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Efficacy and safety of rofecoxib 12.5 mg versus nabumetone 1,000 mg in patients with osteoarthritis of the knee: a randomized controlled trial.

AbstractOBJECTIVES:
To evaluate the use of starting doses of rofecoxib and nabumetone in patients with osteoarthritis (OA) of the knee.
DESIGN:
A 6-week, randomized, parallel-group, double-blind, placebo-controlled study.
SETTING:
One hundred thirteen outpatient sites in the United States.
PARTICIPANTS:
A total of 1,042 male and female patients aged 40 and older with OA of the knee (>6 months).
INTERVENTIONS:
Rofecoxib 12.5 mg once a day (n=424), nabumetone 1,000 mg once a day (n=410), or placebo (n=208) for 6 weeks.
MEASUREMENTS:
The primary efficacy endpoint was patient global assessment of response to therapy (PGART) over 6 weeks, which was also specifically evaluated over the first 6 days. The main safety measure was adverse events during the 6 weeks of treatment.
RESULTS:
The percentage of patients with a good or excellent response to therapy as assessed using PGART at Week 6 was significantly higher with rofecoxib (55.4%) than nabumetone (47.5%; P=.018) or placebo (26.7%; P<.001 vs rofecoxib or nabumetone). Median time to first report of a good or excellent PGART response was significantly shorter in patients treated with rofecoxib (2 days) than with nabumetone (4 days, P=.002) and placebo (>5 days, P<.001) (nabumetone vs placebo; P=.007). The safety profiles of rofecoxib and nabumetone were generally similar, including gastrointestinal, hypertensive, and renal adverse events.
CONCLUSION:
Rofecoxib 12.5 mg daily demonstrated better efficacy over 6 weeks of treatment and quicker onset of OA efficacy over the first 6 days than nabumetone 1,000 mg daily. Both therapies were generally well tolerated.
AuthorsAlan J Kivitz, Maria W Greenwald, Stanley B Cohen, Adam B Polis, Daryl K Najarian, Mary E Dixon, Robert A Moidel, Jerry A Green, Herbert S B Baraf, Richard A Petruschke, Alan K Matsumoto, Gregory P Geba, Protocol 085 Study Investigators
JournalJournal of the American Geriatrics Society (J Am Geriatr Soc) Vol. 52 Issue 5 Pg. 666-74 (May 2004) ISSN: 0002-8614 [Print] United States
PMID15086644 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Inflammatory Agents, Non-Steroidal
  • Butanones
  • Cyclooxygenase Inhibitors
  • Lactones
  • Placebos
  • Sulfones
  • rofecoxib
  • Nabumetone
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects, therapeutic use)
  • Butanones (administration & dosage, therapeutic use)
  • Cyclooxygenase Inhibitors (administration & dosage, adverse effects, therapeutic use)
  • Data Interpretation, Statistical
  • Double-Blind Method
  • Female
  • Humans
  • Lactones (administration & dosage, adverse effects, therapeutic use)
  • Male
  • Middle Aged
  • Nabumetone
  • Osteoarthritis, Knee (diagnosis, drug therapy)
  • Placebos
  • Safety
  • Sulfones
  • Time Factors

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