AHS: American Headache Society

Almost a third of patients with migraine have experienced some form of stigma, new research shows. Results from the OVERCOME population-based survey study, which included more than 59,000 respondents, showed about 32% reported experiencing migraine-related stigma “often” or “very often.”

Even those experiencing only a few headaches per month said they experienced negative attitudes from others about migraine.

“We have been utterly blind to the burden people with migraine experience in terms of how their disease is appreciated by others. It’s time to get busy and address this very stubborn social phenomenon,” said the study’s coinvestigator, Robert E. Shapiro, MD, PhD, professor emeritus, department of neurological sciences, Larner College of Medicine, University of Vermont, Burlington.

Population-based research

Stigma is defined as the discounting or discrediting of an individual with a trait that deviates from social norms. To date, there have been no significant population-based studies of how these attitudes affect individuals with migraine.

OVERCOME is a cross-sectional, longitudinal, prospective, web-based survey conducted in a representative sample of the United States population. For this new analysis, researchers pooled data from surveys conducted in 2018, 2019, and 2020.

The analysis included 59,004 respondents (mean age, 41.3 years; 75% women; 70% White) who reported one or more headache or migraine attacks during the previous 12 months and who met criteria for migraine from the International Classification of Headache Disorders. Among the patients, 35% had a college degree, and 89% suffered episodic-type headaches.

Researchers used the following four patient-reported outcome measures:

• Migraine Disability Assessment, which quantifies number of days missed at work, home, or social events over the previous 3 months
• Migraine Interictal Burden Scale–4, which measures burden of migraine between attacks over the previous 4 weeks
• Migraine-Specific Quality of Life Role-Function Restrictive, which assesses the functional effect of migraine on social and work-related activities over the previous 4 weeks
• Migraine-Related Stigma

For the latter, the investigators used two measures – the degree to which others think migraine is used to acquire secondary gain, such as avoiding commitments, and the degree to which others minimize the burden of migraine.
 

One of the most stigmatizing disorders

Results showed that 31.7% of participants reported experiencing stigmatization from one or both migraine-related stigma categories often or very often – a result Dr. Shapiro characterized as “pretty shocking.”

Participants with chronic headaches, defined as having 15 or more headache days per month, made up 11% of the sample. About 47% of these respondents felt stigma often or very often.

However, even 25% of participants with three or fewer headache days per month reported stigma.

“This is a fundamental tip that we are not really understanding the concerns that drive burden for people living with this disabling disease,” Dr. Shapiro said.

Some previous studies that compared levels of stigmatizing attitudes regarding various diseases showed that migraine is more stigmatized than even epilepsy, a condition “equated with demonic possession in biblical times,” he noted.

One study used machine learning to measure the number of pejorative or negative terms associated with various diseases. “Shockingly, migraine was one of the most stigmatized diseases,” said Dr. Shapiro. “It was as stigmatized as gonorrhea by certain measures.”

Results from the new study showed that, irrespective of the number of headache days experienced per month, there was a threefold increase in interictal burden among those reporting stigma often or very often, compared with those who didn’t report stigma.
 

Large impact on QoL

“Stigma is a social concept, so maybe it’s not surprising that it would be present whether or not someone is experiencing other symptoms of migraine,” said Dr. Shapiro.

Across all monthly headache days, experiencing more migraine-related stigma was associated with increased disability and decreased quality of life.

Dr. Shapiro noted that when it comes to migraine-specific quality of life, stigma appears to have more of an effect than number of headache days. “That means there are big gaps in our appreciation for what drives the burdens in the patient experience of living with this disabling disease,” he said.

He added that headache’s place within the migraine sphere needs to be reconsidered. “Its singular emphasis has limited our full appreciation of this disease and how we should be paying attention to the things that are important to patients,” he said.

Dr. Shapiro predicts that future clinical trials will include migraine-related stigma as a measure to guide trial enrollment.

In addition, researchers are now digging deeper to try to understand what factors are most likely to drive stigma. “We need to understand why those attitudes are held and who is more likely to hold those attitudes, and that may allow us to develop mitigating strategies to reduce those attitudes,” said Dr. Shapiro.
 

‘Worrisome’ findings

Commenting on the findings, Deborah Friedman, MD, professor, departments of neurology and of ophthalmology, UT Southwestern Medical Center, Dallas, said the data on stigma were “worrisome.”

Missing social occasions and lost productivity may make migraine more visible to others so perhaps may “provoke stigma or stigmatizing comments or stigmatizing attitudes,” said Dr. Friedman, who was not involved with the research.

She noted that patients with migraine might also have trouble functioning in the workplace. “They may not be able to tolerate the computer screen or smells of perfume at the office and not get accommodation for that,” she said.

In addition to external stigma, which was investigated in the study, individuals with migraine may also experience internal stigma – blaming themselves for their disease, which may make it less likely they will seek care, said Dr. Friedman.

“That’s a huge problem,” she added.

The OVERCOME study is funded by Lilly. Dr. Shapiro has been compensated by Lilly as a research consultant and as a member of the data monitoring committee for clinical trials for galcanezumab, a Lilly pharmaceutical. Dr. Friedman has reported no relevant financial relationships.

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

Almost a third of patients with migraine have experienced some form of stigma, new research shows. Results from the OVERCOME population-based survey study, which included more than 59,000 respondents, showed about 32% reported experiencing migraine-related stigma “often” or “very often.”

Even those experiencing only a few headaches per month said they experienced negative attitudes from others about migraine.

“We have been utterly blind to the burden people with migraine experience in terms of how their disease is appreciated by others. It’s time to get busy and address this very stubborn social phenomenon,” said the study’s coinvestigator, Robert E. Shapiro, MD, PhD, professor emeritus, department of neurological sciences, Larner College of Medicine, University of Vermont, Burlington.

Population-based research

Stigma is defined as the discounting or discrediting of an individual with a trait that deviates from social norms. To date, there have been no significant population-based studies of how these attitudes affect individuals with migraine.

OVERCOME is a cross-sectional, longitudinal, prospective, web-based survey conducted in a representative sample of the United States population. For this new analysis, researchers pooled data from surveys conducted in 2018, 2019, and 2020.

The analysis included 59,004 respondents (mean age, 41.3 years; 75% women; 70% White) who reported one or more headache or migraine attacks during the previous 12 months and who met criteria for migraine from the International Classification of Headache Disorders. Among the patients, 35% had a college degree, and 89% suffered episodic-type headaches.

Researchers used the following four patient-reported outcome measures:

• Migraine Disability Assessment, which quantifies number of days missed at work, home, or social events over the previous 3 months
• Migraine Interictal Burden Scale–4, which measures burden of migraine between attacks over the previous 4 weeks
• Migraine-Specific Quality of Life Role-Function Restrictive, which assesses the functional effect of migraine on social and work-related activities over the previous 4 weeks
• Migraine-Related Stigma

For the latter, the investigators used two measures – the degree to which others think migraine is used to acquire secondary gain, such as avoiding commitments, and the degree to which others minimize the burden of migraine.
 

One of the most stigmatizing disorders

Results showed that 31.7% of participants reported experiencing stigmatization from one or both migraine-related stigma categories often or very often – a result Dr. Shapiro characterized as “pretty shocking.”

Participants with chronic headaches, defined as having 15 or more headache days per month, made up 11% of the sample. About 47% of these respondents felt stigma often or very often.

However, even 25% of participants with three or fewer headache days per month reported stigma.

“This is a fundamental tip that we are not really understanding the concerns that drive burden for people living with this disabling disease,” Dr. Shapiro said.

Some previous studies that compared levels of stigmatizing attitudes regarding various diseases showed that migraine is more stigmatized than even epilepsy, a condition “equated with demonic possession in biblical times,” he noted.

One study used machine learning to measure the number of pejorative or negative terms associated with various diseases. “Shockingly, migraine was one of the most stigmatized diseases,” said Dr. Shapiro. “It was as stigmatized as gonorrhea by certain measures.”

Results from the new study showed that, irrespective of the number of headache days experienced per month, there was a threefold increase in interictal burden among those reporting stigma often or very often, compared with those who didn’t report stigma.
 

Large impact on QoL

“Stigma is a social concept, so maybe it’s not surprising that it would be present whether or not someone is experiencing other symptoms of migraine,” said Dr. Shapiro.

Across all monthly headache days, experiencing more migraine-related stigma was associated with increased disability and decreased quality of life.

Dr. Shapiro noted that when it comes to migraine-specific quality of life, stigma appears to have more of an effect than number of headache days. “That means there are big gaps in our appreciation for what drives the burdens in the patient experience of living with this disabling disease,” he said.

He added that headache’s place within the migraine sphere needs to be reconsidered. “Its singular emphasis has limited our full appreciation of this disease and how we should be paying attention to the things that are important to patients,” he said.

Dr. Shapiro predicts that future clinical trials will include migraine-related stigma as a measure to guide trial enrollment.

In addition, researchers are now digging deeper to try to understand what factors are most likely to drive stigma. “We need to understand why those attitudes are held and who is more likely to hold those attitudes, and that may allow us to develop mitigating strategies to reduce those attitudes,” said Dr. Shapiro.
 

‘Worrisome’ findings

Commenting on the findings, Deborah Friedman, MD, professor, departments of neurology and of ophthalmology, UT Southwestern Medical Center, Dallas, said the data on stigma were “worrisome.”

Missing social occasions and lost productivity may make migraine more visible to others so perhaps may “provoke stigma or stigmatizing comments or stigmatizing attitudes,” said Dr. Friedman, who was not involved with the research.

She noted that patients with migraine might also have trouble functioning in the workplace. “They may not be able to tolerate the computer screen or smells of perfume at the office and not get accommodation for that,” she said.

In addition to external stigma, which was investigated in the study, individuals with migraine may also experience internal stigma – blaming themselves for their disease, which may make it less likely they will seek care, said Dr. Friedman.

“That’s a huge problem,” she added.

The OVERCOME study is funded by Lilly. Dr. Shapiro has been compensated by Lilly as a research consultant and as a member of the data monitoring committee for clinical trials for galcanezumab, a Lilly pharmaceutical. Dr. Friedman has reported no relevant financial relationships.

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

Almost a third of patients with migraine have experienced some form of stigma, new research shows. Results from the OVERCOME population-based survey study, which included more than 59,000 respondents, showed about 32% reported experiencing migraine-related stigma “often” or “very often.”

Even those experiencing only a few headaches per month said they experienced negative attitudes from others about migraine.

“We have been utterly blind to the burden people with migraine experience in terms of how their disease is appreciated by others. It’s time to get busy and address this very stubborn social phenomenon,” said the study’s coinvestigator, Robert E. Shapiro, MD, PhD, professor emeritus, department of neurological sciences, Larner College of Medicine, University of Vermont, Burlington.

Population-based research

Stigma is defined as the discounting or discrediting of an individual with a trait that deviates from social norms. To date, there have been no significant population-based studies of how these attitudes affect individuals with migraine.

OVERCOME is a cross-sectional, longitudinal, prospective, web-based survey conducted in a representative sample of the United States population. For this new analysis, researchers pooled data from surveys conducted in 2018, 2019, and 2020.

The analysis included 59,004 respondents (mean age, 41.3 years; 75% women; 70% White) who reported one or more headache or migraine attacks during the previous 12 months and who met criteria for migraine from the International Classification of Headache Disorders. Among the patients, 35% had a college degree, and 89% suffered episodic-type headaches.

Researchers used the following four patient-reported outcome measures:

• Migraine Disability Assessment, which quantifies number of days missed at work, home, or social events over the previous 3 months
• Migraine Interictal Burden Scale–4, which measures burden of migraine between attacks over the previous 4 weeks
• Migraine-Specific Quality of Life Role-Function Restrictive, which assesses the functional effect of migraine on social and work-related activities over the previous 4 weeks
• Migraine-Related Stigma

For the latter, the investigators used two measures – the degree to which others think migraine is used to acquire secondary gain, such as avoiding commitments, and the degree to which others minimize the burden of migraine.
 

One of the most stigmatizing disorders

Results showed that 31.7% of participants reported experiencing stigmatization from one or both migraine-related stigma categories often or very often – a result Dr. Shapiro characterized as “pretty shocking.”

Participants with chronic headaches, defined as having 15 or more headache days per month, made up 11% of the sample. About 47% of these respondents felt stigma often or very often.

However, even 25% of participants with three or fewer headache days per month reported stigma.

“This is a fundamental tip that we are not really understanding the concerns that drive burden for people living with this disabling disease,” Dr. Shapiro said.

Some previous studies that compared levels of stigmatizing attitudes regarding various diseases showed that migraine is more stigmatized than even epilepsy, a condition “equated with demonic possession in biblical times,” he noted.

One study used machine learning to measure the number of pejorative or negative terms associated with various diseases. “Shockingly, migraine was one of the most stigmatized diseases,” said Dr. Shapiro. “It was as stigmatized as gonorrhea by certain measures.”

Results from the new study showed that, irrespective of the number of headache days experienced per month, there was a threefold increase in interictal burden among those reporting stigma often or very often, compared with those who didn’t report stigma.
 

Large impact on QoL

“Stigma is a social concept, so maybe it’s not surprising that it would be present whether or not someone is experiencing other symptoms of migraine,” said Dr. Shapiro.

Across all monthly headache days, experiencing more migraine-related stigma was associated with increased disability and decreased quality of life.

Dr. Shapiro noted that when it comes to migraine-specific quality of life, stigma appears to have more of an effect than number of headache days. “That means there are big gaps in our appreciation for what drives the burdens in the patient experience of living with this disabling disease,” he said.

He added that headache’s place within the migraine sphere needs to be reconsidered. “Its singular emphasis has limited our full appreciation of this disease and how we should be paying attention to the things that are important to patients,” he said.

Dr. Shapiro predicts that future clinical trials will include migraine-related stigma as a measure to guide trial enrollment.

In addition, researchers are now digging deeper to try to understand what factors are most likely to drive stigma. “We need to understand why those attitudes are held and who is more likely to hold those attitudes, and that may allow us to develop mitigating strategies to reduce those attitudes,” said Dr. Shapiro.
 

‘Worrisome’ findings

Commenting on the findings, Deborah Friedman, MD, professor, departments of neurology and of ophthalmology, UT Southwestern Medical Center, Dallas, said the data on stigma were “worrisome.”

Missing social occasions and lost productivity may make migraine more visible to others so perhaps may “provoke stigma or stigmatizing comments or stigmatizing attitudes,” said Dr. Friedman, who was not involved with the research.

She noted that patients with migraine might also have trouble functioning in the workplace. “They may not be able to tolerate the computer screen or smells of perfume at the office and not get accommodation for that,” she said.

In addition to external stigma, which was investigated in the study, individuals with migraine may also experience internal stigma – blaming themselves for their disease, which may make it less likely they will seek care, said Dr. Friedman.

“That’s a huge problem,” she added.

The OVERCOME study is funded by Lilly. Dr. Shapiro has been compensated by Lilly as a research consultant and as a member of the data monitoring committee for clinical trials for galcanezumab, a Lilly pharmaceutical. Dr. Friedman has reported no relevant financial relationships.

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

SAN FRANCISCO—Chronic migraine is associated with increased age-related cortical thinning of some brain areas and decreased age-related cortical thinning in other areas, according to research presented at the 60th Annual Scientific Meeting of the American Headache Society. It remains uncertain whether these cortical changes are a cause or an effect of chronic migraine.

Age-related cortical integrity had not been explored in chronic migraine previously. To investigate this topic, Yohannes Woubishet Woldeamanuel, MD, Instructor in Neurology and Neurologic Sciences at Stanford University in California, and colleagues enrolled 30 patients with chronic migraine and 30 age- and sex-matched healthy controls into a study. All participants were right-handed. The mean age in the chronic migraine group was 40.5, and the male-to-female ratio was 1:4. Investigators obtained the duration of chronic migraine and lifetime migraine from participants with chronic migraine.

Suggested Reading

Chong CD, Dodick DW, Schlaggar BL, Schwedt TJ. Atypical age-related cortical thinning in episodic migraine. Cephalalgia. 2014;34(14):1115-1124.

Schwedt TJ, Berisha V, Chong CD. Temporal lobe cortical thickness correlations differentiate the migraine brain from the healthy brain. PLoS One. 2015 Feb 13;10(2):e0116687.

SAN FRANCISCO—Chronic migraine is associated with increased age-related cortical thinning of some brain areas and decreased age-related cortical thinning in other areas, according to research presented at the 60th Annual Scientific Meeting of the American Headache Society. It remains uncertain whether these cortical changes are a cause or an effect of chronic migraine.

Age-related cortical integrity had not been explored in chronic migraine previously. To investigate this topic, Yohannes Woubishet Woldeamanuel, MD, Instructor in Neurology and Neurologic Sciences at Stanford University in California, and colleagues enrolled 30 patients with chronic migraine and 30 age- and sex-matched healthy controls into a study. All participants were right-handed. The mean age in the chronic migraine group was 40.5, and the male-to-female ratio was 1:4. Investigators obtained the duration of chronic migraine and lifetime migraine from participants with chronic migraine.

Suggested Reading

Chong CD, Dodick DW, Schlaggar BL, Schwedt TJ. Atypical age-related cortical thinning in episodic migraine. Cephalalgia. 2014;34(14):1115-1124.

Schwedt TJ, Berisha V, Chong CD. Temporal lobe cortical thickness correlations differentiate the migraine brain from the healthy brain. PLoS One. 2015 Feb 13;10(2):e0116687.

SAN FRANCISCO—Chronic migraine is associated with increased age-related cortical thinning of some brain areas and decreased age-related cortical thinning in other areas, according to research presented at the 60th Annual Scientific Meeting of the American Headache Society. It remains uncertain whether these cortical changes are a cause or an effect of chronic migraine.

Age-related cortical integrity had not been explored in chronic migraine previously. To investigate this topic, Yohannes Woubishet Woldeamanuel, MD, Instructor in Neurology and Neurologic Sciences at Stanford University in California, and colleagues enrolled 30 patients with chronic migraine and 30 age- and sex-matched healthy controls into a study. All participants were right-handed. The mean age in the chronic migraine group was 40.5, and the male-to-female ratio was 1:4. Investigators obtained the duration of chronic migraine and lifetime migraine from participants with chronic migraine.

Suggested Reading

Chong CD, Dodick DW, Schlaggar BL, Schwedt TJ. Atypical age-related cortical thinning in episodic migraine. Cephalalgia. 2014;34(14):1115-1124.

Schwedt TJ, Berisha V, Chong CD. Temporal lobe cortical thickness correlations differentiate the migraine brain from the healthy brain. PLoS One. 2015 Feb 13;10(2):e0116687.

SAN FRANCISCO—Unmet treatment needs among migraineurs receiving oral prescription medications include therapies to reduce nausea and disturbed sleep, according to a study described at the 60th Annual Scientific Meeting of the American Headache Society. The population also has unmet needs for therapies that provide pain freedom and rapid onset of action.

In 2017, investigators conducted the Migraine in America Symptoms and Treatment (MAST) study, which focused on migraine symptoms, current treatment patterns, and the assessment of unmet treatment needs. Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in the Bronx, New York, and colleagues examined MAST data to empirically characterize the patterns of poorly controlled migraine and assess corresponding rates of migraine-related disability.

A Survey of American Migraineurs

The MAST survey data were obtained from a general US population sample of migraineurs age 18 and older. Migraineurs were identified using a validated migraine symptom screen based on modified ICHD-3b criteria. Eligible participants had an average of at least one headache day per month during the previous three months.

Respondents provided information about sociodemographics and medication use and responded to a 13-item battery evaluating headache burden and response to medication. The items on the battery were derived from a review of relevant literature, clinician input, and interviews with migraine patients. Participants provided frequency data for each item on a five-point scale ranging from “1) Never” to “5) All or Nearly All of the Time.” To measure construct validity for the scale, the investigators assessed moderate to severe disability for each respondent using the Migraine Disability Assessment Scale (MIDAS).

To determine the underlying structure of unmet treatment needs, Dr. Lipton and colleagues conducted Exploratory Factor Analysis (EFA) among the subset of respondents currently using oral acute prescription medications. They assessed the internal consistency for the derived factors using Cronbach’s alpha. Mean factor scores (range, 1 to 5) were calculated by summing item responses for each factor and dividing by the number of items loading on that factor. The researchers used Mantel-Haenszel Chi Square Test for Trend to evaluate the relationship between mean factor score and rates of moderate to severe migraine-related disability.

Treatment May Act Too Slowly

Among 15,133 respondents meeting inclusion criteria, 3,930 reported current use of acute oral prescription headache medication (mean age, 45.0, 73.6% women, 81.6% Caucasian). Injection and nasal spray medication users were eliminated from the sample. The most commonly endorsed needs were “severe headache attacks come on very rapidly” (52.8%), “attacks reach peak intensity in less than 30 minutes” (50.4%), “severe headache presents upon awakening” (40.9%), and “the return of pain within 24 hours after initial pain relief” (38.6%). EFA identified the following four unmet needs: nausea interference, disturbed sleep, rapid onset, and lack of pain freedom. Internal consistency exceeded acceptable levels for all factors except disturbed sleep. MIDAS disability increased in a clear linear pattern with increasing mean factor scores.

Suggested Reading

Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015;15:100.

Lipton RB, Buse DC, Serrano D, et al. Examination of unmet treatment needs among persons with episodic migraine: results of the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2013;53(8):1300-1311.

SAN FRANCISCO—Unmet treatment needs among migraineurs receiving oral prescription medications include therapies to reduce nausea and disturbed sleep, according to a study described at the 60th Annual Scientific Meeting of the American Headache Society. The population also has unmet needs for therapies that provide pain freedom and rapid onset of action.

In 2017, investigators conducted the Migraine in America Symptoms and Treatment (MAST) study, which focused on migraine symptoms, current treatment patterns, and the assessment of unmet treatment needs. Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in the Bronx, New York, and colleagues examined MAST data to empirically characterize the patterns of poorly controlled migraine and assess corresponding rates of migraine-related disability.

A Survey of American Migraineurs

The MAST survey data were obtained from a general US population sample of migraineurs age 18 and older. Migraineurs were identified using a validated migraine symptom screen based on modified ICHD-3b criteria. Eligible participants had an average of at least one headache day per month during the previous three months.

Respondents provided information about sociodemographics and medication use and responded to a 13-item battery evaluating headache burden and response to medication. The items on the battery were derived from a review of relevant literature, clinician input, and interviews with migraine patients. Participants provided frequency data for each item on a five-point scale ranging from “1) Never” to “5) All or Nearly All of the Time.” To measure construct validity for the scale, the investigators assessed moderate to severe disability for each respondent using the Migraine Disability Assessment Scale (MIDAS).

To determine the underlying structure of unmet treatment needs, Dr. Lipton and colleagues conducted Exploratory Factor Analysis (EFA) among the subset of respondents currently using oral acute prescription medications. They assessed the internal consistency for the derived factors using Cronbach’s alpha. Mean factor scores (range, 1 to 5) were calculated by summing item responses for each factor and dividing by the number of items loading on that factor. The researchers used Mantel-Haenszel Chi Square Test for Trend to evaluate the relationship between mean factor score and rates of moderate to severe migraine-related disability.

Treatment May Act Too Slowly

Among 15,133 respondents meeting inclusion criteria, 3,930 reported current use of acute oral prescription headache medication (mean age, 45.0, 73.6% women, 81.6% Caucasian). Injection and nasal spray medication users were eliminated from the sample. The most commonly endorsed needs were “severe headache attacks come on very rapidly” (52.8%), “attacks reach peak intensity in less than 30 minutes” (50.4%), “severe headache presents upon awakening” (40.9%), and “the return of pain within 24 hours after initial pain relief” (38.6%). EFA identified the following four unmet needs: nausea interference, disturbed sleep, rapid onset, and lack of pain freedom. Internal consistency exceeded acceptable levels for all factors except disturbed sleep. MIDAS disability increased in a clear linear pattern with increasing mean factor scores.

Suggested Reading

Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015;15:100.

Lipton RB, Buse DC, Serrano D, et al. Examination of unmet treatment needs among persons with episodic migraine: results of the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2013;53(8):1300-1311.

SAN FRANCISCO—Unmet treatment needs among migraineurs receiving oral prescription medications include therapies to reduce nausea and disturbed sleep, according to a study described at the 60th Annual Scientific Meeting of the American Headache Society. The population also has unmet needs for therapies that provide pain freedom and rapid onset of action.

In 2017, investigators conducted the Migraine in America Symptoms and Treatment (MAST) study, which focused on migraine symptoms, current treatment patterns, and the assessment of unmet treatment needs. Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in the Bronx, New York, and colleagues examined MAST data to empirically characterize the patterns of poorly controlled migraine and assess corresponding rates of migraine-related disability.

A Survey of American Migraineurs

The MAST survey data were obtained from a general US population sample of migraineurs age 18 and older. Migraineurs were identified using a validated migraine symptom screen based on modified ICHD-3b criteria. Eligible participants had an average of at least one headache day per month during the previous three months.

Respondents provided information about sociodemographics and medication use and responded to a 13-item battery evaluating headache burden and response to medication. The items on the battery were derived from a review of relevant literature, clinician input, and interviews with migraine patients. Participants provided frequency data for each item on a five-point scale ranging from “1) Never” to “5) All or Nearly All of the Time.” To measure construct validity for the scale, the investigators assessed moderate to severe disability for each respondent using the Migraine Disability Assessment Scale (MIDAS).

To determine the underlying structure of unmet treatment needs, Dr. Lipton and colleagues conducted Exploratory Factor Analysis (EFA) among the subset of respondents currently using oral acute prescription medications. They assessed the internal consistency for the derived factors using Cronbach’s alpha. Mean factor scores (range, 1 to 5) were calculated by summing item responses for each factor and dividing by the number of items loading on that factor. The researchers used Mantel-Haenszel Chi Square Test for Trend to evaluate the relationship between mean factor score and rates of moderate to severe migraine-related disability.

Treatment May Act Too Slowly

Among 15,133 respondents meeting inclusion criteria, 3,930 reported current use of acute oral prescription headache medication (mean age, 45.0, 73.6% women, 81.6% Caucasian). Injection and nasal spray medication users were eliminated from the sample. The most commonly endorsed needs were “severe headache attacks come on very rapidly” (52.8%), “attacks reach peak intensity in less than 30 minutes” (50.4%), “severe headache presents upon awakening” (40.9%), and “the return of pain within 24 hours after initial pain relief” (38.6%). EFA identified the following four unmet needs: nausea interference, disturbed sleep, rapid onset, and lack of pain freedom. Internal consistency exceeded acceptable levels for all factors except disturbed sleep. MIDAS disability increased in a clear linear pattern with increasing mean factor scores.

Suggested Reading

Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015;15:100.

Lipton RB, Buse DC, Serrano D, et al. Examination of unmet treatment needs among persons with episodic migraine: results of the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2013;53(8):1300-1311.

SAN FRANCISCO—Lasmiditan may provide pain freedom in the acute treatment of migraine, according to data described at the 60th Annual Scientific Meeting of the American Headache Society. The treatment also may alleviate a patient’s most bothersome symptom (MBS).

Lasmiditan is a novel, centrally acting serotonin (5-HT_1F) agonist that has no vasoconstrictive effect. Linda A. Wietecha, BSN, MS, Medical Advisor for Migraine and Headache Disorders at Eli Lilly and Company in Indianapolis, and colleagues conducted two pivotal phase III studies of lasmiditan to evaluate its efficacy and safety as an acute treatment of migraine.

The two trials, SAMURAI and SPARTAN, were randomized, double-blinded, and placebo-controlled. Eligible participants had a Migraine Disability Assessment Score of 11 or higher (indicating moderate disability) and three to eight migraine attacks per month. The researchers randomized patients to a first dose of treatment, which was taken within four hours of onset of a migraine with moderate or worse severity that was not improving. In the SAMURAI trial, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, or placebo. In the SPARTAN study, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, 50 mg of lasmiditan, or placebo.

For rescue or recurrence treatment, patients took a randomly assigned second dose of the previously assigned lasmiditan dose or placebo. The primary and key secondary analyses compared the proportions of patients in the lasmiditan 200-mg group with that in the placebo group who were free of headache pain and free of their MBS at two hours after the first dose. Treatment-emergent adverse events (TEAEs) were used to assess safety. The investigators performed logistic regression to make comparisons.

At two hours after the first dose, significantly greater proportions of patients taking 200 mg of lasmiditan were free of headache pain and free of MBS, compared with controls. In SAMURAI, the rate of headache pain freedom was 32.2% in the 200-mg group and 15.3% among controls. In SPARTAN, the rate of headache pain freedom was 38.8% in the 200-mg group and 21.3% in controls. The rate of patients free of MBS in SAMURAI was 40.7% in the 200-mg group and 29.5% in controls. The rate of patients free of MBS in SPARTAN was 48.7% in the 200-mg group and 33.5% in controls. For both end points, the investigators also found significant differences for other lasmiditan dose groups, compared with placebo.

The most frequently reported TEAEs with lasmiditan (ie, those occurring with a frequency of 2% or greater and at a rate greater than that among controls) after the first dose were dizziness, paresthesia, somnolence, fatigue, nausea, and lethargy. Most events were mild to moderate in severity.

Suggested Reading

Färkkilä M, Diener HC, Géraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012;11(5):405-413.

SAN FRANCISCO—Lasmiditan may provide pain freedom in the acute treatment of migraine, according to data described at the 60th Annual Scientific Meeting of the American Headache Society. The treatment also may alleviate a patient’s most bothersome symptom (MBS).

Lasmiditan is a novel, centrally acting serotonin (5-HT_1F) agonist that has no vasoconstrictive effect. Linda A. Wietecha, BSN, MS, Medical Advisor for Migraine and Headache Disorders at Eli Lilly and Company in Indianapolis, and colleagues conducted two pivotal phase III studies of lasmiditan to evaluate its efficacy and safety as an acute treatment of migraine.

The two trials, SAMURAI and SPARTAN, were randomized, double-blinded, and placebo-controlled. Eligible participants had a Migraine Disability Assessment Score of 11 or higher (indicating moderate disability) and three to eight migraine attacks per month. The researchers randomized patients to a first dose of treatment, which was taken within four hours of onset of a migraine with moderate or worse severity that was not improving. In the SAMURAI trial, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, or placebo. In the SPARTAN study, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, 50 mg of lasmiditan, or placebo.

For rescue or recurrence treatment, patients took a randomly assigned second dose of the previously assigned lasmiditan dose or placebo. The primary and key secondary analyses compared the proportions of patients in the lasmiditan 200-mg group with that in the placebo group who were free of headache pain and free of their MBS at two hours after the first dose. Treatment-emergent adverse events (TEAEs) were used to assess safety. The investigators performed logistic regression to make comparisons.

At two hours after the first dose, significantly greater proportions of patients taking 200 mg of lasmiditan were free of headache pain and free of MBS, compared with controls. In SAMURAI, the rate of headache pain freedom was 32.2% in the 200-mg group and 15.3% among controls. In SPARTAN, the rate of headache pain freedom was 38.8% in the 200-mg group and 21.3% in controls. The rate of patients free of MBS in SAMURAI was 40.7% in the 200-mg group and 29.5% in controls. The rate of patients free of MBS in SPARTAN was 48.7% in the 200-mg group and 33.5% in controls. For both end points, the investigators also found significant differences for other lasmiditan dose groups, compared with placebo.

The most frequently reported TEAEs with lasmiditan (ie, those occurring with a frequency of 2% or greater and at a rate greater than that among controls) after the first dose were dizziness, paresthesia, somnolence, fatigue, nausea, and lethargy. Most events were mild to moderate in severity.

Suggested Reading

Färkkilä M, Diener HC, Géraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012;11(5):405-413.

SAN FRANCISCO—Lasmiditan may provide pain freedom in the acute treatment of migraine, according to data described at the 60th Annual Scientific Meeting of the American Headache Society. The treatment also may alleviate a patient’s most bothersome symptom (MBS).

Lasmiditan is a novel, centrally acting serotonin (5-HT_1F) agonist that has no vasoconstrictive effect. Linda A. Wietecha, BSN, MS, Medical Advisor for Migraine and Headache Disorders at Eli Lilly and Company in Indianapolis, and colleagues conducted two pivotal phase III studies of lasmiditan to evaluate its efficacy and safety as an acute treatment of migraine.

The two trials, SAMURAI and SPARTAN, were randomized, double-blinded, and placebo-controlled. Eligible participants had a Migraine Disability Assessment Score of 11 or higher (indicating moderate disability) and three to eight migraine attacks per month. The researchers randomized patients to a first dose of treatment, which was taken within four hours of onset of a migraine with moderate or worse severity that was not improving. In the SAMURAI trial, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, or placebo. In the SPARTAN study, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, 50 mg of lasmiditan, or placebo.

For rescue or recurrence treatment, patients took a randomly assigned second dose of the previously assigned lasmiditan dose or placebo. The primary and key secondary analyses compared the proportions of patients in the lasmiditan 200-mg group with that in the placebo group who were free of headache pain and free of their MBS at two hours after the first dose. Treatment-emergent adverse events (TEAEs) were used to assess safety. The investigators performed logistic regression to make comparisons.

At two hours after the first dose, significantly greater proportions of patients taking 200 mg of lasmiditan were free of headache pain and free of MBS, compared with controls. In SAMURAI, the rate of headache pain freedom was 32.2% in the 200-mg group and 15.3% among controls. In SPARTAN, the rate of headache pain freedom was 38.8% in the 200-mg group and 21.3% in controls. The rate of patients free of MBS in SAMURAI was 40.7% in the 200-mg group and 29.5% in controls. The rate of patients free of MBS in SPARTAN was 48.7% in the 200-mg group and 33.5% in controls. For both end points, the investigators also found significant differences for other lasmiditan dose groups, compared with placebo.

The most frequently reported TEAEs with lasmiditan (ie, those occurring with a frequency of 2% or greater and at a rate greater than that among controls) after the first dose were dizziness, paresthesia, somnolence, fatigue, nausea, and lethargy. Most events were mild to moderate in severity.

Suggested Reading

Färkkilä M, Diener HC, Géraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012;11(5):405-413.

BOSTON—Over five years after traumatic brain injury (TBI), a relatively large (24% to 30%) group of individuals experience chronic headache pain and a significant functional impact of headache, according to a pattern analysis of headache pain and impact following moderate to severe TBI. These results were presented at the 59th Annual Scientific Meeting of the American Headache Society. “Identification of members within these groups may be important to assist with an appropriate intensity of treatment to improve satisfaction with life and employment opportunity after TBI,” said Sylvia Lucas, MD, PhD, Clinical Professor of Neurology and Neurological Surgery at the University of Washington in Seattle. “The identification of trajectory membership may also be useful in evaluation of appropriate subjects for inclusion in studies of headache treatment after TBI.”

Headache is the most common symptom following TBI of any severity. Dr. Lucas and her research colleagues have previously reported high rates of headache in a prospective cohort of patients who experienced moderate to severe TBI. These patients have been followed for five years. New or worse headache occurred at a rate of 37% at three months, 33% at six months, 34% at 12 months, and 35% at 60 months post injury. The present study examined whether certain patterns or trajectories of headache occur over five years after TBI and whether demographic or injury characteristics are related to these trajectories. Trajectory type was also examined in relation to satisfaction with life and employment status five years after injury.

Data on 316 individuals were evaluated at five years. These patients were initially enrolled during inpatient rehabilitation after moderate to severe TBI. Enrollment was performed in person in the hospital. Structured telephone interviews were conducted at three, six, 12, and 60 months after TBI. At each time point, individuals who reported headache in the previous three months were asked to rate their headache pain on a 0 to 10 scale (0 = no pain, 10 = worst pain) and to complete the Headache Impact Test (HIT-6). Discrete mixture modeling was used to estimate trajectory groups based on pain rating and on headache impact scores.

Four trajectories were found for headache pain over five years: minimal pain over time (25% of individuals), worsening pain over time (37%), improving pain over time (7%), and chronic pain over time (30%). A chronic pain trajectory was more common in females, those incurring TBI by violence, those who were unemployed prior to injury, those with a headache history prior to injury, and those with mental health problems. Those with a chronic pain trajectory had significantly lower satisfaction with life five years after injury, compared with other trajectory groups.  

A chronic impact trajectory was more common in females and in those who incurred TBI by violence, had a prior history of headache, or were unemployed prior to injury. At five years post TBI, the chronic impact group was significantly more likely to be unemployed and less satisfied with life, compared with individuals in the minimal or worsening impact trajectory groups. Those employed prior to injury were more frequently in the worsening group for pain and impact, compared with those not employed prior to injury. No relationship was found for other demographic and injury data, including age, posttraumatic amnesia, or substance abuse prior to injury.

BOSTON—Over five years after traumatic brain injury (TBI), a relatively large (24% to 30%) group of individuals experience chronic headache pain and a significant functional impact of headache, according to a pattern analysis of headache pain and impact following moderate to severe TBI. These results were presented at the 59th Annual Scientific Meeting of the American Headache Society. “Identification of members within these groups may be important to assist with an appropriate intensity of treatment to improve satisfaction with life and employment opportunity after TBI,” said Sylvia Lucas, MD, PhD, Clinical Professor of Neurology and Neurological Surgery at the University of Washington in Seattle. “The identification of trajectory membership may also be useful in evaluation of appropriate subjects for inclusion in studies of headache treatment after TBI.”

Headache is the most common symptom following TBI of any severity. Dr. Lucas and her research colleagues have previously reported high rates of headache in a prospective cohort of patients who experienced moderate to severe TBI. These patients have been followed for five years. New or worse headache occurred at a rate of 37% at three months, 33% at six months, 34% at 12 months, and 35% at 60 months post injury. The present study examined whether certain patterns or trajectories of headache occur over five years after TBI and whether demographic or injury characteristics are related to these trajectories. Trajectory type was also examined in relation to satisfaction with life and employment status five years after injury.

Data on 316 individuals were evaluated at five years. These patients were initially enrolled during inpatient rehabilitation after moderate to severe TBI. Enrollment was performed in person in the hospital. Structured telephone interviews were conducted at three, six, 12, and 60 months after TBI. At each time point, individuals who reported headache in the previous three months were asked to rate their headache pain on a 0 to 10 scale (0 = no pain, 10 = worst pain) and to complete the Headache Impact Test (HIT-6). Discrete mixture modeling was used to estimate trajectory groups based on pain rating and on headache impact scores.

Four trajectories were found for headache pain over five years: minimal pain over time (25% of individuals), worsening pain over time (37%), improving pain over time (7%), and chronic pain over time (30%). A chronic pain trajectory was more common in females, those incurring TBI by violence, those who were unemployed prior to injury, those with a headache history prior to injury, and those with mental health problems. Those with a chronic pain trajectory had significantly lower satisfaction with life five years after injury, compared with other trajectory groups.  

A chronic impact trajectory was more common in females and in those who incurred TBI by violence, had a prior history of headache, or were unemployed prior to injury. At five years post TBI, the chronic impact group was significantly more likely to be unemployed and less satisfied with life, compared with individuals in the minimal or worsening impact trajectory groups. Those employed prior to injury were more frequently in the worsening group for pain and impact, compared with those not employed prior to injury. No relationship was found for other demographic and injury data, including age, posttraumatic amnesia, or substance abuse prior to injury.

BOSTON—Over five years after traumatic brain injury (TBI), a relatively large (24% to 30%) group of individuals experience chronic headache pain and a significant functional impact of headache, according to a pattern analysis of headache pain and impact following moderate to severe TBI. These results were presented at the 59th Annual Scientific Meeting of the American Headache Society. “Identification of members within these groups may be important to assist with an appropriate intensity of treatment to improve satisfaction with life and employment opportunity after TBI,” said Sylvia Lucas, MD, PhD, Clinical Professor of Neurology and Neurological Surgery at the University of Washington in Seattle. “The identification of trajectory membership may also be useful in evaluation of appropriate subjects for inclusion in studies of headache treatment after TBI.”

Headache is the most common symptom following TBI of any severity. Dr. Lucas and her research colleagues have previously reported high rates of headache in a prospective cohort of patients who experienced moderate to severe TBI. These patients have been followed for five years. New or worse headache occurred at a rate of 37% at three months, 33% at six months, 34% at 12 months, and 35% at 60 months post injury. The present study examined whether certain patterns or trajectories of headache occur over five years after TBI and whether demographic or injury characteristics are related to these trajectories. Trajectory type was also examined in relation to satisfaction with life and employment status five years after injury.

Data on 316 individuals were evaluated at five years. These patients were initially enrolled during inpatient rehabilitation after moderate to severe TBI. Enrollment was performed in person in the hospital. Structured telephone interviews were conducted at three, six, 12, and 60 months after TBI. At each time point, individuals who reported headache in the previous three months were asked to rate their headache pain on a 0 to 10 scale (0 = no pain, 10 = worst pain) and to complete the Headache Impact Test (HIT-6). Discrete mixture modeling was used to estimate trajectory groups based on pain rating and on headache impact scores.

Four trajectories were found for headache pain over five years: minimal pain over time (25% of individuals), worsening pain over time (37%), improving pain over time (7%), and chronic pain over time (30%). A chronic pain trajectory was more common in females, those incurring TBI by violence, those who were unemployed prior to injury, those with a headache history prior to injury, and those with mental health problems. Those with a chronic pain trajectory had significantly lower satisfaction with life five years after injury, compared with other trajectory groups.  

A chronic impact trajectory was more common in females and in those who incurred TBI by violence, had a prior history of headache, or were unemployed prior to injury. At five years post TBI, the chronic impact group was significantly more likely to be unemployed and less satisfied with life, compared with individuals in the minimal or worsening impact trajectory groups. Those employed prior to injury were more frequently in the worsening group for pain and impact, compared with those not employed prior to injury. No relationship was found for other demographic and injury data, including age, posttraumatic amnesia, or substance abuse prior to injury.

BOSTON—Effectiveness and tolerability were the key factors influencing patients’ satisfaction with prophylactic migraine medications, according to a study presented at the 59th Annual Scientific Meeting of the American Headache Society. “There is an unmet need for treatments that have better efficacy and tolerability profiles than existing prophylactic migraine medications,” said lead author Marci Clark, PharmD, Director of Patient-Centered Outcomes Assessment at RTI Health Solutions in Ann Arbor, Michigan, on behalf of her study collaborators.

To gain insight into reasons for patient satisfaction or dissatisfaction with prophylactic migraine medications and identify medication characteristics that would increase patient satisfaction with future prophylactic migraine medications, the researchers recruited study participants from research facilities in Charlotte, North Carolina; St. Louis, Missouri; Southfield, Michigan; and Tampa, Florida. Individuals were eligible to participate if they met the following self-reported criteria: age 18 to 55, physician diagnosis of migraine for 12 or more months, current or prior experience taking one or more prescription prophylactic migraine medication in the past six months, experiencing four or more migraine headache days per month, and further classification as having episodic or chronic migraine (based on the headache/migraine days reported). Individual discussions with all participants were conducted by two experienced interviewers.

Forty participants were recruited and interviewed; 36 met all eligibility criteria. Twenty-one participants met the criteria for episodic migraine, 15 met the criteria for chronic migraine, and four participants, who were current migraineurs, were unable to be classified as episodic or chronic migraine. Participants provided feedback on 20 prescription prophylactic migraine medications. The most commonly used current or prior migraine prophylactics were topiramate (n = 27), amitriptyline (n = 6), propranolol (n = 6), onabotulinumtoxinA (n = 5), and zonisamide (n = 3).

In general, medication effectiveness and tolerability were the most influential factors on patient satisfaction or dissatisfaction with their prophylactic migraine medications. Lack of efficacy, cited by 56% of respondents, was the most frequently reported reason for participants’ dissatisfaction with their medications. Regarding tolerability, 51% of participants reported that a particular side effect was the most dissatisfying characteristic of their medication. The most bothersome side effects reported by participants were memory loss (n = 6), dizziness or light-headedness (n = 5), tiredness/drowsiness/grogginess/sluggishness (n = 5), nausea (n = 3), and dry mouth (n = 2).

Among those who were satisfied with their prophylactic migraine medications, decreased migraine frequency was the most common reason for their satisfaction (65%), followed by decreased migraine severity or intensity, which was reported by 28% of participants.

The most frequently reported desirable characteristics of a new prophylactic migraine medication that would increase participants’ satisfaction were related to the medication’s ability to decrease the frequency and severity or intensity of migraines. Nausea (36%), weight gain (26%), dizziness/light-headedness (23%), drowsiness/grogginess (15%), and memory loss, including the ability to remember words and speak clearly (13%), are side effects that patients reported that they do not want to see in a new or future prophylactic migraine medication.

BOSTON—Effectiveness and tolerability were the key factors influencing patients’ satisfaction with prophylactic migraine medications, according to a study presented at the 59th Annual Scientific Meeting of the American Headache Society. “There is an unmet need for treatments that have better efficacy and tolerability profiles than existing prophylactic migraine medications,” said lead author Marci Clark, PharmD, Director of Patient-Centered Outcomes Assessment at RTI Health Solutions in Ann Arbor, Michigan, on behalf of her study collaborators.

To gain insight into reasons for patient satisfaction or dissatisfaction with prophylactic migraine medications and identify medication characteristics that would increase patient satisfaction with future prophylactic migraine medications, the researchers recruited study participants from research facilities in Charlotte, North Carolina; St. Louis, Missouri; Southfield, Michigan; and Tampa, Florida. Individuals were eligible to participate if they met the following self-reported criteria: age 18 to 55, physician diagnosis of migraine for 12 or more months, current or prior experience taking one or more prescription prophylactic migraine medication in the past six months, experiencing four or more migraine headache days per month, and further classification as having episodic or chronic migraine (based on the headache/migraine days reported). Individual discussions with all participants were conducted by two experienced interviewers.

Forty participants were recruited and interviewed; 36 met all eligibility criteria. Twenty-one participants met the criteria for episodic migraine, 15 met the criteria for chronic migraine, and four participants, who were current migraineurs, were unable to be classified as episodic or chronic migraine. Participants provided feedback on 20 prescription prophylactic migraine medications. The most commonly used current or prior migraine prophylactics were topiramate (n = 27), amitriptyline (n = 6), propranolol (n = 6), onabotulinumtoxinA (n = 5), and zonisamide (n = 3).

In general, medication effectiveness and tolerability were the most influential factors on patient satisfaction or dissatisfaction with their prophylactic migraine medications. Lack of efficacy, cited by 56% of respondents, was the most frequently reported reason for participants’ dissatisfaction with their medications. Regarding tolerability, 51% of participants reported that a particular side effect was the most dissatisfying characteristic of their medication. The most bothersome side effects reported by participants were memory loss (n = 6), dizziness or light-headedness (n = 5), tiredness/drowsiness/grogginess/sluggishness (n = 5), nausea (n = 3), and dry mouth (n = 2).

Among those who were satisfied with their prophylactic migraine medications, decreased migraine frequency was the most common reason for their satisfaction (65%), followed by decreased migraine severity or intensity, which was reported by 28% of participants.

The most frequently reported desirable characteristics of a new prophylactic migraine medication that would increase participants’ satisfaction were related to the medication’s ability to decrease the frequency and severity or intensity of migraines. Nausea (36%), weight gain (26%), dizziness/light-headedness (23%), drowsiness/grogginess (15%), and memory loss, including the ability to remember words and speak clearly (13%), are side effects that patients reported that they do not want to see in a new or future prophylactic migraine medication.

BOSTON—Effectiveness and tolerability were the key factors influencing patients’ satisfaction with prophylactic migraine medications, according to a study presented at the 59th Annual Scientific Meeting of the American Headache Society. “There is an unmet need for treatments that have better efficacy and tolerability profiles than existing prophylactic migraine medications,” said lead author Marci Clark, PharmD, Director of Patient-Centered Outcomes Assessment at RTI Health Solutions in Ann Arbor, Michigan, on behalf of her study collaborators.

To gain insight into reasons for patient satisfaction or dissatisfaction with prophylactic migraine medications and identify medication characteristics that would increase patient satisfaction with future prophylactic migraine medications, the researchers recruited study participants from research facilities in Charlotte, North Carolina; St. Louis, Missouri; Southfield, Michigan; and Tampa, Florida. Individuals were eligible to participate if they met the following self-reported criteria: age 18 to 55, physician diagnosis of migraine for 12 or more months, current or prior experience taking one or more prescription prophylactic migraine medication in the past six months, experiencing four or more migraine headache days per month, and further classification as having episodic or chronic migraine (based on the headache/migraine days reported). Individual discussions with all participants were conducted by two experienced interviewers.

Forty participants were recruited and interviewed; 36 met all eligibility criteria. Twenty-one participants met the criteria for episodic migraine, 15 met the criteria for chronic migraine, and four participants, who were current migraineurs, were unable to be classified as episodic or chronic migraine. Participants provided feedback on 20 prescription prophylactic migraine medications. The most commonly used current or prior migraine prophylactics were topiramate (n = 27), amitriptyline (n = 6), propranolol (n = 6), onabotulinumtoxinA (n = 5), and zonisamide (n = 3).

In general, medication effectiveness and tolerability were the most influential factors on patient satisfaction or dissatisfaction with their prophylactic migraine medications. Lack of efficacy, cited by 56% of respondents, was the most frequently reported reason for participants’ dissatisfaction with their medications. Regarding tolerability, 51% of participants reported that a particular side effect was the most dissatisfying characteristic of their medication. The most bothersome side effects reported by participants were memory loss (n = 6), dizziness or light-headedness (n = 5), tiredness/drowsiness/grogginess/sluggishness (n = 5), nausea (n = 3), and dry mouth (n = 2).

Among those who were satisfied with their prophylactic migraine medications, decreased migraine frequency was the most common reason for their satisfaction (65%), followed by decreased migraine severity or intensity, which was reported by 28% of participants.

The most frequently reported desirable characteristics of a new prophylactic migraine medication that would increase participants’ satisfaction were related to the medication’s ability to decrease the frequency and severity or intensity of migraines. Nausea (36%), weight gain (26%), dizziness/light-headedness (23%), drowsiness/grogginess (15%), and memory loss, including the ability to remember words and speak clearly (13%), are side effects that patients reported that they do not want to see in a new or future prophylactic migraine medication.