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

Abstract

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and −1.7 ± 2.2 at visits 3 and 4 (spaced 3–4 weeks apart), respectively, and −1.1 ± 2.4 at visit 5 (included patients withdrawn from the study who were no longer taking the study drug).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

A multicenter, primary-care-based, open-label study to assess the success of converting opioid-experienced patients with chronic moderate-to-severe pain to morphine sulfate and naltrexone hydrochloride extended-release capsules using a standardized conversion guide

“… 12 , 18 – 20 Gastrointestinal side effects such as constipation and nausea observed in the present study are consistent with those previously described for MSN 12 , 18 – 20 and those commonly observed during ER morphine sulfate therapy. 38 Specifically, the rate of TEAEs resulting in discontinuation in the present study (22.4%) was consistent with that described by Katz et al 18 (n=130/547; 23.8%) and Webster et al (n=46/197; 23.3%). 12 Brown et al evaluated ER morphine sulfate in both opioid-naïve and opioid-experienced patients in a primary care setting and found TEAEs resulting in discontinuation to be 21%.…”

“… 37 This supports existing data reporting the analgesic efficacy of MSN for chronic moderate-to-severe pain 12 , 18 – 20 and data reporting analgesic efficacy of ER morphine sulfate formulations. 38 Pain scores remained elevated in patients who did not achieve a stable dose, and the magnitude of pain relief experienced by the majority of those who achieved a stable dose was consistent with that previously reported. 12 This suggests that inadequate pain control may be a risk factor for not achieving conversion.…”

“… 12 Brown et al evaluated ER morphine sulfate in both opioid-naïve and opioid-experienced patients in a primary care setting and found TEAEs resulting in discontinuation to be 21%. 38 Similarly, of the discontinuations, commonly reported AEs in the present study versus Katz et al, 18 respectively, were nausea (3.8% vs 4.2%), constipation (3.2% vs 3.7%), vomiting (1.9% vs 2.7%), and somnolence (1.8% vs 2.7%). The majority of AEs were judged mild-to-moderate in both studies.…”

Morphine and Clonidine Synergize to Ameliorate Low Back Pain in Mice

“…Although non-steroidal anti-inflammatory drugs are the first line of defense against LBP, they do not sufficiently treat chronic and severe LBP. Opioids are often prescribed with varying therapeutic outcome [ 1 , 14 , 15 ] and are associated with undesired effects that limit their use, such as constipation, nausea, somnolence, fatigue, and the development of tolerance [ 16 ]. Since opioids such as morphine remain the gold standard of chronic pain treatment, it is vital to investigate strategies that would decrease required doses without diminishing the therapeutic effects.…”