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EFFICACY AND SAFETY OF THE SIX-DOSE REGIMEN OF ARTEMETHER-LUMEFANTRINE IN PEDIATRICS WITH UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA: A POOLED ANALYSIS OF INDIVIDUAL PATIENT DATA

Patient data from eight clinical trials were pooled and analyzed to study the efficacy and safety of the six-dose versus four-dose regimen of artemether-lumefantrine (coartemether; Coartem) in children weighing 5–25 kg. A total of 544 patients with uncomplicated P. falciparum malaria (six-dose: 343; four-dose: 201), matched for demographic and baseline characteristics and individual coartemether doses were included in the analysis. Analysis of day 28 cure rate based on the intention-to-treat and evaluable populations yielded corrected cure rates for the six-dose regimen of 93% and 96% compared with 61% and 76%, respectively, for the four-dose regimen (P < 0.0001 for both comparisons). Similarly high cure rates were achieved with the six-dose regimen in non-immune infants weighing as little as 5 kg. The six- and four-dose regimens were equally well tolerated. The main finding of this analysis is that the six-dose regimen of coartemether is safe and more efficacious than the four-dose regimen in children.

Received December 21, 2005. Accepted for publication February 6, 2006.

Acknowledgments: Biometry and statistical analysis was carried out by DATAMAP GmbH, Freiburg, Germany. We are grateful to Mrs. Mailis Virtanen for her help and support in conducting this analysis.

Financial support: This pooled analysis was funded by Novartis Pharma AG, Basel, Switzerland.

Disclosure: Some of the authors are Novartis employees and have no conflicts of interest concerning the work reported in this paper.

^* Address correspondence to Edgar A. Mueller, Institute for Clinical Pharmacology, Public Health Research Association Saxony, Medical Faculty, Technical University, Fiedlerstrasse 27, D-01307 Dresden, Germany. E-mail: Edgar.Mueller{at}mailbox.tu-dresden.de

Authors’ addresses: Michael Makanga, European and Developing Countries Clinical Trials Partnership (EDCTP), PO Box 19070, Francie van Zijl Drive, Parow Valley 7500, Cape Town, Tygerberg 7505, South Africa. Zul Premji, Department of Parasitology and Entomology, Muhimbili Medical Centre, PO Box 65001, Dar es Salaam, Tanzania. Catherine Falade, Department of Pharmacology and Therapeutics, College of Medicine, University of Ibadan, Ibadan, Nigeria. Juntra Karbwang, WHO, Avenue Appia 20, CH-1211 Geneva 27, Switzerland. Edgar A. Mueller, Institute for Clinical Pharmacology, Public Health Research Association Saxony, Medical Faculty, Technical University, Fiedlerstrasse 27, D-01307 Dresden, Germany, E-mail: Edgar.Mueller{at}mailbox.tu-dresden.de. Kim Andriano, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936-1080. Philip Hunt, Novartis Horsham Research Centre, Wimblehurst Road, Horsham, RH12 5AB, UK. Patricia Ibarra de Palacios, Novartis Pharma AG, Clinical Research, Lichtstrasse 35, CH-4056 Basel, Switzerland.

Reprint requests: Edgar A. Mueller, MD, Institute for Clinical Pharmacology, Public Health Research Association Saxony, Medical Faculty, Technical University, Fiedlerstrasse 27, D-01307 Dresden, Germany. E-mail: Edgar.Mueller{at}mailbox.tu-dresden.de.