Chagas Disease by Unknown

Author:Unknown
Language: eng
Format: epub
ISBN: 9783030440541
Publisher: Springer International Publishing

8.3 Recent Randomized Clinical Trials of Etiological Treatments of Chronic Chagas Disease

8.3.1 Benznidazole Evaluation for Interrupting Trypanosomiasis (BENEFIT) Trial

BENEFIT ([49, 50]; ClinicalTrials.​gov Identifier: NCT00123916) was the first randomized, double-blind, placebo-controlled phase III trial on the effects of benznidazole (300 mg/d, 40–80 days, depending on weight) on a composite endpoint of death, rescued cardiac arrest, sustained ventricular tachycardia, implant of a pacemaker or implantable cardiac defibrillator, heart failure, stroke or systemic embolism and heart transplant in chronic Chagas disease patients with cardiac compromise (NYHA Class I–III and up to 75 years of age) when compared with placebo. Follow-up period was 4–8 years (mean: 6 years). The study recruited and randomized 2850 patients in Brazil, Argentina, Bolivia, Colombia, and El Salvador. The BENEFIT Pilot Study was a randomized, double-blind trial on the effects of benznidazole (300 mg/d, 40–80 days, depending on weight) on the blood T. cruzi load of chronic Chagas disease patients with cardiac compromise, evaluated by PCR. 1896 patients were randomized at baseline and 1618 patients evaluated at the end of treatment, 1530 patients at 2 years, and 1487 patients at the final follow-up visit. Sixty percent of the originally randomized patients had positive basal PCR.

The main authors’ conclusion was “Trypanocidal therapy with benznidazole in patients with established Chagas cardiomyopathy significantly reduced serum parasite detection but did not significantly reduce cardiac clinical deterioration through 5 years of follow-up.”

Other specific findings and important caveats are listed below:1.The rate of drug interruption because of an adverse event was significantly higher in the benznidazole group than in the placebo group (23.9% vs. 9.5%, P < 0.001).

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