Development of opioid-induced constipation: post hoc analysis of data from a 12-week prospective, open-label, blinded-endpoint streamlined study in low-back pain patients treated with prolonged-release WHO step III opioids
| Autor: | Michael A Ueberall, Gerhard Hh Mueller-Schwefe |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
bowel function
medicine.medical_specialty Constipation business.industry Analgesic Chronic pain medicine.disease Surgery Anesthesiology and Pain Medicine Tolerability Opioid quality of life Anesthesia Clinical endpoint Medicine media_common.cataloged_instance Journal of Pain Research European union medicine.symptom business chronic pain Oxycodone media_common medicine.drug Original Research |
| Zdroj: | Journal of Pain Research |
| ISSN: | 1178-7090 |
| Popis: | Michael A Ueberall,1 Gerhard HH Mueller-Schwefe2 1Institute for Neurological Sciences, Nuremberg, Germany; 2Interdisciplinary Center for Pain and Palliative Care Medicine, Göppingen, Germany Background: Opioid-induced constipation is the most prevalent patient complaint associated with longer-term opioid use and interferes with analgesic efficacy, functionality, quality of life, and patient compliance.Objectives: We aimed to compare the effects of prolonged-release (PR) oxycodone plus PR naloxone (OXN) vs PR oxycodone (OXY) vs PR morphine (MOR) on bowel function under real-life conditions in chronic low-back pain patients refractory to World Health Organization (WHO) step I and/or II analgesics.Research design and methods: This was a post hoc analysis of the complete data set from a prospective, randomized, open-label, blinded endpoint (PROBE) streamlined study (German pain study registry: 2012-0012-05; European Union Drug Regulating Authorities Clinical Trials [EudraCT]: 2012-001317-16), carried out in 88 centers in Germany, where a total of 901 patients requiring WHO step III opioids to treat low-back pain were enrolled and prospectively observed for 3 months. Opioid allocation was based on either optional randomization (n=453) or physician decision (n=448). In both groups, treatment doses could be adjusted as per the German prescribing information, and physicians were free to address all side effects and tolerability issues as usual. The primary endpoint was the proportion of patients maintaining normal bowel function throughout the complete treatment period, assessed with the Bowel Function Index (BFI). Secondary analyses addressed absolute and relative BFI changes, complete spontaneous bowel movements, use of laxatives, treatment emergent adverse events, analgesic effects, and differences between randomized vs nonrandomized patient groups.Results: BFI changed significantly with all three WHO step III treatments, however significantly less with OXN vs OXY and MOR despite a significantly higher use of laxatives with the latter ones (P |
| Databáze: | OpenAIRE |
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