Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated Plasmodium falciparum malaria in India

Malaria Journal

Research

Prabhash C Bhattacharyya¹  Nagesh Dubashi²  David Ubben³  Bina Srivastava⁴  Neena Valecha⁴  Susanta K Ghosh⁵  Ashwani Kumar⁶  Vas Dev⁷  Silva Tommasini⁸  Nicola Gargano⁸  Marco Corsi⁸  Antonella Bacchieri⁸  Bappanad HK Rao⁹ 

[1] Down Town Hospital, Guwahati, Assam, India;Goa Medical College, Bambolim, Goa, India;Medicines for Malaria Venture (MMV), Geneva, Switzerland;National Institute of Malaria Research (ICMR), Sector-8, 110 077, Dwarka, New Delhi, India;National Institute of Malaria Research, Field Station, Bangalore, Karnataka, India;National Institute of Malaria Research, Field Station, Goa, India;National Institute of Malaria Research, Field Station, Guwahati, Assam, India;Sigma-Tau Industrie Farmaceutiche Riunite, Pomezia, Italy;Wenlock District Government Hospital, Mangalore, Karnataka, India;

关键词: Plasmodium falciparum;    Malaria;    Artemisinin-based combination therapy (ACT);    Dihydroartemisinin-piperaquine;    Artesunate;    Mefloquine;    India;   

DOI  :  10.1186/1475-2875-11-233

 received in 2012-04-10, accepted in 2012-07-05,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundResistance in Plasmodium falciparum to commonly used anti-malarial drugs, especially chloroquine, is being increasingly documented in India. By 2007, the first-line treatment for uncomplicated malaria has been revised to recommend artemisinin-based combination therapy (ACT) for all confirmed P. falciparum cases.ObjectiveThe objective of this study was to compare the efficacy, safety and tolerability between dihydroartemisinin-piperaquine (DP) and artesunate plus mefloquine (A + M) drug combinations in the treatment of uncomplicated P. falciparum malaria in India.MethodsBetween 2006 and 2007, 150 patients with acute uncomplicated P. falciparum malaria were enrolled, randomized to DP (101) or A + M (49) and followed up for 63 days as part of an open-label, non-inferiority, randomized, phase III multicenter trial in Asia.ResultsThe heterogeneity analysis showed no statistically significant difference between India and the other countries involved in the phase III study, for both the PCR-corrected and uncorrected cure rates. As shown at the whole study level, both forms of ACT were highly efficacious in India. In fact, in the per protocol population, the 63-day cure rates were 100% for A + M and 98.8% for DP. The DP combination exerted a significant post-treatment prophylactic effect, and compared with A + M a significant reduction in the incidence of new infections for DP was observed (respectively 17.1% versus 7.5% of patients experienced new infection within follow up). Parasite and fever clearance was rapid in both treatment arms (median time to parasite clearance of one day for both groups). Both DP and A + M were well tolerated, with the majority of adverse events of mild or moderate severity. The frequencies of individual adverse events were generally similar between treatments, although the incidence of post treatment adverse events was slightly higher in patients who received A + M with respect to those treated with DP.ConclusionDP is a new ACT displaying high efficacy and safety in the treatment of uncomplicated P. falciparum malaria and could potentially be considered for the first-line treatment of uncomplicated falciparum malaria in India.Trial registrationCurrent Controlled Trials ISRCTN 81306618

【 授权许可】

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© Gargano et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.