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- Title
Oral Almotriptan in the Treatment of Migraine: Safety and Tolerability.
- Authors
Dodick, David W.
- Abstract
Objective.--To summarize safety and tolerability data on orally administered almotriptan from premarketing clinical trials. Background.--Almotriptan is a new 5-HT[sub 1B/1D] receptor agonist similar to sumatriptan in mode of action and therapeutic efficacy. In addition, the safety and tolerability profile of almotriptan has been demonstrated in a number of controlled clinical trials. Sumatriptan is generally safe and well tolerated; however, in controlled clinical trials, it has been associated with chest symptoms (pressure, warmth, and other unpleasant sensations) with an incidence of 3% to 5%. Design.--Three phase 1 dose-finding and pharmacokinetic studies in healthy men and women volunteers were reviewed to assess the safety and tolerability of oral almotriptan at single doses ranging from 2 to 200 mg. The objective of one study was to evaluate cardiovascular safety. Two phase 2 trials assessed the safety and tolerability of single doses of 2 to 150 mg in migraine (n=911). Two phase 3 trials assessed the safety and tolerability of a single 12.5-mg oral dose after three attacks (n=910) and repeated doses of 12.5 mg for multiple attacks over the long term (n=747). All studies were conducted in Europe. Data from the United States is currently being analyzed and will be published at a later date. Results.--In phase 2 and 3 trials comprising more than 2500 patients with migraine and 15 000 attacks, adverse events were infrequent and mild. The most common events--dizziness, nausea and vomiting, headache, fatigue, paresthesia, and drowsiness--were reported in fewer than 3% of patients. At the recommended therapeutic dose of 12.5 mg, the adverse events profile was not statistically different from placebo. The incidence of chest symptoms was 0.2% in the phase 3 trials. The long-term safety and tolerability profile after treatment of more than 10 000 attacks was similar to that following the single-dose studies. In all clinical trials, almotriptan demonstrated ...
- Subjects
CLINICAL trials; DRUG administration; DRUG interactions
- Publication
Headache: The Journal of Head & Face Pain, 2001, Vol 41, Issue 5, p449
- ISSN
0017-8748
- Publication type
Article
- DOI
10.1046/j.1526-4610.2001.01082.x