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    Mar 03, 2021
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    Safety and effectiveness of first line eflornithine for Trypanosoma brucei gambiense sleeping sickness in Sudan: cohort study

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    Authors
    Priotto, G
    Pinoges, L
    Badi Fursa, I
    Burke, B
    Nicolay, N
    Grillet, G
    Hewison, C
    Balasegaram, M
    Affiliation
    Epicentre, Paris, France; Médecins Sans Frontières, Paris, France
    Issue Date
    2008-03-05
    Submitted date
    2008-05-08
    
    Metadata
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    Journal
    BMJ/British Medical Journal
    Abstract
    Objective: To assess the safety and effectiveness of eflornithine as first line treatment for human African trypanosomiasis. Design: Cohort study. Setting: Control programme in Ibba, southern Sudan. Participants: 1055 adults and children newly diagnosed with second stage disease in a 16 month period. Main outcome measures: Deaths, severe drug reactions, and cure at 24 months. Results: 1055 patients received eflornithine for 14 days (400 mg/kg/day in adults and 600 mg/kg/day in a subgroup of 96 children). Overall, 2824 drug reactions (2.7 per patient) occurred during hospital stay, 1219 (43.2%) after the first week. Severe reactions affected 138 (13.1%) patients (mainly seizures, fever, diarrhoea, and bacterial infections), leading to 15 deaths. Risk factors for severe reactions included cerebrospinal fluid leucocyte counts ≥100x109/l (adults: odds ratio 2.6, 95% confidence interval 1.5 to 4.6), seizures (adults: 5.9, 2.0 to 13.3), and stupor (children: 9.3, 2.5 to 34.2). Children receiving higher doses did not experience increased toxicity. Follow-up data were obtained for 924 (87.6%) patients at any follow-up but for only 533 (50.5%) at 24 months. Of 924 cases followed, 16 (1.7%) died during treatment, 70 (7.6%) relapsed, 15 (1.6%) died of disease, 403 (43.6%) were confirmed cured, and 420 (45.5%) were probably cured. The probability of event free survival at 24 months was 0.88 (0.86 to 0.91). Most (65.8%, 52/79) relapses and disease related deaths occurred after 12 months. Risk factors for relapse included being male (incidence rate ratio 2.42, 1.47 to 3.97) and cerebrospinal fluid leucocytosis: 20-99x109/l (2.35, 1.36 to 4.06); ≥100x109/l (1.87, 1.07 to 3.27). Higher doses did not yield better effectiveness among children (0.87 v 0.85, P=0.981). Conclusions: Eflornithine shows acceptable safety and effectiveness as first line treatment for human African trypanosomiasis. Relapses did occur more than 12 months after treatment. Higher doses in children were well tolerated but showed no advantage in effectiveness.
    URI
    http://hdl.handle.net/10144/25192
    DOI
    10.1136/bmj.39485.592674.BE
    PubMed ID
    18321960
    PubMed Central ID
    PMC2276259
    PMC2276259
    PMC2276259
    Additional Links
    http://www.bmj.com/cgi/content/full/bmj.39485.592674.BEv1
    http://dx.doi.org/10.1136/bmj.39485.592674.BE
    Type
    Article
    Language
    en
    ISSN
    09598138
    14685833
    Sponsors
    Funding: French section of Médecins Sans Frontières.
    ae974a485f413a2113503eed53cd6c53
    10.1136/bmj.39485.592674.BE
    Scopus Count
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    Trypanosomiasis/Sleeping Sickness

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