Comparative safety of artemether-lumefantrine and other artemisinin-based combinations in children: a systematic review

Egunsola, Oluwaseun; Oshikoya, Kazeem A.

Abstract

Background
The purpose of the study was to compare the safety of artemether-lumefantrine (AL) with other artemisinin-based combinations in children.

Methods
A search of EMBASE (from 1974 to April 2013), MEDLINE (from 1946 to April 2013) and the Cochrane library of registered controlled trials for randomized controlled trials (RCTs) which compared AL with other artemisinin-based combinations was done. Only studies involving children ≤ 17 years old in which safety of AL was an outcome measure were included.

Results
Four thousand, seven hundred and twenty six adverse events (AEs) were recorded in 6,000 patients receiving AL. Common AEs (≥1/100 and <1/10) included: coryza, vomiting, anaemia, diarrhoea, vomiting and abdominal pain; while cough was the only very commonly reported AE (≥1/10). AL-treated children have a higher risk of body weakness (64.9%) than those on artesunate-mefloquine (58.2%) (p = 0.004, RR: 1.12 95% CI: 1.04-1.21). The risk of vomiting was significantly lower in patients on AL (8.8%) than artesunate-amodiaquine (10.6%) (p = 0.002, RR: 0.76, 95% CI: 0.63-0.90). Similarly, children on AL had a lower risk of vomiting (1.2%) than chlorproguanil-dapsone-artesunate (ACD) treated children (5.2%) (p = 0.002, RR: 0.63, 95% CI: 0.47-0.85). The risk of serious adverse events was significantly lower for AL (1.3%) than ACD (5.2%) (p = 0.002, RR: 0.45, 95% CI: 0.27-0.74).

Conclusion
Artemether-lumefantrine combination is as safe as ASAQ and DP for use in children. Common adverse events are cough and gastrointestinal symptoms. More studies comparing AL with artesunate-mefloquine and artesunate-azithromycin are needed to determine the comparative safety of these drugs.

Citation

Egunsola, O., & Oshikoya, K. A. (2013). Comparative safety of artemether-lumefantrine and other artemisinin-based combinations in children: a systematic review. Malaria Journal, 12(Novemb), Article 8. https://doi.org/10.1186/1475-2875-12-385

• Journal Article Type: Article
• Publication Date: Nov 1, 2013
• Deposit Date: Apr 22, 2014
• Publicly Available Date: Apr 22, 2014
• Journal: Malaria Journal
• Electronic ISSN: 1475-2875
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 12
• Issue: Novemb
• Article Number: 8
• DOI: https://doi.org/10.1186/1475-2875-12-385
• Keywords: Artemether-lumefantrine, Adverse event, Paediatrics, Children, Safety
• Public URL: https://nottingham-repository.worktribe.com/output/718188
• Publisher URL: http://www.malariajournal.com/content/12/1/385