What to expect and when: benznidazole toxicity in chronic
                Chagas' disease treatment

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RECERCAT Home > Universitat de Barcelona > IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer > Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) > View document

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dc.contributor.author	Aldasoro, Edelweiss
dc.contributor.author	Posada, Elizabeth
dc.contributor.author	Requena-Méndez, Ana
dc.contributor.author	Calvo-Cano, Antonia
dc.contributor.author	Serret, N.
dc.contributor.author	Casellas, Aina
dc.contributor.author	Sanz, Sergi
dc.contributor.author	Soy Muner, Dolors
dc.contributor.author	Pinazo, Maria-Jesus
dc.contributor.author	Gascón i Brustenga, Joaquim
dc.date	2018-02-26T10:40:46Z
dc.date	2019-01-16T06:10:19Z
dc.date	2018-01-16
dc.date	2018-02-07T18:59:43Z
dc.identifier	0305-7453
dc.identifier.uri	http://hdl.handle.net/2445/120236
dc.description	Background: Benznidazole is one of the two most effective antiparasitic drugs for Chagas' disease treatment. However, knowledge about its toxicity profile is mostly based on post-marketing observational studies. Objectives: Our study combines data from two prospective clinical trials designed to assess the safety of the drug newly produced by ELEA Laboratories (Abarax(R)). Methods: Eligible participants were selected using a consecutive sampling strategy in the CINEBENZ and BIOMARCHA studies between 2013 and 2016 (EUDRACT 2011-002900-34 and 2012-002645-38, respectively, and clinicaltrials.gov NCT01755403 and NCT01755377, respectively). Enrolled subjects received treatment with 5 mg/kg/day benznidazole orally in two divided doses for 8 weeks and were followed up fortnightly. Results: We observed 305 adverse reactions in 85 of 99 participants (85.9%). Each patient had a median of three adverse reactions, 89.5% were mild and the median duration was 12 days. Most adverse reactions appeared in the first month of treatment except arthritis and peripheral neuropathy. Twenty-six patients did not complete treatment: 2 were withdrawn, 1 for ectopic pregnancy and 1 for epilepsy relapse due to cysticercosis; 2 were lost to follow-up; and 22 were owing to adverse reactions, two of them severe. We observed some unexpected adverse reactions that have not been described previously, such as psychiatric symptoms, erectile dysfunction, menstrual cycle alterations and lung infiltration. Conclusions: There is a very high frequency of adverse reactions to benznidazole. Most adverse reactions are mild, but the treatment burden is significant and unexpected reactions are not rare. Severe reactions are uncommon, but they can be life-threatening. Further studies are necessary to optimize treatment.
dc.format	30 p.
dc.format	application/pdf
dc.language	eng
dc.publisher	Oxford University Press
dc.relation	Versió postprint del document publicat a: http://dx.doi.org/10.1093/jac/dkx516
dc.relation	Journal of Antimicrobial Chemotherapy, 2018
dc.relation	http://dx.doi.org/10.1093/jac/dkx516
dc.rights	(c) Aldasoro et al., 2018
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	Malaltia de Chagas
dc.subject	Medicaments
dc.subject	Toxicitat dels medicaments
dc.subject	Chagas' disease
dc.subject	Drugs
dc.subject	Drug toxicity
dc.title	What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment
dc.type	info:eu-repo/semantics/article
dc.type	info:eu-repo/semantics/acceptedVersion

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