75 patients, respectively) or placebo (75 patients).

The mean age of the patients was 56 years, 26.2% were women, and the average apnea-hypopnea index (AHI3a) at baseline was 29 n/h. Patients were treated at centers in Spain, France, Belgium, Germany, and the Czech Republic. Baseline demographics and clinical characteristics were similar among the treatment groups.

The primary endpoint was the change in AHI3a from baseline to 15 weeks, and significant changes occurred in patients who received the 100-mg, 200-mg, and 300-mg doses, with decreases of 17.8%, 34.8%, and 39.9%, respectively.

Peak efficacy occurred in the range of 200-300 mg and was similar for patients with moderate or severe OSA, Dr. Hedner said in his presentation.

Notably, in a post hoc analysis, apnea improved by 47.1% at a 300-mg dose when the AHI4 measure (apnea/hypopnea with ≥ 4% O₂ desaturation) was used in a placebo-adjusted dose-dependent reduction, the researchers wrote. The changes in AHI4 from baseline in this analysis also were significant for 200 mg and 100 mg doses (36.8% and 26.2%, respectively).

Patients underwent polysomnography at baseline and at weeks 4 and 12.

Mean overnight oxygen saturation also improved significantly from baseline with doses of 200 mg and 300 mg, compared with placebo (P < .0001 for both).

In addition, scores on the Epworth Sleepiness Scale (ESS) improved from baseline to week 15 in all dosage groups, and the subgroup of patients with ESS scores of ≥ 11 at baseline showed even greater improvement in ESS, Dr. Hedner said in his presentation.

Total arousal index and sleep quality also improved from baseline compared with placebo, and no clinically relevant reduction in REM sleep was noted, Dr. Hedner added.

Treatment-emergent adverse events were in line with the known safety profile of sulthiame and included paresthesia, headache, fatigue, and nausea; these were mainly moderate and dose-dependent, with no evidence of cardiovascular safety issues, he said.

Although the study results were not surprising given previous research, the investigators were pleased with the potency of the therapy. “We are also happy about potential added values such as a blood pressure lowering effect, which is beneficial in this group of patients; however, we need to further study these mechanisms in detail,” Dr. Hedner noted.

The study findings were limited by the relatively small scale, and larger studies on long-term efficacy and tolerability are also needed, he said.

“The current study was a dose-finding study, and we now have useful information on most suitable dose,” he said.

However, the results support sulthiame as an effective, well-tolerated, and promising novel candidate for drug therapy in patients with OSA, worthy of phase 3 studies, Dr. Hedner said.
 

Oral Option Could Be Game-Changer, But Not Yet

The gold standard of treatment for OSA is a CPAP machine, but the effectiveness is limited by patient tolerance, Q. Afifa Shamim-Uzzaman, MD, an associate professor and a sleep medicine specialist at the University of Michigan, Ann Arbor, said in an interview.

“Presently, there are no effective pharmacological treatments for OSA — having a pill that treats OSA would be a total game changer and huge advance for the treatment of OSA and the field of sleep medicine,” said Dr. Shamim-Uzzaman, who was not involved in the study. “More patients may be able to obtain treatment for OSA and thereby reduce the potential complications of untreated OSA.

“Carbonic anhydrase inhibitors such as acetazolamide and sulthiame have been studied with limited success for the treatment of other forms of sleep disordered breathing such as central sleep apnea [CSA] but have shown less efficacy for OSA and are presently not recommended in the treatment of OSA by the American Academy of Sleep Medicine,” Dr. Shamim-Uzzaman said.

Recently, emerging evidence about different phenotypes of OSA suggests that nonanatomic features (such as high loop gain) may play a role in patients with OSA, not only in those with CSA, she said. Whether carbonic anhydrase inhibitors could play a greater role in treating sleep apnea in patients with predominantly nonanatomic pathophysiologic traits remains to be seen.

The sulthiame data are promising, but more research is needed, Dr. Shamim-Uzzaman said. Although patients in the highest dose group showed a reduction in AHI of nearly 40%, they still would have moderate OSA, and the OSA did not appear to decrease to a normal range in any of the treatment groups.

“More research is needed to identify which types of patients would be responders to this form of therapy, to understand if these effects are maintained long term (beyond 15 weeks), to evaluate patient-centered outcomes, especially in different sleep apnea subgroups (such as phenotypes with high loop gain vs those without), and to assess interactions with other therapies,” she said.

The study was supported by manufacturer Desitin. Dr. Hedner disclosed serving as a consultant to AstraZeneca, Bayer, CereusScience, Jazz Pharmaceuticals, MSD, Weinmann, Desitin, SomnoMed, and Itamar Medical; serving on the speakers’ bureau for Almirall, AstraZeneca, Jazz Pharmaceuticals, ResMed, Philips Respironics, and Weinmann; and receiving grants or research support from Bayer, ResMed, Philips Respironics, and SomnoMed. He also disclosed shared ownership of intellectual property related to sleep apnea therapy. Dr. Shamim-Uzzaman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

An epilepsy drug sold in Europe as Ospolot and also known as sulthiame showed promise in reducing sleep disordered breathing and other symptoms of obstructive sleep apnea (OSA), based on data from nearly 300 individuals presented in a late-breaking study at the annual congress of the European Respiratory Society.

“Current therapies are mechanical and based on the notion of an airway splint,” presenting author Jan Hedner, MD, professor of respiratory medicine at Sahlgrenska University Hospital and the University of Gothenburg, both in Sweden, said in an interview. “In other words, applying an airflow at elevated pressure [continuous positive airway pressure] or advancing the jaw with a dental device. Adherence to this type of therapy is limited. In the case of continuous positive airway pressure [CPAP], it is < 50% after 3-4 years of therapy.” Therefore, there is a need for a better-tolerated therapy, such as a drug, and possibly a combination of mechanical and pharmaceutical therapies.

The use of medication has emerged as a viable option for OSA, with a high rate of compliance and acceptable safety profile, Dr. Hedner said in his presentation.

“Modified carbonic anhydrase activity may be a pathophysiological mechanism in OSA,” said Dr. Hedner. Sulthiame, a carbonic anhydrase inhibitor, showed safety and effectiveness for improving OSA in a previous phase 2b trial.

In the current study, the researchers sought to determine the most effective dose of sulthiame for patients with OSA. They randomized 298 adults with OSA who could not accept or tolerate oral splints or CPAP to 100 mg, 200 mg, or 300 mg of sulthiame daily (74, 74, and 75 patients, respectively) or placebo (75 patients).

The mean age of the patients was 56 years, 26.2% were women, and the average apnea-hypopnea index (AHI3a) at baseline was 29 n/h. Patients were treated at centers in Spain, France, Belgium, Germany, and the Czech Republic. Baseline demographics and clinical characteristics were similar among the treatment groups.

The primary endpoint was the change in AHI3a from baseline to 15 weeks, and significant changes occurred in patients who received the 100-mg, 200-mg, and 300-mg doses, with decreases of 17.8%, 34.8%, and 39.9%, respectively.

Peak efficacy occurred in the range of 200-300 mg and was similar for patients with moderate or severe OSA, Dr. Hedner said in his presentation.

Notably, in a post hoc analysis, apnea improved by 47.1% at a 300-mg dose when the AHI4 measure (apnea/hypopnea with ≥ 4% O₂ desaturation) was used in a placebo-adjusted dose-dependent reduction, the researchers wrote. The changes in AHI4 from baseline in this analysis also were significant for 200 mg and 100 mg doses (36.8% and 26.2%, respectively).

Patients underwent polysomnography at baseline and at weeks 4 and 12.

Mean overnight oxygen saturation also improved significantly from baseline with doses of 200 mg and 300 mg, compared with placebo (P < .0001 for both).

In addition, scores on the Epworth Sleepiness Scale (ESS) improved from baseline to week 15 in all dosage groups, and the subgroup of patients with ESS scores of ≥ 11 at baseline showed even greater improvement in ESS, Dr. Hedner said in his presentation.

Total arousal index and sleep quality also improved from baseline compared with placebo, and no clinically relevant reduction in REM sleep was noted, Dr. Hedner added.

Treatment-emergent adverse events were in line with the known safety profile of sulthiame and included paresthesia, headache, fatigue, and nausea; these were mainly moderate and dose-dependent, with no evidence of cardiovascular safety issues, he said.

Although the study results were not surprising given previous research, the investigators were pleased with the potency of the therapy. “We are also happy about potential added values such as a blood pressure lowering effect, which is beneficial in this group of patients; however, we need to further study these mechanisms in detail,” Dr. Hedner noted.

The study findings were limited by the relatively small scale, and larger studies on long-term efficacy and tolerability are also needed, he said.

“The current study was a dose-finding study, and we now have useful information on most suitable dose,” he said.

However, the results support sulthiame as an effective, well-tolerated, and promising novel candidate for drug therapy in patients with OSA, worthy of phase 3 studies, Dr. Hedner said.
 

Oral Option Could Be Game-Changer, But Not Yet

The gold standard of treatment for OSA is a CPAP machine, but the effectiveness is limited by patient tolerance, Q. Afifa Shamim-Uzzaman, MD, an associate professor and a sleep medicine specialist at the University of Michigan, Ann Arbor, said in an interview.

“Presently, there are no effective pharmacological treatments for OSA — having a pill that treats OSA would be a total game changer and huge advance for the treatment of OSA and the field of sleep medicine,” said Dr. Shamim-Uzzaman, who was not involved in the study. “More patients may be able to obtain treatment for OSA and thereby reduce the potential complications of untreated OSA.

“Carbonic anhydrase inhibitors such as acetazolamide and sulthiame have been studied with limited success for the treatment of other forms of sleep disordered breathing such as central sleep apnea [CSA] but have shown less efficacy for OSA and are presently not recommended in the treatment of OSA by the American Academy of Sleep Medicine,” Dr. Shamim-Uzzaman said.

Recently, emerging evidence about different phenotypes of OSA suggests that nonanatomic features (such as high loop gain) may play a role in patients with OSA, not only in those with CSA, she said. Whether carbonic anhydrase inhibitors could play a greater role in treating sleep apnea in patients with predominantly nonanatomic pathophysiologic traits remains to be seen.

The sulthiame data are promising, but more research is needed, Dr. Shamim-Uzzaman said. Although patients in the highest dose group showed a reduction in AHI of nearly 40%, they still would have moderate OSA, and the OSA did not appear to decrease to a normal range in any of the treatment groups.

“More research is needed to identify which types of patients would be responders to this form of therapy, to understand if these effects are maintained long term (beyond 15 weeks), to evaluate patient-centered outcomes, especially in different sleep apnea subgroups (such as phenotypes with high loop gain vs those without), and to assess interactions with other therapies,” she said.

The study was supported by manufacturer Desitin. Dr. Hedner disclosed serving as a consultant to AstraZeneca, Bayer, CereusScience, Jazz Pharmaceuticals, MSD, Weinmann, Desitin, SomnoMed, and Itamar Medical; serving on the speakers’ bureau for Almirall, AstraZeneca, Jazz Pharmaceuticals, ResMed, Philips Respironics, and Weinmann; and receiving grants or research support from Bayer, ResMed, Philips Respironics, and SomnoMed. He also disclosed shared ownership of intellectual property related to sleep apnea therapy. Dr. Shamim-Uzzaman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

An epilepsy drug sold in Europe as Ospolot and also known as sulthiame showed promise in reducing sleep disordered breathing and other symptoms of obstructive sleep apnea (OSA), based on data from nearly 300 individuals presented in a late-breaking study at the annual congress of the European Respiratory Society.

“Current therapies are mechanical and based on the notion of an airway splint,” presenting author Jan Hedner, MD, professor of respiratory medicine at Sahlgrenska University Hospital and the University of Gothenburg, both in Sweden, said in an interview. “In other words, applying an airflow at elevated pressure [continuous positive airway pressure] or advancing the jaw with a dental device. Adherence to this type of therapy is limited. In the case of continuous positive airway pressure [CPAP], it is < 50% after 3-4 years of therapy.” Therefore, there is a need for a better-tolerated therapy, such as a drug, and possibly a combination of mechanical and pharmaceutical therapies.

The use of medication has emerged as a viable option for OSA, with a high rate of compliance and acceptable safety profile, Dr. Hedner said in his presentation.

“Modified carbonic anhydrase activity may be a pathophysiological mechanism in OSA,” said Dr. Hedner. Sulthiame, a carbonic anhydrase inhibitor, showed safety and effectiveness for improving OSA in a previous phase 2b trial.

In the current study, the researchers sought to determine the most effective dose of sulthiame for patients with OSA. They randomized 298 adults with OSA who could not accept or tolerate oral splints or CPAP to 100 mg, 200 mg, or 300 mg of sulthiame daily (74, 74, and 75 patients, respectively) or placebo (75 patients).

The mean age of the patients was 56 years, 26.2% were women, and the average apnea-hypopnea index (AHI3a) at baseline was 29 n/h. Patients were treated at centers in Spain, France, Belgium, Germany, and the Czech Republic. Baseline demographics and clinical characteristics were similar among the treatment groups.

The primary endpoint was the change in AHI3a from baseline to 15 weeks, and significant changes occurred in patients who received the 100-mg, 200-mg, and 300-mg doses, with decreases of 17.8%, 34.8%, and 39.9%, respectively.

Peak efficacy occurred in the range of 200-300 mg and was similar for patients with moderate or severe OSA, Dr. Hedner said in his presentation.

Notably, in a post hoc analysis, apnea improved by 47.1% at a 300-mg dose when the AHI4 measure (apnea/hypopnea with ≥ 4% O₂ desaturation) was used in a placebo-adjusted dose-dependent reduction, the researchers wrote. The changes in AHI4 from baseline in this analysis also were significant for 200 mg and 100 mg doses (36.8% and 26.2%, respectively).

Patients underwent polysomnography at baseline and at weeks 4 and 12.

Mean overnight oxygen saturation also improved significantly from baseline with doses of 200 mg and 300 mg, compared with placebo (P < .0001 for both).

In addition, scores on the Epworth Sleepiness Scale (ESS) improved from baseline to week 15 in all dosage groups, and the subgroup of patients with ESS scores of ≥ 11 at baseline showed even greater improvement in ESS, Dr. Hedner said in his presentation.

Total arousal index and sleep quality also improved from baseline compared with placebo, and no clinically relevant reduction in REM sleep was noted, Dr. Hedner added.

Treatment-emergent adverse events were in line with the known safety profile of sulthiame and included paresthesia, headache, fatigue, and nausea; these were mainly moderate and dose-dependent, with no evidence of cardiovascular safety issues, he said.

Although the study results were not surprising given previous research, the investigators were pleased with the potency of the therapy. “We are also happy about potential added values such as a blood pressure lowering effect, which is beneficial in this group of patients; however, we need to further study these mechanisms in detail,” Dr. Hedner noted.

The study findings were limited by the relatively small scale, and larger studies on long-term efficacy and tolerability are also needed, he said.

“The current study was a dose-finding study, and we now have useful information on most suitable dose,” he said.

However, the results support sulthiame as an effective, well-tolerated, and promising novel candidate for drug therapy in patients with OSA, worthy of phase 3 studies, Dr. Hedner said.
 

Oral Option Could Be Game-Changer, But Not Yet

The gold standard of treatment for OSA is a CPAP machine, but the effectiveness is limited by patient tolerance, Q. Afifa Shamim-Uzzaman, MD, an associate professor and a sleep medicine specialist at the University of Michigan, Ann Arbor, said in an interview.

“Presently, there are no effective pharmacological treatments for OSA — having a pill that treats OSA would be a total game changer and huge advance for the treatment of OSA and the field of sleep medicine,” said Dr. Shamim-Uzzaman, who was not involved in the study. “More patients may be able to obtain treatment for OSA and thereby reduce the potential complications of untreated OSA.

“Carbonic anhydrase inhibitors such as acetazolamide and sulthiame have been studied with limited success for the treatment of other forms of sleep disordered breathing such as central sleep apnea [CSA] but have shown less efficacy for OSA and are presently not recommended in the treatment of OSA by the American Academy of Sleep Medicine,” Dr. Shamim-Uzzaman said.

Recently, emerging evidence about different phenotypes of OSA suggests that nonanatomic features (such as high loop gain) may play a role in patients with OSA, not only in those with CSA, she said. Whether carbonic anhydrase inhibitors could play a greater role in treating sleep apnea in patients with predominantly nonanatomic pathophysiologic traits remains to be seen.

The sulthiame data are promising, but more research is needed, Dr. Shamim-Uzzaman said. Although patients in the highest dose group showed a reduction in AHI of nearly 40%, they still would have moderate OSA, and the OSA did not appear to decrease to a normal range in any of the treatment groups.

“More research is needed to identify which types of patients would be responders to this form of therapy, to understand if these effects are maintained long term (beyond 15 weeks), to evaluate patient-centered outcomes, especially in different sleep apnea subgroups (such as phenotypes with high loop gain vs those without), and to assess interactions with other therapies,” she said.

The study was supported by manufacturer Desitin. Dr. Hedner disclosed serving as a consultant to AstraZeneca, Bayer, CereusScience, Jazz Pharmaceuticals, MSD, Weinmann, Desitin, SomnoMed, and Itamar Medical; serving on the speakers’ bureau for Almirall, AstraZeneca, Jazz Pharmaceuticals, ResMed, Philips Respironics, and Weinmann; and receiving grants or research support from Bayer, ResMed, Philips Respironics, and SomnoMed. He also disclosed shared ownership of intellectual property related to sleep apnea therapy. Dr. Shamim-Uzzaman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Four triptans are more effective for acute migraine than newer, more expensive medications for this headache type, new research suggested.

Results of a large systematic review and meta-analysis showed that eletriptan, rizatriptan, sumatriptan, and zolmitriptan were more effective than lasmiditan, rimegepant, and ubrogepant, which investigators found were as effective as nonsteroidal anti-inflammatory drugs (NSAIDs).

International guidelines generally endorse NSAIDs as the first-line treatment for migraine and recommend triptans for moderate to severe episodes or when the response to NSAIDs is insufficient.

However, based on the study’s findings, these four triptans should be considered the treatment of choice for migraine, study investigator Andrea Cipriani, MD, PhD, professor of psychiatry at the University of Oxford in England and director of the Oxford Health Clinical Research Facility, told a press briefing.

The investigators added that these particular triptans should be “included in the WHO [World Health Organization] List of Essential Medicines to promote global accessibility and uniform standards of care.”

The study was published online in The BMJ.
 

Filling the Knowledge Gap

To date, almost all migraine studies have compared migraine drugs with placebo, so there’s a knowledge gap, said Dr. Cipriani. As a result, “there’s no clear consensus among experts and guidelines about which specific drug classes should be prescribed initially, and this is a clinical problem.”

The researchers pointed out that, in recent years, lasmiditan and gepants have been introduced as further treatment options, especially for patients in whom triptans are contraindicated because of their potential vasoconstrictive effects and higher risk for ischemic events.

The analysis included 137 double-blind, randomized, controlled trials that were primarily sponsored by the pharmaceutical industry. It included 89,445 adult outpatients with migraine (mean age, 40.3 years; 85.6% women).

Only drugs licensed for migraine or headache that are recommended in at least one country were included. Researchers divided these 17 drugs into five categories: Antipyretics (paracetamol), ditans (lasmiditan), gepants (rimegepant and ubrogepant), NSAIDs (acetylsalicylic acid, celecoxib, diclofenac potassium, ibuprofen, naproxen sodium, and phenazone), and triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan).

The study’s primary outcomes were freedom from pain at 2 hours and at 2-24 hours, without the use of rescue drugs.

Investigators used sumatriptan as the reference intervention because it is the most commonly prescribed migraine drug and is included in the WHO Model Lists of Essential Medicines.

The study showed all active interventions were better than placebo for pain freedom at 2 hours; with the exception of paracetamol and naratriptan, all were better for sustained pain freedom from 2 to 24 hours.

When the active interventions were compared with each other, eletriptan outperformed other drugs for achieving pain freedom at 2 hours. It was followed by rizatriptan, sumatriptan, and zolmitriptan (odds ratio [OR], 1.35-3.01). For sustained pain freedom up to 24 hours, the most efficacious interventions were eletriptan (OR, 1.41-2.73) and ibuprofen (OR, 3.16-4.82).

As for secondary efficacy outcomes, in head-to-head comparisons, eletriptan was superior to nearly all other active interventions for pain relief at 2 hours and for the use of rescue drugs.

As for adverse events, dizziness was more commonly associated with lasmiditan, eletriptan, sumatriptan, and zolmitriptan, while fatigue and sedation occurred more frequently with eletriptan and lasmiditan. Nausea was more often associated with lasmiditan, sumatriptan, zolmitriptan, and ubrogepant. Eletriptan was the only intervention most frequently associated with chest pain or discomfort.
 

Need to Update Guidelines?

Considering the new results, Dr. Cipriani and study coauthor Messoud Ashina, MD, PhD, professor of neurology, University of Copenhagen in Denmark, said clinical guidelines for acute migraine management should be updated.

While triptans are contraindicated in patients with vascular disease, the researchers noted that “cerebrovascular events may present primarily as migraine-like headaches, and misdiagnosis of transient ischemic attack and minor stroke as migraine is not rare.”

Recently, lasmiditan, rimegepant, and ubrogepant — which are not associated with vasoconstrictive effects — have been promoted as alternatives in patients for whom triptans are contraindicated or not tolerated. But the high costs of these drugs put them out of reach for some patients, the investigators noted.

Triptans are widely underutilized, Dr. Ashina noted during the press briefing. Current use ranges from 17% to 22% in the United States and from 3% to 22.5% in Europe.

The investigators said that triptans have been shown to be superior and should be promoted globally, adding that the limited access and substantial underutilization of these medications are “missed opportunities to offer more effective treatments.”

The new results underscore the importance of head-to-head trials, which is the gold standard, said Dr. Cipriani.

The investigators noted that the study’s main limitation was the quality of the data, which was deemed to be low, or very low, for most comparisons. Other potential limitations included lack of individual patient data; exclusion of combination drugs; inclusion of only oral treatments; and not considering type of oral formulation, consistency in response across migraine episodes, or cost-effectiveness.

The study also did not cover important clinical issues that might inform treatment decision-making, including drug overuse headache or potential withdrawal symptoms. And the authors were unable to quantify some outcomes, such as global functioning.
 

‘Best Profile’?

Reached for comment, Neurologist Nina Riggins, MD, PhD, Headache Center of Excellence, Palo Alto VA Medical Center in California, praised the authors for a “great job” of bringing attention to the topic.

However, she noted that the investigators’ characterization of the four triptans as having the “best profile” for acute migraine gave her pause.

“Calling triptans the medication with the ‘best profile’ might be not applicable in many cases,” she said. For example, those who need acute medication more than two to three times a week in addition to those with cardiovascular contraindications to triptans may fall outside of that category.

Dr. Riggins said that “it makes sense” that longer-acting triptans like frovatriptan and naratriptan may not rank highly for efficacy within the first 2 hours. However, these agents likely offer a superior therapeutic profile in specific contexts, such as menstrual-related migraine.

In addition, while triptans are known to cause medication overuse headache, this may not be the case with gepants, she noted.

In a release from the Science Media Center, a nonprofit organization promoting voices and views of the scientific community, Eloísa Rubio-Beltrán, PhD, research associate with The Migraine Trust at the Wolfson Sensory, Pain and Regeneration Centre, King’s College London in England, said the findings should affect migraine treatment guidelines.

“As the study highlights, due to their high efficacy and low cost, triptans should be the first-line treatment option for the acute treatment of migraine. These results should inform treatment guidelines and support the inclusion of the best performing triptans into the List of Essential Medicines, to optimize treatment, allowing patients to access more efficacious options,” said Dr. Rubio-Beltrán.

It is also important to note that gepants and ditans were developed to offer alternatives for patients who show no improvement from triptans, she added.

She pointed out that these medications were not developed as a substitute for triptans, but rather to expand the number of treatment options for migraine.

“Nonetheless,” she added, “this study highlights the need for further research on the pathophysiology of migraine, which will allow the discovery of novel targets, and thus, novel treatments options that will benefit all patient populations.”

The study was funded by the NIHR Oxford Health Biomedical Research Centre and the Lundbeck Foundation. Dr. Cipriani reported receiving research, educational, and consultancy fees from Italian Network for Pediatric Clinical Trials, Fondazione Cariplo, Lundbeck, and Angelini Pharma. Dr. Ashina is a consultant, speaker, or scientific adviser for AbbVie, Amgen, AstraZeneca, Eli Lilly, GSK, Lundbeck, Novartis, Pfizer, and Teva; is the past president of the International Headache Society; and an associate editor of The Journal of Headache and Pain and Brain. Dr. Riggins has consulted for Gerson Lehrman Group; participated in compensated work with AcademicCME and Association of Migraine Disorders; was a principal investigator on research with electroCore, Theranica, and Eli Lilly; serves on advisory boards for Theranica, Teva, Lundbeck, Amneal Pharmaceuticals, NeurologyLive, and Miles for Migraine; and is a project advisor for Clinical Awareness Initiative with Clinical Neurological Society of America. Dr. Rubio-Beltrán reported serving as a junior editorial board member of The Journal of Headache and Pain and a junior representative of the International Headache Society; receiving research support from The Migraine Trust, Eli Lilly, CoLucid Pharmaceuticals, Amgen, Novartis, and Kallyope; and receiving travel support from CoLucid Pharmaceuticals, Allergan, and Novartis.

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

Four triptans are more effective for acute migraine than newer, more expensive medications for this headache type, new research suggested.

Results of a large systematic review and meta-analysis showed that eletriptan, rizatriptan, sumatriptan, and zolmitriptan were more effective than lasmiditan, rimegepant, and ubrogepant, which investigators found were as effective as nonsteroidal anti-inflammatory drugs (NSAIDs).

International guidelines generally endorse NSAIDs as the first-line treatment for migraine and recommend triptans for moderate to severe episodes or when the response to NSAIDs is insufficient.

However, based on the study’s findings, these four triptans should be considered the treatment of choice for migraine, study investigator Andrea Cipriani, MD, PhD, professor of psychiatry at the University of Oxford in England and director of the Oxford Health Clinical Research Facility, told a press briefing.

The investigators added that these particular triptans should be “included in the WHO [World Health Organization] List of Essential Medicines to promote global accessibility and uniform standards of care.”

The study was published online in The BMJ.
 

Filling the Knowledge Gap

To date, almost all migraine studies have compared migraine drugs with placebo, so there’s a knowledge gap, said Dr. Cipriani. As a result, “there’s no clear consensus among experts and guidelines about which specific drug classes should be prescribed initially, and this is a clinical problem.”

The researchers pointed out that, in recent years, lasmiditan and gepants have been introduced as further treatment options, especially for patients in whom triptans are contraindicated because of their potential vasoconstrictive effects and higher risk for ischemic events.

The analysis included 137 double-blind, randomized, controlled trials that were primarily sponsored by the pharmaceutical industry. It included 89,445 adult outpatients with migraine (mean age, 40.3 years; 85.6% women).

Only drugs licensed for migraine or headache that are recommended in at least one country were included. Researchers divided these 17 drugs into five categories: Antipyretics (paracetamol), ditans (lasmiditan), gepants (rimegepant and ubrogepant), NSAIDs (acetylsalicylic acid, celecoxib, diclofenac potassium, ibuprofen, naproxen sodium, and phenazone), and triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan).

The study’s primary outcomes were freedom from pain at 2 hours and at 2-24 hours, without the use of rescue drugs.

Investigators used sumatriptan as the reference intervention because it is the most commonly prescribed migraine drug and is included in the WHO Model Lists of Essential Medicines.

The study showed all active interventions were better than placebo for pain freedom at 2 hours; with the exception of paracetamol and naratriptan, all were better for sustained pain freedom from 2 to 24 hours.

When the active interventions were compared with each other, eletriptan outperformed other drugs for achieving pain freedom at 2 hours. It was followed by rizatriptan, sumatriptan, and zolmitriptan (odds ratio [OR], 1.35-3.01). For sustained pain freedom up to 24 hours, the most efficacious interventions were eletriptan (OR, 1.41-2.73) and ibuprofen (OR, 3.16-4.82).

As for secondary efficacy outcomes, in head-to-head comparisons, eletriptan was superior to nearly all other active interventions for pain relief at 2 hours and for the use of rescue drugs.

As for adverse events, dizziness was more commonly associated with lasmiditan, eletriptan, sumatriptan, and zolmitriptan, while fatigue and sedation occurred more frequently with eletriptan and lasmiditan. Nausea was more often associated with lasmiditan, sumatriptan, zolmitriptan, and ubrogepant. Eletriptan was the only intervention most frequently associated with chest pain or discomfort.
 

Need to Update Guidelines?

Considering the new results, Dr. Cipriani and study coauthor Messoud Ashina, MD, PhD, professor of neurology, University of Copenhagen in Denmark, said clinical guidelines for acute migraine management should be updated.

While triptans are contraindicated in patients with vascular disease, the researchers noted that “cerebrovascular events may present primarily as migraine-like headaches, and misdiagnosis of transient ischemic attack and minor stroke as migraine is not rare.”

Recently, lasmiditan, rimegepant, and ubrogepant — which are not associated with vasoconstrictive effects — have been promoted as alternatives in patients for whom triptans are contraindicated or not tolerated. But the high costs of these drugs put them out of reach for some patients, the investigators noted.

Triptans are widely underutilized, Dr. Ashina noted during the press briefing. Current use ranges from 17% to 22% in the United States and from 3% to 22.5% in Europe.

The investigators said that triptans have been shown to be superior and should be promoted globally, adding that the limited access and substantial underutilization of these medications are “missed opportunities to offer more effective treatments.”

The new results underscore the importance of head-to-head trials, which is the gold standard, said Dr. Cipriani.

The investigators noted that the study’s main limitation was the quality of the data, which was deemed to be low, or very low, for most comparisons. Other potential limitations included lack of individual patient data; exclusion of combination drugs; inclusion of only oral treatments; and not considering type of oral formulation, consistency in response across migraine episodes, or cost-effectiveness.

The study also did not cover important clinical issues that might inform treatment decision-making, including drug overuse headache or potential withdrawal symptoms. And the authors were unable to quantify some outcomes, such as global functioning.
 

‘Best Profile’?

Reached for comment, Neurologist Nina Riggins, MD, PhD, Headache Center of Excellence, Palo Alto VA Medical Center in California, praised the authors for a “great job” of bringing attention to the topic.

However, she noted that the investigators’ characterization of the four triptans as having the “best profile” for acute migraine gave her pause.

“Calling triptans the medication with the ‘best profile’ might be not applicable in many cases,” she said. For example, those who need acute medication more than two to three times a week in addition to those with cardiovascular contraindications to triptans may fall outside of that category.

Dr. Riggins said that “it makes sense” that longer-acting triptans like frovatriptan and naratriptan may not rank highly for efficacy within the first 2 hours. However, these agents likely offer a superior therapeutic profile in specific contexts, such as menstrual-related migraine.

In addition, while triptans are known to cause medication overuse headache, this may not be the case with gepants, she noted.

In a release from the Science Media Center, a nonprofit organization promoting voices and views of the scientific community, Eloísa Rubio-Beltrán, PhD, research associate with The Migraine Trust at the Wolfson Sensory, Pain and Regeneration Centre, King’s College London in England, said the findings should affect migraine treatment guidelines.

“As the study highlights, due to their high efficacy and low cost, triptans should be the first-line treatment option for the acute treatment of migraine. These results should inform treatment guidelines and support the inclusion of the best performing triptans into the List of Essential Medicines, to optimize treatment, allowing patients to access more efficacious options,” said Dr. Rubio-Beltrán.

It is also important to note that gepants and ditans were developed to offer alternatives for patients who show no improvement from triptans, she added.

She pointed out that these medications were not developed as a substitute for triptans, but rather to expand the number of treatment options for migraine.

“Nonetheless,” she added, “this study highlights the need for further research on the pathophysiology of migraine, which will allow the discovery of novel targets, and thus, novel treatments options that will benefit all patient populations.”

The study was funded by the NIHR Oxford Health Biomedical Research Centre and the Lundbeck Foundation. Dr. Cipriani reported receiving research, educational, and consultancy fees from Italian Network for Pediatric Clinical Trials, Fondazione Cariplo, Lundbeck, and Angelini Pharma. Dr. Ashina is a consultant, speaker, or scientific adviser for AbbVie, Amgen, AstraZeneca, Eli Lilly, GSK, Lundbeck, Novartis, Pfizer, and Teva; is the past president of the International Headache Society; and an associate editor of The Journal of Headache and Pain and Brain. Dr. Riggins has consulted for Gerson Lehrman Group; participated in compensated work with AcademicCME and Association of Migraine Disorders; was a principal investigator on research with electroCore, Theranica, and Eli Lilly; serves on advisory boards for Theranica, Teva, Lundbeck, Amneal Pharmaceuticals, NeurologyLive, and Miles for Migraine; and is a project advisor for Clinical Awareness Initiative with Clinical Neurological Society of America. Dr. Rubio-Beltrán reported serving as a junior editorial board member of The Journal of Headache and Pain and a junior representative of the International Headache Society; receiving research support from The Migraine Trust, Eli Lilly, CoLucid Pharmaceuticals, Amgen, Novartis, and Kallyope; and receiving travel support from CoLucid Pharmaceuticals, Allergan, and Novartis.

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

Four triptans are more effective for acute migraine than newer, more expensive medications for this headache type, new research suggested.

Results of a large systematic review and meta-analysis showed that eletriptan, rizatriptan, sumatriptan, and zolmitriptan were more effective than lasmiditan, rimegepant, and ubrogepant, which investigators found were as effective as nonsteroidal anti-inflammatory drugs (NSAIDs).

International guidelines generally endorse NSAIDs as the first-line treatment for migraine and recommend triptans for moderate to severe episodes or when the response to NSAIDs is insufficient.

However, based on the study’s findings, these four triptans should be considered the treatment of choice for migraine, study investigator Andrea Cipriani, MD, PhD, professor of psychiatry at the University of Oxford in England and director of the Oxford Health Clinical Research Facility, told a press briefing.

The investigators added that these particular triptans should be “included in the WHO [World Health Organization] List of Essential Medicines to promote global accessibility and uniform standards of care.”

The study was published online in The BMJ.
 

Filling the Knowledge Gap

To date, almost all migraine studies have compared migraine drugs with placebo, so there’s a knowledge gap, said Dr. Cipriani. As a result, “there’s no clear consensus among experts and guidelines about which specific drug classes should be prescribed initially, and this is a clinical problem.”

The researchers pointed out that, in recent years, lasmiditan and gepants have been introduced as further treatment options, especially for patients in whom triptans are contraindicated because of their potential vasoconstrictive effects and higher risk for ischemic events.

The analysis included 137 double-blind, randomized, controlled trials that were primarily sponsored by the pharmaceutical industry. It included 89,445 adult outpatients with migraine (mean age, 40.3 years; 85.6% women).

Only drugs licensed for migraine or headache that are recommended in at least one country were included. Researchers divided these 17 drugs into five categories: Antipyretics (paracetamol), ditans (lasmiditan), gepants (rimegepant and ubrogepant), NSAIDs (acetylsalicylic acid, celecoxib, diclofenac potassium, ibuprofen, naproxen sodium, and phenazone), and triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan).

The study’s primary outcomes were freedom from pain at 2 hours and at 2-24 hours, without the use of rescue drugs.

Investigators used sumatriptan as the reference intervention because it is the most commonly prescribed migraine drug and is included in the WHO Model Lists of Essential Medicines.

The study showed all active interventions were better than placebo for pain freedom at 2 hours; with the exception of paracetamol and naratriptan, all were better for sustained pain freedom from 2 to 24 hours.

When the active interventions were compared with each other, eletriptan outperformed other drugs for achieving pain freedom at 2 hours. It was followed by rizatriptan, sumatriptan, and zolmitriptan (odds ratio [OR], 1.35-3.01). For sustained pain freedom up to 24 hours, the most efficacious interventions were eletriptan (OR, 1.41-2.73) and ibuprofen (OR, 3.16-4.82).

As for secondary efficacy outcomes, in head-to-head comparisons, eletriptan was superior to nearly all other active interventions for pain relief at 2 hours and for the use of rescue drugs.

As for adverse events, dizziness was more commonly associated with lasmiditan, eletriptan, sumatriptan, and zolmitriptan, while fatigue and sedation occurred more frequently with eletriptan and lasmiditan. Nausea was more often associated with lasmiditan, sumatriptan, zolmitriptan, and ubrogepant. Eletriptan was the only intervention most frequently associated with chest pain or discomfort.
 

Need to Update Guidelines?

Considering the new results, Dr. Cipriani and study coauthor Messoud Ashina, MD, PhD, professor of neurology, University of Copenhagen in Denmark, said clinical guidelines for acute migraine management should be updated.

While triptans are contraindicated in patients with vascular disease, the researchers noted that “cerebrovascular events may present primarily as migraine-like headaches, and misdiagnosis of transient ischemic attack and minor stroke as migraine is not rare.”

Recently, lasmiditan, rimegepant, and ubrogepant — which are not associated with vasoconstrictive effects — have been promoted as alternatives in patients for whom triptans are contraindicated or not tolerated. But the high costs of these drugs put them out of reach for some patients, the investigators noted.

Triptans are widely underutilized, Dr. Ashina noted during the press briefing. Current use ranges from 17% to 22% in the United States and from 3% to 22.5% in Europe.

The investigators said that triptans have been shown to be superior and should be promoted globally, adding that the limited access and substantial underutilization of these medications are “missed opportunities to offer more effective treatments.”

The new results underscore the importance of head-to-head trials, which is the gold standard, said Dr. Cipriani.

The investigators noted that the study’s main limitation was the quality of the data, which was deemed to be low, or very low, for most comparisons. Other potential limitations included lack of individual patient data; exclusion of combination drugs; inclusion of only oral treatments; and not considering type of oral formulation, consistency in response across migraine episodes, or cost-effectiveness.

The study also did not cover important clinical issues that might inform treatment decision-making, including drug overuse headache or potential withdrawal symptoms. And the authors were unable to quantify some outcomes, such as global functioning.
 

‘Best Profile’?

Reached for comment, Neurologist Nina Riggins, MD, PhD, Headache Center of Excellence, Palo Alto VA Medical Center in California, praised the authors for a “great job” of bringing attention to the topic.

However, she noted that the investigators’ characterization of the four triptans as having the “best profile” for acute migraine gave her pause.

“Calling triptans the medication with the ‘best profile’ might be not applicable in many cases,” she said. For example, those who need acute medication more than two to three times a week in addition to those with cardiovascular contraindications to triptans may fall outside of that category.

Dr. Riggins said that “it makes sense” that longer-acting triptans like frovatriptan and naratriptan may not rank highly for efficacy within the first 2 hours. However, these agents likely offer a superior therapeutic profile in specific contexts, such as menstrual-related migraine.

In addition, while triptans are known to cause medication overuse headache, this may not be the case with gepants, she noted.

In a release from the Science Media Center, a nonprofit organization promoting voices and views of the scientific community, Eloísa Rubio-Beltrán, PhD, research associate with The Migraine Trust at the Wolfson Sensory, Pain and Regeneration Centre, King’s College London in England, said the findings should affect migraine treatment guidelines.

“As the study highlights, due to their high efficacy and low cost, triptans should be the first-line treatment option for the acute treatment of migraine. These results should inform treatment guidelines and support the inclusion of the best performing triptans into the List of Essential Medicines, to optimize treatment, allowing patients to access more efficacious options,” said Dr. Rubio-Beltrán.

It is also important to note that gepants and ditans were developed to offer alternatives for patients who show no improvement from triptans, she added.

She pointed out that these medications were not developed as a substitute for triptans, but rather to expand the number of treatment options for migraine.

“Nonetheless,” she added, “this study highlights the need for further research on the pathophysiology of migraine, which will allow the discovery of novel targets, and thus, novel treatments options that will benefit all patient populations.”

The study was funded by the NIHR Oxford Health Biomedical Research Centre and the Lundbeck Foundation. Dr. Cipriani reported receiving research, educational, and consultancy fees from Italian Network for Pediatric Clinical Trials, Fondazione Cariplo, Lundbeck, and Angelini Pharma. Dr. Ashina is a consultant, speaker, or scientific adviser for AbbVie, Amgen, AstraZeneca, Eli Lilly, GSK, Lundbeck, Novartis, Pfizer, and Teva; is the past president of the International Headache Society; and an associate editor of The Journal of Headache and Pain and Brain. Dr. Riggins has consulted for Gerson Lehrman Group; participated in compensated work with AcademicCME and Association of Migraine Disorders; was a principal investigator on research with electroCore, Theranica, and Eli Lilly; serves on advisory boards for Theranica, Teva, Lundbeck, Amneal Pharmaceuticals, NeurologyLive, and Miles for Migraine; and is a project advisor for Clinical Awareness Initiative with Clinical Neurological Society of America. Dr. Rubio-Beltrán reported serving as a junior editorial board member of The Journal of Headache and Pain and a junior representative of the International Headache Society; receiving research support from The Migraine Trust, Eli Lilly, CoLucid Pharmaceuticals, Amgen, Novartis, and Kallyope; and receiving travel support from CoLucid Pharmaceuticals, Allergan, and Novartis.

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

In a groundbreaking procedure, a team of surgeons from New York University Langone Health successfully performed the first combined face and eye transplant on a patient with extensive craniofacial tissue loss after an electrical accident.

The highly complex surgery lasted for 21 hours and involved more than 140 surgeons, nurses, and other healthcare professionals under the leadership of Eduardo D. Rodriguez. MD. It not only restored the patient’s facial features, but also integrated a functional eyeball, potentially setting a new standard for future treatments in similar cases.

The transplant took place in May 2023, and the case report was published on September 5 this year in JAMA.

The 46-year-old man lost a large part of his craniofacial tissue and his left eyeball. The approach was highly specialized. Advanced microsurgical techniques such as anastomoses of microscopic vessels and delicate suturing techniques were crucial for the transplant’s success.

Moreover, customized surgical devices, specific implants, and tissue manipulation tools were developed specifically for this case, thus ensuring the viability of the transplant and adequate perfusion of the transplanted ocular tissue.

The initial results are encouraging. Retinal arterial perfusion has been maintained, and retinal architecture has been preserved, as demonstrated by optical coherence tomography. Electroretinography confirmed retinal responses to light, suggesting that the transplanted eye may eventually contribute to the patient’s visual perception. These results are comparable to those of previous facial tissue transplants, but with the significant addition of ocular functionality, which is a notable advance.

“The successful revascularization of the transplanted eye achieved in this study may serve as a step toward the goal of globe transplant for restoration of vision,” wrote the authors.

The complexity of the combined transplant required a deep understanding of facial and ocular anatomy, as well as tissue preservation techniques. The surgical team reported significant challenges, including the need to align delicate anatomical structures and ensure immunological compatibility between the donor and recipient. Meticulous planning from donor selection to postoperative follow-up was considered essential to maximize the likelihood of success and minimize the risk for allograft rejection.

The patient will now be continuously monitored and receive treatment with immunosuppressants such as tacrolimus and prednisone, adjusted according to his response to the transplant. According to the researchers, further studies will be needed to assess the long-term functionality of the transplanted eye and its integration with the central nervous system.

Despite being the fifth facial transplant surgery performed under Dr. Rodriguez’s leadership, this is the first record of a whole-eye transplant. “The mere fact that we have successfully performed the first whole-eye transplant along with a face transplant is a tremendous achievement that many believed to be impossible,” the doctor said in a statement. “We have taken a giant step forward and paved the way for the next chapter in vision restoration.”
 

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

In a groundbreaking procedure, a team of surgeons from New York University Langone Health successfully performed the first combined face and eye transplant on a patient with extensive craniofacial tissue loss after an electrical accident.

The highly complex surgery lasted for 21 hours and involved more than 140 surgeons, nurses, and other healthcare professionals under the leadership of Eduardo D. Rodriguez. MD. It not only restored the patient’s facial features, but also integrated a functional eyeball, potentially setting a new standard for future treatments in similar cases.

The transplant took place in May 2023, and the case report was published on September 5 this year in JAMA.

The 46-year-old man lost a large part of his craniofacial tissue and his left eyeball. The approach was highly specialized. Advanced microsurgical techniques such as anastomoses of microscopic vessels and delicate suturing techniques were crucial for the transplant’s success.

Moreover, customized surgical devices, specific implants, and tissue manipulation tools were developed specifically for this case, thus ensuring the viability of the transplant and adequate perfusion of the transplanted ocular tissue.

The initial results are encouraging. Retinal arterial perfusion has been maintained, and retinal architecture has been preserved, as demonstrated by optical coherence tomography. Electroretinography confirmed retinal responses to light, suggesting that the transplanted eye may eventually contribute to the patient’s visual perception. These results are comparable to those of previous facial tissue transplants, but with the significant addition of ocular functionality, which is a notable advance.

“The successful revascularization of the transplanted eye achieved in this study may serve as a step toward the goal of globe transplant for restoration of vision,” wrote the authors.

The complexity of the combined transplant required a deep understanding of facial and ocular anatomy, as well as tissue preservation techniques. The surgical team reported significant challenges, including the need to align delicate anatomical structures and ensure immunological compatibility between the donor and recipient. Meticulous planning from donor selection to postoperative follow-up was considered essential to maximize the likelihood of success and minimize the risk for allograft rejection.

The patient will now be continuously monitored and receive treatment with immunosuppressants such as tacrolimus and prednisone, adjusted according to his response to the transplant. According to the researchers, further studies will be needed to assess the long-term functionality of the transplanted eye and its integration with the central nervous system.

Despite being the fifth facial transplant surgery performed under Dr. Rodriguez’s leadership, this is the first record of a whole-eye transplant. “The mere fact that we have successfully performed the first whole-eye transplant along with a face transplant is a tremendous achievement that many believed to be impossible,” the doctor said in a statement. “We have taken a giant step forward and paved the way for the next chapter in vision restoration.”
 

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

In a groundbreaking procedure, a team of surgeons from New York University Langone Health successfully performed the first combined face and eye transplant on a patient with extensive craniofacial tissue loss after an electrical accident.

The highly complex surgery lasted for 21 hours and involved more than 140 surgeons, nurses, and other healthcare professionals under the leadership of Eduardo D. Rodriguez. MD. It not only restored the patient’s facial features, but also integrated a functional eyeball, potentially setting a new standard for future treatments in similar cases.

The transplant took place in May 2023, and the case report was published on September 5 this year in JAMA.

The 46-year-old man lost a large part of his craniofacial tissue and his left eyeball. The approach was highly specialized. Advanced microsurgical techniques such as anastomoses of microscopic vessels and delicate suturing techniques were crucial for the transplant’s success.

Moreover, customized surgical devices, specific implants, and tissue manipulation tools were developed specifically for this case, thus ensuring the viability of the transplant and adequate perfusion of the transplanted ocular tissue.

The initial results are encouraging. Retinal arterial perfusion has been maintained, and retinal architecture has been preserved, as demonstrated by optical coherence tomography. Electroretinography confirmed retinal responses to light, suggesting that the transplanted eye may eventually contribute to the patient’s visual perception. These results are comparable to those of previous facial tissue transplants, but with the significant addition of ocular functionality, which is a notable advance.

“The successful revascularization of the transplanted eye achieved in this study may serve as a step toward the goal of globe transplant for restoration of vision,” wrote the authors.

The complexity of the combined transplant required a deep understanding of facial and ocular anatomy, as well as tissue preservation techniques. The surgical team reported significant challenges, including the need to align delicate anatomical structures and ensure immunological compatibility between the donor and recipient. Meticulous planning from donor selection to postoperative follow-up was considered essential to maximize the likelihood of success and minimize the risk for allograft rejection.

The patient will now be continuously monitored and receive treatment with immunosuppressants such as tacrolimus and prednisone, adjusted according to his response to the transplant. According to the researchers, further studies will be needed to assess the long-term functionality of the transplanted eye and its integration with the central nervous system.

Despite being the fifth facial transplant surgery performed under Dr. Rodriguez’s leadership, this is the first record of a whole-eye transplant. “The mere fact that we have successfully performed the first whole-eye transplant along with a face transplant is a tremendous achievement that many believed to be impossible,” the doctor said in a statement. “We have taken a giant step forward and paved the way for the next chapter in vision restoration.”
 

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a subcutaneous formulation of the anti-CD20 antibody ocrelizumab (Ocrevus Zunovo, Genentech) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 

The subcutaneous (SC) injection can be administered by a healthcare professional in approximately 10 minutes and is the first and only twice-a-year SC injection approved for both RMS and PPMS, according to a company news release.

The FDA approval is based on pivotal data from the phase 3 OCARINA II trial, which showed no clinically significant difference in blood levels of ocrelizumab when administered subcutaneously and an efficacy profile consistent with the intravenous (IV) formulation. 

“The trial met its primary and secondary endpoints, demonstrating SC injection was noninferior to IV infusion based on [ocrelizumab] levels in the blood, and consistent control of clinical (relapses) and radiological (MRI lesions) disease activity,” the company said in the release. 

The safety profile of SC ocrelizumab was consistent with the safety profile of IV ocrelizumab, with the exception of injection site reactions, the most common adverse event.

Injection reactions were more often reported with the first injection, with 49% of trial participants experiencing an injection reaction after the first injection. All injection reactions were mild or moderate, and none led to treatment withdrawal.

Ocrevus Zunovo “may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs,” Levi Garraway, MD, PhD, chief medical officer for Genentech, said in the press release. “We are pleased that with a new method of delivery, there is now an additional option for those who need flexibility in the route of administration or treatment time,” Natalie Blake, executive director of the MS Foundation, said in the release. 

The SC formulation of ocrelizumab was approved by the European Commission in June.

Complete prescribing information is available online.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a subcutaneous formulation of the anti-CD20 antibody ocrelizumab (Ocrevus Zunovo, Genentech) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 

The subcutaneous (SC) injection can be administered by a healthcare professional in approximately 10 minutes and is the first and only twice-a-year SC injection approved for both RMS and PPMS, according to a company news release.

The FDA approval is based on pivotal data from the phase 3 OCARINA II trial, which showed no clinically significant difference in blood levels of ocrelizumab when administered subcutaneously and an efficacy profile consistent with the intravenous (IV) formulation. 

“The trial met its primary and secondary endpoints, demonstrating SC injection was noninferior to IV infusion based on [ocrelizumab] levels in the blood, and consistent control of clinical (relapses) and radiological (MRI lesions) disease activity,” the company said in the release. 

The safety profile of SC ocrelizumab was consistent with the safety profile of IV ocrelizumab, with the exception of injection site reactions, the most common adverse event.

Injection reactions were more often reported with the first injection, with 49% of trial participants experiencing an injection reaction after the first injection. All injection reactions were mild or moderate, and none led to treatment withdrawal.

Ocrevus Zunovo “may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs,” Levi Garraway, MD, PhD, chief medical officer for Genentech, said in the press release. “We are pleased that with a new method of delivery, there is now an additional option for those who need flexibility in the route of administration or treatment time,” Natalie Blake, executive director of the MS Foundation, said in the release. 

The SC formulation of ocrelizumab was approved by the European Commission in June.

Complete prescribing information is available online.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a subcutaneous formulation of the anti-CD20 antibody ocrelizumab (Ocrevus Zunovo, Genentech) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 

The subcutaneous (SC) injection can be administered by a healthcare professional in approximately 10 minutes and is the first and only twice-a-year SC injection approved for both RMS and PPMS, according to a company news release.

The FDA approval is based on pivotal data from the phase 3 OCARINA II trial, which showed no clinically significant difference in blood levels of ocrelizumab when administered subcutaneously and an efficacy profile consistent with the intravenous (IV) formulation. 

“The trial met its primary and secondary endpoints, demonstrating SC injection was noninferior to IV infusion based on [ocrelizumab] levels in the blood, and consistent control of clinical (relapses) and radiological (MRI lesions) disease activity,” the company said in the release. 

The safety profile of SC ocrelizumab was consistent with the safety profile of IV ocrelizumab, with the exception of injection site reactions, the most common adverse event.

Injection reactions were more often reported with the first injection, with 49% of trial participants experiencing an injection reaction after the first injection. All injection reactions were mild or moderate, and none led to treatment withdrawal.

Ocrevus Zunovo “may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs,” Levi Garraway, MD, PhD, chief medical officer for Genentech, said in the press release. “We are pleased that with a new method of delivery, there is now an additional option for those who need flexibility in the route of administration or treatment time,” Natalie Blake, executive director of the MS Foundation, said in the release. 

The SC formulation of ocrelizumab was approved by the European Commission in June.

Complete prescribing information is available online.

A version of this article appeared on Medscape.com.

MADRID — Patients with type 2 diabetes treated with sodium-glucose cotransporter 2 inhibitors (SGLT2is) show significant reductions in the risk of developing neurodegenerative disorders including Alzheimer’s disease, vascular dementia, and Parkinson’s disease, compared with those treated with other antidiabetic drugs, results from a large population-based cohort show.

“This was the largest nationwide population-based longitudinal cohort study to investigate the association between the use of SGLT2 inhibitors and the incidence of all-cause dementia and Parkinson’s disease,” said first author Hae Kyung Kim, MD, of the Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea, in presenting the findings at the annual meeting of the European Association for the Study of Diabetes.

Type 2 diabetes is known to increase the risk for neurodegenerative diseases such as dementia or Alzheimer’s disease, said Dr. Kim. Key factors attributed to the risk include shared pathophysiological mechanisms such as central nervous system insulin resistance and reduced cerebral glucose metabolism.

While research is lacking on the role of antidiabetic drugs in the treatment of neurodegenerative diseases, the researcher noted that “SGLT2 inhibitors, which have shown significant cardiorenal benefits and enhanced energy metabolism through ketogenesis, offer promise.”

To further investigate, Dr. Kim and her colleagues conducted the retrospective study, evaluating data on more than 1.3 million enrollees in Korea’s National Health Insurance Service Database who were aged 40 years or older, diagnosed with type 2 diabetes, and had initiated antidiabetic drugs between September 2014 and December 2019.

In the propensity score analysis, 358,862 patients were matched 1:1, in groups of 179,431 participants each, based on whether they were treated with SGLT2is or other oral antidiabetic drugs. Patients with a history of neurodegenerative disease, cancer, or use of glucagon-like peptide 1 receptor agonists were excluded.

The patients had a mean age of 57.8 years, 57.9% were men, and 6837 had incident dementia or Parkinson’s disease events reported.

With a mean follow-up of 2.88 years, after adjustment for key variables, those treated with SGLT2is had a 19% reduced risk of developing Alzheimer’s disease (adjusted hazard ratio [aHR], 0.81), a 31% reduced risk for vascular dementia (aHR, 0.69), and a 20% reduced risk for Parkinson’s disease (aHR, 0.80) compared with the non-SGLT2i group.

Furthermore, those receiving SGLT2i treatment had a 21% reduced risk for all-cause dementia (aHR, 0.79) and a 22% reduced risk for all-cause dementia and Parkinson’s disease compared with the oral antidiabetic drug group (aHR, 0.78) with a 6-month drug use lag period.

The association was observed regardless of SGLT2i exposure duration. Subgroup analyses indicated that the reductions in neurodegenerative disorders among those receiving SGLT2is were not associated with factors including age, sex, body mass index, blood pressure, glucose, lipid profiles, kidney function, health behaviors, comorbidities, diabetic complications, or other medication use.

Dr. Kim speculated that mechanisms underlying the reduced dementia risk could include SGLT2i effects of mitigating the common severe risk factors of type 2 diabetes and neurodegenerative diseases, including hypertension, heart failure, and chronic kidney disease, and improving hyperperfusion in the heart and cerebral vascular insufficiency.

Commenting on the study to this news organization, Erik H. Serné, MD, of the VU University Medical Centre, Amsterdam, the Netherlands, who comoderated the session, noted that “people with type 2 diabetes have a 50%-100% increased risk of developing dementia, particularly Alzheimer’s disease and vascular dementia.”

“The increasing prevalence of both conditions poses significant public health challenges, highlighting the need for effective prevention strategies and interventions.”

Currently, treatments for dementia are limited, with most primarily addressing symptoms and not the underlying cause of the neurodegenerative disease, he said.

He noted that, in addition to the effects mentioned by Dr. Kim, SGLT2is are also speculated to provide potential neuroprotective effects through improved glycemic control and insulin sensitivity, reduced inflammation and oxidative stress, enhanced mitochondrial function and energy metabolism, and reduced beta-amyloid and tau pathology.

“These mechanisms collectively may reduce the risk of cognitive decline, particularly in diabetic patients, and warrant further investigation in clinical trials to solidify the neuroprotective role of SGLT2 inhibitors,” said Dr. Serné.

In addition to their benefits in type 2 diabetes, SGLT2is “now offer hope in the prevention of dementia, a disease that has very limited therapeutic options thus far. The current data [presented by Dr. Kim] seem to corroborate this,” he added.

Dr. Kim and Dr. Serné had no disclosures to report.

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

MADRID — Patients with type 2 diabetes treated with sodium-glucose cotransporter 2 inhibitors (SGLT2is) show significant reductions in the risk of developing neurodegenerative disorders including Alzheimer’s disease, vascular dementia, and Parkinson’s disease, compared with those treated with other antidiabetic drugs, results from a large population-based cohort show.

“This was the largest nationwide population-based longitudinal cohort study to investigate the association between the use of SGLT2 inhibitors and the incidence of all-cause dementia and Parkinson’s disease,” said first author Hae Kyung Kim, MD, of the Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea, in presenting the findings at the annual meeting of the European Association for the Study of Diabetes.

Type 2 diabetes is known to increase the risk for neurodegenerative diseases such as dementia or Alzheimer’s disease, said Dr. Kim. Key factors attributed to the risk include shared pathophysiological mechanisms such as central nervous system insulin resistance and reduced cerebral glucose metabolism.

While research is lacking on the role of antidiabetic drugs in the treatment of neurodegenerative diseases, the researcher noted that “SGLT2 inhibitors, which have shown significant cardiorenal benefits and enhanced energy metabolism through ketogenesis, offer promise.”

To further investigate, Dr. Kim and her colleagues conducted the retrospective study, evaluating data on more than 1.3 million enrollees in Korea’s National Health Insurance Service Database who were aged 40 years or older, diagnosed with type 2 diabetes, and had initiated antidiabetic drugs between September 2014 and December 2019.

In the propensity score analysis, 358,862 patients were matched 1:1, in groups of 179,431 participants each, based on whether they were treated with SGLT2is or other oral antidiabetic drugs. Patients with a history of neurodegenerative disease, cancer, or use of glucagon-like peptide 1 receptor agonists were excluded.

The patients had a mean age of 57.8 years, 57.9% were men, and 6837 had incident dementia or Parkinson’s disease events reported.

With a mean follow-up of 2.88 years, after adjustment for key variables, those treated with SGLT2is had a 19% reduced risk of developing Alzheimer’s disease (adjusted hazard ratio [aHR], 0.81), a 31% reduced risk for vascular dementia (aHR, 0.69), and a 20% reduced risk for Parkinson’s disease (aHR, 0.80) compared with the non-SGLT2i group.

Furthermore, those receiving SGLT2i treatment had a 21% reduced risk for all-cause dementia (aHR, 0.79) and a 22% reduced risk for all-cause dementia and Parkinson’s disease compared with the oral antidiabetic drug group (aHR, 0.78) with a 6-month drug use lag period.

The association was observed regardless of SGLT2i exposure duration. Subgroup analyses indicated that the reductions in neurodegenerative disorders among those receiving SGLT2is were not associated with factors including age, sex, body mass index, blood pressure, glucose, lipid profiles, kidney function, health behaviors, comorbidities, diabetic complications, or other medication use.

Dr. Kim speculated that mechanisms underlying the reduced dementia risk could include SGLT2i effects of mitigating the common severe risk factors of type 2 diabetes and neurodegenerative diseases, including hypertension, heart failure, and chronic kidney disease, and improving hyperperfusion in the heart and cerebral vascular insufficiency.

Commenting on the study to this news organization, Erik H. Serné, MD, of the VU University Medical Centre, Amsterdam, the Netherlands, who comoderated the session, noted that “people with type 2 diabetes have a 50%-100% increased risk of developing dementia, particularly Alzheimer’s disease and vascular dementia.”

“The increasing prevalence of both conditions poses significant public health challenges, highlighting the need for effective prevention strategies and interventions.”

Currently, treatments for dementia are limited, with most primarily addressing symptoms and not the underlying cause of the neurodegenerative disease, he said.

He noted that, in addition to the effects mentioned by Dr. Kim, SGLT2is are also speculated to provide potential neuroprotective effects through improved glycemic control and insulin sensitivity, reduced inflammation and oxidative stress, enhanced mitochondrial function and energy metabolism, and reduced beta-amyloid and tau pathology.

“These mechanisms collectively may reduce the risk of cognitive decline, particularly in diabetic patients, and warrant further investigation in clinical trials to solidify the neuroprotective role of SGLT2 inhibitors,” said Dr. Serné.

In addition to their benefits in type 2 diabetes, SGLT2is “now offer hope in the prevention of dementia, a disease that has very limited therapeutic options thus far. The current data [presented by Dr. Kim] seem to corroborate this,” he added.

Dr. Kim and Dr. Serné had no disclosures to report.

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

MADRID — Patients with type 2 diabetes treated with sodium-glucose cotransporter 2 inhibitors (SGLT2is) show significant reductions in the risk of developing neurodegenerative disorders including Alzheimer’s disease, vascular dementia, and Parkinson’s disease, compared with those treated with other antidiabetic drugs, results from a large population-based cohort show.

“This was the largest nationwide population-based longitudinal cohort study to investigate the association between the use of SGLT2 inhibitors and the incidence of all-cause dementia and Parkinson’s disease,” said first author Hae Kyung Kim, MD, of the Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea, in presenting the findings at the annual meeting of the European Association for the Study of Diabetes.

Type 2 diabetes is known to increase the risk for neurodegenerative diseases such as dementia or Alzheimer’s disease, said Dr. Kim. Key factors attributed to the risk include shared pathophysiological mechanisms such as central nervous system insulin resistance and reduced cerebral glucose metabolism.

While research is lacking on the role of antidiabetic drugs in the treatment of neurodegenerative diseases, the researcher noted that “SGLT2 inhibitors, which have shown significant cardiorenal benefits and enhanced energy metabolism through ketogenesis, offer promise.”

To further investigate, Dr. Kim and her colleagues conducted the retrospective study, evaluating data on more than 1.3 million enrollees in Korea’s National Health Insurance Service Database who were aged 40 years or older, diagnosed with type 2 diabetes, and had initiated antidiabetic drugs between September 2014 and December 2019.

In the propensity score analysis, 358,862 patients were matched 1:1, in groups of 179,431 participants each, based on whether they were treated with SGLT2is or other oral antidiabetic drugs. Patients with a history of neurodegenerative disease, cancer, or use of glucagon-like peptide 1 receptor agonists were excluded.

The patients had a mean age of 57.8 years, 57.9% were men, and 6837 had incident dementia or Parkinson’s disease events reported.

With a mean follow-up of 2.88 years, after adjustment for key variables, those treated with SGLT2is had a 19% reduced risk of developing Alzheimer’s disease (adjusted hazard ratio [aHR], 0.81), a 31% reduced risk for vascular dementia (aHR, 0.69), and a 20% reduced risk for Parkinson’s disease (aHR, 0.80) compared with the non-SGLT2i group.

Furthermore, those receiving SGLT2i treatment had a 21% reduced risk for all-cause dementia (aHR, 0.79) and a 22% reduced risk for all-cause dementia and Parkinson’s disease compared with the oral antidiabetic drug group (aHR, 0.78) with a 6-month drug use lag period.

The association was observed regardless of SGLT2i exposure duration. Subgroup analyses indicated that the reductions in neurodegenerative disorders among those receiving SGLT2is were not associated with factors including age, sex, body mass index, blood pressure, glucose, lipid profiles, kidney function, health behaviors, comorbidities, diabetic complications, or other medication use.

Dr. Kim speculated that mechanisms underlying the reduced dementia risk could include SGLT2i effects of mitigating the common severe risk factors of type 2 diabetes and neurodegenerative diseases, including hypertension, heart failure, and chronic kidney disease, and improving hyperperfusion in the heart and cerebral vascular insufficiency.

Commenting on the study to this news organization, Erik H. Serné, MD, of the VU University Medical Centre, Amsterdam, the Netherlands, who comoderated the session, noted that “people with type 2 diabetes have a 50%-100% increased risk of developing dementia, particularly Alzheimer’s disease and vascular dementia.”

“The increasing prevalence of both conditions poses significant public health challenges, highlighting the need for effective prevention strategies and interventions.”

Currently, treatments for dementia are limited, with most primarily addressing symptoms and not the underlying cause of the neurodegenerative disease, he said.

He noted that, in addition to the effects mentioned by Dr. Kim, SGLT2is are also speculated to provide potential neuroprotective effects through improved glycemic control and insulin sensitivity, reduced inflammation and oxidative stress, enhanced mitochondrial function and energy metabolism, and reduced beta-amyloid and tau pathology.

“These mechanisms collectively may reduce the risk of cognitive decline, particularly in diabetic patients, and warrant further investigation in clinical trials to solidify the neuroprotective role of SGLT2 inhibitors,” said Dr. Serné.

In addition to their benefits in type 2 diabetes, SGLT2is “now offer hope in the prevention of dementia, a disease that has very limited therapeutic options thus far. The current data [presented by Dr. Kim] seem to corroborate this,” he added.

Dr. Kim and Dr. Serné had no disclosures to report.

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

In 2024, a record number of people are celebrating their 65th birthdays. Increasing age is associated with a higher risk for falls, fractures, and other injuries that may require hospitalization. 

In older adults with type 1 and type 2 diabetes, the risk for falls is double that seen in older people without these conditions. Increased clinician awareness of the many factors that result in this higher risk in people with diabetes, and timely implementation of strategies to prevent falls, are essential.

The annual incidence of falls in people with diabetes older than 65 years is about 39%, compared with 19% among those without diabetes. People with diabetes on insulin face an even greater increased risk for falls compared with those who are not using insulin (94% vs 27% increased risk).

Many well-known aspects of diabetes contribute to this greater risk. These include decreased sensorimotor function, musculoskeletal and neuromuscular deficits, foot and body pain, poor vision, hypoglycemic episodes, pharmacologic complications, and problems with hearing and balance. 

Optimal management of diabetes and its complications is essential, and the American Diabetes Association has developed clear guidelines for clinicians to follow to reduce the risk for diabetes related complications and manage these conditions.

The prevalence of diabetic peripheral neuropathy increases with age and duration of diabetes. People with diabetic peripheral neuropathy and diminished sensation on their feet are at increased risk for loss of postural control. Loss of proprioceptive feedback (the ability to sense movement, action and location) during standing and walking leads increases the risk for falls.

In addition, less physical activity, impaired muscle strength, and suboptimal postural control all influence gait patterns and increase the risk for falling. Adults with diabetes have a two to three times higher risk for sarcopenia (decreased muscle strength and muscle mass). They also have low plantar flexion strength, causing increased displacement of their center of gravity, which in turn reduces their maximum forward stride and may result in falls and injury.

Many people with diabetes experience neuropathic foot and body pain, requiring psychotropic and other medications that may exacerbate the risk, such as amitriptyline and duloxetine. Furthermore, older adults with diabetes are more likely to take more prescription medications and may be more sensitive to effects of multiple medications than are individuals without diabetes.

A hazard of managing diabetes, particularly with insulin, is the increased risk for unexpected low blood glucose levels. These episodes can also occur in patients taking certain kinds of oral diabetes medications, but they are more common in those on insulin. Low blood glucose can cause dizziness, confusion, and postural instability, increasing the risk for falling.

Diabetic eye complications include retinopathy, macular edema, cataracts, and glaucoma. In a study of close to 10,000 middle-aged and older adults with diabetes, those with moderate eye complications had almost double the risk of falls as those without eye complications.

Another concern with diabetes is its effect on nerves and blood vessels in the inner ear, leading to a negative effect on balance and hearing loss, both of which are also associated with a higher risk for falling and injury.

Clinicians can reduce the risk for falls in patients by taking measures to improve diabetes control and reduce the risk for microvascular disease affecting the nerves, eyes, and ears. 

In addition, exercises that optimize muscle mass, bone strength, gait, and balance, and use of specialized footwear in people with neuropathy, may reduce fall risk. Chair yoga and tai chi have also been shown to be helpful. Clinicians can also advise patients on commonsense strategies to implement in their homes, such as ensuring proper lighting, reducing, clutter and minimizing the use of floor rugs.

The risk for falls and the associated risk for fracture and possible hospitalization are of significant concern in older adults — particularly those with diabetes, and even more so in those with diabetes who are on insulin. It is our responsibility as clinicians to implement strategies to optimize diabetes control in our patients and monitor them for microvascular and other complications that may increase this risk, and manage them appropriately if and when these complications occur.

Madhusmita Misra, Professor, Chair, Physician-in-Chief, Department of Pediatrics, University of Virginia and UVA Health Children’s, Charlottesville, has disclosed being a key opinion leader for Lumos Pharma. Sidhartha Pani, Assistant Professor, Department of Internal Medicine, UVA School of Medicine; Medical Director, Department of General Medicine, Same Day Care Clinic, Charlottesville, disclosed no relevant financial relationships.

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

In 2024, a record number of people are celebrating their 65th birthdays. Increasing age is associated with a higher risk for falls, fractures, and other injuries that may require hospitalization. 

In older adults with type 1 and type 2 diabetes, the risk for falls is double that seen in older people without these conditions. Increased clinician awareness of the many factors that result in this higher risk in people with diabetes, and timely implementation of strategies to prevent falls, are essential.

The annual incidence of falls in people with diabetes older than 65 years is about 39%, compared with 19% among those without diabetes. People with diabetes on insulin face an even greater increased risk for falls compared with those who are not using insulin (94% vs 27% increased risk).

Many well-known aspects of diabetes contribute to this greater risk. These include decreased sensorimotor function, musculoskeletal and neuromuscular deficits, foot and body pain, poor vision, hypoglycemic episodes, pharmacologic complications, and problems with hearing and balance. 

Optimal management of diabetes and its complications is essential, and the American Diabetes Association has developed clear guidelines for clinicians to follow to reduce the risk for diabetes related complications and manage these conditions.

The prevalence of diabetic peripheral neuropathy increases with age and duration of diabetes. People with diabetic peripheral neuropathy and diminished sensation on their feet are at increased risk for loss of postural control. Loss of proprioceptive feedback (the ability to sense movement, action and location) during standing and walking leads increases the risk for falls.

In addition, less physical activity, impaired muscle strength, and suboptimal postural control all influence gait patterns and increase the risk for falling. Adults with diabetes have a two to three times higher risk for sarcopenia (decreased muscle strength and muscle mass). They also have low plantar flexion strength, causing increased displacement of their center of gravity, which in turn reduces their maximum forward stride and may result in falls and injury.

Many people with diabetes experience neuropathic foot and body pain, requiring psychotropic and other medications that may exacerbate the risk, such as amitriptyline and duloxetine. Furthermore, older adults with diabetes are more likely to take more prescription medications and may be more sensitive to effects of multiple medications than are individuals without diabetes.

A hazard of managing diabetes, particularly with insulin, is the increased risk for unexpected low blood glucose levels. These episodes can also occur in patients taking certain kinds of oral diabetes medications, but they are more common in those on insulin. Low blood glucose can cause dizziness, confusion, and postural instability, increasing the risk for falling.

Diabetic eye complications include retinopathy, macular edema, cataracts, and glaucoma. In a study of close to 10,000 middle-aged and older adults with diabetes, those with moderate eye complications had almost double the risk of falls as those without eye complications.

Another concern with diabetes is its effect on nerves and blood vessels in the inner ear, leading to a negative effect on balance and hearing loss, both of which are also associated with a higher risk for falling and injury.

Clinicians can reduce the risk for falls in patients by taking measures to improve diabetes control and reduce the risk for microvascular disease affecting the nerves, eyes, and ears. 

In addition, exercises that optimize muscle mass, bone strength, gait, and balance, and use of specialized footwear in people with neuropathy, may reduce fall risk. Chair yoga and tai chi have also been shown to be helpful. Clinicians can also advise patients on commonsense strategies to implement in their homes, such as ensuring proper lighting, reducing, clutter and minimizing the use of floor rugs.

The risk for falls and the associated risk for fracture and possible hospitalization are of significant concern in older adults — particularly those with diabetes, and even more so in those with diabetes who are on insulin. It is our responsibility as clinicians to implement strategies to optimize diabetes control in our patients and monitor them for microvascular and other complications that may increase this risk, and manage them appropriately if and when these complications occur.

Madhusmita Misra, Professor, Chair, Physician-in-Chief, Department of Pediatrics, University of Virginia and UVA Health Children’s, Charlottesville, has disclosed being a key opinion leader for Lumos Pharma. Sidhartha Pani, Assistant Professor, Department of Internal Medicine, UVA School of Medicine; Medical Director, Department of General Medicine, Same Day Care Clinic, Charlottesville, disclosed no relevant financial relationships.

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

In 2024, a record number of people are celebrating their 65th birthdays. Increasing age is associated with a higher risk for falls, fractures, and other injuries that may require hospitalization. 

In older adults with type 1 and type 2 diabetes, the risk for falls is double that seen in older people without these conditions. Increased clinician awareness of the many factors that result in this higher risk in people with diabetes, and timely implementation of strategies to prevent falls, are essential.

The annual incidence of falls in people with diabetes older than 65 years is about 39%, compared with 19% among those without diabetes. People with diabetes on insulin face an even greater increased risk for falls compared with those who are not using insulin (94% vs 27% increased risk).

Many well-known aspects of diabetes contribute to this greater risk. These include decreased sensorimotor function, musculoskeletal and neuromuscular deficits, foot and body pain, poor vision, hypoglycemic episodes, pharmacologic complications, and problems with hearing and balance. 

Optimal management of diabetes and its complications is essential, and the American Diabetes Association has developed clear guidelines for clinicians to follow to reduce the risk for diabetes related complications and manage these conditions.

The prevalence of diabetic peripheral neuropathy increases with age and duration of diabetes. People with diabetic peripheral neuropathy and diminished sensation on their feet are at increased risk for loss of postural control. Loss of proprioceptive feedback (the ability to sense movement, action and location) during standing and walking leads increases the risk for falls.

In addition, less physical activity, impaired muscle strength, and suboptimal postural control all influence gait patterns and increase the risk for falling. Adults with diabetes have a two to three times higher risk for sarcopenia (decreased muscle strength and muscle mass). They also have low plantar flexion strength, causing increased displacement of their center of gravity, which in turn reduces their maximum forward stride and may result in falls and injury.

Many people with diabetes experience neuropathic foot and body pain, requiring psychotropic and other medications that may exacerbate the risk, such as amitriptyline and duloxetine. Furthermore, older adults with diabetes are more likely to take more prescription medications and may be more sensitive to effects of multiple medications than are individuals without diabetes.

A hazard of managing diabetes, particularly with insulin, is the increased risk for unexpected low blood glucose levels. These episodes can also occur in patients taking certain kinds of oral diabetes medications, but they are more common in those on insulin. Low blood glucose can cause dizziness, confusion, and postural instability, increasing the risk for falling.

Diabetic eye complications include retinopathy, macular edema, cataracts, and glaucoma. In a study of close to 10,000 middle-aged and older adults with diabetes, those with moderate eye complications had almost double the risk of falls as those without eye complications.

Another concern with diabetes is its effect on nerves and blood vessels in the inner ear, leading to a negative effect on balance and hearing loss, both of which are also associated with a higher risk for falling and injury.

Clinicians can reduce the risk for falls in patients by taking measures to improve diabetes control and reduce the risk for microvascular disease affecting the nerves, eyes, and ears. 

In addition, exercises that optimize muscle mass, bone strength, gait, and balance, and use of specialized footwear in people with neuropathy, may reduce fall risk. Chair yoga and tai chi have also been shown to be helpful. Clinicians can also advise patients on commonsense strategies to implement in their homes, such as ensuring proper lighting, reducing, clutter and minimizing the use of floor rugs.

The risk for falls and the associated risk for fracture and possible hospitalization are of significant concern in older adults — particularly those with diabetes, and even more so in those with diabetes who are on insulin. It is our responsibility as clinicians to implement strategies to optimize diabetes control in our patients and monitor them for microvascular and other complications that may increase this risk, and manage them appropriately if and when these complications occur.

Madhusmita Misra, Professor, Chair, Physician-in-Chief, Department of Pediatrics, University of Virginia and UVA Health Children’s, Charlottesville, has disclosed being a key opinion leader for Lumos Pharma. Sidhartha Pani, Assistant Professor, Department of Internal Medicine, UVA School of Medicine; Medical Director, Department of General Medicine, Same Day Care Clinic, Charlottesville, disclosed no relevant financial relationships.

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

Postoperative cognitive dysfunction (POCD) is a form of cognitive decline that involves a functional deterioration of activities of the nervous system, such as selective attention, vigilance, perception, learning, memory, executive function, verbal and language abilities, emotion, visuospatial and visuomotor skills. It occurs in the absence of cranial trauma or other brain injuries, and prevalence rates range from 36.6% in young adults to 42.4% in older adults, as a consequence of significant invasive procedures such as cardiac, noncardiac, and carotid surgeries that are lengthy and intensive.

Alzheimer’s disease (AD), the most common form of dementia, accounts for about two thirds of all cases of dementia globally. It is estimated that 41 million patients with dementia remain undiagnosed worldwide, and 25% of patients are diagnosed only when they are fully symptomatic. AD is a neurodegenerative disorder defined by neuropathologic changes, including beta-amyloid (Abeta) plaques composed of aggregated Abeta and neurofibrillary tangles containing aggregated tau proteins.

Patients with AD are unaware of their condition. Dementia, especially in its early stages, is often a hidden disease. Even when suspected, patients and families may believe that the symptoms are part of normal aging and may not report them to the doctor. In these patients, surgery may unmask subclinical dementia.

The complex correlation between POCD and AD has sparked debate following numerous anecdotal reports of how older adults undergoing surgical procedures may experience long-term cognitive decline with clinical characteristics such as those of patients with dementia. Despite advances in knowledge, it is still difficult to establish a priori how much surgery and anesthesia can increase the risk or accelerate the progression of a prodromal and asymptomatic AD condition (stages I-II) to clinically evident stage III AD. The current trend of an aging population poses a challenge for anesthesiology surgery because as the age of patients undergoing surgery increases, so does the likelihood of developing POCD.

Recent research in these fields has improved knowledge of the characteristics, epidemiology, risk factors, pathogenesis, and potential prevention strategies associated with POCD. It has improved the perspectives of future prevention and treatment.
 

Definition and Diagnostic Criteria

POCD, according to the cognitive impairment classification in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, is characterized by mild neurologic disturbance resulting from routine surgical procedures, excluding conditions such as deafness, dementia, or amnesia. The definition of POCD involves prolonged cognitive decline that can last for weeks, months, or even years. POCD may be confused with postoperative delirium, an acute and fluctuating disorder of consciousness that typically occurs within 3 days of surgery.

The diagnosis of POCD is based primarily on neurocognitive function scales. Widely used assessments include the Montreal Cognitive Assessment, the Wechsler Memory Scale, and the Mini-Mental State Examination.
 

Epidemiology

POCD is prevalent among patients undergoing cardiac or orthopedic surgery. In patients undergoing aortic-coronary bypass and cardiopulmonary bypass, 50%-70% develop POCD 1 week after surgery. In addition, 10%-30% experience long-term effects on cognitive function at 6 months after the procedure. In patients undergoing hip arthroplasty, 20%-50% exhibit POCD within 1 week of surgery, with 10%-14% still presenting it after 3 months.

Risk Factors

Age

POCD is typically observed in patients older than 65 years. However, after surgery, around 30% of younger patients and about 40% of older patients develop POCD at the time of hospital discharge. Specifically, 12.7% of older patients continue to have POCD 3 months after surgery, compared with 5% of younger patients.

Type of Surgery 

Hip and knee arthroplasty procedures entail a higher risk for POCD than general surgery. The same is true of cardiac surgery, especially aortic-coronary bypass and cardiopulmonary bypass.

Types of Anesthesia 

Initial assessments of postoperative cognitive function in cardiac surgery did not provide significant correlations between observed changes and the type of anesthesia because of the high number of confounding factors involved. A more recent meta-analysis of 28 randomized clinical trials concluded that the incidence of POCD is lower in surgeries using intravenous anesthesia with propofol than in those using inhalation anesthesia with isoflurane or sevoflurane.

Pain

Postoperative pain is a common issue, mainly resulting from substantial surgical trauma or potential wound infection. Patient-controlled postoperative analgesia independently increases the risk for POCD, compared with oral postoperative analgesia. Meta-analyses indicate that persistent pain can lead to a decline in patients’ cognitive abilities, attention, memory, and information processing.

Evolving Scenarios

Current research on POCD has deepened our understanding of its pathogenesis, implicating factors such as central nervous system inflammation, neuronal apoptosis, synaptic plasticity damage, abnormal tau protein modification, chronic pain, and mitochondrial metabolic disorders. Several neuroprotective drugs are currently under study, but none have shown consistent benefits for the prevention and treatment of POCD. The available evidence on the subject does not unambiguously guide the practicing physician. But neither does it exclude the importance of a careful assessment of POCD risk factors and the cognitive status of an older patient before surgery to provide useful information to the patient, family, and doctors when deciding on appropriate and shared procedures.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Postoperative cognitive dysfunction (POCD) is a form of cognitive decline that involves a functional deterioration of activities of the nervous system, such as selective attention, vigilance, perception, learning, memory, executive function, verbal and language abilities, emotion, visuospatial and visuomotor skills. It occurs in the absence of cranial trauma or other brain injuries, and prevalence rates range from 36.6% in young adults to 42.4% in older adults, as a consequence of significant invasive procedures such as cardiac, noncardiac, and carotid surgeries that are lengthy and intensive.

Alzheimer’s disease (AD), the most common form of dementia, accounts for about two thirds of all cases of dementia globally. It is estimated that 41 million patients with dementia remain undiagnosed worldwide, and 25% of patients are diagnosed only when they are fully symptomatic. AD is a neurodegenerative disorder defined by neuropathologic changes, including beta-amyloid (Abeta) plaques composed of aggregated Abeta and neurofibrillary tangles containing aggregated tau proteins.

Patients with AD are unaware of their condition. Dementia, especially in its early stages, is often a hidden disease. Even when suspected, patients and families may believe that the symptoms are part of normal aging and may not report them to the doctor. In these patients, surgery may unmask subclinical dementia.

The complex correlation between POCD and AD has sparked debate following numerous anecdotal reports of how older adults undergoing surgical procedures may experience long-term cognitive decline with clinical characteristics such as those of patients with dementia. Despite advances in knowledge, it is still difficult to establish a priori how much surgery and anesthesia can increase the risk or accelerate the progression of a prodromal and asymptomatic AD condition (stages I-II) to clinically evident stage III AD. The current trend of an aging population poses a challenge for anesthesiology surgery because as the age of patients undergoing surgery increases, so does the likelihood of developing POCD.

Recent research in these fields has improved knowledge of the characteristics, epidemiology, risk factors, pathogenesis, and potential prevention strategies associated with POCD. It has improved the perspectives of future prevention and treatment.
 

Definition and Diagnostic Criteria

POCD, according to the cognitive impairment classification in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, is characterized by mild neurologic disturbance resulting from routine surgical procedures, excluding conditions such as deafness, dementia, or amnesia. The definition of POCD involves prolonged cognitive decline that can last for weeks, months, or even years. POCD may be confused with postoperative delirium, an acute and fluctuating disorder of consciousness that typically occurs within 3 days of surgery.

The diagnosis of POCD is based primarily on neurocognitive function scales. Widely used assessments include the Montreal Cognitive Assessment, the Wechsler Memory Scale, and the Mini-Mental State Examination.
 

Epidemiology

POCD is prevalent among patients undergoing cardiac or orthopedic surgery. In patients undergoing aortic-coronary bypass and cardiopulmonary bypass, 50%-70% develop POCD 1 week after surgery. In addition, 10%-30% experience long-term effects on cognitive function at 6 months after the procedure. In patients undergoing hip arthroplasty, 20%-50% exhibit POCD within 1 week of surgery, with 10%-14% still presenting it after 3 months.

Risk Factors

Age

POCD is typically observed in patients older than 65 years. However, after surgery, around 30% of younger patients and about 40% of older patients develop POCD at the time of hospital discharge. Specifically, 12.7% of older patients continue to have POCD 3 months after surgery, compared with 5% of younger patients.

Type of Surgery 

Hip and knee arthroplasty procedures entail a higher risk for POCD than general surgery. The same is true of cardiac surgery, especially aortic-coronary bypass and cardiopulmonary bypass.

Types of Anesthesia 

Initial assessments of postoperative cognitive function in cardiac surgery did not provide significant correlations between observed changes and the type of anesthesia because of the high number of confounding factors involved. A more recent meta-analysis of 28 randomized clinical trials concluded that the incidence of POCD is lower in surgeries using intravenous anesthesia with propofol than in those using inhalation anesthesia with isoflurane or sevoflurane.

Pain

Postoperative pain is a common issue, mainly resulting from substantial surgical trauma or potential wound infection. Patient-controlled postoperative analgesia independently increases the risk for POCD, compared with oral postoperative analgesia. Meta-analyses indicate that persistent pain can lead to a decline in patients’ cognitive abilities, attention, memory, and information processing.

Evolving Scenarios

Current research on POCD has deepened our understanding of its pathogenesis, implicating factors such as central nervous system inflammation, neuronal apoptosis, synaptic plasticity damage, abnormal tau protein modification, chronic pain, and mitochondrial metabolic disorders. Several neuroprotective drugs are currently under study, but none have shown consistent benefits for the prevention and treatment of POCD. The available evidence on the subject does not unambiguously guide the practicing physician. But neither does it exclude the importance of a careful assessment of POCD risk factors and the cognitive status of an older patient before surgery to provide useful information to the patient, family, and doctors when deciding on appropriate and shared procedures.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Postoperative cognitive dysfunction (POCD) is a form of cognitive decline that involves a functional deterioration of activities of the nervous system, such as selective attention, vigilance, perception, learning, memory, executive function, verbal and language abilities, emotion, visuospatial and visuomotor skills. It occurs in the absence of cranial trauma or other brain injuries, and prevalence rates range from 36.6% in young adults to 42.4% in older adults, as a consequence of significant invasive procedures such as cardiac, noncardiac, and carotid surgeries that are lengthy and intensive.

Alzheimer’s disease (AD), the most common form of dementia, accounts for about two thirds of all cases of dementia globally. It is estimated that 41 million patients with dementia remain undiagnosed worldwide, and 25% of patients are diagnosed only when they are fully symptomatic. AD is a neurodegenerative disorder defined by neuropathologic changes, including beta-amyloid (Abeta) plaques composed of aggregated Abeta and neurofibrillary tangles containing aggregated tau proteins.

Patients with AD are unaware of their condition. Dementia, especially in its early stages, is often a hidden disease. Even when suspected, patients and families may believe that the symptoms are part of normal aging and may not report them to the doctor. In these patients, surgery may unmask subclinical dementia.

The complex correlation between POCD and AD has sparked debate following numerous anecdotal reports of how older adults undergoing surgical procedures may experience long-term cognitive decline with clinical characteristics such as those of patients with dementia. Despite advances in knowledge, it is still difficult to establish a priori how much surgery and anesthesia can increase the risk or accelerate the progression of a prodromal and asymptomatic AD condition (stages I-II) to clinically evident stage III AD. The current trend of an aging population poses a challenge for anesthesiology surgery because as the age of patients undergoing surgery increases, so does the likelihood of developing POCD.

Recent research in these fields has improved knowledge of the characteristics, epidemiology, risk factors, pathogenesis, and potential prevention strategies associated with POCD. It has improved the perspectives of future prevention and treatment.
 

Definition and Diagnostic Criteria

POCD, according to the cognitive impairment classification in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, is characterized by mild neurologic disturbance resulting from routine surgical procedures, excluding conditions such as deafness, dementia, or amnesia. The definition of POCD involves prolonged cognitive decline that can last for weeks, months, or even years. POCD may be confused with postoperative delirium, an acute and fluctuating disorder of consciousness that typically occurs within 3 days of surgery.

The diagnosis of POCD is based primarily on neurocognitive function scales. Widely used assessments include the Montreal Cognitive Assessment, the Wechsler Memory Scale, and the Mini-Mental State Examination.
 

Epidemiology

POCD is prevalent among patients undergoing cardiac or orthopedic surgery. In patients undergoing aortic-coronary bypass and cardiopulmonary bypass, 50%-70% develop POCD 1 week after surgery. In addition, 10%-30% experience long-term effects on cognitive function at 6 months after the procedure. In patients undergoing hip arthroplasty, 20%-50% exhibit POCD within 1 week of surgery, with 10%-14% still presenting it after 3 months.

Risk Factors

Age

POCD is typically observed in patients older than 65 years. However, after surgery, around 30% of younger patients and about 40% of older patients develop POCD at the time of hospital discharge. Specifically, 12.7% of older patients continue to have POCD 3 months after surgery, compared with 5% of younger patients.

Type of Surgery 

Hip and knee arthroplasty procedures entail a higher risk for POCD than general surgery. The same is true of cardiac surgery, especially aortic-coronary bypass and cardiopulmonary bypass.

Types of Anesthesia 

Initial assessments of postoperative cognitive function in cardiac surgery did not provide significant correlations between observed changes and the type of anesthesia because of the high number of confounding factors involved. A more recent meta-analysis of 28 randomized clinical trials concluded that the incidence of POCD is lower in surgeries using intravenous anesthesia with propofol than in those using inhalation anesthesia with isoflurane or sevoflurane.

Pain

Postoperative pain is a common issue, mainly resulting from substantial surgical trauma or potential wound infection. Patient-controlled postoperative analgesia independently increases the risk for POCD, compared with oral postoperative analgesia. Meta-analyses indicate that persistent pain can lead to a decline in patients’ cognitive abilities, attention, memory, and information processing.

Evolving Scenarios

Current research on POCD has deepened our understanding of its pathogenesis, implicating factors such as central nervous system inflammation, neuronal apoptosis, synaptic plasticity damage, abnormal tau protein modification, chronic pain, and mitochondrial metabolic disorders. Several neuroprotective drugs are currently under study, but none have shown consistent benefits for the prevention and treatment of POCD. The available evidence on the subject does not unambiguously guide the practicing physician. But neither does it exclude the importance of a careful assessment of POCD risk factors and the cognitive status of an older patient before surgery to provide useful information to the patient, family, and doctors when deciding on appropriate and shared procedures.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The likelihood of receiving a dementia diagnosis in older adults varies significantly by region across the United States, a new study suggests. Rates ranged from 1.7% to 5.4%, with variations more pronounced in those aged 66-74 years and Black or Hispanic individuals.

METHODOLOGY:

• Researchers analyzed newly diagnosed cases of Alzheimer’s disease and related dementias (ADRD) using the 2018-2019 Medicare claims data for 4.8 million older adults across 306 hospital referral regions (HRRs).
• Participants were categorized by age and race or ethnicity to examine variations in diagnosis rates.
• Regional characteristics such as education level and prevalence of obesity, smoking, and diabetes were included to adjust for population risk factors.
• ADRD-specific diagnostic intensity was calculated as the ratio of the observed-to-expected new cases of ADRD in each HRR.

TAKEAWAY:

• Unadjusted analysis for that overall, 3% of older adults received a new ADRD diagnosis in 2019, with rates ranging from 1.7 to 5.4 per 100 individuals across HRRs and varied by age category.
• Regions in the South had the highest unadjusted ADRD case concentration, and the areas in the West/Northwest had the lowest.
• The ADRD-specific diagnosis intensity was 0.69-1.47 and varied the most in Black and Hispanic individuals and those aged 66-74 years.
• Regional differences in ADRD diagnosis rates are not fully explained by population risk factors, indicating potential health system-level differences.

IN PRACTICE:

“From place to place, the likelihood of getting your dementia diagnosed varies, and that may happen because of everything from practice norms for healthcare providers to individual patients’ knowledge and care-seeking behavior. These findings go beyond demographic and population-level differences in risk and indicate that there are health system-level differences that could be targeted and remediated,” lead author Julie P.W. Bynum, MD, MPH, said in a press release.

SOURCE:

The study was led by Dr. Bynum, professor of internal medicine, University of Michigan Medical School, Ann Arbor, Michigan, and published online in Alzheimer’s & Dementia.

LIMITATIONS:

The results may not be generalizable to other groups. The observational design of the study cannot completely negate residual confounding. The measures of population risks are coarser than those used in well-characterized epidemiologic studies, leading to potential imprecision. Finally, the study was not designed to determine whether regional differences in the likelihood of ADRD diagnosis resulted in differences in the population health outcomes.

DISCLOSURES:

The study was supported by a grant from the National Institute on Aging. The authors reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The likelihood of receiving a dementia diagnosis in older adults varies significantly by region across the United States, a new study suggests. Rates ranged from 1.7% to 5.4%, with variations more pronounced in those aged 66-74 years and Black or Hispanic individuals.

METHODOLOGY:

• Researchers analyzed newly diagnosed cases of Alzheimer’s disease and related dementias (ADRD) using the 2018-2019 Medicare claims data for 4.8 million older adults across 306 hospital referral regions (HRRs).
• Participants were categorized by age and race or ethnicity to examine variations in diagnosis rates.
• Regional characteristics such as education level and prevalence of obesity, smoking, and diabetes were included to adjust for population risk factors.
• ADRD-specific diagnostic intensity was calculated as the ratio of the observed-to-expected new cases of ADRD in each HRR.

TAKEAWAY:

• Unadjusted analysis for that overall, 3% of older adults received a new ADRD diagnosis in 2019, with rates ranging from 1.7 to 5.4 per 100 individuals across HRRs and varied by age category.
• Regions in the South had the highest unadjusted ADRD case concentration, and the areas in the West/Northwest had the lowest.
• The ADRD-specific diagnosis intensity was 0.69-1.47 and varied the most in Black and Hispanic individuals and those aged 66-74 years.
• Regional differences in ADRD diagnosis rates are not fully explained by population risk factors, indicating potential health system-level differences.

IN PRACTICE:

“From place to place, the likelihood of getting your dementia diagnosed varies, and that may happen because of everything from practice norms for healthcare providers to individual patients’ knowledge and care-seeking behavior. These findings go beyond demographic and population-level differences in risk and indicate that there are health system-level differences that could be targeted and remediated,” lead author Julie P.W. Bynum, MD, MPH, said in a press release.

SOURCE:

The study was led by Dr. Bynum, professor of internal medicine, University of Michigan Medical School, Ann Arbor, Michigan, and published online in Alzheimer’s & Dementia.

LIMITATIONS:

The results may not be generalizable to other groups. The observational design of the study cannot completely negate residual confounding. The measures of population risks are coarser than those used in well-characterized epidemiologic studies, leading to potential imprecision. Finally, the study was not designed to determine whether regional differences in the likelihood of ADRD diagnosis resulted in differences in the population health outcomes.

DISCLOSURES:

The study was supported by a grant from the National Institute on Aging. The authors reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The likelihood of receiving a dementia diagnosis in older adults varies significantly by region across the United States, a new study suggests. Rates ranged from 1.7% to 5.4%, with variations more pronounced in those aged 66-74 years and Black or Hispanic individuals.

METHODOLOGY:

• Researchers analyzed newly diagnosed cases of Alzheimer’s disease and related dementias (ADRD) using the 2018-2019 Medicare claims data for 4.8 million older adults across 306 hospital referral regions (HRRs).
• Participants were categorized by age and race or ethnicity to examine variations in diagnosis rates.
• Regional characteristics such as education level and prevalence of obesity, smoking, and diabetes were included to adjust for population risk factors.
• ADRD-specific diagnostic intensity was calculated as the ratio of the observed-to-expected new cases of ADRD in each HRR.

TAKEAWAY:

• Unadjusted analysis for that overall, 3% of older adults received a new ADRD diagnosis in 2019, with rates ranging from 1.7 to 5.4 per 100 individuals across HRRs and varied by age category.
• Regions in the South had the highest unadjusted ADRD case concentration, and the areas in the West/Northwest had the lowest.
• The ADRD-specific diagnosis intensity was 0.69-1.47 and varied the most in Black and Hispanic individuals and those aged 66-74 years.
• Regional differences in ADRD diagnosis rates are not fully explained by population risk factors, indicating potential health system-level differences.

IN PRACTICE:

“From place to place, the likelihood of getting your dementia diagnosed varies, and that may happen because of everything from practice norms for healthcare providers to individual patients’ knowledge and care-seeking behavior. These findings go beyond demographic and population-level differences in risk and indicate that there are health system-level differences that could be targeted and remediated,” lead author Julie P.W. Bynum, MD, MPH, said in a press release.

SOURCE:

The study was led by Dr. Bynum, professor of internal medicine, University of Michigan Medical School, Ann Arbor, Michigan, and published online in Alzheimer’s & Dementia.

LIMITATIONS:

The results may not be generalizable to other groups. The observational design of the study cannot completely negate residual confounding. The measures of population risks are coarser than those used in well-characterized epidemiologic studies, leading to potential imprecision. Finally, the study was not designed to determine whether regional differences in the likelihood of ADRD diagnosis resulted in differences in the population health outcomes.

DISCLOSURES:

The study was supported by a grant from the National Institute on Aging. The authors reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A history of migraine is not associated with an elevated risk for Parkinson’s disease (PD) in women, regardless of headache frequency or migraine subtype, a new study suggests.

METHODOLOGY:

• Researchers analyzed data on 39,312 women health professionals aged ≥ 45 years and having no history of PD who enrolled in the Women’s Health Study between 1992 and 1995 and were followed until 2021.
• At baseline, 7321 women (18.6%) had migraine.
• The mean follow-up duration was 22 years.
• The primary outcome was a self-reported, physician-confirmed diagnosis of PD.

TAKEAWAY:

• During the study period, 685 women self-reported a diagnosis of PD.
• Of these, 18.7% of reported cases were in women with any migraine and 81.3% in women without migraine.
• No significant association was found between PD risk and a history of migraine, migraine subtypes (with or without aura), or migraine frequency.
• Migraine was not associated with a higher risk for PD than that of nonmigraine headaches.

IN PRACTICE:

“These results are reassuring for women who have migraine, which itself causes many burdens, that they don’t have to worry about an increased risk of Parkinson’s disease in the future,” study author Tobias Kurth, Charité - Universitätsmedizin Berlin, Germany, said in a press release.

SOURCE:

The study was led by Ricarda S. Schulz, MSc, Charité - Universitätsmedizin Berlin. It was published online in Neurology.

LIMITATIONS:

The study’s findings may not be generalizable to other populations, such as men and non-White individuals. The self-reported data on migraine and PD may be subject to inaccuracies. PD is often not diagnosed until symptoms have reached an advanced stage, potentially leading to cases being underreported. Changes in the status and frequency of migraine over the study period were not accounted for, which may have affected the results.

DISCLOSURES:

The authors did not disclose any specific funding for this work. The Women’s Health Study was supported by the National Cancer Institute and National Heart, Lung, and Blood Institute. Two authors reported having financial ties outside this work. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A history of migraine is not associated with an elevated risk for Parkinson’s disease (PD) in women, regardless of headache frequency or migraine subtype, a new study suggests.

METHODOLOGY:

• Researchers analyzed data on 39,312 women health professionals aged ≥ 45 years and having no history of PD who enrolled in the Women’s Health Study between 1992 and 1995 and were followed until 2021.
• At baseline, 7321 women (18.6%) had migraine.
• The mean follow-up duration was 22 years.
• The primary outcome was a self-reported, physician-confirmed diagnosis of PD.

TAKEAWAY:

• During the study period, 685 women self-reported a diagnosis of PD.
• Of these, 18.7% of reported cases were in women with any migraine and 81.3% in women without migraine.
• No significant association was found between PD risk and a history of migraine, migraine subtypes (with or without aura), or migraine frequency.
• Migraine was not associated with a higher risk for PD than that of nonmigraine headaches.

IN PRACTICE:

“These results are reassuring for women who have migraine, which itself causes many burdens, that they don’t have to worry about an increased risk of Parkinson’s disease in the future,” study author Tobias Kurth, Charité - Universitätsmedizin Berlin, Germany, said in a press release.

SOURCE:

The study was led by Ricarda S. Schulz, MSc, Charité - Universitätsmedizin Berlin. It was published online in Neurology.

LIMITATIONS:

The study’s findings may not be generalizable to other populations, such as men and non-White individuals. The self-reported data on migraine and PD may be subject to inaccuracies. PD is often not diagnosed until symptoms have reached an advanced stage, potentially leading to cases being underreported. Changes in the status and frequency of migraine over the study period were not accounted for, which may have affected the results.

DISCLOSURES:

The authors did not disclose any specific funding for this work. The Women’s Health Study was supported by the National Cancer Institute and National Heart, Lung, and Blood Institute. Two authors reported having financial ties outside this work. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A history of migraine is not associated with an elevated risk for Parkinson’s disease (PD) in women, regardless of headache frequency or migraine subtype, a new study suggests.

METHODOLOGY:

• Researchers analyzed data on 39,312 women health professionals aged ≥ 45 years and having no history of PD who enrolled in the Women’s Health Study between 1992 and 1995 and were followed until 2021.
• At baseline, 7321 women (18.6%) had migraine.
• The mean follow-up duration was 22 years.
• The primary outcome was a self-reported, physician-confirmed diagnosis of PD.

TAKEAWAY:

• During the study period, 685 women self-reported a diagnosis of PD.
• Of these, 18.7% of reported cases were in women with any migraine and 81.3% in women without migraine.
• No significant association was found between PD risk and a history of migraine, migraine subtypes (with or without aura), or migraine frequency.
• Migraine was not associated with a higher risk for PD than that of nonmigraine headaches.

IN PRACTICE:

“These results are reassuring for women who have migraine, which itself causes many burdens, that they don’t have to worry about an increased risk of Parkinson’s disease in the future,” study author Tobias Kurth, Charité - Universitätsmedizin Berlin, Germany, said in a press release.

SOURCE:

The study was led by Ricarda S. Schulz, MSc, Charité - Universitätsmedizin Berlin. It was published online in Neurology.

LIMITATIONS:

The study’s findings may not be generalizable to other populations, such as men and non-White individuals. The self-reported data on migraine and PD may be subject to inaccuracies. PD is often not diagnosed until symptoms have reached an advanced stage, potentially leading to cases being underreported. Changes in the status and frequency of migraine over the study period were not accounted for, which may have affected the results.

DISCLOSURES:

The authors did not disclose any specific funding for this work. The Women’s Health Study was supported by the National Cancer Institute and National Heart, Lung, and Blood Institute. Two authors reported having financial ties outside this work. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.