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In 19821984 we conducted a six-month clinical trial in 50 previously untreated lepromatous leprosy patients randomly assigned to directly observed monotherapy with one of two thioamides, ethionamide or prothionamide, each given six times a week at doses of either 250 mg or 500 mg. The findings of this study have only recently been analyzed, and the potential for the use of these thioamides in leprosy patients placed in perspective. However, because of the small number of patients included in this study, the results must be interpreted with some caution. Clinical improvement was noted in 74% of the patients treated with ethionamide and in 83% of those treated with prothionamide. Therapy was well tolerated and drug-related hepatotoxicity did not require discontinuation of therapy. The 500-mg dose of both ethionamide and prothionamide resulted in loss in Mycobacterium leprae viability more rapidly than did the 250-mg dose, and prothionamide at both dose levels was superior to the equivalent dose of ethionamide. Overall killing of M. leprae in this study was found to be similar to that obtained previously with dapsone and clofazimine, but less than was obtained with rifampin, minocycline, clarithromycin, pefloxacin, and ofloxacin.
Received January 26, 2005. Accepted for publication October 24, 2005.
Acknowledgments: We thank Judy Maseli (School of Medicine, University of California, San Francisco) for statistical consultations.
Financial support: This study was supported by the United Nations Development Program/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases.
* Address correspondence to Robert H. Gelber, 220 Scenic Avenue, San Anselmo, CA 94960. E-mail: ikgelber{at}hotmail.com
Authors address: Tranquilino T. Fajardo, Ricardo S. Guinto, Roland V. Cellona, Rodolfo M. Abalos, and Eduardo C. Dela Cruz, Leonard Wood Memorial Center for Leprosy Research, Cebu City, Philippines, Telephone and Fax: 63-32-345-2751, E-mails: lwmrectr{at}cvis.net.ph, csc-epi{at}cvis.net.ph, and lwmrectr{at}cvis.net.ph. Robert H. Gelber, 220 Scenic Avenue, San Anselmo, CA 94960, Telephone: 415-154-8765, Fax: 415-454-8197, E-mail: ikgelber{at}hotmail.com.
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