Abstract | OBJECTIVE: 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.
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Authors | Neal E Slatkin, Michelle I Rhiner, Errol M Gould, Tina Ma, Harry Ahdieh |
Journal | Journal of opioid management
(J Opioid Manag)
2010 May-Jun
Vol. 6
Issue 3
Pg. 181-91
ISSN: 1551-7489 [Print] United States |
PMID | 20642247
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Analgesics, Opioid
- Delayed-Action Preparations
- Oxymorphone
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Analgesics, Opioid
(therapeutic use)
- Delayed-Action Preparations
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Neoplasms
(physiopathology)
- Oxymorphone
(administration & dosage, adverse effects, therapeutic use)
- Pain, Intractable
(drug therapy)
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