Treatment of chronic moderate-to-severe non-malignant pain with polymer-coated extended-release morphine sulfate capsules
| Autor: | Gerald Sacks, Bruce Nicholson, John Sasaki, Arnold J. Weil, Edgar L. Ross |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
Adult
Male Polymers Population Pain Capsules Statistics Nonparametric Quality of life Medicine Humans Dosing education Aged Pain Measurement Morphine sulfate Aged 80 and over education.field_of_study Analysis of Variance Chi-Square Distribution Morphine business.industry Chronic pain General Medicine Middle Aged medicine.disease Treatment Outcome Opioid Tolerability Anesthesia Delayed-Action Preparations Chronic Disease Quality of Life Female business Sleep medicine.drug |
| Zdroj: | Current medical research and opinion. 22(3) |
| ISSN: | 0300-7995 |
| Popis: | To demonstrate the efficacy and tolerability of polymer-coated extended-release morphine sulfate (P-ERMS)(KADIAN) for the treatment of chronic, moderate-to-severe, non-malignant pain in a community-based outpatient population not satisfactorily relieved with their current therapies.Phase IV, prospective, randomized, open-label, blinded endpoint.Adults (N = 1428) with chronic, moderate-to-severe, non-malignant pain with visual numeric scale scoresor= 4 (0 = no pain; 10 = worst pain).Patients were randomized to P-ERMS once daily in AM or PM for a 4-week treatment period. Dose increases were allowed; however, switching to twice-daily dosing was reserved until week 2.Improvement from baseline in pain and sleep scales (0-10) (after weeks 2 and 4), quality of life (physical and mental component summary scores of the SF-36v2 Health Survey) (week 4), and patient (weeks 2 and 4) and clinician (week 4) assessments of current therapy (-4 to +4). Patient satisfaction was assessed again 1 month after the study.Approximately 70% of patients completed the study, with 2.4% (n = 34) discontinuing due to lack of efficacy, and 9.6% (n = 136) discontinuing due to an adverse event. Improvements were seen in pain and sleep scores, physical and mental component scores of the SF-36v2, and patient and clinician global assessment scores (p0.0001, all assessments). Patients attained similar results regardless of AM vs. PM dosing. More than half (55.4%) of patients were maintained on once-daily therapy, with the remainder on a twice-daily regimen, in accordance with the prescribing information. Most adverse events (71.6%) were mild to moderate in severity, the most common being constipation (11.6%) and nausea (9.2%). One-month follow-up indicated continued satisfaction with P-ERMS vs. previous medication (p0.0001).P-ERMS was efficacious and well tolerated in patients with chronic, moderate-to-severe, non-malignant pain when used once or twice daily. |
| Databáze: | OpenAIRE |
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