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LETTER TO THE EDITOR

Dear Sir,

In a recent issue of The American Journal of Tropical Medicine and Hygiene, we reported the first Brazilian experience with the use of artemether-lumefantrine (Coartem) a fixed-dosed ACT combination.¹

We considered it relevant to emphasize the objectives of the study and its purposes. We are aware of the most recent World Health Organization (WHO) guidelines for in vivo studies of the efficacy of anti-malarials, which recommend a follow-up period of 42 days for Coartem.² However, the policy of the Brazilian Ministry of Health, determined in consultation with an Advisory Board on Antimalarial Therapy (composed of 10 Brazilian malaria experts from research institutes and universities), is to recommend a local preliminary study on safety and early treatment failure for any new anti-malarial . Therefore, the study, supported by Novartis, which was designed at the beginning of 2000, was conducted in response to a formal request from this Advisory Board to the Brazilian Ministry of Health, because Coartem had never previously been used in Brazil, as stated in the paper.

Obviously, the 7-day follow-up does not allow the real efficacy of the combination to be determined, but we believe that the preliminary data from this study on the safety and early treatment failure, as well as on the time to parasite clearance, were crucial for the design of a more robust field study. Such a study has been in progress in communities in the Amazon Basin in Brazil since 2003, with the support of UNDP/WORLD BANK/WHO Special Program for Research and Training in Tropical Diseases (TDR). In this study, a larger number of patients are being enrolled with the proper follow-up period of 42 days.

The authors of the paper, most of them members of the Advisory Board on Antimalarial Therapy from the Brazilian Ministry of Health and local coordinators of the PAHO’s Amazon Network for the Surveillance of Antimalarial Drug Resistance (RAVREDA) in cooperation with USAID’s Amazon Malaria Initiative, believe that the introduction of a new anti-malarial combination as a first-line treatment should be regarded as an important step in Public Health Programs, and the protocols used to obtain preliminary data should be distinguished from those used for a full evaluation of the efficacy of new antimalarials.

1. Alecrim MG, Lacerda MV, Mourao MP, Alecrim WD, Padilha A, Cardoso BS, Boulos M, 2006. Successful treatment of Plasmodium falciparum malaria with a six-dose regimen of artemether-lumefantrine versus quinine-doxycycline in the Western Amazon region of Brazil. Am J Trop Med Hyg 74: 20–25.[Abstract/Free Full Text]
2. World Health Organization, 2002. Monitoring Antimalarial Drug Resistance, Report of a WHO Consultation. Available at http://www.who.int/malaria/cmc_upload/0/000/015/800/200239.pdf. Accessed April 11, 2006.

This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Web of Science (2) Citing Articles via Google Scholar Google Scholar Articles by Alecrim, M. d. G. C. Articles by Boulos, M. Search for Related Content PubMed PubMed Citation Articles by Alecrim, M. d. G. C. Articles by Boulos, M.