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Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial.
Arthritis Rheum. 2005 Apr; 52(4):1264-73.AR

Abstract

OBJECTIVE

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 alpha(2)-delta ligand, for treatment of symptoms associated with FMS.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

Authors+Show Affiliations

University of Michigan, Ann Arbor, USA. lcrofford@uky.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15818684

Citation

Crofford, Leslie J., et al. "Pregabalin for the Treatment of Fibromyalgia Syndrome: Results of a Randomized, Double-blind, Placebo-controlled Trial." Arthritis and Rheumatism, vol. 52, no. 4, 2005, pp. 1264-73.
Crofford LJ, Rowbotham MC, Mease PJ, et al. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2005;52(4):1264-73.
Crofford, L. J., Rowbotham, M. C., Mease, P. J., Russell, I. J., Dworkin, R. H., Corbin, A. E., Young, J. P., LaMoreaux, L. K., Martin, S. A., & Sharma, U. (2005). Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis and Rheumatism, 52(4), 1264-73.
Crofford LJ, et al. Pregabalin for the Treatment of Fibromyalgia Syndrome: Results of a Randomized, Double-blind, Placebo-controlled Trial. Arthritis Rheum. 2005;52(4):1264-73. PubMed PMID: 15818684.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. AU - Crofford,Leslie J, AU - Rowbotham,Michael C, AU - Mease,Philip J, AU - Russell,I Jon, AU - Dworkin,Robert H, AU - Corbin,Ann E, AU - Young,James P,Jr AU - LaMoreaux,Linda K, AU - Martin,Susan A, AU - Sharma,Uma, AU - ,, PY - 2005/4/9/pubmed PY - 2005/5/13/medline PY - 2005/4/9/entrez SP - 1264 EP - 73 JF - Arthritis and rheumatism JO - Arthritis Rheum VL - 52 IS - 4 N2 - OBJECTIVE: 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 alpha(2)-delta ligand, for treatment of symptoms associated with FMS. METHODS: 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. RESULTS: 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. CONCLUSION: 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. SN - 0004-3591 UR - https://www.unboundmedicine.com/medline/citation/15818684/Pregabalin_for_the_treatment_of_fibromyalgia_syndrome:_results_of_a_randomized_double_blind_placebo_controlled_trial_ L2 - https://doi.org/10.1002/art.20983 DB - PRIME DP - Unbound Medicine ER -