Effectiveness and safety of morphine sulfate extended-release capsules in patients with chronic, moderate-to-severe pain in a primary care setting

Abstract

James Brown1, Beatrice Setnik2, Keung Lee3, Jody M Cleveland2, Carl L Roland2, Linda Wase4, Lynn Webster5 1Jena Medical, Ormond Beach, FL; 2Pfizer Inc, Cary, NC; 3Randolph Medical Associates, Asheboro, NC; 4Archimedes Pharma US Inc, Bedminster, NJ; 5Lifetree Clinical Research, Salt Lake City, UT, USA Background: The purpose of this study was to determine the effectiveness and safety of morphine sulfate extended-release capsules among primary care patients with chronic, moderate-to-severe pain using a universal precautions approach that assessed and monitored risk for opioid misuse and abuse. Methods: This open-label, uncontrolled, multicenter, prospective study was conducted in primary care centers (n = 281) and included opioid-naïve and opioid-experienced patients with either a pain score ≥4 (0 = no pain, 10 = pain as bad as you can imagine), or with unacceptable side effects while taking opioids. The patients were treated with morphine sulfate extended-release capsules for up to four months. Patient-rated pain intensity (worst, least, average) over the past 24 hours (0–10 scale), pain interference with seven activities of daily living (0 = no interference, 10 = completely interferes), and adverse events were recorded. Results: Of 1487 patients who filled at least one prescription, 561 (38%) completed the study. Patients were primarily white (87%) and female (57%); 92% had pain for more than one year; and 79% were opioid-experienced. Median age was 52 years. Decreases in mean (± standard deviation) average pain scores (baseline 6.2 ± 2.3) were -0.8 ± 2.2 at visit 2 (5–14 days later), and -1.6 ± 2.3 and -1.7 ± 2.2 at visits 3 and 4 (spaced 3–4 weeks apart), respectively, and -1.1 ± 2.4 at visit 5 (included patients withdrawn from the study who were no longer taking the study drug). A similar trend was observed for worst pain and least pain scores and for pain interference with activities. Fifty-one percent of the safety population patients and 81% in the completer population reported being satisfied or very satisfied with the study treatment. Most common adverse events were typical of opioids, ie, constipation (14%), nausea (11%), vomiting (5%), and somnolence (5%). Conclusion: The results suggest that pain outcomes improved in patients with chronic, moderate-to-severe pain receiving morphine sulfate extended-release capsules within the context of a structured universal precautions approach in the primary care setting. Keywords: opioids, analgesics, primary care, pain assessment, substance abuse, universal precautions