Research Article

Pregabalin for the treatment of fibromyalgia syndrome: Results of a randomized, double-blind, placebo-controlled trial 2004

Leslie J. Crofford 1 *, Michael C. Rowbotham 2, Philip J. Mease 3, I. Jon Russell 4, Robert H. Dworkin 5, Ann E. Corbin 6, James P. Young Jr. 6, Linda K. LaMoreaux 6, Susan A. Martin 6, Uma Sharma 6, Pregabalin 1008-105 Study Group
1University of Michigan, Ann Arbor
2University of California, San Francisco
3Rheumatology Associates, and Swedish Medical Center, Seattle, Washington
4University of Texas Health Science Center, San Antonio
5University of Rochester School of Medicine and Dentistry, Rochester, New York
6Pfizer Global Research and Development, Ann Arbor, Michigan
email: Leslie J. Crofford (

*Correspondence to Leslie J. Crofford, Room J-503, Kentucky Clinic, 740 South Limestone Street, Lexington, KY 40539
Dr. Crofford has received consulting fees of less than $10,000 from Cypress Bioscience, Eli Lilly & Co., Orphan Pharmaceuticals, Pfizer, and Wyeth.
Dr. Rowbotham has received consulting fees of less than $10,000 from Eli Lilly & Co. and Xenoport, owns stock in Xenoport and Neuromolecular, and was a coinvestigator on a study of gabapentin funded by Pfizer.
Dr. Mease has received consulting fees of less than $10,000 from Pfizer, Cypress Bioscience, Eli Lilly & Co., and Pierre Fabre and owns stock in Cypress Bioscience.
Dr. Dworkin has served on the advisory board or as a consultant for fees of less than $10,000 for Abbott Laboratories, Alpharma, AstraZeneca Pharmaceuticals, Bristol-Myers Squibb, Elan Pharmaceuticals, Eli Lilly & Co., GlaxoSmithKline, Johnson & Johnson, Merck KGaA, NeurogesX, Inc., Ortho-McNeil Pharmaceutical, and UCB Pharma; has received consulting fees of more than $10,000 from Pfizer, Allergan, Novartis, Epicept, and Endo; and owns stock in NeurogesX, Inc.
Ms Corbin, Mr. Young, Ms LaMoreaux, Ms Martin, and Dr. Sharma own stock in Pfizer.

Funded by:
Pfizer Global Research and Development, Ann Arbor, Michigan


Fibromyalgia syndrome (FMS) is characterized by widespread musculoskeletal pain and lowered pain threshold. Other prominent symptoms include disordered sleep and fatigue. FMS affects an estimated 2% of the population, predominantly women. This trial was designed to evaluate the efficacy and safety of pregabalin, a novel 2- ligand, for treatment of symptoms associated with FMS.

This multicenter, double-blind, 8-week, randomized clinical trial compared the effects of placebo with those of 150, 300, and 450 mg/day pregabalin on pain, sleep, fatigue, and health-related quality of life in 529 patients with FMS. The primary outcome variable was the comparison of end point mean pain scores, derived from daily diary ratings of pain intensity, between each of the pregabalin treatment groups and the placebo group.

Pregabalin at 450 mg/day significantly reduced the average severity of pain in the primary analysis compared with placebo (-0.93 on a 0-10 scale) (P 0.001), and significantly more patients in this group had 50% improvement in pain at the end point (29%, versus 13% in the placebo group; P = 0.003). Pregabalin at 300 and 450 mg/day was associated with significant improvements in sleep quality, fatigue, and global measures of change. Pregabalin at 450 mg/day improved several domains of health-related quality of life. Dizziness and somnolence were the most frequent adverse events. Rates of discontinuation due to adverse events were similar across all 4 treatment groups.

Pregabalin at 450 mg/day was efficacious for the treatment of FMS, reducing symptoms of pain, disturbed sleep, and fatigue compared with placebo. Pregabalin was well tolerated and improved global measures and health-related quality of life. Received: 21 June 2004; Accepted: 11 January 2005