Benznidazole

(Benznidazole®)

Benznidazole

Drug updated on 10/30/2024

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.

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Summary
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  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • Benznidazole significantly reduced congenital transmission of Chagas disease, with no congenital cases reported in children born to treated women (OR (odds ratio) 0.05, 95% CI (confidence interval) 0.01-0.27), based on a meta-analysis involving 744 children.
  • Benznidazole was associated with high seroconversion rates in chronic Chagas disease, achieving 91.3%-100% depending on dosage and duration. In children, the odds of seroreversion were notably high (OR 38.3, 95% CI 10.7-137).
  • In adults without cardiomyopathy, benznidazole promoted parasitological clearance with no significant difference between fixed and adjusted doses (ROR for negative qPCR: 8.83, 95% CI 1.02-76.48), but it showed no significant effect on clinical progression in chronic Chagas disease.
  • Benznidazole treatment was associated with a significantly higher rate of adverse effects compared to placebo (RR (relative risk) 2.52; 95% CI 2.09-3.03), with 23.9% of patients experiencing adverse events compared to 9.5% in the placebo group. Common adverse reactions included gastrointestinal symptoms, cutaneous rash, and peripheral polyneuropathy, leading to treatment discontinuation in 1.5% to 57% of cases.
  • In women previously treated with antitrypanocidal therapies, the prevalence of adverse events was 14.01% (95% CI 1.87-26.14%), reflecting a notable safety concern.
  • Benznidazole was studied in various populations, including women of childbearing age for preventing congenital Chagas disease, adults without cardiomyopathy for parasitological clearance, and children and adults with chronic Chagas disease for seroconversion and clinical progression. The drug showed high seroconversion rates in children, but its effectiveness in clinical progression for adults with chronic disease was uncertain. Additionally, benznidazole reduced hypercoagulable states in patients with chronic T. cruzi infection, and most studies were conducted in endemic countries.

Product Monograph / Prescribing Information

Document TitleYearSource
Benznidazole (benznidazole) Prescribing Information.2017Exeltis USA, Inc., Florham Park, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Guidelines for the diagnosis and treatment of Chagas disease2019Pan American Health Organization and World Health Organization