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Telcagepant Shows Increased Efficacy, Consistency, and Tolerability for the Treatment of Migraines: Presented at IHS/AHS

By Liz Meszaros

PHILADELPHIA -- September 12, 2009 -- For the intermittent treatment of migraine with or without aura, telcagepant may be more consistently effective compared with placebo, according to a study presented here at the 14th Congress of the International Headache Society & the 51st Annual Scientific Meeting of the American Headache Society (IHS/AHS).

"This study confirms previously published data about telcagepant as far as efficacy," said lead author Andrew P. Ho, MD, Merck Research Laboratory, Merck & Co., Inc., North Wales, Pennsylvania, in his presentation on September 12. "Telcagepant is not only more efficacious in the treatment of a single migraine attack paradigm, but also in the multiple attack paradigm. It also has superior consistency to placebo."

In the double-blind, placebo-controlled study, 1,935 patients were randomised to treat at least 1 migraine attack with telcagepant 140 mg (T140) or telcagepant 280 mg (T280; n = 1,677) or to treat 3 attacks with placebo and then use T140 for either attack 3 or 4.

According to Dr. Ho, this study made significant improvements in methodology that were not achieved with the previous studies.

"This is a consistency study in which we treated 4 attacks. Our design is unique in that we were actually able to compare the consistent efficacy of the drug versus placebo. We used a modified parallel design, in which patients were treated with active drug for 4 attacks, or with placebo for 3 out of 4 attacks in which 1 of the attacks was active," said Dr. Ho.

The percentage of patients with consistent 2-hour freedom from pain was 9.3% in the T140 group, 14.1% in the T280 group, and 2.7% in the placebo group. The percentage of patients with consistent 2-hour pain relief was 41.8% in the T140 group, 46.8% in the T280 group, and 22.3% in the placebo group (P < .001).

"Consistency of response was defined as either pain relief or pain freedom within 2 hours in 3 out of 4 attacks. Response rates to telcagepant were fairly consistent across treatment of all 4 attacks, compared with placebo," noted Dr. Ho.

Over the course of treating 4 attacks, both doses of telcagepant were significantly better than placebo in achieving pain relief at 2 hours compared with placebo (~58% vs 33%, respectively).

"This shows us that there is no reduction in efficacy with telcagepant over the sequentially treated attacks," noted Dr. Ho. "It appears that the higher dose has a slight advantage over the lower dose, but we are now studying that further."

Side effects were minimal with both doses. The most common of these was somnolence, which occurred in 6.1% of T140 patients, 5.9% of T280 patients, and 2.3% of placebo patients.

"Of particular note is the short list of adverse events. The list includes only very mild events, and the difference between those seen with the drug versus those seen with placebo is very slight," noted Dr. Ho.

Funding for this study was provided by Merck & Co., Inc.

[Presentation title: Consistency of Efficacy and Tolerability of Telcagepant 140 mg and 280 mg for the Intermittent Acute Treatment of Migraine: A Multiple Attack, Double-Blind, Placebo-Controlled Study. Abstract LBPO03]

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