Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine for the treatment of chronic low back pain: results of a 12 week prospective, randomized, open-label blinded endpoint streamlined study with prolonged-release preparations
| Autor: | Gerhard Hh Mueller-Schwefe, Michael A Ueberall |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male Analgesic Young Adult Germany Naloxone medicine Humans Prospective Studies Aged Oxycodone/naloxone Morphine business.industry Chronic pain General Medicine Middle Aged medicine.disease Analgesics Opioid Drug Combinations Tolerability Opioid Delayed-Action Preparations Anesthesia Female business Constipation Low Back Pain Oxycodone medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 31:1413-1429 |
| ISSN: | 1473-4877 0300-7995 |
| DOI: | 10.1185/03007995.2015.1047747 |
| Popis: | Opioid-induced constipation (OIC) is the most prevalent patient complaint associated with opioid use and interferes with analgesic efficacy.This PROBE trial compares the overall safety and tolerability of oxycodone/naloxone (OXN) with those of traditional opioid therapy with oxycodone (OXY) or morphine (MOR) in the setting of the German healthcare system.This was a prospective, randomized, open-label, blinded endpoint (PROBE) streamlined study (German pain study registry: 2012-0012-05; EudraCT: 2012-001317-16), carried out in 88 centers in Germany, where a total of 453 patients, requiring WHO step III opioids to treat low back pain, were randomized to OXN, OXY or MOR (1:1:1) for 3 months. The primary outcome was the percentage of patients without adverse event-related study discontinuations who presented with a combination of a ≥50% improvement of pain intensity, disability and quality-of-life and a ≤50% worsening of bowel function at study end.Significantly more OXN patients met the primary endpoint (22.2%) vs. OXY (9.3%; OR: 2.80; p0.001) vs. MOR (6.3%; OR: 4.23; p0.001), with insignificant differences between OXY vs. MOR (p = 0.155). A ≥50% improvement of pain intensity, functional disability and quality-of-life has been found for OXN in 75.0/61.1/66.0% of patients and thus for all parameters significantly more than with OXY (58.9/49.0/48.3; p0.001 for each) or MOR (52.5/46.2/37.3; p0.001 for each). A total of 86.8% of OXN patients kept normal BFI scores during treatment, vs. 63.6% for OXY (p0.001) vs. 53.8% for MOR (p0.001). Overall 189 TEAEs (OXN: 45, OXY: 69, MOR: 75) in 92 patients (OXN: 21, OXY: 44, MOR: 37) occurred, most gastrointestinal (50.8%). One limitation is the open-label design, which presents the possibility of interpretive bias.Under the conditions of this PROBE design, OXN was associated with a significantly better tolerability, a lower risk of OIC and a significantly better analgesic efficacy than OXY or MOR. |
| Databáze: | OpenAIRE |
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