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

# metadata.dc.description.abstract[].value
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                were withdrawn, 1 for ectopic pregnancy and 1 for epilepsy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.

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Versió postprint del document publicat a:
                http://dx.doi.org/10.1093/jac/dkx516

# metadata.dc.relation.ispartof[].value
Journal of Antimicrobial Chemotherapy, 2018

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
What to expect and when: benznidazole toxicity in chronic
                Chagas' disease treatment