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A Randomized, Double-blind, Placebo-Controlled, Phase III Trial of Pregabalin in the Treatment of Patients with Fibromyalgia
PHILIP J. MEASE, I. JON RUSSELL, LESLEY M. ARNOLD, HANA FLORIAN, JAMES P. YOUNG Jr, SUSAN A. MARTIN, and UMA SHARMA
ABSTRACT. Methods. This multicenter, double-blind, placebo-controlled trial randomly assigned 748 patients with FM to receive placebo or pregabalin 300, 450, or 600 mg/day (dosed twice daily) for 13 weeks. The primary outcome variable for study objective 1, symptomatic relief of pain associated with FM, was comparison of endpoint mean pain scores between each pregabalin group and placebo. The outcome variable for study objective 2, management of FM, included endpoint mean pain scores, Patient Global Impression of Change (PGIC), and Fibromyalgia Impact Questionnaire (FIQ)–Total Score. Secondary outcomes included assessments of sleep, fatigue, and mood disturbance. Results. Patients in all pregabalin groups showed statistically significant improvement in endpoint mean pain score and in PGIC response compared with placebo. Improvements in FIQ–Total Score for the pregabalin groups were numerically but not significantly greater than those for the placebo group. Compared with placebo, all pregabalin treatment groups showed statistically significant improvement in assessments of sleep and in patients' impressions of their global improvement. Dizziness and somnolence were the most frequently reported adverse events. Conclusion. Pregabalin at 300, 450, and 600 mg/day was efficacious and safe for treatment of pain associated with FM. Pregabalin monotherapy provides clinically meaningful benefit to patients with FM. (First Release Feb 15 2008; J Rheumatol 2008;35:502-14) Key Indexing Terms:
FIBROMYALGIA
From Seattle Rheumatology Associates and Swedish Medical Center, Seattle, Washington, USA. Supported by Pfizer Inc., Ann Arbor, Michigan, USA. Dr. Mease has received research grant support from Pfizer Inc., Cypress Bioscience, Forest Laboratories, Inc., Eli Lilly and Company, Allergan, Wyeth Pharmaceuticals, Jazz Pharmaceuticals, and Fralex Therapeutics. Dr. Russell has received research grant support from Pfizer Inc., Eli Lilly and Company, Allergan, Boehringer Ingelheim, Cypress Biosciences, Inc., Jazz Pharmaceuticals, Grunenthal GMB, and Pierre Fabré. Dr. Arnold has received research grant support from Eli Lilly and Company, Pfizer, Inc., Cypress Biosciences Inc., Wyeth Pharmaceuticals, Sanofi-Aventis, Boehringer Ingelheim, Allergan, and Forest Laboratories Inc. Dr. Florian, Mr. Young, and Ms Martin are employees of Pfizer and own stock in Pfizer. Dr. Sharma was an employee of Pfizer when this study was conducted and owns stock in Pfizer. P.J. Mease, MD, Seattle Rheumatology Associates and Swedish Medical Center, Seattle, Washington; I.J. Russell, MD, PhD, Associate Professor of Medicine and Clinical Immunology, University of Texas Health Sciences Center, San Antonio, Texas; L.M. Arnold, MD, Women's Health Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Ohio; H. Florian, MD; J.P. Young Jr, MS; S.A. Martin, MSPH, Pfizer Global Research and Development, Ann Arbor, Michigan; U. Sharma, PhD, MMS Holdings, Inc., Canton, Michigan, USA. Address reprint requests to Dr. P.J. Mease, Seattle Rheumatology Associates, 1101 Madison Street, Suite 320, Seattle, WA 98104. E-mail: pmease@nwlink.com Accepted for publication September 6, 2007. |
