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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.