Summary

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• Benznidazole is indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi.
• This summary is based on the review of six systematic review(s)/meta-analysis(es). ^[1-6]
• Benznidazole demonstrated strong parasitological efficacy with an odds ratio (ROR^F/A) of 8.83 (95% CI 1.02-76.48) for negative qPCR and 4.60 (95% CI 0.40-52.51) for sustained parasitological clearance across all dose types and subgroups analyzed in five RCTs involving 1198 patients.
• In children, benznidazole significantly increased the odds of seroreversion with an OR of 38.3 (95% CI: 10.7-137) in RCTs and 34.9 (95% CI: 1.96-624.09) in observational studies, whereas in adults, the OR for seroreversion in observational studies was 17.1 (95% CI: 2.3-129.1).
• Benznidazole did not show a significant beneficial effect on clinical progression in adults, with an OR of 0.93 (95% CI: 0.8-1.1) in RCTs and 0.49 (95% CI: 0.2-1.2) in observational studies.
• In a large RCT, adverse events were significantly higher in benznidazole-treated patients compared to placebo (RR 2.52, 95% CI 2.09 to 3.03), with 23.9% of patients in the benznidazole group experiencing adverse effects compared to 9.5% in the placebo group. The most frequent adverse effects included cutaneous rash, gastrointestinal symptoms, and peripheral polyneuropathy.
• The ROR^F/A for treatment interruption due to adverse events was 0.44 (95% CI 0.14-1.38), indicating no worse tolerance of fixed doses compared to adjusted doses. Low-certainty evidence suggested similar effects for any serious adverse events.
• There is no population type or subgroup information available in the reviewed studies.