ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 1861

Efficacy and Safety of Pregabalin in Japanese Patients with Fibromyalgia: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase III Trial and Open-Label Extension Study

Hiroyoshi Ohta1, Masayuki Ohkura1, Makoto Suzuki1, Hiroshi Oka2, Chie Usui3 and Kusuki Nishioka4, 1Pfizer Japan Inc, Tokyo, Japan, 2Rheumatic Disease Center, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan, 3Department of Psychiatry, Juntendo University School of Medicine, Juntendo University Nerima Hospital, Tokyo, Japan, 4Institute of Innovative Medical Science and Education, Tokyo Medical University, Tokyo, Japan

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Clinical trials and fibromyalgia

  • Tweet
  • Email
  • Print
Session Information

Title: Fibromyalgia and Soft Tissue Disorders

Session Type: Abstract Submissions (ACR)

Background/Purpose: Fibromyalgia (FM) is a common, chronic pain disorder, however, at the time of this study there was no approved medicine for FM patients in Japan. This study aimed to assess the efficacy and safety of the α2δ ligand pregabalin for the symptomatic relief of pain in Japanese patients with FM.

Methods: In a randomized, double-blind, multicenter, placebo-controlled phase III trial conducted at 44 centers in Japan, patients aged ≥18 years who had met the 1990 American College of Rheumatology criteria for FM 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 16 weeks (3-week dose-escalation/optimization phase; 12-week fixed-dose treatment phase; 1-week taper phase). The primary endpoint was mean pain score at final assessment. Secondary endpoints included Patient Global Impression of Change (PGIC), Fibromyalgia Impact Questionnaire (FIQ), and measures of sleep (quality of sleep score and Medical Outcomes Study-Sleep Scale). Patients completing the double-blind study were eligible for a 53-week open-label extension study to evaluate the longer-term safety and efficacy of pregabalin (maintenance dose 300-450 mg/day).

Results: In total, 498 patients (89% female) were randomized to receive either pregabalin (n = 250; mean age 47.9 years) or placebo (n = 248; mean age 46.7 years). Pregabalin significantly reduced mean pain score at final assessment (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 of patients reporting symptoms "very much improved” or "much improved”; p = 0.0078); pain visual analog scale (p = 0.0013); FIQ total score (p = 0.0144); and quality of sleep score (p < 0.0001). The safety profile of pregabalin was consistent with previous clinical trials. Somnolence, dizziness, nasopharyngitis and increased weight were the most frequently reported adverse events; the majority of adverse events were mild to moderate in severity. A total of 106 patients completing the double-blind trial entered the open-label extension study. Total exposure to pregabalin in the open-label study was 100 person-years, with no new patterns in the type, incidence or severity of adverse events observed. Improvements in measures of pain, sleep and physical functioning were also maintained throughout the 53 weeks of the open-label extension study.

Conclusion: Pregabalin, at doses of up to 450 mg/day, was safe and efficacious for the symptomatic relief of pain when compared with placebo in the double-blind trial. Treatment also improved measures of sleep and physical functioning. Treatment was generally well tolerated and no new safety signals were observed over 53 weeks’ treatment in the open-label extension study. Together, these results indicate that pregabalin is an effective treatment option for Japanese patients with FM.


Disclosure:

H. Ohta,

Pfizer Japan Inc,

3;

M. Ohkura,

Pfizer Japan Inc,

3;

M. Suzuki,

Pfizer Japan Inc,

3;

H. Oka,

Pfizer Japan Inc,

5;

C. Usui,
None;

K. Nishioka,

Pfizer Japan Inc,

5.

  • Tweet
  • Email
  • Print

« Back to 2012 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-pregabalin-in-japanese-patients-with-fibromyalgia-a-randomized-double-blind-multicenter-placebo-controlled-phase-iii-trial-and-open-label-extension-study/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology