Tolerance and Safety of Nifurtimox in Patients with Chronic Chagas Disease

Jackson, Yves-Laurent Julien; Alirol, Emilie; Gétaz, Laurent; Wolff, Hans; Combescure, Christophe; Chappuis, François

doi:10.1086/656917

Cited by 172 publications

(151 citation statements)

References 22 publications

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“…SAEs are also described and mainly related to allergic reactions (eosinophilia, rash, pruritus, edema, dyspnea). 26 Nevertheless, the duration of treatment with nifurtimox is much longer in Chagas disease (60-120 days).…”

Section: Discussion: Comparison With Previous Datamentioning

confidence: 99%

Monitoring the use of nifurtimox-eflornithine combination therapy (NECT) in the treatment of second stage gambiense human African trypanosomiasis

Franco¹,

Diarra²,

Postigo³

et al. 2012

RRTM

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Abstract:After inclusion of the nifurtimox-eflornithine combination therapy (NECT) in the Model List of Essential Medicines for the treatment of second-stage gambiense human African trypanosomiasis (HAT), the World Health Organization, in collaboration with National Sleeping Sickness Control Programs and nongovernmental organizations set up a pharmacovigilance system to assess the safety and efficacy of NECT during its routine use. Data were collected for 1735 patients treated with NECT in nine disease endemic countries during 2010-2011. At least one adverse event (AE) was described in 1043 patients (60.1%) and a total of 3060 AE were reported. Serious adverse events (SAE) were reported for 19 patients (1.1% of treated), leading to nine deaths (case fatality rate of 0.5%). The most frequent AE were gastroin testinal disorders (vomiting/nausea and abdominal pain), followed by headache, musculoskeletal pains, and vertigo. The most frequent SAE and cause of death were convulsions, fever, and coma that were considered as reactive encephalopathy. Two hundred and sixty-two children below 15 years old were treated. The characteristics of AE were similar to adults, but the major AE were less frequent in children with only one SAE and no deaths registered in this group. Gastrointestinal problems (vomiting and abdominal pain) were more frequent than in adults, but musculosk eletal pains, vertigo, asthenia, neuropsychiatric troubles (headaches, seizures, tremors, hallucinations, insomnia) were less frequent in children. Patient follow-up after treatment is continuing, but initial data could suggest that NECT is effective as only a low number of relapses have so far been reported (19 cases). However, additional monitoring is required to assess the efficacy of the treatment, particularly in children. NECT has given satisfactory results of safety in the usual conditions where HAT patients are managed and it is currently the best option for treatment of second stage of gambiense HAT.

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Section: Discussion: Comparison With Previous Datamentioning

confidence: 99%

Monitoring the use of nifurtimox-eflornithine combination therapy (NECT) in the treatment of second stage gambiense human African trypanosomiasis

Franco¹,

Diarra²,

Postigo³

et al. 2012

RRTM

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“…Due to the above evidence, the current trend is to treat cases of Chagas disease without heart complications 8 . The major disadvantage of both drugs is their toxicity profi les [9][10][11][12] . Due to the high incidence of adverse drug reactions, patients require clinical monitoring and laboratory tests in order to promptly identify severe adverse effects 13,14 .…”

Section: Introductionmentioning

confidence: 99%

Therapeutic drug monitoring of benznidazole and nifurtimox: a systematic review and quality assessment of published clinical practice guidelines

Olivera

Fory

Olivera

2017

Rev. Soc. Bras. Med. Trop.

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The pharmacological management of adults with chronic-phase Chagas disease is challenging despite it being the recent focus of extensive research. One of the challenges in the current clinical practice guidelines (CPGs) landscape is the existence of nonevidence-based recommendations for the use of laboratory tests in treatment monitoring. This study aimed to systematically assess the quality and consistency of recommendations of CPGs on the pharmacological management of adults with chronicphase Chagas disease. Systematic literature searches were conducted in MEDLINE, EMBASE, SciELO and Google to identify all published CPGs relevant to the pharmacological management of Chagas disease, between January 2010 and March 2016. Three independent reviewers assessed the quality of each CPG using the Appraisal of Guidelines Research and Evaluation (AGREE) II instrument. A total of fi ve CPGs were included and the overall quality of the guidelines for therapeutic drug monitoring of Chagas disease was moderate-to-low. There was considerable variation in the quality of the CPGs across the AGREE II domains. The domains of scope/purpose, stakeholder involvement, and clarity of presentation were rated well, and the domains of applicability and editorial independence received poor ratings. This review showed that the methodological quality of CPGs for Chagas disease was generally inappropriate, and there was no explicit link between the best available evidence and current recommendations.

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“…2,3 Both drugs require prolonged treatments and can have severe adverse effects. 4,5 Patients also require palliative care for the cardiomyopathy, ranging from drug therapy to pacemakers and cardiac transplants. 6 Thus treatment can cost up to over 1,000 USD per year and per patient.…”

Section: Introductionmentioning

confidence: 99%