Slatkin, N.E., Rhiner, M.I., Gould, E.M., Ma, T., & Ahdieh, H. (2010). Long-term tolerability and effectiveness of oxymorphone extended release in patients with cancer. Journal of Opioid Management, 6(3), 181–191.

DOI Link

Study Purpose

To evaluate the long-term safety, tolerability, and effectiveness of oxymorphone, extended release (ER), used to relieve cancer-related pain

Intervention Characteristics/Basic Study Process

Patients who had been taking oxymorphone ER in a previous study continued the dose they had been taking. Patients who had been taking a comparator opioid switched to an equianalgesic dose of oxymorphone ER. All patients underwent individualized dose titration to optimize effectiveness and tolerability of the opioid.

Sample Characteristics

  • The sample was composed of 26 patients.
  • Mean patient age was 57 years.
  • Of all patients, 51.2% were females and 48.8% were males. All patients had cancer pain.

Setting

Multisite

Study Design

Post-hoc analysis of two open-label extension studies, each at least one year long

Measurement Instruments/Methods

  • Visual analog scale (VAS), 100 mm, to measure pain
  • Brief Pain Inventory-Short Form (BPI-SF)
  • Global assessment of study medication (1 = poor, 5 = excellent)

Results

Of the 80 patients who entered the extension trial, 26 completed all 52 weeks. Seven patients discontinued the trial because of loss of medication effectiveness; 20 discontinued because of adverse events, most of which were unrelated to the study drug. Authors observed no significant increase in average pain intensity. The most common adverse events were concomitant disease progression (which 28.8% of patients experienced, n = 23), nausea (22.5%, n = 18), dyspnea (16.3%, n = 13), fatigue (16.3%, n = 13), and edema of the lower limb (15%, n = 12).

Conclusions

Patients appear to tolerate oxymorphone ER well. Oxymorphone ER provided stable long-term pain control, making it a potential alternative in the management of long-term pain.

Limitations

  • The study had a small sample, with fewer than 30 patients.
  • The pooled extension trials had different designs and assessed effectiveness using different outcome measures and assessment intervals. The trials lacked diary data to confirm exposure to oxymorphone ER.

Nursing Implications

In this study oxymorphone ER was a well-tolerated opioid that provided long-term control of cancer-related pain. In appropriate contexts, clinicians may want to consider oxymorphone ER an alternative to standard medication.