Benznidazole

(Benznidazole®)

Benznidazole

Drug updated on 9/5/2024

Dosage Formtablet (oral; 12.5 mg, 100 mg)
Drug ClassNitroimidazole antimicrobials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • 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 (RORF/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 RORF/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.