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| |  Methylnaltrexone for Opioid-Induced Constipation Does Not Adversely Affect Pain, Withdrawal Symptoms: Presented at AAPM By Jennifer Reising SAN ANTONIO, Tex -- February 9, 2010 -- Subcutaneous methylnaltrexone does not adversely affect pain control or show any clinically significant increases in opioid withdrawal symptoms in the treatment of opioid-induced constipation in patients with chronic, nonmalignant pain, according to a study presented here at the 26th annual meeting of the American Academy of Pain Medicine (AAPM). E. Richard Blonsky, MD, Professional Pain & Rehabilitation Clinic of Chicago, Chicago, Illinois, presented the results of a double-blind, randomised, placebo-controlled phase 3 study during a poster presentation here on February 3. The study included 460 patients treated with daily opioids for chronic nonmalignant pain, who had opioid-induced constipation. Patients were receiving a daily dose of >=50 mg of oral morphine equivalents for 2 weeks or more. Patients were randomised to receive 12 mg of injectable methylnaltrexone for 4 weeks either once daily or once every other day or a daily placebo. Pain intensity was measured at baseline and on days 14 and 28 using an 11-point Likert scale. Opioid withdrawal symptoms, measured by the Objective Opioid Withdrawal Scale (OOWS), were evaluated at baseline and on days 1, 14, and 28. Opioid use was assessed on a daily basis. Results showed that mean pain intensity scores were similar between all treatment groups at each double-blind assessment and changed minimally over time. There were no significant differences in change between methylnaltrexone taken once daily and placebo in OOWS total scores on day 14 (0.1 vs 0, respectively) and day 28 (0 vs 0). However, on day 1, a statistically significant difference in OOWS total scores was observed between patients taking methylnaltrexone every other day and placebo (0.3 vs 0.0; P < .001); however, this was not considered clinically meaningful. The average daily use of morphine equivalents changed only slightly over the 4 weeks of double-blind treatment. “Results from this study suggest that subcutaneous methylnaltrexone used in the treatment of opioid-induced constipation in patients with chronic, nonmalignant pain conditions does not affect pain control,” concluded Dr. Blonsky. “Additionally, the use of methylnaltrexone did not result in clinically significant changes in the morphine equivalent dose used, and did not precipitate objective opioid withdrawal symptoms.” Funding for this study was provided by Wyeth Research, which was acquired by Pfizer, Inc. in October 2009. [Presentation title: Subcutaneous Methylnaltrexone Treatment for Opioid-Induced Constipation: Effect on Pain and Opioid Withdrawal Symptoms. Abstract 193]
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