Headache & Migraine

The white matter hyperintensities (WMH) in patients with sporadic hemiplegic migraine (SHM) is significantly more in the parietal lobe when compared with those with migraine headaches, a new study found. Fifty patients met the criteria for SHM and 100 patients met the criteria for migraine headaches. Patients in the study group were similar to the control groups in terms of age and gender. Researchers found:

• WMH were found in 28 (56%) patients with SHM and 44 (44%) in patients with migraine headache.
• The proportion of patients with WMH was not different between the groups.
• WMH burden was higher in patients with SHM, and larger white matter lesions occurred more frequently in these patients compared to ordinary migraineurs.

Nagarajan E, Bollu PC, Manjamalai S, Yelam A, Quereshi AI. White matter hyperintensities in patients with sporadic hemiplegic migraine. [Published online ahead of print July 15, 2019]. J Neuroimaging. doi: 10.1111/jon.12656.

The white matter hyperintensities (WMH) in patients with sporadic hemiplegic migraine (SHM) is significantly more in the parietal lobe when compared with those with migraine headaches, a new study found. Fifty patients met the criteria for SHM and 100 patients met the criteria for migraine headaches. Patients in the study group were similar to the control groups in terms of age and gender. Researchers found:

• WMH were found in 28 (56%) patients with SHM and 44 (44%) in patients with migraine headache.
• The proportion of patients with WMH was not different between the groups.
• WMH burden was higher in patients with SHM, and larger white matter lesions occurred more frequently in these patients compared to ordinary migraineurs.

Nagarajan E, Bollu PC, Manjamalai S, Yelam A, Quereshi AI. White matter hyperintensities in patients with sporadic hemiplegic migraine. [Published online ahead of print July 15, 2019]. J Neuroimaging. doi: 10.1111/jon.12656.

The white matter hyperintensities (WMH) in patients with sporadic hemiplegic migraine (SHM) is significantly more in the parietal lobe when compared with those with migraine headaches, a new study found. Fifty patients met the criteria for SHM and 100 patients met the criteria for migraine headaches. Patients in the study group were similar to the control groups in terms of age and gender. Researchers found:

• WMH were found in 28 (56%) patients with SHM and 44 (44%) in patients with migraine headache.
• The proportion of patients with WMH was not different between the groups.
• WMH burden was higher in patients with SHM, and larger white matter lesions occurred more frequently in these patients compared to ordinary migraineurs.

Nagarajan E, Bollu PC, Manjamalai S, Yelam A, Quereshi AI. White matter hyperintensities in patients with sporadic hemiplegic migraine. [Published online ahead of print July 15, 2019]. J Neuroimaging. doi: 10.1111/jon.12656.

Individuals who had a median intake of 0.84-1.06 g of tryptophan per day had reduced odds of developing migraine by approximately 54% to 60%, relative to those who consumed ≤0.56 g/day, a new study found. The migraine group (n=514) was recruited from a tertiary headache clinic while controls consisted of 582 sex-matched healthy volunteers randomly selected from the general population. A validated 168-item semi-quantitative food frequency questionnaire was used for dietary intake assessments. Researchers found:

• Multiple regression models were adjusted for age, sex, body mass index, total daily energy intake, dietary intakes of total carbohydrates, animal-based protein, plant-based protein, total fat, saturated fat, and cholesterol.

• There was a negative association between tryptophan intake and migraine risk.

Razeghi Jahromi S, Togha M, Ghorbani Z, et al. The association between dietary tryptophan intake and migraine. [Published online ahead of print June 28, 2019]. Neurol Sci. doi: 10.1007/s10072-019-03984-3.

Individuals who had a median intake of 0.84-1.06 g of tryptophan per day had reduced odds of developing migraine by approximately 54% to 60%, relative to those who consumed ≤0.56 g/day, a new study found. The migraine group (n=514) was recruited from a tertiary headache clinic while controls consisted of 582 sex-matched healthy volunteers randomly selected from the general population. A validated 168-item semi-quantitative food frequency questionnaire was used for dietary intake assessments. Researchers found:

• Multiple regression models were adjusted for age, sex, body mass index, total daily energy intake, dietary intakes of total carbohydrates, animal-based protein, plant-based protein, total fat, saturated fat, and cholesterol.

• There was a negative association between tryptophan intake and migraine risk.

Razeghi Jahromi S, Togha M, Ghorbani Z, et al. The association between dietary tryptophan intake and migraine. [Published online ahead of print June 28, 2019]. Neurol Sci. doi: 10.1007/s10072-019-03984-3.

Individuals who had a median intake of 0.84-1.06 g of tryptophan per day had reduced odds of developing migraine by approximately 54% to 60%, relative to those who consumed ≤0.56 g/day, a new study found. The migraine group (n=514) was recruited from a tertiary headache clinic while controls consisted of 582 sex-matched healthy volunteers randomly selected from the general population. A validated 168-item semi-quantitative food frequency questionnaire was used for dietary intake assessments. Researchers found:

• Multiple regression models were adjusted for age, sex, body mass index, total daily energy intake, dietary intakes of total carbohydrates, animal-based protein, plant-based protein, total fat, saturated fat, and cholesterol.

• There was a negative association between tryptophan intake and migraine risk.

Razeghi Jahromi S, Togha M, Ghorbani Z, et al. The association between dietary tryptophan intake and migraine. [Published online ahead of print June 28, 2019]. Neurol Sci. doi: 10.1007/s10072-019-03984-3.

Migraine is a traumatic brain injury (TBI) risk factor, according to a recent population-based study in Taiwan. Researchers identified 7267 patients with newly diagnosed migraine between 1996 and 2010. The migraineurs to non-migraineurs ratio was 1:4. Multivariate Cox proportional hazard regression models were used to assess the effects of migraines on the risk of TBI after adjusting for potential confounders. Among the findings:

• The overall TBI risk was 1.78 times greater in the migraine group vs the non-migraine group after controlling for covariates.
• Additionally, patients with previous diagnoses of alcohol-attributed disease, mental disorders, and diabetes mellitus had a significantly higher TBI risk compare with those with no history of these diagnoses.

Wang QR, Lu YY, Su YJ, et al. Migraine and traumatic brain injury: a cohort study in Taiwan. [Published online ahead of print July 30, 2019]. BMJ Open. doi: 10.1136/bmjopen-2018-027251.

Migraine is a traumatic brain injury (TBI) risk factor, according to a recent population-based study in Taiwan. Researchers identified 7267 patients with newly diagnosed migraine between 1996 and 2010. The migraineurs to non-migraineurs ratio was 1:4. Multivariate Cox proportional hazard regression models were used to assess the effects of migraines on the risk of TBI after adjusting for potential confounders. Among the findings:

• The overall TBI risk was 1.78 times greater in the migraine group vs the non-migraine group after controlling for covariates.
• Additionally, patients with previous diagnoses of alcohol-attributed disease, mental disorders, and diabetes mellitus had a significantly higher TBI risk compare with those with no history of these diagnoses.

Wang QR, Lu YY, Su YJ, et al. Migraine and traumatic brain injury: a cohort study in Taiwan. [Published online ahead of print July 30, 2019]. BMJ Open. doi: 10.1136/bmjopen-2018-027251.

Migraine is a traumatic brain injury (TBI) risk factor, according to a recent population-based study in Taiwan. Researchers identified 7267 patients with newly diagnosed migraine between 1996 and 2010. The migraineurs to non-migraineurs ratio was 1:4. Multivariate Cox proportional hazard regression models were used to assess the effects of migraines on the risk of TBI after adjusting for potential confounders. Among the findings:

• The overall TBI risk was 1.78 times greater in the migraine group vs the non-migraine group after controlling for covariates.
• Additionally, patients with previous diagnoses of alcohol-attributed disease, mental disorders, and diabetes mellitus had a significantly higher TBI risk compare with those with no history of these diagnoses.

Wang QR, Lu YY, Su YJ, et al. Migraine and traumatic brain injury: a cohort study in Taiwan. [Published online ahead of print July 30, 2019]. BMJ Open. doi: 10.1136/bmjopen-2018-027251.

In a sampling of 300 individuals with a mean age of 41 years and nearly 16 self-reported headache days per month over the past 6 months, respondents agreed that they were willing to trade some degree of efficacy for less severe adverse events—namely weight gain and memory problems—and that they were even willing to pay more for these tradeoffs in some cases. On average, respondents were willing to pay:

• $84 more (95% confidence interval [CI], $64‐$103) per month to avoid a 10% weight gain
• $59 more (95% CI, $42‐$76) per month to avoid memory problems
• $35 more (95% CI, $20‐$51) per month to avoid a 5% weight gain, and
• $32 (95% CI, $18‐$46) per month to avoid thinking problems.

Within the pool, 81% of respondents confirmed that they had taken a prescription medicine to prevent migraine in the past 6 months.

I think the broad message of this study is important: migraine is not just about migraine or headache days per month. This should not come as news to anyone with more than a passing interest in this condition. As an epidemiological study, it is useful to understand how migraine patients, as a group, view the relative value of cost, side effects, etc. For clinicians, the value of this study is to remind us of the complexity we need to consider when prescribing a migraine treatment. Issues of co-morbidity, economic resources, type of work or daily activities, and most bothersome symptom all play into the decision process, and it is critical to have the patient expressly involved in this process. It is not just about migraine days. It never has been.

Implicit in this article is the reality that we now have a wide variety of pharmacologic and device options for treating migraine. In the past, this was not the case. There is no clear winner among the preventives in terms of headache or migraine days per month. Rather, as the article suggests, we now have the option of selecting our preventives based on a cost-benefit analysis. Because of the near parity in terms of efficacy, the choices are often based on accessibility, financial burden, delivery system, and side effect profile. Properly presented, this can be an empowering experience for the patient. Choices may involve the need for trialing one or more treatments before gaining access to a preferred treatment, or the willingness to risk the chance of an untoward side effect against the promise of a more convivial dosing regimen. This collaborative decision-making process helps center the locus of control with the patient and secure a healthy relationship between the provider and patient.

It should also be remembered that the promise of a given side effect profile is based on the observation in trials and does not reflect the probability of a given outcome in a single patient. Neither does the side effect profile generated in a controlled trial necessarily reflect the side effect profile in any given individual. Too often we fail to stress this to patients and a 1% risk becomes an unavoidable consequence or a promise of smooth sailing. Time spent educating patients (and providers) with regard to the interpretation of efficacy and risk data, is time well spent.

Dr. Cowan is a Higgins Professor of Neurology, Chief of the Division of Headache Medicine and the Department of Neurology and Neurosciences, and Director of the Center for Headache and Facial Pain, at Stanford University School of Medicine.

In a sampling of 300 individuals with a mean age of 41 years and nearly 16 self-reported headache days per month over the past 6 months, respondents agreed that they were willing to trade some degree of efficacy for less severe adverse events—namely weight gain and memory problems—and that they were even willing to pay more for these tradeoffs in some cases. On average, respondents were willing to pay:

• $84 more (95% confidence interval [CI], $64‐$103) per month to avoid a 10% weight gain
• $59 more (95% CI, $42‐$76) per month to avoid memory problems
• $35 more (95% CI, $20‐$51) per month to avoid a 5% weight gain, and
• $32 (95% CI, $18‐$46) per month to avoid thinking problems.

Within the pool, 81% of respondents confirmed that they had taken a prescription medicine to prevent migraine in the past 6 months.

I think the broad message of this study is important: migraine is not just about migraine or headache days per month. This should not come as news to anyone with more than a passing interest in this condition. As an epidemiological study, it is useful to understand how migraine patients, as a group, view the relative value of cost, side effects, etc. For clinicians, the value of this study is to remind us of the complexity we need to consider when prescribing a migraine treatment. Issues of co-morbidity, economic resources, type of work or daily activities, and most bothersome symptom all play into the decision process, and it is critical to have the patient expressly involved in this process. It is not just about migraine days. It never has been.

Implicit in this article is the reality that we now have a wide variety of pharmacologic and device options for treating migraine. In the past, this was not the case. There is no clear winner among the preventives in terms of headache or migraine days per month. Rather, as the article suggests, we now have the option of selecting our preventives based on a cost-benefit analysis. Because of the near parity in terms of efficacy, the choices are often based on accessibility, financial burden, delivery system, and side effect profile. Properly presented, this can be an empowering experience for the patient. Choices may involve the need for trialing one or more treatments before gaining access to a preferred treatment, or the willingness to risk the chance of an untoward side effect against the promise of a more convivial dosing regimen. This collaborative decision-making process helps center the locus of control with the patient and secure a healthy relationship between the provider and patient.

It should also be remembered that the promise of a given side effect profile is based on the observation in trials and does not reflect the probability of a given outcome in a single patient. Neither does the side effect profile generated in a controlled trial necessarily reflect the side effect profile in any given individual. Too often we fail to stress this to patients and a 1% risk becomes an unavoidable consequence or a promise of smooth sailing. Time spent educating patients (and providers) with regard to the interpretation of efficacy and risk data, is time well spent.

Dr. Cowan is a Higgins Professor of Neurology, Chief of the Division of Headache Medicine and the Department of Neurology and Neurosciences, and Director of the Center for Headache and Facial Pain, at Stanford University School of Medicine.

In a sampling of 300 individuals with a mean age of 41 years and nearly 16 self-reported headache days per month over the past 6 months, respondents agreed that they were willing to trade some degree of efficacy for less severe adverse events—namely weight gain and memory problems—and that they were even willing to pay more for these tradeoffs in some cases. On average, respondents were willing to pay:

• $84 more (95% confidence interval [CI], $64‐$103) per month to avoid a 10% weight gain
• $59 more (95% CI, $42‐$76) per month to avoid memory problems
• $35 more (95% CI, $20‐$51) per month to avoid a 5% weight gain, and
• $32 (95% CI, $18‐$46) per month to avoid thinking problems.

Within the pool, 81% of respondents confirmed that they had taken a prescription medicine to prevent migraine in the past 6 months.

I think the broad message of this study is important: migraine is not just about migraine or headache days per month. This should not come as news to anyone with more than a passing interest in this condition. As an epidemiological study, it is useful to understand how migraine patients, as a group, view the relative value of cost, side effects, etc. For clinicians, the value of this study is to remind us of the complexity we need to consider when prescribing a migraine treatment. Issues of co-morbidity, economic resources, type of work or daily activities, and most bothersome symptom all play into the decision process, and it is critical to have the patient expressly involved in this process. It is not just about migraine days. It never has been.

Implicit in this article is the reality that we now have a wide variety of pharmacologic and device options for treating migraine. In the past, this was not the case. There is no clear winner among the preventives in terms of headache or migraine days per month. Rather, as the article suggests, we now have the option of selecting our preventives based on a cost-benefit analysis. Because of the near parity in terms of efficacy, the choices are often based on accessibility, financial burden, delivery system, and side effect profile. Properly presented, this can be an empowering experience for the patient. Choices may involve the need for trialing one or more treatments before gaining access to a preferred treatment, or the willingness to risk the chance of an untoward side effect against the promise of a more convivial dosing regimen. This collaborative decision-making process helps center the locus of control with the patient and secure a healthy relationship between the provider and patient.

It should also be remembered that the promise of a given side effect profile is based on the observation in trials and does not reflect the probability of a given outcome in a single patient. Neither does the side effect profile generated in a controlled trial necessarily reflect the side effect profile in any given individual. Too often we fail to stress this to patients and a 1% risk becomes an unavoidable consequence or a promise of smooth sailing. Time spent educating patients (and providers) with regard to the interpretation of efficacy and risk data, is time well spent.

Dr. Cowan is a Higgins Professor of Neurology, Chief of the Division of Headache Medicine and the Department of Neurology and Neurosciences, and Director of the Center for Headache and Facial Pain, at Stanford University School of Medicine.

PHILADELPHIA – In patients with migraine and medication overuse, galcanezumab reduces the number of mean monthly migraine headache days, according to research presented at the annual meeting of the American Headache Society. Furthermore, galcanezumab is associated with a reduction in medication overuse, compared with placebo, in this population.

“When you have targeted preventive treatment and you reduce the burden of illness, medication overuse seems to be reduced as well,” said Sheena Aurora, MD, adjunct clinical associate professor of anesthesiology and perioperative and pain medicine at Stanford (Calif.) Health Care. Dr. Aurora also is a medical fellow and global launch leader for galcanezumab at Eli Lilly, which has developed the treatment.

Galcanezumab is a humanized monoclonal antibody that selectively binds to the calcitonin gene-related peptide. The phase 3 EVOLVE-1, EVOLVE-2, and REGAIN studies indicated galcanezumab’s superiority to placebo in preventing episodic and chronic migraine.
 

A post hoc analysis of phase 3 data

Dr. Aurora and colleagues conducted a post hoc analysis of data from the three phase 3 studies to examine galcanezumab’s effect in patients with medication overuse. EVOLVE-1 and EVOLVE-2 included patients with episodic migraine, and REGAIN included patients with chronic migraine. All participants were randomized to monthly subcutaneous injections of placebo or galcanezumab (120 mg/month or 240 mg/month) for 3-6 months. Based on information obtained through electronic patient-reported outcome diaries, investigators determined headache medication overuse using criteria adapted from the International Classification of Headache Disorders, third edition. They estimated mean changes in monthly headache days and the proportion of patients with medication overuse after randomization using mixed modeling.

The demographic characteristics of the three study populations were similar to those reported in epidemiologic studies of migraine, said Dr. Aurora. Most participants were women, and most patients were between ages 40 and 49 years. At baseline, the mean number of monthly migraine headache days was 20 among patients with chronic migraine and 9 among patients with episodic migraine.

The rate of medication overuse was higher in the combined study population than in the literature. Patients with medication overuse had greater disability and greater health care resource utilization, compared with patients without medication overuse. Among patients with chronic migraine, participants who overused medication were not significantly different from those who did not. But among patients with episodic migraine, participants who overused medication had higher headache frequency than those who did not.

In the EVOLVE trials, the proportion of patients with baseline medication overuse was 19.3% in the placebo arm, 17.0% in the galcanezumab 120-mg arm, and 19.2% in the galcanezumab 240-mg arm. In REGAIN, the proportion of patients with baseline medication overuse was 63.4% in the placebo arm, 64.3% in the galcanezumab 120-mg arm, and 64.1% in the galcanezumab 240-mg arm.

Galcanezumab reduced medication overuse

Compared with placebo, both doses of galcanezumab significantly decreased mean monthly migraine headache days in patients with baseline medication overuse. In the EVOLVE studies, this endpoint decreased by 2.71 in the placebo group, 6.26 in the galcanezumab 120-mg group, and 5.77 in the galcanezumab 240-mg group. In REGAIN, the reductions were 2.25 in the placebo group, 4.78 in the galcanezumab 120-mg group, and 4.51 in the galcanezumab 240-mg group. The effect size was higher in patients who were overusing medications, compared with those who were not, said Dr. Aurora. “This is clinically relevant, because most of us ... had this belief that patients who were overusing medications may be more treatment-resistant to prevention.”

In addition, galcanezumab was associated with significantly lower rates of average monthly medication overuse, compared with placebo. In the EVOLVE studies, the average rate of monthly medication overuse was 15.9% for the placebo group, 6.2% for the galcanezumab 120-mg group, and 7.9% for the galcanezumab 240-mg group. In REGAIN, the average rate of monthly medication overuse was 40.6% in the placebo group, 24.3% in the galcanezumab 120-mg group, and 23.1% in the galcanezumab 240-mg group. About 85% of patients with episodic migraine and medication overuse had a reduction in medication overuse, and approximately 50% of patients with chronic migraine and medication overuse had a reduction in medication overuse, said Dr. Aurora.

Dr. Aurora and coinvestigators are employees of Eli Lilly, which developed galcanezumab and funded the EVOLVE and REGAIN studies.

[email protected]

SOURCE: Aurora S et al. AHS 2019. Abstract IOR07.

PHILADELPHIA – In patients with migraine and medication overuse, galcanezumab reduces the number of mean monthly migraine headache days, according to research presented at the annual meeting of the American Headache Society. Furthermore, galcanezumab is associated with a reduction in medication overuse, compared with placebo, in this population.

“When you have targeted preventive treatment and you reduce the burden of illness, medication overuse seems to be reduced as well,” said Sheena Aurora, MD, adjunct clinical associate professor of anesthesiology and perioperative and pain medicine at Stanford (Calif.) Health Care. Dr. Aurora also is a medical fellow and global launch leader for galcanezumab at Eli Lilly, which has developed the treatment.

Galcanezumab is a humanized monoclonal antibody that selectively binds to the calcitonin gene-related peptide. The phase 3 EVOLVE-1, EVOLVE-2, and REGAIN studies indicated galcanezumab’s superiority to placebo in preventing episodic and chronic migraine.
 

A post hoc analysis of phase 3 data

Dr. Aurora and colleagues conducted a post hoc analysis of data from the three phase 3 studies to examine galcanezumab’s effect in patients with medication overuse. EVOLVE-1 and EVOLVE-2 included patients with episodic migraine, and REGAIN included patients with chronic migraine. All participants were randomized to monthly subcutaneous injections of placebo or galcanezumab (120 mg/month or 240 mg/month) for 3-6 months. Based on information obtained through electronic patient-reported outcome diaries, investigators determined headache medication overuse using criteria adapted from the International Classification of Headache Disorders, third edition. They estimated mean changes in monthly headache days and the proportion of patients with medication overuse after randomization using mixed modeling.

The demographic characteristics of the three study populations were similar to those reported in epidemiologic studies of migraine, said Dr. Aurora. Most participants were women, and most patients were between ages 40 and 49 years. At baseline, the mean number of monthly migraine headache days was 20 among patients with chronic migraine and 9 among patients with episodic migraine.

The rate of medication overuse was higher in the combined study population than in the literature. Patients with medication overuse had greater disability and greater health care resource utilization, compared with patients without medication overuse. Among patients with chronic migraine, participants who overused medication were not significantly different from those who did not. But among patients with episodic migraine, participants who overused medication had higher headache frequency than those who did not.

In the EVOLVE trials, the proportion of patients with baseline medication overuse was 19.3% in the placebo arm, 17.0% in the galcanezumab 120-mg arm, and 19.2% in the galcanezumab 240-mg arm. In REGAIN, the proportion of patients with baseline medication overuse was 63.4% in the placebo arm, 64.3% in the galcanezumab 120-mg arm, and 64.1% in the galcanezumab 240-mg arm.

Galcanezumab reduced medication overuse

Compared with placebo, both doses of galcanezumab significantly decreased mean monthly migraine headache days in patients with baseline medication overuse. In the EVOLVE studies, this endpoint decreased by 2.71 in the placebo group, 6.26 in the galcanezumab 120-mg group, and 5.77 in the galcanezumab 240-mg group. In REGAIN, the reductions were 2.25 in the placebo group, 4.78 in the galcanezumab 120-mg group, and 4.51 in the galcanezumab 240-mg group. The effect size was higher in patients who were overusing medications, compared with those who were not, said Dr. Aurora. “This is clinically relevant, because most of us ... had this belief that patients who were overusing medications may be more treatment-resistant to prevention.”

In addition, galcanezumab was associated with significantly lower rates of average monthly medication overuse, compared with placebo. In the EVOLVE studies, the average rate of monthly medication overuse was 15.9% for the placebo group, 6.2% for the galcanezumab 120-mg group, and 7.9% for the galcanezumab 240-mg group. In REGAIN, the average rate of monthly medication overuse was 40.6% in the placebo group, 24.3% in the galcanezumab 120-mg group, and 23.1% in the galcanezumab 240-mg group. About 85% of patients with episodic migraine and medication overuse had a reduction in medication overuse, and approximately 50% of patients with chronic migraine and medication overuse had a reduction in medication overuse, said Dr. Aurora.

Dr. Aurora and coinvestigators are employees of Eli Lilly, which developed galcanezumab and funded the EVOLVE and REGAIN studies.

[email protected]

SOURCE: Aurora S et al. AHS 2019. Abstract IOR07.

PHILADELPHIA – In patients with migraine and medication overuse, galcanezumab reduces the number of mean monthly migraine headache days, according to research presented at the annual meeting of the American Headache Society. Furthermore, galcanezumab is associated with a reduction in medication overuse, compared with placebo, in this population.

“When you have targeted preventive treatment and you reduce the burden of illness, medication overuse seems to be reduced as well,” said Sheena Aurora, MD, adjunct clinical associate professor of anesthesiology and perioperative and pain medicine at Stanford (Calif.) Health Care. Dr. Aurora also is a medical fellow and global launch leader for galcanezumab at Eli Lilly, which has developed the treatment.

Galcanezumab is a humanized monoclonal antibody that selectively binds to the calcitonin gene-related peptide. The phase 3 EVOLVE-1, EVOLVE-2, and REGAIN studies indicated galcanezumab’s superiority to placebo in preventing episodic and chronic migraine.
 

A post hoc analysis of phase 3 data

Dr. Aurora and colleagues conducted a post hoc analysis of data from the three phase 3 studies to examine galcanezumab’s effect in patients with medication overuse. EVOLVE-1 and EVOLVE-2 included patients with episodic migraine, and REGAIN included patients with chronic migraine. All participants were randomized to monthly subcutaneous injections of placebo or galcanezumab (120 mg/month or 240 mg/month) for 3-6 months. Based on information obtained through electronic patient-reported outcome diaries, investigators determined headache medication overuse using criteria adapted from the International Classification of Headache Disorders, third edition. They estimated mean changes in monthly headache days and the proportion of patients with medication overuse after randomization using mixed modeling.

The demographic characteristics of the three study populations were similar to those reported in epidemiologic studies of migraine, said Dr. Aurora. Most participants were women, and most patients were between ages 40 and 49 years. At baseline, the mean number of monthly migraine headache days was 20 among patients with chronic migraine and 9 among patients with episodic migraine.

The rate of medication overuse was higher in the combined study population than in the literature. Patients with medication overuse had greater disability and greater health care resource utilization, compared with patients without medication overuse. Among patients with chronic migraine, participants who overused medication were not significantly different from those who did not. But among patients with episodic migraine, participants who overused medication had higher headache frequency than those who did not.

In the EVOLVE trials, the proportion of patients with baseline medication overuse was 19.3% in the placebo arm, 17.0% in the galcanezumab 120-mg arm, and 19.2% in the galcanezumab 240-mg arm. In REGAIN, the proportion of patients with baseline medication overuse was 63.4% in the placebo arm, 64.3% in the galcanezumab 120-mg arm, and 64.1% in the galcanezumab 240-mg arm.

Galcanezumab reduced medication overuse

Compared with placebo, both doses of galcanezumab significantly decreased mean monthly migraine headache days in patients with baseline medication overuse. In the EVOLVE studies, this endpoint decreased by 2.71 in the placebo group, 6.26 in the galcanezumab 120-mg group, and 5.77 in the galcanezumab 240-mg group. In REGAIN, the reductions were 2.25 in the placebo group, 4.78 in the galcanezumab 120-mg group, and 4.51 in the galcanezumab 240-mg group. The effect size was higher in patients who were overusing medications, compared with those who were not, said Dr. Aurora. “This is clinically relevant, because most of us ... had this belief that patients who were overusing medications may be more treatment-resistant to prevention.”

In addition, galcanezumab was associated with significantly lower rates of average monthly medication overuse, compared with placebo. In the EVOLVE studies, the average rate of monthly medication overuse was 15.9% for the placebo group, 6.2% for the galcanezumab 120-mg group, and 7.9% for the galcanezumab 240-mg group. In REGAIN, the average rate of monthly medication overuse was 40.6% in the placebo group, 24.3% in the galcanezumab 120-mg group, and 23.1% in the galcanezumab 240-mg group. About 85% of patients with episodic migraine and medication overuse had a reduction in medication overuse, and approximately 50% of patients with chronic migraine and medication overuse had a reduction in medication overuse, said Dr. Aurora.

Dr. Aurora and coinvestigators are employees of Eli Lilly, which developed galcanezumab and funded the EVOLVE and REGAIN studies.

[email protected]

SOURCE: Aurora S et al. AHS 2019. Abstract IOR07.

The Psychosocial Assessment Tool (PAT) is a promising tool for screening psychosocial risk that could potentially facilitate identification of psychosocial treatment needs among youth with recurrent headache at risk for poor outcomes, a new study found. Youth with recurrent migraine or tension-type headache completed the PAT and validated measures of adolescent emotional and behavioral functioning, parent emotional functioning, and family functioning at baseline (n=239) and 6-month follow-up (n=221). Researchers found:

• Internal consistency for the PAT total score was strong (α = .88).
• At baseline, the PAT total score was significantly associated in the expected direction with established measures of child emotional and behavioral functioning, parent anxiety and depressive symptoms, and family functioning.
• Predictive validity was demonstrated by a significant association between the PAT total scores at baseline with child emotional and behavioral functioning, parent anxiety, parent depression, and family functioning at 6-month follow-up.

Law EF, et al. Screening family and psychosocial risk in pediatric migraine and tension-type headache: Validation of the Psychosocial Assessment Tool (PAT). [Published online ahead of print July 18, 2019]. Headache. doi: 10.1111/head.13599.

The Psychosocial Assessment Tool (PAT) is a promising tool for screening psychosocial risk that could potentially facilitate identification of psychosocial treatment needs among youth with recurrent headache at risk for poor outcomes, a new study found. Youth with recurrent migraine or tension-type headache completed the PAT and validated measures of adolescent emotional and behavioral functioning, parent emotional functioning, and family functioning at baseline (n=239) and 6-month follow-up (n=221). Researchers found:

• Internal consistency for the PAT total score was strong (α = .88).
• At baseline, the PAT total score was significantly associated in the expected direction with established measures of child emotional and behavioral functioning, parent anxiety and depressive symptoms, and family functioning.
• Predictive validity was demonstrated by a significant association between the PAT total scores at baseline with child emotional and behavioral functioning, parent anxiety, parent depression, and family functioning at 6-month follow-up.

Law EF, et al. Screening family and psychosocial risk in pediatric migraine and tension-type headache: Validation of the Psychosocial Assessment Tool (PAT). [Published online ahead of print July 18, 2019]. Headache. doi: 10.1111/head.13599.

The Psychosocial Assessment Tool (PAT) is a promising tool for screening psychosocial risk that could potentially facilitate identification of psychosocial treatment needs among youth with recurrent headache at risk for poor outcomes, a new study found. Youth with recurrent migraine or tension-type headache completed the PAT and validated measures of adolescent emotional and behavioral functioning, parent emotional functioning, and family functioning at baseline (n=239) and 6-month follow-up (n=221). Researchers found:

• Internal consistency for the PAT total score was strong (α = .88).
• At baseline, the PAT total score was significantly associated in the expected direction with established measures of child emotional and behavioral functioning, parent anxiety and depressive symptoms, and family functioning.
• Predictive validity was demonstrated by a significant association between the PAT total scores at baseline with child emotional and behavioral functioning, parent anxiety, parent depression, and family functioning at 6-month follow-up.

Law EF, et al. Screening family and psychosocial risk in pediatric migraine and tension-type headache: Validation of the Psychosocial Assessment Tool (PAT). [Published online ahead of print July 18, 2019]. Headache. doi: 10.1111/head.13599.

Sodium divalproate (SD) in low alternating doses appears to be effective as with higher doses, but may induce modest weight gain, a new study found. Consecutive migraineurs to whom SD was prescribed as monotherapy were studied retrospectively. The doses were 250 mg alternated with 500 mg. Headache frequency compared to baseline, adherence expressed by returning to a visit after 2 and 4 months, and side effects reported by patients were evaluated. The study included 68 patients (53 women, 15 men) aged 18 to 58 years.
 

Researchers found:

• The average headache frequency (HF) during baseline was decreased from 8.2 to 5.1 headache days/month among the 50 out of 68 patients returning at 2 months, with adherence rate at 73.5%.
• Weight gain was reported in 30% of patients.
• At 4 months, HF was reduced to 4.2 days/month, with adherence rate at 61.8%, and weight gain reported by 42.8% of patients.

Krymchantowski AV, et al. Sodium divalproate in low alternating daily doses for migraine prevention: A retrospective study. [Published online ahead of print July 1, 2019]. Headache. doi:  10.1111/head.13579.

Sodium divalproate (SD) in low alternating doses appears to be effective as with higher doses, but may induce modest weight gain, a new study found. Consecutive migraineurs to whom SD was prescribed as monotherapy were studied retrospectively. The doses were 250 mg alternated with 500 mg. Headache frequency compared to baseline, adherence expressed by returning to a visit after 2 and 4 months, and side effects reported by patients were evaluated. The study included 68 patients (53 women, 15 men) aged 18 to 58 years.
 

Researchers found:

• The average headache frequency (HF) during baseline was decreased from 8.2 to 5.1 headache days/month among the 50 out of 68 patients returning at 2 months, with adherence rate at 73.5%.
• Weight gain was reported in 30% of patients.
• At 4 months, HF was reduced to 4.2 days/month, with adherence rate at 61.8%, and weight gain reported by 42.8% of patients.

Krymchantowski AV, et al. Sodium divalproate in low alternating daily doses for migraine prevention: A retrospective study. [Published online ahead of print July 1, 2019]. Headache. doi:  10.1111/head.13579.

Sodium divalproate (SD) in low alternating doses appears to be effective as with higher doses, but may induce modest weight gain, a new study found. Consecutive migraineurs to whom SD was prescribed as monotherapy were studied retrospectively. The doses were 250 mg alternated with 500 mg. Headache frequency compared to baseline, adherence expressed by returning to a visit after 2 and 4 months, and side effects reported by patients were evaluated. The study included 68 patients (53 women, 15 men) aged 18 to 58 years.
 

Researchers found:

• The average headache frequency (HF) during baseline was decreased from 8.2 to 5.1 headache days/month among the 50 out of 68 patients returning at 2 months, with adherence rate at 73.5%.
• Weight gain was reported in 30% of patients.
• At 4 months, HF was reduced to 4.2 days/month, with adherence rate at 61.8%, and weight gain reported by 42.8% of patients.

Krymchantowski AV, et al. Sodium divalproate in low alternating daily doses for migraine prevention: A retrospective study. [Published online ahead of print July 1, 2019]. Headache. doi:  10.1111/head.13579.

Migraine-associated vertigo and motion sickness may involve distinct susceptibility genes, according to a new study. Researchers identified a large American family of 29 individuals of which 17 members suffered from at least 1 of the following disorders: migraine, vertigo, or motion sickness. Many suffered from several simultaneously. Family members were phenotyped for each condition and analyzed separately. Among the findings:

• A novel locus for migraine, 9q13-q22 was identified.
• Suggestive LOD scores localized to different chromosomes for each phenotype; vertigo (chromosome 18, LOD score 1.82) and motion sickness (chromosome 4, LOD score 2.09).

Peddareddygari LR, et al. Genetic analysis of a large family with migraine, vertigo, and motion sickness. [Published online ahead of print July 1, 2019]. Can J Neuro Sci. doi: 10.1017/cjn.2019.64.

Migraine-associated vertigo and motion sickness may involve distinct susceptibility genes, according to a new study. Researchers identified a large American family of 29 individuals of which 17 members suffered from at least 1 of the following disorders: migraine, vertigo, or motion sickness. Many suffered from several simultaneously. Family members were phenotyped for each condition and analyzed separately. Among the findings:

• A novel locus for migraine, 9q13-q22 was identified.
• Suggestive LOD scores localized to different chromosomes for each phenotype; vertigo (chromosome 18, LOD score 1.82) and motion sickness (chromosome 4, LOD score 2.09).

Peddareddygari LR, et al. Genetic analysis of a large family with migraine, vertigo, and motion sickness. [Published online ahead of print July 1, 2019]. Can J Neuro Sci. doi: 10.1017/cjn.2019.64.

Migraine-associated vertigo and motion sickness may involve distinct susceptibility genes, according to a new study. Researchers identified a large American family of 29 individuals of which 17 members suffered from at least 1 of the following disorders: migraine, vertigo, or motion sickness. Many suffered from several simultaneously. Family members were phenotyped for each condition and analyzed separately. Among the findings:

• A novel locus for migraine, 9q13-q22 was identified.
• Suggestive LOD scores localized to different chromosomes for each phenotype; vertigo (chromosome 18, LOD score 1.82) and motion sickness (chromosome 4, LOD score 2.09).

Peddareddygari LR, et al. Genetic analysis of a large family with migraine, vertigo, and motion sickness. [Published online ahead of print July 1, 2019]. Can J Neuro Sci. doi: 10.1017/cjn.2019.64.

Two new guidelines on the treatment and prevention of migraines in children and adolescents have been released by the American Academy of Neurology and the American Headache Society.

This update to the previous guidelines released by the American Academy of Neurology in 2004 reflects the expansion in pharmacologic and nonpharmacologic approaches during the last 15 years, Andrew D. Hershey, MD, PhD, director of the division of neurology at Cincinnati Children’s Hospital and a fellow of the American Academy of Neurology, said in an interview.

“There has also been an increase in the number of randomized controlled studies, which have allowed for a more robust statement on acute and preventive treatments to be made,” said Dr. Hershey, who is also a senior author for both guidelines.

The two reports focused on separate issues: One guideline outlined the options for treatment of acute migraine, and the second guideline summarized the available studies on the effectiveness of preventive medications for migraine in children and adolescents.

The guidelines recommend a physical examination and history to establish a specific headache diagnosis and afford a treatment that provides fast and complete pain relief. Treatment should be initiated as soon as a patient realizes an attack is occurring. Patients with signs of secondary headache should be evaluated by a neurologist or a headache specialist.

Studies support the use of ibuprofen and acetaminophen for pain relief in cases of acute migraine, but only some triptans (such as almotriptan, rizatriptan, sumatriptan/naproxen, and zolmitriptan nasal spray) are approved for use in adolescents. Specifically, sumatriptan/naproxen was shown to be effective when compared with placebo in studies with adolescents, whose headache symptoms resolved within 2 hours.

It may be necessary to try more than one triptan, the guidelines noted, because patients respond differently to medications. A failure to respond to one triptan does not necessarily mean that treatment with another triptan will be unsuccessful.

The guidelines also focused on patient and family education to improve medication safety and adherence. Lifestyle modification, avoidance of migraine triggers, creating good sleep habits, and staying hydrated can help reduce migraines. While no medications improved associated symptoms of migraines such as nausea or vomiting, triptans did show a benefit in reducing phonophobia and photophobia.

Evidence for pharmacologic prevention of migraines in children and adolescents is limited, according to the guidelines. In the 15 studies included in a literature review, there was not sufficient evidence to show preventive treatments, such as divalproex, onabotulinumtoxinA, amitriptyline, nimodipine, and flunarizine, were more effective than placebo at reducing the frequency of headaches. There was some evidence to show propranolol in children and topiramate and cinnarizine in children and adolescents can reduce headache frequency. Children and adolescents who received cognitive-behavioral therapy together with amitriptyline were more likely to have reduced frequency of headaches than were those who received amitriptyline with patient education.

“The consensus conclusion was that a multidisciplinary approach that combines acute treatments, preventive treatments, and healthy habits is likely to have the best outcomes,” said Dr. Hershey.

Dr. Hershey acknowledged the many gaps between what is clinically observed and what the studies in the guidelines demonstrated.

“One of the biggest questions is how to minimize the expectation response in the controlled studies,” he said. “Additionally, we are moving toward a better recognition of the mechanism by which the various treatments work in a genetic-based disease that is polygenic in nature” with up to 38 different gene polymorphisms identified to date.

The guidelines also do not address newer treatments, such as calcitonin gene–related peptide (CGRP) antibodies, CGRP antagonists, serotonin antagonists, and devices because there are as yet no studies of their effectiveness in children and adolescents.

“They have been studied in adults, so will be prone to the expectation response; but given the large number of diverse therapies, one can hope that many of the gaps can be filled,” said Dr. Hershey.

The American Academy of Neurology provided funding for development of the guidelines and reimbursed authors who served as subcommittee members for travel expenses and in-person meetings. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, grants, honorariums, consultancies, and publishing royalties for pharmaceutical companies and other organizations.

SOURCES: Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008095. Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008105.

Two new guidelines on the treatment and prevention of migraines in children and adolescents have been released by the American Academy of Neurology and the American Headache Society.

This update to the previous guidelines released by the American Academy of Neurology in 2004 reflects the expansion in pharmacologic and nonpharmacologic approaches during the last 15 years, Andrew D. Hershey, MD, PhD, director of the division of neurology at Cincinnati Children’s Hospital and a fellow of the American Academy of Neurology, said in an interview.

“There has also been an increase in the number of randomized controlled studies, which have allowed for a more robust statement on acute and preventive treatments to be made,” said Dr. Hershey, who is also a senior author for both guidelines.

The two reports focused on separate issues: One guideline outlined the options for treatment of acute migraine, and the second guideline summarized the available studies on the effectiveness of preventive medications for migraine in children and adolescents.

The guidelines recommend a physical examination and history to establish a specific headache diagnosis and afford a treatment that provides fast and complete pain relief. Treatment should be initiated as soon as a patient realizes an attack is occurring. Patients with signs of secondary headache should be evaluated by a neurologist or a headache specialist.

Studies support the use of ibuprofen and acetaminophen for pain relief in cases of acute migraine, but only some triptans (such as almotriptan, rizatriptan, sumatriptan/naproxen, and zolmitriptan nasal spray) are approved for use in adolescents. Specifically, sumatriptan/naproxen was shown to be effective when compared with placebo in studies with adolescents, whose headache symptoms resolved within 2 hours.

It may be necessary to try more than one triptan, the guidelines noted, because patients respond differently to medications. A failure to respond to one triptan does not necessarily mean that treatment with another triptan will be unsuccessful.

The guidelines also focused on patient and family education to improve medication safety and adherence. Lifestyle modification, avoidance of migraine triggers, creating good sleep habits, and staying hydrated can help reduce migraines. While no medications improved associated symptoms of migraines such as nausea or vomiting, triptans did show a benefit in reducing phonophobia and photophobia.

Evidence for pharmacologic prevention of migraines in children and adolescents is limited, according to the guidelines. In the 15 studies included in a literature review, there was not sufficient evidence to show preventive treatments, such as divalproex, onabotulinumtoxinA, amitriptyline, nimodipine, and flunarizine, were more effective than placebo at reducing the frequency of headaches. There was some evidence to show propranolol in children and topiramate and cinnarizine in children and adolescents can reduce headache frequency. Children and adolescents who received cognitive-behavioral therapy together with amitriptyline were more likely to have reduced frequency of headaches than were those who received amitriptyline with patient education.

“The consensus conclusion was that a multidisciplinary approach that combines acute treatments, preventive treatments, and healthy habits is likely to have the best outcomes,” said Dr. Hershey.

Dr. Hershey acknowledged the many gaps between what is clinically observed and what the studies in the guidelines demonstrated.

“One of the biggest questions is how to minimize the expectation response in the controlled studies,” he said. “Additionally, we are moving toward a better recognition of the mechanism by which the various treatments work in a genetic-based disease that is polygenic in nature” with up to 38 different gene polymorphisms identified to date.

The guidelines also do not address newer treatments, such as calcitonin gene–related peptide (CGRP) antibodies, CGRP antagonists, serotonin antagonists, and devices because there are as yet no studies of their effectiveness in children and adolescents.

“They have been studied in adults, so will be prone to the expectation response; but given the large number of diverse therapies, one can hope that many of the gaps can be filled,” said Dr. Hershey.

The American Academy of Neurology provided funding for development of the guidelines and reimbursed authors who served as subcommittee members for travel expenses and in-person meetings. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, grants, honorariums, consultancies, and publishing royalties for pharmaceutical companies and other organizations.

SOURCES: Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008095. Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008105.

Two new guidelines on the treatment and prevention of migraines in children and adolescents have been released by the American Academy of Neurology and the American Headache Society.

This update to the previous guidelines released by the American Academy of Neurology in 2004 reflects the expansion in pharmacologic and nonpharmacologic approaches during the last 15 years, Andrew D. Hershey, MD, PhD, director of the division of neurology at Cincinnati Children’s Hospital and a fellow of the American Academy of Neurology, said in an interview.

“There has also been an increase in the number of randomized controlled studies, which have allowed for a more robust statement on acute and preventive treatments to be made,” said Dr. Hershey, who is also a senior author for both guidelines.

The two reports focused on separate issues: One guideline outlined the options for treatment of acute migraine, and the second guideline summarized the available studies on the effectiveness of preventive medications for migraine in children and adolescents.

The guidelines recommend a physical examination and history to establish a specific headache diagnosis and afford a treatment that provides fast and complete pain relief. Treatment should be initiated as soon as a patient realizes an attack is occurring. Patients with signs of secondary headache should be evaluated by a neurologist or a headache specialist.

Studies support the use of ibuprofen and acetaminophen for pain relief in cases of acute migraine, but only some triptans (such as almotriptan, rizatriptan, sumatriptan/naproxen, and zolmitriptan nasal spray) are approved for use in adolescents. Specifically, sumatriptan/naproxen was shown to be effective when compared with placebo in studies with adolescents, whose headache symptoms resolved within 2 hours.

It may be necessary to try more than one triptan, the guidelines noted, because patients respond differently to medications. A failure to respond to one triptan does not necessarily mean that treatment with another triptan will be unsuccessful.

The guidelines also focused on patient and family education to improve medication safety and adherence. Lifestyle modification, avoidance of migraine triggers, creating good sleep habits, and staying hydrated can help reduce migraines. While no medications improved associated symptoms of migraines such as nausea or vomiting, triptans did show a benefit in reducing phonophobia and photophobia.

Evidence for pharmacologic prevention of migraines in children and adolescents is limited, according to the guidelines. In the 15 studies included in a literature review, there was not sufficient evidence to show preventive treatments, such as divalproex, onabotulinumtoxinA, amitriptyline, nimodipine, and flunarizine, were more effective than placebo at reducing the frequency of headaches. There was some evidence to show propranolol in children and topiramate and cinnarizine in children and adolescents can reduce headache frequency. Children and adolescents who received cognitive-behavioral therapy together with amitriptyline were more likely to have reduced frequency of headaches than were those who received amitriptyline with patient education.

“The consensus conclusion was that a multidisciplinary approach that combines acute treatments, preventive treatments, and healthy habits is likely to have the best outcomes,” said Dr. Hershey.

Dr. Hershey acknowledged the many gaps between what is clinically observed and what the studies in the guidelines demonstrated.

“One of the biggest questions is how to minimize the expectation response in the controlled studies,” he said. “Additionally, we are moving toward a better recognition of the mechanism by which the various treatments work in a genetic-based disease that is polygenic in nature” with up to 38 different gene polymorphisms identified to date.

The guidelines also do not address newer treatments, such as calcitonin gene–related peptide (CGRP) antibodies, CGRP antagonists, serotonin antagonists, and devices because there are as yet no studies of their effectiveness in children and adolescents.

“They have been studied in adults, so will be prone to the expectation response; but given the large number of diverse therapies, one can hope that many of the gaps can be filled,” said Dr. Hershey.

The American Academy of Neurology provided funding for development of the guidelines and reimbursed authors who served as subcommittee members for travel expenses and in-person meetings. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, grants, honorariums, consultancies, and publishing royalties for pharmaceutical companies and other organizations.

SOURCES: Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008095. Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008105.

PHILADELPHIA – The oral, small molecule, calcitonin gene-related peptide receptor antagonist ubrogepant, currently under regulatory review for approval as a treatment for acute migraine headache, was as effective for migraine relief in patients with a history of triptan ineffectiveness as it was in patients for whom triptans had been effective, based on a post hoc analysis of data collected from 1,798 patients enrolled in two phase 3 trials.

Mitchel L. Zoler/MDedge News

In the roughly one-quarter of all patients who had a clinical history consistent with triptan ineffectiveness, one 50-mg dose of ubrogepant led to pain freedom 2 hours after treatment in 16% of patients, compared with a response rate of 8% in placebo-treated patients. Ubrogepant’s effectiveness rate that was about the same as seen in patients with a history of triptan effectiveness, who were about 37% of the study population, Susan Hutchinson, MD, said at the annual meeting of the American Headache Society.

Among those with a history of triptan effectiveness, 20% were pain free after 2 hours, compared with 11% of placebo-treated controls, said Dr. Hutchinson, a family physician and headache specialist who practices in Irvine, Calif. Both of these between-group differences were statistically significant. The remaining patients included in the analysis had no triptan history, and among these patients a single, 50-mg dose of ubrogepant produced pain freedom at 2 hours in 24% of patients, versus an 18% response in placebo-treated controls, a difference that fell short of statistical significance.

The analysis Dr. Hutchinson reported came from data collected in two pivotal trials of ubrogepant for treatment of an acute migraine headache, the ACHIEVE I and ACHIEVE II trials, which together randomized more than 2,600 migraine patients eligible for the study’s modified intention-to-treat analysis, and 1,798 patients from that analysis who received a 50-mg dose of ubrogepant or placebo. In March 2019, the company developing ubrogepant, Allergan, announced that the Food and Drug Administration had accepted the company’s application for marketing approval of ubrogepant as a treatment for acute migraine largely based on data from ACHIEVE I and ACHIEVE II.

The researchers defined a history of triptan ineffectiveness as a patient who never used a triptan because of a warning, precaution, or contraindication, a patient who recently used triptans but did not achieve pain freedom within 2 hours more than half the time taking the drugs, or a patient who no longer used triptans because of adverse effects or lack of efficacy. Patients who had used triptans in the past and had complete pain relief within 2 hours more than half the time were deemed triptan-effective patients.

The analysis also looked at two other endpoints in addition to complete pain freedom: complete relief of the most-bothersome symptom of the migraine headache (photophobia for most patients), which resolved in 39% and 36% of the triptan-effective and triptan-ineffective patients, respectively, compared with placebo response rates of 27% and 23%; both between-group differences were statistically significant. A third measure of efficacy was some degree of pain relief after 2 hours, which occurred in 62% of patients in whom triptans were effective and 55% in those in whom triptans were ineffective, which were again statistically significant higher rates than among patients who received placebo.

Safety findings from the two ubrogepant pivotal trials showed good drug tolerability, with no treatment-related serious adverse events, and a profile of modest numbers of treatment-related and total adverse events similar to what occurred among patients who received placebo.

ACHIEVE I and II were funded by Allergan, the company developing ubrogepant. Dr. Hutchinson has been an adviser to and a speaker on behalf of Allergan and several other companies.

[email protected]

SOURCE: Blumenfeld AM. Headache. 2019 June;59[S1]:1-208, Abstract IOR02.

PHILADELPHIA – The oral, small molecule, calcitonin gene-related peptide receptor antagonist ubrogepant, currently under regulatory review for approval as a treatment for acute migraine headache, was as effective for migraine relief in patients with a history of triptan ineffectiveness as it was in patients for whom triptans had been effective, based on a post hoc analysis of data collected from 1,798 patients enrolled in two phase 3 trials.

Mitchel L. Zoler/MDedge News

In the roughly one-quarter of all patients who had a clinical history consistent with triptan ineffectiveness, one 50-mg dose of ubrogepant led to pain freedom 2 hours after treatment in 16% of patients, compared with a response rate of 8% in placebo-treated patients. Ubrogepant’s effectiveness rate that was about the same as seen in patients with a history of triptan effectiveness, who were about 37% of the study population, Susan Hutchinson, MD, said at the annual meeting of the American Headache Society.

Among those with a history of triptan effectiveness, 20% were pain free after 2 hours, compared with 11% of placebo-treated controls, said Dr. Hutchinson, a family physician and headache specialist who practices in Irvine, Calif. Both of these between-group differences were statistically significant. The remaining patients included in the analysis had no triptan history, and among these patients a single, 50-mg dose of ubrogepant produced pain freedom at 2 hours in 24% of patients, versus an 18% response in placebo-treated controls, a difference that fell short of statistical significance.

The analysis Dr. Hutchinson reported came from data collected in two pivotal trials of ubrogepant for treatment of an acute migraine headache, the ACHIEVE I and ACHIEVE II trials, which together randomized more than 2,600 migraine patients eligible for the study’s modified intention-to-treat analysis, and 1,798 patients from that analysis who received a 50-mg dose of ubrogepant or placebo. In March 2019, the company developing ubrogepant, Allergan, announced that the Food and Drug Administration had accepted the company’s application for marketing approval of ubrogepant as a treatment for acute migraine largely based on data from ACHIEVE I and ACHIEVE II.

The researchers defined a history of triptan ineffectiveness as a patient who never used a triptan because of a warning, precaution, or contraindication, a patient who recently used triptans but did not achieve pain freedom within 2 hours more than half the time taking the drugs, or a patient who no longer used triptans because of adverse effects or lack of efficacy. Patients who had used triptans in the past and had complete pain relief within 2 hours more than half the time were deemed triptan-effective patients.

The analysis also looked at two other endpoints in addition to complete pain freedom: complete relief of the most-bothersome symptom of the migraine headache (photophobia for most patients), which resolved in 39% and 36% of the triptan-effective and triptan-ineffective patients, respectively, compared with placebo response rates of 27% and 23%; both between-group differences were statistically significant. A third measure of efficacy was some degree of pain relief after 2 hours, which occurred in 62% of patients in whom triptans were effective and 55% in those in whom triptans were ineffective, which were again statistically significant higher rates than among patients who received placebo.

Safety findings from the two ubrogepant pivotal trials showed good drug tolerability, with no treatment-related serious adverse events, and a profile of modest numbers of treatment-related and total adverse events similar to what occurred among patients who received placebo.

ACHIEVE I and II were funded by Allergan, the company developing ubrogepant. Dr. Hutchinson has been an adviser to and a speaker on behalf of Allergan and several other companies.

[email protected]

SOURCE: Blumenfeld AM. Headache. 2019 June;59[S1]:1-208, Abstract IOR02.

PHILADELPHIA – The oral, small molecule, calcitonin gene-related peptide receptor antagonist ubrogepant, currently under regulatory review for approval as a treatment for acute migraine headache, was as effective for migraine relief in patients with a history of triptan ineffectiveness as it was in patients for whom triptans had been effective, based on a post hoc analysis of data collected from 1,798 patients enrolled in two phase 3 trials.

Mitchel L. Zoler/MDedge News

In the roughly one-quarter of all patients who had a clinical history consistent with triptan ineffectiveness, one 50-mg dose of ubrogepant led to pain freedom 2 hours after treatment in 16% of patients, compared with a response rate of 8% in placebo-treated patients. Ubrogepant’s effectiveness rate that was about the same as seen in patients with a history of triptan effectiveness, who were about 37% of the study population, Susan Hutchinson, MD, said at the annual meeting of the American Headache Society.

Among those with a history of triptan effectiveness, 20% were pain free after 2 hours, compared with 11% of placebo-treated controls, said Dr. Hutchinson, a family physician and headache specialist who practices in Irvine, Calif. Both of these between-group differences were statistically significant. The remaining patients included in the analysis had no triptan history, and among these patients a single, 50-mg dose of ubrogepant produced pain freedom at 2 hours in 24% of patients, versus an 18% response in placebo-treated controls, a difference that fell short of statistical significance.

The analysis Dr. Hutchinson reported came from data collected in two pivotal trials of ubrogepant for treatment of an acute migraine headache, the ACHIEVE I and ACHIEVE II trials, which together randomized more than 2,600 migraine patients eligible for the study’s modified intention-to-treat analysis, and 1,798 patients from that analysis who received a 50-mg dose of ubrogepant or placebo. In March 2019, the company developing ubrogepant, Allergan, announced that the Food and Drug Administration had accepted the company’s application for marketing approval of ubrogepant as a treatment for acute migraine largely based on data from ACHIEVE I and ACHIEVE II.

The researchers defined a history of triptan ineffectiveness as a patient who never used a triptan because of a warning, precaution, or contraindication, a patient who recently used triptans but did not achieve pain freedom within 2 hours more than half the time taking the drugs, or a patient who no longer used triptans because of adverse effects or lack of efficacy. Patients who had used triptans in the past and had complete pain relief within 2 hours more than half the time were deemed triptan-effective patients.

The analysis also looked at two other endpoints in addition to complete pain freedom: complete relief of the most-bothersome symptom of the migraine headache (photophobia for most patients), which resolved in 39% and 36% of the triptan-effective and triptan-ineffective patients, respectively, compared with placebo response rates of 27% and 23%; both between-group differences were statistically significant. A third measure of efficacy was some degree of pain relief after 2 hours, which occurred in 62% of patients in whom triptans were effective and 55% in those in whom triptans were ineffective, which were again statistically significant higher rates than among patients who received placebo.

Safety findings from the two ubrogepant pivotal trials showed good drug tolerability, with no treatment-related serious adverse events, and a profile of modest numbers of treatment-related and total adverse events similar to what occurred among patients who received placebo.

ACHIEVE I and II were funded by Allergan, the company developing ubrogepant. Dr. Hutchinson has been an adviser to and a speaker on behalf of Allergan and several other companies.

[email protected]

SOURCE: Blumenfeld AM. Headache. 2019 June;59[S1]:1-208, Abstract IOR02.