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Conference News Roundup—European Academy of Neurology
Thrombectomy Is Feasible for the Elderly, but Entails Risks
Mechanical thrombectomy is an increasingly important therapy for acute stroke that can benefit the very old, assuming a careful selection of patients and risk assessment, according to a Portuguese study.
For several years, endovascular thrombectomy has been a way of removing larger vascular obstructions. In this procedure, the thrombus is extracted from the cerebral vessel via a catheter inserted in the groin. Numerous international studies have shown that endovascular treatment is a substantial improvement over purely drug-based therapy. The procedure is especially effective in dealing with extremely long blood clots and large obstructions of the cerebral arteries and often yields positive results. Thanks to this procedure, more than 60% of patients treated survive the stroke with no or minor subsequent impairment.
“More and more study results show the high effectiveness of mechanical removal of blood clots after a stroke. But researchers are still trying to determine the type of patient for whom this relatively new procedure is the best treatment option,” said Ary Lopes de Sousa, MD, a neurology resident at Central Lisbon Hospital Center.
Dr. de Sousa and his colleagues reviewed the treatment success of thrombectomy in more than 200 patients with anterior acute ischemic stroke and no or slight disability prior to this event. The researchers separated patients into two groups: one with individuals younger than 80 and one with individuals age 80 and older.
In the group of patients age 80 and older, hypertension and transient ischemic attacks were more frequent. The treatment did not differ between the two groups (eg, in terms of the time frame of the revascularization). But in the older group, two-thirds of the patients exhibited a poor functional outcome at three months after the treatment (ie, they were moderately or severely limited in their ability to handle their daily tasks). The number of impaired individuals in that group was substantially larger than in the younger group, where 46% faced limitations in their everyday lives. On the other hand, one-third of the patients age 80 and older were able to handle their everyday lives three months after the treatment with no or mild impairments from the stroke. No difference in mortality was observed between the two age groups.
“For patients over 80, thrombectomy appears to be riskier than for younger patients,” said Dr. de Sousa. “But one third of the patients over 80 can be fully functional in their everyday lives after the procedure, so we must identify the factors associated with this favorable outcome. This [step] will support us applying this modern procedure efficiently to those individuals among the very old who can benefit from it.”
Studies Gauge the Cost of Migraine
A pair of studies have evaluated the cost of migraine to individuals, society, and businesses. A French study looked at the socioeconomic impact of the condition. In a survey of more than 7,700 people, a representative sample of the general population, 3.8% indicated that they experienced severe migraines on at least eight days per month. “Two-thirds of those [patients] were women, and the average age of those affected was 41, meaning that migraines significantly affect people at the peak of their careers, and who have families to provide for. These regular attacks represent a serious problem as far as keeping their jobs is concerned,” said Dr. Guillaume Leiba, Pricing and Market Access Manager at Novartis in Paris. In the current study, patients with severe migraine reported missing 33 working days per year because of their condition. This absence translates into a cost to society of approximately EUR 3.8 billion. Migraine also has an impact on patients’ social environment: 14% of respondents indicated that family members had to adjust their working hours because of patients’ migraine headaches. The study also quantified the financial burden placed on migraineurs: 58% reported an average monthly cost of more than EUR 30 per month for nonreimbursed medicines. Approximately 43% spent more than EUR 50 each month on other, nonpharmaceutical therapies. Despite the high level of public and private spending associated with the condition, quality of life for migraineurs remains far from satisfactory. More than three-quarters have sleep disorders and benefit less from their free time than healthy controls.
A Swiss study obtained more detailed results regarding absenteeism in the workplace. A group of 700 working migraineurs reported losing an average of 32 days per year because of migraine. This rate is similar to that reported in the French study. But there were significant differences depending on the specific type of headache, according to study author François Cadiou, CEO of Healint in Singapore. “With an average of more than 56 working days missed per year, patients with chronic migraine had the highest rate of absenteeism. People with episodic migraine were unable to go to work on 33 days of the year, while those with low-frequency episodic migraine took an average of 15 days off because of their condition.” Another finding has implications for preventive measures: the number of sick days was not always constant. In fact, the total steadily increased, and with it the amount of medication taken if patients indicated anxiety or depression as a symptom or trigger at least once within the 28-day observation period. In light of the outcomes presented, experts at the EAN Congress have issued a call for increased investment in migraine research and prevention, citing the advantages to society.
Both studies were funded by Novartis Pharma.
Parkinson’s Disease Progression Varies by Gender
A current study has now furnished the first neurophysiologic evidence that Parkinson’s disease progresses differently in women than in men. “Numerous demographic studies have provided evidence that men contract Parkinson’s disease nearly twice as often as women. What was unclear, however, was whether a gender-specific pathophysiology exists as soon as the first symptoms appear,” said Maja Kojovic, MD, PhD, a consultant neurologist at Ljubljana University Medical Center in Slovenia.
The international research team proceeded from the concept that in early Parkinson’s disease, functional changes can be detected in the primary motor cortex (M1) using transcranial magnetic stimulation (TMS). If pathophysiology differs between genders in Parkinson’s disease, they hypothesized, it will be reflected in differences of M1 TMS measurements.
Thirty-nine newly diagnosed and untreated patients with Parkinson’s disease (23 males) were assessed using the Unified Parkinson’s Disease Rating Scale (UPDRS). Then the patients and a group of healthy controls underwent TMS measurements of motor thresholds of the brain, input–output curve, short interval intracortical inhibition, cortical silent period, and intracortical facilitation. Brain plasticity was also measured using paired associative stimulation.
The UPDRS tests did not yield any differences in motor scores between the genders. However, the female patients had a less steep input–output curve than the male patients on the side of the brain more affected by Parkinson’s disease.
The women with Parkinson’s disease also exhibited better preserved short interval intracortical inhibition in both hemispheres, compared with affected men, and tended to have a better response to the paired associative stimulation protocol on the side less affected by symptoms. No gender-specific differences were determined, however, in the motor thresholds, intracortical facilitation, and the cortical silent period. The healthy control group did not show any gender or interhemispheric differences for any of the TMS parameters measured. “The detected gender differences in corticospinal and intracortical excitability in patients with early untreated Parkinson’s disease represent differences in disease pathophysiology. Gender may also prove to be a relevant factor when choosing appropriate treatment,” said Dr. Kojovic.
EAN Develops Guideline on Palliative Care of Patients With Severe MS
A cohort of 934 individuals affected by multiple sclerosis (MS) from seven European countries played an instrumental part in developing the European Academy of Neurology’s (EAN) new guideline on palliative care for people with severe MS. “There were 751 MS patients and 183 caregiver relatives involved,” said Sascha Köpke, PhD, Professor of Nursing Research at the University of Lübeck in Germany.
With the involvement of patients and their families in a new guideline, the EAN is emphasizing shared decision-making as an increasingly important concept that underscores patient autonomy and promotes the individualization of diagnosis and therapy. According to this approach, patients and physicians undergo a detailed consultation and then choose the medical treatment. The EAN has supported this patient-centered approach for a long time, and it is becoming increasingly established in other medical areas as well.
“It was resource- and time-intensive to include consumers in the guideline process, but also highly rewarding,” said Prof. Köpke. “Patients and caregivers really helped us to formulate the guideline in a way that was in line with actual practice and their own needs. We were able to see clearly which of our ideas met with approval or rejection.” The comments were also instructive for the group of EAN experts. They raised new aspects as well as sensitive issues that had been left out of the first draft.
Two approaches were chosen to ensure that consumers would participate. “First, there was an international online survey launched by national MS societies following a trial run involving 20 patients and 18 caregivers. Second, we invited MS patients and caregiver relatives to focus group meetings,” said Prof. Köpke. The majority of participants approved the topics proposed by the EAN group of experts. About 98% agreed to incorporate the subject of multidisciplinary rehabilitation in the guideline. There were 569 free comments, of which 182 (32%) pertained to the specified topics. A further 227 comments (40%) addressed additional topics, of which 16 were pertinent to the guideline. Five of the focus group meetings corroborated the results of the online survey and helped to work out important issues for the individuals affected. “The involvement of patients and caregivers increases the reliability and relevance of the guideline for clinical practice,” said Prof. Köpke.
Thrombectomy Is Feasible for the Elderly, but Entails Risks
Mechanical thrombectomy is an increasingly important therapy for acute stroke that can benefit the very old, assuming a careful selection of patients and risk assessment, according to a Portuguese study.
For several years, endovascular thrombectomy has been a way of removing larger vascular obstructions. In this procedure, the thrombus is extracted from the cerebral vessel via a catheter inserted in the groin. Numerous international studies have shown that endovascular treatment is a substantial improvement over purely drug-based therapy. The procedure is especially effective in dealing with extremely long blood clots and large obstructions of the cerebral arteries and often yields positive results. Thanks to this procedure, more than 60% of patients treated survive the stroke with no or minor subsequent impairment.
“More and more study results show the high effectiveness of mechanical removal of blood clots after a stroke. But researchers are still trying to determine the type of patient for whom this relatively new procedure is the best treatment option,” said Ary Lopes de Sousa, MD, a neurology resident at Central Lisbon Hospital Center.
Dr. de Sousa and his colleagues reviewed the treatment success of thrombectomy in more than 200 patients with anterior acute ischemic stroke and no or slight disability prior to this event. The researchers separated patients into two groups: one with individuals younger than 80 and one with individuals age 80 and older.
In the group of patients age 80 and older, hypertension and transient ischemic attacks were more frequent. The treatment did not differ between the two groups (eg, in terms of the time frame of the revascularization). But in the older group, two-thirds of the patients exhibited a poor functional outcome at three months after the treatment (ie, they were moderately or severely limited in their ability to handle their daily tasks). The number of impaired individuals in that group was substantially larger than in the younger group, where 46% faced limitations in their everyday lives. On the other hand, one-third of the patients age 80 and older were able to handle their everyday lives three months after the treatment with no or mild impairments from the stroke. No difference in mortality was observed between the two age groups.
“For patients over 80, thrombectomy appears to be riskier than for younger patients,” said Dr. de Sousa. “But one third of the patients over 80 can be fully functional in their everyday lives after the procedure, so we must identify the factors associated with this favorable outcome. This [step] will support us applying this modern procedure efficiently to those individuals among the very old who can benefit from it.”
Studies Gauge the Cost of Migraine
A pair of studies have evaluated the cost of migraine to individuals, society, and businesses. A French study looked at the socioeconomic impact of the condition. In a survey of more than 7,700 people, a representative sample of the general population, 3.8% indicated that they experienced severe migraines on at least eight days per month. “Two-thirds of those [patients] were women, and the average age of those affected was 41, meaning that migraines significantly affect people at the peak of their careers, and who have families to provide for. These regular attacks represent a serious problem as far as keeping their jobs is concerned,” said Dr. Guillaume Leiba, Pricing and Market Access Manager at Novartis in Paris. In the current study, patients with severe migraine reported missing 33 working days per year because of their condition. This absence translates into a cost to society of approximately EUR 3.8 billion. Migraine also has an impact on patients’ social environment: 14% of respondents indicated that family members had to adjust their working hours because of patients’ migraine headaches. The study also quantified the financial burden placed on migraineurs: 58% reported an average monthly cost of more than EUR 30 per month for nonreimbursed medicines. Approximately 43% spent more than EUR 50 each month on other, nonpharmaceutical therapies. Despite the high level of public and private spending associated with the condition, quality of life for migraineurs remains far from satisfactory. More than three-quarters have sleep disorders and benefit less from their free time than healthy controls.
A Swiss study obtained more detailed results regarding absenteeism in the workplace. A group of 700 working migraineurs reported losing an average of 32 days per year because of migraine. This rate is similar to that reported in the French study. But there were significant differences depending on the specific type of headache, according to study author François Cadiou, CEO of Healint in Singapore. “With an average of more than 56 working days missed per year, patients with chronic migraine had the highest rate of absenteeism. People with episodic migraine were unable to go to work on 33 days of the year, while those with low-frequency episodic migraine took an average of 15 days off because of their condition.” Another finding has implications for preventive measures: the number of sick days was not always constant. In fact, the total steadily increased, and with it the amount of medication taken if patients indicated anxiety or depression as a symptom or trigger at least once within the 28-day observation period. In light of the outcomes presented, experts at the EAN Congress have issued a call for increased investment in migraine research and prevention, citing the advantages to society.
Both studies were funded by Novartis Pharma.
Parkinson’s Disease Progression Varies by Gender
A current study has now furnished the first neurophysiologic evidence that Parkinson’s disease progresses differently in women than in men. “Numerous demographic studies have provided evidence that men contract Parkinson’s disease nearly twice as often as women. What was unclear, however, was whether a gender-specific pathophysiology exists as soon as the first symptoms appear,” said Maja Kojovic, MD, PhD, a consultant neurologist at Ljubljana University Medical Center in Slovenia.
The international research team proceeded from the concept that in early Parkinson’s disease, functional changes can be detected in the primary motor cortex (M1) using transcranial magnetic stimulation (TMS). If pathophysiology differs between genders in Parkinson’s disease, they hypothesized, it will be reflected in differences of M1 TMS measurements.
Thirty-nine newly diagnosed and untreated patients with Parkinson’s disease (23 males) were assessed using the Unified Parkinson’s Disease Rating Scale (UPDRS). Then the patients and a group of healthy controls underwent TMS measurements of motor thresholds of the brain, input–output curve, short interval intracortical inhibition, cortical silent period, and intracortical facilitation. Brain plasticity was also measured using paired associative stimulation.
The UPDRS tests did not yield any differences in motor scores between the genders. However, the female patients had a less steep input–output curve than the male patients on the side of the brain more affected by Parkinson’s disease.
The women with Parkinson’s disease also exhibited better preserved short interval intracortical inhibition in both hemispheres, compared with affected men, and tended to have a better response to the paired associative stimulation protocol on the side less affected by symptoms. No gender-specific differences were determined, however, in the motor thresholds, intracortical facilitation, and the cortical silent period. The healthy control group did not show any gender or interhemispheric differences for any of the TMS parameters measured. “The detected gender differences in corticospinal and intracortical excitability in patients with early untreated Parkinson’s disease represent differences in disease pathophysiology. Gender may also prove to be a relevant factor when choosing appropriate treatment,” said Dr. Kojovic.
EAN Develops Guideline on Palliative Care of Patients With Severe MS
A cohort of 934 individuals affected by multiple sclerosis (MS) from seven European countries played an instrumental part in developing the European Academy of Neurology’s (EAN) new guideline on palliative care for people with severe MS. “There were 751 MS patients and 183 caregiver relatives involved,” said Sascha Köpke, PhD, Professor of Nursing Research at the University of Lübeck in Germany.
With the involvement of patients and their families in a new guideline, the EAN is emphasizing shared decision-making as an increasingly important concept that underscores patient autonomy and promotes the individualization of diagnosis and therapy. According to this approach, patients and physicians undergo a detailed consultation and then choose the medical treatment. The EAN has supported this patient-centered approach for a long time, and it is becoming increasingly established in other medical areas as well.
“It was resource- and time-intensive to include consumers in the guideline process, but also highly rewarding,” said Prof. Köpke. “Patients and caregivers really helped us to formulate the guideline in a way that was in line with actual practice and their own needs. We were able to see clearly which of our ideas met with approval or rejection.” The comments were also instructive for the group of EAN experts. They raised new aspects as well as sensitive issues that had been left out of the first draft.
Two approaches were chosen to ensure that consumers would participate. “First, there was an international online survey launched by national MS societies following a trial run involving 20 patients and 18 caregivers. Second, we invited MS patients and caregiver relatives to focus group meetings,” said Prof. Köpke. The majority of participants approved the topics proposed by the EAN group of experts. About 98% agreed to incorporate the subject of multidisciplinary rehabilitation in the guideline. There were 569 free comments, of which 182 (32%) pertained to the specified topics. A further 227 comments (40%) addressed additional topics, of which 16 were pertinent to the guideline. Five of the focus group meetings corroborated the results of the online survey and helped to work out important issues for the individuals affected. “The involvement of patients and caregivers increases the reliability and relevance of the guideline for clinical practice,” said Prof. Köpke.
Thrombectomy Is Feasible for the Elderly, but Entails Risks
Mechanical thrombectomy is an increasingly important therapy for acute stroke that can benefit the very old, assuming a careful selection of patients and risk assessment, according to a Portuguese study.
For several years, endovascular thrombectomy has been a way of removing larger vascular obstructions. In this procedure, the thrombus is extracted from the cerebral vessel via a catheter inserted in the groin. Numerous international studies have shown that endovascular treatment is a substantial improvement over purely drug-based therapy. The procedure is especially effective in dealing with extremely long blood clots and large obstructions of the cerebral arteries and often yields positive results. Thanks to this procedure, more than 60% of patients treated survive the stroke with no or minor subsequent impairment.
“More and more study results show the high effectiveness of mechanical removal of blood clots after a stroke. But researchers are still trying to determine the type of patient for whom this relatively new procedure is the best treatment option,” said Ary Lopes de Sousa, MD, a neurology resident at Central Lisbon Hospital Center.
Dr. de Sousa and his colleagues reviewed the treatment success of thrombectomy in more than 200 patients with anterior acute ischemic stroke and no or slight disability prior to this event. The researchers separated patients into two groups: one with individuals younger than 80 and one with individuals age 80 and older.
In the group of patients age 80 and older, hypertension and transient ischemic attacks were more frequent. The treatment did not differ between the two groups (eg, in terms of the time frame of the revascularization). But in the older group, two-thirds of the patients exhibited a poor functional outcome at three months after the treatment (ie, they were moderately or severely limited in their ability to handle their daily tasks). The number of impaired individuals in that group was substantially larger than in the younger group, where 46% faced limitations in their everyday lives. On the other hand, one-third of the patients age 80 and older were able to handle their everyday lives three months after the treatment with no or mild impairments from the stroke. No difference in mortality was observed between the two age groups.
“For patients over 80, thrombectomy appears to be riskier than for younger patients,” said Dr. de Sousa. “But one third of the patients over 80 can be fully functional in their everyday lives after the procedure, so we must identify the factors associated with this favorable outcome. This [step] will support us applying this modern procedure efficiently to those individuals among the very old who can benefit from it.”
Studies Gauge the Cost of Migraine
A pair of studies have evaluated the cost of migraine to individuals, society, and businesses. A French study looked at the socioeconomic impact of the condition. In a survey of more than 7,700 people, a representative sample of the general population, 3.8% indicated that they experienced severe migraines on at least eight days per month. “Two-thirds of those [patients] were women, and the average age of those affected was 41, meaning that migraines significantly affect people at the peak of their careers, and who have families to provide for. These regular attacks represent a serious problem as far as keeping their jobs is concerned,” said Dr. Guillaume Leiba, Pricing and Market Access Manager at Novartis in Paris. In the current study, patients with severe migraine reported missing 33 working days per year because of their condition. This absence translates into a cost to society of approximately EUR 3.8 billion. Migraine also has an impact on patients’ social environment: 14% of respondents indicated that family members had to adjust their working hours because of patients’ migraine headaches. The study also quantified the financial burden placed on migraineurs: 58% reported an average monthly cost of more than EUR 30 per month for nonreimbursed medicines. Approximately 43% spent more than EUR 50 each month on other, nonpharmaceutical therapies. Despite the high level of public and private spending associated with the condition, quality of life for migraineurs remains far from satisfactory. More than three-quarters have sleep disorders and benefit less from their free time than healthy controls.
A Swiss study obtained more detailed results regarding absenteeism in the workplace. A group of 700 working migraineurs reported losing an average of 32 days per year because of migraine. This rate is similar to that reported in the French study. But there were significant differences depending on the specific type of headache, according to study author François Cadiou, CEO of Healint in Singapore. “With an average of more than 56 working days missed per year, patients with chronic migraine had the highest rate of absenteeism. People with episodic migraine were unable to go to work on 33 days of the year, while those with low-frequency episodic migraine took an average of 15 days off because of their condition.” Another finding has implications for preventive measures: the number of sick days was not always constant. In fact, the total steadily increased, and with it the amount of medication taken if patients indicated anxiety or depression as a symptom or trigger at least once within the 28-day observation period. In light of the outcomes presented, experts at the EAN Congress have issued a call for increased investment in migraine research and prevention, citing the advantages to society.
Both studies were funded by Novartis Pharma.
Parkinson’s Disease Progression Varies by Gender
A current study has now furnished the first neurophysiologic evidence that Parkinson’s disease progresses differently in women than in men. “Numerous demographic studies have provided evidence that men contract Parkinson’s disease nearly twice as often as women. What was unclear, however, was whether a gender-specific pathophysiology exists as soon as the first symptoms appear,” said Maja Kojovic, MD, PhD, a consultant neurologist at Ljubljana University Medical Center in Slovenia.
The international research team proceeded from the concept that in early Parkinson’s disease, functional changes can be detected in the primary motor cortex (M1) using transcranial magnetic stimulation (TMS). If pathophysiology differs between genders in Parkinson’s disease, they hypothesized, it will be reflected in differences of M1 TMS measurements.
Thirty-nine newly diagnosed and untreated patients with Parkinson’s disease (23 males) were assessed using the Unified Parkinson’s Disease Rating Scale (UPDRS). Then the patients and a group of healthy controls underwent TMS measurements of motor thresholds of the brain, input–output curve, short interval intracortical inhibition, cortical silent period, and intracortical facilitation. Brain plasticity was also measured using paired associative stimulation.
The UPDRS tests did not yield any differences in motor scores between the genders. However, the female patients had a less steep input–output curve than the male patients on the side of the brain more affected by Parkinson’s disease.
The women with Parkinson’s disease also exhibited better preserved short interval intracortical inhibition in both hemispheres, compared with affected men, and tended to have a better response to the paired associative stimulation protocol on the side less affected by symptoms. No gender-specific differences were determined, however, in the motor thresholds, intracortical facilitation, and the cortical silent period. The healthy control group did not show any gender or interhemispheric differences for any of the TMS parameters measured. “The detected gender differences in corticospinal and intracortical excitability in patients with early untreated Parkinson’s disease represent differences in disease pathophysiology. Gender may also prove to be a relevant factor when choosing appropriate treatment,” said Dr. Kojovic.
EAN Develops Guideline on Palliative Care of Patients With Severe MS
A cohort of 934 individuals affected by multiple sclerosis (MS) from seven European countries played an instrumental part in developing the European Academy of Neurology’s (EAN) new guideline on palliative care for people with severe MS. “There were 751 MS patients and 183 caregiver relatives involved,” said Sascha Köpke, PhD, Professor of Nursing Research at the University of Lübeck in Germany.
With the involvement of patients and their families in a new guideline, the EAN is emphasizing shared decision-making as an increasingly important concept that underscores patient autonomy and promotes the individualization of diagnosis and therapy. According to this approach, patients and physicians undergo a detailed consultation and then choose the medical treatment. The EAN has supported this patient-centered approach for a long time, and it is becoming increasingly established in other medical areas as well.
“It was resource- and time-intensive to include consumers in the guideline process, but also highly rewarding,” said Prof. Köpke. “Patients and caregivers really helped us to formulate the guideline in a way that was in line with actual practice and their own needs. We were able to see clearly which of our ideas met with approval or rejection.” The comments were also instructive for the group of EAN experts. They raised new aspects as well as sensitive issues that had been left out of the first draft.
Two approaches were chosen to ensure that consumers would participate. “First, there was an international online survey launched by national MS societies following a trial run involving 20 patients and 18 caregivers. Second, we invited MS patients and caregiver relatives to focus group meetings,” said Prof. Köpke. The majority of participants approved the topics proposed by the EAN group of experts. About 98% agreed to incorporate the subject of multidisciplinary rehabilitation in the guideline. There were 569 free comments, of which 182 (32%) pertained to the specified topics. A further 227 comments (40%) addressed additional topics, of which 16 were pertinent to the guideline. Five of the focus group meetings corroborated the results of the online survey and helped to work out important issues for the individuals affected. “The involvement of patients and caregivers increases the reliability and relevance of the guideline for clinical practice,” said Prof. Köpke.
Chronic Migraine Is Associated With Changes in Age-Related Cortical Thickness
Some brain areas are thicker, and others thinner, in patients with chronic migraine, compared with controls.
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.
Dr. Woldeamanuel and colleagues acquired T1-weighted brain images on a 3T MRI from all participants. They analyzed whole-brain cortical thickness on unmasked images. The investigators used linear regression to examine group differences on age by cortical thickness between people with chronic migraine and controls. Multiple regression enabled the researchers to control for the confounding effect of duration of chronic migraine and lifetime migraine on age-related cortical thickness changes.
Compared with controls, patients with chronic migraine had significant age-related thinning of the lateral orbitofrontal and supramarginal cortex of the left hemisphere. Patients with chronic migraine had a lack of age-related thinning of the pars orbitalis, superior and inferior parietal, superior temporal, pars opercularis, posterior cingulate, precuneus, superior frontal of the left hemisphere, and the left hemisphere mean cortical thickness, however. In the right hemisphere, the chronic migraine group had significant age-related thinning of the banks of the superior temporal sulcus, caudal anterior cingulate, inferior parietal, precuneus, and supramarginal cortex. The chronic migraine group lacked age-related thinning of the caudal middle frontal, isthmus cingulate, lateral orbitofrontal, paracentral, pars orbitalis, posterior cingulate, rostral middle frontal, superior frontal, and temporal pole of the right hemisphere. These results were not influenced by duration of chronic migraine and lifetime migraine.
The absence of normative age-related cortical thinning in implicated brain areas possibly indicates a perpetually enhanced headache response, head pain cognition, visual and auditory processing, affective behavior, interaction with internal and external cues, and multisensory integration, said the researchers. Accelerated age-related thinning in brain areas involved in sensory pain pathways could represent reduced habituation in chronic migraine, they added. In addition, age-related cortical thinning might indicate progressive loss of migraine modulation. The investigators hypothesized that repetitive migraine attacks might increase allostatic load from headache and nonheadache migraine symptoms.
“We are following these cohorts to determine whether these age-related cortical thickness changes signify cause or effect of chronic migraine,” said Dr. Woldeamanuel.
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.
Some brain areas are thicker, and others thinner, in patients with chronic migraine, compared with controls.
Some brain areas are thicker, and others thinner, in patients with chronic migraine, compared with controls.
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.
Dr. Woldeamanuel and colleagues acquired T1-weighted brain images on a 3T MRI from all participants. They analyzed whole-brain cortical thickness on unmasked images. The investigators used linear regression to examine group differences on age by cortical thickness between people with chronic migraine and controls. Multiple regression enabled the researchers to control for the confounding effect of duration of chronic migraine and lifetime migraine on age-related cortical thickness changes.
Compared with controls, patients with chronic migraine had significant age-related thinning of the lateral orbitofrontal and supramarginal cortex of the left hemisphere. Patients with chronic migraine had a lack of age-related thinning of the pars orbitalis, superior and inferior parietal, superior temporal, pars opercularis, posterior cingulate, precuneus, superior frontal of the left hemisphere, and the left hemisphere mean cortical thickness, however. In the right hemisphere, the chronic migraine group had significant age-related thinning of the banks of the superior temporal sulcus, caudal anterior cingulate, inferior parietal, precuneus, and supramarginal cortex. The chronic migraine group lacked age-related thinning of the caudal middle frontal, isthmus cingulate, lateral orbitofrontal, paracentral, pars orbitalis, posterior cingulate, rostral middle frontal, superior frontal, and temporal pole of the right hemisphere. These results were not influenced by duration of chronic migraine and lifetime migraine.
The absence of normative age-related cortical thinning in implicated brain areas possibly indicates a perpetually enhanced headache response, head pain cognition, visual and auditory processing, affective behavior, interaction with internal and external cues, and multisensory integration, said the researchers. Accelerated age-related thinning in brain areas involved in sensory pain pathways could represent reduced habituation in chronic migraine, they added. In addition, age-related cortical thinning might indicate progressive loss of migraine modulation. The investigators hypothesized that repetitive migraine attacks might increase allostatic load from headache and nonheadache migraine symptoms.
“We are following these cohorts to determine whether these age-related cortical thickness changes signify cause or effect of chronic migraine,” said Dr. Woldeamanuel.
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.
Dr. Woldeamanuel and colleagues acquired T1-weighted brain images on a 3T MRI from all participants. They analyzed whole-brain cortical thickness on unmasked images. The investigators used linear regression to examine group differences on age by cortical thickness between people with chronic migraine and controls. Multiple regression enabled the researchers to control for the confounding effect of duration of chronic migraine and lifetime migraine on age-related cortical thickness changes.
Compared with controls, patients with chronic migraine had significant age-related thinning of the lateral orbitofrontal and supramarginal cortex of the left hemisphere. Patients with chronic migraine had a lack of age-related thinning of the pars orbitalis, superior and inferior parietal, superior temporal, pars opercularis, posterior cingulate, precuneus, superior frontal of the left hemisphere, and the left hemisphere mean cortical thickness, however. In the right hemisphere, the chronic migraine group had significant age-related thinning of the banks of the superior temporal sulcus, caudal anterior cingulate, inferior parietal, precuneus, and supramarginal cortex. The chronic migraine group lacked age-related thinning of the caudal middle frontal, isthmus cingulate, lateral orbitofrontal, paracentral, pars orbitalis, posterior cingulate, rostral middle frontal, superior frontal, and temporal pole of the right hemisphere. These results were not influenced by duration of chronic migraine and lifetime migraine.
The absence of normative age-related cortical thinning in implicated brain areas possibly indicates a perpetually enhanced headache response, head pain cognition, visual and auditory processing, affective behavior, interaction with internal and external cues, and multisensory integration, said the researchers. Accelerated age-related thinning in brain areas involved in sensory pain pathways could represent reduced habituation in chronic migraine, they added. In addition, age-related cortical thinning might indicate progressive loss of migraine modulation. The investigators hypothesized that repetitive migraine attacks might increase allostatic load from headache and nonheadache migraine symptoms.
“We are following these cohorts to determine whether these age-related cortical thickness changes signify cause or effect of chronic migraine,” said Dr. Woldeamanuel.
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.
Researchers Identify Unmet Treatment Needs Among Migraineurs
An analysis of survey data indicates that migraineurs do not receive adequate treatment for nausea.
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;15:1
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.
An analysis of survey data indicates that migraineurs do not receive adequate treatment for nausea.
An analysis of survey data indicates that migraineurs do not receive adequate treatment for nausea.
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;15:1
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;15:1
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.
Can Lasmiditan Relieve Pain in Migraineurs?
An analysis of data from two phase III trials suggests that the drug is effective.
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-HT1F) 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.
An analysis of data from two phase III trials suggests that the drug is effective.
An analysis of data from two phase III trials suggests that the drug is effective.
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-HT1F) 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-HT1F) 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.
Single Dose of Rimegepant Shows Durable Effects in Acute Migraine
Rimegepant may be a novel approach to the treatment of acute migraine.
SAN FRANCISCO—Among patients with acute migraine, significant and durable clinical effects were seen with a single dose of rimegepant across multiple outcome measures, including pain freedom, freedom from most bothersome symptom, pain relief, and recovery of normal function, according to data presented at the 60th Annual Scientific Meeting of the American Headache Society. Rimegepant (75 mg oral tablet) demonstrated favorable tolerability and safety, including a liver safety profile, similar to placebo. “These clinically meaningful results complement the benefits seen in an identical phase III study and a previous phase IIb study,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. “Rimegepant may ultimately offer patients a novel approach for the acute treatment of migraine.”
Dr. Lipton and colleagues conducted a double-blind, randomized, placebo-controlled trial to compare the efficacy, safety, and tolerability of the calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant (75 mg oral tablet) with placebo in the acute treatment of migraine in adults.
The study included adults 18 or older with at least a one-year history of migraine according to ICHD 3-beta criteria. Following a three- to 28-day screening period, subjects were randomized to receive 75 mg of rimegepant or placebo and instructed to treat a single migraine attack with one dose of the blinded study drug (ie, rimegepant or placebo) when headache pain reached moderate or severe intensity. The coprimary end points were pain freedom at two hours postdose and freedom from the most bothersome symptom at two hours postdose. Safety assessments included adverse events, ECGs, vital signs, physical measurements, and routine laboratory tests, including assessment of liver function.
In total, 1,162 subjects were randomized to receive rimegepant (n = 582) or placebo (n = 580), and 1,084 were evaluated for efficacy (rimegepant [n = 543], placebo [n = 541]). Subjects had a mean age of 41.6, 85.5% were female, and participants by history averaged 4.7 attacks per month. At two hours postdose, rimegepant-treated patients had higher pain-free rates than placebo-treated patients did (19.2% vs 14.2%, respectively), were more likely to be free of their most bothersome symptom (36.6% vs 27.7%, respectively), and had higher rates of pain relief (56.0% vs 45.7%, respectively).
A single dose of rimegepant, without the use of rescue medication, demonstrated superiority versus placebo for sustained pain freedom and pain relief from two through 48 hours postdose. On a measure of functional disability, a greater proportion of rimegepant-treated patients achieved normal function at two hours. The safety and tolerability profiles of rimegepant were similar to those of placebo. The most common adverse events in the rimegepant and placebo groups were nausea (0.9% [5 of 546] vs 1.1% [6 of 549], respectively) and dizziness (0.7% [4 of 546] vs 0.4% [2 of 549], respectively).
Rimegepant may be a novel approach to the treatment of acute migraine.
Rimegepant may be a novel approach to the treatment of acute migraine.
SAN FRANCISCO—Among patients with acute migraine, significant and durable clinical effects were seen with a single dose of rimegepant across multiple outcome measures, including pain freedom, freedom from most bothersome symptom, pain relief, and recovery of normal function, according to data presented at the 60th Annual Scientific Meeting of the American Headache Society. Rimegepant (75 mg oral tablet) demonstrated favorable tolerability and safety, including a liver safety profile, similar to placebo. “These clinically meaningful results complement the benefits seen in an identical phase III study and a previous phase IIb study,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. “Rimegepant may ultimately offer patients a novel approach for the acute treatment of migraine.”
Dr. Lipton and colleagues conducted a double-blind, randomized, placebo-controlled trial to compare the efficacy, safety, and tolerability of the calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant (75 mg oral tablet) with placebo in the acute treatment of migraine in adults.
The study included adults 18 or older with at least a one-year history of migraine according to ICHD 3-beta criteria. Following a three- to 28-day screening period, subjects were randomized to receive 75 mg of rimegepant or placebo and instructed to treat a single migraine attack with one dose of the blinded study drug (ie, rimegepant or placebo) when headache pain reached moderate or severe intensity. The coprimary end points were pain freedom at two hours postdose and freedom from the most bothersome symptom at two hours postdose. Safety assessments included adverse events, ECGs, vital signs, physical measurements, and routine laboratory tests, including assessment of liver function.
In total, 1,162 subjects were randomized to receive rimegepant (n = 582) or placebo (n = 580), and 1,084 were evaluated for efficacy (rimegepant [n = 543], placebo [n = 541]). Subjects had a mean age of 41.6, 85.5% were female, and participants by history averaged 4.7 attacks per month. At two hours postdose, rimegepant-treated patients had higher pain-free rates than placebo-treated patients did (19.2% vs 14.2%, respectively), were more likely to be free of their most bothersome symptom (36.6% vs 27.7%, respectively), and had higher rates of pain relief (56.0% vs 45.7%, respectively).
A single dose of rimegepant, without the use of rescue medication, demonstrated superiority versus placebo for sustained pain freedom and pain relief from two through 48 hours postdose. On a measure of functional disability, a greater proportion of rimegepant-treated patients achieved normal function at two hours. The safety and tolerability profiles of rimegepant were similar to those of placebo. The most common adverse events in the rimegepant and placebo groups were nausea (0.9% [5 of 546] vs 1.1% [6 of 549], respectively) and dizziness (0.7% [4 of 546] vs 0.4% [2 of 549], respectively).
SAN FRANCISCO—Among patients with acute migraine, significant and durable clinical effects were seen with a single dose of rimegepant across multiple outcome measures, including pain freedom, freedom from most bothersome symptom, pain relief, and recovery of normal function, according to data presented at the 60th Annual Scientific Meeting of the American Headache Society. Rimegepant (75 mg oral tablet) demonstrated favorable tolerability and safety, including a liver safety profile, similar to placebo. “These clinically meaningful results complement the benefits seen in an identical phase III study and a previous phase IIb study,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. “Rimegepant may ultimately offer patients a novel approach for the acute treatment of migraine.”
Dr. Lipton and colleagues conducted a double-blind, randomized, placebo-controlled trial to compare the efficacy, safety, and tolerability of the calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant (75 mg oral tablet) with placebo in the acute treatment of migraine in adults.
The study included adults 18 or older with at least a one-year history of migraine according to ICHD 3-beta criteria. Following a three- to 28-day screening period, subjects were randomized to receive 75 mg of rimegepant or placebo and instructed to treat a single migraine attack with one dose of the blinded study drug (ie, rimegepant or placebo) when headache pain reached moderate or severe intensity. The coprimary end points were pain freedom at two hours postdose and freedom from the most bothersome symptom at two hours postdose. Safety assessments included adverse events, ECGs, vital signs, physical measurements, and routine laboratory tests, including assessment of liver function.
In total, 1,162 subjects were randomized to receive rimegepant (n = 582) or placebo (n = 580), and 1,084 were evaluated for efficacy (rimegepant [n = 543], placebo [n = 541]). Subjects had a mean age of 41.6, 85.5% were female, and participants by history averaged 4.7 attacks per month. At two hours postdose, rimegepant-treated patients had higher pain-free rates than placebo-treated patients did (19.2% vs 14.2%, respectively), were more likely to be free of their most bothersome symptom (36.6% vs 27.7%, respectively), and had higher rates of pain relief (56.0% vs 45.7%, respectively).
A single dose of rimegepant, without the use of rescue medication, demonstrated superiority versus placebo for sustained pain freedom and pain relief from two through 48 hours postdose. On a measure of functional disability, a greater proportion of rimegepant-treated patients achieved normal function at two hours. The safety and tolerability profiles of rimegepant were similar to those of placebo. The most common adverse events in the rimegepant and placebo groups were nausea (0.9% [5 of 546] vs 1.1% [6 of 549], respectively) and dizziness (0.7% [4 of 546] vs 0.4% [2 of 549], respectively).
Triptan Use and Discontinuation: Results From the MAST Study
Migraine continues to be associated with significant unmet acute treatment need.
SAN FRANCISCO—Although triptans are considered the gold standard for acute migraine therapy, only 37% of migraineurs had ever used a triptan and just 15.9% were current triptan users, according to the results of a study presented at the 60th Annual Scientific Meeting of the American Headache Society. Aftab Alam, MBBS, MBA, from Medical Affairs at Dr. Reddy’s Laboratories in Princeton, New Jersey, and colleagues from the Migraine in America Symptoms and Treatment (MAST) study determined that while oral treatment was the most common route of administration, only 11.5% of their total sample (31.1% of ever triptan users and 40.4% of current triptan users) had ever used a non-oral formulation.
The MAST Study collected detailed information regarding patterns of medication use in a sample of patients with migraine. The objectives of the analysis were to understand past and current usage patterns for triptans by route of administration and the rates and reasons for discontinuation.
Study respondents were recruited from a nationwide online research panel. Stratified random sampling identified a representative cohort of individuals 18 and older. A validated migraine symptom screen based on modified ICHD-3 beta criteria identified those with migraine. Study inclusion required an average of at least one headache day per month over the previous three months. Qualified respondents provided sociodemographic data (age, gender, and race) as well as patterns of past and current medication use. For past triptan users, Dr. Alam and his MAST study collaborators assessed reasons for discontinuation from a pre-coded list of side effects and triptan sensation symptoms. Other responses were allowed and coded. The researchers examined descriptive results for each route of administration, but “the groups are not mutually exclusive,” Dr. Alam noted.
Triptan Usage Results
Among 15,133 respondents with migraine, the mean age was 43.1; 73% were women, and 81% were Caucasian. Median monthly headache frequency was 3.3 days per month. A total of 5,596 (37%) had ever used a triptan. Among this subgroup, 81.8% had used oral, 21.3% had used a nasal spray, and 19.0% had used injectable forms; 22.2% had used more than one route of administration. Among current triptan users (2,421, 15.9%), 84.7% use oral, 16.5% use nasal spray, and 8.1% use injectable; 9.3% currently use more than one route of administration. Discontinuation rates were highest for injectable triptans (81.5%), followed by nasal sprays (66.5%) and oral medications (55.2%).
Reasons for Discontinuation
The most common reason for discontinuation was perceived lack of efficacy (38.4% oral, 39.8% nasal spray, 25.7% injectable), followed by side effects (22.8% oral, 17% nasal spray, 20.6% injectable). The most commonly reported side effects were dizziness (37.4% oral, 29.4% nasal spray, 33.5% injectable) followed by nausea (30.7% oral, 32.4% nasal spray, 24.6% injectable) and fatigue (26.2% oral, 24.3% nasal spray, 21.2% injectable). One or more triptan sensation symptom was reported among 60.3% of injection users, 46.5% of oral users, and 39.7% of nasal spray users.
—Glenn S. Williams
Suggested Reading
Wells RE, Markowitz SY, Baron EP, et al. Identifying factors underlying discontinuation of triptans. Headache. 2014;54(2):278-289.
Migraine continues to be associated with significant unmet acute treatment need.
Migraine continues to be associated with significant unmet acute treatment need.
SAN FRANCISCO—Although triptans are considered the gold standard for acute migraine therapy, only 37% of migraineurs had ever used a triptan and just 15.9% were current triptan users, according to the results of a study presented at the 60th Annual Scientific Meeting of the American Headache Society. Aftab Alam, MBBS, MBA, from Medical Affairs at Dr. Reddy’s Laboratories in Princeton, New Jersey, and colleagues from the Migraine in America Symptoms and Treatment (MAST) study determined that while oral treatment was the most common route of administration, only 11.5% of their total sample (31.1% of ever triptan users and 40.4% of current triptan users) had ever used a non-oral formulation.
The MAST Study collected detailed information regarding patterns of medication use in a sample of patients with migraine. The objectives of the analysis were to understand past and current usage patterns for triptans by route of administration and the rates and reasons for discontinuation.
Study respondents were recruited from a nationwide online research panel. Stratified random sampling identified a representative cohort of individuals 18 and older. A validated migraine symptom screen based on modified ICHD-3 beta criteria identified those with migraine. Study inclusion required an average of at least one headache day per month over the previous three months. Qualified respondents provided sociodemographic data (age, gender, and race) as well as patterns of past and current medication use. For past triptan users, Dr. Alam and his MAST study collaborators assessed reasons for discontinuation from a pre-coded list of side effects and triptan sensation symptoms. Other responses were allowed and coded. The researchers examined descriptive results for each route of administration, but “the groups are not mutually exclusive,” Dr. Alam noted.
Triptan Usage Results
Among 15,133 respondents with migraine, the mean age was 43.1; 73% were women, and 81% were Caucasian. Median monthly headache frequency was 3.3 days per month. A total of 5,596 (37%) had ever used a triptan. Among this subgroup, 81.8% had used oral, 21.3% had used a nasal spray, and 19.0% had used injectable forms; 22.2% had used more than one route of administration. Among current triptan users (2,421, 15.9%), 84.7% use oral, 16.5% use nasal spray, and 8.1% use injectable; 9.3% currently use more than one route of administration. Discontinuation rates were highest for injectable triptans (81.5%), followed by nasal sprays (66.5%) and oral medications (55.2%).
Reasons for Discontinuation
The most common reason for discontinuation was perceived lack of efficacy (38.4% oral, 39.8% nasal spray, 25.7% injectable), followed by side effects (22.8% oral, 17% nasal spray, 20.6% injectable). The most commonly reported side effects were dizziness (37.4% oral, 29.4% nasal spray, 33.5% injectable) followed by nausea (30.7% oral, 32.4% nasal spray, 24.6% injectable) and fatigue (26.2% oral, 24.3% nasal spray, 21.2% injectable). One or more triptan sensation symptom was reported among 60.3% of injection users, 46.5% of oral users, and 39.7% of nasal spray users.
—Glenn S. Williams
Suggested Reading
Wells RE, Markowitz SY, Baron EP, et al. Identifying factors underlying discontinuation of triptans. Headache. 2014;54(2):278-289.
SAN FRANCISCO—Although triptans are considered the gold standard for acute migraine therapy, only 37% of migraineurs had ever used a triptan and just 15.9% were current triptan users, according to the results of a study presented at the 60th Annual Scientific Meeting of the American Headache Society. Aftab Alam, MBBS, MBA, from Medical Affairs at Dr. Reddy’s Laboratories in Princeton, New Jersey, and colleagues from the Migraine in America Symptoms and Treatment (MAST) study determined that while oral treatment was the most common route of administration, only 11.5% of their total sample (31.1% of ever triptan users and 40.4% of current triptan users) had ever used a non-oral formulation.
The MAST Study collected detailed information regarding patterns of medication use in a sample of patients with migraine. The objectives of the analysis were to understand past and current usage patterns for triptans by route of administration and the rates and reasons for discontinuation.
Study respondents were recruited from a nationwide online research panel. Stratified random sampling identified a representative cohort of individuals 18 and older. A validated migraine symptom screen based on modified ICHD-3 beta criteria identified those with migraine. Study inclusion required an average of at least one headache day per month over the previous three months. Qualified respondents provided sociodemographic data (age, gender, and race) as well as patterns of past and current medication use. For past triptan users, Dr. Alam and his MAST study collaborators assessed reasons for discontinuation from a pre-coded list of side effects and triptan sensation symptoms. Other responses were allowed and coded. The researchers examined descriptive results for each route of administration, but “the groups are not mutually exclusive,” Dr. Alam noted.
Triptan Usage Results
Among 15,133 respondents with migraine, the mean age was 43.1; 73% were women, and 81% were Caucasian. Median monthly headache frequency was 3.3 days per month. A total of 5,596 (37%) had ever used a triptan. Among this subgroup, 81.8% had used oral, 21.3% had used a nasal spray, and 19.0% had used injectable forms; 22.2% had used more than one route of administration. Among current triptan users (2,421, 15.9%), 84.7% use oral, 16.5% use nasal spray, and 8.1% use injectable; 9.3% currently use more than one route of administration. Discontinuation rates were highest for injectable triptans (81.5%), followed by nasal sprays (66.5%) and oral medications (55.2%).
Reasons for Discontinuation
The most common reason for discontinuation was perceived lack of efficacy (38.4% oral, 39.8% nasal spray, 25.7% injectable), followed by side effects (22.8% oral, 17% nasal spray, 20.6% injectable). The most commonly reported side effects were dizziness (37.4% oral, 29.4% nasal spray, 33.5% injectable) followed by nausea (30.7% oral, 32.4% nasal spray, 24.6% injectable) and fatigue (26.2% oral, 24.3% nasal spray, 21.2% injectable). One or more triptan sensation symptom was reported among 60.3% of injection users, 46.5% of oral users, and 39.7% of nasal spray users.
—Glenn S. Williams
Suggested Reading
Wells RE, Markowitz SY, Baron EP, et al. Identifying factors underlying discontinuation of triptans. Headache. 2014;54(2):278-289.
How Does Migraine Change During the Menopausal Transition?
Migraine may worsen or change its pattern for many women approaching menopause.
SAN FRANCISCO—Most women with migraine develop migraine pattern change, worsening migraine, or new-onset migraine at the age of menopause, according to a study presented at the 60th Annual Scientific Meeting of the American Headache Society. These changes most often occur during the perimenopausal or postmenopausal stages.
Previous research indicates that the prevalence and frequency of migraine are higher in perimenopausal women than in other women. Yu-Chen Cheng, MD, MPH, a postdoctoral fellow at Massachusetts General Hospital in Boston, and colleagues investigated patterns of migraine in women at menopausal age (ie, age 40–60) with migraine who presented to the Partners Healthcare Hospitals. The investigators reviewed participants’ medical records, brain image reports, and laboratory data, including levels of estradiol and follicle-stimulating hormone (FSH).
In their retrospective study, Dr. Cheng and colleagues identified 81 patients with concurrent diagnoses of migraine and menopause who had clinical data available. They excluded patients with missing or inaccessible data, as well as patients with organic brain lesions such as those associated with multiple sclerosis or brain tumor. The researchers included 69 patients in the study.
Sixty patients (86.96%) had a history of migraine, and the other nine patients (13.04%) had new-onset migraine. Among participants with a history of migraine, 35 (58.33%) had a change in migraine pattern or worsening of their migraine headaches. The investigators categorized patients in this group as having migraine worsening (60.00%), migraine pattern change (28.57%), worsening related to other cause (8.57%), and not sure (2.86%). Twenty-five patients with migraine history were stable and had no change in the pattern of their headaches.
Dr. Cheng and colleagues also examined the population’s menopausal status when they had migraine change or worsening or new migraine. Among patients with migraine history, nine of 35 (25.71%) were at the perimenopausal stage, 12 (34.29%) were postmenopausal, five (14.29%) were premenopausal, three (8.57%) had worsening because of other causes, and three (8.57%) did not have records on their menopausal status. For patients with new-onset migraine, three of nine (33%) were perimenopausal, three (33%) were postmenopausal, and one (11.11%) was premenopausal.
Among patients with new-onset migraine, brain MRI was normal in 44.44%, showed pituitary abnormality in 22.22%, and showed other brain lesion in 33.33%. In patients with migraine history, brain MRI was normal in 45%, showed pituitary abnormality in 8.3%, showed nonspecific T2 high white matter lesion in 16.67%, and showed other brain lesion in 11.67%.
“Identifying migraine worsening or new-onset migraine during the menopausal transition age may help the diagnosis and treatment optimization of migraine for women during the menopausal age,” said Dr. Cheng.
Migraine may worsen or change its pattern for many women approaching menopause.
Migraine may worsen or change its pattern for many women approaching menopause.
SAN FRANCISCO—Most women with migraine develop migraine pattern change, worsening migraine, or new-onset migraine at the age of menopause, according to a study presented at the 60th Annual Scientific Meeting of the American Headache Society. These changes most often occur during the perimenopausal or postmenopausal stages.
Previous research indicates that the prevalence and frequency of migraine are higher in perimenopausal women than in other women. Yu-Chen Cheng, MD, MPH, a postdoctoral fellow at Massachusetts General Hospital in Boston, and colleagues investigated patterns of migraine in women at menopausal age (ie, age 40–60) with migraine who presented to the Partners Healthcare Hospitals. The investigators reviewed participants’ medical records, brain image reports, and laboratory data, including levels of estradiol and follicle-stimulating hormone (FSH).
In their retrospective study, Dr. Cheng and colleagues identified 81 patients with concurrent diagnoses of migraine and menopause who had clinical data available. They excluded patients with missing or inaccessible data, as well as patients with organic brain lesions such as those associated with multiple sclerosis or brain tumor. The researchers included 69 patients in the study.
Sixty patients (86.96%) had a history of migraine, and the other nine patients (13.04%) had new-onset migraine. Among participants with a history of migraine, 35 (58.33%) had a change in migraine pattern or worsening of their migraine headaches. The investigators categorized patients in this group as having migraine worsening (60.00%), migraine pattern change (28.57%), worsening related to other cause (8.57%), and not sure (2.86%). Twenty-five patients with migraine history were stable and had no change in the pattern of their headaches.
Dr. Cheng and colleagues also examined the population’s menopausal status when they had migraine change or worsening or new migraine. Among patients with migraine history, nine of 35 (25.71%) were at the perimenopausal stage, 12 (34.29%) were postmenopausal, five (14.29%) were premenopausal, three (8.57%) had worsening because of other causes, and three (8.57%) did not have records on their menopausal status. For patients with new-onset migraine, three of nine (33%) were perimenopausal, three (33%) were postmenopausal, and one (11.11%) was premenopausal.
Among patients with new-onset migraine, brain MRI was normal in 44.44%, showed pituitary abnormality in 22.22%, and showed other brain lesion in 33.33%. In patients with migraine history, brain MRI was normal in 45%, showed pituitary abnormality in 8.3%, showed nonspecific T2 high white matter lesion in 16.67%, and showed other brain lesion in 11.67%.
“Identifying migraine worsening or new-onset migraine during the menopausal transition age may help the diagnosis and treatment optimization of migraine for women during the menopausal age,” said Dr. Cheng.
SAN FRANCISCO—Most women with migraine develop migraine pattern change, worsening migraine, or new-onset migraine at the age of menopause, according to a study presented at the 60th Annual Scientific Meeting of the American Headache Society. These changes most often occur during the perimenopausal or postmenopausal stages.
Previous research indicates that the prevalence and frequency of migraine are higher in perimenopausal women than in other women. Yu-Chen Cheng, MD, MPH, a postdoctoral fellow at Massachusetts General Hospital in Boston, and colleagues investigated patterns of migraine in women at menopausal age (ie, age 40–60) with migraine who presented to the Partners Healthcare Hospitals. The investigators reviewed participants’ medical records, brain image reports, and laboratory data, including levels of estradiol and follicle-stimulating hormone (FSH).
In their retrospective study, Dr. Cheng and colleagues identified 81 patients with concurrent diagnoses of migraine and menopause who had clinical data available. They excluded patients with missing or inaccessible data, as well as patients with organic brain lesions such as those associated with multiple sclerosis or brain tumor. The researchers included 69 patients in the study.
Sixty patients (86.96%) had a history of migraine, and the other nine patients (13.04%) had new-onset migraine. Among participants with a history of migraine, 35 (58.33%) had a change in migraine pattern or worsening of their migraine headaches. The investigators categorized patients in this group as having migraine worsening (60.00%), migraine pattern change (28.57%), worsening related to other cause (8.57%), and not sure (2.86%). Twenty-five patients with migraine history were stable and had no change in the pattern of their headaches.
Dr. Cheng and colleagues also examined the population’s menopausal status when they had migraine change or worsening or new migraine. Among patients with migraine history, nine of 35 (25.71%) were at the perimenopausal stage, 12 (34.29%) were postmenopausal, five (14.29%) were premenopausal, three (8.57%) had worsening because of other causes, and three (8.57%) did not have records on their menopausal status. For patients with new-onset migraine, three of nine (33%) were perimenopausal, three (33%) were postmenopausal, and one (11.11%) was premenopausal.
Among patients with new-onset migraine, brain MRI was normal in 44.44%, showed pituitary abnormality in 22.22%, and showed other brain lesion in 33.33%. In patients with migraine history, brain MRI was normal in 45%, showed pituitary abnormality in 8.3%, showed nonspecific T2 high white matter lesion in 16.67%, and showed other brain lesion in 11.67%.
“Identifying migraine worsening or new-onset migraine during the menopausal transition age may help the diagnosis and treatment optimization of migraine for women during the menopausal age,” said Dr. Cheng.
OnabotulinumtoxinA Versus Topiramate for Prevention of Chronic Migraine: The FORWARD Study
A randomized trial examines discontinuations, efficacy, cognition, and depressive symptoms over 36 weeks of treatment.
SAN FRANCISCO—For the prevention of chronic migraine, onabotulinumtoxinA has a superior tolerability profile versus topiramate based on treatment-related adverse events and overall discontinuations, according to data presented at the 60th Annual Scientific Meeting of the American Headache Society. In addition, “patient-reported outcomes data suggest that changes in cognition, an important adverse event leading to treatment discontinuation with topiramate, may be seen as early as week 12,” said Andrew M. Blumenfeld, MD, Director of the Headache Center of Southern California in Oceanside, and colleagues. Dr. Blumenfeld also reported that onabotulinumtoxinA has a more favorable effect on depressive symptoms than does topiramate.
According to Dr. Blumenfeld and colleagues, many adults with chronic migraine are not receiving appropriate preventive treatment and when prescribed, adherence to treatment is relatively low. To address this problem, he and his colleagues conducted a multicenter, prospective, randomized, parallel-group, open-label study to compare onabotulinumtoxinA and topiramate for headache prevention in adults with chronic migraine (the FORWARD study).
The study assessed the effectiveness of onabotulinumtoxinA 155 U administered to 31 sites across seven head and neck muscles, fixed-site, fixed-dose, every 12 weeks for three cycles versus topiramate 50 to 100 mg/day up to week 36. The primary efficacy measure was the proportion of patients with a 50% or greater reduction in headache days versus baseline in the 28 days before week 32. Safety and tolerability were assessed; adverse events were monitored. Patient-reported outcomes collected from questionnaires at day 1 and weeks 12, 24, and 36 included the Controlled Oral Word Association Test (COWAT) and the nine-item Patient Health Questionnaire (PHQ-9). Baseline observation carried forward (BLOCF) was used to impute missing values at primary time points, followed by questionnaire guidelines for missing questionnaire data.
A total of 282 patients were enrolled—140 in the onabotulinumtoxinA arm and 142 in the topiramate arm. Mean baseline headache days (onabotulinumtoxinA, 22.1; topiramate, 21.8) were similar. Of the patients enrolled, 148 completed randomized treatment (onabotulinumtoxinA, 85.7%; topiramate, 19.7%). Primary reasons for withdrawal were ineffective treatment (onabotulinumtoxinA, 5.0%; topiramate, 19.0%) and adverse events (onabotulinumtoxinA, 3.6%; topiramate, 50.7%). Based on BLOCF, more patients on onabotulinumtoxinA had a 50% or greater reduction in headache frequency compared with baseline versus topiramate (40.0% vs 12.0%). Adverse events were reported by 45.5% of patients who received onabotulinumtoxinA and 76.8% of patients who received topiramate; treatment-related adverse events were reported by 17.3% and 69.0%, respectively. No new safety signals were identified for onabotulinumtoxinA. Adverse events relating to nervous system disorders most commonly led to treatment discontinuation for topiramate. Topiramate reduced mean COWAT scores from as early as week 12, suggesting cognitive changes occurred early in treatment with topiramate. As the study progressed, topiramate’s effect may have been obscured by the BLOCF imputation methodology due to the large proportion of patients withdrawing from topiramate, the investigators said. In contrast, onabotulinumtoxinA resulted in a small increase in COWAT scores from week 12 to week 36. OnabotulinumtoxinA had a significantly greater effect on mean PHQ-9 scores at week 36 (4.4), compared with topiramate (7.1; estimated mean difference, –1.86).
A randomized trial examines discontinuations, efficacy, cognition, and depressive symptoms over 36 weeks of treatment.
A randomized trial examines discontinuations, efficacy, cognition, and depressive symptoms over 36 weeks of treatment.
SAN FRANCISCO—For the prevention of chronic migraine, onabotulinumtoxinA has a superior tolerability profile versus topiramate based on treatment-related adverse events and overall discontinuations, according to data presented at the 60th Annual Scientific Meeting of the American Headache Society. In addition, “patient-reported outcomes data suggest that changes in cognition, an important adverse event leading to treatment discontinuation with topiramate, may be seen as early as week 12,” said Andrew M. Blumenfeld, MD, Director of the Headache Center of Southern California in Oceanside, and colleagues. Dr. Blumenfeld also reported that onabotulinumtoxinA has a more favorable effect on depressive symptoms than does topiramate.
According to Dr. Blumenfeld and colleagues, many adults with chronic migraine are not receiving appropriate preventive treatment and when prescribed, adherence to treatment is relatively low. To address this problem, he and his colleagues conducted a multicenter, prospective, randomized, parallel-group, open-label study to compare onabotulinumtoxinA and topiramate for headache prevention in adults with chronic migraine (the FORWARD study).
The study assessed the effectiveness of onabotulinumtoxinA 155 U administered to 31 sites across seven head and neck muscles, fixed-site, fixed-dose, every 12 weeks for three cycles versus topiramate 50 to 100 mg/day up to week 36. The primary efficacy measure was the proportion of patients with a 50% or greater reduction in headache days versus baseline in the 28 days before week 32. Safety and tolerability were assessed; adverse events were monitored. Patient-reported outcomes collected from questionnaires at day 1 and weeks 12, 24, and 36 included the Controlled Oral Word Association Test (COWAT) and the nine-item Patient Health Questionnaire (PHQ-9). Baseline observation carried forward (BLOCF) was used to impute missing values at primary time points, followed by questionnaire guidelines for missing questionnaire data.
A total of 282 patients were enrolled—140 in the onabotulinumtoxinA arm and 142 in the topiramate arm. Mean baseline headache days (onabotulinumtoxinA, 22.1; topiramate, 21.8) were similar. Of the patients enrolled, 148 completed randomized treatment (onabotulinumtoxinA, 85.7%; topiramate, 19.7%). Primary reasons for withdrawal were ineffective treatment (onabotulinumtoxinA, 5.0%; topiramate, 19.0%) and adverse events (onabotulinumtoxinA, 3.6%; topiramate, 50.7%). Based on BLOCF, more patients on onabotulinumtoxinA had a 50% or greater reduction in headache frequency compared with baseline versus topiramate (40.0% vs 12.0%). Adverse events were reported by 45.5% of patients who received onabotulinumtoxinA and 76.8% of patients who received topiramate; treatment-related adverse events were reported by 17.3% and 69.0%, respectively. No new safety signals were identified for onabotulinumtoxinA. Adverse events relating to nervous system disorders most commonly led to treatment discontinuation for topiramate. Topiramate reduced mean COWAT scores from as early as week 12, suggesting cognitive changes occurred early in treatment with topiramate. As the study progressed, topiramate’s effect may have been obscured by the BLOCF imputation methodology due to the large proportion of patients withdrawing from topiramate, the investigators said. In contrast, onabotulinumtoxinA resulted in a small increase in COWAT scores from week 12 to week 36. OnabotulinumtoxinA had a significantly greater effect on mean PHQ-9 scores at week 36 (4.4), compared with topiramate (7.1; estimated mean difference, –1.86).
SAN FRANCISCO—For the prevention of chronic migraine, onabotulinumtoxinA has a superior tolerability profile versus topiramate based on treatment-related adverse events and overall discontinuations, according to data presented at the 60th Annual Scientific Meeting of the American Headache Society. In addition, “patient-reported outcomes data suggest that changes in cognition, an important adverse event leading to treatment discontinuation with topiramate, may be seen as early as week 12,” said Andrew M. Blumenfeld, MD, Director of the Headache Center of Southern California in Oceanside, and colleagues. Dr. Blumenfeld also reported that onabotulinumtoxinA has a more favorable effect on depressive symptoms than does topiramate.
According to Dr. Blumenfeld and colleagues, many adults with chronic migraine are not receiving appropriate preventive treatment and when prescribed, adherence to treatment is relatively low. To address this problem, he and his colleagues conducted a multicenter, prospective, randomized, parallel-group, open-label study to compare onabotulinumtoxinA and topiramate for headache prevention in adults with chronic migraine (the FORWARD study).
The study assessed the effectiveness of onabotulinumtoxinA 155 U administered to 31 sites across seven head and neck muscles, fixed-site, fixed-dose, every 12 weeks for three cycles versus topiramate 50 to 100 mg/day up to week 36. The primary efficacy measure was the proportion of patients with a 50% or greater reduction in headache days versus baseline in the 28 days before week 32. Safety and tolerability were assessed; adverse events were monitored. Patient-reported outcomes collected from questionnaires at day 1 and weeks 12, 24, and 36 included the Controlled Oral Word Association Test (COWAT) and the nine-item Patient Health Questionnaire (PHQ-9). Baseline observation carried forward (BLOCF) was used to impute missing values at primary time points, followed by questionnaire guidelines for missing questionnaire data.
A total of 282 patients were enrolled—140 in the onabotulinumtoxinA arm and 142 in the topiramate arm. Mean baseline headache days (onabotulinumtoxinA, 22.1; topiramate, 21.8) were similar. Of the patients enrolled, 148 completed randomized treatment (onabotulinumtoxinA, 85.7%; topiramate, 19.7%). Primary reasons for withdrawal were ineffective treatment (onabotulinumtoxinA, 5.0%; topiramate, 19.0%) and adverse events (onabotulinumtoxinA, 3.6%; topiramate, 50.7%). Based on BLOCF, more patients on onabotulinumtoxinA had a 50% or greater reduction in headache frequency compared with baseline versus topiramate (40.0% vs 12.0%). Adverse events were reported by 45.5% of patients who received onabotulinumtoxinA and 76.8% of patients who received topiramate; treatment-related adverse events were reported by 17.3% and 69.0%, respectively. No new safety signals were identified for onabotulinumtoxinA. Adverse events relating to nervous system disorders most commonly led to treatment discontinuation for topiramate. Topiramate reduced mean COWAT scores from as early as week 12, suggesting cognitive changes occurred early in treatment with topiramate. As the study progressed, topiramate’s effect may have been obscured by the BLOCF imputation methodology due to the large proportion of patients withdrawing from topiramate, the investigators said. In contrast, onabotulinumtoxinA resulted in a small increase in COWAT scores from week 12 to week 36. OnabotulinumtoxinA had a significantly greater effect on mean PHQ-9 scores at week 36 (4.4), compared with topiramate (7.1; estimated mean difference, –1.86).
Occipital Nerve Blocks May Be an Effective Option for Acute Migraine in the Emergency Room
When IV metoclopramide fails to relieve acute migraine in the emergency department, greater occipital nerve block may be an effective treatment.
SAN FRANCISCO—Greater occipital nerve blocks with bupivacaine may be an effective treatment for patients with acute migraine in the emergency department who continue to experience moderate or severe headache after administration of intravenous metoclopramide, according to a presentation at the 60th Annual Scientific Meeting of the American Headache Society.
Greater occipital nerve block is thought to be an effective treatment for acute migraine, although no randomized efficacy data have been published for this indication. Benjamin W. Friedman, MD, Professor of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, and colleagues hypothesized that bilateral greater occipital nerve block with bupivacaine would provide greater rates of headache freedom than a sham injection among a population of emergency department patients who reported persistence of moderate or severe headache despite standard treatment with intravenous metoclopramide.
Dr. Friedman and colleagues conducted a randomized, sham-controlled trial of bilateral greater occipital nerve blocks with bupivacaine in two urban emergency departments. Patients with acute migraine who reported persistence of a moderate or severe headache for at least one hour or longer after treatment with 10 mg of intravenous metoclopramide were randomized to bilateral greater occipital nerve block with a total of 6 cc of 0.5% bupivacaine or bilateral intradermal scalp injection with a total of 1 cc of 0.5% bupivacaine. The primary outcome was complete headache freedom 30 minutes after the injection. An important secondary outcome was sustained headache relief, defined as achieving a headache level of mild or none in the emergency department and maintaining a level of mild or no headache without the use of any additional medication for 48 hours.
Over a 32-month period, 76 patients were screened for participation and 28 were enrolled, of whom 15 received sham injection and 13 received greater occipital nerve block. The primary outcome, headache freedom at 30 minutes, was achieved by none of the patients in the sham arm and by four patients (31%) in the nerve block arm. The secondary outcome, sustained headache relief for 48 hours, was reported by none of the patients who received sham and by three of the patients (23%) who received greater occipital nerve blocks. Reported side effects did not differ substantially between the two groups.
When IV metoclopramide fails to relieve acute migraine in the emergency department, greater occipital nerve block may be an effective treatment.
When IV metoclopramide fails to relieve acute migraine in the emergency department, greater occipital nerve block may be an effective treatment.
SAN FRANCISCO—Greater occipital nerve blocks with bupivacaine may be an effective treatment for patients with acute migraine in the emergency department who continue to experience moderate or severe headache after administration of intravenous metoclopramide, according to a presentation at the 60th Annual Scientific Meeting of the American Headache Society.
Greater occipital nerve block is thought to be an effective treatment for acute migraine, although no randomized efficacy data have been published for this indication. Benjamin W. Friedman, MD, Professor of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, and colleagues hypothesized that bilateral greater occipital nerve block with bupivacaine would provide greater rates of headache freedom than a sham injection among a population of emergency department patients who reported persistence of moderate or severe headache despite standard treatment with intravenous metoclopramide.
Dr. Friedman and colleagues conducted a randomized, sham-controlled trial of bilateral greater occipital nerve blocks with bupivacaine in two urban emergency departments. Patients with acute migraine who reported persistence of a moderate or severe headache for at least one hour or longer after treatment with 10 mg of intravenous metoclopramide were randomized to bilateral greater occipital nerve block with a total of 6 cc of 0.5% bupivacaine or bilateral intradermal scalp injection with a total of 1 cc of 0.5% bupivacaine. The primary outcome was complete headache freedom 30 minutes after the injection. An important secondary outcome was sustained headache relief, defined as achieving a headache level of mild or none in the emergency department and maintaining a level of mild or no headache without the use of any additional medication for 48 hours.
Over a 32-month period, 76 patients were screened for participation and 28 were enrolled, of whom 15 received sham injection and 13 received greater occipital nerve block. The primary outcome, headache freedom at 30 minutes, was achieved by none of the patients in the sham arm and by four patients (31%) in the nerve block arm. The secondary outcome, sustained headache relief for 48 hours, was reported by none of the patients who received sham and by three of the patients (23%) who received greater occipital nerve blocks. Reported side effects did not differ substantially between the two groups.
SAN FRANCISCO—Greater occipital nerve blocks with bupivacaine may be an effective treatment for patients with acute migraine in the emergency department who continue to experience moderate or severe headache after administration of intravenous metoclopramide, according to a presentation at the 60th Annual Scientific Meeting of the American Headache Society.
Greater occipital nerve block is thought to be an effective treatment for acute migraine, although no randomized efficacy data have been published for this indication. Benjamin W. Friedman, MD, Professor of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, and colleagues hypothesized that bilateral greater occipital nerve block with bupivacaine would provide greater rates of headache freedom than a sham injection among a population of emergency department patients who reported persistence of moderate or severe headache despite standard treatment with intravenous metoclopramide.
Dr. Friedman and colleagues conducted a randomized, sham-controlled trial of bilateral greater occipital nerve blocks with bupivacaine in two urban emergency departments. Patients with acute migraine who reported persistence of a moderate or severe headache for at least one hour or longer after treatment with 10 mg of intravenous metoclopramide were randomized to bilateral greater occipital nerve block with a total of 6 cc of 0.5% bupivacaine or bilateral intradermal scalp injection with a total of 1 cc of 0.5% bupivacaine. The primary outcome was complete headache freedom 30 minutes after the injection. An important secondary outcome was sustained headache relief, defined as achieving a headache level of mild or none in the emergency department and maintaining a level of mild or no headache without the use of any additional medication for 48 hours.
Over a 32-month period, 76 patients were screened for participation and 28 were enrolled, of whom 15 received sham injection and 13 received greater occipital nerve block. The primary outcome, headache freedom at 30 minutes, was achieved by none of the patients in the sham arm and by four patients (31%) in the nerve block arm. The secondary outcome, sustained headache relief for 48 hours, was reported by none of the patients who received sham and by three of the patients (23%) who received greater occipital nerve blocks. Reported side effects did not differ substantially between the two groups.
Fremanezumab May Reduce Medication Overuse in Migraineurs
A reduction in medication overuse is apparent after four weeks of treatment.
SAN FRANCISCO—Treatment with fremanezumab is associated with reduced overuse of acute medications and a corresponding decrease in days on which a patient uses acute medications, according to a phase III study described at the 60th Annual Scientific Meeting of the American Headache Society.
The overuse of acute or symptomatic headache medications (eg, triptans, ergot derivatives, opioids, and combination analgesics) can cause medication overuse headache (MOH). Chronic migraine is often accompanied by MOH, and the prevention of MOH is one of the main goals in the preventive treatment of migraine.
Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, reduced the frequency and severity of headaches in patients with chronic migraine who participated in clinical trials. Stephen D. Silberstein, MD, Director of the Headache Center at Thomas Jefferson University Hospital in Philadelphia, and colleagues assessed the effect of fremanezumab, compared with placebo, on medication overuse and acute headache medication use in patients with chronic migraine.
Comparing Two Fremanezumab Doses With Placebo
The investigators conducted a multicenter, randomized, double-blind, placebo-controlled, phase III study, during which they randomized eligible patients with chronic migraine in equal groups to receive subcutaneous injections of fremanezumab quarterly dosing (ie, 675 mg at baseline and placebo at Weeks 4 and 8), fremanezumab monthly dosing (ie, 675 mg at baseline and 225 mg at Weeks 4 and 8), or placebo at each time point over a 12-week treatment period. Dr. Silberstein’s group defined medication overuse as the use of acute headache medication on 15 or more days, the use of migraine-specific acute medication on 10 or more days, or the use of combination medications for headache on 10 or more days during the 28-day baseline period.
In a post hoc analysis, the researchers assessed the proportion of patients who reverted from overusing medications at baseline to not overusing medications at Week 12, as well as the change from baseline in the number of days of acute headache medication use among these patients. Analyses were performed using data for all randomized patients who received at least one dose of study drug and had at least 10 days of postbaseline efficacy assessments on the primary end point.
Fremanezumab Was More Likely to Reduce Overuse
At baseline, the number of patients with medication overuse was 201 in the quarterly arm, 198 in the monthly arm, and 188 in the placebo arm. Among these participants, significantly more fremanezumab-treated patients reported no medication overuse during the 12-week treatment period. The number of patients reporting no medication overuse was 111 (55%) in the quarterly arm, 120 (61%) in the monthly arm, and 87 (46%) in the placebo arm. The investigators observed a response to treatment as early as Week 4 (102 [51%] quarterly patients, 107 [54%] monthly patients, and 73 [39%] controls).
Among the patients who responded to treatment over the 12-week treatment period, the baseline number of days with medication overuse was similar across treatment groups (approximately 16.6). Within this population, fremanezumab treatment significantly reduced the number of days of acute headache medication use over the 12-week treatment period by nine in the quarterly arm and 8.9 in the monthly arm, compared with 7.1 among controls.
A reduction in medication overuse is apparent after four weeks of treatment.
A reduction in medication overuse is apparent after four weeks of treatment.
SAN FRANCISCO—Treatment with fremanezumab is associated with reduced overuse of acute medications and a corresponding decrease in days on which a patient uses acute medications, according to a phase III study described at the 60th Annual Scientific Meeting of the American Headache Society.
The overuse of acute or symptomatic headache medications (eg, triptans, ergot derivatives, opioids, and combination analgesics) can cause medication overuse headache (MOH). Chronic migraine is often accompanied by MOH, and the prevention of MOH is one of the main goals in the preventive treatment of migraine.
Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, reduced the frequency and severity of headaches in patients with chronic migraine who participated in clinical trials. Stephen D. Silberstein, MD, Director of the Headache Center at Thomas Jefferson University Hospital in Philadelphia, and colleagues assessed the effect of fremanezumab, compared with placebo, on medication overuse and acute headache medication use in patients with chronic migraine.
Comparing Two Fremanezumab Doses With Placebo
The investigators conducted a multicenter, randomized, double-blind, placebo-controlled, phase III study, during which they randomized eligible patients with chronic migraine in equal groups to receive subcutaneous injections of fremanezumab quarterly dosing (ie, 675 mg at baseline and placebo at Weeks 4 and 8), fremanezumab monthly dosing (ie, 675 mg at baseline and 225 mg at Weeks 4 and 8), or placebo at each time point over a 12-week treatment period. Dr. Silberstein’s group defined medication overuse as the use of acute headache medication on 15 or more days, the use of migraine-specific acute medication on 10 or more days, or the use of combination medications for headache on 10 or more days during the 28-day baseline period.
In a post hoc analysis, the researchers assessed the proportion of patients who reverted from overusing medications at baseline to not overusing medications at Week 12, as well as the change from baseline in the number of days of acute headache medication use among these patients. Analyses were performed using data for all randomized patients who received at least one dose of study drug and had at least 10 days of postbaseline efficacy assessments on the primary end point.
Fremanezumab Was More Likely to Reduce Overuse
At baseline, the number of patients with medication overuse was 201 in the quarterly arm, 198 in the monthly arm, and 188 in the placebo arm. Among these participants, significantly more fremanezumab-treated patients reported no medication overuse during the 12-week treatment period. The number of patients reporting no medication overuse was 111 (55%) in the quarterly arm, 120 (61%) in the monthly arm, and 87 (46%) in the placebo arm. The investigators observed a response to treatment as early as Week 4 (102 [51%] quarterly patients, 107 [54%] monthly patients, and 73 [39%] controls).
Among the patients who responded to treatment over the 12-week treatment period, the baseline number of days with medication overuse was similar across treatment groups (approximately 16.6). Within this population, fremanezumab treatment significantly reduced the number of days of acute headache medication use over the 12-week treatment period by nine in the quarterly arm and 8.9 in the monthly arm, compared with 7.1 among controls.
SAN FRANCISCO—Treatment with fremanezumab is associated with reduced overuse of acute medications and a corresponding decrease in days on which a patient uses acute medications, according to a phase III study described at the 60th Annual Scientific Meeting of the American Headache Society.
The overuse of acute or symptomatic headache medications (eg, triptans, ergot derivatives, opioids, and combination analgesics) can cause medication overuse headache (MOH). Chronic migraine is often accompanied by MOH, and the prevention of MOH is one of the main goals in the preventive treatment of migraine.
Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, reduced the frequency and severity of headaches in patients with chronic migraine who participated in clinical trials. Stephen D. Silberstein, MD, Director of the Headache Center at Thomas Jefferson University Hospital in Philadelphia, and colleagues assessed the effect of fremanezumab, compared with placebo, on medication overuse and acute headache medication use in patients with chronic migraine.
Comparing Two Fremanezumab Doses With Placebo
The investigators conducted a multicenter, randomized, double-blind, placebo-controlled, phase III study, during which they randomized eligible patients with chronic migraine in equal groups to receive subcutaneous injections of fremanezumab quarterly dosing (ie, 675 mg at baseline and placebo at Weeks 4 and 8), fremanezumab monthly dosing (ie, 675 mg at baseline and 225 mg at Weeks 4 and 8), or placebo at each time point over a 12-week treatment period. Dr. Silberstein’s group defined medication overuse as the use of acute headache medication on 15 or more days, the use of migraine-specific acute medication on 10 or more days, or the use of combination medications for headache on 10 or more days during the 28-day baseline period.
In a post hoc analysis, the researchers assessed the proportion of patients who reverted from overusing medications at baseline to not overusing medications at Week 12, as well as the change from baseline in the number of days of acute headache medication use among these patients. Analyses were performed using data for all randomized patients who received at least one dose of study drug and had at least 10 days of postbaseline efficacy assessments on the primary end point.
Fremanezumab Was More Likely to Reduce Overuse
At baseline, the number of patients with medication overuse was 201 in the quarterly arm, 198 in the monthly arm, and 188 in the placebo arm. Among these participants, significantly more fremanezumab-treated patients reported no medication overuse during the 12-week treatment period. The number of patients reporting no medication overuse was 111 (55%) in the quarterly arm, 120 (61%) in the monthly arm, and 87 (46%) in the placebo arm. The investigators observed a response to treatment as early as Week 4 (102 [51%] quarterly patients, 107 [54%] monthly patients, and 73 [39%] controls).
Among the patients who responded to treatment over the 12-week treatment period, the baseline number of days with medication overuse was similar across treatment groups (approximately 16.6). Within this population, fremanezumab treatment significantly reduced the number of days of acute headache medication use over the 12-week treatment period by nine in the quarterly arm and 8.9 in the monthly arm, compared with 7.1 among controls.