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Lidocaine Nerve Block Effective for Severe, Refractory Migraine in Children

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Changed
Fri, 04/19/2024 - 16:41

 

Lidocaine injections into the greater occipital nerve relieve severe, refractory migraine attacks in children, results of a randomized controlled trial show. 

Investigators found children receiving bilateral occipital nerve blocks with 2% lidocaine had significantly greater pain relief than that of peers receiving saline injections. 

Cases series have shown a benefit of peripheral nerve blocks (PNBs) — injections of local anesthetics over branches of the occipital or trigeminal nerve — for severe, refractory headache in children.  

Although 80% of pediatric headache specialists use PNBs, there is “inconsistent insurance coverage” for this treatment, which had not been tested in a randomized controlled trial in children before now, lead investigator Christina Szperka, MD, with the Pediatric Headache Program, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, told delegates attending the 2024 annual meeting of the American Academy of Neurology. 
 

Significant Results

Investigators enrolled 58 children and adolescents with acute status migrainosus. The mean age was 16 years, and reported gender was female for 44 participants, male for 11 participants, and nonbinary or transgender in 3 participants. Participants had a migraine flare duration of 22 days and had not responded to other treatments. 

All participants had topical lidocaine cream applied for 30 minutes as a run-in step and could decline injections if they experienced sufficient benefit from cream alone. 

“We used a lidocaine cream lead-in for two reasons. One was to try to see if we could address the issue of high placebo response in pediatric trials in particular, and also to see if we could help with blinding to injection,” said Dr. Szperka. 

Topical lidocaine cream led to a small decrease in pain score overall (0.2 point on a 0-10 scale), and all participants proceeded to randomized blinded bilateral greater occipital nerve injection with 2% lidocaine or saline, she reported. 

On the primary endpoint — change in pain score at 30 minutes — lidocaine was significantly more effective than saline, achieving a 2.3-point decrease on average (on a 0-10 scale) vs a 1.1-point decrease with saline (P = .01).

A 2-point pain reduction was achieved in 69% of patients in the lidocaine group versus 34% in the saline group.

Three quarters (76%) of patients getting lidocaine reported at least partial relief in severity or location of pain compared with 48% of those getting saline (P = .03). Rates of pain freedom at 30 minutes were 17% and 7%, respectively, and at 24 hours were 14% and 0%, respectively.

The majority of adverse events were mild and fairly equal across groups and included anxiety, worsening headache, injection site pain, dizziness, and numbness (more so with lidocaine). There was one case of anaphylaxis after lidocaine injection.

Quite unexpectedly, said Dr. Szperka, patients rated the saline injection as more painful than the lidocaine injection. “This was not what I expected going in, and I think is relevant for future trials,” she said.
 

Encouraging Results 

Reached for comment, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, said that as a neurologist and pain physician, he sees firsthand the “devastating impact of status migrainosus on children.”

 

 

“These debilitating headaches can rob them of precious school days, hindering learning and social interaction,” said Dr. Lakhan. “The constant pain and fear of the next attack can also take a toll on their emotional well-being.”

The impact on families is significant as well, highlighting the need to find more effective treatments, Dr. Lakhan said. 

“Traditionally, we’ve relied on case studies to see the benefits of nerve blocks for migraine in younger patients. This is the first randomized controlled trial that shows lidocaine injections can be significantly more effective than a placebo for these unrelenting migraines,” he said.

“It’s important to note that this is a relatively small study, and not without safety concerns, including rare but potentially life-threatening anaphylaxis to lidocaine,” Dr. Lakhan added. “More research is needed, but these findings are encouraging. Lidocaine injections could become a valuable tool for managing treatment-resistant migraines in adolescents and young adults.”

The study was supported by a grant from the National Institute of Neurological Disorders and Stroke. Dr. Szperka is a consultant for AbbVie and Teva; serves on a Data Safety Monitoring Board for Eli Lilly and Upsher-Smith; and is a site principal investigator for AbbVie, Amgen, Biohaven/Pfizer, Teva, and Theranica. Dr. Lakhan had no disclosures.
 

A version of this article appeared on Medscape.com.

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Lidocaine injections into the greater occipital nerve relieve severe, refractory migraine attacks in children, results of a randomized controlled trial show. 

Investigators found children receiving bilateral occipital nerve blocks with 2% lidocaine had significantly greater pain relief than that of peers receiving saline injections. 

Cases series have shown a benefit of peripheral nerve blocks (PNBs) — injections of local anesthetics over branches of the occipital or trigeminal nerve — for severe, refractory headache in children.  

Although 80% of pediatric headache specialists use PNBs, there is “inconsistent insurance coverage” for this treatment, which had not been tested in a randomized controlled trial in children before now, lead investigator Christina Szperka, MD, with the Pediatric Headache Program, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, told delegates attending the 2024 annual meeting of the American Academy of Neurology. 
 

Significant Results

Investigators enrolled 58 children and adolescents with acute status migrainosus. The mean age was 16 years, and reported gender was female for 44 participants, male for 11 participants, and nonbinary or transgender in 3 participants. Participants had a migraine flare duration of 22 days and had not responded to other treatments. 

All participants had topical lidocaine cream applied for 30 minutes as a run-in step and could decline injections if they experienced sufficient benefit from cream alone. 

“We used a lidocaine cream lead-in for two reasons. One was to try to see if we could address the issue of high placebo response in pediatric trials in particular, and also to see if we could help with blinding to injection,” said Dr. Szperka. 

Topical lidocaine cream led to a small decrease in pain score overall (0.2 point on a 0-10 scale), and all participants proceeded to randomized blinded bilateral greater occipital nerve injection with 2% lidocaine or saline, she reported. 

On the primary endpoint — change in pain score at 30 minutes — lidocaine was significantly more effective than saline, achieving a 2.3-point decrease on average (on a 0-10 scale) vs a 1.1-point decrease with saline (P = .01).

A 2-point pain reduction was achieved in 69% of patients in the lidocaine group versus 34% in the saline group.

Three quarters (76%) of patients getting lidocaine reported at least partial relief in severity or location of pain compared with 48% of those getting saline (P = .03). Rates of pain freedom at 30 minutes were 17% and 7%, respectively, and at 24 hours were 14% and 0%, respectively.

The majority of adverse events were mild and fairly equal across groups and included anxiety, worsening headache, injection site pain, dizziness, and numbness (more so with lidocaine). There was one case of anaphylaxis after lidocaine injection.

Quite unexpectedly, said Dr. Szperka, patients rated the saline injection as more painful than the lidocaine injection. “This was not what I expected going in, and I think is relevant for future trials,” she said.
 

Encouraging Results 

Reached for comment, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, said that as a neurologist and pain physician, he sees firsthand the “devastating impact of status migrainosus on children.”

 

 

“These debilitating headaches can rob them of precious school days, hindering learning and social interaction,” said Dr. Lakhan. “The constant pain and fear of the next attack can also take a toll on their emotional well-being.”

The impact on families is significant as well, highlighting the need to find more effective treatments, Dr. Lakhan said. 

“Traditionally, we’ve relied on case studies to see the benefits of nerve blocks for migraine in younger patients. This is the first randomized controlled trial that shows lidocaine injections can be significantly more effective than a placebo for these unrelenting migraines,” he said.

“It’s important to note that this is a relatively small study, and not without safety concerns, including rare but potentially life-threatening anaphylaxis to lidocaine,” Dr. Lakhan added. “More research is needed, but these findings are encouraging. Lidocaine injections could become a valuable tool for managing treatment-resistant migraines in adolescents and young adults.”

The study was supported by a grant from the National Institute of Neurological Disorders and Stroke. Dr. Szperka is a consultant for AbbVie and Teva; serves on a Data Safety Monitoring Board for Eli Lilly and Upsher-Smith; and is a site principal investigator for AbbVie, Amgen, Biohaven/Pfizer, Teva, and Theranica. Dr. Lakhan had no disclosures.
 

A version of this article appeared on Medscape.com.

 

Lidocaine injections into the greater occipital nerve relieve severe, refractory migraine attacks in children, results of a randomized controlled trial show. 

Investigators found children receiving bilateral occipital nerve blocks with 2% lidocaine had significantly greater pain relief than that of peers receiving saline injections. 

Cases series have shown a benefit of peripheral nerve blocks (PNBs) — injections of local anesthetics over branches of the occipital or trigeminal nerve — for severe, refractory headache in children.  

Although 80% of pediatric headache specialists use PNBs, there is “inconsistent insurance coverage” for this treatment, which had not been tested in a randomized controlled trial in children before now, lead investigator Christina Szperka, MD, with the Pediatric Headache Program, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, told delegates attending the 2024 annual meeting of the American Academy of Neurology. 
 

Significant Results

Investigators enrolled 58 children and adolescents with acute status migrainosus. The mean age was 16 years, and reported gender was female for 44 participants, male for 11 participants, and nonbinary or transgender in 3 participants. Participants had a migraine flare duration of 22 days and had not responded to other treatments. 

All participants had topical lidocaine cream applied for 30 minutes as a run-in step and could decline injections if they experienced sufficient benefit from cream alone. 

“We used a lidocaine cream lead-in for two reasons. One was to try to see if we could address the issue of high placebo response in pediatric trials in particular, and also to see if we could help with blinding to injection,” said Dr. Szperka. 

Topical lidocaine cream led to a small decrease in pain score overall (0.2 point on a 0-10 scale), and all participants proceeded to randomized blinded bilateral greater occipital nerve injection with 2% lidocaine or saline, she reported. 

On the primary endpoint — change in pain score at 30 minutes — lidocaine was significantly more effective than saline, achieving a 2.3-point decrease on average (on a 0-10 scale) vs a 1.1-point decrease with saline (P = .01).

A 2-point pain reduction was achieved in 69% of patients in the lidocaine group versus 34% in the saline group.

Three quarters (76%) of patients getting lidocaine reported at least partial relief in severity or location of pain compared with 48% of those getting saline (P = .03). Rates of pain freedom at 30 minutes were 17% and 7%, respectively, and at 24 hours were 14% and 0%, respectively.

The majority of adverse events were mild and fairly equal across groups and included anxiety, worsening headache, injection site pain, dizziness, and numbness (more so with lidocaine). There was one case of anaphylaxis after lidocaine injection.

Quite unexpectedly, said Dr. Szperka, patients rated the saline injection as more painful than the lidocaine injection. “This was not what I expected going in, and I think is relevant for future trials,” she said.
 

Encouraging Results 

Reached for comment, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, said that as a neurologist and pain physician, he sees firsthand the “devastating impact of status migrainosus on children.”

 

 

“These debilitating headaches can rob them of precious school days, hindering learning and social interaction,” said Dr. Lakhan. “The constant pain and fear of the next attack can also take a toll on their emotional well-being.”

The impact on families is significant as well, highlighting the need to find more effective treatments, Dr. Lakhan said. 

“Traditionally, we’ve relied on case studies to see the benefits of nerve blocks for migraine in younger patients. This is the first randomized controlled trial that shows lidocaine injections can be significantly more effective than a placebo for these unrelenting migraines,” he said.

“It’s important to note that this is a relatively small study, and not without safety concerns, including rare but potentially life-threatening anaphylaxis to lidocaine,” Dr. Lakhan added. “More research is needed, but these findings are encouraging. Lidocaine injections could become a valuable tool for managing treatment-resistant migraines in adolescents and young adults.”

The study was supported by a grant from the National Institute of Neurological Disorders and Stroke. Dr. Szperka is a consultant for AbbVie and Teva; serves on a Data Safety Monitoring Board for Eli Lilly and Upsher-Smith; and is a site principal investigator for AbbVie, Amgen, Biohaven/Pfizer, Teva, and Theranica. Dr. Lakhan had no disclosures.
 

A version of this article appeared on Medscape.com.

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Vaporized Cannabis for Acute Migraine Yields Rapid, Sustained Relief

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Changed
Mon, 04/22/2024 - 11:31

 

Vaporized cannabis containing tetrahydrocannabinol (THC) and cannabidiol (CBD) may provide rapid and sustained relief of acute migraine pain with no serious side effects, new research suggests. 

“In this single-center randomized controlled trial across 247 treated migraine attacks, four puffs of vaporized THC-CBD mix were efficacious for acute migraine treatment,” said study investigator Nathaniel Marc Schuster, MD, with University of California San Diego Center for Pain Medicine. 

The superiority of THC-CBD over placebo was “unlikely explained by unmasking given that in our blinding analysis most patients who got THC actually did not think they got some THC,” Dr. Schuster said. 

He presented the results at the 2024 annual meeting of the American Academy of Neurology. 
 

Sustained Pain Relief

Preclinical and retrospective studies point to antimigraine effects of cannabinoids, yet strong evidence of efficacy from a randomized controlled trial has been lacking. 

The researchers tested the efficacy of cannabis for acute migraine in what they report is the first randomized, double-blind, placebo-controlled, crossover trial of adults with migraine.

Participants treated up to four separate moderate to severe migraine attacks, each with one of four different treatments. The four treatments were: 6% THC, 11% CBD, a mix of 6% THC and 11% CBD, or placebo flower from the National Institute on Drug Abuse that has a similar taste and smell to the other products.

The four treatments were vaporized in a randomized order, with at least 1 week washout between treatments. The primary endpoint was pain relief at 2 hours from vaporization. Secondary endpoints were freedom from pain and most bothersome symptom (MBS) at 2 hours from vaporization.

Of the 92 enrolled patients (mean age 41 years, 83% women), 19 treated zero migraine attacks thus leaving 73 patients who treated a total of 247 migraine attacks over the 1-year study.

The THC-CBD mix was superior to placebo at achieving pain relief (67.2% vs 46.6%; P = .016), pain freedom (34.5% vs 15.5%; P = .017), and MBS freedom (60.3% vs 34.5%; P = .005) at 2 hours.

The THC-CBD mix was also superior to placebo for sustained pain freedom at 24 hours and sustained MBS freedom at 24 and 48 hours. 

There were no serious adverse events. The THC-CBD mix was better tolerated than THC-only was, with lower rates of euphoria and cognitive impairment and lower subjective highness, Dr. Schuster said. 

Adverse events were more common with THC only (vs THC-CBD) “and this is really expected because CBD is known to bring down the side effects of THC,” Dr. Schuster noted. 

Summing up his presentation, Dr. Schuster said, “This is one single-center study, and, of course, we need more data. We need to study the rates of medication overuse headache and the rates of cannabis use disorder that may develop with the use of cannabis for migraine.”
 

Cautious Optimism

Reached for comment, Hsiangkuo (Scott) Yuan, MD, PhD, Department of Neurology, Thomas Jefferson University, and director of clinical research, Jefferson Headache Center, Philadelphia, Pennsylvania, noted that the “statistically significant” differences between THC-CBD versus placebo on 2-hour pain relief, pain freedom and MBS freedom are “certainly very exciting, especially when no serious adverse event was reported.”

 

 

“Since THC has a narrow therapeutic window for analgesia (too high causes psychoactive side effects and may even worsen the pain), its dosing needs to be carefully controlled. The study was wisely designed to ensure uniform dosing from the vaporizer, which is usually safer than smoking or a vape pen and has a quicker onset than ingestion for acute usage,” said Dr. Yuan, who was not involved in the study.

“However, the optimal THC-CBD ratio and potency (percent THC) for acute migraine remain to be studied. Perhaps there is an individualized dose that can be obtained by titration. We also don’t know if the effect changes after repeated use,” Dr. Yuan cautioned. 

He also noted that cannabis use was associated with medication overuse headache in a retrospective study, “although the causality remains to be determined.”

“While there was no serious adverse event, it is not completely risk-free, especially when cannabis is used repeatedly for a short duration. Since the physician does not have direct control over what happens at the dispensary, we need to counsel our patients more carefully when recommending cannabis/cannabinoids,” Dr. Yuan said. 

Overall, he said he is “cautiously optimistic about cannabis use for acute migraine.”

This was an investigator-initiated study, with no commercial funding. Dr. Schuster has disclosed relationships with Schedule 1 Therapeutics, Averitas, Lundbeck, Eli Lilly, ShiraTronics, and Syneos. In the past 24 months, Dr. Yuan has served as a site investigator for Teva, AbbVie, Ipsen, Parema; received advisory/consultant fees from Salvia, Pfizer, AbbVie, Cerenovus; and royalties from Cambridge University Press and MedLink.

A version of this article appeared on Medscape.com.

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Vaporized cannabis containing tetrahydrocannabinol (THC) and cannabidiol (CBD) may provide rapid and sustained relief of acute migraine pain with no serious side effects, new research suggests. 

“In this single-center randomized controlled trial across 247 treated migraine attacks, four puffs of vaporized THC-CBD mix were efficacious for acute migraine treatment,” said study investigator Nathaniel Marc Schuster, MD, with University of California San Diego Center for Pain Medicine. 

The superiority of THC-CBD over placebo was “unlikely explained by unmasking given that in our blinding analysis most patients who got THC actually did not think they got some THC,” Dr. Schuster said. 

He presented the results at the 2024 annual meeting of the American Academy of Neurology. 
 

Sustained Pain Relief

Preclinical and retrospective studies point to antimigraine effects of cannabinoids, yet strong evidence of efficacy from a randomized controlled trial has been lacking. 

The researchers tested the efficacy of cannabis for acute migraine in what they report is the first randomized, double-blind, placebo-controlled, crossover trial of adults with migraine.

Participants treated up to four separate moderate to severe migraine attacks, each with one of four different treatments. The four treatments were: 6% THC, 11% CBD, a mix of 6% THC and 11% CBD, or placebo flower from the National Institute on Drug Abuse that has a similar taste and smell to the other products.

The four treatments were vaporized in a randomized order, with at least 1 week washout between treatments. The primary endpoint was pain relief at 2 hours from vaporization. Secondary endpoints were freedom from pain and most bothersome symptom (MBS) at 2 hours from vaporization.

Of the 92 enrolled patients (mean age 41 years, 83% women), 19 treated zero migraine attacks thus leaving 73 patients who treated a total of 247 migraine attacks over the 1-year study.

The THC-CBD mix was superior to placebo at achieving pain relief (67.2% vs 46.6%; P = .016), pain freedom (34.5% vs 15.5%; P = .017), and MBS freedom (60.3% vs 34.5%; P = .005) at 2 hours.

The THC-CBD mix was also superior to placebo for sustained pain freedom at 24 hours and sustained MBS freedom at 24 and 48 hours. 

There were no serious adverse events. The THC-CBD mix was better tolerated than THC-only was, with lower rates of euphoria and cognitive impairment and lower subjective highness, Dr. Schuster said. 

Adverse events were more common with THC only (vs THC-CBD) “and this is really expected because CBD is known to bring down the side effects of THC,” Dr. Schuster noted. 

Summing up his presentation, Dr. Schuster said, “This is one single-center study, and, of course, we need more data. We need to study the rates of medication overuse headache and the rates of cannabis use disorder that may develop with the use of cannabis for migraine.”
 

Cautious Optimism

Reached for comment, Hsiangkuo (Scott) Yuan, MD, PhD, Department of Neurology, Thomas Jefferson University, and director of clinical research, Jefferson Headache Center, Philadelphia, Pennsylvania, noted that the “statistically significant” differences between THC-CBD versus placebo on 2-hour pain relief, pain freedom and MBS freedom are “certainly very exciting, especially when no serious adverse event was reported.”

 

 

“Since THC has a narrow therapeutic window for analgesia (too high causes psychoactive side effects and may even worsen the pain), its dosing needs to be carefully controlled. The study was wisely designed to ensure uniform dosing from the vaporizer, which is usually safer than smoking or a vape pen and has a quicker onset than ingestion for acute usage,” said Dr. Yuan, who was not involved in the study.

“However, the optimal THC-CBD ratio and potency (percent THC) for acute migraine remain to be studied. Perhaps there is an individualized dose that can be obtained by titration. We also don’t know if the effect changes after repeated use,” Dr. Yuan cautioned. 

He also noted that cannabis use was associated with medication overuse headache in a retrospective study, “although the causality remains to be determined.”

“While there was no serious adverse event, it is not completely risk-free, especially when cannabis is used repeatedly for a short duration. Since the physician does not have direct control over what happens at the dispensary, we need to counsel our patients more carefully when recommending cannabis/cannabinoids,” Dr. Yuan said. 

Overall, he said he is “cautiously optimistic about cannabis use for acute migraine.”

This was an investigator-initiated study, with no commercial funding. Dr. Schuster has disclosed relationships with Schedule 1 Therapeutics, Averitas, Lundbeck, Eli Lilly, ShiraTronics, and Syneos. In the past 24 months, Dr. Yuan has served as a site investigator for Teva, AbbVie, Ipsen, Parema; received advisory/consultant fees from Salvia, Pfizer, AbbVie, Cerenovus; and royalties from Cambridge University Press and MedLink.

A version of this article appeared on Medscape.com.

 

Vaporized cannabis containing tetrahydrocannabinol (THC) and cannabidiol (CBD) may provide rapid and sustained relief of acute migraine pain with no serious side effects, new research suggests. 

“In this single-center randomized controlled trial across 247 treated migraine attacks, four puffs of vaporized THC-CBD mix were efficacious for acute migraine treatment,” said study investigator Nathaniel Marc Schuster, MD, with University of California San Diego Center for Pain Medicine. 

The superiority of THC-CBD over placebo was “unlikely explained by unmasking given that in our blinding analysis most patients who got THC actually did not think they got some THC,” Dr. Schuster said. 

He presented the results at the 2024 annual meeting of the American Academy of Neurology. 
 

Sustained Pain Relief

Preclinical and retrospective studies point to antimigraine effects of cannabinoids, yet strong evidence of efficacy from a randomized controlled trial has been lacking. 

The researchers tested the efficacy of cannabis for acute migraine in what they report is the first randomized, double-blind, placebo-controlled, crossover trial of adults with migraine.

Participants treated up to four separate moderate to severe migraine attacks, each with one of four different treatments. The four treatments were: 6% THC, 11% CBD, a mix of 6% THC and 11% CBD, or placebo flower from the National Institute on Drug Abuse that has a similar taste and smell to the other products.

The four treatments were vaporized in a randomized order, with at least 1 week washout between treatments. The primary endpoint was pain relief at 2 hours from vaporization. Secondary endpoints were freedom from pain and most bothersome symptom (MBS) at 2 hours from vaporization.

Of the 92 enrolled patients (mean age 41 years, 83% women), 19 treated zero migraine attacks thus leaving 73 patients who treated a total of 247 migraine attacks over the 1-year study.

The THC-CBD mix was superior to placebo at achieving pain relief (67.2% vs 46.6%; P = .016), pain freedom (34.5% vs 15.5%; P = .017), and MBS freedom (60.3% vs 34.5%; P = .005) at 2 hours.

The THC-CBD mix was also superior to placebo for sustained pain freedom at 24 hours and sustained MBS freedom at 24 and 48 hours. 

There were no serious adverse events. The THC-CBD mix was better tolerated than THC-only was, with lower rates of euphoria and cognitive impairment and lower subjective highness, Dr. Schuster said. 

Adverse events were more common with THC only (vs THC-CBD) “and this is really expected because CBD is known to bring down the side effects of THC,” Dr. Schuster noted. 

Summing up his presentation, Dr. Schuster said, “This is one single-center study, and, of course, we need more data. We need to study the rates of medication overuse headache and the rates of cannabis use disorder that may develop with the use of cannabis for migraine.”
 

Cautious Optimism

Reached for comment, Hsiangkuo (Scott) Yuan, MD, PhD, Department of Neurology, Thomas Jefferson University, and director of clinical research, Jefferson Headache Center, Philadelphia, Pennsylvania, noted that the “statistically significant” differences between THC-CBD versus placebo on 2-hour pain relief, pain freedom and MBS freedom are “certainly very exciting, especially when no serious adverse event was reported.”

 

 

“Since THC has a narrow therapeutic window for analgesia (too high causes psychoactive side effects and may even worsen the pain), its dosing needs to be carefully controlled. The study was wisely designed to ensure uniform dosing from the vaporizer, which is usually safer than smoking or a vape pen and has a quicker onset than ingestion for acute usage,” said Dr. Yuan, who was not involved in the study.

“However, the optimal THC-CBD ratio and potency (percent THC) for acute migraine remain to be studied. Perhaps there is an individualized dose that can be obtained by titration. We also don’t know if the effect changes after repeated use,” Dr. Yuan cautioned. 

He also noted that cannabis use was associated with medication overuse headache in a retrospective study, “although the causality remains to be determined.”

“While there was no serious adverse event, it is not completely risk-free, especially when cannabis is used repeatedly for a short duration. Since the physician does not have direct control over what happens at the dispensary, we need to counsel our patients more carefully when recommending cannabis/cannabinoids,” Dr. Yuan said. 

Overall, he said he is “cautiously optimistic about cannabis use for acute migraine.”

This was an investigator-initiated study, with no commercial funding. Dr. Schuster has disclosed relationships with Schedule 1 Therapeutics, Averitas, Lundbeck, Eli Lilly, ShiraTronics, and Syneos. In the past 24 months, Dr. Yuan has served as a site investigator for Teva, AbbVie, Ipsen, Parema; received advisory/consultant fees from Salvia, Pfizer, AbbVie, Cerenovus; and royalties from Cambridge University Press and MedLink.

A version of this article appeared on Medscape.com.

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IV Ketamine Promising for Severe Refractory Headache in Children

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Thu, 04/18/2024 - 11:25

 

Intravenous (IV) ketamine is an effective and safe treatment option for children with severe refractory headache, new research suggests. In a retrospective chart review, IV ketamine led to in a 50% reduction in pain at discharge, with “nearly two-thirds” of patients having no recurrence within 30 days, noted lead investigator Scott Rosenthal, MD, from the University of Colorado Anschutz Medical Campus, Aurora.

Dr. Rosenthal reported the findings at the 2024 annual meeting of the American Academy of Neurology.
 

Statistically Significant Pain Relief

“IV ketamine has shown benefit in nonheadache chronic pain syndromes and refractory mood disorders. Patients with refractory status migraines are often left with ongoing pain and dysfunction after failing typical interventions,” Dr. Rosenthal said. 

“Ketamine has emerged as a potential treatment option in this population. However, there’s very little research on the efficacy and tolerability of it in general as well as the pediatric population,” he noted. 

Dr. Rosenthal and colleagues took a look back at patients admitted to Children’s Hospital Colorado between 2019 and 2022 for treatment of severe refractory headache who were treated with continuous IV ketamine. 

They analyzed 68 encounters of 41 unique patients aged 5-21 years (median age 16 years; 85% girls). Chronic migraine without aura made up 79% of cases. 

On presentation, most patients had an exacerbation or ongoing worsening of pain for about 10 days, and all but two were taking a preventive medication. Nearly 70% had a comorbid psychiatric diagnosis such as anxiety or depression, and 60% had a comorbid chronic pain diagnosis separate from their headache diagnosis. 

The primary outcome was percent pain reduction at discharge and headache recurrence within 72 hours, with headache recurrence defined as receipt of neurology care via phone, clinic, or hospital encounter. 

Patients received IV ketamine at a median dose of 0.25 mg/kg/hr for a median of 3 days.

Overall, the treatment was “safe and well tolerated,” Dr. Rosenthal said. 

There were no serious adverse events and no cardiac side effects; 7% (five out of 68) stopped treatment due to side effects. The most common side effects were dizziness (23%), nausea (16%), blurred vision (12%), hallucinations (19%), cognitive fog (7%), vomiting (6%) and dysphoria (4%), worsening headache (4%), and paresthesia and cramping (1.5%).
 

‘Exciting Starting Point’

At baseline, pain scores were 8 (on a scale of 0-10) and progressively fell (improved) during treatment. Pain scores were 6 on day 1 and were 5 on day 2, with a slight rebound to 5 at discharge, although the pain reduction at discharge (vs baseline) remained statistically significant (P < .001). 

“The median percent pain reduction after 3 days of ketamine was about 40%,” Dr. Rosenthal said. 

He noted that on the first day of treatment, 16% of patients responded to treatment (with a > 50% reduction in their initial pain); this doubled to 33% on day 2 and increased to 44% at discharge. 

In terms of recurrence, 38% had a recurrence within 1 month, “meaning two thirds did not,” Dr. Rosenthal noted. Median time to recurrence was 7 days. There were no recurrences within 72 hours. 

The researchers also tried to tease out which patients might respond best to ketamine.

“Surprisingly,” there wasn’t a strong effect of most demographic variables such as age, sex, gender identity, chronic pain, psychiatric comorbidities, duration of headache, or prior interventions, Dr. Rosenthal noted. 

“Interestingly,” he said, patients who were on two or more preventive medications had a 50% reduction in their pain at discharge compared with a 33% reduction in patients taking one or no preventive medication. It’s possible that more preventative medications may “prime” a patient’s response to ketamine, Dr. Rosenthal said. 

She added that future randomized studies are needed to further assess IV ketamine for refractory headache in children, but these results are “an exciting starting point.” 
 

 

 

‘Still an Unknown’

Seniha Nur Ozudogru, MD, assistant professor of clinical neurology at Penn Medicine in Philadelphia, echoed the need for further study.

The role of IV ketamine in refractory pediatric headache is “still an unknown,” said Dr. Ozudogru, who was not involved in the study. 

She noted that currently, there is “no standard protocol for ketamine infusion, even for adults. Every institution has their own protocols, which makes it difficult.” 

Dr. Ozudogru also wonders how “doable” in-hospital IV infusions over 3 days may be for children. 

“Especially for chronic migraine patients, it can be really tricky to manage expectations in that even if they don’t respond and the headache doesn’t go away, they still may have to be discharged. That requires a specific approach and discussion with the patients,” Dr. Ozudogru said. 

Intranasal ketamine is another potential option, she said, with a recent study suggesting that intranasal ketamine is an effective treatment for children hospitalized with refractory migraine. 

“However, there is some concern about the potential of addiction and the side effects of hallucinations and what the main protocol will be, so this not a standard treatment and has to be studied further,” she said. 

The study had no specific funding. Dr. Rosenthal and Dr. Ozudogru have no relevant disclosures.
 

A version of this article appeared on Medscape.com.

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Intravenous (IV) ketamine is an effective and safe treatment option for children with severe refractory headache, new research suggests. In a retrospective chart review, IV ketamine led to in a 50% reduction in pain at discharge, with “nearly two-thirds” of patients having no recurrence within 30 days, noted lead investigator Scott Rosenthal, MD, from the University of Colorado Anschutz Medical Campus, Aurora.

Dr. Rosenthal reported the findings at the 2024 annual meeting of the American Academy of Neurology.
 

Statistically Significant Pain Relief

“IV ketamine has shown benefit in nonheadache chronic pain syndromes and refractory mood disorders. Patients with refractory status migraines are often left with ongoing pain and dysfunction after failing typical interventions,” Dr. Rosenthal said. 

“Ketamine has emerged as a potential treatment option in this population. However, there’s very little research on the efficacy and tolerability of it in general as well as the pediatric population,” he noted. 

Dr. Rosenthal and colleagues took a look back at patients admitted to Children’s Hospital Colorado between 2019 and 2022 for treatment of severe refractory headache who were treated with continuous IV ketamine. 

They analyzed 68 encounters of 41 unique patients aged 5-21 years (median age 16 years; 85% girls). Chronic migraine without aura made up 79% of cases. 

On presentation, most patients had an exacerbation or ongoing worsening of pain for about 10 days, and all but two were taking a preventive medication. Nearly 70% had a comorbid psychiatric diagnosis such as anxiety or depression, and 60% had a comorbid chronic pain diagnosis separate from their headache diagnosis. 

The primary outcome was percent pain reduction at discharge and headache recurrence within 72 hours, with headache recurrence defined as receipt of neurology care via phone, clinic, or hospital encounter. 

Patients received IV ketamine at a median dose of 0.25 mg/kg/hr for a median of 3 days.

Overall, the treatment was “safe and well tolerated,” Dr. Rosenthal said. 

There were no serious adverse events and no cardiac side effects; 7% (five out of 68) stopped treatment due to side effects. The most common side effects were dizziness (23%), nausea (16%), blurred vision (12%), hallucinations (19%), cognitive fog (7%), vomiting (6%) and dysphoria (4%), worsening headache (4%), and paresthesia and cramping (1.5%).
 

‘Exciting Starting Point’

At baseline, pain scores were 8 (on a scale of 0-10) and progressively fell (improved) during treatment. Pain scores were 6 on day 1 and were 5 on day 2, with a slight rebound to 5 at discharge, although the pain reduction at discharge (vs baseline) remained statistically significant (P < .001). 

“The median percent pain reduction after 3 days of ketamine was about 40%,” Dr. Rosenthal said. 

He noted that on the first day of treatment, 16% of patients responded to treatment (with a > 50% reduction in their initial pain); this doubled to 33% on day 2 and increased to 44% at discharge. 

In terms of recurrence, 38% had a recurrence within 1 month, “meaning two thirds did not,” Dr. Rosenthal noted. Median time to recurrence was 7 days. There were no recurrences within 72 hours. 

The researchers also tried to tease out which patients might respond best to ketamine.

“Surprisingly,” there wasn’t a strong effect of most demographic variables such as age, sex, gender identity, chronic pain, psychiatric comorbidities, duration of headache, or prior interventions, Dr. Rosenthal noted. 

“Interestingly,” he said, patients who were on two or more preventive medications had a 50% reduction in their pain at discharge compared with a 33% reduction in patients taking one or no preventive medication. It’s possible that more preventative medications may “prime” a patient’s response to ketamine, Dr. Rosenthal said. 

She added that future randomized studies are needed to further assess IV ketamine for refractory headache in children, but these results are “an exciting starting point.” 
 

 

 

‘Still an Unknown’

Seniha Nur Ozudogru, MD, assistant professor of clinical neurology at Penn Medicine in Philadelphia, echoed the need for further study.

The role of IV ketamine in refractory pediatric headache is “still an unknown,” said Dr. Ozudogru, who was not involved in the study. 

She noted that currently, there is “no standard protocol for ketamine infusion, even for adults. Every institution has their own protocols, which makes it difficult.” 

Dr. Ozudogru also wonders how “doable” in-hospital IV infusions over 3 days may be for children. 

“Especially for chronic migraine patients, it can be really tricky to manage expectations in that even if they don’t respond and the headache doesn’t go away, they still may have to be discharged. That requires a specific approach and discussion with the patients,” Dr. Ozudogru said. 

Intranasal ketamine is another potential option, she said, with a recent study suggesting that intranasal ketamine is an effective treatment for children hospitalized with refractory migraine. 

“However, there is some concern about the potential of addiction and the side effects of hallucinations and what the main protocol will be, so this not a standard treatment and has to be studied further,” she said. 

The study had no specific funding. Dr. Rosenthal and Dr. Ozudogru have no relevant disclosures.
 

A version of this article appeared on Medscape.com.

 

Intravenous (IV) ketamine is an effective and safe treatment option for children with severe refractory headache, new research suggests. In a retrospective chart review, IV ketamine led to in a 50% reduction in pain at discharge, with “nearly two-thirds” of patients having no recurrence within 30 days, noted lead investigator Scott Rosenthal, MD, from the University of Colorado Anschutz Medical Campus, Aurora.

Dr. Rosenthal reported the findings at the 2024 annual meeting of the American Academy of Neurology.
 

Statistically Significant Pain Relief

“IV ketamine has shown benefit in nonheadache chronic pain syndromes and refractory mood disorders. Patients with refractory status migraines are often left with ongoing pain and dysfunction after failing typical interventions,” Dr. Rosenthal said. 

“Ketamine has emerged as a potential treatment option in this population. However, there’s very little research on the efficacy and tolerability of it in general as well as the pediatric population,” he noted. 

Dr. Rosenthal and colleagues took a look back at patients admitted to Children’s Hospital Colorado between 2019 and 2022 for treatment of severe refractory headache who were treated with continuous IV ketamine. 

They analyzed 68 encounters of 41 unique patients aged 5-21 years (median age 16 years; 85% girls). Chronic migraine without aura made up 79% of cases. 

On presentation, most patients had an exacerbation or ongoing worsening of pain for about 10 days, and all but two were taking a preventive medication. Nearly 70% had a comorbid psychiatric diagnosis such as anxiety or depression, and 60% had a comorbid chronic pain diagnosis separate from their headache diagnosis. 

The primary outcome was percent pain reduction at discharge and headache recurrence within 72 hours, with headache recurrence defined as receipt of neurology care via phone, clinic, or hospital encounter. 

Patients received IV ketamine at a median dose of 0.25 mg/kg/hr for a median of 3 days.

Overall, the treatment was “safe and well tolerated,” Dr. Rosenthal said. 

There were no serious adverse events and no cardiac side effects; 7% (five out of 68) stopped treatment due to side effects. The most common side effects were dizziness (23%), nausea (16%), blurred vision (12%), hallucinations (19%), cognitive fog (7%), vomiting (6%) and dysphoria (4%), worsening headache (4%), and paresthesia and cramping (1.5%).
 

‘Exciting Starting Point’

At baseline, pain scores were 8 (on a scale of 0-10) and progressively fell (improved) during treatment. Pain scores were 6 on day 1 and were 5 on day 2, with a slight rebound to 5 at discharge, although the pain reduction at discharge (vs baseline) remained statistically significant (P < .001). 

“The median percent pain reduction after 3 days of ketamine was about 40%,” Dr. Rosenthal said. 

He noted that on the first day of treatment, 16% of patients responded to treatment (with a > 50% reduction in their initial pain); this doubled to 33% on day 2 and increased to 44% at discharge. 

In terms of recurrence, 38% had a recurrence within 1 month, “meaning two thirds did not,” Dr. Rosenthal noted. Median time to recurrence was 7 days. There were no recurrences within 72 hours. 

The researchers also tried to tease out which patients might respond best to ketamine.

“Surprisingly,” there wasn’t a strong effect of most demographic variables such as age, sex, gender identity, chronic pain, psychiatric comorbidities, duration of headache, or prior interventions, Dr. Rosenthal noted. 

“Interestingly,” he said, patients who were on two or more preventive medications had a 50% reduction in their pain at discharge compared with a 33% reduction in patients taking one or no preventive medication. It’s possible that more preventative medications may “prime” a patient’s response to ketamine, Dr. Rosenthal said. 

She added that future randomized studies are needed to further assess IV ketamine for refractory headache in children, but these results are “an exciting starting point.” 
 

 

 

‘Still an Unknown’

Seniha Nur Ozudogru, MD, assistant professor of clinical neurology at Penn Medicine in Philadelphia, echoed the need for further study.

The role of IV ketamine in refractory pediatric headache is “still an unknown,” said Dr. Ozudogru, who was not involved in the study. 

She noted that currently, there is “no standard protocol for ketamine infusion, even for adults. Every institution has their own protocols, which makes it difficult.” 

Dr. Ozudogru also wonders how “doable” in-hospital IV infusions over 3 days may be for children. 

“Especially for chronic migraine patients, it can be really tricky to manage expectations in that even if they don’t respond and the headache doesn’t go away, they still may have to be discharged. That requires a specific approach and discussion with the patients,” Dr. Ozudogru said. 

Intranasal ketamine is another potential option, she said, with a recent study suggesting that intranasal ketamine is an effective treatment for children hospitalized with refractory migraine. 

“However, there is some concern about the potential of addiction and the side effects of hallucinations and what the main protocol will be, so this not a standard treatment and has to be studied further,” she said. 

The study had no specific funding. Dr. Rosenthal and Dr. Ozudogru have no relevant disclosures.
 

A version of this article appeared on Medscape.com.

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First Long-Term Data on Atogepant for Migraine Prevention

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DENER — An interim analysis of an ongoing extension study supports the long-term safety and efficacy of the oral calcitonin gene-related peptide (CGRP) receptor antagonist atogepant (Qulipta, AbbVie) to prevent chronic and episodic migraine.

The data show that 70% of patients treated with atogepant 60 mg daily achieved at least a 50% reduction in monthly migraine days at weeks 13-16 and this was maintained over 48 weeks of treatment. 

“This is the first long-term study for assessing the safety and efficacy of a drug belonging to the gepant class, atogepant, used in the prevention of migraine in persons with episodic migraine who did not benefit from several previous preventive treatments or with chronic migraine,” said study investigator Cristina Tassorelli, MD, professor and chair of neurology, University of Pavia, Italy. 

“It shows consistency of efficacy over 48 weeks and confirms the known safety profile of atogepant reported in randomized controlled trials, without detecting any new signal with the open-label use over 1 year,” Dr. Tassorelli said.

The results were reported at the 2024 annual meeting of the American Academy of Neurology by Sait Ashina, MD, with the Comprehensive Headache Center at Beth Israel Deaconess Medical Center in Boston.
 

Novel Longer-Term Data

The extension study includes more than 500 patients who completed the phase 3 PROGRESS or ELEVATE randomized placebo-controlled trials of atogepant 60 mg once daily for prevention of episodic or chronic migraine. It will run for 156 weeks. 

Dr. Ashina reported safety and tolerability data at 52 weeks of treatment and efficacy data between 13 and 48 weeks of treatment. The mean duration of atogepant exposure was 496.5 days, and the mean number of migraine days at baseline was 14.5. 

With atogepant, monthly migraine days improved on average by 8.5 days at weeks 13-16, and this was consistent over 48 weeks, Dr. Ashina reported. Similar improvements were observed for monthly headache days and monthly acute medication use days.

In addition, 70% of patients achieved a 50% or greater reduction in monthly migraine days at weeks 13-16, and this was consistent during the 48 weeks of open-label treatment.

Overall safety results were consistent with the known safety profile of atogepant. “A small percentage of subjects (< 6%) discontinue the treatment because of side effects,” Dr. Tassorelli said. 

The most common treatment-emergent adverse events (≥ 5% of participants) were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).

As the first report of 1-year atogepant data, the results are “very encouraging” for patients and clinicians, Dr. Ashina said in wrapping up his presentation. 
 

Important Advance, but Not Transformative

Reached for comment, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, noted that “[w]hile the anti-CGRP medications represent an important advancement in migraine treatment, the data suggests they have not necessarily transformed the landscape as dramatically as some may have expected. 

“The efficacy of the anti-CGRP drugs appears to be generally similar to previous preventive and mostly genericized treatments, offering modest but meaningful improvements in migraine frequency and severity for many patients,” Dr. Lakhan said.

“In terms of safety, the anti-CGRPs do seem to have a somewhat cleaner profile compared to earlier migraine preventives, which is certainly a positive. However, the long-term data is still emerging, so the full safety picture is not yet clear,” Dr. Lakhan added. 

“These medications are also associated with significantly higher overall healthcare costs compared to other treatment approaches. The substantial cost implications, both for patients and the healthcare system, deserve careful consideration as we assess their overall value and role in migraine care going forward,” Dr. Lakhan said.

Funding was provided by AbbVie. Several investigators have disclosed financial relationships with the company. Dr. Lakhan has no relevant disclosures.
 

A version of this article appeared on Medscape.com.

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DENER — An interim analysis of an ongoing extension study supports the long-term safety and efficacy of the oral calcitonin gene-related peptide (CGRP) receptor antagonist atogepant (Qulipta, AbbVie) to prevent chronic and episodic migraine.

The data show that 70% of patients treated with atogepant 60 mg daily achieved at least a 50% reduction in monthly migraine days at weeks 13-16 and this was maintained over 48 weeks of treatment. 

“This is the first long-term study for assessing the safety and efficacy of a drug belonging to the gepant class, atogepant, used in the prevention of migraine in persons with episodic migraine who did not benefit from several previous preventive treatments or with chronic migraine,” said study investigator Cristina Tassorelli, MD, professor and chair of neurology, University of Pavia, Italy. 

“It shows consistency of efficacy over 48 weeks and confirms the known safety profile of atogepant reported in randomized controlled trials, without detecting any new signal with the open-label use over 1 year,” Dr. Tassorelli said.

The results were reported at the 2024 annual meeting of the American Academy of Neurology by Sait Ashina, MD, with the Comprehensive Headache Center at Beth Israel Deaconess Medical Center in Boston.
 

Novel Longer-Term Data

The extension study includes more than 500 patients who completed the phase 3 PROGRESS or ELEVATE randomized placebo-controlled trials of atogepant 60 mg once daily for prevention of episodic or chronic migraine. It will run for 156 weeks. 

Dr. Ashina reported safety and tolerability data at 52 weeks of treatment and efficacy data between 13 and 48 weeks of treatment. The mean duration of atogepant exposure was 496.5 days, and the mean number of migraine days at baseline was 14.5. 

With atogepant, monthly migraine days improved on average by 8.5 days at weeks 13-16, and this was consistent over 48 weeks, Dr. Ashina reported. Similar improvements were observed for monthly headache days and monthly acute medication use days.

In addition, 70% of patients achieved a 50% or greater reduction in monthly migraine days at weeks 13-16, and this was consistent during the 48 weeks of open-label treatment.

Overall safety results were consistent with the known safety profile of atogepant. “A small percentage of subjects (< 6%) discontinue the treatment because of side effects,” Dr. Tassorelli said. 

The most common treatment-emergent adverse events (≥ 5% of participants) were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).

As the first report of 1-year atogepant data, the results are “very encouraging” for patients and clinicians, Dr. Ashina said in wrapping up his presentation. 
 

Important Advance, but Not Transformative

Reached for comment, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, noted that “[w]hile the anti-CGRP medications represent an important advancement in migraine treatment, the data suggests they have not necessarily transformed the landscape as dramatically as some may have expected. 

“The efficacy of the anti-CGRP drugs appears to be generally similar to previous preventive and mostly genericized treatments, offering modest but meaningful improvements in migraine frequency and severity for many patients,” Dr. Lakhan said.

“In terms of safety, the anti-CGRPs do seem to have a somewhat cleaner profile compared to earlier migraine preventives, which is certainly a positive. However, the long-term data is still emerging, so the full safety picture is not yet clear,” Dr. Lakhan added. 

“These medications are also associated with significantly higher overall healthcare costs compared to other treatment approaches. The substantial cost implications, both for patients and the healthcare system, deserve careful consideration as we assess their overall value and role in migraine care going forward,” Dr. Lakhan said.

Funding was provided by AbbVie. Several investigators have disclosed financial relationships with the company. Dr. Lakhan has no relevant disclosures.
 

A version of this article appeared on Medscape.com.

DENER — An interim analysis of an ongoing extension study supports the long-term safety and efficacy of the oral calcitonin gene-related peptide (CGRP) receptor antagonist atogepant (Qulipta, AbbVie) to prevent chronic and episodic migraine.

The data show that 70% of patients treated with atogepant 60 mg daily achieved at least a 50% reduction in monthly migraine days at weeks 13-16 and this was maintained over 48 weeks of treatment. 

“This is the first long-term study for assessing the safety and efficacy of a drug belonging to the gepant class, atogepant, used in the prevention of migraine in persons with episodic migraine who did not benefit from several previous preventive treatments or with chronic migraine,” said study investigator Cristina Tassorelli, MD, professor and chair of neurology, University of Pavia, Italy. 

“It shows consistency of efficacy over 48 weeks and confirms the known safety profile of atogepant reported in randomized controlled trials, without detecting any new signal with the open-label use over 1 year,” Dr. Tassorelli said.

The results were reported at the 2024 annual meeting of the American Academy of Neurology by Sait Ashina, MD, with the Comprehensive Headache Center at Beth Israel Deaconess Medical Center in Boston.
 

Novel Longer-Term Data

The extension study includes more than 500 patients who completed the phase 3 PROGRESS or ELEVATE randomized placebo-controlled trials of atogepant 60 mg once daily for prevention of episodic or chronic migraine. It will run for 156 weeks. 

Dr. Ashina reported safety and tolerability data at 52 weeks of treatment and efficacy data between 13 and 48 weeks of treatment. The mean duration of atogepant exposure was 496.5 days, and the mean number of migraine days at baseline was 14.5. 

With atogepant, monthly migraine days improved on average by 8.5 days at weeks 13-16, and this was consistent over 48 weeks, Dr. Ashina reported. Similar improvements were observed for monthly headache days and monthly acute medication use days.

In addition, 70% of patients achieved a 50% or greater reduction in monthly migraine days at weeks 13-16, and this was consistent during the 48 weeks of open-label treatment.

Overall safety results were consistent with the known safety profile of atogepant. “A small percentage of subjects (< 6%) discontinue the treatment because of side effects,” Dr. Tassorelli said. 

The most common treatment-emergent adverse events (≥ 5% of participants) were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).

As the first report of 1-year atogepant data, the results are “very encouraging” for patients and clinicians, Dr. Ashina said in wrapping up his presentation. 
 

Important Advance, but Not Transformative

Reached for comment, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, noted that “[w]hile the anti-CGRP medications represent an important advancement in migraine treatment, the data suggests they have not necessarily transformed the landscape as dramatically as some may have expected. 

“The efficacy of the anti-CGRP drugs appears to be generally similar to previous preventive and mostly genericized treatments, offering modest but meaningful improvements in migraine frequency and severity for many patients,” Dr. Lakhan said.

“In terms of safety, the anti-CGRPs do seem to have a somewhat cleaner profile compared to earlier migraine preventives, which is certainly a positive. However, the long-term data is still emerging, so the full safety picture is not yet clear,” Dr. Lakhan added. 

“These medications are also associated with significantly higher overall healthcare costs compared to other treatment approaches. The substantial cost implications, both for patients and the healthcare system, deserve careful consideration as we assess their overall value and role in migraine care going forward,” Dr. Lakhan said.

Funding was provided by AbbVie. Several investigators have disclosed financial relationships with the company. Dr. Lakhan has no relevant disclosures.
 

A version of this article appeared on Medscape.com.

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Tension, Other Headache Types Robustly Linked to Attempted, Completed Suicide

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Thu, 04/18/2024 - 15:33

 

DENVER – Headaches, including tension-type, migraine, and posttraumatic, are robustly associated with both attempted and completed suicide, results of a large study suggest. 

The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.

The retrospective analysis included data on more than 100,000 headache patients from a Danish registry. 

“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
 

Underestimated Problem

Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability. 

Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.

However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.

Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.

Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.

Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.

Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.

Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.

For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
 

Robust Link

The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.

The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.

After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).

“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.

For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).

The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.

The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
 

 

 

Ask About Mood

The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.

After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.

Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.

A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.

Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.

Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”

It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.

The study received support from Aarhus University. No relevant conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

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DENVER – Headaches, including tension-type, migraine, and posttraumatic, are robustly associated with both attempted and completed suicide, results of a large study suggest. 

The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.

The retrospective analysis included data on more than 100,000 headache patients from a Danish registry. 

“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
 

Underestimated Problem

Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability. 

Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.

However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.

Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.

Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.

Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.

Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.

Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.

For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
 

Robust Link

The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.

The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.

After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).

“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.

For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).

The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.

The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
 

 

 

Ask About Mood

The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.

After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.

Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.

A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.

Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.

Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”

It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.

The study received support from Aarhus University. No relevant conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

 

DENVER – Headaches, including tension-type, migraine, and posttraumatic, are robustly associated with both attempted and completed suicide, results of a large study suggest. 

The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.

The retrospective analysis included data on more than 100,000 headache patients from a Danish registry. 

“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
 

Underestimated Problem

Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability. 

Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.

However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.

Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.

Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.

Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.

Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.

Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.

For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
 

Robust Link

The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.

The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.

After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).

“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.

For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).

The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.

The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
 

 

 

Ask About Mood

The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.

After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.

Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.

A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.

Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.

Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”

It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.

The study received support from Aarhus University. No relevant conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

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Time Wasted to Avoid Penalties

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Depression is a serious issue. I want to say that off the top, because nothing below is intended to minimize it.

But does everyone need to be tested for it?

A lot of general practices test for it with every patient and every visit. After all, mandates say you have to or you’ll get penalized a few bucks. Since no one wants to leave any money on the table in the razor-thin margins of running a medical practice, they ask these questions (I don’t blame them for that).

I can see where this might be useful, but does it really do much? Or is it just a mandatory waste of time?

Good question.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

A recent review by the American College of Physicians found it was mostly a waste of time (which surprises no one). Only one of the eight measures involved in depression screening (suicide risk assessment) turned out to be useful. So, basically, 88% of the time spent on these questions contributed absolutely nothing of clinical relevance.

Of course, this isn’t unique to family medicine. Every time I see a Medicare or Medicare Advantage patient I have to document whether they’ve had flu and pneumonia vaccines. While there are occasional cases where asking about recent vaccines is critical to the history, for most it’s not. But I do it so I don’t get penalized, even though the answer changes nothing. It’s not like I give vaccines in my practice.

A fair number of people come to me for hospital follow-ups, so I go into the system and review the chart. The notes inevitably contain questions of sexual activity, fear of violence, fear of domestic abuse, food security, recent travel patterns, and so on. Some of them are useful in certain situations, but not in all, or even most. All they do is increase the length of the note until anything of relevance is obscured, and allow someone in coding to check the boxes to raise the billing level. Realistically, the ER staff involved probably didn’t ask any of them, and just clicked “no.”

Once this probably seemed like a good idea, but clearly most of it is now a waste of time. These “quality measures” have turned the art of taking a good history into a session of mouse and box clicking.

Does that really improve care?
 

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

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Depression is a serious issue. I want to say that off the top, because nothing below is intended to minimize it.

But does everyone need to be tested for it?

A lot of general practices test for it with every patient and every visit. After all, mandates say you have to or you’ll get penalized a few bucks. Since no one wants to leave any money on the table in the razor-thin margins of running a medical practice, they ask these questions (I don’t blame them for that).

I can see where this might be useful, but does it really do much? Or is it just a mandatory waste of time?

Good question.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

A recent review by the American College of Physicians found it was mostly a waste of time (which surprises no one). Only one of the eight measures involved in depression screening (suicide risk assessment) turned out to be useful. So, basically, 88% of the time spent on these questions contributed absolutely nothing of clinical relevance.

Of course, this isn’t unique to family medicine. Every time I see a Medicare or Medicare Advantage patient I have to document whether they’ve had flu and pneumonia vaccines. While there are occasional cases where asking about recent vaccines is critical to the history, for most it’s not. But I do it so I don’t get penalized, even though the answer changes nothing. It’s not like I give vaccines in my practice.

A fair number of people come to me for hospital follow-ups, so I go into the system and review the chart. The notes inevitably contain questions of sexual activity, fear of violence, fear of domestic abuse, food security, recent travel patterns, and so on. Some of them are useful in certain situations, but not in all, or even most. All they do is increase the length of the note until anything of relevance is obscured, and allow someone in coding to check the boxes to raise the billing level. Realistically, the ER staff involved probably didn’t ask any of them, and just clicked “no.”

Once this probably seemed like a good idea, but clearly most of it is now a waste of time. These “quality measures” have turned the art of taking a good history into a session of mouse and box clicking.

Does that really improve care?
 

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

Depression is a serious issue. I want to say that off the top, because nothing below is intended to minimize it.

But does everyone need to be tested for it?

A lot of general practices test for it with every patient and every visit. After all, mandates say you have to or you’ll get penalized a few bucks. Since no one wants to leave any money on the table in the razor-thin margins of running a medical practice, they ask these questions (I don’t blame them for that).

I can see where this might be useful, but does it really do much? Or is it just a mandatory waste of time?

Good question.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

A recent review by the American College of Physicians found it was mostly a waste of time (which surprises no one). Only one of the eight measures involved in depression screening (suicide risk assessment) turned out to be useful. So, basically, 88% of the time spent on these questions contributed absolutely nothing of clinical relevance.

Of course, this isn’t unique to family medicine. Every time I see a Medicare or Medicare Advantage patient I have to document whether they’ve had flu and pneumonia vaccines. While there are occasional cases where asking about recent vaccines is critical to the history, for most it’s not. But I do it so I don’t get penalized, even though the answer changes nothing. It’s not like I give vaccines in my practice.

A fair number of people come to me for hospital follow-ups, so I go into the system and review the chart. The notes inevitably contain questions of sexual activity, fear of violence, fear of domestic abuse, food security, recent travel patterns, and so on. Some of them are useful in certain situations, but not in all, or even most. All they do is increase the length of the note until anything of relevance is obscured, and allow someone in coding to check the boxes to raise the billing level. Realistically, the ER staff involved probably didn’t ask any of them, and just clicked “no.”

Once this probably seemed like a good idea, but clearly most of it is now a waste of time. These “quality measures” have turned the art of taking a good history into a session of mouse and box clicking.

Does that really improve care?
 

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

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CGRP-Targeted Therapies for Chronic Migraine Management

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CGRP-Targeted Therapies for Chronic Migraine Management

Migraine attacks are classified as chronic or episodic. Chronic migraines occur at least 15 days a month, and often prove functionally debilitating. In 2018, therapies that target the calcitonin gene-related peptide (CGRP) were first introduced to help manage migraine attacks.

Dr Stephanie Nahas from Thomas Jefferson University in Philadelphia, Pennsylvania, discusses optimal approaches for incorporating these therapies, which include small molecule agents called gepants, and monoclonal antibodies. In both cases, these therapies prevent CGRP from binding to its receptor, which helps to reduce migraine symptomatology, both acutely and over time

According to Dr Nahas, the choice of therapy for an individual patient depends primarily on patient preferences. Most gepants are administered orally, and monoclonal antibodies are injected.

Dr Nahas  recommends that these therapies should be considered when a previous treatment proves insufficient to reduce disease burden to the degree that allows improved functioning and quality of life for the patient.

--

Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor, Department of Neurology, Division of Headache Medicine, Thomas Jefferson University; Assistant Director, Headache Medicine Fellowship Program, Jefferson Headache Center, Philadelphia, Pennsylvania

Stephanie J. Nahas-Geiger, MD, MSEd, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Eli Lilly; Lundbeck; Pfizer; Theranica; Tonix (no relationships are active)

 

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Migraine attacks are classified as chronic or episodic. Chronic migraines occur at least 15 days a month, and often prove functionally debilitating. In 2018, therapies that target the calcitonin gene-related peptide (CGRP) were first introduced to help manage migraine attacks.

Dr Stephanie Nahas from Thomas Jefferson University in Philadelphia, Pennsylvania, discusses optimal approaches for incorporating these therapies, which include small molecule agents called gepants, and monoclonal antibodies. In both cases, these therapies prevent CGRP from binding to its receptor, which helps to reduce migraine symptomatology, both acutely and over time

According to Dr Nahas, the choice of therapy for an individual patient depends primarily on patient preferences. Most gepants are administered orally, and monoclonal antibodies are injected.

Dr Nahas  recommends that these therapies should be considered when a previous treatment proves insufficient to reduce disease burden to the degree that allows improved functioning and quality of life for the patient.

--

Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor, Department of Neurology, Division of Headache Medicine, Thomas Jefferson University; Assistant Director, Headache Medicine Fellowship Program, Jefferson Headache Center, Philadelphia, Pennsylvania

Stephanie J. Nahas-Geiger, MD, MSEd, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Eli Lilly; Lundbeck; Pfizer; Theranica; Tonix (no relationships are active)

 

Migraine attacks are classified as chronic or episodic. Chronic migraines occur at least 15 days a month, and often prove functionally debilitating. In 2018, therapies that target the calcitonin gene-related peptide (CGRP) were first introduced to help manage migraine attacks.

Dr Stephanie Nahas from Thomas Jefferson University in Philadelphia, Pennsylvania, discusses optimal approaches for incorporating these therapies, which include small molecule agents called gepants, and monoclonal antibodies. In both cases, these therapies prevent CGRP from binding to its receptor, which helps to reduce migraine symptomatology, both acutely and over time

According to Dr Nahas, the choice of therapy for an individual patient depends primarily on patient preferences. Most gepants are administered orally, and monoclonal antibodies are injected.

Dr Nahas  recommends that these therapies should be considered when a previous treatment proves insufficient to reduce disease burden to the degree that allows improved functioning and quality of life for the patient.

--

Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor, Department of Neurology, Division of Headache Medicine, Thomas Jefferson University; Assistant Director, Headache Medicine Fellowship Program, Jefferson Headache Center, Philadelphia, Pennsylvania

Stephanie J. Nahas-Geiger, MD, MSEd, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Eli Lilly; Lundbeck; Pfizer; Theranica; Tonix (no relationships are active)

 

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Optimal Preventive Therapy for Episodic Migraine

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Optimal Preventive Therapy for Episodic Migraine

Episodic migraine occurs fewer than 15 days per month but can become chronic if poorly controlled. It is estimated that preventive therapy is indicated in over one third of patients with episodic migraine. Dr Barbara Nye from Wake Forest University in Winston-Salem, North Carolina, discusses optimal approaches for managing episodic migraine. According to Dr Nye, several factors, including patient preference, clinical evidence, and insurance coverage, will help inform which treatments can be offered.

She mentions that currently approved treatments include nonspecific therapeutics such as antiseizure, antidepressant, and blood pressure medications. Newer therapies known as gepants and injectable monoclonal antibodies are also available to manage and prevent episodic migraine.

Dr Nye concludes that the appropriate therapeutic goal is a reduction in headache frequency, reduction in headache severity, and improved response to medications, as well as decreasing the level of disability that patients are experiencing.

--

Barbara L. Nye, MD, Associate Professor of Neurology, Wake Forest University; Director, Headache Fellowship, Department of Neurology, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina

Barbara L. Nye, MD, has disclosed no relevant financial relationships.

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Optimal Preventive Therapy for Episodic Migraine
Optimal Preventive Therapy for Episodic Migraine

Episodic migraine occurs fewer than 15 days per month but can become chronic if poorly controlled. It is estimated that preventive therapy is indicated in over one third of patients with episodic migraine. Dr Barbara Nye from Wake Forest University in Winston-Salem, North Carolina, discusses optimal approaches for managing episodic migraine. According to Dr Nye, several factors, including patient preference, clinical evidence, and insurance coverage, will help inform which treatments can be offered.

She mentions that currently approved treatments include nonspecific therapeutics such as antiseizure, antidepressant, and blood pressure medications. Newer therapies known as gepants and injectable monoclonal antibodies are also available to manage and prevent episodic migraine.

Dr Nye concludes that the appropriate therapeutic goal is a reduction in headache frequency, reduction in headache severity, and improved response to medications, as well as decreasing the level of disability that patients are experiencing.

--

Barbara L. Nye, MD, Associate Professor of Neurology, Wake Forest University; Director, Headache Fellowship, Department of Neurology, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina

Barbara L. Nye, MD, has disclosed no relevant financial relationships.

Episodic migraine occurs fewer than 15 days per month but can become chronic if poorly controlled. It is estimated that preventive therapy is indicated in over one third of patients with episodic migraine. Dr Barbara Nye from Wake Forest University in Winston-Salem, North Carolina, discusses optimal approaches for managing episodic migraine. According to Dr Nye, several factors, including patient preference, clinical evidence, and insurance coverage, will help inform which treatments can be offered.

She mentions that currently approved treatments include nonspecific therapeutics such as antiseizure, antidepressant, and blood pressure medications. Newer therapies known as gepants and injectable monoclonal antibodies are also available to manage and prevent episodic migraine.

Dr Nye concludes that the appropriate therapeutic goal is a reduction in headache frequency, reduction in headache severity, and improved response to medications, as well as decreasing the level of disability that patients are experiencing.

--

Barbara L. Nye, MD, Associate Professor of Neurology, Wake Forest University; Director, Headache Fellowship, Department of Neurology, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina

Barbara L. Nye, MD, has disclosed no relevant financial relationships.

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Erenumab Linked to Better Migraine Prevention

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TOPLINE:

Earlier treatment with erenumab was associated with significantly better migraine prevention than that with nonspecific oral migraine preventive medications (OMPMs) in patients with resistant episodic migraine. Based on this research, the investigators suggest clinicians should start erenumab early and not prolong use of OMPMs.

METHODOLOGY:

  • The 12-month prospective, international, multicenter, phase 4 randomized clinical APPRAISE trial included 621 adult patients (mean age, 41 years; 88% female) with a ≥ 12-month history of migraine and between 4 and 15 monthly migraine days (MMDs).
  • Primary endpoint was the proportion of patients who completed 12 months of the initially assigned treatment and experiencing a reduction of ≥ 50% from baseline in MMDs at the end of the year.
  • Secondary endpoints included cumulative mean change from baseline in MMDs during the treatment period and the proportion of responders (based on the Patients’ Global Impression of Change scale) at month 12 for patients taking the initially assigned treatment.

TAKEAWAY:

  • At month 12, patients receiving erenumab were six times more likely to report a ≥ 50% reduction in MMDs than those receiving OMPMs (odds ratio [OR], 6.48; < .001).
  • Compared with OMPMs, treatment with erenumab yielded a higher responder rate at 1 year (76% vs 19%; OR, 13.75; P < .001) and a significantly greater reduction in cumulative average MMDs (−4.32 days vs −2.65 days; P < .001).
  • Substantially, fewer patients in the erenumab vs the OMPM group switched medication (2% vs 35%) or discontinued treatment due to adverse events (3% vs 23%).
  • Incidence of treatment-emergent adverse events was similar between the treatment arms (75% vs 76%) until the researchers adjusted for exposure to treatment, which revealed a roughly 30% lower exposure-adjusted rate (per 100 patient-years) in the erenumab group.

IN PRACTICE:

“Earlier initiation of erenumab may ultimately lead to fewer patients discontinuing or switching medication in a real-world clinical practice,” the authors wrote. In addition, the findings “lend further support to the recent guideline update issued by the European Headache Federation, in which CGRP-targeted mAbs are considered a first-line treatment option for patients with migraine who require preventive treatment.”

SOURCE:

Patricia Pozo-Rosich, MD, PhD, of the Headache and Neurological Pain Research Group, Vall d’Hebron Institute of Research, Department of Medicine, Universitat Autònoma de Barcelona, Spain, and the Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain, was the lead and corresponding author of the study. It was published online in JAMA Neurology.

LIMITATIONS:

Only locally approved and marketed OMPMs at study onset were used as comparators. The open-label study design might have led to a placebo response, which could have played a role in the findings because erenumab can only be administered in a clinic and was administered subcutaneously.

DISCLOSURES:

This study was funded by Novartis Pharma AG, Basel, Switzerland. Dr. Pozo-Rosich reported receiving grants from AbbVie, Novartis, and Teva and personal fees from AbbVie, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva outside the submitted work. The other authors’ disclosures were listed on the original paper.

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

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TOPLINE:

Earlier treatment with erenumab was associated with significantly better migraine prevention than that with nonspecific oral migraine preventive medications (OMPMs) in patients with resistant episodic migraine. Based on this research, the investigators suggest clinicians should start erenumab early and not prolong use of OMPMs.

METHODOLOGY:

  • The 12-month prospective, international, multicenter, phase 4 randomized clinical APPRAISE trial included 621 adult patients (mean age, 41 years; 88% female) with a ≥ 12-month history of migraine and between 4 and 15 monthly migraine days (MMDs).
  • Primary endpoint was the proportion of patients who completed 12 months of the initially assigned treatment and experiencing a reduction of ≥ 50% from baseline in MMDs at the end of the year.
  • Secondary endpoints included cumulative mean change from baseline in MMDs during the treatment period and the proportion of responders (based on the Patients’ Global Impression of Change scale) at month 12 for patients taking the initially assigned treatment.

TAKEAWAY:

  • At month 12, patients receiving erenumab were six times more likely to report a ≥ 50% reduction in MMDs than those receiving OMPMs (odds ratio [OR], 6.48; < .001).
  • Compared with OMPMs, treatment with erenumab yielded a higher responder rate at 1 year (76% vs 19%; OR, 13.75; P < .001) and a significantly greater reduction in cumulative average MMDs (−4.32 days vs −2.65 days; P < .001).
  • Substantially, fewer patients in the erenumab vs the OMPM group switched medication (2% vs 35%) or discontinued treatment due to adverse events (3% vs 23%).
  • Incidence of treatment-emergent adverse events was similar between the treatment arms (75% vs 76%) until the researchers adjusted for exposure to treatment, which revealed a roughly 30% lower exposure-adjusted rate (per 100 patient-years) in the erenumab group.

IN PRACTICE:

“Earlier initiation of erenumab may ultimately lead to fewer patients discontinuing or switching medication in a real-world clinical practice,” the authors wrote. In addition, the findings “lend further support to the recent guideline update issued by the European Headache Federation, in which CGRP-targeted mAbs are considered a first-line treatment option for patients with migraine who require preventive treatment.”

SOURCE:

Patricia Pozo-Rosich, MD, PhD, of the Headache and Neurological Pain Research Group, Vall d’Hebron Institute of Research, Department of Medicine, Universitat Autònoma de Barcelona, Spain, and the Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain, was the lead and corresponding author of the study. It was published online in JAMA Neurology.

LIMITATIONS:

Only locally approved and marketed OMPMs at study onset were used as comparators. The open-label study design might have led to a placebo response, which could have played a role in the findings because erenumab can only be administered in a clinic and was administered subcutaneously.

DISCLOSURES:

This study was funded by Novartis Pharma AG, Basel, Switzerland. Dr. Pozo-Rosich reported receiving grants from AbbVie, Novartis, and Teva and personal fees from AbbVie, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva outside the submitted work. The other authors’ disclosures were listed on the original paper.

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

 

TOPLINE:

Earlier treatment with erenumab was associated with significantly better migraine prevention than that with nonspecific oral migraine preventive medications (OMPMs) in patients with resistant episodic migraine. Based on this research, the investigators suggest clinicians should start erenumab early and not prolong use of OMPMs.

METHODOLOGY:

  • The 12-month prospective, international, multicenter, phase 4 randomized clinical APPRAISE trial included 621 adult patients (mean age, 41 years; 88% female) with a ≥ 12-month history of migraine and between 4 and 15 monthly migraine days (MMDs).
  • Primary endpoint was the proportion of patients who completed 12 months of the initially assigned treatment and experiencing a reduction of ≥ 50% from baseline in MMDs at the end of the year.
  • Secondary endpoints included cumulative mean change from baseline in MMDs during the treatment period and the proportion of responders (based on the Patients’ Global Impression of Change scale) at month 12 for patients taking the initially assigned treatment.

TAKEAWAY:

  • At month 12, patients receiving erenumab were six times more likely to report a ≥ 50% reduction in MMDs than those receiving OMPMs (odds ratio [OR], 6.48; < .001).
  • Compared with OMPMs, treatment with erenumab yielded a higher responder rate at 1 year (76% vs 19%; OR, 13.75; P < .001) and a significantly greater reduction in cumulative average MMDs (−4.32 days vs −2.65 days; P < .001).
  • Substantially, fewer patients in the erenumab vs the OMPM group switched medication (2% vs 35%) or discontinued treatment due to adverse events (3% vs 23%).
  • Incidence of treatment-emergent adverse events was similar between the treatment arms (75% vs 76%) until the researchers adjusted for exposure to treatment, which revealed a roughly 30% lower exposure-adjusted rate (per 100 patient-years) in the erenumab group.

IN PRACTICE:

“Earlier initiation of erenumab may ultimately lead to fewer patients discontinuing or switching medication in a real-world clinical practice,” the authors wrote. In addition, the findings “lend further support to the recent guideline update issued by the European Headache Federation, in which CGRP-targeted mAbs are considered a first-line treatment option for patients with migraine who require preventive treatment.”

SOURCE:

Patricia Pozo-Rosich, MD, PhD, of the Headache and Neurological Pain Research Group, Vall d’Hebron Institute of Research, Department of Medicine, Universitat Autònoma de Barcelona, Spain, and the Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain, was the lead and corresponding author of the study. It was published online in JAMA Neurology.

LIMITATIONS:

Only locally approved and marketed OMPMs at study onset were used as comparators. The open-label study design might have led to a placebo response, which could have played a role in the findings because erenumab can only be administered in a clinic and was administered subcutaneously.

DISCLOSURES:

This study was funded by Novartis Pharma AG, Basel, Switzerland. Dr. Pozo-Rosich reported receiving grants from AbbVie, Novartis, and Teva and personal fees from AbbVie, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva outside the submitted work. The other authors’ disclosures were listed on the original paper.

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

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Commentary: Migraine and Cardiovascular Risk, April 2024

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Tue, 04/09/2024 - 17:50
Dr Moawad scans the journals so you don't have to!

Migraine is one of the most common ailments worldwide, and it is known to be a lifelong condition that often begins during adolescence and continues to affect adults of all ages. Yet, the prevalence of migraine can make patients and healthcare providers underestimate the impact of the condition on overall health, underscoring the importance of pursuing effective treatment and surveillance of comorbidities — especially cardiovascular disease.

 

A recent study, published in the March 2024 issue of Sleep Medicine, identified shift work as one of the risk factors for headache and migraine. The researchers conducted a meta-analysis, including seven studies and involving 422,869 participants. The authors defined shift work as characterized by individuals or teams working consecutively to exceed the standard 8-hour day. They reported that the pooled analysis revealed a significant association between shift work and an increased risk for headache. Specifically, they determined that "individuals working night shifts had a 44% higher risk of developing headaches and a higher incidence of migraines." The authors stated that this association did not establish any causal relationship, and they suggested that future research should investigate the impact of genetics or health behaviors, which could be considered shared risk factors.

 

An article that had been published in 2019 in Headache included two case reports detailing the effects of shift work on patients with migraine. The authors of the case reports stated that "in the two cases presented, shift work appeared to be associated with chronification of migraine and higher headache-related disability, despite optimal headache management and good patient adherence."[1] They observed that "a switch to only day shifts promoted transition to an episodic, less disabling pattern of migraine."[1] These publications both support the idea that, while patients may have an underlying predisposition to migraine, certain lifestyle factors can play a role in exacerbating symptoms.

 

Erenumab, one of the relatively new therapies for migraine, was found to have a potential link to worsening hypertension. According to an article published in February in Headache: The Journal of Head and Face Pain, there has not been evidence of hypertension in preclinical models or clinical trials, yet postmarketing data suggest that erenumab may be associated with hypertension. The authors conducted an observational retrospective cohort study that included 335 patients who had been seen at a tertiary headache or neurology department. At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The researchers observed that 23.3% (78/335) of the patients were found to have worsening hypertension, and 13 patients of the 225 who continued on erenumab experienced an improvement in their blood pressure. The authors noted that there was no association between worsening hypertension and preexisting hypertension, sex, body mass index, or age, but patients with atrial fibrillation were more likely to develop worsening hypertension (odds ratio 4.9; 95% CI 1.12-21.4; P = .035).

 

Consideration of a relationship between hypertension and anti-calcitonin gene–related peptide migraine (CGRP) therapies has been found in other studies as well. Results of a retrospective study conducted at the University Hospital of Modena, to explore the rate of hypertension among patients treated with anti-CGRP monoclonal antibodies, were published in April 2024 in Neurological Sciences (published online November 6, 2023). Those authors reported that no significant increase in blood pressure was detected overall, yet 5.7% of the patients developed a significant increase in their blood pressure.[2] Specifically, the researchers reported that patients with preexisting hypertension were more likely to have a significant increase in blood pressure.[2] The study authors of the Neurological Sciences publication suggested that patients with preexisting hypertension should be cautiously monitored for signs of hypertension. A more recent publication noted that "CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension," which could explain these findings. As the two studies noted different underlying risk factors for hypertension for patients taking anti-CGRP migraine therapies, it is important to monitor patients for signs of hypertension regardless of their underlying cardiovascular status.

 

Migraine was also noted to potentially be associated with an increased risk for cerebrovascular disease and stroke among women who have underlying cardiovascular disease risk factors. According to a cross-sectional analysis whose results were published in Mayo Clinic Proceedings in May 2023, women with migraine were significantly more likely to have severe hot flashes compared with women without migraine.[3] Additionally, the authors stated that migraine was associated with a diagnosis of hypertension.[3]

 

Results of a secondary data analysis of a subset of 1954 women in the Coronary Artery Risk Development in Young Adults (CARDIA) study were published in the April 2024 issue of Menopause. After adjustment for age, race, estrogen use, oophorectomy, and hysterectomy, women with histories of migraine and persistent vasomotor symptoms were found to have a greater risk for cerebrovascular disease (hazard ratio [HR] 2.25; 95% CI 1.15-4.38), and stroke (HR 3.15; 95% CI 1.35-7.34), compared with women without migraine histories and with minimal vasomotor symptoms. After adjustment for cerebrovascular disease risk factors, the associations between migraine/vasomotor symptoms and cerebrovascular disease were attenuated (HR 1.51; 95% CI 0.73-3.10), and associations between migraine/vasomotor symptoms and stroke were similarly attenuated (HR 1.70; 95% CI 0.66-4.38). The authors of this research article concluded that migraine and persistent vasomotor symptoms are jointly associated with greater risk for cerebrovascular disease and stroke, particularly for women who already have traditional risk factors for cerebrovascular disease.

 

This new research brings the importance of managing migraine risk factors and symptoms to the forefront. Patients who experience migraine may have a higher risk for cerebrovascular disease. Minimizing migraine risk factors could potentially help reduce this risk for cerebrovascular disease for some patients, and effectively treating migraines may also play a role in reducing the risk for cerebrovascular disease. Some migraine therapies could worsen cardiovascular disease for some patients, however — particularly patients who already have underlying risk factors. Therefore, it is crucial for physicians to approach migraine care with a comprehensive strategy to reduce risk factors, assess underlying disease, and monitor for comorbidities.

 

Additional References

 

1. Sandoe CH, Sasikumar S, Lay C, Lawler V. The impact of shift work on migraine: A case series and narrative review. Headache. 2019;59:1631-1640. doi: 10.1111/head.13622  Source

 

2. Guerzoni S, Castro FL, Brovia D, Baraldi C, Pani L. Evaluation of the risk of hypertension in patients treated with anti-CGRP monoclonal antibodies in a real-life study. Neurol Sci. 2024;45:1661-1668. doi: 10.1007/s10072-023-07167-z Source

 

3. Faubion SS, Smith T, Thielen J, et al. Association of migraine and vasomotor symptoms. Mayo Clin Proc. 2023;98:701-712. doi: 10.1016/j.mayocp.2023.01.010 Source

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Case Western Reserve School of Medicine
Cleveland, OH

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Dr Moawad scans the journals so you don't have to!
Dr Moawad scans the journals so you don't have to!

Migraine is one of the most common ailments worldwide, and it is known to be a lifelong condition that often begins during adolescence and continues to affect adults of all ages. Yet, the prevalence of migraine can make patients and healthcare providers underestimate the impact of the condition on overall health, underscoring the importance of pursuing effective treatment and surveillance of comorbidities — especially cardiovascular disease.

 

A recent study, published in the March 2024 issue of Sleep Medicine, identified shift work as one of the risk factors for headache and migraine. The researchers conducted a meta-analysis, including seven studies and involving 422,869 participants. The authors defined shift work as characterized by individuals or teams working consecutively to exceed the standard 8-hour day. They reported that the pooled analysis revealed a significant association between shift work and an increased risk for headache. Specifically, they determined that "individuals working night shifts had a 44% higher risk of developing headaches and a higher incidence of migraines." The authors stated that this association did not establish any causal relationship, and they suggested that future research should investigate the impact of genetics or health behaviors, which could be considered shared risk factors.

 

An article that had been published in 2019 in Headache included two case reports detailing the effects of shift work on patients with migraine. The authors of the case reports stated that "in the two cases presented, shift work appeared to be associated with chronification of migraine and higher headache-related disability, despite optimal headache management and good patient adherence."[1] They observed that "a switch to only day shifts promoted transition to an episodic, less disabling pattern of migraine."[1] These publications both support the idea that, while patients may have an underlying predisposition to migraine, certain lifestyle factors can play a role in exacerbating symptoms.

 

Erenumab, one of the relatively new therapies for migraine, was found to have a potential link to worsening hypertension. According to an article published in February in Headache: The Journal of Head and Face Pain, there has not been evidence of hypertension in preclinical models or clinical trials, yet postmarketing data suggest that erenumab may be associated with hypertension. The authors conducted an observational retrospective cohort study that included 335 patients who had been seen at a tertiary headache or neurology department. At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The researchers observed that 23.3% (78/335) of the patients were found to have worsening hypertension, and 13 patients of the 225 who continued on erenumab experienced an improvement in their blood pressure. The authors noted that there was no association between worsening hypertension and preexisting hypertension, sex, body mass index, or age, but patients with atrial fibrillation were more likely to develop worsening hypertension (odds ratio 4.9; 95% CI 1.12-21.4; P = .035).

 

Consideration of a relationship between hypertension and anti-calcitonin gene–related peptide migraine (CGRP) therapies has been found in other studies as well. Results of a retrospective study conducted at the University Hospital of Modena, to explore the rate of hypertension among patients treated with anti-CGRP monoclonal antibodies, were published in April 2024 in Neurological Sciences (published online November 6, 2023). Those authors reported that no significant increase in blood pressure was detected overall, yet 5.7% of the patients developed a significant increase in their blood pressure.[2] Specifically, the researchers reported that patients with preexisting hypertension were more likely to have a significant increase in blood pressure.[2] The study authors of the Neurological Sciences publication suggested that patients with preexisting hypertension should be cautiously monitored for signs of hypertension. A more recent publication noted that "CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension," which could explain these findings. As the two studies noted different underlying risk factors for hypertension for patients taking anti-CGRP migraine therapies, it is important to monitor patients for signs of hypertension regardless of their underlying cardiovascular status.

 

Migraine was also noted to potentially be associated with an increased risk for cerebrovascular disease and stroke among women who have underlying cardiovascular disease risk factors. According to a cross-sectional analysis whose results were published in Mayo Clinic Proceedings in May 2023, women with migraine were significantly more likely to have severe hot flashes compared with women without migraine.[3] Additionally, the authors stated that migraine was associated with a diagnosis of hypertension.[3]

 

Results of a secondary data analysis of a subset of 1954 women in the Coronary Artery Risk Development in Young Adults (CARDIA) study were published in the April 2024 issue of Menopause. After adjustment for age, race, estrogen use, oophorectomy, and hysterectomy, women with histories of migraine and persistent vasomotor symptoms were found to have a greater risk for cerebrovascular disease (hazard ratio [HR] 2.25; 95% CI 1.15-4.38), and stroke (HR 3.15; 95% CI 1.35-7.34), compared with women without migraine histories and with minimal vasomotor symptoms. After adjustment for cerebrovascular disease risk factors, the associations between migraine/vasomotor symptoms and cerebrovascular disease were attenuated (HR 1.51; 95% CI 0.73-3.10), and associations between migraine/vasomotor symptoms and stroke were similarly attenuated (HR 1.70; 95% CI 0.66-4.38). The authors of this research article concluded that migraine and persistent vasomotor symptoms are jointly associated with greater risk for cerebrovascular disease and stroke, particularly for women who already have traditional risk factors for cerebrovascular disease.

 

This new research brings the importance of managing migraine risk factors and symptoms to the forefront. Patients who experience migraine may have a higher risk for cerebrovascular disease. Minimizing migraine risk factors could potentially help reduce this risk for cerebrovascular disease for some patients, and effectively treating migraines may also play a role in reducing the risk for cerebrovascular disease. Some migraine therapies could worsen cardiovascular disease for some patients, however — particularly patients who already have underlying risk factors. Therefore, it is crucial for physicians to approach migraine care with a comprehensive strategy to reduce risk factors, assess underlying disease, and monitor for comorbidities.

 

Additional References

 

1. Sandoe CH, Sasikumar S, Lay C, Lawler V. The impact of shift work on migraine: A case series and narrative review. Headache. 2019;59:1631-1640. doi: 10.1111/head.13622  Source

 

2. Guerzoni S, Castro FL, Brovia D, Baraldi C, Pani L. Evaluation of the risk of hypertension in patients treated with anti-CGRP monoclonal antibodies in a real-life study. Neurol Sci. 2024;45:1661-1668. doi: 10.1007/s10072-023-07167-z Source

 

3. Faubion SS, Smith T, Thielen J, et al. Association of migraine and vasomotor symptoms. Mayo Clin Proc. 2023;98:701-712. doi: 10.1016/j.mayocp.2023.01.010 Source

Migraine is one of the most common ailments worldwide, and it is known to be a lifelong condition that often begins during adolescence and continues to affect adults of all ages. Yet, the prevalence of migraine can make patients and healthcare providers underestimate the impact of the condition on overall health, underscoring the importance of pursuing effective treatment and surveillance of comorbidities — especially cardiovascular disease.

 

A recent study, published in the March 2024 issue of Sleep Medicine, identified shift work as one of the risk factors for headache and migraine. The researchers conducted a meta-analysis, including seven studies and involving 422,869 participants. The authors defined shift work as characterized by individuals or teams working consecutively to exceed the standard 8-hour day. They reported that the pooled analysis revealed a significant association between shift work and an increased risk for headache. Specifically, they determined that "individuals working night shifts had a 44% higher risk of developing headaches and a higher incidence of migraines." The authors stated that this association did not establish any causal relationship, and they suggested that future research should investigate the impact of genetics or health behaviors, which could be considered shared risk factors.

 

An article that had been published in 2019 in Headache included two case reports detailing the effects of shift work on patients with migraine. The authors of the case reports stated that "in the two cases presented, shift work appeared to be associated with chronification of migraine and higher headache-related disability, despite optimal headache management and good patient adherence."[1] They observed that "a switch to only day shifts promoted transition to an episodic, less disabling pattern of migraine."[1] These publications both support the idea that, while patients may have an underlying predisposition to migraine, certain lifestyle factors can play a role in exacerbating symptoms.

 

Erenumab, one of the relatively new therapies for migraine, was found to have a potential link to worsening hypertension. According to an article published in February in Headache: The Journal of Head and Face Pain, there has not been evidence of hypertension in preclinical models or clinical trials, yet postmarketing data suggest that erenumab may be associated with hypertension. The authors conducted an observational retrospective cohort study that included 335 patients who had been seen at a tertiary headache or neurology department. At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The researchers observed that 23.3% (78/335) of the patients were found to have worsening hypertension, and 13 patients of the 225 who continued on erenumab experienced an improvement in their blood pressure. The authors noted that there was no association between worsening hypertension and preexisting hypertension, sex, body mass index, or age, but patients with atrial fibrillation were more likely to develop worsening hypertension (odds ratio 4.9; 95% CI 1.12-21.4; P = .035).

 

Consideration of a relationship between hypertension and anti-calcitonin gene–related peptide migraine (CGRP) therapies has been found in other studies as well. Results of a retrospective study conducted at the University Hospital of Modena, to explore the rate of hypertension among patients treated with anti-CGRP monoclonal antibodies, were published in April 2024 in Neurological Sciences (published online November 6, 2023). Those authors reported that no significant increase in blood pressure was detected overall, yet 5.7% of the patients developed a significant increase in their blood pressure.[2] Specifically, the researchers reported that patients with preexisting hypertension were more likely to have a significant increase in blood pressure.[2] The study authors of the Neurological Sciences publication suggested that patients with preexisting hypertension should be cautiously monitored for signs of hypertension. A more recent publication noted that "CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension," which could explain these findings. As the two studies noted different underlying risk factors for hypertension for patients taking anti-CGRP migraine therapies, it is important to monitor patients for signs of hypertension regardless of their underlying cardiovascular status.

 

Migraine was also noted to potentially be associated with an increased risk for cerebrovascular disease and stroke among women who have underlying cardiovascular disease risk factors. According to a cross-sectional analysis whose results were published in Mayo Clinic Proceedings in May 2023, women with migraine were significantly more likely to have severe hot flashes compared with women without migraine.[3] Additionally, the authors stated that migraine was associated with a diagnosis of hypertension.[3]

 

Results of a secondary data analysis of a subset of 1954 women in the Coronary Artery Risk Development in Young Adults (CARDIA) study were published in the April 2024 issue of Menopause. After adjustment for age, race, estrogen use, oophorectomy, and hysterectomy, women with histories of migraine and persistent vasomotor symptoms were found to have a greater risk for cerebrovascular disease (hazard ratio [HR] 2.25; 95% CI 1.15-4.38), and stroke (HR 3.15; 95% CI 1.35-7.34), compared with women without migraine histories and with minimal vasomotor symptoms. After adjustment for cerebrovascular disease risk factors, the associations between migraine/vasomotor symptoms and cerebrovascular disease were attenuated (HR 1.51; 95% CI 0.73-3.10), and associations between migraine/vasomotor symptoms and stroke were similarly attenuated (HR 1.70; 95% CI 0.66-4.38). The authors of this research article concluded that migraine and persistent vasomotor symptoms are jointly associated with greater risk for cerebrovascular disease and stroke, particularly for women who already have traditional risk factors for cerebrovascular disease.

 

This new research brings the importance of managing migraine risk factors and symptoms to the forefront. Patients who experience migraine may have a higher risk for cerebrovascular disease. Minimizing migraine risk factors could potentially help reduce this risk for cerebrovascular disease for some patients, and effectively treating migraines may also play a role in reducing the risk for cerebrovascular disease. Some migraine therapies could worsen cardiovascular disease for some patients, however — particularly patients who already have underlying risk factors. Therefore, it is crucial for physicians to approach migraine care with a comprehensive strategy to reduce risk factors, assess underlying disease, and monitor for comorbidities.

 

Additional References

 

1. Sandoe CH, Sasikumar S, Lay C, Lawler V. The impact of shift work on migraine: A case series and narrative review. Headache. 2019;59:1631-1640. doi: 10.1111/head.13622  Source

 

2. Guerzoni S, Castro FL, Brovia D, Baraldi C, Pani L. Evaluation of the risk of hypertension in patients treated with anti-CGRP monoclonal antibodies in a real-life study. Neurol Sci. 2024;45:1661-1668. doi: 10.1007/s10072-023-07167-z Source

 

3. Faubion SS, Smith T, Thielen J, et al. Association of migraine and vasomotor symptoms. Mayo Clin Proc. 2023;98:701-712. doi: 10.1016/j.mayocp.2023.01.010 Source

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