SHM Converge Scientific Abstract ePoster Gallery-Attenuation of Adverse Events Over 7 Doses in Methylnaltrexone-Treated Patients With Opioid-Induced Constipation and Severe Medical Illness

Attenuation of Adverse Events Over 7 Doses in Methylnaltrexone-Treated Patients With Opioid-Induced Constipation and Severe Medical Illness

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This post hoc analysis pooled data from two randomized, placebo-controlled trials of subcutaneous methylnaltrexone (MNTX) for opioid-induced constipation (OIC) in 363 patients with advanced illness, including cancer and noncancer populations. The study evaluated whether treatment-emergent adverse events (TEAEs), especially gastrointestinal (GI) events and abdominal pain, changed over seven doses and whether these events were related to rescue-free laxation (RFL) response.<br /><br />Most patients experienced at least one TEAE, and the most common events were GI-related, including abdominal pain, nausea, and flatulence. Overall, TEAEs in MNTX-treated patients decreased over time: in the full cohort, TEAEs fell from 26.3% after dose 1 to 10.2% after dose 7, with similar declines in cancer and noncancer subgroups. GI TEAEs also declined with repeated MNTX dosing, from 20.7% after dose 1 to 7.4% after dose 7 in the full cohort. Placebo patients showed smaller reductions over time.<br /><br />When patients were grouped by laxation response, TEAE and GI TEAE rates were similar between MNTX and placebo among responders at each dose. Across treatment groups, responders generally had more TEAEs than nonresponders. Abdominal pain also decreased over time in responders, but among nonresponders, abdominal pain was higher in MNTX-treated patients than placebo at some doses.<br /><br />The authors conclude that the adverse events observed with MNTX are mainly GI in nature and appear to be linked to laxation response. They suggest that as OIC improves with repeated MNTX dosing, GI adverse events tend to lessen.

Asset Subtitle

Rowe B. Brookfield

Meta Tag

Author List Bobbie Sue Brown, Eric D. Shah, Gregory S. Sayuk, Nancy Stambler, Neal E. Slatkin, Qi Tong T. Yu, Rowe B. Brookfield

Category Research

Concept Methylnaltrexone

Concept Opioid-Induced Constipation

Concept Rescue-Free Laxation

Concept Treatment-Emergent Adverse Event

Concept Gastrointestinal Adverse Event

Distinguished Non-Finalist

Presenter Organization Salix Pharmaceuticals

Presenting Author Rowe B. Brookfield

Track Patient Safety

Keywords

methylnaltrexone

opioid-induced constipation

adverse events

gastrointestinal events

abdominal pain

rescue-free laxation

randomized placebo-controlled trials

advanced illness

cancer patients

noncancer patients

Methylnaltrexone

Opioid-Induced Constipation

Rescue-Free Laxation

Treatment-Emergent Adverse Event

Gastrointestinal Adverse Event