Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients with chronic pain.

Objective: To assess the safety and efficacy of long-term repeated dosing of OROS hydromorphone in chronic pain patients.

Design: This multicenter, open-label extension trial enrolled patients from three short-term OROS hydromorphone trials.

Setting: Fifty-six centers in the United States and Canada.

Patients: Adults with chronic cancer pain or chronic nonmalignant pain who were receiving stable doses of OROS hydromorphone (> or = 8 mg/day). Three hundred and eighty-eight patients were enrolled, 106 patients completed at least 12 months of therapy.

Interventions: OROS hydromorphone (individualized doses) was administered once daily.

Main Outcome Measures: Safety and efficacy (Brief Pain Inventory and patient and investigator global evaluations) were assessed at monthly visits.

Results: The median duration of extended OROS hydromorphone therapy was 274 days. The median daily dose of study medication was 32.0 mg at extension-study baseline, 40.0 mg at month 3, and 48.0 mg at months 6, 9, and 12, respectively. The most frequently reported adverse events were nausea (n = 93, 24.0 percent) and constipation (n = 75, 19.3 percent). The analgesic effects of OROS hydromorphone, assessed using the Brief Pain Inventory, were maintained throughout the extension. At 12 months, 72.4 percent of patients and 75.9 percent of investigators rated overall treatment as good, very good, or excellent.

Conclusions: Once-daily OROS hydromorphone is an osmotically driven, controlled-release preparation that may be particularly well suited to long-term use, because it provides consistent plasma concentrations and sustained around-the-clock analgesia. In this study, the benefits of OROS hydromorphone attained in short-term studies were maintained in the long-term when daily administration was continued.