Randomised trial of efficacy of benznidazole in treatment of early Trypanosoma cruzi infection

Andrade, Ana Lúcia; Zicker, Fábio; Oliveira, Reinaldo Cunha de; Silva, Simone Almeida e; Luquetti, Alejandro O.; Travassos, Luiz R.; Almeida, Igor Correia de; Andrade, Sheila Siqueira; Andrade, João Guimarães de; Martelli, Celina Maria Turchi

doi:10.1016/s0140-6736(96)04128-1

Cited by 420 publications

(153 citation statements)

References 18 publications

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“…benznidazole and nifurtimox) was never studied in children [8]. Even though treatment of children with ChD with benznidazole has been shown to be safe and effective,[13], [11], [8], [27], [28], [29] lack of pediatric PK data makes dosing decisions a matter of guesswork. In fact, currently used pediatric dosing guidelines were developed by merely applying adult dosing to children (using weight-based adjustments).…”

Section: Discussionmentioning

confidence: 99%

“…Based on a small number of studies, treatment of pediatric ChD with benznidazole is considered to be effective and well tolerated, with observed response rates nearing 90% in some series [10], [8], [9], [11], [12], [13]. However, treatment schedules are based on limited data, mostly coming from the only two pharmacokinetics (PK) studies conducted, with a limited number of adult patients [14], [15].…”

Section: Introductionmentioning

confidence: 99%

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Population Pharmacokinetic Study of Benznidazole in Pediatric Chagas Disease Suggests Efficacy despite Lower Plasma Concentrations than in Adults

et al. 2014

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IntroductionChagas disease, caused by the parasite Trypanosoma cruzi, can lead to long term cardiac morbidity. Treatment of children with benznidazole is effective, but no pediatric pharmacokinetics data are available and clinical pharmacology information on the drug is scarce.Patients and MethodsProspective population pharmacokinetic (PK) cohort study in children 2–12 years old with Chagas disease treated with oral benznidazole 5–8 mg/kg/day BID for 60 days. (clinicaltrials.gov #NCT00699387).ResultsForty children were enrolled in the study. Mean age was 7.3 years. A total of 117 samples were obtained from 38 patients for PK analysis. A one compartment model best fit the data. Weight-corrected clearance rate (CL/F) showed a good correlation with age, with younger patients having a significantly higher CL/F than older children and adults. Simulated median steady-state benznidazole concentrations, based on model parameters, were lower for children in our study than for adults and lowest for children under 7 years of age. Treatment was efficacious in the 37 patients who completed the treatment course, and well tolerated, with few, and mild, adverse drug reactions (ADRs).DiscussionObserved benznidazole plasma concentrations in children were markedly lower than those previously reported in adults (treated with comparable mg/kg doses), possibly due to a higher CL/F in smaller children. These lower blood concentrations were nevertheless associated to a high therapeutic response in our cohort. Unlike adults, children have few adverse reactions to the drug, suggesting that there may be a direct correlation between drug concentrations and incidence of ADRs. Our results suggest that studies with lower doses in adults may be warranted.Trial RegistrationClinicalTrails.gov NCT00699387

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Population Pharmacokinetic Study of Benznidazole in Pediatric Chagas Disease Suggests Efficacy despite Lower Plasma Concentrations than in Adults

et al. 2014

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“…Early screening and treatment of infected newborns are associated with high cure rates (10). Older children of mothers with newly diagnosed Chagas disease also benefi t from screening and treatment (11). In addition, because immigrants with inadequate access to healthcare are at risk for being lost to follow-up after delivery, perinatal screening offers a good opportunity to screen other family members and offer treatment as needed.…”

Section: Discussionmentioning

confidence: 99%

Congenital Transmission of Chagas Disease in Latin American Immigrants in Switzerland

Jackson¹,

Myers²,

Diana³

et al. 2009

Emerg. Infect. Dis.

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“…Thirty percent go on to develop a dilated cardiomyopathy or, less frequently, digestive megasyndromes 10-30 years later [31] (figure 4). Management of Chagas disease relies on early diagnosis and treatment with anti-parasitic drugs, which have been shown to be effective in the acute and early indeterminate phase of the disease [32]. Chronic Chagas is currently managed symptomatically, but access to treatment is often limited in resource-poor settings.…”

Section: (D) Chagas Diseasementioning

confidence: 99%

Disease appearance and evolution against a background of climate change and reduced resources

Yacoub

Kotit

Yacoub

2011

Phil. Trans. R. Soc. A.

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Global health continues to face increasing challenges owing to a variety of reasons that include the almost constant changes in disease appearance and evolution. Most, but not all, of these changes affect low-income countries and are influenced by climate change. Tracking the recent and anticipated changes in the demographics and global distribution of these changes is essential for evolving effective new methods for dealing with the problems. The recent recognition by the United Nations of the importance of noncommunicable diseases is a major positive step. For the sake of this paper, the following diseases were chosen: dengue and malaria, to highlight the role of climate change on vector-borne diseases. Drug-resistant tuberculosis illustrates the role of globalization and reduced resources on disease evolution. The continuing rise in cardiovascular mortality and morbidity, particularly in resource-poor countries is largely attributed to lack of preventive and therapeutic measures against such conditions as hypertension, diabetes, atherosclerosis and congenital heart disease as well as neglected diseases, of which Chagas and rheumatic heart disease will be discussed further.

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Randomised trial of efficacy of benznidazole in treatment of early Trypanosoma cruzi infection

Cited by 420 publications

References 18 publications

Population Pharmacokinetic Study of Benznidazole in Pediatric Chagas Disease Suggests Efficacy despite Lower Plasma Concentrations than in Adults

Population Pharmacokinetic Study of Benznidazole in Pediatric Chagas Disease Suggests Efficacy despite Lower Plasma Concentrations than in Adults

Congenital Transmission of Chagas Disease in Latin American Immigrants in Switzerland

Disease appearance and evolution against a background of climate change and reduced resources

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