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

被引:54
作者
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
机构
[1] Jefferson Headache Ctr, Philadelphia, PA 19107 USA
[2] Merck & Co Inc, Merck Res Labs, Dept Clin Neurosci, W Point, PA USA
[3] New England Ctr Headache, Stamford, CT USA
[4] Nashville Neurosci Grp, Nashville, TN USA
[5] Diamond Headache Clin Ltd, Chicago, IL USA
[6] San Francisco Clin Res Ctr, San Francisco, CA USA
[7] Palm Beach Neurol, Premiere Res Inst, W Palm Beach, FL USA
[8] Merck & Co Inc, Merck Res Labs, Clin Biostat & Res Dept, Brussels, Belgium
关键词
D O I
10.1212/01.WNL.0000123260.61631.C4
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Objective: To investigate the clinical profile of rofecoxib, a long-acting (approximate to 17-hour half-life) selective cyclooxygenase-2 inhibitor, for the acute treatment of migraine. Methods: A randomized, double-blind, placebo-controlled, parallel-group study was conducted. Patients age greater than or equal to18 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.
引用
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页码:1552 / 1557
页数:6
相关论文
共 17 条
[1]
Chang DJ, 2003, ANN RHEUM DIS, V62, P301
[2]
Rofecoxib versus codeine/acetaminophen in postoperative dental pain: A double-blind, randomized, placebo- and active comparator-controlled clinical trial [J].
Chang, DJ ;
Fricke, JR ;
Bird, SR ;
Bohidar, NR ;
Dobbins, TW ;
Geba, GP .
CLINICAL THERAPEUTICS, 2001, 23 (09) :1446-1455
[3]
Determinants of patient satisfaction with migraine therapy [J].
Davies, GM ;
Santanello, N ;
Lipton, R .
CEPHALALGIA, 2000, 20 (06) :554-560
[4]
Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials [J].
Ferrari, MD ;
Loder, E ;
McCarroll, KA ;
Lines, CR .
CEPHALALGIA, 2001, 21 (02) :129-136
[5]
FRICKE J, 2002, ANN RHEUM DIS S1, V61, P128
[6]
TESTING FOR QUALITATIVE INTERACTIONS BETWEEN TREATMENT EFFECTS AND PATIENT SUBSETS [J].
GAIL, M ;
SIMON, R .
BIOMETRICS, 1985, 41 (02) :361-372
[7]
*INT HEAD SOC HEAD, 1988, CEPHALALGIA S7, V8, P9
[8]
Burden of migraine - Societal costs and therapeutic opportunities [J].
Lipton, RB ;
Stewart, WF ;
vonKorff, M .
NEUROLOGY, 1997, 48 (03) :S4-S9
[9]
Matchar D, 2000, NEUROLOGY, P55
[10]
*MERCK CO INC, 2003, PHYS DESK REF, P2120