PMID- 21823552 OWN - NLM STAT- MEDLINE DCOM- 20110823 LR - 20191112 IS - 1551-7489 (Print) IS - 1551-7489 (Linking) VI - 7 IP - 3 DP - 2011 May-Jun TI - Analgesic and adverse effects of a fixed-ratio morphine-oxycodone combination (MoxDuo) in the treatment of postoperative pain. PG - 217-28 AB - OBJECTIVE: To compare efficacy and safety profiles of an immediate-release morphine and oxycodone Dual-Opioid combination (MoxDuo) versus its individual components and versus its morphine-equivalent doses in moderate to severe postoperative pain patients. DESIGN: Randomized, double-blind, 48-hour, parallel-treatment, multicenter, six-arm study of MoxDuo. SETTING: Six US centers. PATIENTS: Within 6 hours after bunionectomy surgery, patients were eligible if they reported pain intensity > or = 2 on the 4-point Likert scale and > or = 4 on an 11-point Numerical Pain Rating Scale (197 randomly assigned; 175 completers). INTERVENTIONS: MoxDuo 12 mg/8 mg, MoxDuo 6 mg/4 mg, morphine 12 mg, oxycodone 8 mg, morphine 6 mg, or oxycodone 4 mg (all administered q6h). MAIN OUTCOME MEASURE: Sum of pain intensity differences 0-24 hours after the first dose of study medication (SPID24) and percentage of patients with moderate to severe nausea, emesis, or dizziness. RESULTS: SPID24 was significantly better in the MoxDuo 12 mg/8 mg group when compared with its individual components (morphine 12 mg [p = 0.009] and oxycodone 8 mg [p = 0.037]), and when compared with MoxDuo 6 mg/4 mg (p = 0.011; 54.3 vs 28.5, 35.7, and 30.0, respectively). MoxDuo6 mg/4 mg and its morphine-equivalent doses (morphine 12 mg and oxycodone 8 mg) had comparable analgesic effects. There was a 50-75 percent reduction in moderate to severe adverse events (AEs) commonly associated with opioids (ie, nausea, vomiting, and dizziness) in the MoxDuo 6 mg/4 mg group when compared with its morphine-equivalent dose groups. CONCLUSIONS: MoxDuo produced superior analgesic effects when compared with its individual components, but comparable efficacy when compared with its morphine-equivalent doses. Common AEs were reduced at least 50 percent with MoxDuo when compared with its morphine-equivalent doses. MoxDuo may be an improved intervention in the management of moderate to severe acute pain. FAU - Richards, Patricia AU - Richards P AD - QRxPharma, Inc., Clinical Research, Bedminster, New Jersey, USA. FAU - Riff, Dennis AU - Riff D FAU - Kelen, Robin AU - Kelen R FAU - Stern, Warren AU - Stern W CN - MoxDuo Study Team LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Opioid Manag JT - Journal of opioid management JID - 101234523 RN - 0 (Analgesics, Opioid) RN - 0 (Drug Combinations) RN - 76I7G6D29C (Morphine) RN - CD35PMG570 (Oxycodone) SB - IM MH - Adult MH - Analgesics, Opioid/administration & dosage/adverse effects/*therapeutic use MH - Dizziness/chemically induced MH - Double-Blind Method MH - Drug Combinations MH - Female MH - Hallux Valgus/surgery MH - Humans MH - Male MH - Middle Aged MH - Morphine/administration & dosage/adverse effects/*therapeutic use MH - Oxycodone/administration & dosage/adverse effects/*therapeutic use MH - Pain Measurement/drug effects MH - Pain, Postoperative/*drug therapy MH - Postoperative Nausea and Vomiting/epidemiology FIR - Diamond, E IR - Diamond E FIR - Gottlieb, I IR - Gottlieb I FIR - Raymond, G IR - Raymond G FIR - Riff, D IR - Riff D FIR - Seegmiller, D IR - Seegmiller D FIR - Tallis, A IR - Tallis A EDAT- 2011/08/10 06:00 MHDA- 2011/08/24 06:00 CRDT- 2011/08/10 06:00 PHST- 2011/08/10 06:00 [entrez] PHST- 2011/08/10 06:00 [pubmed] PHST- 2011/08/24 06:00 [medline] AID - 10.5055/jom.2011.0064 [doi] PST - ppublish SO - J Opioid Manag. 2011 May-Jun;7(3):217-28. doi: 10.5055/jom.2011.0064.