A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgiaReport as inadecuate




A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia - Download this document for free, or read online. Document in PDF available to download.

Arthritis Research and Therapy

, 14:R217

First Online: 12 October 2012Received: 17 April 2012Revised: 24 August 2012Accepted: 17 September 2012

Abstract

IntroductionFibromyalgia is a chronic disorder characterized by widespread pain and tenderness. Prior trials have demonstrated the efficacy of pregabalin for the relief of fibromyalgia symptoms, and it is approved for the treatment of fibromyalgia in the United States. However, prior to this study, there has not been a large-scale efficacy trial in patients with fibromyalgia in Japan.

MethodsThis randomized, double-blind, multicenter, placebo-controlled trial was conducted at 44 centers in Japan to assess the efficacy and safety of pregabalin for the symptomatic relief of pain in fibromyalgia patients. Patients aged ≥18 years who had met the criteria for fibromyalgia were randomized to receive either pregabalin, starting at 150 mg-day and increasing to a maintenance dose of 300 or 450 mg-day, or placebo, for 15 weeks. The primary efficacy endpoint was mean pain score at final assessment. Secondary endpoints included Patient Global Impression of Change PGIC together with measures of sleep, physical functioning and quality of life.

ResultsA total of 498 patients 89% female were randomized to receive either pregabalin n = 250 or placebo n = 248. Pregabalin significantly reduced mean pain score at final assessment difference in mean change from baseline, compared with placebo -0.44; P = 0.0046 and at every week during the study P <0.025. Key secondary endpoints were also significantly improved with pregabalin treatment compared with placebo, including PGIC percentage reporting symptoms -very much improved- or -much improved-, 38.6% vs 26.7% with placebo; P = 0.0078; pain visual analog scale difference in mean change from baseline, compared with placebo -6.19; P = 0.0013; Fibromyalgia Impact Questionnaire total score -3.33; P = 0.0144; and quality of sleep score -0.73; P <0.0001. Treatment was generally well tolerated, with somnolence and dizziness the most frequently reported adverse events.

ConclusionsThis trial demonstrated that pregabalin, at doses of up to 450 mg-day, was effective for the symptomatic relief of pain in Japanese patients with fibromyalgia. Pregabalin also improved measures of sleep and functioning and was well tolerated. These data indicate that pregabalin is an effective treatment option for the relief of pain and sleep problems in Japanese patients with fibromyalgia.

Trial RegistrationClinicalTrials.gov: NCT00830167

AbbreviationsACRAmerican College of Rheumatology

AEadverse event

CIconfidence interval

C-SSRSColumbia Suicide Severity Rating Scale

FMfibromyalgia

FIQFibromyalgia Impact Questionnaire

HADSHospital Anxiety and Depression Scale

LOCFlast observation carried forward

LSleast squares

MMRMmixed-effect model repeated measure

MOSMedical Outcomes Study

NNHnumber needed to harm

NNTnumber needed to treat

NSAIDsnonsteroidal anti-inflammatory drugs

PGICPatient Global Impression of Change

SF-3636-Item Short Form Health Survey

VASvisual analog scale.

Electronic supplementary materialThe online version of this article doi:10.1186-ar4056 contains supplementary material, which is available to authorized users.

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Author: Hiroyoshi Ohta - Hiroshi Oka - Chie Usui - Masayuki Ohkura - Makoto Suzuki - Kusuki Nishioka

Source: https://link.springer.com/







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