CONTRAVE Demonstrated Safety and Tolerability Profile
The most frequently reported adverse reactions for CONTRAVE (incidence ≥5% and twice the incidence in placebo) vs. placebo were nausea (33% vs. 7%), constipation (19% vs. 7%), vomiting (11% vs. 3%), dizziness (10% vs. 3%) and dry mouth (8% vs. 2%). Headache was also more commonly observed in CONTRAVE patients than in placebo (18% vs. 10%).1
The vast majority of subjects treated with CONTRAVE who experienced nausea reported the event within four weeks of starting treatment. Events were generally self-limited; the majority of events resolved within four weeks and almost all resolved by Week 24. The incidence of severe nausea was low, but was higher with CONTRAVE than placebo (severe nausea: naltrexone / bupropion 1.9%, placebo <0.1%).1
Gastrointestinal events for patients with type 2 diabetes
Patients with type 2 diabetes treated with CONTRAVE demonstrated a higher incidence of gastrointestinal adverse events, primarily nausea, vomiting, and diarrhea, than subjects without diabetes. Patients with type 2 diabetes may be more prone to these events due to concomitant medicinal product use (e.g., metformin) or may be more likely to have underlying gastrointestinal disorders (e.g., gastroparesis) predisposing to gastrointestinal symptoms.1
24% of CONTRAVE patients discontinued treatment due to an adverse event vs. 12% for placebo. The most frequent adverse reactions leading to discontinuation with CONTRAVE were nausea (6%), headache (2%), dizziness (1%) and vomiting (1%).1
- CONTRAVE Product Monograph. Bausch Health Canada, March 2, 2022.
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