PMID- 21477658 OWN - NLM STAT- MEDLINE DCOM- 20120105 LR - 20220408 IS - 1522-9653 (Electronic) IS - 1063-4584 (Linking) VI - 19 IP - 8 DP - 2011 Aug TI - Transdermal buprenorphine plus oral paracetamol vs an oral codeine-paracetamol combination for osteoarthritis of hip and/or knee: a randomised trial. PG - 930-8 LID - 10.1016/j.joca.2011.03.011 [doi] AB - OBJECTIVE: Low-dose transdermal opioids offer a new therapeutic option for osteoarthritis (OA). This study compared symptom relief obtained with buprenorphine patches plus oral paracetamol with that obtained with an oral codeine-paracetamol combination tablet (co-codamol) in older adults with OA. METHOD: Two hundred and twenty people (aged >/=60 years) with OA hip and/or knee pain were randomised to treatment with 7-day buprenorphine patches plus oral paracetamol (5-25 mug/h buprenorphine patches plus 1000 mg oral paracetamol q.i.d. (4 times daily); n=110) or co-codamol tablets (two 8/500-two 30/500 mg tablets q.i.d.; n=110). They entered a titration period of up to 10 weeks, during which their dose of study medication was adjusted until they reached optimum pain control. Patients who achieved optimum pain control entered a 12-week assessment period. The primary outcome was average daily pain scores recorded using the box scale-11 (BS-11) pain scale. RESULTS: Both treatments significantly reduced patient pain scores. The estimated treatment difference [95% confidence interval (CI)] was -0.02 (-0.64, 0.60) for the per protocol (PP) population. The results were similar for the full analysis population. Patients receiving 7-day buprenorphine patches plus oral paracetamol needed significantly less escape medication (ibuprofen) than those receiving co-codamol tablets (P=0.002; PP population). Less than 10% of patients in the 7-day buprenorphine patches plus oral paracetamol group were receiving the highest dose level at the end of the study, compared with 34% in the co-codamol group. Withdrawal rates were high in both groups. The incidence of adverse events (AEs) was comparable between the groups (86.4% of patients in the 7-day buprenorphine patches plus oral paracetamol group; 81.7% in the co-codamol group). Six serious AEs were reported in three patients (2.7%) in the 7-day buprenorphine patches plus oral paracetamol group and one (0.9%) in the co-codamol group. CONCLUSIONS: 7-day buprenorphine patches plus oral paracetamol were non-inferior to co-codamol tablets with respect to analgesic efficacy in older adults with OA pain in the hip/knee. CI - Copyright (c) 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved. FAU - Conaghan, P G AU - Conaghan PG AD - Section of Musculoskeletal Disease, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK. p.conaghan@leeds.ac.uk FAU - O'Brien, C M AU - O'Brien CM FAU - Wilson, M AU - Wilson M FAU - Schofield, J P AU - Schofield JP LA - eng SI - ClinicalTrials.gov/NCT00324038 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110406 PL - England TA - Osteoarthritis Cartilage JT - Osteoarthritis and cartilage JID - 9305697 RN - 0 (Analgesics) RN - 0 (Analgesics, Non-Narcotic) RN - 0 (Analgesics, Opioid) RN - 0 (Drug Combinations) RN - 0 (acetaminophen, codeine drug combination) RN - 362O9ITL9D (Acetaminophen) RN - 40D3SCR4GZ (Buprenorphine) RN - UX6OWY2V7J (Codeine) SB - IM CIN - Osteoarthritis Cartilage. 2012 Apr;20(4):336; author reply 337-8. PMID: 22285736 MH - Acetaminophen/*administration & dosage MH - Administration, Cutaneous MH - Administration, Oral MH - Aged MH - Aged, 80 and over MH - Analgesics/*administration & dosage MH - Analgesics, Non-Narcotic/administration & dosage MH - Analgesics, Opioid/administration & dosage MH - Buprenorphine/*administration & dosage MH - Codeine/*administration & dosage MH - Drug Administration Schedule MH - Drug Combinations MH - Drug Therapy, Combination MH - Female MH - Humans MH - Male MH - Middle Aged MH - Osteoarthritis, Hip/*drug therapy MH - Osteoarthritis, Knee/*drug therapy MH - Pain Measurement MH - Treatment Outcome EDAT- 2011/04/12 06:00 MHDA- 2012/01/06 06:00 CRDT- 2011/04/12 06:00 PHST- 2010/09/21 00:00 [received] PHST- 2011/02/17 00:00 [revised] PHST- 2011/03/28 00:00 [accepted] PHST- 2011/04/12 06:00 [entrez] PHST- 2011/04/12 06:00 [pubmed] PHST- 2012/01/06 06:00 [medline] AID - S1063-4584(11)00107-5 [pii] AID - 10.1016/j.joca.2011.03.011 [doi] PST - ppublish SO - Osteoarthritis Cartilage. 2011 Aug;19(8):930-8. doi: 10.1016/j.joca.2011.03.011. Epub 2011 Apr 6.