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A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia.
J Pain. 2008 Sep; 9(9):792-805.JP

Abstract

The purpose of the study was to assess the efficacy and safety of pregabalin monotherapy in patients with fibromyalgia in a randomized, double-blinded, placebo-controlled trial. After 1 week of single-blinded administration of placebo, 750 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to pregabalin (300 mg/d, 450 mg/d, 600 mg/d) or placebo, administered twice daily for 14 weeks. The primary outcome variable was comparison of end point mean pain scores, derived from daily diary ratings of pain intensity (0 to 10 scale), between each of the pregabalin groups and the placebo group. If positive, additional primary efficacy parameters included the Patient Global Impression of Change (PGIC) and the Fibromyalgia Impact Questionnaire (FIQ) total score. Compared with placebo-treated patients, mean changes in pain scores at the end point in pregabalin-treated patients were significantly greater (P < .001: 300 mg/d, -0.71; 450 mg/d, -0.98; 600 mg/d, -1.00). Compared with placebo, significantly more pregabalin-treated patients reported improvement on PGIC (P < .01 for all 3 pregabalin doses) and significant improvements in total FIQ score for the 450 mg/d (P = .004) and the 600 mg/d (P = .003) doses. Compared with placebo, all 3 doses of pregabalin were associated with significant improvement in sleep. The most commonly reported pregabalin-related adverse events were dizziness and somnolence, which tended to be dose-related.

PERSPECTIVE

This randomized, placebo-controlled trial of 300, 450, and 600 mg/d of pregabalin monotherapy demonstrated that all 3 doses were efficacious for up to 14 weeks for the treatment of fibromyalgia and were well tolerated by most patients. These results provide evidence that pregabalin is an important treatment option for patients with fibromyalgia.

Authors+Show Affiliations

University of Cincinnati College of Medicine, Cincinnati, Ohio 45219, USA. Lesley.Arnold@uc.eduNo 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)

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

Language

eng

PubMed ID

18524684

Citation

Arnold, Lesley M., et al. "A 14-week, Randomized, Double-blinded, Placebo-controlled Monotherapy Trial of Pregabalin in Patients With Fibromyalgia." The Journal of Pain : Official Journal of the American Pain Society, vol. 9, no. 9, 2008, pp. 792-805.
Arnold LM, Russell IJ, Diri EW, et al. A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain. 2008;9(9):792-805.
Arnold, L. M., Russell, I. J., Diri, E. W., Duan, W. R., Young, J. P., Sharma, U., Martin, S. A., Barrett, J. A., & Haig, G. (2008). A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. The Journal of Pain : Official Journal of the American Pain Society, 9(9), 792-805. https://doi.org/10.1016/j.jpain.2008.03.013
Arnold LM, et al. A 14-week, Randomized, Double-blinded, Placebo-controlled Monotherapy Trial of Pregabalin in Patients With Fibromyalgia. J Pain. 2008;9(9):792-805. PubMed PMID: 18524684.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. AU - Arnold,Lesley M, AU - Russell,I Jon, AU - Diri,E W, AU - Duan,W Rachel, AU - Young,James P,Jr AU - Sharma,Uma, AU - Martin,Susan A, AU - Barrett,Jeannette A, AU - Haig,George, Y1 - 2008/06/03/ PY - 2007/10/02/received PY - 2008/02/04/revised PY - 2008/03/28/accepted PY - 2008/6/6/pubmed PY - 2008/10/22/medline PY - 2008/6/6/entrez SP - 792 EP - 805 JF - The journal of pain : official journal of the American Pain Society JO - J Pain VL - 9 IS - 9 N2 - UNLABELLED: The purpose of the study was to assess the efficacy and safety of pregabalin monotherapy in patients with fibromyalgia in a randomized, double-blinded, placebo-controlled trial. After 1 week of single-blinded administration of placebo, 750 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to pregabalin (300 mg/d, 450 mg/d, 600 mg/d) or placebo, administered twice daily for 14 weeks. The primary outcome variable was comparison of end point mean pain scores, derived from daily diary ratings of pain intensity (0 to 10 scale), between each of the pregabalin groups and the placebo group. If positive, additional primary efficacy parameters included the Patient Global Impression of Change (PGIC) and the Fibromyalgia Impact Questionnaire (FIQ) total score. Compared with placebo-treated patients, mean changes in pain scores at the end point in pregabalin-treated patients were significantly greater (P < .001: 300 mg/d, -0.71; 450 mg/d, -0.98; 600 mg/d, -1.00). Compared with placebo, significantly more pregabalin-treated patients reported improvement on PGIC (P < .01 for all 3 pregabalin doses) and significant improvements in total FIQ score for the 450 mg/d (P = .004) and the 600 mg/d (P = .003) doses. Compared with placebo, all 3 doses of pregabalin were associated with significant improvement in sleep. The most commonly reported pregabalin-related adverse events were dizziness and somnolence, which tended to be dose-related. PERSPECTIVE: This randomized, placebo-controlled trial of 300, 450, and 600 mg/d of pregabalin monotherapy demonstrated that all 3 doses were efficacious for up to 14 weeks for the treatment of fibromyalgia and were well tolerated by most patients. These results provide evidence that pregabalin is an important treatment option for patients with fibromyalgia. SN - 1528-8447 UR - https://www.unboundmedicine.com/medline/citation/18524684/A_14_week_randomized_double_blinded_placebo_controlled_monotherapy_trial_of_pregabalin_in_patients_with_fibromyalgia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1526-5900(08)00506-3 DB - PRIME DP - Unbound Medicine ER -