Efficacy and Safety of a Once-Daily Morphine Formulation in Chronic, Moderate-to-Severe Osteoarthritis Pain

Caldwell, Jacques R.; Rapoport, Ronald J.; Davis, J.; Offenberg, Howard L.; Marker, Howard W.; Roth, Sanford H.; Yuan, William; Eliot, Lise; Babul, Najib; Lynch, Pia Mikkelsen

doi:10.1016/s0885-3924(02)00383-4

Cited by 197 publications

(14 citation statements)

References 27 publications

(32 reference statements)

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“…The overall rates appear toward the higher range of discontinuation rates of 38%–63% observed in other studies using opioid therapy over a 2–6-month period for management of chronic, moderate-to-severe pain,16,23,25–28 possibly due to the amount and types of monitoring required of patients. The discontinuation rates due to adverse events and treatment failure were similar to those reported in other studies 16,23,25–28. Unlike other studies, this study required that patients identified at high risk for opioid abuse be withdrawn.…”

Section: Discussionmentioning

confidence: 69%

“…The current multicenter, uncontrolled, open-label study,14 conducted in the primary care setting among a broad geographically distributed population, evaluated the effectiveness and tolerability of morphine sulfate extended-release capsules (Avinza ® , King Pharmaceuticals Inc, Bristol, TN, acquired by Pfizer Inc in March 2011) in patients with chronic, moderate-to-severe pain 15. Effectiveness, an evaluation of treatment under real-world conditions,16,17 was based on pain and functional assessments. This study was also designed to assess risk of opioid misuse and abuse, and the utility of a universal precautions approach in the primary care setting.…”

Section: Introductionmentioning

confidence: 99%

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

Brown

Setnik

Lee³

et al. 2011

JPR

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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.

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Section: Discussionmentioning

confidence: 69%

Section: Introductionmentioning

confidence: 99%

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

Brown

Setnik

Lee³

et al. 2011

JPR

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“…The efficacy of morphine in this OA model is in accordance with previous studies [11,15,27] where similar doses of morphine had anti-nociceptive effects demonstrated by WB changes. In a human study, morphine was efficacious in reducing pain in patients with moderate-to-severe OA [28]. The demonstrated antinociceptive effect of morphine provides support for the endpoint of unrestricted WB as a reliable method to evaluate MIA-induced pain.…”

Section: Morphinementioning

confidence: 83%

Unrestricted Weight Bearing as a Method for Assessment of Nociceptive Behavior in a Model of Tibiofemoral Osteoarthritis in Rats

Gregersen¹,

Røsland²,

Arendt-Nielsen³

et al. 2013

JBBS

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Background: Novel preclinical models for prediction of osteoarthritis-like pain are necessary for the elucidation of osteoarthritis (OA) pathology and for assessment of novel analgesics. A widely used behavioral test in rat models of tibiofemoral OA is hind limb weight bearing (WB). However, this method evaluates WB in an unnaturally restricted manner. The aim of this study was therefore to characterize the Tekscan Pressure Measurement System as a means to assess OA-like tibiofemoral pain in rats by determination of plantar pressure distribution in a more natural and unrestricted position, defined as unrestricted WB. Methods: Intra-articular injections of 1 mg monosodium iodoacetate (MIA) or saline were administrated in the left hind knee of 84 male Sprague Dawley rats. Changes in unrestricted WB between ipsilateral and contralateral hindlimbs were determined. Morphine (5 mg/kg administered subcutaneously) and naproxen (60 mg/kg per-oral) were examined for their ability to reverse WB changes. Results: Changes in hind limb unrestricted WB were observed 14 (P < 0.05), 21 (P < 0.001) and 28 (P < 0.001) days post intra-articular injections of MIA compared to control. These alterations were attenuated by morphine 1 hour post administration compared to baseline but were not affected by naproxen. Conclusion: This study indicated that unrestricted WB assessed by the Tekscan system can be utilized as a clinically relevant method to assess aberrations in WB induced by intra-articular MIA injections in rodents. Therefore, this system may be useful for understanding the mechanisms of OA pain in humans and may also assist in the discovery of novel pharmacological agents.

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“…The characteristics of each included study are summarized in the Supplementary material. 1–49–1214–1618–232730–3537–4854–5861656770–7275 The frequency of the different types of study design (for the purposes of analysis), control group (controlled studies only), and opioid type along with the quality of the included articles in terms of Jadad score is given for the ‘rescue’ and ‘no rescue’ studies and overall in Table 1. The maximum time of treatment was 2 yr.…”

Section: Resultsmentioning

confidence: 99%

Impact of opioid rescue medication for breakthrough pain on the efficacy and tolerability of long-acting opioids in patients with chronic non-malignant pain

Devulder

Jacobs²,

Richarz

et al. 2009

British Journal of Anaesthesia

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BackgroundThere is little evidence that short-acting opioids as rescue medication for breakthrough pain is an optimal long-term treatment strategy in chronic non-malignant pain. We compared clinical studies of long-acting opioids that allowed short-acting opioid rescue medication with those that did not, to determine the impact of opioid rescue medication use on the analgesic efficacy and tolerability of chronic opioid therapy in patients with chronic non-malignant pain.MethodsWe searched MEDLINE (1950 to July 2006) and EMBASE (1974 to July 2006) using terms for chronic non-malignant pain and long-acting opioids. Independent review of the search results identified 48 studies that met the study selection criteria. The effect of opioid rescue medication on analgesic efficacy and the incidence of common opioid-related side-effects were analysed using meta-regression.ResultsAfter adjusting for potentially confounding variables (study design and type of opioid), the difference in analgesic efficacy between the ‘rescue’ and the ‘no rescue’ studies was not significant, with regression coefficients close to 0 and 95% confidence intervals that excluded an effect of more than 18 points on a 0–100 scale in each case. There was also no significant difference between the ‘rescue’ and the ‘no rescue’ studies for the incidence of nausea, constipation, or somnolence in both the unadjusted and the adjusted analyses.ConclusionsWe found no evidence that rescue medication with short-acting opioids for breakthrough pain affects analgesic efficacy of long-acting opioids or the incidence of common opioid-related side-effects among chronic non-malignant pain patients.

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Efficacy and Safety of a Once-Daily Morphine Formulation in Chronic, Moderate-to-Severe Osteoarthritis Pain

Cited by 197 publications

References 27 publications

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

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

Unrestricted Weight Bearing as a Method for Assessment of Nociceptive Behavior in a Model of Tibiofemoral Osteoarthritis in Rats

Impact of opioid rescue medication for breakthrough pain on the efficacy and tolerability of long-acting opioids in patients with chronic non-malignant pain

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