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Long-term tolerability and effectiveness of oxymorphone extended release in patients with cancer.

AbstractOBJECTIVE:
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.
AuthorsNeal E Slatkin, Michelle I Rhiner, Errol M Gould, Tina Ma, Harry Ahdieh
JournalJournal of opioid management (J Opioid Manag) 2010 May-Jun Vol. 6 Issue 3 Pg. 181-91 ISSN: 1551-7489 [Print] United States
PMID20642247 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Analgesics, Opioid
  • Delayed-Action Preparations
  • Oxymorphone
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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