Clinical tolerability of artesunate-amodiaquine versus comparator treatments for uncomplicated falciparum malaria: an individual-patient analysis of eight randomized controlled trials in sub-Saharan Africa

Abstract

Abstract Background The widespread use of artesunate-amodiaquine (ASAQ) for treating uncomplicated malaria makes it important to gather and analyse information on its tolerability. Methods An individual-patient tolerability analysis was conducted using data from eight randomized controlled clinical trials conducted at 17 sites in nine sub-Saharan countries comparing ASAQ to other anti-malarial treatments. All patients who received at least one dose of the study drug were included in the analysis. Differences in adverse event (AE) and treatment emergent adverse event (TEAE) were analysed by Day 28. Results Of the 6,179 patients enrolled (74% Conclusion ASAQ was comparatively well-tolerated. Safety information is important, and must be collected and analysed in a standardized way. TEAEs are a more objective measure of treatment-induced toxicity.

Keywords

• Malaria
• <it>Plasmodium falciparum</it>
• Safety
• Tolerability
• Adverse event
• Treatment-emergent adverse event
• Artesunate-amodiaquine
• Treatment
• Randomized controlled trial
• Sub-Saharan Africa