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Related Experiment Videos

Rofecoxib for rheumatoid arthritis.

S E Garner1, D D Fidan, R R Frankish

  • 1Department of Community Health Sciences, St George's Hospital Medical School, Cranmer Terrace, Tooting, London, UK, SW17 0RE. SGarner@nice.nhs.uk

The Cochrane Database of Systematic Reviews
|January 28, 2005
PubMed
Summary

Rofecoxib (Vioxx) showed greater efficacy than placebo for rheumatoid arthritis (RA) and similar efficacy to naproxen, with fewer gastrointestinal issues but a higher risk of heart attack and stroke. It is no longer available.

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Area of Science:

  • Pharmacology and Therapeutics
  • Rheumatology
  • Clinical Trial Analysis

Background:

  • Rheumatoid arthritis (RA) is a systemic autoimmune disorder causing persistent joint inflammation.
  • Rofecoxib (Vioxx), an anti-inflammatory drug, was withdrawn in 2004 due to increased risks of heart attack and stroke with long-term use.

Purpose of the Study:

  • To evaluate the efficacy and toxicity of rofecoxib in treating rheumatoid arthritis.
  • To compare rofecoxib's effectiveness and safety against placebo and naproxen.

Main Methods:

  • Systematic review of randomized controlled trials (RCTs) identified through comprehensive database searches up to December 2000.
  • Inclusion criteria focused on RCTs assessing rofecoxib's efficacy and/or toxicity in RA patients.
  • Data extraction and quality assessment (Jadad 1996) were performed independently by two reviewers.

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Main Results:

  • Rofecoxib (25mg and 50mg) demonstrated significantly higher efficacy (ACR 20 responders) compared to placebo.
  • Rofecoxib showed comparable efficacy to naproxen but with a significantly lower rate of complicated gastrointestinal events.
  • Rofecoxib use was associated with a higher risk of cardiovascular events, including non-fatal myocardial infarction (MI), compared to naproxen.

Conclusions:

  • Rofecoxib offered superior efficacy to placebo and comparable efficacy to naproxen with improved gastrointestinal safety.
  • A significantly increased risk of myocardial infarction was observed with rofecoxib, though its pathophysiology remained unclear.
  • Due to its market withdrawal, rofecoxib has no current clinical implications, but highlights variable NSAID toxicity.