Randomized Comparison of Artemether-Benflumetol and Artesunate-Mefloquine in Treatment of MultidrugResistant Falciparum Malaria

Author:

van Vugt M.123,Brockman A.12,Gemperli B.4,Luxemburger C.12,Gathmann I.4,Royce C.4,Slight Thra1,Looareesuwan S.2,White N. J.125,Nosten F.125

Affiliation:

1. Shoklo Malaria Research Unit, Mae Sod, Tak Province,1 and

2. Faculty of Tropical Medicine, Mahidol University, Bangkok,3Thailand;

3. Division of Infectious Diseases, Tropical Medicine and AIDS, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands2;

4. Novartis, International Clinical Research, Basel, Switzerland4; and

5. Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, John Radcliffe Hospital, Headington, Oxford, United Kingdom5

Abstract

ABSTRACT An open, randomized comparison of artemether-benflumetol (CGP 56 697; Novartis) with artesunate-mefloquine was conducted in 617 patients with acute uncomplicated multidrug-resistant falciparum malaria on the western border of Thailand. Both treatments rapidly and reliably cleared fever and parasitemia, and there was no significant difference in the initial therapeutic response parameters. Parasite genotyping was used to distinguish recrudescences from new infections. The 63-day cure rate for artesunate-mefloquine (94%) was significantly higher than the cure rate for artemether-benflumetol (81%) ( P < 0.001). Both regimens were well tolerated. Nausea, vomiting, dizziness, sleep disorders, and other neurological side effects were between two and four times more common in the artesunate-mefloquine group than in the artemether-benflumetol group ( P < 0.001). Artemether-benflumetol is effective and very well tolerated in the treatment of multidrug-resistant falciparum malaria. A higher dose than that used in the present study may improve efficacy.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Reference23 articles.

1. Fatal neurotoxicity of arteether and artemether;Brewer T. G.;Am. J. Trop. Med. Hyg.,1994

2. Brockman A. Unpublished observations.

3. Clinical trial of artesunate and artemether on multidrug resistant falciparum malaria in Thailand: a preliminary report;Bunnag D.;Southeast Asian J. Trop. Med. Public Health,1991

4. Drug resistant malaria with special reference to Thailand;Looareesuwan S.;Southeast Asian J. Trop. Med. Public Health,1992

5. Looareesuwan S. 1994. Overview of clinical studies on artemisinin derivatives in Thailand. Trans. R. Soc. Trop. Med. Hyg. 88 (Suppl. 1) : 9–11.

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