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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Safety and efficacy of dihydroartemisinin-piperaquine in falciparum malaria: A prospective multi-centre individual patient data analysis
PLoS ONE, Volume 4, No. 7, Article e6358, Year 2009
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Description
Background: The fixed dose antimalarial combination of dihydroartemisinin-piperaquine (DP) is a promising new artemisinin-based combination therapy (ACT). We present an individual patient data analysis of efficacy and tolerability in acute uncomplicated falciparum malaria, from seven published randomized clinical trials conducted in Africa and South East Asia using a predefined in-vivo protocol. Comparator drugs were mefloquine-artesunate (MAS3) in Thailand, Myanmar, Laos and Cambodia; artemether-lumefantrine in Uganda; and amodiaquine+sulfadoxine-pyrimethamine and artesunate+amodiaquine in Rwanda. Methods and Findings: In total 3,547 patients were enrolled: 1,814 patients (32% children under five years) received DP and 1,733 received a comparator antimalarial at 12 different sites and were followed for 28-63 days. There was no significant heterogeneity between trials. DP was well tolerated with 1.7% early vomiting. There were less adverse events with DP in children and adults compared to MAS3 except for diarrhea; ORs (95%CI) 2.74 (2.13 to 3.51) and 3.11 (2.31 to 4.18), respectively. DP treatment resulted in a rapid clearance of fever and parasitaemia. The PCR genotype corrected efficacy at Day 28 of DP assessed by survival analysis was 98.7% (95%CI 97.6-99.8). DP was superior to the comparator drugs in protecting against both P.falciparum recurrence and recrudescence (P = 0.001, weighted by site). There was no difference between DP and MAS3 in treating P. vivax co-infections and in suppressing the first relapse (median interval to P. vivax recurrence: 6 weeks). Children under 5 y were at higher risk of recurrence for both infections. The proportion of patients developing gametocytaemia (P = 0.002, weighted by site) and the subsequent gametocyte carriage rates were higher with DP (11/1000 person gametocyte week, PGW) than MAS3 (6/ 1000 PGW, P = 0.001, weighted by site). Conclusions: DP proved a safe, well tolerated, and highly effective treatment of P.falciparum malaria in Asia and Africa, but the effect on gametocyte carriage was inferior to that of MAS3. © 2009 Zwang et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2716525/bin/pone.0006358.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2716525/bin/pone.0006358.s002.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2716525/bin/pone.0006358.s003.doc
Authors & Co-Authors
Zwang, Julien
Thailand, Mae Sod
Shoklo Malaria Research Unit
Ashley, Elizabeth A.
Thailand, Mae Sod
Shoklo Malaria Research Unit
Karema, Corine Kakizi
Rwanda, Kigali
National Malaria Control Program
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
D'Alessandro, Umberto
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Smithuis, Frank M.
Switzerland, Geneva
Medecins Sans Frontieres
Dorsey, Grant M.
United States, San Francisco
Ucsf School of Medicine
Janssens, Bart
Switzerland, Geneva
Medecins Sans Frontieres
Mayxay, Mayfong
United Kingdom, Oxford
Nuffield Department of Medicine
Thailand
Mahosot Hospital, Lao
Laos, Vientiane
University of Health Sciences
Newton, Paul N.
Thailand
Mahosot Hospital, Lao
Singhasivanon, Pratap
Thailand, Nakhon Pathom
Mahidol University
Stepniewska, K. A.
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
Nuffield Department of Medicine
White, Nicholas J.
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
Nuffield Department of Medicine
Nosten, François Henry
Thailand, Mae Sod
Shoklo Malaria Research Unit
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
Nuffield Department of Medicine
Statistics
Citations: 110
Authors: 13
Affiliations: 9
Identifiers
Doi:
10.1371/journal.pone.0006358
e-ISSN:
19326203
Research Areas
Genetics And Genomics
Health System And Policy
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Cohort Study
Study Locations
Rwanda
Uganda