NSAIDs and acetaminophen: Comparison of analgesic efficacy of rofecoxib 50 mg between patients with moderate pain and severe acute pain

Abstract

Rofecoxib 50 mg is effective in the treatment of acute pain. A recently completed study compared patient responses to rofecoxib (ROF) and multidose oxycodone/acetaminophen (OXY/ACET) using a validated postoperative dental pain model. We further compared the response to ROF treatment between patients with moderate pain and severe pain in this double-blind, randomized control trial. Patients experiencing moderate or severe pain after surgical extraction of at least 2 third molars were randomized to a single dose of ROF 50mg (N=118), OXY/ACET 10/650mg followed by 5/325mg q6hrs PRN (N=122), or placebo (N=30) for 24hrs. Key endpoints were overall analgesic efficacy over 6hrs (TOPAR6) and 24hrs (SPID24). To compare responses to ROF between patients with moderate and severe pain, TOPAR6, SPID24, patient global responders, onset (time to confirmed perceptible pain relief), and duration (time to rescue medication within) were analyzed for consistency of treatment effect by baseline pain intensity subgroups. ROF demonstrated comparable overall efficacy to OXY/ACET on TOPAR6 and SPID24. ROF patients with moderate and severe pain achieved numerically similar responses on TOPAR6 and SPID24, which were comparable to moderate and severe pain subgroup responses with OXY/ACET. Patient global response was also numerically similar between ROF patients with moderate and severe pain at 6hrs (82.4% vs 78.7%) and at 24hrs (84.5% vs 78.7%) with similar treatment effects among the moderate and severe subgroups compared to OXY/ACET. ROF patients in the moderate and severe subgroups achieved pain relief in a similar timeframe (38 vs 39 minutes); the proportion of patients achieving onset was also similar (84.5% vs 80.9%). The duration of analgesia for ROF was >24hrs for both subgroups. Rofecoxib 50 mg has similar analgesic efficacy in patients with severe acute postoperative dental pain and moderate pain, based on overall analgesic effect, onset, and duration.