• David W Dodick, James Kost, Christopher Assaid, Christopher Lines, and Tony W Ho.
• Department of Neurology, Mayo Clinic Arizona, 5777 E. Mayo Blvd., Phoenix, AZ 85054, USA. Dodick.David@mayo.edu
• Cephalalgia. 2011 Feb 1; 31 (3): 296-300.

BackgroundEndpoints used to evaluate the efficacy of acute anti-migraine drugs do not measure the tolerability. Sustained pain-free response with no adverse events has been recommended as a composite endpoint which measures the efficacy and tolerability attributes that patients desire.MethodsThe aim of this study was to evaluate new composite efficacy-plus-tolerability endpoints based on a post-hoc analysis of patient-level data from a previous randomized, placebo-controlled trial of the calcitonin gene-related peptide (CGRP) receptor antagonist, telcagepant, and zolmitriptan in the acute treatment of migraine. Endpoints were 2-24-hour sustained pain freedom and no adverse events from 0-24 hours (SPF24NAE), 2-24 hour sustained pain relief and no adverse events from 0-24 hours (SPR24NAE), pain freedom at 2 hours and no adverse events from 0-24 hours (PF2NAE), and pain relief at 2 hours and no adverse events from 0-24 hours (PR2NAE).ResultsCompared with placebo, both telcagepant 300 mg and 150 mg achieved nominal superiority (p values <.05) for SPF24NAE, SPR24NAE, PF2NAE and PR2NAE. Zolmitriptan 5 mg showed nominal superiority versus placebo for SPF24NAE, SPR24NAE and PF2NAE, but not PR2NAE. Telcagepant 300 mg showed nominal superiority versus zolmitriptan for SPF24NAE, SPR24NA and PR2NAE.ConclusionComposite efficacy-plus-tolerability endpoints may be useful for facilitating comparisons between treatments.

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