PMID- 15767827 OWN - NLM STAT- MEDLINE DCOM- 20050708 LR - 20220317 IS - 1075-2765 (Print) IS - 1075-2765 (Linking) VI - 12 IP - 2 DP - 2005 Mar-Apr TI - Safety, tolerability, and effectiveness of oxymorphone extended release for moderate to severe osteoarthritis pain: a one-year study. PG - 106-12 AB - A 52-week, multicenter, open-label extension study was performed to evaluate the safety, tolerability, and effectiveness of oxymorphone extended release (ER), a novel tablet formulation of oxymorphone hydrochloride, in 153 patients with moderate to severe chronic osteoarthritis-related pain. Sixty-one patients (39.9%) completed the study. Common opioid-related nonserious adverse events (AEs) caused most withdrawals. However, approximately one-half of withdrawals due to AEs were among opioid-naive patients who received placebo in a previous trial and were started on a dose of 20 mg every 12 hours, suggesting that tolerability can be improved by titrating from a lower initial dose. Mean pain scores initially decreased as previously opioid-naive patients achieved adequate pain relief, reached stable levels after the first 6 weeks, and remained stable at mild levels throughout the remainder of the study (average pain, 20-25 mm on 100-mm Visual Analog Scale). Average daily dosing remained stable throughout the study (median, 40 mg/d). At each assessment, at least 80% of patients rated their global satisfaction with oxymorphone ER as "excellent," "very good," or "good." Oxymorphone ER provides a new 12-hour analgesic for the treatment of moderate to severe chronic osteoarthritis-related pain in patients who may require long-term opioid therapy. FAU - McIlwain, Harris AU - McIlwain H AD - Tampa Medical Group Research, 4700 N. Habana Avenue, Suite 303, Tampa, FL 33614, USA. hmcil@aol.com FAU - Ahdieh, Harry AU - Ahdieh H LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - Am J Ther JT - American journal of therapeutics JID - 9441347 RN - 0 (Analgesics, Opioid) RN - 0 (Delayed-Action Preparations) RN - 9VXA968E0C (Oxymorphone) SB - IM MH - Analgesics, Opioid/administration & dosage/adverse effects/*therapeutic use MH - Chronic Disease MH - Delayed-Action Preparations MH - Female MH - Humans MH - Male MH - Middle Aged MH - Osteoarthritis/*complications MH - Oxymorphone/administration & dosage/adverse effects/*therapeutic use MH - Pain/*drug therapy/etiology MH - Pain Measurement EDAT- 2005/03/16 09:00 MHDA- 2005/07/09 09:00 CRDT- 2005/03/16 09:00 PHST- 2005/03/16 09:00 [pubmed] PHST- 2005/07/09 09:00 [medline] PHST- 2005/03/16 09:00 [entrez] AID - 00045391-200503000-00002 [pii] AID - 10.1097/01.mjt.0000139442.65914.f9 [doi] PST - ppublish SO - Am J Ther. 2005 Mar-Apr;12(2):106-12. doi: 10.1097/01.mjt.0000139442.65914.f9.