PR_196: Treatment of Chronic Nonmalignant Pain With Polymer-Coated Extended-Release Morphine Sulfate Capsules in Patients Transitioned From Other Sustained-Release Opioids

Abstract

Objective: To assess the effectiveness of polymer-coated extended-release morphine sulfate (morphine sulfate ER) in treating chronic, moderate-to-severe, nonmalignant pain when initiated twice daily in patients with a mean 10-year history of chronic pain. Design: Prospective, open-label, 3 months. Setting: Single-investigator physical medicine and rehabilitation practice. Participants: Patients had chronic, moderate-to-severe, nonmalignant pain requiring treatment with any sustained-release opioid at a stable daily dose. Interventions: Morphine sulfate ER (Kadian formulation) was initiated twice daily, with doses based on prior medication. Dose adjustments were made at the investigator’s discretion. Main Outcome Measures: Numeric rating scales based on Brief Pain Inventory (range, 0 [no pain] to 10 [worst pain]) for worst, least, average, and current pain since last report, and patient satisfaction score (−4 to +4) were assessed monthly. Results: Patients (safety population, n=129; intent-to-treat [ITT] population, n=121) had a mean age of 47 years and a mean pain duration of 10 years. They had been taking other sustained-release opioids for a mean duration of 1 year. Significant changes were seen in all 4 pain assessments and the patient satisfaction score by the 1-month visit through the 3-month visit (P<.001 vs baseline, all scales, ITT population). From baseline to study completion, pain scores improved as follows: worst pain, 8.1±1.3 to 6.1±1.9; least pain, 5.4±1.8 to 3.1±2.1; average pain, 6.9±1.3 to 4.4±2.0; and current pain, 7.1±1.7 to 4.3±2.4 (all P<.001 vs baseline). The changes were ≥2 scale points, considered clinically important. At baseline, mean patient satisfaction with prior medication was 0.7±1.8; at study conclusion, the score with morphine sulfate ER increased to 2.4±1.9 (P<.001). The most common adverse events (safety population) were constipation and nausea (both 3.9%). Conclusions: Patients with a mean 10-year history of chronic, moderate-to-severe, nonmalignant pain attained significant reductions in pain scores and reported increased satisfaction after transitioning from other sustained-release opioids to morphine sulfate ER.