The 5-HT1F receptor agonist lasmiditan as a potential treatment of migraine attacks: a review of two placebo-controlled phase II trialsReport as inadecuate




The 5-HT1F receptor agonist lasmiditan as a potential treatment of migraine attacks: a review of two placebo-controlled phase II trials - Download this document for free, or read online. Document in PDF available to download.

The Journal of Headache and Pain

, Volume 13, Issue 4, pp 271–275

First Online: 20 March 2012Received: 02 January 2012Accepted: 16 February 2012

Abstract

Lasmiditan is a novel selective 5-HT1F receptor agonist. It is both scientifically and clinically relevant to review whether a 5-HT1F receptor agonist is effective in the acute treatment of migraine. Two RCTs in the phase II development of lasmiditan was reviewed. In the intravenous placebo-controlled RCT, lasmiditan doses of 2.5–45 mg were used, and there was a linear association between headache relief HR rates and dose levels P < 0.02. For lasmiditan 20 mg, HR was 64 % and for placebo it was 45 % NS. In the oral placebo-controlled RCT, lasmiditan doses of 50, 100, 200 and 400 mg were used. For HR, all doses of lasmiditan were superior to placebo P < 0.05. For lasmiditan 400 mg, HR was 64 % and it was 25 % for placebo. Adverse events AEs emerging from the treatment were reported by 22 % of the patients receiving placebo and by 65, 73, 87 and 87 % of patients receiving 50, 100, 200 and 400 mg, respectively. The majority of AEs after lasmiditan 100 and 400 mg were moderate or severe. For the understanding of migraine pathophysiology, it is very important to note that a selective 5-HT1F receptor agonist like lasmiditan is effective in the acute treatment of migraine. Thus, migraine can be treated with a drug that has no vasoconstrictor ability. While lasmiditan most likely is effective in the treatment of migraine attacks it had, unfortunately, a high incidence of CNS related AEs in the oral RCT. If confirmed in larger studies in phase III, this might adversely limit the use of this highly specific non-vascular acute treatment of migraine. Larger studies including the parameters of patients’ preferences are necessary to accurately position this new treatment principle in relation to the triptans.

KeywordsLasmiditan 5-HT1F receptor agonism Migraine Randomised controlled trial Phase II  Download fulltext PDF



Author: Peer C. Tfelt-Hansen - Jes Olesen

Source: https://link.springer.com/







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