SHM Converge Scientific Abstract ePoster Gallery-Efficacy of Methylnaltrexone in Patients With Advanced Illness and Opioid-Induced Constipation Refractory to Conventional Laxatives: Impact of Baseline Laxative Use

Efficacy of Methylnaltrexone in Patients With Advanced Illness and Opioid-Induced Constipation Refractory to Conventional Laxatives: Impact of Baseline Laxative Use

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This post hoc pooled analysis examined whether baseline laxative use affected the efficacy and safety of subcutaneous methylnaltrexone (MNTX) in adults with advanced illness and opioid-induced constipation (OIC) that had not responded to conventional laxatives. Data came from two randomized, double-blind, placebo-controlled trials and included 358 patients; over 98% were already using laxatives at baseline.<br /><br />Patients were grouped by laxative regimen (stimulants, osmotic agents, stool softeners, combinations, or none). The main outcome was rescue-free laxation (RFL) within 4 or 24 hours after dosing. Across nearly all laxative subgroups, MNTX produced higher RFL response rates than placebo. At the 4-hour interval, the difference was significant in every subgroup except the no-laxatives group. At the 24-hour interval, MNTX was significantly better in several key subgroups, including stimulants only, stool softeners only, stimulants plus osmotic agents, and stimulants plus stool softeners.<br /><br />MNTX also shortened the time to first RFL response versus placebo in almost all subgroups, with median response times in the MNTX group ranging from 0.4 to 7.0 hours. In contrast, placebo often failed to reach a median response within 24 hours.<br /><br />Safety findings were consistent with prior reports. Treatment-emergent adverse events were common in both groups, somewhat more frequent with MNTX overall, and were mainly gastrointestinal in nature. No new or unexpected safety concerns emerged.<br /><br />Overall, MNTX improved laxation outcomes in patients with advanced illness and laxative-refractory OIC regardless of the baseline laxative regimen, while maintaining a known safety profile.

Asset Subtitle

Rowe B. Brookfield

Meta Tag

Author List Bobbie Sue Brown, Gregory S. Sayuk, Nancy Stambler, Neal E. Slatkin, Rowe B. Brookfield

Category Research

Concept Opioid-Induced Constipation

Concept Methylnaltrexone

Concept Rescue-Free Laxation

Concept Laxative

Concept Efficacy

Distinguished Non-Finalist

Presenter Organization Salix Pharmaceuticals

Presenting Author Rowe B. Brookfield

Track Other

Keywords

methylnaltrexone

opioid-induced constipation

advanced illness

laxative use

rescue-free laxation

placebo-controlled trials

subcutaneous treatment

efficacy and safety

pooled analysis

gastrointestinal adverse events

Opioid-Induced Constipation

Methylnaltrexone

Rescue-Free Laxation

Laxative

Efficacy