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Rofecoxib for osteoarthritis.

S E Garner1, D D Fidan, 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 18, 2005
PubMed
Summary
This summary is machine-generated.

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Rofecoxib (Vioxx) was more effective than placebo for osteoarthritis but carried increased risks of adverse events. Due to safety concerns, it was withdrawn from the market in 2004.

Area of Science:

  • Pharmacology
  • Rheumatology
  • Clinical Trials

Background:

  • Osteoarthritis (OA) is a prevalent, age-related joint disease causing pain, stiffness, and functional loss, particularly in the elderly.
  • Rofecoxib (Vioxx) was an anti-inflammatory drug used for OA management.
  • Concerns regarding increased heart attack and stroke risk led to rofecoxib's market withdrawal in 2004.

Purpose of the Study:

  • To systematically review the efficacy and safety of rofecoxib in managing osteoarthritis.
  • To evaluate rofecoxib's comparative effectiveness and safety against placebo and other non-steroidal anti-inflammatory drugs (NSAIDs).

Main Methods:

  • A systematic review of eligible randomized controlled trials (RCTs) was conducted.
  • Searches included major databases up to August 2004, with additional reference checks.

Related Experiment Videos

  • Data abstraction and quality assessment were performed independently by two reviewers; comparable trials were pooled using a fixed-effects model.

    • Main Results:

    • Rofecoxib demonstrated greater efficacy than placebo for patient global response.
    • Rofecoxib was associated with more adverse events compared to placebo.
    • No consistent efficacy differences were found between rofecoxib and active comparators at equivalent doses.
    • Endoscopic studies showed rofecoxib caused fewer gastric erosions and ulcers than ibuprofen but more than naproxen.
    • Cardiovascular safety data in hypertensive patients suggested rofecoxib increased edema and systolic blood pressure compared to celecoxib, though not consistently in general populations.

    Conclusions:

    • Rofecoxib's voluntary market withdrawal in October 2004 renders its use in practice obsolete.
    • Questions persist regarding the overall benefits and risks of COX-II selective agents.
    • Further research is needed to fully understand the implications of this drug class.