Randomized, placebo-controlled trial of rofecoxib in the acute treatment of migraine.

Abstract:

OBJECTIVE:To investigate the clinical profile of rofecoxib, a long-acting (approximately 17-hour half-life) selective cyclo-oxygenase-2 inhibitor, for the acute treatment of migraine. METHODS:A randomized, double-blind, placebo-controlled, parallel-group study was conducted. Patients age > or =18 treated a moderate or severe migraine headache with placebo (n = 182), rofecoxib 25 mg (n = 183), or rofecoxib 50 mg (n = 192). The primary efficacy measure was headache relief (mild or no pain) 2 hours after dose. RESULTS:The proportions of patients with migraine headache relief at 2 hours after dose were 34.3% for placebo, 54.0% for rofecoxib 25 mg (p < 0.001 vs placebo), and 56.7% for rofecoxib 50 mg (p < 0.001 vs placebo). Rofecoxib 25 and 50 mg were superior to placebo in providing pain freedom at 2 hours, 24-hour sustained headache relief, and 24-hour sustained pain freedom; in reducing photophobia, phonophobia, nausea (50 mg only), and functional disability at 2 hours after dose; and in improving some quality-of-life scores over 24 hours. More patients on rofecoxib 50 mg reported adverse events (39.6%) than patients on rofecoxib 25 mg (26.8%) or placebo (23.6%) regardless of drug relatedness; however, the incidences of drug-related adverse events were similar between treatment groups. These adverse events were generally mild or moderate in severity. The most commonly reported adverse events were dry mouth, dizziness, somnolence, nausea, dyspepsia, paresthesia, and asthenia, with similar incidences between treatment groups. CONCLUSION:Rofecoxib 25 and 50 mg were effective and generally well tolerated for the acute treatment of migraine attacks.

journal_name

Neurology

journal_title

Neurology

authors

Silberstein S,Tepper S,Brandes J,Diamond M,Goldstein J,Winner P,Venkatraman S,Vrijens F,Malbecq W,Lines C,Visser WH,Reines S,Yuen E

doi

10.1212/01.wnl.0000123260.61631.c4

subject

Has Abstract

pub_date

2004-05-11 00:00:00

pages

1552-7

issue

9

eissn

0028-3878

issn

1526-632X

journal_volume

62

pub_type

临床试验,杂志文章,多中心研究,随机对照试验
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