Migraine ICYMI

Key clinical point: Erenumab treatment significantly improved the number of headache days in patients with onabotulinumtoxinA-resistant chronic migraine.

Major finding: Erenumab significantly reduced the number of headache days that limited activities of daily living at 3 months (−6.4 days), 6 months (−6.8 days), and 9 months (−6.5 days; P for all = .001).

Study details: Real-world outcomes were assessed in 98 patients with difficult-to-control chronic migraine and a prior unsatisfactory response to onabotulinumtoxinA.

Disclosures: This study did not receive any funding. Erenumab was provided free of charge by Novartis. S Weatherby attended conferences/received speakers fees from Novartis.

Source:Talbot J et al. J Headache Pain. 2021 Jan 9. doi: 10.1186/s10194-020-01214-2.

Key clinical point: Erenumab treatment significantly improved the number of headache days in patients with onabotulinumtoxinA-resistant chronic migraine.

Major finding: Erenumab significantly reduced the number of headache days that limited activities of daily living at 3 months (−6.4 days), 6 months (−6.8 days), and 9 months (−6.5 days; P for all = .001).

Study details: Real-world outcomes were assessed in 98 patients with difficult-to-control chronic migraine and a prior unsatisfactory response to onabotulinumtoxinA.

Disclosures: This study did not receive any funding. Erenumab was provided free of charge by Novartis. S Weatherby attended conferences/received speakers fees from Novartis.

Source:Talbot J et al. J Headache Pain. 2021 Jan 9. doi: 10.1186/s10194-020-01214-2.

Key clinical point: Erenumab treatment significantly improved the number of headache days in patients with onabotulinumtoxinA-resistant chronic migraine.

Major finding: Erenumab significantly reduced the number of headache days that limited activities of daily living at 3 months (−6.4 days), 6 months (−6.8 days), and 9 months (−6.5 days; P for all = .001).

Study details: Real-world outcomes were assessed in 98 patients with difficult-to-control chronic migraine and a prior unsatisfactory response to onabotulinumtoxinA.

Disclosures: This study did not receive any funding. Erenumab was provided free of charge by Novartis. S Weatherby attended conferences/received speakers fees from Novartis.

Source:Talbot J et al. J Headache Pain. 2021 Jan 9. doi: 10.1186/s10194-020-01214-2.

Key clinical point: People with a history of migraine are more than twice as likely as those with no such history to have irritable bowel syndrome (IBS).

Major finding: IBS odds were significantly higher in patients with migraine vs. those without: overall (pooled odds ratio [OR], 2.49; 95% confidence interval [CI], 2.22-2.78); migraine with aura (pooled OR, 3.03; 95% CI, 1.72-5.35); and migraine without aura (pooled OR, 2.20; 95% CI, 1.49-3.25).

Study details: Meta-analysis of 11 studies including 28,336 migraineurs and 1,535,758 nonmigraineurs.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source:Wongtrakul W et al. Eur J Gastroenterol Hepatol. 2021 Jan 18. doi: 10.1097/MEG.0000000000002065.

Key clinical point: People with a history of migraine are more than twice as likely as those with no such history to have irritable bowel syndrome (IBS).

Major finding: IBS odds were significantly higher in patients with migraine vs. those without: overall (pooled odds ratio [OR], 2.49; 95% confidence interval [CI], 2.22-2.78); migraine with aura (pooled OR, 3.03; 95% CI, 1.72-5.35); and migraine without aura (pooled OR, 2.20; 95% CI, 1.49-3.25).

Study details: Meta-analysis of 11 studies including 28,336 migraineurs and 1,535,758 nonmigraineurs.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source:Wongtrakul W et al. Eur J Gastroenterol Hepatol. 2021 Jan 18. doi: 10.1097/MEG.0000000000002065.

Key clinical point: People with a history of migraine are more than twice as likely as those with no such history to have irritable bowel syndrome (IBS).

Major finding: IBS odds were significantly higher in patients with migraine vs. those without: overall (pooled odds ratio [OR], 2.49; 95% confidence interval [CI], 2.22-2.78); migraine with aura (pooled OR, 3.03; 95% CI, 1.72-5.35); and migraine without aura (pooled OR, 2.20; 95% CI, 1.49-3.25).

Study details: Meta-analysis of 11 studies including 28,336 migraineurs and 1,535,758 nonmigraineurs.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source:Wongtrakul W et al. Eur J Gastroenterol Hepatol. 2021 Jan 18. doi: 10.1097/MEG.0000000000002065.

Key clinical point: Patients with migraine who showed a favorable response to at least one triptan had a higher likelihood to respond to erenumab treatment than those not responding to triptans.

Major finding: Triptan responders had higher odds for responding to erenumab treatment than the triptan nonresponders (odds ratio, 3.64; P = .014).

Study details: Findings are from an ancillary study from a real-life observational study involving 140 patients with migraine treated with erenumab for at least 6 months.

Disclosures: The publication fee was unconditionally granted by Novartis Farma S.r.l. The lead author along with some other authors declared no competing interests. Some authors declared financial and nonfinancial relationships with various pharmaceutical sources such as Eli Lilly, Novartis, Allergan, Teva, Abbott, Innovet Italia Srl, Epitech Group, and Lusofarmaco.

Source:Frattale I et al. J Headache Pain. 2021 Jan 6. doi: 10.1186/s10194-020-01213-3.

Key clinical point: Patients with migraine who showed a favorable response to at least one triptan had a higher likelihood to respond to erenumab treatment than those not responding to triptans.

Major finding: Triptan responders had higher odds for responding to erenumab treatment than the triptan nonresponders (odds ratio, 3.64; P = .014).

Study details: Findings are from an ancillary study from a real-life observational study involving 140 patients with migraine treated with erenumab for at least 6 months.

Disclosures: The publication fee was unconditionally granted by Novartis Farma S.r.l. The lead author along with some other authors declared no competing interests. Some authors declared financial and nonfinancial relationships with various pharmaceutical sources such as Eli Lilly, Novartis, Allergan, Teva, Abbott, Innovet Italia Srl, Epitech Group, and Lusofarmaco.

Source:Frattale I et al. J Headache Pain. 2021 Jan 6. doi: 10.1186/s10194-020-01213-3.

Key clinical point: Patients with migraine who showed a favorable response to at least one triptan had a higher likelihood to respond to erenumab treatment than those not responding to triptans.

Major finding: Triptan responders had higher odds for responding to erenumab treatment than the triptan nonresponders (odds ratio, 3.64; P = .014).

Study details: Findings are from an ancillary study from a real-life observational study involving 140 patients with migraine treated with erenumab for at least 6 months.

Disclosures: The publication fee was unconditionally granted by Novartis Farma S.r.l. The lead author along with some other authors declared no competing interests. Some authors declared financial and nonfinancial relationships with various pharmaceutical sources such as Eli Lilly, Novartis, Allergan, Teva, Abbott, Innovet Italia Srl, Epitech Group, and Lusofarmaco.

Source:Frattale I et al. J Headache Pain. 2021 Jan 6. doi: 10.1186/s10194-020-01213-3.

Although coronavirus 19 disease (COVID-19), caused by severe acute respiratory coronavirus 2, is characterized by symptoms that primarily impact the respiratory system, many patients experience neurological manifestations, with headache among leading complaints. Moreover, headache symptoms, including migraine-like headache, can last long after patients recover from COVID-19. 

Last November, in an interview with 60 Minutes,  Sadie Nagamootoo described her experience. “There are days when I do nothing and cannot get out of bed. The migraines are 10 times worse than a flu headache.”

To help individuals like Nagamootoo and others who experience headache as a result of COVID-19, it is important to understand the data that are emerging and how to incorporate them into practice. Following are answers to important questions that can guide front-line neurologists and other clinicians who are practicing during the pandemic.

Why is headache a symptom of COVID-19? It should come as no surprise that patients with COVID-19 can experience headache. Peng reminds us, in a November 2020 editorial in Cephalalgia, that headache is a common symptom in individuals with acute respiratory disease, representing a physiological response to acute infection. Headache is often the primary reason patients seek treatment. 

How is headache associated with COVID-19? It is too early to know with certainty the mechanisms underlying COVID-19 headache, but a possible explanation—according to Uygun and colleagues, writing in the The Journal of Headache and Pain—is that the virus directly invades trigeminal nerve endings in the nasal and oral cavities. 

How does headache tend to present in COVID-19? Patricia Pozo-Rosich, MD, PhD, presented on this topic at the American Headache Society’s 2020 Virtual Annual Scientific Meeting in June. In a recent interview with Neurology Reviews,  Dr. Pozo-Rosich, head of the Headache & Craniofacial Pain Unit at Vall d’Hebron University Hospital, Barcelona, Spain, noted that “headache seems to have 2 different presentations: 1) migraine-like characteristics that are severe, disabling, and usually start before other COVID symptoms and 2) tension-type headache characteristics, which usually start together with the rest of COVID symptoms.”

Are there symptoms that tend to occur more frequently in patients with COVID-19 and headache? Caronna and colleagues recently published an analysis in Cephalalgia of 130 individuals with COVID-19, showing that loss of smell and/or taste occurred in more than half of patients with headache, compared with fewer than 20% of those without headache. This finding is notable because it has been frequently reported in case reports of patients with COVID-19 and headache.

What does the presence of headache indicate about COVID-19 prognosis? The good news for individuals with COVID-19 who experience headache is that the duration of their COVID-19 illness might very well be shorter. In the Caronna study, COVID-19 duration in individuals with headache was, on average, 1 week shorter (24 days) than in those without headache symptoms (31 days).  “We don’t know why,” said Dr. Pozo-Rosich, who is one of the study’s authors. She hypothesizes that it is because of a balance between neuroinflammation and systemic inflammation. “Having an extraordinary initial reaction at the nasal cavity might protect us from having greater systemic inflammation.”

What is the cause of headache from COVID-19? Bolay and colleagues reported in Headache in Spring 2020 that patients developed new-onset, moderate-to-severe, bilateral pulsating or pressing headache toward the frontal area and forehead during the viral phase of disease. The virus activates peripheral trigeminal nerve endings directly or through vasculopathy and/or increased circulating pro-inflammatory cytokines.

What else is important to be aware of regarding headache evolution in individuals with COVID-19? The bad news for many of these individuals is that, although their COVID-19 illness might dissipate more quickly, headaches could linger. Moreover, many will be experiencing chronic headache for the first time in their life. Caronna reported that that one third of follow-up patients who reported headache were experiencing persistent disabling headache daily after 6 weeks, and more than half had no history of recurrent headache.

What is the recommended treatment for headache associated with COVID-19? Dr. Pozo-Rosich recommends starting with a nonsteroidal anti-inflammatory medication. Eventually, steroids might be indicated, “especially if the disease progresses.”

It is important for neurologists to be aware of new-onset headache associated with anosmia early in the disease. Test for the virus in such a patient; hopefully, their course will be shorter, milder, and non-respiratory.

Although coronavirus 19 disease (COVID-19), caused by severe acute respiratory coronavirus 2, is characterized by symptoms that primarily impact the respiratory system, many patients experience neurological manifestations, with headache among leading complaints. Moreover, headache symptoms, including migraine-like headache, can last long after patients recover from COVID-19. 

Last November, in an interview with 60 Minutes,  Sadie Nagamootoo described her experience. “There are days when I do nothing and cannot get out of bed. The migraines are 10 times worse than a flu headache.”

To help individuals like Nagamootoo and others who experience headache as a result of COVID-19, it is important to understand the data that are emerging and how to incorporate them into practice. Following are answers to important questions that can guide front-line neurologists and other clinicians who are practicing during the pandemic.

Why is headache a symptom of COVID-19? It should come as no surprise that patients with COVID-19 can experience headache. Peng reminds us, in a November 2020 editorial in Cephalalgia, that headache is a common symptom in individuals with acute respiratory disease, representing a physiological response to acute infection. Headache is often the primary reason patients seek treatment. 

How is headache associated with COVID-19? It is too early to know with certainty the mechanisms underlying COVID-19 headache, but a possible explanation—according to Uygun and colleagues, writing in the The Journal of Headache and Pain—is that the virus directly invades trigeminal nerve endings in the nasal and oral cavities. 

How does headache tend to present in COVID-19? Patricia Pozo-Rosich, MD, PhD, presented on this topic at the American Headache Society’s 2020 Virtual Annual Scientific Meeting in June. In a recent interview with Neurology Reviews,  Dr. Pozo-Rosich, head of the Headache & Craniofacial Pain Unit at Vall d’Hebron University Hospital, Barcelona, Spain, noted that “headache seems to have 2 different presentations: 1) migraine-like characteristics that are severe, disabling, and usually start before other COVID symptoms and 2) tension-type headache characteristics, which usually start together with the rest of COVID symptoms.”

Are there symptoms that tend to occur more frequently in patients with COVID-19 and headache? Caronna and colleagues recently published an analysis in Cephalalgia of 130 individuals with COVID-19, showing that loss of smell and/or taste occurred in more than half of patients with headache, compared with fewer than 20% of those without headache. This finding is notable because it has been frequently reported in case reports of patients with COVID-19 and headache.

What does the presence of headache indicate about COVID-19 prognosis? The good news for individuals with COVID-19 who experience headache is that the duration of their COVID-19 illness might very well be shorter. In the Caronna study, COVID-19 duration in individuals with headache was, on average, 1 week shorter (24 days) than in those without headache symptoms (31 days).  “We don’t know why,” said Dr. Pozo-Rosich, who is one of the study’s authors. She hypothesizes that it is because of a balance between neuroinflammation and systemic inflammation. “Having an extraordinary initial reaction at the nasal cavity might protect us from having greater systemic inflammation.”

What is the cause of headache from COVID-19? Bolay and colleagues reported in Headache in Spring 2020 that patients developed new-onset, moderate-to-severe, bilateral pulsating or pressing headache toward the frontal area and forehead during the viral phase of disease. The virus activates peripheral trigeminal nerve endings directly or through vasculopathy and/or increased circulating pro-inflammatory cytokines.

What else is important to be aware of regarding headache evolution in individuals with COVID-19? The bad news for many of these individuals is that, although their COVID-19 illness might dissipate more quickly, headaches could linger. Moreover, many will be experiencing chronic headache for the first time in their life. Caronna reported that that one third of follow-up patients who reported headache were experiencing persistent disabling headache daily after 6 weeks, and more than half had no history of recurrent headache.

What is the recommended treatment for headache associated with COVID-19? Dr. Pozo-Rosich recommends starting with a nonsteroidal anti-inflammatory medication. Eventually, steroids might be indicated, “especially if the disease progresses.”

It is important for neurologists to be aware of new-onset headache associated with anosmia early in the disease. Test for the virus in such a patient; hopefully, their course will be shorter, milder, and non-respiratory.

Although coronavirus 19 disease (COVID-19), caused by severe acute respiratory coronavirus 2, is characterized by symptoms that primarily impact the respiratory system, many patients experience neurological manifestations, with headache among leading complaints. Moreover, headache symptoms, including migraine-like headache, can last long after patients recover from COVID-19. 

Last November, in an interview with 60 Minutes,  Sadie Nagamootoo described her experience. “There are days when I do nothing and cannot get out of bed. The migraines are 10 times worse than a flu headache.”

To help individuals like Nagamootoo and others who experience headache as a result of COVID-19, it is important to understand the data that are emerging and how to incorporate them into practice. Following are answers to important questions that can guide front-line neurologists and other clinicians who are practicing during the pandemic.

Why is headache a symptom of COVID-19? It should come as no surprise that patients with COVID-19 can experience headache. Peng reminds us, in a November 2020 editorial in Cephalalgia, that headache is a common symptom in individuals with acute respiratory disease, representing a physiological response to acute infection. Headache is often the primary reason patients seek treatment. 

How is headache associated with COVID-19? It is too early to know with certainty the mechanisms underlying COVID-19 headache, but a possible explanation—according to Uygun and colleagues, writing in the The Journal of Headache and Pain—is that the virus directly invades trigeminal nerve endings in the nasal and oral cavities. 

How does headache tend to present in COVID-19? Patricia Pozo-Rosich, MD, PhD, presented on this topic at the American Headache Society’s 2020 Virtual Annual Scientific Meeting in June. In a recent interview with Neurology Reviews,  Dr. Pozo-Rosich, head of the Headache & Craniofacial Pain Unit at Vall d’Hebron University Hospital, Barcelona, Spain, noted that “headache seems to have 2 different presentations: 1) migraine-like characteristics that are severe, disabling, and usually start before other COVID symptoms and 2) tension-type headache characteristics, which usually start together with the rest of COVID symptoms.”

Are there symptoms that tend to occur more frequently in patients with COVID-19 and headache? Caronna and colleagues recently published an analysis in Cephalalgia of 130 individuals with COVID-19, showing that loss of smell and/or taste occurred in more than half of patients with headache, compared with fewer than 20% of those without headache. This finding is notable because it has been frequently reported in case reports of patients with COVID-19 and headache.

What does the presence of headache indicate about COVID-19 prognosis? The good news for individuals with COVID-19 who experience headache is that the duration of their COVID-19 illness might very well be shorter. In the Caronna study, COVID-19 duration in individuals with headache was, on average, 1 week shorter (24 days) than in those without headache symptoms (31 days).  “We don’t know why,” said Dr. Pozo-Rosich, who is one of the study’s authors. She hypothesizes that it is because of a balance between neuroinflammation and systemic inflammation. “Having an extraordinary initial reaction at the nasal cavity might protect us from having greater systemic inflammation.”

What is the cause of headache from COVID-19? Bolay and colleagues reported in Headache in Spring 2020 that patients developed new-onset, moderate-to-severe, bilateral pulsating or pressing headache toward the frontal area and forehead during the viral phase of disease. The virus activates peripheral trigeminal nerve endings directly or through vasculopathy and/or increased circulating pro-inflammatory cytokines.

What else is important to be aware of regarding headache evolution in individuals with COVID-19? The bad news for many of these individuals is that, although their COVID-19 illness might dissipate more quickly, headaches could linger. Moreover, many will be experiencing chronic headache for the first time in their life. Caronna reported that that one third of follow-up patients who reported headache were experiencing persistent disabling headache daily after 6 weeks, and more than half had no history of recurrent headache.

What is the recommended treatment for headache associated with COVID-19? Dr. Pozo-Rosich recommends starting with a nonsteroidal anti-inflammatory medication. Eventually, steroids might be indicated, “especially if the disease progresses.”

It is important for neurologists to be aware of new-onset headache associated with anosmia early in the disease. Test for the virus in such a patient; hopefully, their course will be shorter, milder, and non-respiratory.

Patients with cluster headache face a double whammy: Physicians too often fail to recognize it, and their condition is among the most severe and debilitating among headache types. In fact, a new survey of patients with cluster headache shows that they rank the pain as worse than most other painful experiences in life, including childbirth, passing of kidney stones, and pancreatitis, among others.

The study’s comparison of cluster headaches to other common painful experiences can help nonsufferers relate to the experience, said Larry Schor, PhD, a coauthor of the paper. “Headache is a terrible word. Bee stings sting, burns burn. [A cluster headache] doesn’t ache. It’s a piercing intensity like you just can’t believe,” said Dr. Schor, professor of psychology at the University of West Georgia, Carrollton, and a cluster headache patient since he first experienced an attack at the age of 21.

The study was published in the January 2021 issue of Headache.

Ranking cluster headaches as worse than experiences such as childbirth or kidney stones is “kind of eye opening, and helps to describe the experience in terms that more people can relate to. I think it helps to share the experience of cluster headache more broadly, because we’re in a situation where cluster headache remains underfunded, and we don’t have enough treatments for it. I think one way to overcome that is to spread awareness of what this problem is, and the impact it has on human life,” said Rashmi Halker Singh, MD, associate professor of neurology at the Mayo Clinic in Scottsdale, Ariz., and deputy editor of Headache. She was not involved in the study.

Dr. Schor called for physicians to consider cluster headache an emergency, because of the severity of pain and also the potential for suicidality. Treatments remain comparatively sparse, but high-flow oxygen can help some patients, and intranasal or intravenous triptans can treat acute pain. In 2018, the Food and Drug Administration approved galcanezumab (Eli Lilly) for prevention of episodic cluster headaches.

But cluster headaches are often misdiagnosed. For many patients, it takes more than a year or even as long as 5 years to get an accurate diagnosis, according to Dr. Schor. Women may be particularly vulnerable to misdiagnosis, because migraines are more common in women. It doesn’t help that many neurologists are taught that cluster headache is primarily a male disease. “Because that idea is so ingrained, I think a lot of women who have cluster headache are probably missed and told they have migraine instead. There are a lot of women who have cluster headache, and that gender difference might not be as big a difference as we were initially taught. We need to do a better job of recognizing cluster headache to better understand what the true prevalence is,” said Dr. Halker Singh.

She noted that patients with side-locked headache should be evaluated for cluster headache, and asked how long the pain lasts in the absence of medication. “Also ask about the presence of cranial autonomic symptoms, and if they occur in the context of headache pain, and if they are side-locked to the side of the headache. Those are important questions that can tease out cluster headache from other conditions,” said Dr. Halker Singh.

For the survey, the researchers asked 1,604 patients with cluster headache patients to rate pain on a scale of 1 to 10. Cluster headache ranked highest at 9.7, then labor pain (7.2), pancreatitis (7.0), and nephrolithiasis (6.9). Cluster headache pain was ranked at 10.0 by 72.1% of respondents. Those reporting maximal pain or were more likely to have cranial autonomic features in comparison with patients who reported less pain, including conjunctival injection or lacrimation (91% versus 85%), eyelid edema (77% versus 66%), forehead/facial sweating (60% versus 49%), fullness in the ear (47% versus 35%), and miosis or ptosis (85% versus 75%). They had more frequent attacks (4.0 versus 3.5 per day), higher Hopelessness Depression Symptom Questionnaire scores (24.5 versus 21.1), and reduced effectiveness of calcium channel blockers (2.2 versus 2.5 on a 5-point Likert scale). They were more often female (34% versus 24%). (P < .001 for all).

The study received funding from Autonomic Technologies and Cluster Busters. Dr. Schor and Dr. Halker Singh had no relevant financial disclosures.

Patients with cluster headache face a double whammy: Physicians too often fail to recognize it, and their condition is among the most severe and debilitating among headache types. In fact, a new survey of patients with cluster headache shows that they rank the pain as worse than most other painful experiences in life, including childbirth, passing of kidney stones, and pancreatitis, among others.

The study’s comparison of cluster headaches to other common painful experiences can help nonsufferers relate to the experience, said Larry Schor, PhD, a coauthor of the paper. “Headache is a terrible word. Bee stings sting, burns burn. [A cluster headache] doesn’t ache. It’s a piercing intensity like you just can’t believe,” said Dr. Schor, professor of psychology at the University of West Georgia, Carrollton, and a cluster headache patient since he first experienced an attack at the age of 21.

The study was published in the January 2021 issue of Headache.

Ranking cluster headaches as worse than experiences such as childbirth or kidney stones is “kind of eye opening, and helps to describe the experience in terms that more people can relate to. I think it helps to share the experience of cluster headache more broadly, because we’re in a situation where cluster headache remains underfunded, and we don’t have enough treatments for it. I think one way to overcome that is to spread awareness of what this problem is, and the impact it has on human life,” said Rashmi Halker Singh, MD, associate professor of neurology at the Mayo Clinic in Scottsdale, Ariz., and deputy editor of Headache. She was not involved in the study.

Dr. Schor called for physicians to consider cluster headache an emergency, because of the severity of pain and also the potential for suicidality. Treatments remain comparatively sparse, but high-flow oxygen can help some patients, and intranasal or intravenous triptans can treat acute pain. In 2018, the Food and Drug Administration approved galcanezumab (Eli Lilly) for prevention of episodic cluster headaches.

But cluster headaches are often misdiagnosed. For many patients, it takes more than a year or even as long as 5 years to get an accurate diagnosis, according to Dr. Schor. Women may be particularly vulnerable to misdiagnosis, because migraines are more common in women. It doesn’t help that many neurologists are taught that cluster headache is primarily a male disease. “Because that idea is so ingrained, I think a lot of women who have cluster headache are probably missed and told they have migraine instead. There are a lot of women who have cluster headache, and that gender difference might not be as big a difference as we were initially taught. We need to do a better job of recognizing cluster headache to better understand what the true prevalence is,” said Dr. Halker Singh.

She noted that patients with side-locked headache should be evaluated for cluster headache, and asked how long the pain lasts in the absence of medication. “Also ask about the presence of cranial autonomic symptoms, and if they occur in the context of headache pain, and if they are side-locked to the side of the headache. Those are important questions that can tease out cluster headache from other conditions,” said Dr. Halker Singh.

For the survey, the researchers asked 1,604 patients with cluster headache patients to rate pain on a scale of 1 to 10. Cluster headache ranked highest at 9.7, then labor pain (7.2), pancreatitis (7.0), and nephrolithiasis (6.9). Cluster headache pain was ranked at 10.0 by 72.1% of respondents. Those reporting maximal pain or were more likely to have cranial autonomic features in comparison with patients who reported less pain, including conjunctival injection or lacrimation (91% versus 85%), eyelid edema (77% versus 66%), forehead/facial sweating (60% versus 49%), fullness in the ear (47% versus 35%), and miosis or ptosis (85% versus 75%). They had more frequent attacks (4.0 versus 3.5 per day), higher Hopelessness Depression Symptom Questionnaire scores (24.5 versus 21.1), and reduced effectiveness of calcium channel blockers (2.2 versus 2.5 on a 5-point Likert scale). They were more often female (34% versus 24%). (P < .001 for all).

The study received funding from Autonomic Technologies and Cluster Busters. Dr. Schor and Dr. Halker Singh had no relevant financial disclosures.

Patients with cluster headache face a double whammy: Physicians too often fail to recognize it, and their condition is among the most severe and debilitating among headache types. In fact, a new survey of patients with cluster headache shows that they rank the pain as worse than most other painful experiences in life, including childbirth, passing of kidney stones, and pancreatitis, among others.

The study’s comparison of cluster headaches to other common painful experiences can help nonsufferers relate to the experience, said Larry Schor, PhD, a coauthor of the paper. “Headache is a terrible word. Bee stings sting, burns burn. [A cluster headache] doesn’t ache. It’s a piercing intensity like you just can’t believe,” said Dr. Schor, professor of psychology at the University of West Georgia, Carrollton, and a cluster headache patient since he first experienced an attack at the age of 21.

The study was published in the January 2021 issue of Headache.

Ranking cluster headaches as worse than experiences such as childbirth or kidney stones is “kind of eye opening, and helps to describe the experience in terms that more people can relate to. I think it helps to share the experience of cluster headache more broadly, because we’re in a situation where cluster headache remains underfunded, and we don’t have enough treatments for it. I think one way to overcome that is to spread awareness of what this problem is, and the impact it has on human life,” said Rashmi Halker Singh, MD, associate professor of neurology at the Mayo Clinic in Scottsdale, Ariz., and deputy editor of Headache. She was not involved in the study.

Dr. Schor called for physicians to consider cluster headache an emergency, because of the severity of pain and also the potential for suicidality. Treatments remain comparatively sparse, but high-flow oxygen can help some patients, and intranasal or intravenous triptans can treat acute pain. In 2018, the Food and Drug Administration approved galcanezumab (Eli Lilly) for prevention of episodic cluster headaches.

But cluster headaches are often misdiagnosed. For many patients, it takes more than a year or even as long as 5 years to get an accurate diagnosis, according to Dr. Schor. Women may be particularly vulnerable to misdiagnosis, because migraines are more common in women. It doesn’t help that many neurologists are taught that cluster headache is primarily a male disease. “Because that idea is so ingrained, I think a lot of women who have cluster headache are probably missed and told they have migraine instead. There are a lot of women who have cluster headache, and that gender difference might not be as big a difference as we were initially taught. We need to do a better job of recognizing cluster headache to better understand what the true prevalence is,” said Dr. Halker Singh.

She noted that patients with side-locked headache should be evaluated for cluster headache, and asked how long the pain lasts in the absence of medication. “Also ask about the presence of cranial autonomic symptoms, and if they occur in the context of headache pain, and if they are side-locked to the side of the headache. Those are important questions that can tease out cluster headache from other conditions,” said Dr. Halker Singh.

For the survey, the researchers asked 1,604 patients with cluster headache patients to rate pain on a scale of 1 to 10. Cluster headache ranked highest at 9.7, then labor pain (7.2), pancreatitis (7.0), and nephrolithiasis (6.9). Cluster headache pain was ranked at 10.0 by 72.1% of respondents. Those reporting maximal pain or were more likely to have cranial autonomic features in comparison with patients who reported less pain, including conjunctival injection or lacrimation (91% versus 85%), eyelid edema (77% versus 66%), forehead/facial sweating (60% versus 49%), fullness in the ear (47% versus 35%), and miosis or ptosis (85% versus 75%). They had more frequent attacks (4.0 versus 3.5 per day), higher Hopelessness Depression Symptom Questionnaire scores (24.5 versus 21.1), and reduced effectiveness of calcium channel blockers (2.2 versus 2.5 on a 5-point Likert scale). They were more often female (34% versus 24%). (P < .001 for all).

The study received funding from Autonomic Technologies and Cluster Busters. Dr. Schor and Dr. Halker Singh had no relevant financial disclosures.

Among patients with migraine who use prescription medications, the increasing use of prescription opioids is associated with chronic migraine, more severe disability, and anxiety and depression, according to an analysis published in the January issue of Headache . The use of prescription opioids also is associated with treatment-related variables such as poor acute treatment optimization and treatment in a pain clinic. The results indicate the continued need to educate patients and clinicians about the potential risks of opioids for migraineurs, according to the researchers.

A review of MAST data

Dr. Lipton and colleagues set out to identify the variables associated with the frequency of opioid use in people with migraine. Among the variables that they sought to examine were demographic characteristics, comorbidities, headache characteristics, medication use, and patterns of health care use. Dr. Lipton’s group hypothesized that migraine-related severity and burden would increase with increasing frequency of opioid use.

To conduct their research, the investigators examined data from the MAST study, a nationwide sample of American adults with migraine. They focused specifically on participants who reported receiving prescription acute medications. Participants eligible for this analysis reported 3 or more headache days in the previous 3 months and at least 1 monthly headache day in the previous month. In all, 15,133 participants met these criteria.

Dr. Lipton and colleagues categorized participants into four groups based on their frequency of opioid use. The groups had no opioid use, 3 or fewer monthly days of opioid use, 4 to 9 monthly days of opioid use, and 10 or more days of monthly opioid use. The last category is consistent with the International Classification of Headache Disorders-3 criteria for overuse of opioids in migraine.

At baseline, MAST participants provided information about variables such as gender, age, marital status, smoking status, education, and income. Participants also reported how many times in the previous 6 months they had visited a primary care doctor, a neurologist, a headache specialist, or a pain specialist. Dr. Lipton’s group calculated monthly headache days using the number of days during the previous 3 months affected by headache. The Migraine Disability Assessment (MIDAS) questionnaire was used to measure headache-related disability. The four-item Patient Health Questionnaire (PHQ-4) was used to screen for anxiety and depression, and the Migraine Treatment Optimization Questionnaire (mTOQ-4) evaluated participants’ treatment optimization.
 

Men predominated among opioid users

The investigators included 4,701 MAST participants in their analysis. The population’s mean age was 45 years, and 71.6% of participants were women. Of the entire sample, 67.5% reported no opioid use, and 32.5% reported opioid use. Of the total study population, 18.7% of patients took opioids 3 or fewer days per month, 6.5% took opioids 4 to 9 days per month, and 7.3% took opioids on 10 or more days per month.

Opioid users did not differ from nonusers on race or marital status. Men were overrepresented among all groups of opioid users, however. In addition, opioid use was more prevalent among participants with fewer than 4 years of college education (34.9%) than among participants with 4 or more years of college (30.8%). The proportion of participants with fewer than 4 years of college increased with increasing monthly opioid use. Furthermore, opioid use increased with decreasing household income. As opioid use increased, rates of employment decreased. Approximately 33% of the entire sample were obese, and the proportion of obese participants increased with increasing days per month of opioid use.

The most frequent setting during the previous 6 months for participants seeking care was primary care (49.7%). The next most frequent setting was neurology units (20.9%), pain clinics (8.3%), and headache clinics (7.7%). The prevalence of opioid use was 37.5% among participants with primary care visits, 37.3% among participants with neurologist visits, 43.0% among participants with headache clinic visits, and 53.5% with pain clinic visits.

About 15% of the population had chronic migraine. The prevalence of chronic migraine increased with increasing frequency of opioid use. About 49% of the sample had allodynia, and the prevalence of allodynia increased with increasing frequency of opioid use. Overall, disability was moderate to severe in 57.3% of participants. Participants who used opioids on 3 or fewer days per month had the lowest prevalence of moderate to severe disability (50.2%), and participants who used opioids on 10 or more days per month had the highest prevalence of moderate to severe disability (83.8%).

Approximately 21% of participants had anxiety or depression. The lowest prevalence of anxiety or depression was among participants who took opioids on 3 or fewer days per month (17.4%), and the highest prevalence was among participants who took opioids on 10 or more days per month (43.2%). About 39% of the population had very poor to poor treatment optimization. Among opioid nonusers, 35.6% had very poor to poor treatment optimization, and 59.4% of participants who used opioids on 10 or more days per month had very poor to poor treatment optimization.

Dr. Lipton and colleagues also examined the study population’s use of triptans. Overall, 51.5% of participants reported taking triptans. The prevalence of triptan use was highest among participants who did not use opioids (64.1%) and lowest among participants who used opioids on 3 or fewer days per month (20.5%). Triptan use increased as monthly days of opioid use increased.
 

Pain clinics and opioid prescription

“In the general population, women are more likely to receive opioids than men,” said Dr. Lipton. “This [finding] could reflect, in part, that women have more pain disorders than men and are more likely to seek medical care for pain than men.” In the current study, however, men with migraine were more likely to receive opioid prescriptions than were women with migraine. One potential explanation for this finding is that men with migraine are less likely to receive a migraine diagnosis, which might attenuate opioid prescribing, than women with migraine. “It may be that opioids are perceived to be serious drugs for serious pain, and that some physicians may be more likely to prescribe opioids to men because the disorder is taken more seriously in men than women,” said Dr. Lipton.

The observation that opioids were more likely to be prescribed for people treated in pain clinics “is consistent with my understanding of practice patterns,” he added. “Generally, neurologists strive to find effective acute treatment alternatives to opioids. The emergence of [drug classes known as] gepants and ditans provides a helpful set of alternatives to tritpans.”

Dr. Lipton and his colleagues plan further research into the treatment of migraineurs. “In a claims analysis, we showed that when people with migraine fail a triptan, they are most likely to get an opioid as their next drug,” he said. “Reasonable [clinicians] might disagree on the next step. The next step, in the absence of contraindications, could be a different oral triptan, a nonoral triptan, or a gepant or ditan. We are planning a randomized trial to probe this question.”
 

Why are opioids still being used?

The study’s reliance on patients’ self-report and its retrospective design are two of its weaknesses, said Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and editor-in-chief of Neurology Reviews. One strength, however, is that the stratified sampling methodology produced a study population that accurately reflects the demographic characteristics of the U.S. adult population, he added. Another strength is the investigators’ examination of opioid use by patient characteristics such as marital status, education, income, obesity, and smoking.

Given the harmful effects of opioids in migraine, it is hard to understand why as much as one-third of study participants using acute care medication for migraine were using opioids, said Dr. Rapoport. Using opioids for the acute treatment of migraine attacks often indicates inadequate treatment optimization, which leads to ongoing headache. As a consequence, patients may take more medication, which can increase headache frequency and lead to diagnoses of chronic migraine and medication overuse headache. Although the study found an association between the increased use of opioids and decreased household income and increased unemployment, smoking, and obesity, “it is not possible to assign causality to any of these associations, even though some would argue that decreased socioeconomic status was somehow related to more headache, disability, obesity, smoking, and unemployment,” he added.

“The paper suggests that future research should look at the risk factors for use of opioids and should determine if depression is a risk factor for or a consequence of opioid use,” said Dr. Rapoport. “Interventional studies designed to improve the acute care of migraine attacks might be able to reduce the use of opioids. I have not used opioids or butalbital-containing medication in my office for many years.”

This study was funded and sponsored by Dr. Reddy’s Laboratories group of companies, Princeton, N.J. Dr. Lipton has received grant support from the National Institutes of Health, the National Headache Foundation, and the Migraine Research Fund. He serves as a consultant, serves as an advisory board member, or has received honoraria from Alder, Allergan, American Headache Society, Autonomic Technologies, Biohaven, Dr. Reddy’s Laboratories, Eli Lilly, eNeura Therapeutics, Merck, Novartis, Pfizer, and Teva, Inc. He receives royalties from Wolff’s Headache, 8th Edition (New York: Oxford University Press, 2009) and holds stock options in eNeura Therapeutics and Biohaven.

SOURCE: Lipton RB, et al. Headache. https://doi.org/10.1111/head.14018. 2020;61(1):103-16.

Among patients with migraine who use prescription medications, the increasing use of prescription opioids is associated with chronic migraine, more severe disability, and anxiety and depression, according to an analysis published in the January issue of Headache . The use of prescription opioids also is associated with treatment-related variables such as poor acute treatment optimization and treatment in a pain clinic. The results indicate the continued need to educate patients and clinicians about the potential risks of opioids for migraineurs, according to the researchers.

A review of MAST data

Dr. Lipton and colleagues set out to identify the variables associated with the frequency of opioid use in people with migraine. Among the variables that they sought to examine were demographic characteristics, comorbidities, headache characteristics, medication use, and patterns of health care use. Dr. Lipton’s group hypothesized that migraine-related severity and burden would increase with increasing frequency of opioid use.

To conduct their research, the investigators examined data from the MAST study, a nationwide sample of American adults with migraine. They focused specifically on participants who reported receiving prescription acute medications. Participants eligible for this analysis reported 3 or more headache days in the previous 3 months and at least 1 monthly headache day in the previous month. In all, 15,133 participants met these criteria.

Dr. Lipton and colleagues categorized participants into four groups based on their frequency of opioid use. The groups had no opioid use, 3 or fewer monthly days of opioid use, 4 to 9 monthly days of opioid use, and 10 or more days of monthly opioid use. The last category is consistent with the International Classification of Headache Disorders-3 criteria for overuse of opioids in migraine.

At baseline, MAST participants provided information about variables such as gender, age, marital status, smoking status, education, and income. Participants also reported how many times in the previous 6 months they had visited a primary care doctor, a neurologist, a headache specialist, or a pain specialist. Dr. Lipton’s group calculated monthly headache days using the number of days during the previous 3 months affected by headache. The Migraine Disability Assessment (MIDAS) questionnaire was used to measure headache-related disability. The four-item Patient Health Questionnaire (PHQ-4) was used to screen for anxiety and depression, and the Migraine Treatment Optimization Questionnaire (mTOQ-4) evaluated participants’ treatment optimization.
 

Men predominated among opioid users

The investigators included 4,701 MAST participants in their analysis. The population’s mean age was 45 years, and 71.6% of participants were women. Of the entire sample, 67.5% reported no opioid use, and 32.5% reported opioid use. Of the total study population, 18.7% of patients took opioids 3 or fewer days per month, 6.5% took opioids 4 to 9 days per month, and 7.3% took opioids on 10 or more days per month.

Opioid users did not differ from nonusers on race or marital status. Men were overrepresented among all groups of opioid users, however. In addition, opioid use was more prevalent among participants with fewer than 4 years of college education (34.9%) than among participants with 4 or more years of college (30.8%). The proportion of participants with fewer than 4 years of college increased with increasing monthly opioid use. Furthermore, opioid use increased with decreasing household income. As opioid use increased, rates of employment decreased. Approximately 33% of the entire sample were obese, and the proportion of obese participants increased with increasing days per month of opioid use.

The most frequent setting during the previous 6 months for participants seeking care was primary care (49.7%). The next most frequent setting was neurology units (20.9%), pain clinics (8.3%), and headache clinics (7.7%). The prevalence of opioid use was 37.5% among participants with primary care visits, 37.3% among participants with neurologist visits, 43.0% among participants with headache clinic visits, and 53.5% with pain clinic visits.

About 15% of the population had chronic migraine. The prevalence of chronic migraine increased with increasing frequency of opioid use. About 49% of the sample had allodynia, and the prevalence of allodynia increased with increasing frequency of opioid use. Overall, disability was moderate to severe in 57.3% of participants. Participants who used opioids on 3 or fewer days per month had the lowest prevalence of moderate to severe disability (50.2%), and participants who used opioids on 10 or more days per month had the highest prevalence of moderate to severe disability (83.8%).

Approximately 21% of participants had anxiety or depression. The lowest prevalence of anxiety or depression was among participants who took opioids on 3 or fewer days per month (17.4%), and the highest prevalence was among participants who took opioids on 10 or more days per month (43.2%). About 39% of the population had very poor to poor treatment optimization. Among opioid nonusers, 35.6% had very poor to poor treatment optimization, and 59.4% of participants who used opioids on 10 or more days per month had very poor to poor treatment optimization.

Dr. Lipton and colleagues also examined the study population’s use of triptans. Overall, 51.5% of participants reported taking triptans. The prevalence of triptan use was highest among participants who did not use opioids (64.1%) and lowest among participants who used opioids on 3 or fewer days per month (20.5%). Triptan use increased as monthly days of opioid use increased.
 

Pain clinics and opioid prescription

“In the general population, women are more likely to receive opioids than men,” said Dr. Lipton. “This [finding] could reflect, in part, that women have more pain disorders than men and are more likely to seek medical care for pain than men.” In the current study, however, men with migraine were more likely to receive opioid prescriptions than were women with migraine. One potential explanation for this finding is that men with migraine are less likely to receive a migraine diagnosis, which might attenuate opioid prescribing, than women with migraine. “It may be that opioids are perceived to be serious drugs for serious pain, and that some physicians may be more likely to prescribe opioids to men because the disorder is taken more seriously in men than women,” said Dr. Lipton.

The observation that opioids were more likely to be prescribed for people treated in pain clinics “is consistent with my understanding of practice patterns,” he added. “Generally, neurologists strive to find effective acute treatment alternatives to opioids. The emergence of [drug classes known as] gepants and ditans provides a helpful set of alternatives to tritpans.”

Dr. Lipton and his colleagues plan further research into the treatment of migraineurs. “In a claims analysis, we showed that when people with migraine fail a triptan, they are most likely to get an opioid as their next drug,” he said. “Reasonable [clinicians] might disagree on the next step. The next step, in the absence of contraindications, could be a different oral triptan, a nonoral triptan, or a gepant or ditan. We are planning a randomized trial to probe this question.”
 

Why are opioids still being used?

The study’s reliance on patients’ self-report and its retrospective design are two of its weaknesses, said Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and editor-in-chief of Neurology Reviews. One strength, however, is that the stratified sampling methodology produced a study population that accurately reflects the demographic characteristics of the U.S. adult population, he added. Another strength is the investigators’ examination of opioid use by patient characteristics such as marital status, education, income, obesity, and smoking.

Given the harmful effects of opioids in migraine, it is hard to understand why as much as one-third of study participants using acute care medication for migraine were using opioids, said Dr. Rapoport. Using opioids for the acute treatment of migraine attacks often indicates inadequate treatment optimization, which leads to ongoing headache. As a consequence, patients may take more medication, which can increase headache frequency and lead to diagnoses of chronic migraine and medication overuse headache. Although the study found an association between the increased use of opioids and decreased household income and increased unemployment, smoking, and obesity, “it is not possible to assign causality to any of these associations, even though some would argue that decreased socioeconomic status was somehow related to more headache, disability, obesity, smoking, and unemployment,” he added.

“The paper suggests that future research should look at the risk factors for use of opioids and should determine if depression is a risk factor for or a consequence of opioid use,” said Dr. Rapoport. “Interventional studies designed to improve the acute care of migraine attacks might be able to reduce the use of opioids. I have not used opioids or butalbital-containing medication in my office for many years.”

This study was funded and sponsored by Dr. Reddy’s Laboratories group of companies, Princeton, N.J. Dr. Lipton has received grant support from the National Institutes of Health, the National Headache Foundation, and the Migraine Research Fund. He serves as a consultant, serves as an advisory board member, or has received honoraria from Alder, Allergan, American Headache Society, Autonomic Technologies, Biohaven, Dr. Reddy’s Laboratories, Eli Lilly, eNeura Therapeutics, Merck, Novartis, Pfizer, and Teva, Inc. He receives royalties from Wolff’s Headache, 8th Edition (New York: Oxford University Press, 2009) and holds stock options in eNeura Therapeutics and Biohaven.

SOURCE: Lipton RB, et al. Headache. https://doi.org/10.1111/head.14018. 2020;61(1):103-16.

Among patients with migraine who use prescription medications, the increasing use of prescription opioids is associated with chronic migraine, more severe disability, and anxiety and depression, according to an analysis published in the January issue of Headache . The use of prescription opioids also is associated with treatment-related variables such as poor acute treatment optimization and treatment in a pain clinic. The results indicate the continued need to educate patients and clinicians about the potential risks of opioids for migraineurs, according to the researchers.

A review of MAST data

Dr. Lipton and colleagues set out to identify the variables associated with the frequency of opioid use in people with migraine. Among the variables that they sought to examine were demographic characteristics, comorbidities, headache characteristics, medication use, and patterns of health care use. Dr. Lipton’s group hypothesized that migraine-related severity and burden would increase with increasing frequency of opioid use.

To conduct their research, the investigators examined data from the MAST study, a nationwide sample of American adults with migraine. They focused specifically on participants who reported receiving prescription acute medications. Participants eligible for this analysis reported 3 or more headache days in the previous 3 months and at least 1 monthly headache day in the previous month. In all, 15,133 participants met these criteria.

Dr. Lipton and colleagues categorized participants into four groups based on their frequency of opioid use. The groups had no opioid use, 3 or fewer monthly days of opioid use, 4 to 9 monthly days of opioid use, and 10 or more days of monthly opioid use. The last category is consistent with the International Classification of Headache Disorders-3 criteria for overuse of opioids in migraine.

At baseline, MAST participants provided information about variables such as gender, age, marital status, smoking status, education, and income. Participants also reported how many times in the previous 6 months they had visited a primary care doctor, a neurologist, a headache specialist, or a pain specialist. Dr. Lipton’s group calculated monthly headache days using the number of days during the previous 3 months affected by headache. The Migraine Disability Assessment (MIDAS) questionnaire was used to measure headache-related disability. The four-item Patient Health Questionnaire (PHQ-4) was used to screen for anxiety and depression, and the Migraine Treatment Optimization Questionnaire (mTOQ-4) evaluated participants’ treatment optimization.
 

Men predominated among opioid users

The investigators included 4,701 MAST participants in their analysis. The population’s mean age was 45 years, and 71.6% of participants were women. Of the entire sample, 67.5% reported no opioid use, and 32.5% reported opioid use. Of the total study population, 18.7% of patients took opioids 3 or fewer days per month, 6.5% took opioids 4 to 9 days per month, and 7.3% took opioids on 10 or more days per month.

Opioid users did not differ from nonusers on race or marital status. Men were overrepresented among all groups of opioid users, however. In addition, opioid use was more prevalent among participants with fewer than 4 years of college education (34.9%) than among participants with 4 or more years of college (30.8%). The proportion of participants with fewer than 4 years of college increased with increasing monthly opioid use. Furthermore, opioid use increased with decreasing household income. As opioid use increased, rates of employment decreased. Approximately 33% of the entire sample were obese, and the proportion of obese participants increased with increasing days per month of opioid use.

The most frequent setting during the previous 6 months for participants seeking care was primary care (49.7%). The next most frequent setting was neurology units (20.9%), pain clinics (8.3%), and headache clinics (7.7%). The prevalence of opioid use was 37.5% among participants with primary care visits, 37.3% among participants with neurologist visits, 43.0% among participants with headache clinic visits, and 53.5% with pain clinic visits.

About 15% of the population had chronic migraine. The prevalence of chronic migraine increased with increasing frequency of opioid use. About 49% of the sample had allodynia, and the prevalence of allodynia increased with increasing frequency of opioid use. Overall, disability was moderate to severe in 57.3% of participants. Participants who used opioids on 3 or fewer days per month had the lowest prevalence of moderate to severe disability (50.2%), and participants who used opioids on 10 or more days per month had the highest prevalence of moderate to severe disability (83.8%).

Approximately 21% of participants had anxiety or depression. The lowest prevalence of anxiety or depression was among participants who took opioids on 3 or fewer days per month (17.4%), and the highest prevalence was among participants who took opioids on 10 or more days per month (43.2%). About 39% of the population had very poor to poor treatment optimization. Among opioid nonusers, 35.6% had very poor to poor treatment optimization, and 59.4% of participants who used opioids on 10 or more days per month had very poor to poor treatment optimization.

Dr. Lipton and colleagues also examined the study population’s use of triptans. Overall, 51.5% of participants reported taking triptans. The prevalence of triptan use was highest among participants who did not use opioids (64.1%) and lowest among participants who used opioids on 3 or fewer days per month (20.5%). Triptan use increased as monthly days of opioid use increased.
 

Pain clinics and opioid prescription

“In the general population, women are more likely to receive opioids than men,” said Dr. Lipton. “This [finding] could reflect, in part, that women have more pain disorders than men and are more likely to seek medical care for pain than men.” In the current study, however, men with migraine were more likely to receive opioid prescriptions than were women with migraine. One potential explanation for this finding is that men with migraine are less likely to receive a migraine diagnosis, which might attenuate opioid prescribing, than women with migraine. “It may be that opioids are perceived to be serious drugs for serious pain, and that some physicians may be more likely to prescribe opioids to men because the disorder is taken more seriously in men than women,” said Dr. Lipton.

The observation that opioids were more likely to be prescribed for people treated in pain clinics “is consistent with my understanding of practice patterns,” he added. “Generally, neurologists strive to find effective acute treatment alternatives to opioids. The emergence of [drug classes known as] gepants and ditans provides a helpful set of alternatives to tritpans.”

Dr. Lipton and his colleagues plan further research into the treatment of migraineurs. “In a claims analysis, we showed that when people with migraine fail a triptan, they are most likely to get an opioid as their next drug,” he said. “Reasonable [clinicians] might disagree on the next step. The next step, in the absence of contraindications, could be a different oral triptan, a nonoral triptan, or a gepant or ditan. We are planning a randomized trial to probe this question.”
 

Why are opioids still being used?

The study’s reliance on patients’ self-report and its retrospective design are two of its weaknesses, said Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and editor-in-chief of Neurology Reviews. One strength, however, is that the stratified sampling methodology produced a study population that accurately reflects the demographic characteristics of the U.S. adult population, he added. Another strength is the investigators’ examination of opioid use by patient characteristics such as marital status, education, income, obesity, and smoking.

Given the harmful effects of opioids in migraine, it is hard to understand why as much as one-third of study participants using acute care medication for migraine were using opioids, said Dr. Rapoport. Using opioids for the acute treatment of migraine attacks often indicates inadequate treatment optimization, which leads to ongoing headache. As a consequence, patients may take more medication, which can increase headache frequency and lead to diagnoses of chronic migraine and medication overuse headache. Although the study found an association between the increased use of opioids and decreased household income and increased unemployment, smoking, and obesity, “it is not possible to assign causality to any of these associations, even though some would argue that decreased socioeconomic status was somehow related to more headache, disability, obesity, smoking, and unemployment,” he added.

“The paper suggests that future research should look at the risk factors for use of opioids and should determine if depression is a risk factor for or a consequence of opioid use,” said Dr. Rapoport. “Interventional studies designed to improve the acute care of migraine attacks might be able to reduce the use of opioids. I have not used opioids or butalbital-containing medication in my office for many years.”

This study was funded and sponsored by Dr. Reddy’s Laboratories group of companies, Princeton, N.J. Dr. Lipton has received grant support from the National Institutes of Health, the National Headache Foundation, and the Migraine Research Fund. He serves as a consultant, serves as an advisory board member, or has received honoraria from Alder, Allergan, American Headache Society, Autonomic Technologies, Biohaven, Dr. Reddy’s Laboratories, Eli Lilly, eNeura Therapeutics, Merck, Novartis, Pfizer, and Teva, Inc. He receives royalties from Wolff’s Headache, 8th Edition (New York: Oxford University Press, 2009) and holds stock options in eNeura Therapeutics and Biohaven.

SOURCE: Lipton RB, et al. Headache. https://doi.org/10.1111/head.14018. 2020;61(1):103-16.

A meta-analysis of two randomized studies evaluating patent foramen ovale (PFO) closure as a treatment strategy for migraine has shown significant benefits in several key endpoints, prompting the authors to conclude the approach warrants reevaluation.
 

The pooled analysis of patient-level data from the PRIMA and PREMIUM studies, both of which evaluated the Amplatzer PFO Occluder device (Abbott Vascular), showed that PFO closure significantly reduced the mean number of monthly migraine days and monthly migraine attacks and resulted in a greater number of patients who experienced complete migraine cessation.

The study, led by Mohammad K. Mojadidi, MD, Virginia Commonwealth University, Richmond, was published online in the Journal of the American College of Cardiology on Feb. 8, 2021.

Commenting on the article, the coauthor of an accompanying editorial, Zubair Ahmed, MD, of the Cleveland Clinic said the meta-analysis gave some useful new information but is not enough to recommend PFO closure routinely for patients with migraine.

“This meta-analysis looked at different endpoints that are more relevant to current clinical practice than those in the two original studies, and the results show that we shouldn’t rule out PFO closure as a treatment strategy for some migraine patients,” Dr. Ahmed stated. “But we’re still not sure exactly which patients are most likely to benefit from this approach, and we need additional studies to gain more understanding on that.”

The study authors noted that there is an established link between the presence of PFO and migraine, especially migraine with aura. In observational studies of PFO closure for cryptogenic stroke, the vast majority of patients who also had migraine reported a more than 50% reduction in migraine days per month after PFO closure.

However, two recent randomized clinical trials evaluating the Amplatzer PFO Occluder device for reducing the frequency and duration of episodic migraine headaches did not meet their respective primary endpoints, although they did show significant benefit of PFO closure in most of their secondary endpoints.

The current meta-analysis pooled individual participant data from the two trials to increase the power to detect the effect of percutaneous PFO closure for treating patients with episodic migraine compared with medical therapy alone.

In the two studies including a total of 337 patients, 176 were randomized to PFO closure and 161 to medical treatment only. At 12 months, three of the four efficacy endpoints evaluated in the meta-analysis were significantly reduced in the PFO-closure group. These were mean reduction of monthly migraine days (–3.1 days vs. –1.9 days; P = .02), mean reduction of monthly migraine attacks (–2.0 vs. –1.4; P = .01), and number of patients who experienced complete cessation of migraine (9% vs. 0.7%; P < .001).

The responder rate, defined as more than a 50% reduction in migraine attacks, showed a trend towards an increase in the PFO-closure group but did not achieve statistical significance (38% vs. 29%; P = .13).  

For the safety analysis, nine procedure-related and four device-related adverse events occurred in 245 patients who eventually received devices. All events were transient and resolved.
 

Better effect in patients with aura

Patients with migraine with aura, in particular frequent aura, had a significantly greater reduction in migraine days and a higher incidence of complete migraine cessation following PFO closure versus no closure, the authors reported.

In those without aura, PFO closure did not significantly reduce migraine days or improve complete headache cessation. However, some patients without aura did respond to PFO closure, which was statistically significant for reduction of migraine attacks (–2.0 vs. –1.0; P = .03).

“The interaction between the brain that is susceptible to migraine and the plethora of potential triggers is complex. A PFO may be the potential pathway for a variety of chemical triggers, such as serotonin from platelets, and although less frequent, some people with migraine without aura may trigger their migraine through this mechanism,” the researchers suggested. This hypothesis will be tested in the RELIEF trial, which is now being planned.

In the accompanying editorial, Dr. Ahmed and coauthor Robert J. Sommer, MD, Columbia University Medical Center, New York, pointed out that the meta-analysis demonstrates benefit of PFO closure in the migraine population for the first time.

“Moreover, the investigators defined a population of patients who may benefit most from PFO closure, those with migraine with frequent aura, suggesting that these may be different physiologically than other migraine subtypes. The analysis also places the PRIMA and PREMIUM outcomes in the context of endpoints that are more practical and are more commonly assessed in current clinical trials,” the editorialists noted.
 

Many unanswered questions

But the editorialists highlighted several significant limitations of the analysis, including “pooling of patient cohorts, methods, and outcome measures that might not be entirely comparable,” which they say could have introduced bias.

They also pointed out that the underlying pathophysiological mechanism linking migraine symptoms to PFO remains unknown. They explain that the mechanism is thought to involve the right-to-left passage of systemic venous blood, with some component – which would normally be eliminated or reduced on passage through the pulmonary vasculature – reaching the cerebral circulation via the PFO in supranormal concentrations and acting as a trigger for migraine activity in patients with susceptible brains.

But not all patients with migraine who have PFO benefit from PFO closure, they noted, and therefore presumably have PFO-unrelated migraines. There is no verified way to distinguish between these two groups at present.

“Once we learn to identify the subset of migraine patients in whom PFOs are actually causal of headache symptoms, screening and treatment of PFO for migraine can become a reality,” they wrote.

Although the meta-analysis is a step in the right direction, “it is not a home run,” Dr. Ahmed elaborated. “This was a post hoc analysis of two studies, neither of which showed significant benefits on their primary endpoints. That weakens the findings somewhat.”

He added: “At present, PFO closure is not routinely recommended as a migraine treatment strategy as we haven’t been sure which patients are most likely to benefit. And while this meta-analysis suggests patients with aura may be more likely to benefit, one quarter of patients without aura in the PREMIUM trial responded to PFO closure, so it’s not just about aura.

“There are still many unanswered questions.

“I don’t think the new information from this meta-analysis is enough to persuade me to change my practice, but it is a small building block in the overall picture and suggests this may be a suitable strategy for some patients in future,” he concluded.

The study had no outside funding. Participant-level data were provided by Abbott. Several coauthors were on the steering committee for the PREMIUM or PRIMA trials. Dr. Ahmed reported receiving consulting fees from, Amgen, AbbVie, electroCore, and Eli Lilly; serving on advisory boards for Amgen and Supernus; serving as a speaker for AbbVie; and receiving funding for an investigator-initiated trial from Teva and Eli Lilly.

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

A meta-analysis of two randomized studies evaluating patent foramen ovale (PFO) closure as a treatment strategy for migraine has shown significant benefits in several key endpoints, prompting the authors to conclude the approach warrants reevaluation.
 

The pooled analysis of patient-level data from the PRIMA and PREMIUM studies, both of which evaluated the Amplatzer PFO Occluder device (Abbott Vascular), showed that PFO closure significantly reduced the mean number of monthly migraine days and monthly migraine attacks and resulted in a greater number of patients who experienced complete migraine cessation.

The study, led by Mohammad K. Mojadidi, MD, Virginia Commonwealth University, Richmond, was published online in the Journal of the American College of Cardiology on Feb. 8, 2021.

Commenting on the article, the coauthor of an accompanying editorial, Zubair Ahmed, MD, of the Cleveland Clinic said the meta-analysis gave some useful new information but is not enough to recommend PFO closure routinely for patients with migraine.

“This meta-analysis looked at different endpoints that are more relevant to current clinical practice than those in the two original studies, and the results show that we shouldn’t rule out PFO closure as a treatment strategy for some migraine patients,” Dr. Ahmed stated. “But we’re still not sure exactly which patients are most likely to benefit from this approach, and we need additional studies to gain more understanding on that.”

The study authors noted that there is an established link between the presence of PFO and migraine, especially migraine with aura. In observational studies of PFO closure for cryptogenic stroke, the vast majority of patients who also had migraine reported a more than 50% reduction in migraine days per month after PFO closure.

However, two recent randomized clinical trials evaluating the Amplatzer PFO Occluder device for reducing the frequency and duration of episodic migraine headaches did not meet their respective primary endpoints, although they did show significant benefit of PFO closure in most of their secondary endpoints.

The current meta-analysis pooled individual participant data from the two trials to increase the power to detect the effect of percutaneous PFO closure for treating patients with episodic migraine compared with medical therapy alone.

In the two studies including a total of 337 patients, 176 were randomized to PFO closure and 161 to medical treatment only. At 12 months, three of the four efficacy endpoints evaluated in the meta-analysis were significantly reduced in the PFO-closure group. These were mean reduction of monthly migraine days (–3.1 days vs. –1.9 days; P = .02), mean reduction of monthly migraine attacks (–2.0 vs. –1.4; P = .01), and number of patients who experienced complete cessation of migraine (9% vs. 0.7%; P < .001).

The responder rate, defined as more than a 50% reduction in migraine attacks, showed a trend towards an increase in the PFO-closure group but did not achieve statistical significance (38% vs. 29%; P = .13).  

For the safety analysis, nine procedure-related and four device-related adverse events occurred in 245 patients who eventually received devices. All events were transient and resolved.
 

Better effect in patients with aura

Patients with migraine with aura, in particular frequent aura, had a significantly greater reduction in migraine days and a higher incidence of complete migraine cessation following PFO closure versus no closure, the authors reported.

In those without aura, PFO closure did not significantly reduce migraine days or improve complete headache cessation. However, some patients without aura did respond to PFO closure, which was statistically significant for reduction of migraine attacks (–2.0 vs. –1.0; P = .03).

“The interaction between the brain that is susceptible to migraine and the plethora of potential triggers is complex. A PFO may be the potential pathway for a variety of chemical triggers, such as serotonin from platelets, and although less frequent, some people with migraine without aura may trigger their migraine through this mechanism,” the researchers suggested. This hypothesis will be tested in the RELIEF trial, which is now being planned.

In the accompanying editorial, Dr. Ahmed and coauthor Robert J. Sommer, MD, Columbia University Medical Center, New York, pointed out that the meta-analysis demonstrates benefit of PFO closure in the migraine population for the first time.

“Moreover, the investigators defined a population of patients who may benefit most from PFO closure, those with migraine with frequent aura, suggesting that these may be different physiologically than other migraine subtypes. The analysis also places the PRIMA and PREMIUM outcomes in the context of endpoints that are more practical and are more commonly assessed in current clinical trials,” the editorialists noted.
 

Many unanswered questions

But the editorialists highlighted several significant limitations of the analysis, including “pooling of patient cohorts, methods, and outcome measures that might not be entirely comparable,” which they say could have introduced bias.

They also pointed out that the underlying pathophysiological mechanism linking migraine symptoms to PFO remains unknown. They explain that the mechanism is thought to involve the right-to-left passage of systemic venous blood, with some component – which would normally be eliminated or reduced on passage through the pulmonary vasculature – reaching the cerebral circulation via the PFO in supranormal concentrations and acting as a trigger for migraine activity in patients with susceptible brains.

But not all patients with migraine who have PFO benefit from PFO closure, they noted, and therefore presumably have PFO-unrelated migraines. There is no verified way to distinguish between these two groups at present.

“Once we learn to identify the subset of migraine patients in whom PFOs are actually causal of headache symptoms, screening and treatment of PFO for migraine can become a reality,” they wrote.

Although the meta-analysis is a step in the right direction, “it is not a home run,” Dr. Ahmed elaborated. “This was a post hoc analysis of two studies, neither of which showed significant benefits on their primary endpoints. That weakens the findings somewhat.”

He added: “At present, PFO closure is not routinely recommended as a migraine treatment strategy as we haven’t been sure which patients are most likely to benefit. And while this meta-analysis suggests patients with aura may be more likely to benefit, one quarter of patients without aura in the PREMIUM trial responded to PFO closure, so it’s not just about aura.

“There are still many unanswered questions.

“I don’t think the new information from this meta-analysis is enough to persuade me to change my practice, but it is a small building block in the overall picture and suggests this may be a suitable strategy for some patients in future,” he concluded.

The study had no outside funding. Participant-level data were provided by Abbott. Several coauthors were on the steering committee for the PREMIUM or PRIMA trials. Dr. Ahmed reported receiving consulting fees from, Amgen, AbbVie, electroCore, and Eli Lilly; serving on advisory boards for Amgen and Supernus; serving as a speaker for AbbVie; and receiving funding for an investigator-initiated trial from Teva and Eli Lilly.

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

A meta-analysis of two randomized studies evaluating patent foramen ovale (PFO) closure as a treatment strategy for migraine has shown significant benefits in several key endpoints, prompting the authors to conclude the approach warrants reevaluation.
 

The pooled analysis of patient-level data from the PRIMA and PREMIUM studies, both of which evaluated the Amplatzer PFO Occluder device (Abbott Vascular), showed that PFO closure significantly reduced the mean number of monthly migraine days and monthly migraine attacks and resulted in a greater number of patients who experienced complete migraine cessation.

The study, led by Mohammad K. Mojadidi, MD, Virginia Commonwealth University, Richmond, was published online in the Journal of the American College of Cardiology on Feb. 8, 2021.

Commenting on the article, the coauthor of an accompanying editorial, Zubair Ahmed, MD, of the Cleveland Clinic said the meta-analysis gave some useful new information but is not enough to recommend PFO closure routinely for patients with migraine.

“This meta-analysis looked at different endpoints that are more relevant to current clinical practice than those in the two original studies, and the results show that we shouldn’t rule out PFO closure as a treatment strategy for some migraine patients,” Dr. Ahmed stated. “But we’re still not sure exactly which patients are most likely to benefit from this approach, and we need additional studies to gain more understanding on that.”

The study authors noted that there is an established link between the presence of PFO and migraine, especially migraine with aura. In observational studies of PFO closure for cryptogenic stroke, the vast majority of patients who also had migraine reported a more than 50% reduction in migraine days per month after PFO closure.

However, two recent randomized clinical trials evaluating the Amplatzer PFO Occluder device for reducing the frequency and duration of episodic migraine headaches did not meet their respective primary endpoints, although they did show significant benefit of PFO closure in most of their secondary endpoints.

The current meta-analysis pooled individual participant data from the two trials to increase the power to detect the effect of percutaneous PFO closure for treating patients with episodic migraine compared with medical therapy alone.

In the two studies including a total of 337 patients, 176 were randomized to PFO closure and 161 to medical treatment only. At 12 months, three of the four efficacy endpoints evaluated in the meta-analysis were significantly reduced in the PFO-closure group. These were mean reduction of monthly migraine days (–3.1 days vs. –1.9 days; P = .02), mean reduction of monthly migraine attacks (–2.0 vs. –1.4; P = .01), and number of patients who experienced complete cessation of migraine (9% vs. 0.7%; P < .001).

The responder rate, defined as more than a 50% reduction in migraine attacks, showed a trend towards an increase in the PFO-closure group but did not achieve statistical significance (38% vs. 29%; P = .13).  

For the safety analysis, nine procedure-related and four device-related adverse events occurred in 245 patients who eventually received devices. All events were transient and resolved.
 

Better effect in patients with aura

Patients with migraine with aura, in particular frequent aura, had a significantly greater reduction in migraine days and a higher incidence of complete migraine cessation following PFO closure versus no closure, the authors reported.

In those without aura, PFO closure did not significantly reduce migraine days or improve complete headache cessation. However, some patients without aura did respond to PFO closure, which was statistically significant for reduction of migraine attacks (–2.0 vs. –1.0; P = .03).

“The interaction between the brain that is susceptible to migraine and the plethora of potential triggers is complex. A PFO may be the potential pathway for a variety of chemical triggers, such as serotonin from platelets, and although less frequent, some people with migraine without aura may trigger their migraine through this mechanism,” the researchers suggested. This hypothesis will be tested in the RELIEF trial, which is now being planned.

In the accompanying editorial, Dr. Ahmed and coauthor Robert J. Sommer, MD, Columbia University Medical Center, New York, pointed out that the meta-analysis demonstrates benefit of PFO closure in the migraine population for the first time.

“Moreover, the investigators defined a population of patients who may benefit most from PFO closure, those with migraine with frequent aura, suggesting that these may be different physiologically than other migraine subtypes. The analysis also places the PRIMA and PREMIUM outcomes in the context of endpoints that are more practical and are more commonly assessed in current clinical trials,” the editorialists noted.
 

Many unanswered questions

But the editorialists highlighted several significant limitations of the analysis, including “pooling of patient cohorts, methods, and outcome measures that might not be entirely comparable,” which they say could have introduced bias.

They also pointed out that the underlying pathophysiological mechanism linking migraine symptoms to PFO remains unknown. They explain that the mechanism is thought to involve the right-to-left passage of systemic venous blood, with some component – which would normally be eliminated or reduced on passage through the pulmonary vasculature – reaching the cerebral circulation via the PFO in supranormal concentrations and acting as a trigger for migraine activity in patients with susceptible brains.

But not all patients with migraine who have PFO benefit from PFO closure, they noted, and therefore presumably have PFO-unrelated migraines. There is no verified way to distinguish between these two groups at present.

“Once we learn to identify the subset of migraine patients in whom PFOs are actually causal of headache symptoms, screening and treatment of PFO for migraine can become a reality,” they wrote.

Although the meta-analysis is a step in the right direction, “it is not a home run,” Dr. Ahmed elaborated. “This was a post hoc analysis of two studies, neither of which showed significant benefits on their primary endpoints. That weakens the findings somewhat.”

He added: “At present, PFO closure is not routinely recommended as a migraine treatment strategy as we haven’t been sure which patients are most likely to benefit. And while this meta-analysis suggests patients with aura may be more likely to benefit, one quarter of patients without aura in the PREMIUM trial responded to PFO closure, so it’s not just about aura.

“There are still many unanswered questions.

“I don’t think the new information from this meta-analysis is enough to persuade me to change my practice, but it is a small building block in the overall picture and suggests this may be a suitable strategy for some patients in future,” he concluded.

The study had no outside funding. Participant-level data were provided by Abbott. Several coauthors were on the steering committee for the PREMIUM or PRIMA trials. Dr. Ahmed reported receiving consulting fees from, Amgen, AbbVie, electroCore, and Eli Lilly; serving on advisory boards for Amgen and Supernus; serving as a speaker for AbbVie; and receiving funding for an investigator-initiated trial from Teva and Eli Lilly.

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

Key clinical point: Erenumab 70 mg was effective for the treatment of high-frequency episodic migraine (HFEM) or chronic migraine (CM) in a real-world setting.

Major finding: Erenumab was effective with a rapid progressive decrease in monthly migraine days (week 12: HEFM, 4.5 days; CM, 9.3 days). More than 50% of HEFM and 75% of CM patients responded to the treatment.

Study details: The data come from a real-life prospective cohort study of 372 patients affected by HEFM or CM with 3 or more prior preventive therapeutic failures.

Disclosures: This work was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente). C Altamura, N Brunelli, A Fallacara, CM Costa, D Santangelo, A Salerno, B Mercuri, and A Carnevale declared no conflicts of interest. The remaining authors reported ties with various institutions and/or pharmaceutical companies.

Source: Barbanti P et al. Headache. 2020 Dec 18. doi: 10.1111/head.14032.

Key clinical point: Erenumab 70 mg was effective for the treatment of high-frequency episodic migraine (HFEM) or chronic migraine (CM) in a real-world setting.

Major finding: Erenumab was effective with a rapid progressive decrease in monthly migraine days (week 12: HEFM, 4.5 days; CM, 9.3 days). More than 50% of HEFM and 75% of CM patients responded to the treatment.

Study details: The data come from a real-life prospective cohort study of 372 patients affected by HEFM or CM with 3 or more prior preventive therapeutic failures.

Disclosures: This work was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente). C Altamura, N Brunelli, A Fallacara, CM Costa, D Santangelo, A Salerno, B Mercuri, and A Carnevale declared no conflicts of interest. The remaining authors reported ties with various institutions and/or pharmaceutical companies.

Source: Barbanti P et al. Headache. 2020 Dec 18. doi: 10.1111/head.14032.

Key clinical point: Erenumab 70 mg was effective for the treatment of high-frequency episodic migraine (HFEM) or chronic migraine (CM) in a real-world setting.

Major finding: Erenumab was effective with a rapid progressive decrease in monthly migraine days (week 12: HEFM, 4.5 days; CM, 9.3 days). More than 50% of HEFM and 75% of CM patients responded to the treatment.

Study details: The data come from a real-life prospective cohort study of 372 patients affected by HEFM or CM with 3 or more prior preventive therapeutic failures.

Disclosures: This work was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente). C Altamura, N Brunelli, A Fallacara, CM Costa, D Santangelo, A Salerno, B Mercuri, and A Carnevale declared no conflicts of interest. The remaining authors reported ties with various institutions and/or pharmaceutical companies.

Source: Barbanti P et al. Headache. 2020 Dec 18. doi: 10.1111/head.14032.

Key clinical point: Chronic migraine patients who achieved early reversal to episodic migraine are likely to have persistent reversion with long-term erenumab treatment.

Major finding: At 12 weeks, 54.1% (95% confidence interval [CI], 46.6%-61.6%) of patients showed reversal to episodic migraine. Continued treatment with erenumab showed a long-term persistent reversion in 96.8% (95% CI, 91.1%-99.3%) of patients at week 64.

Study details: Data on 181 migraine patients come from a post hoc analysis of a 12-week randomized double-blind trial and a 52-week open-label extension.

Disclosures: The study was funded by Amgen Inc. The authors reported ties with various institutions and/or pharmaceutical companies. F Zhang, GA Rippon, S Cheng, and DD Mikol are employed by and own stock in Amgen.

Source: Lipton RB et al. Cephalalgia. 2020 Dec 3. doi: 10.1177/0333102420973994.

Key clinical point: Chronic migraine patients who achieved early reversal to episodic migraine are likely to have persistent reversion with long-term erenumab treatment.

Major finding: At 12 weeks, 54.1% (95% confidence interval [CI], 46.6%-61.6%) of patients showed reversal to episodic migraine. Continued treatment with erenumab showed a long-term persistent reversion in 96.8% (95% CI, 91.1%-99.3%) of patients at week 64.

Study details: Data on 181 migraine patients come from a post hoc analysis of a 12-week randomized double-blind trial and a 52-week open-label extension.

Disclosures: The study was funded by Amgen Inc. The authors reported ties with various institutions and/or pharmaceutical companies. F Zhang, GA Rippon, S Cheng, and DD Mikol are employed by and own stock in Amgen.

Source: Lipton RB et al. Cephalalgia. 2020 Dec 3. doi: 10.1177/0333102420973994.

Key clinical point: Chronic migraine patients who achieved early reversal to episodic migraine are likely to have persistent reversion with long-term erenumab treatment.

Major finding: At 12 weeks, 54.1% (95% confidence interval [CI], 46.6%-61.6%) of patients showed reversal to episodic migraine. Continued treatment with erenumab showed a long-term persistent reversion in 96.8% (95% CI, 91.1%-99.3%) of patients at week 64.

Study details: Data on 181 migraine patients come from a post hoc analysis of a 12-week randomized double-blind trial and a 52-week open-label extension.

Disclosures: The study was funded by Amgen Inc. The authors reported ties with various institutions and/or pharmaceutical companies. F Zhang, GA Rippon, S Cheng, and DD Mikol are employed by and own stock in Amgen.

Source: Lipton RB et al. Cephalalgia. 2020 Dec 3. doi: 10.1177/0333102420973994.

The incidence of idiopathic intracranial hypertension (IIH) – characterized by increased cerebrospinal fluid (CSF) pressure – is rising considerably, corresponding to population increases in body mass index (BMI), a new study has shown. “The condition is associated with a high rate of health care utilization, so the increasing incidence has important implications for health care professionals and policy makers in addressing the associated comorbidities,” said senior author William Owen Pickrell, PhD, Swansea University (Wales).

The study was published online Jan. 20 in Neurology.

IIH is a condition of unknown etiology that is strongly associated with obesity, the researchers noted. Predominantly affecting women of childbearing age, it causes chronic disabling headaches, visual disturbance, and in a minority of patients, permanent visual loss. The definitive management is weight loss, but a minority of patients require surgery to preserve vision.

People with IIH potentially have high rates of health care utilization, multiple specialist consultations, diagnostic tests, CSF diversion procedures, and complications related to CSF diversion surgery.  
 

Population study in Wales

Given that there is a paucity of data regarding the epidemiology, health care utilization, and outcomes of people with IIH, Dr. Pickrell and colleagues conducted the current retrospective cohort study, which aimed to determine the temporal trends of IIH incidence and prevalence in Wales and health care utilization associated with IIH. They also investigated the effects of socioeconomic deprivation and obesity on IIH epidemiology.

For the study, they used and validated primary and secondary care IIH diagnostic codes within the Secure Anonymised Information Linkage data bank, which is part of the national e-health records research infrastructure for Wales, to ascertain IIH cases and controls between 2003 and 2017. In total, 35 million patient-years of data were analyzed. Information was recorded on body mass index, deprivation quintile, CSF diversion surgery, and unscheduled hospital admissions in case and control cohorts.

“This is the first time the diagnostic codes for this condition have been validated. This is important as it is critical if we are studying a condition to know that the individuals we are studying actually have that condition,” Dr. Pickrell commented. “We were able to establish that the diagnostic codes were 92% sensitive and 87% specific – that’s pretty good.”

Results showed a significant increase in IIH incidence and prevalence in Wales. The prevalence of IIH in Wales increased sixfold from 12/100,000 in 2003 to 76/100,000 in 2017, and the incidence of IIH increased threefold from 2.3/100,000 per year in 2003 to 7.8/100,000 per year in 2017. This corresponded with increases in obesity rates: 29% of the population was obese in 2003, compared with 40% in 2017.
 

Reasons for the increase

“The considerable increase in IIH incidence is multifactorial but likely predominately due to rising obesity rates,” the authors noted. “The worldwide prevalence of obesity nearly tripled between 1975 and 2016 and therefore these results also have global relevance.”

The increase in IIH incidence may also be attributable to increased IIH diagnosis rates because of raised awareness of the condition and greater use of digital fundoscopy at routine optometry appointments, they suggested.

“We found a strong association between increasing BMI, sex (being female), and IIH. Around 85% of our IIH cohort were female, similar to other studies, and we also found a significant association with increased deprivation and IIH, particularly in women,” the authors reported.

IIH is associated with increasing deprivation in women even after adjusting for obesity suggesting additional etiologic factors associated with deprivation apart from BMI; this effect was not seen in men, pointing to sex-specific drivers for IIH, they added.

The results also show that individuals with IIH have increased rates of unscheduled health care utilization compared with a matched-control cohort. The rate ratio for unscheduled hospital admissions in the IIH cohort, compared with controls was 5.28.

“A considerable proportion of this excess in unscheduled hospital admissions occurs at the time of diagnosis and can be explained by the need for urgent investigation of papilloedema with brain imaging and spinal fluid analysis. However, there is also a considerable excess in unscheduled hospital admissions up to 2 years after diagnosis,” the authors reported.

They suggested that these admissions are likely to be for severe headache, and they say there is some scope to reduce emergency admissions through better management of headache, patient education, and rapid access to outpatient specialist advice.

They also pointed out that the rate of unscheduled admissions is higher in the IIH cohort in the 3 years leading up to diagnosis, suggesting an opportunity for earlier diagnosis and earlier intervention.

In their study population, 8% of patients with IIH received CSF diversion procedures a mean of 1.3 years after diagnosis, and these patients showed significantly increased unscheduled health care admission rates, compared with IIH patients who had not undergone such procedures.

“There are frequent complications with the shunts after surgery, which causes a high revision rate,” Dr. Pickrell commented. In this study, 40% of patients undergoing CSF diversion needed at least one CSF shunt revision procedure.

The study was supported by the Brain Repair and Intracranial Neurotherapeutics unit, Wales Gene Park, Health Data Research UK, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Wales), Public Health Agency (Northern Ireland), British Heart Foundation, and Wellcome Trust. The authors reported no relevant financial relationships.

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

The incidence of idiopathic intracranial hypertension (IIH) – characterized by increased cerebrospinal fluid (CSF) pressure – is rising considerably, corresponding to population increases in body mass index (BMI), a new study has shown. “The condition is associated with a high rate of health care utilization, so the increasing incidence has important implications for health care professionals and policy makers in addressing the associated comorbidities,” said senior author William Owen Pickrell, PhD, Swansea University (Wales).

The study was published online Jan. 20 in Neurology.

IIH is a condition of unknown etiology that is strongly associated with obesity, the researchers noted. Predominantly affecting women of childbearing age, it causes chronic disabling headaches, visual disturbance, and in a minority of patients, permanent visual loss. The definitive management is weight loss, but a minority of patients require surgery to preserve vision.

People with IIH potentially have high rates of health care utilization, multiple specialist consultations, diagnostic tests, CSF diversion procedures, and complications related to CSF diversion surgery.  
 

Population study in Wales

Given that there is a paucity of data regarding the epidemiology, health care utilization, and outcomes of people with IIH, Dr. Pickrell and colleagues conducted the current retrospective cohort study, which aimed to determine the temporal trends of IIH incidence and prevalence in Wales and health care utilization associated with IIH. They also investigated the effects of socioeconomic deprivation and obesity on IIH epidemiology.

For the study, they used and validated primary and secondary care IIH diagnostic codes within the Secure Anonymised Information Linkage data bank, which is part of the national e-health records research infrastructure for Wales, to ascertain IIH cases and controls between 2003 and 2017. In total, 35 million patient-years of data were analyzed. Information was recorded on body mass index, deprivation quintile, CSF diversion surgery, and unscheduled hospital admissions in case and control cohorts.

“This is the first time the diagnostic codes for this condition have been validated. This is important as it is critical if we are studying a condition to know that the individuals we are studying actually have that condition,” Dr. Pickrell commented. “We were able to establish that the diagnostic codes were 92% sensitive and 87% specific – that’s pretty good.”

Results showed a significant increase in IIH incidence and prevalence in Wales. The prevalence of IIH in Wales increased sixfold from 12/100,000 in 2003 to 76/100,000 in 2017, and the incidence of IIH increased threefold from 2.3/100,000 per year in 2003 to 7.8/100,000 per year in 2017. This corresponded with increases in obesity rates: 29% of the population was obese in 2003, compared with 40% in 2017.
 

Reasons for the increase

“The considerable increase in IIH incidence is multifactorial but likely predominately due to rising obesity rates,” the authors noted. “The worldwide prevalence of obesity nearly tripled between 1975 and 2016 and therefore these results also have global relevance.”

The increase in IIH incidence may also be attributable to increased IIH diagnosis rates because of raised awareness of the condition and greater use of digital fundoscopy at routine optometry appointments, they suggested.

“We found a strong association between increasing BMI, sex (being female), and IIH. Around 85% of our IIH cohort were female, similar to other studies, and we also found a significant association with increased deprivation and IIH, particularly in women,” the authors reported.

IIH is associated with increasing deprivation in women even after adjusting for obesity suggesting additional etiologic factors associated with deprivation apart from BMI; this effect was not seen in men, pointing to sex-specific drivers for IIH, they added.

The results also show that individuals with IIH have increased rates of unscheduled health care utilization compared with a matched-control cohort. The rate ratio for unscheduled hospital admissions in the IIH cohort, compared with controls was 5.28.

“A considerable proportion of this excess in unscheduled hospital admissions occurs at the time of diagnosis and can be explained by the need for urgent investigation of papilloedema with brain imaging and spinal fluid analysis. However, there is also a considerable excess in unscheduled hospital admissions up to 2 years after diagnosis,” the authors reported.

They suggested that these admissions are likely to be for severe headache, and they say there is some scope to reduce emergency admissions through better management of headache, patient education, and rapid access to outpatient specialist advice.

They also pointed out that the rate of unscheduled admissions is higher in the IIH cohort in the 3 years leading up to diagnosis, suggesting an opportunity for earlier diagnosis and earlier intervention.

In their study population, 8% of patients with IIH received CSF diversion procedures a mean of 1.3 years after diagnosis, and these patients showed significantly increased unscheduled health care admission rates, compared with IIH patients who had not undergone such procedures.

“There are frequent complications with the shunts after surgery, which causes a high revision rate,” Dr. Pickrell commented. In this study, 40% of patients undergoing CSF diversion needed at least one CSF shunt revision procedure.

The study was supported by the Brain Repair and Intracranial Neurotherapeutics unit, Wales Gene Park, Health Data Research UK, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Wales), Public Health Agency (Northern Ireland), British Heart Foundation, and Wellcome Trust. The authors reported no relevant financial relationships.

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

The incidence of idiopathic intracranial hypertension (IIH) – characterized by increased cerebrospinal fluid (CSF) pressure – is rising considerably, corresponding to population increases in body mass index (BMI), a new study has shown. “The condition is associated with a high rate of health care utilization, so the increasing incidence has important implications for health care professionals and policy makers in addressing the associated comorbidities,” said senior author William Owen Pickrell, PhD, Swansea University (Wales).

The study was published online Jan. 20 in Neurology.

IIH is a condition of unknown etiology that is strongly associated with obesity, the researchers noted. Predominantly affecting women of childbearing age, it causes chronic disabling headaches, visual disturbance, and in a minority of patients, permanent visual loss. The definitive management is weight loss, but a minority of patients require surgery to preserve vision.

People with IIH potentially have high rates of health care utilization, multiple specialist consultations, diagnostic tests, CSF diversion procedures, and complications related to CSF diversion surgery.  
 

Population study in Wales

Given that there is a paucity of data regarding the epidemiology, health care utilization, and outcomes of people with IIH, Dr. Pickrell and colleagues conducted the current retrospective cohort study, which aimed to determine the temporal trends of IIH incidence and prevalence in Wales and health care utilization associated with IIH. They also investigated the effects of socioeconomic deprivation and obesity on IIH epidemiology.

For the study, they used and validated primary and secondary care IIH diagnostic codes within the Secure Anonymised Information Linkage data bank, which is part of the national e-health records research infrastructure for Wales, to ascertain IIH cases and controls between 2003 and 2017. In total, 35 million patient-years of data were analyzed. Information was recorded on body mass index, deprivation quintile, CSF diversion surgery, and unscheduled hospital admissions in case and control cohorts.

“This is the first time the diagnostic codes for this condition have been validated. This is important as it is critical if we are studying a condition to know that the individuals we are studying actually have that condition,” Dr. Pickrell commented. “We were able to establish that the diagnostic codes were 92% sensitive and 87% specific – that’s pretty good.”

Results showed a significant increase in IIH incidence and prevalence in Wales. The prevalence of IIH in Wales increased sixfold from 12/100,000 in 2003 to 76/100,000 in 2017, and the incidence of IIH increased threefold from 2.3/100,000 per year in 2003 to 7.8/100,000 per year in 2017. This corresponded with increases in obesity rates: 29% of the population was obese in 2003, compared with 40% in 2017.
 

Reasons for the increase

“The considerable increase in IIH incidence is multifactorial but likely predominately due to rising obesity rates,” the authors noted. “The worldwide prevalence of obesity nearly tripled between 1975 and 2016 and therefore these results also have global relevance.”

The increase in IIH incidence may also be attributable to increased IIH diagnosis rates because of raised awareness of the condition and greater use of digital fundoscopy at routine optometry appointments, they suggested.

“We found a strong association between increasing BMI, sex (being female), and IIH. Around 85% of our IIH cohort were female, similar to other studies, and we also found a significant association with increased deprivation and IIH, particularly in women,” the authors reported.

IIH is associated with increasing deprivation in women even after adjusting for obesity suggesting additional etiologic factors associated with deprivation apart from BMI; this effect was not seen in men, pointing to sex-specific drivers for IIH, they added.

The results also show that individuals with IIH have increased rates of unscheduled health care utilization compared with a matched-control cohort. The rate ratio for unscheduled hospital admissions in the IIH cohort, compared with controls was 5.28.

“A considerable proportion of this excess in unscheduled hospital admissions occurs at the time of diagnosis and can be explained by the need for urgent investigation of papilloedema with brain imaging and spinal fluid analysis. However, there is also a considerable excess in unscheduled hospital admissions up to 2 years after diagnosis,” the authors reported.

They suggested that these admissions are likely to be for severe headache, and they say there is some scope to reduce emergency admissions through better management of headache, patient education, and rapid access to outpatient specialist advice.

They also pointed out that the rate of unscheduled admissions is higher in the IIH cohort in the 3 years leading up to diagnosis, suggesting an opportunity for earlier diagnosis and earlier intervention.

In their study population, 8% of patients with IIH received CSF diversion procedures a mean of 1.3 years after diagnosis, and these patients showed significantly increased unscheduled health care admission rates, compared with IIH patients who had not undergone such procedures.

“There are frequent complications with the shunts after surgery, which causes a high revision rate,” Dr. Pickrell commented. In this study, 40% of patients undergoing CSF diversion needed at least one CSF shunt revision procedure.

The study was supported by the Brain Repair and Intracranial Neurotherapeutics unit, Wales Gene Park, Health Data Research UK, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Wales), Public Health Agency (Northern Ireland), British Heart Foundation, and Wellcome Trust. The authors reported no relevant financial relationships.

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