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Intranasal DHE shows promise in migraine
, according to results from a phase 3 clinical trial. In development by Impel NeuroPharma, the new formulation could offer patients an at-home alternative to intramuscular infusions or intravenous injections currently used to deliver DHE.
“Our analysis of the data suggests that nothing new or untoward seemed to be happening as a result of delivering DHE to the upper nasal space,” Stephen Shrewsbury, MD, chief medical officer of Impel NeuroPharma, said in an interview. The company released key results from its phase 3 clinical trial, while a poster examining patient satisfaction was presented by Dr. Shrewsbury at the virtual annual meeting of the American Headache Society.
An improved intranasal formulation
The product isn’t the first effort to develop an inhaled form of DHE. An inhaled version called Migranal, marketed by Bausch Health, delivers DHE to the front part of the nose, where it may be lost to the upper lip or down the throat, according to Dr. Shrewsbury. Impel’s formulation (INP104) delivers the drug to the upper nasal space, where an earlier phase 1 trial demonstrated it could achieve higher serum concentrations compared with Migranal.
In 2018, MAP Pharmaceuticals came close to a product, but it was ultimately rejected by the Food and Drug Administration because DHE was not stable in the propellant used in the formulation. This time is different, said Dr. Shrewsbury, who was chief medical officer at MAP before joining Impel. The new device holds DHE and the propellant in separate compartments until they are combined right before use, which should circumvent stability problems.
Dr. Shrewsbury believes that patients will welcome an inhaled version of DHE. “People with migraines don’t want to have to go into hospital or even an infusion center if they can help it,” he said.
The study was one of a number of presentations at the AHS meeting that focused on novel delivery methods for established drugs. “The idea of taking things that we know work and improving upon them, both in terms of formulation and then delivery, that’s a common theme. My impression is that this will be an interesting arrow to have in our sling,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, who was not involved in the study.
Open-label trial results
The STOP 301 phase 3 open-label safety and tolerability trial treated over 5,650 migraine attacks in 354 patients who self-administered INP104 for up to 52 weeks. They were provided up to three doses per week (1.45 mg in a dose of two puffs, one per nostril). Maximum doses included two per day and three per week.
There were no new safety signals or concern trends in nasal safety findings. 15.0% of patients experienced nasal congestion, 6.8% nausea, 5.1% nasal discomfort, and 5.1% unpleasant taste.
A total of 66.3% of participants reported pain relief by 2 hours (severe or moderate pain reduced to mild or none, or mild pain reduced to none) following a dose, and 38% had freedom from pain. 16.3% reported pain relief onset at 15 minutes, with continued improvement over time. During weeks 21-24 of the study, 98.4% and 95% of patients reporting no recurrence of their migraine or use of rescue medications during the 24- and 48-hour periods after using INP104. “Once they got rid of the pain, it didn’t come back, and that’s been one of the shortcomings of many of the available oral therapies – although some of them can be quite effective, that effect can wear off and people can find their migraine comes back within a 24- or 48-hour period,” said Dr. Shrewsbury.
The drug was also rated as convenient, with 83.6% of participants strongly agreeing (50%) or agreeing (33.6%) that it is easy to use.
“It certainly looks like compliance will be good. The possibility is that this will be quite useful,” said Dr. Charles, who is also enthusiastic about some of the other drug formulations announced at the meeting. “It really is just fun times for us as clinicians to be able to have so many different options for patients,” he said.
Dr. Shrewsbury is an employee of Impel NeuroPharma, which funded the study.* Dr. Charles consults for Amgen, BioHaven, Eli Lilly, Novartis, and Lundbeck.
SOURCE: Shrewsbury S, et al. AHS 2020. Abstract 832509.
*Correction, 6/19/20: An earlier version of this article misstated the name of Impel NeuroPharma.
, according to results from a phase 3 clinical trial. In development by Impel NeuroPharma, the new formulation could offer patients an at-home alternative to intramuscular infusions or intravenous injections currently used to deliver DHE.
“Our analysis of the data suggests that nothing new or untoward seemed to be happening as a result of delivering DHE to the upper nasal space,” Stephen Shrewsbury, MD, chief medical officer of Impel NeuroPharma, said in an interview. The company released key results from its phase 3 clinical trial, while a poster examining patient satisfaction was presented by Dr. Shrewsbury at the virtual annual meeting of the American Headache Society.
An improved intranasal formulation
The product isn’t the first effort to develop an inhaled form of DHE. An inhaled version called Migranal, marketed by Bausch Health, delivers DHE to the front part of the nose, where it may be lost to the upper lip or down the throat, according to Dr. Shrewsbury. Impel’s formulation (INP104) delivers the drug to the upper nasal space, where an earlier phase 1 trial demonstrated it could achieve higher serum concentrations compared with Migranal.
In 2018, MAP Pharmaceuticals came close to a product, but it was ultimately rejected by the Food and Drug Administration because DHE was not stable in the propellant used in the formulation. This time is different, said Dr. Shrewsbury, who was chief medical officer at MAP before joining Impel. The new device holds DHE and the propellant in separate compartments until they are combined right before use, which should circumvent stability problems.
Dr. Shrewsbury believes that patients will welcome an inhaled version of DHE. “People with migraines don’t want to have to go into hospital or even an infusion center if they can help it,” he said.
The study was one of a number of presentations at the AHS meeting that focused on novel delivery methods for established drugs. “The idea of taking things that we know work and improving upon them, both in terms of formulation and then delivery, that’s a common theme. My impression is that this will be an interesting arrow to have in our sling,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, who was not involved in the study.
Open-label trial results
The STOP 301 phase 3 open-label safety and tolerability trial treated over 5,650 migraine attacks in 354 patients who self-administered INP104 for up to 52 weeks. They were provided up to three doses per week (1.45 mg in a dose of two puffs, one per nostril). Maximum doses included two per day and three per week.
There were no new safety signals or concern trends in nasal safety findings. 15.0% of patients experienced nasal congestion, 6.8% nausea, 5.1% nasal discomfort, and 5.1% unpleasant taste.
A total of 66.3% of participants reported pain relief by 2 hours (severe or moderate pain reduced to mild or none, or mild pain reduced to none) following a dose, and 38% had freedom from pain. 16.3% reported pain relief onset at 15 minutes, with continued improvement over time. During weeks 21-24 of the study, 98.4% and 95% of patients reporting no recurrence of their migraine or use of rescue medications during the 24- and 48-hour periods after using INP104. “Once they got rid of the pain, it didn’t come back, and that’s been one of the shortcomings of many of the available oral therapies – although some of them can be quite effective, that effect can wear off and people can find their migraine comes back within a 24- or 48-hour period,” said Dr. Shrewsbury.
The drug was also rated as convenient, with 83.6% of participants strongly agreeing (50%) or agreeing (33.6%) that it is easy to use.
“It certainly looks like compliance will be good. The possibility is that this will be quite useful,” said Dr. Charles, who is also enthusiastic about some of the other drug formulations announced at the meeting. “It really is just fun times for us as clinicians to be able to have so many different options for patients,” he said.
Dr. Shrewsbury is an employee of Impel NeuroPharma, which funded the study.* Dr. Charles consults for Amgen, BioHaven, Eli Lilly, Novartis, and Lundbeck.
SOURCE: Shrewsbury S, et al. AHS 2020. Abstract 832509.
*Correction, 6/19/20: An earlier version of this article misstated the name of Impel NeuroPharma.
, according to results from a phase 3 clinical trial. In development by Impel NeuroPharma, the new formulation could offer patients an at-home alternative to intramuscular infusions or intravenous injections currently used to deliver DHE.
“Our analysis of the data suggests that nothing new or untoward seemed to be happening as a result of delivering DHE to the upper nasal space,” Stephen Shrewsbury, MD, chief medical officer of Impel NeuroPharma, said in an interview. The company released key results from its phase 3 clinical trial, while a poster examining patient satisfaction was presented by Dr. Shrewsbury at the virtual annual meeting of the American Headache Society.
An improved intranasal formulation
The product isn’t the first effort to develop an inhaled form of DHE. An inhaled version called Migranal, marketed by Bausch Health, delivers DHE to the front part of the nose, where it may be lost to the upper lip or down the throat, according to Dr. Shrewsbury. Impel’s formulation (INP104) delivers the drug to the upper nasal space, where an earlier phase 1 trial demonstrated it could achieve higher serum concentrations compared with Migranal.
In 2018, MAP Pharmaceuticals came close to a product, but it was ultimately rejected by the Food and Drug Administration because DHE was not stable in the propellant used in the formulation. This time is different, said Dr. Shrewsbury, who was chief medical officer at MAP before joining Impel. The new device holds DHE and the propellant in separate compartments until they are combined right before use, which should circumvent stability problems.
Dr. Shrewsbury believes that patients will welcome an inhaled version of DHE. “People with migraines don’t want to have to go into hospital or even an infusion center if they can help it,” he said.
The study was one of a number of presentations at the AHS meeting that focused on novel delivery methods for established drugs. “The idea of taking things that we know work and improving upon them, both in terms of formulation and then delivery, that’s a common theme. My impression is that this will be an interesting arrow to have in our sling,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, who was not involved in the study.
Open-label trial results
The STOP 301 phase 3 open-label safety and tolerability trial treated over 5,650 migraine attacks in 354 patients who self-administered INP104 for up to 52 weeks. They were provided up to three doses per week (1.45 mg in a dose of two puffs, one per nostril). Maximum doses included two per day and three per week.
There were no new safety signals or concern trends in nasal safety findings. 15.0% of patients experienced nasal congestion, 6.8% nausea, 5.1% nasal discomfort, and 5.1% unpleasant taste.
A total of 66.3% of participants reported pain relief by 2 hours (severe or moderate pain reduced to mild or none, or mild pain reduced to none) following a dose, and 38% had freedom from pain. 16.3% reported pain relief onset at 15 minutes, with continued improvement over time. During weeks 21-24 of the study, 98.4% and 95% of patients reporting no recurrence of their migraine or use of rescue medications during the 24- and 48-hour periods after using INP104. “Once they got rid of the pain, it didn’t come back, and that’s been one of the shortcomings of many of the available oral therapies – although some of them can be quite effective, that effect can wear off and people can find their migraine comes back within a 24- or 48-hour period,” said Dr. Shrewsbury.
The drug was also rated as convenient, with 83.6% of participants strongly agreeing (50%) or agreeing (33.6%) that it is easy to use.
“It certainly looks like compliance will be good. The possibility is that this will be quite useful,” said Dr. Charles, who is also enthusiastic about some of the other drug formulations announced at the meeting. “It really is just fun times for us as clinicians to be able to have so many different options for patients,” he said.
Dr. Shrewsbury is an employee of Impel NeuroPharma, which funded the study.* Dr. Charles consults for Amgen, BioHaven, Eli Lilly, Novartis, and Lundbeck.
SOURCE: Shrewsbury S, et al. AHS 2020. Abstract 832509.
*Correction, 6/19/20: An earlier version of this article misstated the name of Impel NeuroPharma.
FROM AHS 2020
Persistent posttraumatic headache risk factors confirmed
It also revealed a surprisingly high frequency of misdiagnosis. The original sample included 500 patients drawn from the Stanford Research Repository Cohort Discovery Tool, but a review found 200 records that were misdiagnosed and had to be excluded.
“It’s very easy to label someone who suffered a head injury and say this is the reason why they have this (headache),” said lead author Tommy Chan, MBBS, a headache fellow in the department of neurology at Stanford (Calif.) University, in an interview. Such patients are often seen by ED or primary care physicians who do not have a lot of experience with posttraumatic headache, and that can lead to negative consequences if a low-pressure headache is mistaken as stemming from a skull fracture. “It’s a very different treatment plan for one versus the other,” said Dr. Chan in an interview.
He noted that it can help to take a patient history that includes the preaccident headache frequency and determine if there was a change in frequency post injury.
Dr. Chan presented the results at the virtual annual meeting of the American Headache Society.
“The results are what one might expect, although we haven’t studied it enough to really know. We haven’t systematically characterized these risk factors for chronic posttraumatic headache very well, [so] it’s useful to have this information,” said Andrew Charles, MD, professor neurology at the University of California, Los Angeles, and director of the UCLA Goldberg Migraine Program, who was not involved in the study. However, Dr. Charles emphasized the need to confirm the results prospectively.
Defining risk factors
The analysis found that a history of migraines, medication overuse, psychological disorders, and new posttraumatic headache–associated comorbidities were all associated with a greater risk for persistent posttraumatic headache. None of those came as a surprise, “but we live in a world where medicine is practiced based on evidence, and providers want to see data to support that. I think that this will help with resource allocation. It’s important to address [a patient’s] overuse of medications, or if they’re having psychological symptoms,” said Dr. Chan.
A total of 150 patients in the analysis had acute posttraumatic headache (mean duration, 0.7 months) while 150 had persistent posttraumatic headache (mean duration, 24 months; P < .00001). Clinical factors associated with risk of persistent headache included a history migraine (relative risk, 2.4; P < .0001), a previous head injury (odds ratio, 5.8; P < .0001), medication overuse (RR, 2.6; P < .0001), preexisting psychological history (OR, 5; P < .0001), and new posttraumatic headache–associated comorbidities, such as vertigo or posttraumatic stress disorder (RR, 9.8; P < .0001).
Identifying patient subgroups
The researchers also identified four subcategories of patients with persistent posttraumatic headache, each with differing risk factors and clinical characteristics. It’s too soon to use these identifiers to make clinical recommendations, but Dr. Chan hopes that further study of these groups will be informative. “It might point us toward (the idea) that each patient population is actually different, even within the chronic persistent posttraumatic headache population, we can’t group them all under the same umbrella term. If we can tease out that a patient has truly had a head injury, but no history of migraine, no overuse of medication, no psychological history, and no other associated symptoms, this would be a very interesting population to study because they would help us understand the pathophysiology [of persistent posttraumatic headache].”
Although the study was conducted by defining persistent posttraumatic headache as lasting at least 3 months, Dr. Chan took issue with that commonly held definition. That choice is arbitrary, with no pathophysiological basis or data to support it, and is based more on clinical trials testing preventative treatments. But when it is used in clinical practice, it can muddy communication with patients. “When this timeline is told to a patient, and when it’s not achieved, they might become disappointed. We should not put too much emphasis on time. Everybody is different,” he said.
The study did not receive any funding. Dr. Chan had no relevant financial disclosures. Dr. Charles consults for consults for Amgen, BioHaven, Eli Lilly, Novartis, and Lundbeck.
It also revealed a surprisingly high frequency of misdiagnosis. The original sample included 500 patients drawn from the Stanford Research Repository Cohort Discovery Tool, but a review found 200 records that were misdiagnosed and had to be excluded.
“It’s very easy to label someone who suffered a head injury and say this is the reason why they have this (headache),” said lead author Tommy Chan, MBBS, a headache fellow in the department of neurology at Stanford (Calif.) University, in an interview. Such patients are often seen by ED or primary care physicians who do not have a lot of experience with posttraumatic headache, and that can lead to negative consequences if a low-pressure headache is mistaken as stemming from a skull fracture. “It’s a very different treatment plan for one versus the other,” said Dr. Chan in an interview.
He noted that it can help to take a patient history that includes the preaccident headache frequency and determine if there was a change in frequency post injury.
Dr. Chan presented the results at the virtual annual meeting of the American Headache Society.
“The results are what one might expect, although we haven’t studied it enough to really know. We haven’t systematically characterized these risk factors for chronic posttraumatic headache very well, [so] it’s useful to have this information,” said Andrew Charles, MD, professor neurology at the University of California, Los Angeles, and director of the UCLA Goldberg Migraine Program, who was not involved in the study. However, Dr. Charles emphasized the need to confirm the results prospectively.
Defining risk factors
The analysis found that a history of migraines, medication overuse, psychological disorders, and new posttraumatic headache–associated comorbidities were all associated with a greater risk for persistent posttraumatic headache. None of those came as a surprise, “but we live in a world where medicine is practiced based on evidence, and providers want to see data to support that. I think that this will help with resource allocation. It’s important to address [a patient’s] overuse of medications, or if they’re having psychological symptoms,” said Dr. Chan.
A total of 150 patients in the analysis had acute posttraumatic headache (mean duration, 0.7 months) while 150 had persistent posttraumatic headache (mean duration, 24 months; P < .00001). Clinical factors associated with risk of persistent headache included a history migraine (relative risk, 2.4; P < .0001), a previous head injury (odds ratio, 5.8; P < .0001), medication overuse (RR, 2.6; P < .0001), preexisting psychological history (OR, 5; P < .0001), and new posttraumatic headache–associated comorbidities, such as vertigo or posttraumatic stress disorder (RR, 9.8; P < .0001).
Identifying patient subgroups
The researchers also identified four subcategories of patients with persistent posttraumatic headache, each with differing risk factors and clinical characteristics. It’s too soon to use these identifiers to make clinical recommendations, but Dr. Chan hopes that further study of these groups will be informative. “It might point us toward (the idea) that each patient population is actually different, even within the chronic persistent posttraumatic headache population, we can’t group them all under the same umbrella term. If we can tease out that a patient has truly had a head injury, but no history of migraine, no overuse of medication, no psychological history, and no other associated symptoms, this would be a very interesting population to study because they would help us understand the pathophysiology [of persistent posttraumatic headache].”
Although the study was conducted by defining persistent posttraumatic headache as lasting at least 3 months, Dr. Chan took issue with that commonly held definition. That choice is arbitrary, with no pathophysiological basis or data to support it, and is based more on clinical trials testing preventative treatments. But when it is used in clinical practice, it can muddy communication with patients. “When this timeline is told to a patient, and when it’s not achieved, they might become disappointed. We should not put too much emphasis on time. Everybody is different,” he said.
The study did not receive any funding. Dr. Chan had no relevant financial disclosures. Dr. Charles consults for consults for Amgen, BioHaven, Eli Lilly, Novartis, and Lundbeck.
It also revealed a surprisingly high frequency of misdiagnosis. The original sample included 500 patients drawn from the Stanford Research Repository Cohort Discovery Tool, but a review found 200 records that were misdiagnosed and had to be excluded.
“It’s very easy to label someone who suffered a head injury and say this is the reason why they have this (headache),” said lead author Tommy Chan, MBBS, a headache fellow in the department of neurology at Stanford (Calif.) University, in an interview. Such patients are often seen by ED or primary care physicians who do not have a lot of experience with posttraumatic headache, and that can lead to negative consequences if a low-pressure headache is mistaken as stemming from a skull fracture. “It’s a very different treatment plan for one versus the other,” said Dr. Chan in an interview.
He noted that it can help to take a patient history that includes the preaccident headache frequency and determine if there was a change in frequency post injury.
Dr. Chan presented the results at the virtual annual meeting of the American Headache Society.
“The results are what one might expect, although we haven’t studied it enough to really know. We haven’t systematically characterized these risk factors for chronic posttraumatic headache very well, [so] it’s useful to have this information,” said Andrew Charles, MD, professor neurology at the University of California, Los Angeles, and director of the UCLA Goldberg Migraine Program, who was not involved in the study. However, Dr. Charles emphasized the need to confirm the results prospectively.
Defining risk factors
The analysis found that a history of migraines, medication overuse, psychological disorders, and new posttraumatic headache–associated comorbidities were all associated with a greater risk for persistent posttraumatic headache. None of those came as a surprise, “but we live in a world where medicine is practiced based on evidence, and providers want to see data to support that. I think that this will help with resource allocation. It’s important to address [a patient’s] overuse of medications, or if they’re having psychological symptoms,” said Dr. Chan.
A total of 150 patients in the analysis had acute posttraumatic headache (mean duration, 0.7 months) while 150 had persistent posttraumatic headache (mean duration, 24 months; P < .00001). Clinical factors associated with risk of persistent headache included a history migraine (relative risk, 2.4; P < .0001), a previous head injury (odds ratio, 5.8; P < .0001), medication overuse (RR, 2.6; P < .0001), preexisting psychological history (OR, 5; P < .0001), and new posttraumatic headache–associated comorbidities, such as vertigo or posttraumatic stress disorder (RR, 9.8; P < .0001).
Identifying patient subgroups
The researchers also identified four subcategories of patients with persistent posttraumatic headache, each with differing risk factors and clinical characteristics. It’s too soon to use these identifiers to make clinical recommendations, but Dr. Chan hopes that further study of these groups will be informative. “It might point us toward (the idea) that each patient population is actually different, even within the chronic persistent posttraumatic headache population, we can’t group them all under the same umbrella term. If we can tease out that a patient has truly had a head injury, but no history of migraine, no overuse of medication, no psychological history, and no other associated symptoms, this would be a very interesting population to study because they would help us understand the pathophysiology [of persistent posttraumatic headache].”
Although the study was conducted by defining persistent posttraumatic headache as lasting at least 3 months, Dr. Chan took issue with that commonly held definition. That choice is arbitrary, with no pathophysiological basis or data to support it, and is based more on clinical trials testing preventative treatments. But when it is used in clinical practice, it can muddy communication with patients. “When this timeline is told to a patient, and when it’s not achieved, they might become disappointed. We should not put too much emphasis on time. Everybody is different,” he said.
The study did not receive any funding. Dr. Chan had no relevant financial disclosures. Dr. Charles consults for consults for Amgen, BioHaven, Eli Lilly, Novartis, and Lundbeck.
FROM AHS 2020
Few patients with migraine clear barriers to optimal care
, new research shows.
Results from a survey study showed less than 8% of patients with episodic migraine and less than 2% of patients with chronic migraine were able to overcome four key treatment barriers associated with optimal migraine management. These included current medical consultation, appropriate diagnosis, minimally adequate acute and preventive pharmacologic treatment (if indicated), and absence of acute medication overdose.
The researchers also evaluated any potential impact of race, ethnicity, and sociodemographic factors on these barriers.
“While chronic migraine was associated with higher rates of consulting, only 1.8% of respondents with chronic migraine traversed all four barriers compared with 8.5% of those with episodic migraine,” the investigators, led by Dawn C. Buse, PhD, clinical professor of neurology at Albert Einstein College of Medicine of Yeshiva University in New York City, noted.
The study was presented at the virtual annual meeting of the American Headache Society.
Ongoing challenges
Migraineurs’ challenges include receiving an appropriate diagnosis and finding effective acute and preventive treatments, the researchers noted. Many patients do not receive optimal care. Previous research by Dr. Buse and colleagues showed that general clinicians were less likely to provide an appropriate diagnosis of migraine compared with headache specialists.
Among patients with chronic migraine who consulted headache specialists, most did not receive an accurate diagnosis of chronic migraine. Data also indicate that a minority, approximately 34%, of patients with chronic migraine used preventive pharmacologic treatments.
The investigators analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study to determine the proportion of patients who overcame four prespecified barriers to good outcomes.
Eligible participants met modified International Classification of Headache Disorders (3rd edition) criteria for migraine, had Migraine Disability Assessment Scores (MIDAS) of grade II or higher, and provided data on health insurance status. In addition, all eligible participants had to be receiving appropriate treatment for either episodic or chronic migraine.
In all, 16,789 participants met criteria for migraine. Of this group, 9,184 patients had a MIDAS score of grade II or higher and reported health insurance status. In this subgroup, 7,930 (86.3%) patients had episodic migraine and 1,254 (13.7%) had chronic migraine.
A total of 2,187 (27.6%) patients with episodic migraine and 512 (40.8%) patients with chronic migraine were under the care of a healthcare professional. Of this group, 1,655 patients with episodic migraine (75.7%) and 168 with chronic migraine (32.8%) reported receiving an appropriate diagnosis.
Of participants who successfully overcame the first two optimal management barriers—a consultation with a healthcare professional and an appropriate diagnosis—1,133 (68.5%) episodic migraineurs and 113 (67.3%) chronic migraineurs reported receiving minimally adequate acute treatment.
Furthermore, 1,430 (86.4%) episodic migraineurs and 127 (75.6%) chronic migraineurs reported receiving minimally adequate preventive medication treatment. In addition, 982 (59.3%) episodic migraineurs and 88 (52.4%) chronic migraineurs received minimally adequate acute and preventive treatment.
Acute medication overuse was relatively common, the investigators reported. A total of 310 (31.6%) patients with episodic migraine and 66 (75%) patients with chronic migraine met criteria for acute medication overuse.
“Overuse of acute medication for migraine in people with chronic migraine is a serious concern and is associated with increased risks of migraine progression, headache-related disability, and anxiety and depression. Active patient management and education is important to reduce the likelihood of medication overuse,” said Dr. Buse.
Among all eligible respondents, only 672 (8.5%) patients with episodic migraine and 22 (1.8%) with chronic migraine overcame all four barriers to optimal care.
The researchers found no significant effect of ethnicity or race on the likelihood of overcoming any barrier, but they acknowledged that participation bias might have contributed to this lack of difference. Higher annual household income was significantly associated with high likelihood of surmounting all four barriers.
“The analysis of sociodemographics revealed that female sex and higher annual household income showed a strong relationship with likelihood of obtaining an accurate episodic migraine or chronic migraine diagnosis,” said Dr. Buse.
“Although the reasons for this are not clear, it may be that women are more likely to convey the full scope of their symptoms during consultation. Additionally, the known prevalence of migraine in women may influence healthcare providers by reducing suspicion of chronic migraine in men,” she added.
The CaMEO Study was funded by Allergan (now AbbVie). Dr. Buse reports receiving grant support and honoraria from Allergan, Amgen, Biohaven, Eli Lilly and Co, and Promius. She also receives compensation for work on the editorial board of Current Pain and Headache Reports.
This article first appeared on Medscape.com.
, new research shows.
Results from a survey study showed less than 8% of patients with episodic migraine and less than 2% of patients with chronic migraine were able to overcome four key treatment barriers associated with optimal migraine management. These included current medical consultation, appropriate diagnosis, minimally adequate acute and preventive pharmacologic treatment (if indicated), and absence of acute medication overdose.
The researchers also evaluated any potential impact of race, ethnicity, and sociodemographic factors on these barriers.
“While chronic migraine was associated with higher rates of consulting, only 1.8% of respondents with chronic migraine traversed all four barriers compared with 8.5% of those with episodic migraine,” the investigators, led by Dawn C. Buse, PhD, clinical professor of neurology at Albert Einstein College of Medicine of Yeshiva University in New York City, noted.
The study was presented at the virtual annual meeting of the American Headache Society.
Ongoing challenges
Migraineurs’ challenges include receiving an appropriate diagnosis and finding effective acute and preventive treatments, the researchers noted. Many patients do not receive optimal care. Previous research by Dr. Buse and colleagues showed that general clinicians were less likely to provide an appropriate diagnosis of migraine compared with headache specialists.
Among patients with chronic migraine who consulted headache specialists, most did not receive an accurate diagnosis of chronic migraine. Data also indicate that a minority, approximately 34%, of patients with chronic migraine used preventive pharmacologic treatments.
The investigators analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study to determine the proportion of patients who overcame four prespecified barriers to good outcomes.
Eligible participants met modified International Classification of Headache Disorders (3rd edition) criteria for migraine, had Migraine Disability Assessment Scores (MIDAS) of grade II or higher, and provided data on health insurance status. In addition, all eligible participants had to be receiving appropriate treatment for either episodic or chronic migraine.
In all, 16,789 participants met criteria for migraine. Of this group, 9,184 patients had a MIDAS score of grade II or higher and reported health insurance status. In this subgroup, 7,930 (86.3%) patients had episodic migraine and 1,254 (13.7%) had chronic migraine.
A total of 2,187 (27.6%) patients with episodic migraine and 512 (40.8%) patients with chronic migraine were under the care of a healthcare professional. Of this group, 1,655 patients with episodic migraine (75.7%) and 168 with chronic migraine (32.8%) reported receiving an appropriate diagnosis.
Of participants who successfully overcame the first two optimal management barriers—a consultation with a healthcare professional and an appropriate diagnosis—1,133 (68.5%) episodic migraineurs and 113 (67.3%) chronic migraineurs reported receiving minimally adequate acute treatment.
Furthermore, 1,430 (86.4%) episodic migraineurs and 127 (75.6%) chronic migraineurs reported receiving minimally adequate preventive medication treatment. In addition, 982 (59.3%) episodic migraineurs and 88 (52.4%) chronic migraineurs received minimally adequate acute and preventive treatment.
Acute medication overuse was relatively common, the investigators reported. A total of 310 (31.6%) patients with episodic migraine and 66 (75%) patients with chronic migraine met criteria for acute medication overuse.
“Overuse of acute medication for migraine in people with chronic migraine is a serious concern and is associated with increased risks of migraine progression, headache-related disability, and anxiety and depression. Active patient management and education is important to reduce the likelihood of medication overuse,” said Dr. Buse.
Among all eligible respondents, only 672 (8.5%) patients with episodic migraine and 22 (1.8%) with chronic migraine overcame all four barriers to optimal care.
The researchers found no significant effect of ethnicity or race on the likelihood of overcoming any barrier, but they acknowledged that participation bias might have contributed to this lack of difference. Higher annual household income was significantly associated with high likelihood of surmounting all four barriers.
“The analysis of sociodemographics revealed that female sex and higher annual household income showed a strong relationship with likelihood of obtaining an accurate episodic migraine or chronic migraine diagnosis,” said Dr. Buse.
“Although the reasons for this are not clear, it may be that women are more likely to convey the full scope of their symptoms during consultation. Additionally, the known prevalence of migraine in women may influence healthcare providers by reducing suspicion of chronic migraine in men,” she added.
The CaMEO Study was funded by Allergan (now AbbVie). Dr. Buse reports receiving grant support and honoraria from Allergan, Amgen, Biohaven, Eli Lilly and Co, and Promius. She also receives compensation for work on the editorial board of Current Pain and Headache Reports.
This article first appeared on Medscape.com.
, new research shows.
Results from a survey study showed less than 8% of patients with episodic migraine and less than 2% of patients with chronic migraine were able to overcome four key treatment barriers associated with optimal migraine management. These included current medical consultation, appropriate diagnosis, minimally adequate acute and preventive pharmacologic treatment (if indicated), and absence of acute medication overdose.
The researchers also evaluated any potential impact of race, ethnicity, and sociodemographic factors on these barriers.
“While chronic migraine was associated with higher rates of consulting, only 1.8% of respondents with chronic migraine traversed all four barriers compared with 8.5% of those with episodic migraine,” the investigators, led by Dawn C. Buse, PhD, clinical professor of neurology at Albert Einstein College of Medicine of Yeshiva University in New York City, noted.
The study was presented at the virtual annual meeting of the American Headache Society.
Ongoing challenges
Migraineurs’ challenges include receiving an appropriate diagnosis and finding effective acute and preventive treatments, the researchers noted. Many patients do not receive optimal care. Previous research by Dr. Buse and colleagues showed that general clinicians were less likely to provide an appropriate diagnosis of migraine compared with headache specialists.
Among patients with chronic migraine who consulted headache specialists, most did not receive an accurate diagnosis of chronic migraine. Data also indicate that a minority, approximately 34%, of patients with chronic migraine used preventive pharmacologic treatments.
The investigators analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study to determine the proportion of patients who overcame four prespecified barriers to good outcomes.
Eligible participants met modified International Classification of Headache Disorders (3rd edition) criteria for migraine, had Migraine Disability Assessment Scores (MIDAS) of grade II or higher, and provided data on health insurance status. In addition, all eligible participants had to be receiving appropriate treatment for either episodic or chronic migraine.
In all, 16,789 participants met criteria for migraine. Of this group, 9,184 patients had a MIDAS score of grade II or higher and reported health insurance status. In this subgroup, 7,930 (86.3%) patients had episodic migraine and 1,254 (13.7%) had chronic migraine.
A total of 2,187 (27.6%) patients with episodic migraine and 512 (40.8%) patients with chronic migraine were under the care of a healthcare professional. Of this group, 1,655 patients with episodic migraine (75.7%) and 168 with chronic migraine (32.8%) reported receiving an appropriate diagnosis.
Of participants who successfully overcame the first two optimal management barriers—a consultation with a healthcare professional and an appropriate diagnosis—1,133 (68.5%) episodic migraineurs and 113 (67.3%) chronic migraineurs reported receiving minimally adequate acute treatment.
Furthermore, 1,430 (86.4%) episodic migraineurs and 127 (75.6%) chronic migraineurs reported receiving minimally adequate preventive medication treatment. In addition, 982 (59.3%) episodic migraineurs and 88 (52.4%) chronic migraineurs received minimally adequate acute and preventive treatment.
Acute medication overuse was relatively common, the investigators reported. A total of 310 (31.6%) patients with episodic migraine and 66 (75%) patients with chronic migraine met criteria for acute medication overuse.
“Overuse of acute medication for migraine in people with chronic migraine is a serious concern and is associated with increased risks of migraine progression, headache-related disability, and anxiety and depression. Active patient management and education is important to reduce the likelihood of medication overuse,” said Dr. Buse.
Among all eligible respondents, only 672 (8.5%) patients with episodic migraine and 22 (1.8%) with chronic migraine overcame all four barriers to optimal care.
The researchers found no significant effect of ethnicity or race on the likelihood of overcoming any barrier, but they acknowledged that participation bias might have contributed to this lack of difference. Higher annual household income was significantly associated with high likelihood of surmounting all four barriers.
“The analysis of sociodemographics revealed that female sex and higher annual household income showed a strong relationship with likelihood of obtaining an accurate episodic migraine or chronic migraine diagnosis,” said Dr. Buse.
“Although the reasons for this are not clear, it may be that women are more likely to convey the full scope of their symptoms during consultation. Additionally, the known prevalence of migraine in women may influence healthcare providers by reducing suspicion of chronic migraine in men,” she added.
The CaMEO Study was funded by Allergan (now AbbVie). Dr. Buse reports receiving grant support and honoraria from Allergan, Amgen, Biohaven, Eli Lilly and Co, and Promius. She also receives compensation for work on the editorial board of Current Pain and Headache Reports.
This article first appeared on Medscape.com.
From AHS 2020
Population study supports migraine–dementia link
Preliminary results from a population-based cohort study support previous reports that migraine is a midlife risk factor for dementia later in life, but further determined that according to results from a Danish registry presented at the virtual annual meeting of the American Headache Society.
“The findings of this study emphasize the need for studies in the migraine-dementia pathophysiology, in particular in migraine cases with aura,” said Sabrina Islamoska, MSc, PhD, a postdoctoral researcher in the department of public health at the University of Copenhagen. “This study highlights the importance of monitoring severe migraine to potentially prevent dementia.”
A national register-based study
The study used Danish national register–based data from 1988 to 2017 of 1.66 million individuals born between 1935 and 1956, retrieving exposure information until age 59 years and following individuals for dementia after age 60. The matched analysis included 18,135 people registered with migraine before age 59 and 1.38 million without migraine. The matched study population was 62,578.
A diagnosis of dementia or use of dementia medications after age 60 years was the main outcome. Covariates included socioeconomic factors, psychiatric comorbidities and other headache diagnoses.
“To the best of our knowledge, no previous national register–based studies have investigated the risk of dementia among individuals who suffer from migraine with aura,” Dr. Islamoska said.
The preliminary findings revealed that the median age at diagnosis was 49 years and about 70% of the migraine population were women. “There was a 50% higher dementia rate in individuals who had any migraine diagnosis,” Dr. Islamoska said.
“We also found a 20% higher but nonsignificant dementia rate in individuals who had migraine without aura,” she said. However, when the migraine-with-aura population was evaluated, it was found to have a dementia rate two times higher than people with no migraine. “The dementia rate was higher if individuals had more frequent hospital contacts with migraine.”
The findings support the hypothesis that migraine is a midlife risk factor for dementia later in life, she said.
“The findings underline the value of investigating the effect of migraine medications in dementia risk to assess the impact of mild to moderate migraines,” Dr. Islamoska said. “Therefore, the next step is to investigate the risk of dementia among users of migraine medications who are not diagnosed with migraines at hospitals.”
Strengths of the study, Dr. Islamoska noted, were its size and national nature of its population, that it included all migraine diagnoses at hospitals over a 29-year period, that it made adjustments for confounding of well-established dementia risk factors, and that it validated dementia diagnoses after age 60 years.
One limitation was that the study only included hospital-based diagnoses of dementia while 60% of cases in Denmark are undiagnosed, “thus our results only apply to migraine that is severe enough to require a hospital contact,” Dr. Islamoska said, while most migraine cases are treated in the primary care setting.
Also, the young study population may have a lower dementia risk. “We also know that age of migraine registration may not corresponded with the actual onset, since migraine is a complex disorder with individual variation in patient’s burden and course of disease,” Dr. Islamoska said.
“Future studies are needed to understand the pathological mechanisms underlying the relationship between migraine and dementia and to investigate whether proper prophylactic treatment of migraine can potentially prevent dementia,” Dr. Islamoska said. “In addition, when investigating the association between these two prevalent neurological disorders, the timing of migraine diagnosis and dementia onset is important to ensure temporality. We took this into account in our study to strengthen the validity of our results.”
‘Surprising’ findings
Andrew Charles, MD, director of the Goldberg Migraine Program at the University of California, Los Angeles, said the Danish study makes an important contribution to the literature on dementia risk factors. “Vanishingly small amounts of attention have been paid to migraine as a potential risk factor,” he said. However, he called the results “surprising” based on his own clinical experience. “I actually had a sense that migraine was somehow protective against Alzheimer’s or other kinds of dementias.”
He questioned if the migraine-dementia link could be a “reporting artifact” of migraine sufferers merely going to the neurologist, raising the likelihood of a positive migraine diagnosis. Nonetheless, the results are “intriguing” and raise important questions about migraine therapy and dementia risk.
“If it holds up, it really is something that behooves us to understand whether intervening in terms of therapy for migraine has even more consequences beyond just the immediate relief of symptoms,” Dr. Charles said. “It’s something we should be thinking about in terms of preventing longer-term consequences of this disorder.”
Dr. Islamoska disclosed that Veluxfondent funded the study as part of her PhD project. Dr. Charles disclosed he is a consultant to Amgen, Biohaven Pharmaceuticals, Eli Lilly, Lundbeck, and Novartis.
SOURCE: Islamoska S et al. AHS 2020, Submission 846214.
Preliminary results from a population-based cohort study support previous reports that migraine is a midlife risk factor for dementia later in life, but further determined that according to results from a Danish registry presented at the virtual annual meeting of the American Headache Society.
“The findings of this study emphasize the need for studies in the migraine-dementia pathophysiology, in particular in migraine cases with aura,” said Sabrina Islamoska, MSc, PhD, a postdoctoral researcher in the department of public health at the University of Copenhagen. “This study highlights the importance of monitoring severe migraine to potentially prevent dementia.”
A national register-based study
The study used Danish national register–based data from 1988 to 2017 of 1.66 million individuals born between 1935 and 1956, retrieving exposure information until age 59 years and following individuals for dementia after age 60. The matched analysis included 18,135 people registered with migraine before age 59 and 1.38 million without migraine. The matched study population was 62,578.
A diagnosis of dementia or use of dementia medications after age 60 years was the main outcome. Covariates included socioeconomic factors, psychiatric comorbidities and other headache diagnoses.
“To the best of our knowledge, no previous national register–based studies have investigated the risk of dementia among individuals who suffer from migraine with aura,” Dr. Islamoska said.
The preliminary findings revealed that the median age at diagnosis was 49 years and about 70% of the migraine population were women. “There was a 50% higher dementia rate in individuals who had any migraine diagnosis,” Dr. Islamoska said.
“We also found a 20% higher but nonsignificant dementia rate in individuals who had migraine without aura,” she said. However, when the migraine-with-aura population was evaluated, it was found to have a dementia rate two times higher than people with no migraine. “The dementia rate was higher if individuals had more frequent hospital contacts with migraine.”
The findings support the hypothesis that migraine is a midlife risk factor for dementia later in life, she said.
“The findings underline the value of investigating the effect of migraine medications in dementia risk to assess the impact of mild to moderate migraines,” Dr. Islamoska said. “Therefore, the next step is to investigate the risk of dementia among users of migraine medications who are not diagnosed with migraines at hospitals.”
Strengths of the study, Dr. Islamoska noted, were its size and national nature of its population, that it included all migraine diagnoses at hospitals over a 29-year period, that it made adjustments for confounding of well-established dementia risk factors, and that it validated dementia diagnoses after age 60 years.
One limitation was that the study only included hospital-based diagnoses of dementia while 60% of cases in Denmark are undiagnosed, “thus our results only apply to migraine that is severe enough to require a hospital contact,” Dr. Islamoska said, while most migraine cases are treated in the primary care setting.
Also, the young study population may have a lower dementia risk. “We also know that age of migraine registration may not corresponded with the actual onset, since migraine is a complex disorder with individual variation in patient’s burden and course of disease,” Dr. Islamoska said.
“Future studies are needed to understand the pathological mechanisms underlying the relationship between migraine and dementia and to investigate whether proper prophylactic treatment of migraine can potentially prevent dementia,” Dr. Islamoska said. “In addition, when investigating the association between these two prevalent neurological disorders, the timing of migraine diagnosis and dementia onset is important to ensure temporality. We took this into account in our study to strengthen the validity of our results.”
‘Surprising’ findings
Andrew Charles, MD, director of the Goldberg Migraine Program at the University of California, Los Angeles, said the Danish study makes an important contribution to the literature on dementia risk factors. “Vanishingly small amounts of attention have been paid to migraine as a potential risk factor,” he said. However, he called the results “surprising” based on his own clinical experience. “I actually had a sense that migraine was somehow protective against Alzheimer’s or other kinds of dementias.”
He questioned if the migraine-dementia link could be a “reporting artifact” of migraine sufferers merely going to the neurologist, raising the likelihood of a positive migraine diagnosis. Nonetheless, the results are “intriguing” and raise important questions about migraine therapy and dementia risk.
“If it holds up, it really is something that behooves us to understand whether intervening in terms of therapy for migraine has even more consequences beyond just the immediate relief of symptoms,” Dr. Charles said. “It’s something we should be thinking about in terms of preventing longer-term consequences of this disorder.”
Dr. Islamoska disclosed that Veluxfondent funded the study as part of her PhD project. Dr. Charles disclosed he is a consultant to Amgen, Biohaven Pharmaceuticals, Eli Lilly, Lundbeck, and Novartis.
SOURCE: Islamoska S et al. AHS 2020, Submission 846214.
Preliminary results from a population-based cohort study support previous reports that migraine is a midlife risk factor for dementia later in life, but further determined that according to results from a Danish registry presented at the virtual annual meeting of the American Headache Society.
“The findings of this study emphasize the need for studies in the migraine-dementia pathophysiology, in particular in migraine cases with aura,” said Sabrina Islamoska, MSc, PhD, a postdoctoral researcher in the department of public health at the University of Copenhagen. “This study highlights the importance of monitoring severe migraine to potentially prevent dementia.”
A national register-based study
The study used Danish national register–based data from 1988 to 2017 of 1.66 million individuals born between 1935 and 1956, retrieving exposure information until age 59 years and following individuals for dementia after age 60. The matched analysis included 18,135 people registered with migraine before age 59 and 1.38 million without migraine. The matched study population was 62,578.
A diagnosis of dementia or use of dementia medications after age 60 years was the main outcome. Covariates included socioeconomic factors, psychiatric comorbidities and other headache diagnoses.
“To the best of our knowledge, no previous national register–based studies have investigated the risk of dementia among individuals who suffer from migraine with aura,” Dr. Islamoska said.
The preliminary findings revealed that the median age at diagnosis was 49 years and about 70% of the migraine population were women. “There was a 50% higher dementia rate in individuals who had any migraine diagnosis,” Dr. Islamoska said.
“We also found a 20% higher but nonsignificant dementia rate in individuals who had migraine without aura,” she said. However, when the migraine-with-aura population was evaluated, it was found to have a dementia rate two times higher than people with no migraine. “The dementia rate was higher if individuals had more frequent hospital contacts with migraine.”
The findings support the hypothesis that migraine is a midlife risk factor for dementia later in life, she said.
“The findings underline the value of investigating the effect of migraine medications in dementia risk to assess the impact of mild to moderate migraines,” Dr. Islamoska said. “Therefore, the next step is to investigate the risk of dementia among users of migraine medications who are not diagnosed with migraines at hospitals.”
Strengths of the study, Dr. Islamoska noted, were its size and national nature of its population, that it included all migraine diagnoses at hospitals over a 29-year period, that it made adjustments for confounding of well-established dementia risk factors, and that it validated dementia diagnoses after age 60 years.
One limitation was that the study only included hospital-based diagnoses of dementia while 60% of cases in Denmark are undiagnosed, “thus our results only apply to migraine that is severe enough to require a hospital contact,” Dr. Islamoska said, while most migraine cases are treated in the primary care setting.
Also, the young study population may have a lower dementia risk. “We also know that age of migraine registration may not corresponded with the actual onset, since migraine is a complex disorder with individual variation in patient’s burden and course of disease,” Dr. Islamoska said.
“Future studies are needed to understand the pathological mechanisms underlying the relationship between migraine and dementia and to investigate whether proper prophylactic treatment of migraine can potentially prevent dementia,” Dr. Islamoska said. “In addition, when investigating the association between these two prevalent neurological disorders, the timing of migraine diagnosis and dementia onset is important to ensure temporality. We took this into account in our study to strengthen the validity of our results.”
‘Surprising’ findings
Andrew Charles, MD, director of the Goldberg Migraine Program at the University of California, Los Angeles, said the Danish study makes an important contribution to the literature on dementia risk factors. “Vanishingly small amounts of attention have been paid to migraine as a potential risk factor,” he said. However, he called the results “surprising” based on his own clinical experience. “I actually had a sense that migraine was somehow protective against Alzheimer’s or other kinds of dementias.”
He questioned if the migraine-dementia link could be a “reporting artifact” of migraine sufferers merely going to the neurologist, raising the likelihood of a positive migraine diagnosis. Nonetheless, the results are “intriguing” and raise important questions about migraine therapy and dementia risk.
“If it holds up, it really is something that behooves us to understand whether intervening in terms of therapy for migraine has even more consequences beyond just the immediate relief of symptoms,” Dr. Charles said. “It’s something we should be thinking about in terms of preventing longer-term consequences of this disorder.”
Dr. Islamoska disclosed that Veluxfondent funded the study as part of her PhD project. Dr. Charles disclosed he is a consultant to Amgen, Biohaven Pharmaceuticals, Eli Lilly, Lundbeck, and Novartis.
SOURCE: Islamoska S et al. AHS 2020, Submission 846214.
FROM AHS 2020