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Efficacy and safety of mefloquine, artesunate, mefloquine-artesunate, tribendimidine, and praziquantel in patients with Opisthorchis viverrini : a randomised, exploratory, open-label, phase 2 trial

Soukhathammavong, P. and Odermatt, P. and Sayasone, S. and Vonghachack, Y. and Vounatsou, P. and Hatz, C. and Akkhavong, K. and Keiser, J.. (2011) Efficacy and safety of mefloquine, artesunate, mefloquine-artesunate, tribendimidine, and praziquantel in patients with Opisthorchis viverrini : a randomised, exploratory, open-label, phase 2 trial. The Lancet infectious diseases, 11 (2). pp. 110-118.

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Official URL: http://edoc.unibas.ch/dok/A6002182

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Abstract

BACKGROUND: Praziquantel is the only drug available for treatment of Opisthorchis viverrini, although in-vivo studies point to activity of mefloquine, artesunate, and tribendimidine against this liver fluke. We aimed to assess the efficacy and safety of these drugs compared with that of praziquantel in patients with O viverrini infection. METHODS: We did a randomised open-label trial between February and April, 2010, in the Saysetha district, Attapeu Province, Laos. Eligible patients were school children aged 10-15 years who had O viverrini infections. Patients were randomly assigned to one of five different treatment groups by use of a computer-generated randomisation code. We assessed efficacy as cure rate and egg reduction rate in intention-to-treat and per-protocol analyses. The trial was registered with Current Controlled Trials, ISRCTN23425032. RESULTS: 125 children were randomly assigned: 25 received mefloquine, 24 artesunate, 24 mefloquine-artesunate, 27 tribendimidine, and 25 praziquantel. 19 patients were lost to follow-up. In the intention to treat analysis, 14 patients receiving praziquantel were cured compared with none with mefloquine, one with artesunate (odds ratio 0.03, 95% CI 0.004-0.29), one with mefloquine-artesunate (0.03, 0.004-0.29), and 19 with tribendimidine (1.87, 0.60-5.85). Egg reduction rate was 98.4% for praziquantel, 30.2% for mefloquine (egg reduction-rate ratio 1.61, 95% CI 0.21-0.72), 31.5% for artesunate (0.43, 0.23-0.80), 41.3% for mefloquine-artesunate (0.60, 0.31-1.10), and 99.3% for tribendimidine (1.00, 0.44-2.30). Most adverse events were mild or moderate and affected all treatment groups; serious adverse events-vertigo, nausea, vomiting, and anxiety-were reported only by patients taking mefloquine or mefloquine-artesunate. INTERPRETATION: Tribendimidine seems to be at least as efficacious as the drug of choice, praziquantel, for the treatment of O viverrini infections; both drugs were well tolerated. Mefloquine, artesunate, and mefloquine-artesunate did not show an effect. Tribendimidine should be further investigated with large clinical trials. FUNDING: Swiss National Science Foundation, University of Basel
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Klinische Pharmakologie
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Klinische Pharmakologie
03 Faculty of Medicine > Departement Public Health > Sozial- und Präventivmedizin > Medical Services (Neumayr)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medicine (MED) > Medical Services (Neumayr)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Former Units within Swiss TPH > Health Impact Assessment (Utzinger)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Epidemiology and Public Health (EPH) > Infectious Disease Modelling > Epidemiology and Transmission Dynamics (Smith)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medical Parasitology and Infection Biology (MPI) > Helminth Drug Development (Keiser)
UniBasel Contributors:Vounatsou, Penelope and Odermatt, Peter and Hatz, Christoph and Keiser, Jennifer
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:Elsevier
ISSN:1473-3099
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
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Last Modified:30 Aug 2018 14:27
Deposited On:08 Nov 2012 16:08

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