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Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.


ABSTRACT: BACKGROUND/OBJECTIVES:Prolonged-release (PR) naltrexone 32?mg/bupropion 360?mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo. SUBJECTS/METHODS:Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively. RESULTS:Baseline characteristics and comorbidities were comparable for placebo (n?=?1515) and NB (n?=?2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P?

SUBMITTER: Pi-Sunyer X 

PROVIDER: S-EPMC7111229 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.

Pi-Sunyer Xavier X   Apovian Caroline M CM   McElroy Susan L SL   Dunayevich Eduardo E   Acevedo Lisette M LM   Greenway Frank L FL  

International journal of obesity (2005) 20190121 10


<h4>Background/objectives</h4>Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo.<h4>Subjects/methods</h4>Data were pooled from 5 prospect  ...[more]

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