The Lancet, Early Online Publication, 25 November 2008doi:10.1016/S0140-6736(08)61626-8Cite or Link Using DOI
Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial
Original TextDr Tony W Ho MD a , Prof Michel D Ferrari MD b, Prof David W Dodick MD c, Vince Galet PhD a, James Kost PhD a, Xiaoyin Fan PhD a, Heather Leibensperger BS a, Samar Froman BS a, Christopher Assaid PhD a, Christopher Lines PhD a, Hille Koppen MD b, Paul K Winner DO d
Summary
Background
Calcitonin gene-related peptide (CGRP) probably has a role in migraine pathophysiology, and antagonism of its receptors might provide treatment without the vasoconstrictor effects of triptans. We aimed to assess the clinical profile of MK-0974 (telcagepant), an orally bioavailable antagonist of CGRP receptor.
Methods
In a randomised, parallel-treatment, placebo-controlled, double-blind, trial at 81 sites in the Europe and the USA, adults with migraine diagnosed by International Headache Society criteria treated moderate or severe attacks with either oral telcagepant 150 mg or 300 mg, zolmitriptan 5 mg, or placebo. The five co-primary endpoints were pain freedom, pain relief, or absence of photophobia, phonophobia, or nausea at 2 h after treatment. Analysis was by the full analysis set and multiplicity was controlled for with a step-down closed-testing procedure. This trial is registered with ClinicalTrials.gov, number NCT00442936.
Findings
1380 patients were randomly assigned to receive telcagepant 150 mg (n=333) or 300 mg (354), zolmitriptan (345), or placebo (348). Telcagepant 300 mg was more effective than placebo for pain freedom (95 [27%] of 353 patients vs 33 [10%] of 343 [p<0·0001]), pain relief (194 [55%] of 353 vs 95 [28%] of 343 [p<0·0001]), and absences of phonophobia (204 [58%] of 353 vs 126 [37%] of 342 [p<0·0001]), photophobia (180 [51%] of 353 vs 99 [29%] of 342 [p<0·0001]), and nausea (229 [65%] of 352 vs 189 [55%] of 342 [p=0·0061]). Efficacy of telcagepant 300 mg and zolmitriptan 5 mg were much the same, and both were more effective than telcagepant 150 mg. Adverse events were recorded for 31% taking telcagepant 150 mg, 37% taking telcagepant 300 mg, 51% taking zolmitriptan 5 mg, and 32% taking placebo.
Interpretation
Telcagepant 300 mg is effective as an acute treatment for migraine with efficacy comparable to that of zolmitriptan 5 mg, but with fewer associated adverse effects.
Funding
Merck Research Laboratories.
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New Migraine Medication on the Horizon?
Sunday December 7, 2008
It seems that more and more medications are hitting the market all the time, but every once in a while one of them really makes a difference. In a study appearing in the UK medical journal, The Lancet, a new medication called talcagepant was compared to sumatriptan (Imitrex) for migraine treatment. In a nutshell, the study shows that talcagepant was similar in its efficacy but with fewer side effects, making it a good choice as a migraine treatment.
Talcagepant is a calictonin gene-related peptide (CGRP) which seem to treat migraines without constricting the blood vessels. The triptans, like sumatriptan, affect serotonin channels and cause the blood vessels to constrict. This makes them poor choices for patients with migraines as well as cardiovascular disease. Talcagepant could very well be a good choice in heart disease patients suffering from migraines.
Talcagepant isn't FDA approved yet, but it is currently being studied in clinical trials. Be on the lookout for this new treatment and talk with your health care provider to determine if it could be a treatment for you.
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