Guerin PJ, Olliaro P, Sundar S, Boelaert M, Croft SL, Desjeux P, Wasunna MK, Bryceson AD, 2002. Visceral leishmaniasis: current status of control, diagnosis, and treatment, and proposed research and development agenda. Lancet Infect Dis 2: 494–501.
Sundar S, More DK, Singh MK, Singh VP, Sharma S, Makharia A, Kumar PC, Murray HW, 2000. Failure of pentavalent antimony in visceral leishmaniasis in India: report from the center of the Indian epidemic. Clin Infect Dis 31: 1104–1107.
Sundar S, Chakravarty P, Agarwal D, Rai M, Murray HM, 2010. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 362: 504–512.
Meheus F, Balasegaram M, Olliaro P, Sundar S, Rijal S, Faiz MA, Boelaert M, 2010. Cost-effectiveness analysis of combination therapies for visceral leishmaniasis in the Indian subcontinent. PLoS Negl Trop Dis 4: e818.
Sundar S, Jha TK, Thakur CP, Engel J, Sindermann H, Fischer C, Junge K, Bryceson A, Berman J, 2002. Oral miltefosine for Indian visceral leishmaniasis. N Engl J Med 347: 1739–1746.
Bhattacharya SK, Sinha PK, Sundar S, Thakur CP, Jha TK, Pandey K, Das VR, Kumar N, Lal C, Verma N, Singh VP, Ranjan A, Verma RB, Anders G, Sindermann H, Ganguly NK, 2007. Phase 4 trial of miltefosine for the treatment of Indian visceral leishmaniasis. J Infect Dis 196: 591–598.
Boelaert M, El-Safi S, Hailu A, Mukhtar M, Rijal S, Sundar S, Wasunna M, Aseffa A, Mbui J, Menten J, Desjeux P, Peeling R, 2008. Diagnostic tests for kala-azar: a multi-centre study of the freeze-dried DAT, rK39 strip test and KAtex in east Africa and the Indian subcontinent. Trans R Soc Trop Med Hyg 102: 32–40.
Common Toxicity Criteria of the NCI. Version 2.0, 1999. Bethesda, MD: National Cancer Institute.
Jha TK, Sundar S, Thakur CP, Bachmann P, Karbwang J, Fischer C, Voss A, Berman J, 1999. Miltefosine, an oral agent, for the treatment of Indian visceral leishmaniasis. N Engl J Med 341: 1795–1800.
Sundar S, Chakravarty J, Rai VK, Agrawal N, Singh SP, Chauhan V, Murray HW, 2007. Amphotericin B treatment for Indian visceral leishmaniasis: response to 15 daily versus alternate-day infusions. Clin Infect Dis 45: 556–561.
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Miltefosine (target dose of 2.5 mg/kg/day for 28 days) is the recommended treatment for visceral leishmaniasis (kala-azar) in Bangladesh on the basis of data from India. We evaluated miltefosine in a phase IV trial of 977 patients in Bangladesh. At the six-month final follow up, 701 were cured. 24 showed initial treatment failure, and 95 showed treatment failure at 6 months, although 73 of the 95 showed treatment failure solely by the criterion of low hemoglobin values. One hundred twenty-one patients were not assessable. With the conservative assumption that all low hemoglobin values represented treatment failure, the final per protocol cure rate was 85%. Of 13 severe adverse events, 6 led to treatment discontinuation and 7 resulted in deaths, but only 1 death (associated with diarrhea) could be attributed to drug. Nearly all non-serious adverse events were gastrointestinal: vomiting in 25% of patients and diarrhea in 8% of patients. Oral miltefosine is an attractive alternative to intramuscular antimony and intravenous amphotericin B for treatment of kala-azar in Bangladesh.
Financial support: The study was funded by the Special Program for Research and Training in Tropical Diseases (TDR-WHO), by a grant to Mahmudur Rahman.
Authors' addresses: Mahmudur Rahman and Be-Nazir Ahmed, Institute Of Epidemiology, Disease Control and Research, Dhaka, Bangladesh, E-mail: mrahman@citechco.net. M. Abul Faiz, Dhaka Medical College, Dhaka, Bangladesh. M. Zafor Ullah Chowdhury, National Institute of Preventive and Social Medicine, Dhaka, Bangladesh. Quazi Tarikul Islam, Rajshahi Medical College, Rajshahi, Bangladesh. Rahman Sayeedur, Mymensingh Medical College, Mymensingh, Bangladesh. M. Ridwanur Rahman and M. Nazrul Islam, Dhaka Medical College, Dhaka, Bangladesh. Moazzem Hossain, Directorate of Health Services, Dhaka, Bangladesh. Abdul Mannan Bangali and Ziauddin Ahmad, World Health Organization Regional Office, Dhaka, Bangladesh. C. G. Nicholas Mascie-Taylor, Department of Biological Anthropology, Cambridge University, Cambridge CB2 1QH, United Kingdom. Jonathan Berman, Fast-Track Drugs and Biologics LLC, North Bethesda, Potomac, MD, E-mail: jbe9320457@aol.com. Byron Arana, World Health Organization, Special Programme for Research and Training in Tropical Diseases, TDR-WHO, Geneva, Switzerland, E-mail: aranab@who.int.
Guerin PJ, Olliaro P, Sundar S, Boelaert M, Croft SL, Desjeux P, Wasunna MK, Bryceson AD, 2002. Visceral leishmaniasis: current status of control, diagnosis, and treatment, and proposed research and development agenda. Lancet Infect Dis 2: 494–501.
Sundar S, More DK, Singh MK, Singh VP, Sharma S, Makharia A, Kumar PC, Murray HW, 2000. Failure of pentavalent antimony in visceral leishmaniasis in India: report from the center of the Indian epidemic. Clin Infect Dis 31: 1104–1107.
Sundar S, Chakravarty P, Agarwal D, Rai M, Murray HM, 2010. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 362: 504–512.
Meheus F, Balasegaram M, Olliaro P, Sundar S, Rijal S, Faiz MA, Boelaert M, 2010. Cost-effectiveness analysis of combination therapies for visceral leishmaniasis in the Indian subcontinent. PLoS Negl Trop Dis 4: e818.
Sundar S, Jha TK, Thakur CP, Engel J, Sindermann H, Fischer C, Junge K, Bryceson A, Berman J, 2002. Oral miltefosine for Indian visceral leishmaniasis. N Engl J Med 347: 1739–1746.
Bhattacharya SK, Sinha PK, Sundar S, Thakur CP, Jha TK, Pandey K, Das VR, Kumar N, Lal C, Verma N, Singh VP, Ranjan A, Verma RB, Anders G, Sindermann H, Ganguly NK, 2007. Phase 4 trial of miltefosine for the treatment of Indian visceral leishmaniasis. J Infect Dis 196: 591–598.
Boelaert M, El-Safi S, Hailu A, Mukhtar M, Rijal S, Sundar S, Wasunna M, Aseffa A, Mbui J, Menten J, Desjeux P, Peeling R, 2008. Diagnostic tests for kala-azar: a multi-centre study of the freeze-dried DAT, rK39 strip test and KAtex in east Africa and the Indian subcontinent. Trans R Soc Trop Med Hyg 102: 32–40.
Common Toxicity Criteria of the NCI. Version 2.0, 1999. Bethesda, MD: National Cancer Institute.
Jha TK, Sundar S, Thakur CP, Bachmann P, Karbwang J, Fischer C, Voss A, Berman J, 1999. Miltefosine, an oral agent, for the treatment of Indian visceral leishmaniasis. N Engl J Med 341: 1795–1800.
Sundar S, Chakravarty J, Rai VK, Agrawal N, Singh SP, Chauhan V, Murray HW, 2007. Amphotericin B treatment for Indian visceral leishmaniasis: response to 15 daily versus alternate-day infusions. Clin Infect Dis 45: 556–561.
Past two years | Past Year | Past 30 Days | |
---|---|---|---|
Abstract Views | 501 | 419 | 27 |
Full Text Views | 424 | 8 | 0 |
PDF Downloads | 126 | 8 | 0 |