Tapentadol immediate release for moderate to severe acute post-surgery pain.

Abstract

OBJECTIVE\nTo investigate efficacy and tolerability of tapentadol immediate release (IR) in the treatment of moderate to severe acute pain in three surgical pain models.\n\n\nDESIGN\nThree randomized, double-blind, placebo- and active-controlled, multicenter, phase 3 trials were performed in total hip replacement surgery, abdominal hysterectomy, and bunionectomy with trial medications administered every 4-6 hours as needed for up to 72 hours. Tapentadol IR was included in all trials, oxycodone IR in the total hip replacement trial, and morphine IR in the abdominal hysterectomy and bunionectomy trials; active controls ensured assay sensitivity.\n\n\nMAIN OUTCOME MEASURES\nThe primary efficacy endpoint was the sum of pain intensity differences over the first 24 hours of treatment (SPID24) in the abdominal hysterectomy trial and SPID48 in the other two trials. Tolerability was assessed by adverse events reporting.\n\n\nRESULTS\nA total of 330, 832, and 285 patients with total hip replacement, abdominal hysterectomy, and bunionectomy, respectively, were assessed for efficacy. All three trials demonstrated statistically significant improvements of tapentadol IR on the primary endpoint versus placebo and similar improvements compared to morphine IR or oxycodone IR. These findings were consistent with results of total pain relief assessments and patients global impressions of change in their overall health status after 72 hours (abdominal hysterectomy, bunionectomy). The tolerability profile of tapentadol IR was as expected for a centrally acting analgesic in the post-surgery setting.\n\n\nCONCLUSIONS\nTapentadol IR has strong analgesic efficacy and is well tolerated in multiple post-surgery conditions of moderate to severe pain.