Drug updated on 4/18/2024
| Dosage Form | tablet (oral; 12.5 mg, 100 mg) |
| Drug Class | Nitroimidazole 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.
Summary
- Benznidazole is indicated for the treatment of Chagas disease in pediatric patients aged 2 to 12 years, caused by Trypanosoma cruzi. It shows a strong association with negative qPCR and sustainable parasitological clearance in T. cruzi-seropositive adults without cardiomyopathy, indicating probable non-inferiority to weight-adjusted doses when compared with placebo.
- The information was derived from five systematic reviews/meta-analyses on Benznidazole's efficacy and safety.
- In children treated with Benznidazole, a significant odds ratio indicates seroreversion when compared to placebo or no treatment. However, its efficacy remains uncertain in adults, particularly regarding clinical progression in chronic Chagas disease where no significant beneficial effect was observed.
- Compared to other treatments like nifurtimox, Benznidazole is predominantly used (85.4% of cases). Evidence suggests that fixed vs adjusted doses might be equivalent in terms of safety and efficacy, although direct comparisons were not found.
- There exists notable heterogeneity within clinical practice for treating Chagas disease, which underscores the need for more uniform guidelines as well as the development of data-sharing platforms aimed at optimizing treatment strategies.
- Current evidence does not sufficiently support the use of Benznidazole or other nitrofurans/imidazolic drugs for late-stage chronic Chagas disease, especially if overt heart disease is present; this highlights an urgent need for randomized controlled trials exploring new suitable drugs specifically targeting this patient group.
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Guidelines for the diagnosis and treatment of Chagas disease. | 2019 | Pan American Health Organization and World Health Organization |