Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated <it>Plasmodium falciparum</it> malaria in India
<p>Abstract</p> <p>Background</p> <p>Resistance in <it>Plasmodium falciparum</it> 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 re...
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doaj-876df0c39d2947a69196d525898b63c82020-11-24T21:43:26ZengBMCMalaria Journal1475-28752012-07-0111123310.1186/1475-2875-11-233Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated <it>Plasmodium falciparum</it> malaria in IndiaGargano NicolaUbben DavidTommasini SilvaBacchieri AntonellaCorsi MarcoBhattacharyya Prabhash CRao Bappanad HKDubashi NageshDev VasGhosh Susanta KKumar AshwaniSrivastava BinaValecha Neena<p>Abstract</p> <p>Background</p> <p>Resistance in <it>Plasmodium falciparum</it> 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 <it>P. falciparum</it> cases.</p> <p>Objective</p> <p>The 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 <it>P. falciparum</it> malaria in India.</p> <p>Methods</p> <p>Between 2006 and 2007, 150 patients with acute uncomplicated <it>P. falciparum</it> 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.</p> <p>Results</p> <p>The 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.</p> <p>Conclusion</p> <p>DP is a new ACT displaying high efficacy and safety in the treatment of uncomplicated <it>P. falciparum</it> malaria and could potentially be considered for the first-line treatment of uncomplicated falciparum malaria in India.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN 81306618</p> http://www.malariajournal.com/content/11/1/233<it>Plasmodium falciparum</it>MalariaArtemisinin-based combination therapy (ACT)Dihydroartemisinin-piperaquineArtesunateMefloquineIndia |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Gargano Nicola Ubben David Tommasini Silva Bacchieri Antonella Corsi Marco Bhattacharyya Prabhash C Rao Bappanad HK Dubashi Nagesh Dev Vas Ghosh Susanta K Kumar Ashwani Srivastava Bina Valecha Neena |
spellingShingle |
Gargano Nicola Ubben David Tommasini Silva Bacchieri Antonella Corsi Marco Bhattacharyya Prabhash C Rao Bappanad HK Dubashi Nagesh Dev Vas Ghosh Susanta K Kumar Ashwani Srivastava Bina Valecha Neena Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated <it>Plasmodium falciparum</it> malaria in India Malaria Journal <it>Plasmodium falciparum</it> Malaria Artemisinin-based combination therapy (ACT) Dihydroartemisinin-piperaquine Artesunate Mefloquine India |
author_facet |
Gargano Nicola Ubben David Tommasini Silva Bacchieri Antonella Corsi Marco Bhattacharyya Prabhash C Rao Bappanad HK Dubashi Nagesh Dev Vas Ghosh Susanta K Kumar Ashwani Srivastava Bina Valecha Neena |
author_sort |
Gargano Nicola |
title |
Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated <it>Plasmodium falciparum</it> malaria in India |
title_short |
Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated <it>Plasmodium falciparum</it> malaria in India |
title_full |
Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated <it>Plasmodium falciparum</it> malaria in India |
title_fullStr |
Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated <it>Plasmodium falciparum</it> malaria in India |
title_full_unstemmed |
Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated <it>Plasmodium falciparum</it> malaria in India |
title_sort |
therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated <it>plasmodium falciparum</it> malaria in india |
publisher |
BMC |
series |
Malaria Journal |
issn |
1475-2875 |
publishDate |
2012-07-01 |
description |
<p>Abstract</p> <p>Background</p> <p>Resistance in <it>Plasmodium falciparum</it> 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 <it>P. falciparum</it> cases.</p> <p>Objective</p> <p>The 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 <it>P. falciparum</it> malaria in India.</p> <p>Methods</p> <p>Between 2006 and 2007, 150 patients with acute uncomplicated <it>P. falciparum</it> 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.</p> <p>Results</p> <p>The 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.</p> <p>Conclusion</p> <p>DP is a new ACT displaying high efficacy and safety in the treatment of uncomplicated <it>P. falciparum</it> malaria and could potentially be considered for the first-line treatment of uncomplicated falciparum malaria in India.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN 81306618</p> |
topic |
<it>Plasmodium falciparum</it> Malaria Artemisinin-based combination therapy (ACT) Dihydroartemisinin-piperaquine Artesunate Mefloquine India |
url |
http://www.malariajournal.com/content/11/1/233 |
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