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

• Published in: Journal of pain research Vol. 4; no. default; pp. 373 - 384
• Main Authors: Brown, James, Setnik, Beatrice, Lee, Keung, Cleveland, Jody M, Roland, Carl L, Wase, Linda, Webster, Lynn
• Format: Journal Article
• Language: English
• Published: New Zealand Taylor & Francis Ltd 2011; Dove Press; Dove Medical Press
• Subjects: analgesics; Narcotics; opioids; Original Research; Pain; pain assessment; Primary care; substance abuse; universal precautions; pain assessment; primary care; universal precautions; analgesics; substance abuse; opioids
• ISSN: 1178-7090; 1178-7090
• DOI: 10.2147/JPR.S23024

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. 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 extendedrelease 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. 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and -1.7 ± 2.2 at visits 3 and 4 (spaced 3-4 weeks apart), respectively, and -1.1 ± 2.4 at visit 5 (included patients withdrawn from the study who were no longer taking the study drug).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%). 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.