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Efficacy and Safety of Methylnaltrexone for Opioid-Induced Constipation in Patients With Chronic Noncancer Pain: A Placebo Crossover Analysis.

AbstractBACKGROUND AND OBJECTIVES:
In patients with chronic noncancer pain, subcutaneous methylnaltrexone for opioid-induced constipation (OIC) was examined in a randomized controlled trial (RCT) followed by an open-label extension (OLE). This study examined the reproducibility of RCT findings by analyzing data from placebo-treated patients who crossed over to methylnaltrexone.
METHODS:
Adults with less than 3 weekly rescue-free bowel movements (RFBMs), taking 50 mg or more of an oral morphine equivalent per day, were randomized to receive methylnaltrexone 12 mg or placebo for 4 weeks, followed by open-label methylnaltrexone 12 mg as needed for 8 weeks.
RESULTS:
A total of 134 placebo-treated patients (median morphine equivalent dose, 150 mg/d; mean of 1.1 RFBM per week) crossed over to methylnaltrexone in OLE. During the RCT, 9.7% of placebo-treated patients experienced an RFBM within 4 hours of first dose and 9.0% of all placebo injections resulted in an RFBM within 4 hours compared with 45.9% and 34.5%, respectively, with methylnaltrexone treatment in the OLE. When expressed as percentage of patients experiencing 3 or more RFBMs per week and a 1-RFBM increase over baseline, weekly values ranged from 35% to 40% during placebo treatment; at week 5 of OLE methylnaltrexone, this percentage increased to more than 70% and remained relatively stable throughout the OLE. The most common adverse events during methylnaltrexone treatment were abdominal pain (9.7% vs 1.5% for placebo) and nausea (5.2% vs 6.7%).
CONCLUSIONS:
Findings during placebo treatment further establish the profile of OIC and support that little or no gastrointestinal tolerance develops across time. Findings under open-label conditions established the reproducibility and durability of methylnaltrexone for OIC.
AuthorsEugene R Viscusi, Andrew C Barrett, Craig Paterson, William P Forbes
JournalRegional anesthesia and pain medicine (Reg Anesth Pain Med) 2016 Jan-Feb Vol. 41 Issue 1 Pg. 93-8 ISSN: 1532-8651 [Electronic] England
PMID26650429 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Analgesics, Opioid
  • Narcotic Antagonists
  • Quaternary Ammonium Compounds
  • methylnaltrexone
  • Naltrexone
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Analgesics, Opioid (adverse effects)
  • Chronic Pain (diagnosis, drug therapy)
  • Constipation (chemically induced, diagnosis, drug therapy)
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Naltrexone (analogs & derivatives, therapeutic use)
  • Narcotic Antagonists (therapeutic use)
  • Quaternary Ammonium Compounds (therapeutic use)
  • Treatment Outcome
  • Young Adult

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