title: Efficacy and safety of rofecoxib 12.5 mg versus nabumetone 1,000 mg in patients with osteoarthritis of the knee: a randomized controlled trial.
abstract: OBJECTIVE
  To evaluate the use of starting doses of rofecoxib and nabumetone in patients with osteoarthritis (OA) of the knee.
  
  
  METHODS
  A 6-week, randomized, parallel-group, double-blind, placebo-controlled study.
  
  
  METHODS
  One hundred thirteen outpatient sites in the United States.
  
  
  METHODS
  A total of 1,042 male and female patients aged 40 and older with OA of the knee (>6 months).
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Kivitz
authors.forename: Maria W
authors.initials: MW
authors.lastname: Greenwald
authors.forename: Stanley B
authors.initials: SB
authors.lastname: Cohen
authors.forename: Adam B
authors.initials: AB
authors.lastname: Polis
authors.forename: Daryl K
authors.initials: DK
authors.lastname: Najarian
authors.forename: Mary E
authors.initials: ME
authors.lastname: Dixon
authors.forename: Robert A
authors.initials: RA
authors.lastname: Moidel
authors.forename: Jerry A
authors.initials: JA
authors.lastname: Green
authors.forename: Herbert S B
authors.initials: HS
authors.lastname: Baraf
authors.forename: Richard A
authors.initials: RA
authors.lastname: Petruschke
authors.forename: Alan K
authors.initials: AK
authors.lastname: Matsumoto
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Geba
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002074:Butanones / Q000008:administration & dosage / Q000627:therapeutic use*; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007783:Lactones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000077430:Nabumetone; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy*; D010919:Placebos; D012449:Safety; D013450:Sulfones; D013997:Time Factors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D002074:Butanones; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D010919:Placebos; D013450:Sulfones; C116926:rofecoxib; D000077430:Nabumetone