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Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomised comparison.

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dc.contributor Médecins Sans Frontières (Holland), Yangon, Myanmar.
dc.creator Smithuis, F
dc.creator Kyaw, M K
dc.creator Phe, O
dc.creator Aye, K Z
dc.creator Htet, L
dc.creator Barends, M
dc.creator Lindegardh, N
dc.creator Singtoroj, T
dc.creator Ashley, E A
dc.creator Lwin, S
dc.creator Stepniewska, K
dc.creator White, N J
dc.date 2006-06-24
dc.date.accessioned 2017-01-31T07:09:16Z
dc.date.available 2017-01-31T07:09:16Z
dc.identifier Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomised comparison. 2006, 367 (9528):2075-85 Lancet
dc.identifier 1474-547X
dc.identifier 16798391
dc.identifier 10.1016/S0140-6736(06)68931-9
dc.identifier http://hdl.handle.net/10144/17250
dc.identifier http://fieldresearch.msf.org/msf/handle/10144/17250
dc.identifier Lancet
dc.identifier.uri http://dspace.mediu.edu.my:8181/xmlui/handle/10144/17250
dc.description BACKGROUND: Artemisinin-based combinations are judged the best treatments for multidrug-resistant Plasmodium falciparum malaria. Artesunate-mefloquine is widely recommended in southeast Asia, but its high cost and tolerability profile remain obstacles to widespread deployment. To assess whether dihydroartemisinin-piperaquine is a suitable alternative to artesunate-mefloquine, we compared the safety, tolerability, efficacy, and effectiveness of the two regimens for the treatment of uncomplicated falciparum in western Myanmar (Burma). METHODS: We did an open randomised comparison of 3-day regimens of artesunate-mefloquine (12/25 mg/kg) versus dihydroartemisinin-piperaquine (6.3/50 mg/kg) for the treatment of children aged 1 year or older and in adults with uncomplicated falciparum malaria in Rakhine State, western Myanmar. Within each group, patients were randomly assigned supervised or non-supervised treatment. The primary endpoint was the PCR-confirmed parasitological failure rate by day 42. Failure rates at day 42 were estimated by Kaplan-Meier survival analysis. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN27914471. FINDINGS: Of 652 patients enrolled, 327 were assigned dihydroartemisinin-piperaquine (156 supervised and 171 not supervised), and 325 artesunate-mefloquine (162 and 163, respectively). 16 patients were lost to follow-up, and one patient died 22 days after receiving dihydroartemisinin-piperaquine. Recrudescent parasitaemias were confirmed in only two patients; the day 42 failure rate was 0.6% (95% CI 0.2-2.5) for dihydroartemisinin-piperaquine and 0 (0-1.2) for artesunate-mefloquine. Whole-blood piperaquine concentrations at day 7 were similar for patients with observed and non-observed dihydroartemisinin-piperaquine treatment. Gametocytaemia developed more frequently in patients who had received dihydroartemisinin-piperaquine than in those on artesunate-mefloquine: day 7, 18 (10%) of 188 versus five (2%) of 218; relative risk 4.2 (1.6-11.0) p=0.011. INTERPRETATION: Dihydroartemisinin-piperaquine is a highly efficacious and inexpensive treatment of multidrug-resistant falciparum malaria and is well tolerated by all age groups. The effectiveness of the unsupervised treatment, as in the usual context of use, equalled its supervised efficacy, indicating good adherence without supervision. Dihydroartemisinin-piperaquine is a good alternative to artesunate-mefloquine.
dc.language en
dc.publisher Elsevier
dc.relation http://www.thelancet.com
dc.rights Reproduced on this site with permission of Elsevier Ltd. Please see www.thelancet.com for further relevant comment.
dc.title Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomised comparison.


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