Drug updated on 5/17/2024
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.
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Summary
- Benznidazole is approved for the treatment of Chagas disease in pediatric patients aged 2 to 12 years, caused by Trypanosoma cruzi. The medication demonstrates a beneficial effect in children based on serological response, with high odds ratios for seroreversion compared to placebo or no treatment.
- Five studies were examined which focused on Benznidazole's comparative efficacy and safety, specifically in pediatric and adult populations with Chagas disease.
- Contrary to its effectiveness in pediatrics, Benznidazole's efficacy among adults without cardiomyopathy remains uncertain as it does not show a beneficial effect on clinical progression. Additional research is required to determine the medication's effectiveness in this group.
- Safety analyses revealed no significant differences between fixed and adjusted doses of Benznidazole in terms of adverse effects leading to treatment discontinuation. This indicates a similarity in safety profiles across different dosing schemes when compared to placebos.
- Considerations of patient characteristics, such as age or the presence of cardiomyopathy, are important when evaluating treatment options due to the observed variations in responses to Benznidazole therapy within these groups.
- Although there was occasional mention of nifurtimox as an alternative trypanocidal medication, direct comparisons between medications like nifurtimox and Benznidazole are absent from the studies reviewed, thereby limiting the scope for a comprehensive medication-to-medication comparative analysis.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Benznidazole (benznidazole) Prescribing information. | 2021 | Exeltis USA Inc., Florham Park, NJ |
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 |