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Título:
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What to expect and when: benznidazole toxicity in chronic
Chagas' disease treatment
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Autor/a:
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Aldasoro, Edelweiss; Posada, Elizabeth; Requena-Méndez, Ana; Calvo-Cano, Antonia; Serret, N.; Casellas, Aina; Sanz, Sergi; Soy Muner, Dolors; Pinazo, Maria-Jesus; Gascón i Brustenga, Joaquim
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Notas:
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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were withdrawn, 1 for ectopic pregnancy and 1 for epilepsy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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Materia(s):
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-Malaltia de Chagas
-Medicaments
-Toxicitat dels medicaments
-Chagas' disease
-Drugs
-Drug toxicity |
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Derechos:
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(c) Aldasoro et al., 2018
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Tipo de documento:
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Artículo
Artículo - Versión aceptada |
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Editor:
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Oxford University Press
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Compartir:
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