title: Tapentadol immediate-release for acute postbunionectomy pain: a phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of tapentadol immediate-release (IR) for treating acute pain following orthopedic bunionectomy surgery in a Taiwanese population.
  
  
  METHODS
  This was a phase 3, randomized, double-blind, placebo-controlled, parallel-group bridging study in which Taiwanese patients (N = 60) with moderate-to-severe pain following bunionectomy were randomized (1:1:1) to receive tapentadol IR 50 or 75 mg or placebo orally every 4-6 hours over a 72 hour period. The primary endpoint was the sum of pain intensity difference over 48 hours (SPID48), analyzed using analysis of variance.
  
  
  RESULTS
  Out of 60 patients randomized (mainly women [96.7%]; median age 44 years), 41 (68.3%) completed the treatment. Mean SPID48 values were significantly higher for tapentadol IR (p ≤ 0.006: 50 mg, p ≤ 0.004: 75 mg) compared with placebo. Between-group differences in LS means of SPID48 (vs. placebo) were tapentadol IR 50 mg: 105.6 (95% CI: 32.0; 179.2); tapentadol IR 75 mg: 126.6 (95% CI: 49.5; 203.7). Secondary endpoints including SPID at 12, 24, and 72 hours, time to first use of rescue medication, cumulative distribution of responder rates, total pain relief and sum of total pain relief and sum of pain intensity difference at 12, 24, 48, and 72 hours, and patient global impression of change showed numerically better results supporting that tapentadol IR (50 and 75 mg) was more efficacious than placebo in relieving acute pain. The most frequent treatment emergent adverse events reported in ≥ 10% patients in either group were dizziness, nausea, and vomiting. A limitation of this study may possibly include more controlled patient monitoring through 4-6 hour dosing intervals, which reflects optimal conditions and thus may not approximate real-world clinical practice. However, all treatment groups would be equally affected by such bias of frequent monitoring, if any, since it was a randomized and double-blind study.
  
  
  CONCLUSIONS
  Tapentadol IR treatment significantly relieved acute postoperative pain and was well tolerated in a Taiwanese population. ClinicalTrials.gov identifier: NCT01813890.
authors: a a Chang Gung University, Chang Gung Memorial Hospital , Linkou Branch , New Taipei , Taiwan.
authors: Yeung-Jen
authors: YJ
authors: Chen
authors: b b Department of Orthopaedics & Traumatology , Taipei Veterans General Hospital , Taipei , Taiwan.|c c Department of Surgery, School of Medicine , National Yang-Ming University , Taipei , Taiwan.
authors: Chao-Ching
authors: CC
authors: Chiang
authors: d d Department of Orthopaedic Surgery , Kaohsiung Medical University Hospital College of Medicine, Kaoshiung Medical University , Kaohsiung City , Taiwan.
authors: Peng-Ju
authors: PJ
authors: Huang
authors: e e Janssen Research & Development LLC , Taiwan.
authors: Jason
authors: J
authors: Huang
authors: f f Janssen Research & Development LLC , NJ , USA.
authors: Keith
authors: K
authors: Karcher
authors: f f Janssen Research & Development LLC , NJ , USA.
authors: Honglan
authors: H
authors: Li
mesh_terms: D059787:Acute Pain / Q000188:drug therapy*; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D019637:Orthopedic Procedures / Q000009:adverse effects; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D010636:Phenols / Q000008:administration & dosage*; D013624:Taiwan; D000077432:Tapentadol; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000701:Analgesics, Opioid; D010636:Phenols; D000077432:Tapentadol
keywords: Acute pain; Analgesic; Bunionectomy; Immediate-release; Phase 3; Tapentadol