In this double-blind, placebo- and active comparator-controlled, parallel-group study, patients experiencing moderate to severe
pain after the surgical extraction of > or = 2 third molars were randomized to receive a single dose of
rofecoxib 50 mg, 3 doses of enteric-coated
diclofenac sodium 50 mg (50 mg given every 8 hours), or placebo. Patients rated
pain intensity,
pain relief, and global assessments at prespecified times throughout the 24-hour period after initial dosing. Overall
analgesic efficacy was determined by total
pain relief over 8 hours (TOPAR8) and 24 hours (TOPAR24) and patient global assessments at 8 and 24 hours. Onset of
analgesic effect was determined by using the 2-stopwatch method for confirmed perceptible
pain relief. Peak
analgesic effect was the maximum
pain relief attained during the first 8 hours. The duration of
analgesic effect was determined by median time to rescue
analgesia use.
RESULTS: A total of 305 patients were randomized to treatment: 121 received
rofecoxib, 121 received
diclofenac sodium, and 63 received placebo. The baseline demographics were similar among the groups. Overall, 61.3% experienced moderate
pain and 38.7% experienced severe
pain; 53.1% were female; and the mean age was 23.4 years. The overall
analgesic efficacy, as assessed by TOPAR8, of a single dose of
rofecoxib 50 mg was significantly greater than a single dose of enteric-coated
diclofenac sodium 50 mg (20.5 vs 8.2) and placebo (20.5 vs 5.9). Patient global assessment at 8 hours was also significantly better for
rofecoxib compared with enteric-coated
diclofenac sodium and placebo. TOPAR24 was significantly greater for a single dose of
rofecoxib 50 mg compared with 3 doses of enteric-coated
diclofenac sodium 50 mg (64.1 vs 25.1) and placebo (64.1 vs 19.2). At 24 hours, the patient global assessment for
rofecoxib was significantly better than that achieved with enteric-coated
diclofenac sodium and placebo. The onset of
analgesic effect was significantly more rapid for
rofecoxib than for enteric-coated
diclofenac sodium and placebo (median times: 31 minutes, >4 hours, and >4 hours, respectively). The peak
analgesic effect was significantly greater for
rofecoxib compared with enteric-coated
diclofenac sodium (3.2 vs 1.5) and placebo (3.2 vs 1.1). The duration of
analgesia was significantly longer for
rofecoxib than enteric-coated
diclofenac sodium (median times: >24 hours vs 1 hour and 37 minutes) and placebo (>24 hours vs 1 hour and 37 minutes). Enteric-coated
diclofenac sodium was numerically greater than placebo for the key end points measuring overall efficacy (total
pain relief and patient global assessment), but
diclofenac sodium did not provide as much
analgesic effect as expected for a drug effective for
pain,
osteoarthritis, and
rheumatoid arthritis and did not differ significantly from placebo. Overall, both
rofecoxib and enteric-coated
diclofenac sodium were generally well tolerated, although the
rofecoxib group had a significantly lower incidence of clinical and drug-related adverse events than the enteric-coated
diclofenac sodium group.
CONCLUSIONS: