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A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia.
J Rheumatol. 2008 Mar; 35(3):502-14.JR

Abstract

OBJECTIVE

To evaluate the efficacy and safety of pregabalin for symptomatic relief of pain associated with fibromyalgia (FM) and for management of FM.

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.

Authors+Show Affiliations

Seattle Rheumatology Associates, Seattle, Washington 98104, USA. pmease@nwlink.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18278830

Citation

Mease, Philip J., et al. "A Randomized, Double-blind, Placebo-controlled, Phase III Trial of Pregabalin in the Treatment of Patients With Fibromyalgia." The Journal of Rheumatology, vol. 35, no. 3, 2008, pp. 502-14.
Mease PJ, Russell IJ, Arnold LM, et al. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol. 2008;35(3):502-14.
Mease, P. J., Russell, I. J., Arnold, L. M., Florian, H., Young, J. P., Martin, S. A., & Sharma, U. (2008). A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. The Journal of Rheumatology, 35(3), 502-14.
Mease PJ, et al. A Randomized, Double-blind, Placebo-controlled, Phase III Trial of Pregabalin in the Treatment of Patients With Fibromyalgia. J Rheumatol. 2008;35(3):502-14. PubMed PMID: 18278830.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. AU - Mease,Philip J, AU - Russell,I Jon, AU - Arnold,Lesley M, AU - Florian,Hana, AU - Young,James P,Jr AU - Martin,Susan A, AU - Sharma,Uma, Y1 - 2008/02/15/ PY - 2008/2/19/pubmed PY - 2008/6/11/medline PY - 2008/2/19/entrez SP - 502 EP - 14 JF - The Journal of rheumatology JO - J Rheumatol VL - 35 IS - 3 N2 - OBJECTIVE: To evaluate the efficacy and safety of pregabalin for symptomatic relief of pain associated with fibromyalgia (FM) and for management of FM. 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. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/18278830/A_randomized_double_blind_placebo_controlled_phase_III_trial_of_pregabalin_in_the_treatment_of_patients_with_fibromyalgia_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&pmid=18278830 DB - PRIME DP - Unbound Medicine ER -