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A phase III randomized controlled study on the efficacy and improved bowel function of prolonged‐release (PR) oxycodone‐naloxone (up to 160/80 mg daily) vs oxycodone PR
Author(s) -
Dupoiron D.,
Stachowiak A.,
Loewenstein O.,
Ellery A.,
Kremers W.,
Bosse B.,
Hopp M.
Publication year - 2017
Publication title -
european journal of pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.305
H-Index - 109
eISSN - 1532-2149
pISSN - 1090-3801
DOI - 10.1002/ejp.1054
Subject(s) - medicine , oxycodone , tolerability , laxative , anesthesia , analgesic , opioid , constipation , randomized controlled trial , adverse effect , receptor
Background Oxycodone/naloxone ( OXN PR ) is a prolonged‐release formulation containing oxycodone and naloxone in a 2:1 ratio. This study aimed to evaluate the tolerability and efficacy of doses up to OXN 160/80 mg PR compared with oxycodone prolonged‐release formulation (Oxy PR ) in a randomised controlled trial. Methods Two hundred and forty‐three patients were randomised to treatment with OXN PR ( n = 123) or Oxy PR ( n = 120) during the 5‐week double‐blind study. Measured were: opioid‐induced constipation [bowel function index score ( BFI )]; analgesic efficacy ( NRS 0–10); daily laxative rescue medication use; rescue medication use, and the number of complete spontaneous bowel movements ( CSBM s) per week. A subanalysis was conducted in cancer patients. Results Greater reductions in mean BFI scores were reported for the OXN PR group compared with Oxy PR from Week 1 onwards; at Week 5 the mean change from baseline was −32.5 versus −14.2. Average 24‐h pain scores were low and remained stable in the range 3–4 in both treatment groups. Analgesic rescue medication use was similar between the groups. Patients receiving OXN PR used significantly lower mean daily doses of laxative rescue medication than those receiving Oxy PR ( P = 0.006). The number of CSBM in the OXN PR group approximately doubled compared with a 25% decrease in the Oxy PR group. Comparable results to the total study population were reported in the cancer patient subgroup. Conclusions OXN PR in daily doses of up to 160/80 mg significantly improves bowel function compared with equivalent doses of Oxy PR while still providing comparable analgesic efficacy. Significance Effective analgesia can be achieved using oxycodone/naloxone PR up to 160/80 mg daily without compromising bowel function. A similar outcome was reported in cancer and non‐cancer patients.