| Author | Morillo, Carlos A. | |
| Author | Marin Neto, José Antonio | |
| Author | Avezum, Alvaro | |
| Author | Sosa-Estani, Sergio | |
| Author | Rassi Jr., Anis | |
| Author | Rosas, Fernando | |
| Author | Villena, Erick | |
| Author | Quiroz, Roberto | |
| Author | Bonilla, Rina | |
| Author | Britto, Constança | |
| Author | Guhl, Felipe | |
| Author | Velazquez, Elsa | |
| Author | Bonilla, Laura | |
| Author | Meeks, Brandi | |
| Author | Rao-Melacini, Purnima | |
| Author | Pogue, Janice | |
| Author | Mattos, Antonio | |
| Author | Rassi, Anis | |
| Author | Connolly, Stuart J. | |
| Author | Yusuf, Salim | |
| Access date | 2016-05-10T16:46:47Z | |
| Available date | 2016-05-11T07:30:08Z | |
| Document date | 2015 | |
| Citation | MORILLO, Carlos A. et al. Randomized Trial of Benznidazole for Chronic Chagas’ Cardiomyopathy. New England Journal of Medicine, v. 373, n. 14, p. 1295-1306, Oct. 2015. | pt_BR |
| ISSN | 0028-4793 | |
| URI | https://www.arca.fiocruz.br/handle/icict/14166 | |
| Language | eng | pt_BR |
| Publisher | Massachusetts Medical Society | pt_BR |
| Rights | restricted access | |
| Subject in Portuguese | Estudo randomizado | pt_BR |
| Subject in Portuguese | Cardiomiopatia Chagásica | pt_BR |
| Subject in Portuguese | Benzonidazol | pt_BR |
| Title | Randomized Trial of Benznidazole for Chronic Chagas Cardiomyopathy | pt_BR |
| Type | Article | |
| DOI | 10.1056/NEJMoa1507574 | |
| Abstract | BACKGROUND
The role of trypanocidal therapy in patients with established Chagas’ cardiomyopathy
is unproven.
METHODS
We conducted a prospective, multicenter, randomized study involving 2854 patients
with Chagas’ cardiomyopathy who received benznidazole or placebo for up
to 80 days and were followed for a mean of 5.4 years. The primary outcome in the
time-to-event analysis was the first event of any of the components of the composite
outcome of death, resuscitated cardiac arrest, sustained ventricular tachycardia,
insertion of a pacemaker or implantable cardioverter–defibrillator, cardiac transplantation,
new heart failure, stroke, or other thromboembolic event.
RESULTS
The primary outcome occurred in 394 patients (27.5%) in the benznidazole group
and in 414 (29.1%) in the placebo group (hazard ratio, 0.93; 95% confidence interval
[CI], 0.81 to 1.07; P=0.31). At baseline, a polymerase-chain-reaction (PCR)
assay was performed on blood samples obtained from 1896 patients; 60.5% had
positive results for Trypanosoma cruzi on PCR. The rates of conversion to negative
PCR results (PCR conversion) were 66.2% in the benznidazole group and 33.5% in
the placebo group at the end of treatment, 55.4% and 35.3%, respectively, at 2 years,
and 46.7% and 33.1%, respectively, at 5 years or more (P<0.001 for all comparisons).
The effect of treatment on PCR conversion varied according to geographic
region: in Brazil, the odds ratio for PCR conversion was 3.03 (95% CI, 2.12 to 4.34)
at 2 years and 1.87 (95% CI, 1.33 to 2.63) at 5 or more years; in Colombia and El
Salvador, the odds ratio was 1.33 (95% CI, 0.90 to 1.98) at 2 years and 0.96 (95%
CI, 0.63 to 1.45) at 5 or more years; and in Argentina and Bolivia, the odds ratio
was 2.63 (95% CI, 1.89 to 3.66) at 2 years and 2.79 (95% CI, 1.99 to 3.92) at 5 or
more years (P<0.001 for interaction). However, the rates of PCR conversion did not
correspond to effects on clinical outcome (P=0.16 for interaction).
CONCLUSIONS
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. | pt_BR |
| Affilliation | Population Health Research Institute. Hamilton, ON, Canada / Hamilton Health Sciences. ON, Canada / McMaster University. ON, Canada. | pt_BR |
| Affilliation | Escola de Medicina de Ribeirão Preto. Departamento de Medicina Interna. Divisão de Cardiologia. Ribeirão Preto, SP, Brasil. | pt_BR |
| Affilliation | Instituto Dante Pazzanese de Cardiologia. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Instituto Nacional de Parasitología Dr. Mario Fatala Chaben–Administración Nacional de Laboratorios. Buenos Aires, Argentina / Institutos de Salud. Buenos AIres, Argentina. | pt_BR |
| Affilliation | Hospital do Coração Anis Rassi. Goiânia, GO, Brasil. | pt_BR |
| Affilliation | Fundación Clínica Abood Shaio. | pt_BR |
| Affilliation | Hospital Eduardo Eguia. Programa Chagas. Tupiza, Bolivia. | pt_BR |
| Affilliation | Fundación Cardiovascular de Colombia. Bucaramanga, Colombia. | pt_BR |
| Affilliation | Hospital Nacional Rosales. San Salvador, El Salvador. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Biologia Molecular e Doenças Endêmicas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | CIMPAT–Facultad de Ciencias. Universidad de los Andes. Bogota, Colombia. | pt_BR |
| Affilliation | Instituto Nacional de Parasitología Dr. Mario Fatala Chaben–Administración Nacional de Laboratorios. Buenos Aires, Argentina / Institutos de Salud. Buenos AIres, Argentina. | pt_BR |
| Affilliation | Population Health Research Institute. Hamilton, ON, Canada / Hamilton Health Sciences. ON, Canada / McMaster University. ON, Canada. | pt_BR |
| Affilliation | Population Health Research Institute. Hamilton, ON, Canada / Hamilton Health Sciences. ON, Canada / McMaster University. ON, Canada. | pt_BR |
| Affilliation | Population Health Research Institute. Hamilton, ON, Canada / Hamilton Health Sciences. ON, Canada / McMaster University. ON, Canada. | pt_BR |
| Affilliation | Population Health Research Institute. Hamilton, ON, Canada / Hamilton Health Sciences. ON, Canada / McMaster University. ON, Canada. | pt_BR |
| Affilliation | Instituto Dante Pazzanese de Cardiologia. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Hospital do Coração Anis Rassi. Goiânia, GO, Brasil. | pt_BR |
| Affilliation | Population Health Research Institute. Hamilton, ON, Canada / Hamilton Health Sciences. ON, Canada / McMaster University. ON, Canada. | pt_BR |
| Affilliation | Population Health Research Institute. Hamilton, ON, Canada / Hamilton Health Sciences. ON, Canada / McMaster University. ON, Canada. | pt_BR |
| Subject | Randomized Trial | pt_BR |
| Subject | Benznidazole | pt_BR |
| Subject | Chronic Chagas’ Cardiomyopathy | pt_BR |
| e-ISSN | 1533-4406 | |
| Embargo date | 2028-12-31 | |
