Lasmiditan Provides Rapid Relief in Acute Migraine
Lasmiditan, a new type of drug for acute treatment of migraine, provided prompt relief of pain and other bothersome symptoms as soon as an hour after administration, researchers reported here.About 20% of patients treated with the highest dose of lasmiditan in one of two phase III trials reported being free of headache pain at 1 hour post-treatment, rising to nearly 40% at 2 hours.This drug doesnot have any cardiovascular complications as seen with ergotamine or tryptans.
The results were presented at the American Headache Society annual meeting.Lasmiditan could potentially represent the first major innovation for the treatment of acute migraine in two decades. The drug is a serotonin agonist selective for the 5-HT1F receptor. Triptans activate that receptor, but they are also active at other 5-HT receptor subtypes that are believed to be responsible for these agents' unwanted cardiovascular effects.
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Lasmiditan, a new type of drug for acute treatment of migraine, provided prompt relief of pain and other bothersome symptoms as soon as an hour after administration, researchers reported here.About 20% of patients treated with the highest dose of lasmiditan in one of two phase III trials reported being free of headache pain at 1 hour post-treatment, rising to nearly 40% at 2 hours.This drug doesnot have any cardiovascular complications as seen with ergotamine or tryptans.The results were presented at the American Headache Society annual meeting.Lasmiditan could potentially represent the first major innovation for the treatment of acute migraine in two decades. The drug is a serotonin agonist selective for the 5-HT1F receptor. Triptans activate that receptor, but they are also active at other 5-HT receptor subtypes that are believed to be responsible for these agents' unwanted cardiovascular effects.
These phase III results follow the recent approval of the first of another new class of migraine drugs, the calcitonin gene-related peptide (CGRP) inhibitors. Other research presented at the meeting showed that lasmiditan inhibits the release of CGRP from central and peripheral trigeminal nerve terminals in the mouse brain to the same degree as sumatriptan.
SAMURAI and SPARTAN were randomized, double-blind trials comparing lasmiditan versus placebo for the treatment of acute migraine. Together, the studies included 4,439 participants. More than 80% were women, most were white, and the mean age was approximately 42 years. They had an average of about five migraines per month, one-third experienced aura, and they had moderate migraine-related disability (MIDAS score of 11 or higher). About 20% used prophylactic medications to reduce migraine frequency.
About 80% of patients had at least one risk factor for cardiovascular disease, including family history, smoking, hypertension, hyperlipidemia, and type 2 diabetes. SAMURAI, but not SPARTAN, excluded people with known coronary artery disease, arrhythmias, or uncontrolled hypertension.
In both studies, participants were randomly assigned to receive lasmiditan or placebo within 4 hours after the onset of migraine. Both studies evaluated oral doses of 100 mg and 200 mg, and SPARTAN also included a 50-mg dose. Patients could receive a randomized second dose, if needed, 2 to 24 hours after the first.In both studies, patients experienced headache pain relief in as little as one hour, with better response rates seen at the higher doses, Aurora reported.
In SAMURAI, about 15% of people taking the 200-mg dose were pain-free at 1 hour after lasmiditan administration, rising to 32.2% at 2 hours in a modified intention-to-treat analysis. The same proportion in SPARTAN taking the highest dose were pain-free at 1 hour, rising to nearly 30% at 1.5 hours and 38.8% at 2 hours. Response rates in the placebo group at 2 hours were 15.3% and 21.3% in the two studies. Participants taking the 50-mg dose did not see a significant advantage over placebo until 2 hours post-administration.
In SAMURAI, about 15% of people taking the 200-mg dose were pain-free at 1 hour after lasmiditan administration, rising to 32.2% at 2 hours in a modified intention-to-treat analysis. The same proportion in SPARTAN taking the highest dose were pain-free at 1 hour, rising to nearly 30% at 1.5 hours and 38.8% at 2 hours. Response rates in the placebo group at 2 hours were 15.3% and 21.3% in the two studies. Participants taking the 50-mg dose did not see a significant advantage over placebo until 2 hours post-administration.
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