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| |  Pooled Analysis Confirms Efficacy of Pregabalin for Fibromyalgia Pain: Presented at ACR By Bruce Sylvester BOSTON, MA -- November 13, 2007 -- A pooled analysis of data from 2 trials shows that pregabalin treatment at several doses significantly reduces pain associated with fibromyalgia (FM). The researchers -- who pooled data from 2 similarly designed, double-blind, randomized, placebo-controlled trials -- reported their findings on November 10 in a poster session at the 71st annual meeting of the American College of Rheumatology (ACR). "Treatment with pregabalin 300, 450, and 600 mg/d BID [twice daily] was associated with robust efficacy for the management of FM," the authors reported. In these trials, patients meeting 1990 ACR (American College of Rheumatology) criteria for fibromyalgia (widespread pain for >=3 months and pain in >=11 of 18 tender points) with mean pain score >=4 (0-10 numeric rating scale) and pain VAS (Visual Analogue Scale) score >=40 mm (0-100 mm scale) were eligible for randomization to pregabalin 300, 450, or 600 mg/d BID or placebo for 13 or 14 weeks (1- or 2-week dosage escalation). The primary endpoint in both trials was pain score. Fibromyalgia Impact Questionnaire (FIQ) scores and Patient Global Impression of Change (PGIC) data were also collected in both trials Supplementary analyses in both trials included >=30% or >=50% response in weekly mean pain score from baseline to endpoint. A total of 1,493 subjects were randomized in the two trials: 368 to pregabalin 300 mg/d, 373 to 450 mg/d, 378 to 600 mg/d, and 374 to placebo. Ninety-one percent were white, 94% were women, mean age was 49 years, median fibromyalgia duration was 9.7 years, and baseline mean pain score was 6.9. After analyzing the pooled data, the investigators reported that pregabalin therapy significantly improved pain scores. They reported differences from placebo in mean change -- from baseline to endpoint -- in pain score as follows: 300 mg/d, -0.55 (P =.0003); 450 mg/d, -0.71; 600 mg/d, -0.82 (each P <.0001). The researchers also found that pregabalin 450- and 600-mg/d therapy was associated with significant improvements in FIQ total score. Mean differences from placebo at endpoint were 450 mg/d, -3.43 (P =.0116) and 600 mg/d, -3.05 (P =.0243). Mean treatment difference for 300 mg/d was -2.47 (P =.0707). PGIC results were significant in all pregabalin treatment groups (P <=.0002). The proportion of responders generally increased with increasing pregabalin dosing. The >=30% response for placebo was 32.6%. For pregabalin 300 mg/d, 450 mg/d, and 600 mg/d, it was 42.1%, 46.4%, and 45.8% respectively. The >=50% response for placebo was 17.4%. For pregabalin 300, 450, and 600 mg/d, it was 24.5%, 26.3%, and 28.6% respectively. The researchers added that pregabalin was generally well tolerated. "Results of the analysis of the 1,493 patients randomized to these two 13- to 14-week studies confirm that pregabalin 300 to 600 mg/d BID is efficacious and well tolerated as treatment for FM," the authors concluded. Funding for this study was provided by Pfizer Global Pharmaceuticals.
[Presentation title: Pregabalin Monotherapy for Management of Fibromyalgia: Analysis of 2 Double-Blind, Randomized, Placebo-Controlled Trials. Abstract 1524]
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