Efficacy and safety of rofecoxib 12.5 mg versus nabumetone 1,000 mg in patients with osteoarthritis of the knee: a randomized controlled trial.
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.
Kivitz
Alan J
AJ
Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.
Greenwald
Maria W
MW
Cohen
Stanley B
SB
Polis
Adam B
AB
Najarian
Daryl K
DK
Dixon
Mary E
ME
Moidel
Robert A
RA
Green
Jerry A
JA
Baraf
Herbert S B
HS
Petruschke
Richard A
RA
Matsumoto
Alan K
AK
Geba
Gregory P
GP
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
D000894:Anti-Inflammatory Agents, Non-Steroidal; D002074:Butanones; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D010919:Placebos; D013450:Sulfones; C116926:rofecoxib; D000077430:Nabumetone