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Migraine: Anti-CGRP mAbs beneficial in partial and nonresponders to onabotulinumtoxinA

Article Type
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Fri, 04/16/2021 - 11:15

Key clinical point: Patients with migraine respond to preventive treatment with monoclonal antibodies targeting calcitonin gene-related peptide (anti-CGRP mAbs) irrespective of their previous failure or partial response to onabotulinumtoxinA.

Major finding: A response of 50% or higher improvement in headache (P = .395) or migraine (P = .408) frequency was not significantly different in partial or complete nonresponders to onabotulinumtoxinA.

Study details: This was a real-world prospective observational study including 155 patients with migraine who initiated preventive treatment with anti-CGRP mAbs and were partial or nonresponders to onabotulinumtoxinA.

Disclosures: The authors declared receiving no financial support for the research, authorship, and/or publication of this article. The authors report no conflicts of interest in relation with this article.

Source: Alpuente A et al. Eur J Neurol. 2021 Mar 17. doi: 10.1111/ene.14828.

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Key clinical point: Patients with migraine respond to preventive treatment with monoclonal antibodies targeting calcitonin gene-related peptide (anti-CGRP mAbs) irrespective of their previous failure or partial response to onabotulinumtoxinA.

Major finding: A response of 50% or higher improvement in headache (P = .395) or migraine (P = .408) frequency was not significantly different in partial or complete nonresponders to onabotulinumtoxinA.

Study details: This was a real-world prospective observational study including 155 patients with migraine who initiated preventive treatment with anti-CGRP mAbs and were partial or nonresponders to onabotulinumtoxinA.

Disclosures: The authors declared receiving no financial support for the research, authorship, and/or publication of this article. The authors report no conflicts of interest in relation with this article.

Source: Alpuente A et al. Eur J Neurol. 2021 Mar 17. doi: 10.1111/ene.14828.

Key clinical point: Patients with migraine respond to preventive treatment with monoclonal antibodies targeting calcitonin gene-related peptide (anti-CGRP mAbs) irrespective of their previous failure or partial response to onabotulinumtoxinA.

Major finding: A response of 50% or higher improvement in headache (P = .395) or migraine (P = .408) frequency was not significantly different in partial or complete nonresponders to onabotulinumtoxinA.

Study details: This was a real-world prospective observational study including 155 patients with migraine who initiated preventive treatment with anti-CGRP mAbs and were partial or nonresponders to onabotulinumtoxinA.

Disclosures: The authors declared receiving no financial support for the research, authorship, and/or publication of this article. The authors report no conflicts of interest in relation with this article.

Source: Alpuente A et al. Eur J Neurol. 2021 Mar 17. doi: 10.1111/ene.14828.

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Ubrogepant safety and efficacy not affected by triptan therapy

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Changed
Thu, 12/15/2022 - 15:41

Previous and concomitant triptan therapy bears no effect on ubrogepant efficacy and tolerability, according to a study published in Headache.

Dr. Andrew Blumenfeld

“The goal is to get migraine attacks under control as quickly as you can with as few adverse events as possible,” said lead author Andrew Blumenfeld, MD, director of the Headache Center of Southern California in Carlsbad, California. “Ubrogepant is very efficacious and well tolerated because it has few adverse events.”

Migraine disorder is the third most prevalent disease, and at least one person living in 25% of all U.S. households has the condition.

Clinicians have a wide range of medications at their disposal to treat migraines. These drug classes include triptans, ditans, NSAIDs, dihydroergotamine, and combination analgesics. Although numerous pharmacologic options are available to manage this patient population, an estimated 95% of patients who take oral medications to alleviate their migraine symptoms still fail to achieve relief with at least one acute episode.

Triptans remain a common option and first-line choice for acute migraine relief, but poor tolerability, among other factors, continue to limit their effectiveness. Moreover, their vasoconstrictive properties preclude their use in specific patient populations, such as those who have hypertension, peripheral vascular disease, and cerebral vascular accident. These circumstances, combined with other unmet clinical needs in migraine, have prompted researchers to explore new options, including a newer class of drugs – CGRP receptor antagonists. An endogenous protein, CGRP, has inflammatory and pronociceptive properties that play an active role in contributing to migraine pathogenesis.
 

Efficacy analyzed by triptan response

To investigate the effects of anti-CGRP treatment in patients with migraine who have a previous history of triptan use, researchers conducted two phase 3, randomized, double-blind, multicenter, single-attack trials, known as ACHIEVE I and ACHIEVE II.

Trial participants ranged in age from 18 to 75 years with a documented history of migraines with or without aura. In ACHIEVE I, investigators randomized 1,327 participants 1:1:1 to receive placebo, ubrogepant 50 mg, or ubrogepant 100 mg and placebo. Randomized patients in ACHIEVE II (n = 1,355) received placebo, ubrogepant 25 mg, or ubrogepant 50 mg to treat a single episode. During the screening process, researchers further placed patients in one of three groups based on their previous triptan use – triptan responder, triptan-insufficient responder, and triptan naive. Patients were further randomized based on their previous experience with triptans and whether they currently used them for migraine prevention. Patients participating in the study had up to 60 days to treat one qualifying migraine of moderate or severe nature at home.

The studies had two primary endpoints. The first was freedom from pain at the 2-hour mark following the initial dose, defined as decreased headache severity from moderate or severe at baseline to no pain. The other primary endpoint was the absence of most bothersome migraine-associated symptom (MBS) – photophobia, phonophobia, or nausea – 2 hours after the initial ubrogepant dose.

The pooled analysis collated data from 1,799 patients in both studies (placebo, n = 912; ubrogepant 50 mg, n = 887). Patients fell into the following categories: 682 triptan responders (placebo, n = 350; ubrogepant, n = 332); 451 triptan-insufficient responders (placebo, n = 223; ubrogepant, n = 228), and 666 triptan naive (placebo, n = 339; ubrogepant, n = 337).

Based on the data, approximately 25% of the patients enrolled in the study fell into the triptan-insufficient category. Of this subpopulation, about 80% of the patients in each treatment group experienced insufficient efficacy when using triptans. In each treatment group of insufficient responders, approximately 17% of patients cited tolerability issues, and 3% had contraindications that precluded them from triptan therapy.

The incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs did not differ appreciably across historical triptan experience subgroups. The highest percentage of participants experiencing a treatment-related TEAE in the pooled ubrogepant 50-mg treatment group was found in the triptan-insufficient responders (10.4%), whereas the highest percentage in the placebo group was found in the triptan-naive subgroup (9.7%). No serious AEs (SAEs) were reported in any subgroup.

The researchers concluded that “ubrogepant efficacy and tolerability did not differ for the acute treatment of migraine in participants classified as triptan responders, triptan-insufficient responders, and triptan naive based on their historical experience with triptans.”
 

 

 

Payers limit use

Despite the promising data, payer hurdles limit ubrogepant’s use, said Stewart Tepper, MD, who was asked to comment on the study. Dr. Tepper, a professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H., was not involved in the study. “The study shows that ubrogepant will work as well as those who have not responded well to triptans, which is key,” Dr. Tepper said. “However, payers have set up step edits in which patients aren’t allowed to get ubrogepant unless they fail therapy with at least two triptans.”

Dr. Blumenfeld discounts the rationale behind requiring patients to try a second triptan after failing initial triptan therapy. “There are plenty of studies showing that if you fail one triptan, you’re likely to fail another,” he said. “Why would you put the patient on a different triptan when you could switch them to another drug with a different mechanism of action?”

The results showed that more patients in the ubrogepant 50-mg arm achieved pain freedom than those in the placebo arm within 2 hours after the initial dose in each group.

“Migraine is a very disabling condition, so you want to get the attack under control as quickly as possible while limiting the risk for potential side effects,” said Dr. Blumenfeld. “Ubrogepant is very efficacious and with very few adverse effects, but its use is limited because insurance companies require the failure of several triptans.”

One limitation of the study is that it is a subanalysis.

Dr. Blumenfeld has disclosed advisory board service, consulting, speaking, and authorship for AbbVie, Alder, Amgen, Biohaven, Lilly, Novartis, Teva, Theranica, and Zoscano.

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Previous and concomitant triptan therapy bears no effect on ubrogepant efficacy and tolerability, according to a study published in Headache.

Dr. Andrew Blumenfeld

“The goal is to get migraine attacks under control as quickly as you can with as few adverse events as possible,” said lead author Andrew Blumenfeld, MD, director of the Headache Center of Southern California in Carlsbad, California. “Ubrogepant is very efficacious and well tolerated because it has few adverse events.”

Migraine disorder is the third most prevalent disease, and at least one person living in 25% of all U.S. households has the condition.

Clinicians have a wide range of medications at their disposal to treat migraines. These drug classes include triptans, ditans, NSAIDs, dihydroergotamine, and combination analgesics. Although numerous pharmacologic options are available to manage this patient population, an estimated 95% of patients who take oral medications to alleviate their migraine symptoms still fail to achieve relief with at least one acute episode.

Triptans remain a common option and first-line choice for acute migraine relief, but poor tolerability, among other factors, continue to limit their effectiveness. Moreover, their vasoconstrictive properties preclude their use in specific patient populations, such as those who have hypertension, peripheral vascular disease, and cerebral vascular accident. These circumstances, combined with other unmet clinical needs in migraine, have prompted researchers to explore new options, including a newer class of drugs – CGRP receptor antagonists. An endogenous protein, CGRP, has inflammatory and pronociceptive properties that play an active role in contributing to migraine pathogenesis.
 

Efficacy analyzed by triptan response

To investigate the effects of anti-CGRP treatment in patients with migraine who have a previous history of triptan use, researchers conducted two phase 3, randomized, double-blind, multicenter, single-attack trials, known as ACHIEVE I and ACHIEVE II.

Trial participants ranged in age from 18 to 75 years with a documented history of migraines with or without aura. In ACHIEVE I, investigators randomized 1,327 participants 1:1:1 to receive placebo, ubrogepant 50 mg, or ubrogepant 100 mg and placebo. Randomized patients in ACHIEVE II (n = 1,355) received placebo, ubrogepant 25 mg, or ubrogepant 50 mg to treat a single episode. During the screening process, researchers further placed patients in one of three groups based on their previous triptan use – triptan responder, triptan-insufficient responder, and triptan naive. Patients were further randomized based on their previous experience with triptans and whether they currently used them for migraine prevention. Patients participating in the study had up to 60 days to treat one qualifying migraine of moderate or severe nature at home.

The studies had two primary endpoints. The first was freedom from pain at the 2-hour mark following the initial dose, defined as decreased headache severity from moderate or severe at baseline to no pain. The other primary endpoint was the absence of most bothersome migraine-associated symptom (MBS) – photophobia, phonophobia, or nausea – 2 hours after the initial ubrogepant dose.

The pooled analysis collated data from 1,799 patients in both studies (placebo, n = 912; ubrogepant 50 mg, n = 887). Patients fell into the following categories: 682 triptan responders (placebo, n = 350; ubrogepant, n = 332); 451 triptan-insufficient responders (placebo, n = 223; ubrogepant, n = 228), and 666 triptan naive (placebo, n = 339; ubrogepant, n = 337).

Based on the data, approximately 25% of the patients enrolled in the study fell into the triptan-insufficient category. Of this subpopulation, about 80% of the patients in each treatment group experienced insufficient efficacy when using triptans. In each treatment group of insufficient responders, approximately 17% of patients cited tolerability issues, and 3% had contraindications that precluded them from triptan therapy.

The incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs did not differ appreciably across historical triptan experience subgroups. The highest percentage of participants experiencing a treatment-related TEAE in the pooled ubrogepant 50-mg treatment group was found in the triptan-insufficient responders (10.4%), whereas the highest percentage in the placebo group was found in the triptan-naive subgroup (9.7%). No serious AEs (SAEs) were reported in any subgroup.

The researchers concluded that “ubrogepant efficacy and tolerability did not differ for the acute treatment of migraine in participants classified as triptan responders, triptan-insufficient responders, and triptan naive based on their historical experience with triptans.”
 

 

 

Payers limit use

Despite the promising data, payer hurdles limit ubrogepant’s use, said Stewart Tepper, MD, who was asked to comment on the study. Dr. Tepper, a professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H., was not involved in the study. “The study shows that ubrogepant will work as well as those who have not responded well to triptans, which is key,” Dr. Tepper said. “However, payers have set up step edits in which patients aren’t allowed to get ubrogepant unless they fail therapy with at least two triptans.”

Dr. Blumenfeld discounts the rationale behind requiring patients to try a second triptan after failing initial triptan therapy. “There are plenty of studies showing that if you fail one triptan, you’re likely to fail another,” he said. “Why would you put the patient on a different triptan when you could switch them to another drug with a different mechanism of action?”

The results showed that more patients in the ubrogepant 50-mg arm achieved pain freedom than those in the placebo arm within 2 hours after the initial dose in each group.

“Migraine is a very disabling condition, so you want to get the attack under control as quickly as possible while limiting the risk for potential side effects,” said Dr. Blumenfeld. “Ubrogepant is very efficacious and with very few adverse effects, but its use is limited because insurance companies require the failure of several triptans.”

One limitation of the study is that it is a subanalysis.

Dr. Blumenfeld has disclosed advisory board service, consulting, speaking, and authorship for AbbVie, Alder, Amgen, Biohaven, Lilly, Novartis, Teva, Theranica, and Zoscano.

Previous and concomitant triptan therapy bears no effect on ubrogepant efficacy and tolerability, according to a study published in Headache.

Dr. Andrew Blumenfeld

“The goal is to get migraine attacks under control as quickly as you can with as few adverse events as possible,” said lead author Andrew Blumenfeld, MD, director of the Headache Center of Southern California in Carlsbad, California. “Ubrogepant is very efficacious and well tolerated because it has few adverse events.”

Migraine disorder is the third most prevalent disease, and at least one person living in 25% of all U.S. households has the condition.

Clinicians have a wide range of medications at their disposal to treat migraines. These drug classes include triptans, ditans, NSAIDs, dihydroergotamine, and combination analgesics. Although numerous pharmacologic options are available to manage this patient population, an estimated 95% of patients who take oral medications to alleviate their migraine symptoms still fail to achieve relief with at least one acute episode.

Triptans remain a common option and first-line choice for acute migraine relief, but poor tolerability, among other factors, continue to limit their effectiveness. Moreover, their vasoconstrictive properties preclude their use in specific patient populations, such as those who have hypertension, peripheral vascular disease, and cerebral vascular accident. These circumstances, combined with other unmet clinical needs in migraine, have prompted researchers to explore new options, including a newer class of drugs – CGRP receptor antagonists. An endogenous protein, CGRP, has inflammatory and pronociceptive properties that play an active role in contributing to migraine pathogenesis.
 

Efficacy analyzed by triptan response

To investigate the effects of anti-CGRP treatment in patients with migraine who have a previous history of triptan use, researchers conducted two phase 3, randomized, double-blind, multicenter, single-attack trials, known as ACHIEVE I and ACHIEVE II.

Trial participants ranged in age from 18 to 75 years with a documented history of migraines with or without aura. In ACHIEVE I, investigators randomized 1,327 participants 1:1:1 to receive placebo, ubrogepant 50 mg, or ubrogepant 100 mg and placebo. Randomized patients in ACHIEVE II (n = 1,355) received placebo, ubrogepant 25 mg, or ubrogepant 50 mg to treat a single episode. During the screening process, researchers further placed patients in one of three groups based on their previous triptan use – triptan responder, triptan-insufficient responder, and triptan naive. Patients were further randomized based on their previous experience with triptans and whether they currently used them for migraine prevention. Patients participating in the study had up to 60 days to treat one qualifying migraine of moderate or severe nature at home.

The studies had two primary endpoints. The first was freedom from pain at the 2-hour mark following the initial dose, defined as decreased headache severity from moderate or severe at baseline to no pain. The other primary endpoint was the absence of most bothersome migraine-associated symptom (MBS) – photophobia, phonophobia, or nausea – 2 hours after the initial ubrogepant dose.

The pooled analysis collated data from 1,799 patients in both studies (placebo, n = 912; ubrogepant 50 mg, n = 887). Patients fell into the following categories: 682 triptan responders (placebo, n = 350; ubrogepant, n = 332); 451 triptan-insufficient responders (placebo, n = 223; ubrogepant, n = 228), and 666 triptan naive (placebo, n = 339; ubrogepant, n = 337).

Based on the data, approximately 25% of the patients enrolled in the study fell into the triptan-insufficient category. Of this subpopulation, about 80% of the patients in each treatment group experienced insufficient efficacy when using triptans. In each treatment group of insufficient responders, approximately 17% of patients cited tolerability issues, and 3% had contraindications that precluded them from triptan therapy.

The incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs did not differ appreciably across historical triptan experience subgroups. The highest percentage of participants experiencing a treatment-related TEAE in the pooled ubrogepant 50-mg treatment group was found in the triptan-insufficient responders (10.4%), whereas the highest percentage in the placebo group was found in the triptan-naive subgroup (9.7%). No serious AEs (SAEs) were reported in any subgroup.

The researchers concluded that “ubrogepant efficacy and tolerability did not differ for the acute treatment of migraine in participants classified as triptan responders, triptan-insufficient responders, and triptan naive based on their historical experience with triptans.”
 

 

 

Payers limit use

Despite the promising data, payer hurdles limit ubrogepant’s use, said Stewart Tepper, MD, who was asked to comment on the study. Dr. Tepper, a professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H., was not involved in the study. “The study shows that ubrogepant will work as well as those who have not responded well to triptans, which is key,” Dr. Tepper said. “However, payers have set up step edits in which patients aren’t allowed to get ubrogepant unless they fail therapy with at least two triptans.”

Dr. Blumenfeld discounts the rationale behind requiring patients to try a second triptan after failing initial triptan therapy. “There are plenty of studies showing that if you fail one triptan, you’re likely to fail another,” he said. “Why would you put the patient on a different triptan when you could switch them to another drug with a different mechanism of action?”

The results showed that more patients in the ubrogepant 50-mg arm achieved pain freedom than those in the placebo arm within 2 hours after the initial dose in each group.

“Migraine is a very disabling condition, so you want to get the attack under control as quickly as possible while limiting the risk for potential side effects,” said Dr. Blumenfeld. “Ubrogepant is very efficacious and with very few adverse effects, but its use is limited because insurance companies require the failure of several triptans.”

One limitation of the study is that it is a subanalysis.

Dr. Blumenfeld has disclosed advisory board service, consulting, speaking, and authorship for AbbVie, Alder, Amgen, Biohaven, Lilly, Novartis, Teva, Theranica, and Zoscano.

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Green light puts the stop on migraine

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Patients with migraine experienced about a 60% reduction in pain intensity and number of headache days per month after exposure to green light therapy, according to results of a small study from the University of Arizona, Tucson.

“This is the first clinical study to evaluate green light exposure as a potential preventive therapy for patients with migraine, “ senior author Mohab M. Ibrahim, MD, PhD, said in a press release. “Now I have another tool in my toolbox to treat one of the most difficult neurologic conditions – migraine.”

“Given the safety, affordability, and efficacy of green light exposure, there is merit to conduct a larger study,” he and coauthors from the university wrote in their paper.

The study included 29 adult patients (average age 52.2 years), 22 with chronic migraine and the rest with episodic migraine who were recruited from the University of Arizona/Banner Medical Center chronic pain clinic. To be included, patients had to meet the International Headache Society diagnostic criteria for chronic or episodic migraine, have an average headache pain intensity of 5 out of 10 or greater on the numeric pain scale (NPS) over the 10 weeks prior to enrolling in the study, and be dissatisfied with their current migraine therapy.

The patients were free to start, continue, or discontinue any other migraine treatments as recommended by their physicians as long as this was reported to the study team.
 

White versus green

The one-way crossover design involved exposure to 10 weeks of white light emitting diodes, for 1-2 hours per day, followed by a 2-week washout period and then 10 weeks’ exposure to green light emitting diodes (GLED) for the same daily duration. The protocol involved use of a light strip emitting an intensity of between 4 and 100 lux measured at approximately 2 m and 1 m from a lux meter.

Patients were instructed to use the light in a dark room, without falling asleep, and to participate in activities that did not require external light sources, such as listening to music, reading books, doing exercises, or engaging in similar activities. The daily minimum exposure of 1 hour, up to a maximum of 2 hours, was to be completed in one sitting.

The primary outcome measure was the number of headache days per month, defined as days with moderate to severe headache pain for at least 4 hours. Secondary outcomes included perceived reduction in duration and intensity of the headache phase of the migraine episodes assessed every 2 weeks with the NPS, improved ability to fall and stay asleep, improved ability to perform work and daily activity, improved quality of life, and reduction of pain medications.

The researchers found that when the patients with chronic migraine and episodic migraine were examined as separate groups, white light exposure did not significantly reduce the number of headache days per month, but when the chronic migraine and episodic migraine groups were combined there was a significant reduction from 18.2 to 16.5 headache days per month.

On the other hand, green light did result in significantly reduced headache days both in the separate (from 7.9 to 2.4 days in the episodic migraine group and 22.3 to 9.4 days in the chronic migraine group) and combined groups (from 18.4 to 7.4 days).

“While some improvement in secondary outcomes was observed with white light emitting diodes, more secondary outcomes with significantly greater magnitude including assessments of quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects were observed with green light emitting diodes,” the authors reported.

“The use of a nonpharmacological therapy such as green light can be of tremendous help to a variety of patients that either do not want to be on medications or do not respond to them,” coauthor Amol M. Patwardhan, MD, PhD, said in the press release. “The beauty of this approach is the lack of associated side effects. If at all, it appears to improve sleep and other quality of life measures,” said Dr. Patwardhan, associate professor and vice chair of research in the University of Arizona’s department of anesthesiology.
 

Better than white light

Asked to comment on the findings, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said research has shown for some time that exposure to green light has beneficial effects in migraine patients. This study, although small, does indicate that green light is more beneficial than is white light and reduces headache days and intensity. “I believe patients would be willing to spend 1-2 hours a day in green light to reduce and improve their migraine with few side effects. A larger randomized trial should be done,” he said.

The study was funded by support from the National Center for Complementary and Integrative Health (to Dr. Ibrahim), the Comprehensive Chronic Pain and Addiction Center–University of Arizona, and the University of Arizona CHiLLI initiative. Dr. Ibrahim and one coauthor have a patent pending through the University of Arizona for use of green light therapy for the management of chronic pain. Dr. Rapoport is a former president of the International Headache Society. He is an editor of Headache and CNS Drugs, and Editor-in-Chief of Neurology Reviews. He reviews for many peer-reviewed journals such as Cephalalgia, Neurology, New England Journal of Medicine, and Headache.

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Patients with migraine experienced about a 60% reduction in pain intensity and number of headache days per month after exposure to green light therapy, according to results of a small study from the University of Arizona, Tucson.

“This is the first clinical study to evaluate green light exposure as a potential preventive therapy for patients with migraine, “ senior author Mohab M. Ibrahim, MD, PhD, said in a press release. “Now I have another tool in my toolbox to treat one of the most difficult neurologic conditions – migraine.”

“Given the safety, affordability, and efficacy of green light exposure, there is merit to conduct a larger study,” he and coauthors from the university wrote in their paper.

The study included 29 adult patients (average age 52.2 years), 22 with chronic migraine and the rest with episodic migraine who were recruited from the University of Arizona/Banner Medical Center chronic pain clinic. To be included, patients had to meet the International Headache Society diagnostic criteria for chronic or episodic migraine, have an average headache pain intensity of 5 out of 10 or greater on the numeric pain scale (NPS) over the 10 weeks prior to enrolling in the study, and be dissatisfied with their current migraine therapy.

The patients were free to start, continue, or discontinue any other migraine treatments as recommended by their physicians as long as this was reported to the study team.
 

White versus green

The one-way crossover design involved exposure to 10 weeks of white light emitting diodes, for 1-2 hours per day, followed by a 2-week washout period and then 10 weeks’ exposure to green light emitting diodes (GLED) for the same daily duration. The protocol involved use of a light strip emitting an intensity of between 4 and 100 lux measured at approximately 2 m and 1 m from a lux meter.

Patients were instructed to use the light in a dark room, without falling asleep, and to participate in activities that did not require external light sources, such as listening to music, reading books, doing exercises, or engaging in similar activities. The daily minimum exposure of 1 hour, up to a maximum of 2 hours, was to be completed in one sitting.

The primary outcome measure was the number of headache days per month, defined as days with moderate to severe headache pain for at least 4 hours. Secondary outcomes included perceived reduction in duration and intensity of the headache phase of the migraine episodes assessed every 2 weeks with the NPS, improved ability to fall and stay asleep, improved ability to perform work and daily activity, improved quality of life, and reduction of pain medications.

The researchers found that when the patients with chronic migraine and episodic migraine were examined as separate groups, white light exposure did not significantly reduce the number of headache days per month, but when the chronic migraine and episodic migraine groups were combined there was a significant reduction from 18.2 to 16.5 headache days per month.

On the other hand, green light did result in significantly reduced headache days both in the separate (from 7.9 to 2.4 days in the episodic migraine group and 22.3 to 9.4 days in the chronic migraine group) and combined groups (from 18.4 to 7.4 days).

“While some improvement in secondary outcomes was observed with white light emitting diodes, more secondary outcomes with significantly greater magnitude including assessments of quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects were observed with green light emitting diodes,” the authors reported.

“The use of a nonpharmacological therapy such as green light can be of tremendous help to a variety of patients that either do not want to be on medications or do not respond to them,” coauthor Amol M. Patwardhan, MD, PhD, said in the press release. “The beauty of this approach is the lack of associated side effects. If at all, it appears to improve sleep and other quality of life measures,” said Dr. Patwardhan, associate professor and vice chair of research in the University of Arizona’s department of anesthesiology.
 

Better than white light

Asked to comment on the findings, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said research has shown for some time that exposure to green light has beneficial effects in migraine patients. This study, although small, does indicate that green light is more beneficial than is white light and reduces headache days and intensity. “I believe patients would be willing to spend 1-2 hours a day in green light to reduce and improve their migraine with few side effects. A larger randomized trial should be done,” he said.

The study was funded by support from the National Center for Complementary and Integrative Health (to Dr. Ibrahim), the Comprehensive Chronic Pain and Addiction Center–University of Arizona, and the University of Arizona CHiLLI initiative. Dr. Ibrahim and one coauthor have a patent pending through the University of Arizona for use of green light therapy for the management of chronic pain. Dr. Rapoport is a former president of the International Headache Society. He is an editor of Headache and CNS Drugs, and Editor-in-Chief of Neurology Reviews. He reviews for many peer-reviewed journals such as Cephalalgia, Neurology, New England Journal of Medicine, and Headache.

 

Patients with migraine experienced about a 60% reduction in pain intensity and number of headache days per month after exposure to green light therapy, according to results of a small study from the University of Arizona, Tucson.

“This is the first clinical study to evaluate green light exposure as a potential preventive therapy for patients with migraine, “ senior author Mohab M. Ibrahim, MD, PhD, said in a press release. “Now I have another tool in my toolbox to treat one of the most difficult neurologic conditions – migraine.”

“Given the safety, affordability, and efficacy of green light exposure, there is merit to conduct a larger study,” he and coauthors from the university wrote in their paper.

The study included 29 adult patients (average age 52.2 years), 22 with chronic migraine and the rest with episodic migraine who were recruited from the University of Arizona/Banner Medical Center chronic pain clinic. To be included, patients had to meet the International Headache Society diagnostic criteria for chronic or episodic migraine, have an average headache pain intensity of 5 out of 10 or greater on the numeric pain scale (NPS) over the 10 weeks prior to enrolling in the study, and be dissatisfied with their current migraine therapy.

The patients were free to start, continue, or discontinue any other migraine treatments as recommended by their physicians as long as this was reported to the study team.
 

White versus green

The one-way crossover design involved exposure to 10 weeks of white light emitting diodes, for 1-2 hours per day, followed by a 2-week washout period and then 10 weeks’ exposure to green light emitting diodes (GLED) for the same daily duration. The protocol involved use of a light strip emitting an intensity of between 4 and 100 lux measured at approximately 2 m and 1 m from a lux meter.

Patients were instructed to use the light in a dark room, without falling asleep, and to participate in activities that did not require external light sources, such as listening to music, reading books, doing exercises, or engaging in similar activities. The daily minimum exposure of 1 hour, up to a maximum of 2 hours, was to be completed in one sitting.

The primary outcome measure was the number of headache days per month, defined as days with moderate to severe headache pain for at least 4 hours. Secondary outcomes included perceived reduction in duration and intensity of the headache phase of the migraine episodes assessed every 2 weeks with the NPS, improved ability to fall and stay asleep, improved ability to perform work and daily activity, improved quality of life, and reduction of pain medications.

The researchers found that when the patients with chronic migraine and episodic migraine were examined as separate groups, white light exposure did not significantly reduce the number of headache days per month, but when the chronic migraine and episodic migraine groups were combined there was a significant reduction from 18.2 to 16.5 headache days per month.

On the other hand, green light did result in significantly reduced headache days both in the separate (from 7.9 to 2.4 days in the episodic migraine group and 22.3 to 9.4 days in the chronic migraine group) and combined groups (from 18.4 to 7.4 days).

“While some improvement in secondary outcomes was observed with white light emitting diodes, more secondary outcomes with significantly greater magnitude including assessments of quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects were observed with green light emitting diodes,” the authors reported.

“The use of a nonpharmacological therapy such as green light can be of tremendous help to a variety of patients that either do not want to be on medications or do not respond to them,” coauthor Amol M. Patwardhan, MD, PhD, said in the press release. “The beauty of this approach is the lack of associated side effects. If at all, it appears to improve sleep and other quality of life measures,” said Dr. Patwardhan, associate professor and vice chair of research in the University of Arizona’s department of anesthesiology.
 

Better than white light

Asked to comment on the findings, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said research has shown for some time that exposure to green light has beneficial effects in migraine patients. This study, although small, does indicate that green light is more beneficial than is white light and reduces headache days and intensity. “I believe patients would be willing to spend 1-2 hours a day in green light to reduce and improve their migraine with few side effects. A larger randomized trial should be done,” he said.

The study was funded by support from the National Center for Complementary and Integrative Health (to Dr. Ibrahim), the Comprehensive Chronic Pain and Addiction Center–University of Arizona, and the University of Arizona CHiLLI initiative. Dr. Ibrahim and one coauthor have a patent pending through the University of Arizona for use of green light therapy for the management of chronic pain. Dr. Rapoport is a former president of the International Headache Society. He is an editor of Headache and CNS Drugs, and Editor-in-Chief of Neurology Reviews. He reviews for many peer-reviewed journals such as Cephalalgia, Neurology, New England Journal of Medicine, and Headache.

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Migraine: Women have a higher prevalence of neck pain and cutaneous allodynia

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Key clinical point: Women vs. men with migraine had a higher frequency of self-reported neck pain and higher prevalence and severity of cutaneous allodynia (CA).

Major finding: Women vs. men showed higher prevalence of self-reported neck pain (73.33% vs. 43.33%; P = .04), CA (P = .001), and 4 times higher risk of having severe CA (P = .007).

Study details: Findings are from a cross-sectional study of 30 men and 30 women with migraine.

Disclosures: The study was supported by a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo to NDS Xavier. No other conflicts of interest were reported.

Source: Xavier NDS et al. Pain Med. 2021 Mar 19. doi: 10.1093/pm/pnab106.

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Key clinical point: Women vs. men with migraine had a higher frequency of self-reported neck pain and higher prevalence and severity of cutaneous allodynia (CA).

Major finding: Women vs. men showed higher prevalence of self-reported neck pain (73.33% vs. 43.33%; P = .04), CA (P = .001), and 4 times higher risk of having severe CA (P = .007).

Study details: Findings are from a cross-sectional study of 30 men and 30 women with migraine.

Disclosures: The study was supported by a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo to NDS Xavier. No other conflicts of interest were reported.

Source: Xavier NDS et al. Pain Med. 2021 Mar 19. doi: 10.1093/pm/pnab106.

Key clinical point: Women vs. men with migraine had a higher frequency of self-reported neck pain and higher prevalence and severity of cutaneous allodynia (CA).

Major finding: Women vs. men showed higher prevalence of self-reported neck pain (73.33% vs. 43.33%; P = .04), CA (P = .001), and 4 times higher risk of having severe CA (P = .007).

Study details: Findings are from a cross-sectional study of 30 men and 30 women with migraine.

Disclosures: The study was supported by a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo to NDS Xavier. No other conflicts of interest were reported.

Source: Xavier NDS et al. Pain Med. 2021 Mar 19. doi: 10.1093/pm/pnab106.

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Patients with migraine more likely to report comorbidities and health problems

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Key clinical point: People with migraine may experience a wide range of comorbidities and co-occurring conditions, which should be managed effectively.

Major finding: Patients with vs. without migraine were 3 times more likely to experience insomnia (adjusted odds ratio [aOR], 3.79; 95% confidence interval, [95% CI], 3.6-4.0), depression (aOR, 3.18; 95% CI, 3.0-3.3), anxiety (aOR, 3.18; 95% CI, 3.0-3.3), and gastric ulcer/gastrointestinal bleeding (aOR, 3.11; 95% CI, 2.8-3.5).

Study details: Data come from the prospective, web-based Migraine in America Symptoms and Treatment survey involving adults with (n=15,133) and without migraine (n=77,453).

Disclosures: The study was funded and sponsored by Dr. Reddy’s Laboratories group of companies, Princeton, USA. The lead author along with others declared receiving grant support and/or honoraria from various sources. S Munjal and P Singh declared being employees while RB Lipton, DC Buse, ML Reed, TJ Schwedt, and DW Dodick reported being consultants at Dr. Reddy’s Laboratories.

Source: Buse DC et al. J Headache Pain. 2020 Mar 2. doi: 10.1186/s10194-020-1084-y.

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Key clinical point: People with migraine may experience a wide range of comorbidities and co-occurring conditions, which should be managed effectively.

Major finding: Patients with vs. without migraine were 3 times more likely to experience insomnia (adjusted odds ratio [aOR], 3.79; 95% confidence interval, [95% CI], 3.6-4.0), depression (aOR, 3.18; 95% CI, 3.0-3.3), anxiety (aOR, 3.18; 95% CI, 3.0-3.3), and gastric ulcer/gastrointestinal bleeding (aOR, 3.11; 95% CI, 2.8-3.5).

Study details: Data come from the prospective, web-based Migraine in America Symptoms and Treatment survey involving adults with (n=15,133) and without migraine (n=77,453).

Disclosures: The study was funded and sponsored by Dr. Reddy’s Laboratories group of companies, Princeton, USA. The lead author along with others declared receiving grant support and/or honoraria from various sources. S Munjal and P Singh declared being employees while RB Lipton, DC Buse, ML Reed, TJ Schwedt, and DW Dodick reported being consultants at Dr. Reddy’s Laboratories.

Source: Buse DC et al. J Headache Pain. 2020 Mar 2. doi: 10.1186/s10194-020-1084-y.

Key clinical point: People with migraine may experience a wide range of comorbidities and co-occurring conditions, which should be managed effectively.

Major finding: Patients with vs. without migraine were 3 times more likely to experience insomnia (adjusted odds ratio [aOR], 3.79; 95% confidence interval, [95% CI], 3.6-4.0), depression (aOR, 3.18; 95% CI, 3.0-3.3), anxiety (aOR, 3.18; 95% CI, 3.0-3.3), and gastric ulcer/gastrointestinal bleeding (aOR, 3.11; 95% CI, 2.8-3.5).

Study details: Data come from the prospective, web-based Migraine in America Symptoms and Treatment survey involving adults with (n=15,133) and without migraine (n=77,453).

Disclosures: The study was funded and sponsored by Dr. Reddy’s Laboratories group of companies, Princeton, USA. The lead author along with others declared receiving grant support and/or honoraria from various sources. S Munjal and P Singh declared being employees while RB Lipton, DC Buse, ML Reed, TJ Schwedt, and DW Dodick reported being consultants at Dr. Reddy’s Laboratories.

Source: Buse DC et al. J Headache Pain. 2020 Mar 2. doi: 10.1186/s10194-020-1084-y.

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Chronic migraine: Addition of CGRP-targeted mAb to onabot further improves headache control

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Key clinical point: Addition of a calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies (mAbs) in patients with chronic migraine (CM) receiving onabotulinumtoxinA (onabot) resulted in further reductions in monthly headache days (MHDs) without major tolerability issues.

Major finding: Patients reported an average decrease of 10.9 MHDs (P less than .001) after onabot treatment and a further decrease of 5.7 MHDs (P less than .001) after addition of CGRP-targeted mAbs resulting in a total decrease of 16.6 MHDs (P less than .001) with combined therapy. No serious adverse events were reported.

Study details: The data come from a retrospective review of 153 patients with CM receiving onabot and subsequently prescribed CGRP-targeted mAbs.

Disclosures: The study did not receive any funding. The lead author F Cohen reported no conflicts of interest. The other authors declared receiving honoraria and research support from various sources and serving as consultant and/or advisory board member for various pharmaceutical companies.

Source: Cohen F et al. Pain Med. 2021 Mar 8. doi: 10.1093/pm/pnab093.

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Key clinical point: Addition of a calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies (mAbs) in patients with chronic migraine (CM) receiving onabotulinumtoxinA (onabot) resulted in further reductions in monthly headache days (MHDs) without major tolerability issues.

Major finding: Patients reported an average decrease of 10.9 MHDs (P less than .001) after onabot treatment and a further decrease of 5.7 MHDs (P less than .001) after addition of CGRP-targeted mAbs resulting in a total decrease of 16.6 MHDs (P less than .001) with combined therapy. No serious adverse events were reported.

Study details: The data come from a retrospective review of 153 patients with CM receiving onabot and subsequently prescribed CGRP-targeted mAbs.

Disclosures: The study did not receive any funding. The lead author F Cohen reported no conflicts of interest. The other authors declared receiving honoraria and research support from various sources and serving as consultant and/or advisory board member for various pharmaceutical companies.

Source: Cohen F et al. Pain Med. 2021 Mar 8. doi: 10.1093/pm/pnab093.

Key clinical point: Addition of a calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies (mAbs) in patients with chronic migraine (CM) receiving onabotulinumtoxinA (onabot) resulted in further reductions in monthly headache days (MHDs) without major tolerability issues.

Major finding: Patients reported an average decrease of 10.9 MHDs (P less than .001) after onabot treatment and a further decrease of 5.7 MHDs (P less than .001) after addition of CGRP-targeted mAbs resulting in a total decrease of 16.6 MHDs (P less than .001) with combined therapy. No serious adverse events were reported.

Study details: The data come from a retrospective review of 153 patients with CM receiving onabot and subsequently prescribed CGRP-targeted mAbs.

Disclosures: The study did not receive any funding. The lead author F Cohen reported no conflicts of interest. The other authors declared receiving honoraria and research support from various sources and serving as consultant and/or advisory board member for various pharmaceutical companies.

Source: Cohen F et al. Pain Med. 2021 Mar 8. doi: 10.1093/pm/pnab093.

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Eptinezumab shows long-term safety and tolerability in chronic migraine

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Key clinical point: Intravenous eptinezumab demonstrated a favorable safety profile in patients with chronic migraine (CM).

Major finding: Overall, 71.1% of patients experienced 1 or more treatment-emergent adverse events (TEAEs) during the entire 2 years of study duration with majority (95.6%) being mild or moderate. TEAEs leading to drug discontinuation or withdrawal were observed in only 7.8% and 6.3% of patients, respectively. Incidence of serious TEAEs and drug-related AEs was low.

Study details: PREVAIL, an open-label phase 3 trial, included 128 adults with CM who received at least 1 dose of eptinezumab (300 mg) every 12 weeks for up to 8 doses.

Disclosures: This study was funded by H. Lundbeck A/S, Copenhagen, Denmark. D Kudrow reported receiving grant support from, being on advisory board, and/or being speaker for multiple sources. Some of the authors reported being current/former full-time employees at Lundbeck Seattle BioPharmaceuticals or Alder Biopharmaceuticals (CKA Lundbeck Seattle Biopharmaceuticals, Inc).

Source: Kudrow D et al. BMC Neurol. 2021 Mar 19. doi: 10.1186/s12883-021-02123-w.

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Key clinical point: Intravenous eptinezumab demonstrated a favorable safety profile in patients with chronic migraine (CM).

Major finding: Overall, 71.1% of patients experienced 1 or more treatment-emergent adverse events (TEAEs) during the entire 2 years of study duration with majority (95.6%) being mild or moderate. TEAEs leading to drug discontinuation or withdrawal were observed in only 7.8% and 6.3% of patients, respectively. Incidence of serious TEAEs and drug-related AEs was low.

Study details: PREVAIL, an open-label phase 3 trial, included 128 adults with CM who received at least 1 dose of eptinezumab (300 mg) every 12 weeks for up to 8 doses.

Disclosures: This study was funded by H. Lundbeck A/S, Copenhagen, Denmark. D Kudrow reported receiving grant support from, being on advisory board, and/or being speaker for multiple sources. Some of the authors reported being current/former full-time employees at Lundbeck Seattle BioPharmaceuticals or Alder Biopharmaceuticals (CKA Lundbeck Seattle Biopharmaceuticals, Inc).

Source: Kudrow D et al. BMC Neurol. 2021 Mar 19. doi: 10.1186/s12883-021-02123-w.

Key clinical point: Intravenous eptinezumab demonstrated a favorable safety profile in patients with chronic migraine (CM).

Major finding: Overall, 71.1% of patients experienced 1 or more treatment-emergent adverse events (TEAEs) during the entire 2 years of study duration with majority (95.6%) being mild or moderate. TEAEs leading to drug discontinuation or withdrawal were observed in only 7.8% and 6.3% of patients, respectively. Incidence of serious TEAEs and drug-related AEs was low.

Study details: PREVAIL, an open-label phase 3 trial, included 128 adults with CM who received at least 1 dose of eptinezumab (300 mg) every 12 weeks for up to 8 doses.

Disclosures: This study was funded by H. Lundbeck A/S, Copenhagen, Denmark. D Kudrow reported receiving grant support from, being on advisory board, and/or being speaker for multiple sources. Some of the authors reported being current/former full-time employees at Lundbeck Seattle BioPharmaceuticals or Alder Biopharmaceuticals (CKA Lundbeck Seattle Biopharmaceuticals, Inc).

Source: Kudrow D et al. BMC Neurol. 2021 Mar 19. doi: 10.1186/s12883-021-02123-w.

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Type of bariatric surgery influences likelihood of migraine remission

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Key clinical point: Over half of the patients with migraine who underwent bariatric surgery experienced migraine remission following surgery, with likelihood of remission being higher after Roux-en-Y gastric bypass (RYGB) than after vertical sleeve gastrectomy (VSG).

Major finding: Remission of migraine was observed in 55.4% of patients who underwent surgery. Likelihood of migraine remission was higher with RYGB vs. VSG (adjusted relative rate, 1.11; 95% confidence interval, 1.05-1.17).

Study details: The data come from a retrospective analysis of 1,680 patients with chronic migraine who underwent bariatric surgery (RYGB, n=742; VSG, n=938) between 2010 and 2017.

Disclosures: No source of funding was declared. The authors declared no conflicts of interest.

Source: Nudotor R et al. Obes Surg. 2021 Feb 11. doi: 10.1007/s11695-020-05204-w.

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Key clinical point: Over half of the patients with migraine who underwent bariatric surgery experienced migraine remission following surgery, with likelihood of remission being higher after Roux-en-Y gastric bypass (RYGB) than after vertical sleeve gastrectomy (VSG).

Major finding: Remission of migraine was observed in 55.4% of patients who underwent surgery. Likelihood of migraine remission was higher with RYGB vs. VSG (adjusted relative rate, 1.11; 95% confidence interval, 1.05-1.17).

Study details: The data come from a retrospective analysis of 1,680 patients with chronic migraine who underwent bariatric surgery (RYGB, n=742; VSG, n=938) between 2010 and 2017.

Disclosures: No source of funding was declared. The authors declared no conflicts of interest.

Source: Nudotor R et al. Obes Surg. 2021 Feb 11. doi: 10.1007/s11695-020-05204-w.

Key clinical point: Over half of the patients with migraine who underwent bariatric surgery experienced migraine remission following surgery, with likelihood of remission being higher after Roux-en-Y gastric bypass (RYGB) than after vertical sleeve gastrectomy (VSG).

Major finding: Remission of migraine was observed in 55.4% of patients who underwent surgery. Likelihood of migraine remission was higher with RYGB vs. VSG (adjusted relative rate, 1.11; 95% confidence interval, 1.05-1.17).

Study details: The data come from a retrospective analysis of 1,680 patients with chronic migraine who underwent bariatric surgery (RYGB, n=742; VSG, n=938) between 2010 and 2017.

Disclosures: No source of funding was declared. The authors declared no conflicts of interest.

Source: Nudotor R et al. Obes Surg. 2021 Feb 11. doi: 10.1007/s11695-020-05204-w.

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Real-world efficacy of candesartan as a preventive migraine treatment

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Key clinical point: In real-world settings, candesartan showed benefit as a preventive treatment for migraine with a 50% responder rate, similar to that observed in previous trials.

Major finding: Candesartan significantly reduced the number of headache days per month compared with baseline at weeks 8-12 (−4.3 days) and 20-24 (−4.7 days; both P less than .001). By weeks 8-12 and 20-24, 50% response was observed in 32.5% and 31.7% of patients, respectively. Common adverse events were light-headedness (5.0%), hypotension (4.2%), sleepiness (0.8%), and asthenia (0.8%).

Study details: The data come from a retrospective cohort study of 120 patients with chronic or episodic migraine who received candesartan between April 2008 and February 2019.

Disclosures: The study was a dissertation project supported by Junta de Castilla y León (Spain) and the European Social Fund. The authors declared no conflicts of interest.

Source: Sánchez-Rodríguez C et al. Sci Rep. 2021 Feb 15. doi: 10.1038/s41598-021-83508-2.

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Key clinical point: In real-world settings, candesartan showed benefit as a preventive treatment for migraine with a 50% responder rate, similar to that observed in previous trials.

Major finding: Candesartan significantly reduced the number of headache days per month compared with baseline at weeks 8-12 (−4.3 days) and 20-24 (−4.7 days; both P less than .001). By weeks 8-12 and 20-24, 50% response was observed in 32.5% and 31.7% of patients, respectively. Common adverse events were light-headedness (5.0%), hypotension (4.2%), sleepiness (0.8%), and asthenia (0.8%).

Study details: The data come from a retrospective cohort study of 120 patients with chronic or episodic migraine who received candesartan between April 2008 and February 2019.

Disclosures: The study was a dissertation project supported by Junta de Castilla y León (Spain) and the European Social Fund. The authors declared no conflicts of interest.

Source: Sánchez-Rodríguez C et al. Sci Rep. 2021 Feb 15. doi: 10.1038/s41598-021-83508-2.

Key clinical point: In real-world settings, candesartan showed benefit as a preventive treatment for migraine with a 50% responder rate, similar to that observed in previous trials.

Major finding: Candesartan significantly reduced the number of headache days per month compared with baseline at weeks 8-12 (−4.3 days) and 20-24 (−4.7 days; both P less than .001). By weeks 8-12 and 20-24, 50% response was observed in 32.5% and 31.7% of patients, respectively. Common adverse events were light-headedness (5.0%), hypotension (4.2%), sleepiness (0.8%), and asthenia (0.8%).

Study details: The data come from a retrospective cohort study of 120 patients with chronic or episodic migraine who received candesartan between April 2008 and February 2019.

Disclosures: The study was a dissertation project supported by Junta de Castilla y León (Spain) and the European Social Fund. The authors declared no conflicts of interest.

Source: Sánchez-Rodríguez C et al. Sci Rep. 2021 Feb 15. doi: 10.1038/s41598-021-83508-2.

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Cutaneous allodynia prevalence comparable in patients with migraine and probable migraine

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Key clinical point: The prevalence of cutaneous allodynia (CA) was comparable among patients with probable migraine (PM) and migraine. Anxiety, depression, and headache frequency/intensity were significant factors for CA in PM.

Major finding: Participants with PM (n=289) and migraine (n=125) showed a similar prevalence of CA (14.5% vs. 16.0%; P = .701). The factors significantly associated with CA in PM were moderate (adjusted odds ratio [aOR], 2.4; 95% confidence interval [CI], 1.1-5.4) and severe (aOR, 4.0; 95% CI, 1.1-13.9) headache intensity, anxiety (aOR, 5.2; 95% CI, 1.7-16.3), and depression (aOR, 3.3; 95% CI, 1.5-7.6).

Study details: The data come from the Korean Sleep-Headache Study, a population-based, cross-sectional survey on headache and sleep involving 2,501 participants.

Disclosures: This study was supported by the National Research Foundation of Korea grant from the Korean government. S‐J Cho and M K Chu were site investigators for a multicenter trial sponsored by Otsuka Korea, Eli Lilly and Co., and others. S-J Cho and MK Chu have worked as advisory members for Teva and have declared research support/lecture honoraria/grants from different sources. The other authors declared no conflicts of interest.

Source: Han SM et al. Sci Rep. 2021 Jan 28. doi: 10.1038/s41598-021-82080-z.

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Key clinical point: The prevalence of cutaneous allodynia (CA) was comparable among patients with probable migraine (PM) and migraine. Anxiety, depression, and headache frequency/intensity were significant factors for CA in PM.

Major finding: Participants with PM (n=289) and migraine (n=125) showed a similar prevalence of CA (14.5% vs. 16.0%; P = .701). The factors significantly associated with CA in PM were moderate (adjusted odds ratio [aOR], 2.4; 95% confidence interval [CI], 1.1-5.4) and severe (aOR, 4.0; 95% CI, 1.1-13.9) headache intensity, anxiety (aOR, 5.2; 95% CI, 1.7-16.3), and depression (aOR, 3.3; 95% CI, 1.5-7.6).

Study details: The data come from the Korean Sleep-Headache Study, a population-based, cross-sectional survey on headache and sleep involving 2,501 participants.

Disclosures: This study was supported by the National Research Foundation of Korea grant from the Korean government. S‐J Cho and M K Chu were site investigators for a multicenter trial sponsored by Otsuka Korea, Eli Lilly and Co., and others. S-J Cho and MK Chu have worked as advisory members for Teva and have declared research support/lecture honoraria/grants from different sources. The other authors declared no conflicts of interest.

Source: Han SM et al. Sci Rep. 2021 Jan 28. doi: 10.1038/s41598-021-82080-z.

Key clinical point: The prevalence of cutaneous allodynia (CA) was comparable among patients with probable migraine (PM) and migraine. Anxiety, depression, and headache frequency/intensity were significant factors for CA in PM.

Major finding: Participants with PM (n=289) and migraine (n=125) showed a similar prevalence of CA (14.5% vs. 16.0%; P = .701). The factors significantly associated with CA in PM were moderate (adjusted odds ratio [aOR], 2.4; 95% confidence interval [CI], 1.1-5.4) and severe (aOR, 4.0; 95% CI, 1.1-13.9) headache intensity, anxiety (aOR, 5.2; 95% CI, 1.7-16.3), and depression (aOR, 3.3; 95% CI, 1.5-7.6).

Study details: The data come from the Korean Sleep-Headache Study, a population-based, cross-sectional survey on headache and sleep involving 2,501 participants.

Disclosures: This study was supported by the National Research Foundation of Korea grant from the Korean government. S‐J Cho and M K Chu were site investigators for a multicenter trial sponsored by Otsuka Korea, Eli Lilly and Co., and others. S-J Cho and MK Chu have worked as advisory members for Teva and have declared research support/lecture honoraria/grants from different sources. The other authors declared no conflicts of interest.

Source: Han SM et al. Sci Rep. 2021 Jan 28. doi: 10.1038/s41598-021-82080-z.

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