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NEUROLOGY 2004;62:1552-1557
© 2004 American Academy of Neurology

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

S. Silberstein, MD, S. Tepper, MD, J. Brandes, MD, M. Diamond, MD, J. Goldstein, MD, P. Winner, DO, S. Venkatraman, MS, F. Vrijens, MS, W. Malbecq, PhD, C. Lines, PhD, W. H. Visser, MD PhD, S. Reines, MD PhD and E. Yuen, MD

From the Jefferson Headache Center (Dr. Silberstein), Philadelphia, and Department of Clinical Neuroscience (Drs. Lines, Visser, Reines, and Yuen, S. Venkatraman), Merck Research Laboratories, Merck & Co., Inc., West Point, PA, New England Center for Headache (Dr. Tepper), Stamford, CT, Nashville Neuroscience Group (Dr. Brandes), Nashville, TN, Diamond Headache Clinic (Dr. Diamond), Chicago, IL, San Francisco Clinical Research Center (Dr. Goldstein), San Francisco, CA, and Premiere Research Institute at Palm Beach Neurology (Dr. Winner), West Palm Beach, FL; and Clinical Biostatistics and Research Department (Dr. Malbecq, F. Vrijens), Merck Research Laboratories, Merck & Co., Inc., Brussels, Belgium.

Address correspondence and reprint requests to Dr. S. Silberstein, Jefferson Headache Center, 111 S. 11 St., 8130 Gibbon, Philadelphia, PA, 19107; e-mail: Stephen.Silberstein{at}jefferson.edu

Objective: To investigate the clinical profile of rofecoxib, a long-acting ({approx}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 >=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.

Received April 18, 2003. Accepted in final form December 30, 2003.

Drs. Silberstein, Tepper, Brandes, Diamond, Goldstein, and Winner have received grant support and speaking honoraria from Merck & Co., Inc. Drs. Diamond, Goldstein, and Winner have received consulting fees from Merck & Co., Inc. S. Venkatraman and F. Vrijens and Drs. Malbecq, Lines, Visser, Reines, and Yuen are employees of Merck & Co., Inc., and hold stock options and equity positions.




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Evid. Based Med., September 1, 2004; 9(5): e5 - e5.
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