PMID- 20642247 OWN - NLM STAT- MEDLINE DCOM- 20100810 LR - 20191111 IS - 1551-7489 (Print) IS - 1551-7489 (Linking) VI - 6 IP - 3 DP - 2010 May-Jun TI - Long-term tolerability and effectiveness of oxymorphone extended release in patients with cancer. PG - 181-91 AB - OBJECTIVE: To evaluate the long-term safety, tolerability, and effectiveness of oxymorphone extended release (ER) in patients with cancer-related pain. DESIGN: Post hoc analysis of two-1-year open-label extension studies. SETTING: Multiple US cancer treatment facilities. PATIENTS: Patients with cancer pain who had participated in two short-term crossover comparator trials of oxymorphone ER: one open-label and one double-blind randomized. INTERVENTIONS: Patients who had been taking oxymorphone ER continued the dose established in the previous study. Patients who had been taking a comparator opioid were switched to an equianalgesic dose of oxymorphone ER. All patients underwent individualized oxymorphone ER dose titration to optimize effectiveness and tolerability. ASSESSMENTS: Current, average, worst, and least pain scores were normalized to a 100-point scale. Patients rated treatment on a five-point global assessment of study medication (Poor = 1 to Excellent = 5). All adverse events (AEs) were recorded. RESULTS: Of the 80 patients who entered the extension trials, 26 completed 52 weeks, 7 discontinued owing to loss of effectiveness, and 20 discontinued owing to AEs, most of which were unrelated to study drug. No significant increase in mean (standard deviation [SDD average pain intensity was observed from baseline (30.5 [19.6], 100-point scale) to final visit (35.9 [21.1], p = 0.37). The most common AEs were concomitant disease progression (28.8 percent, n=23), nausea (22.5 percent, n=18), dyspnea (16.3 percent, n=13), fatigue (16.3 percent, n=13), and edema of the lower limb (15 percent, n=12). CONCLUSIONS: In these patients with pain related to cancer, oxymorphone ER was generally well tolerated and provided stable long-term pain control. FAU - Slatkin, Neal E AU - Slatkin NE AD - Department of Supportive Care, Pain & Palliative Medicine, City of Hope Medical Group (California Cancer Specialists Medical Group), Pasadena, California, USA. FAU - Rhiner, Michelle I AU - Rhiner MI FAU - Gould, Errol M AU - Gould EM FAU - Ma, Tina AU - Ma T FAU - Ahdieh, Harry AU - Ahdieh H LA - eng PT - Journal Article 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 (Delayed-Action Preparations) RN - 9VXA968E0C (Oxymorphone) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Analgesics, Opioid/*therapeutic use MH - Delayed-Action Preparations MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Neoplasms/*physiopathology MH - Oxymorphone/administration & dosage/adverse effects/*therapeutic use MH - Pain, Intractable/*drug therapy EDAT- 2010/07/21 06:00 MHDA- 2010/08/11 06:00 CRDT- 2010/07/21 06:00 PHST- 2010/07/21 06:00 [entrez] PHST- 2010/07/21 06:00 [pubmed] PHST- 2010/08/11 06:00 [medline] AID - 10.5055/jom.2010.0016 [doi] PST - ppublish SO - J Opioid Manag. 2010 May-Jun;6(3):181-91. doi: 10.5055/jom.2010.0016.