World Health Organization, 1998. The World Health Report, 1998: Life in the 21st Century: A Vision for All. Geneva, Switzerland: World Health Organization, 45.
Directorate of National Vector Borne Disease Control Programme, 2008. National Vector Borne Disease Control Programme. Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, New Delhi.
World Health Organization, 2010. Control of the Leishmaniasis: Report of a Meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22–26 March 2010. Geneva, Switzerland: World Health Organization, 73.
Meyboom RHB, Royer RJ, 1992. Causality classification in pharmacovigilance centres in the European community. Pharmacoepidemiol Drug Saf 1: 87–97.
Meyboom RHB, Hekster YA, Egberts ACG, Gribnau FWJ, Edwards IR, 1997. Causal or casual? The role of causality assessment in pharmacovigilance. Drug Saf 17: 374–389.
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 lesihmaniasis. J Infect Dis 196: 591–598.
National Vector Borne Disease Control Programme, 2008. Project Implementation Plan: National Vector Borne Disease Control Support Project under World Bank on Malaria Control and Kala-Azar Elimination (2008–2013). Available at: http://nvbdcp.gov.in/Doc/PIP.pdf. Accessed January 20, 2014.
Sundar S, Rai M, 2002. Laboratory diagnosis of visceral leishmaniasis. Clin Diagn Lab Immunol 9: 951–958.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ, 1981. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 30: 239–245.
Uppsala Monitoring Centre, 2011. The Use of the WHO–UMC System for Standardized Case Causality Assessment. Available at: http://www.WHO-UMC.org/graphics/26649.pdf. Accessed April 21, 2015.
Pandey K, Singh D, Lal CS, Das VNR, Das P, 2013. Fatal acute pancreatitis in a patient with visceral leishmaniasis during miltefosine treatment. J Postgrad Med 59: 306–308.
Sundar S, Singh A, Chakravarty J, Rai M, 2015. Efficacy and safety of miltefosine in treatment of post-kala-azar dermal leishmaniasis. Scientific World J 2015: 414378.
Sundar S, Singh A, Rai M, Prajapati VK, Singh AK, Ostyn B, Boelaert M, Dujardin JC, Chakravarty J, 2012. Efficacy of miltefosine in the treatment of visceral leishmaniasis in India after a decade of use. CID 55: 543–550.
Dorlo TPC, Balasegaram M, Beijnen JH, de Vries PJ, 2012. Miltefosine: a review of its pharmacology and therapeutic efficacy in the treatment of leishmaniasis. J Antimicrob Chemother 67: 2576–2597.
Burza S, Sinha PK, Mahajan R, Lima MA, Mitra G, Verma N, Balsegaram M, Das P, 2014. Risk factors for visceral leishmaniasis relapse in immunocompetent patients following treatment with 20 mg/kg liposomal amphotericin B (ambisome) in Bihar, India. PLoS Negl Trop Dis 8: e2536.
|Past two years||Past Year||Past 30 Days|
|Full Text Views||323||114||2|
Miltefosine, the only oral drug for visceral leishmaniasis (VL), is being used as the first-line drug under the VL elimination program in the Indian subcontinent. Miltefosine is an oral drug which was used as a topical application for skin metastasis of breast cancer. It was found to be effective against Leishmania donovani. The main adverse events (AE) reported previously with miltefosine use includes diarrhea, vomiting, and dehydration. Other AEs include, raised serum alanine transaminase/aspartate aminotransferase and renal parameters such as creatinine. In this study, we report AEs in a large patient cohort of VL treated with miltefosine. The purpose of this pharmacovigilance study was to assess adverse drug reactions (ADRs)/AE of miltefosine treatment under unrestricted condition in the field setup. Patients were followed up to 6 months for therapeutic effectiveness. Outcomes of a larger data set of patients treated with this regimen from April 2012 to March 2015 were recorded. In the present study, 646 patients of VL were given miltefosine. Majority of the study subjects (58%) were male. Relapse occurred in 7% during follow-up period. Main causes of death were VL–pulmonary tuberculosis coinfection, extreme diarrhea, and acute pancreatitis which were reported in 1.7% subjects. Of 553 (85.6%) patients completing full course of treatment, 463 (83.7%) showed ADR with miltefosine during the study period. About 2.3% were suffering severe ADR, 51% from moderate, and the rest had mild ADR. The initial and final cure rate was 97.4% and 85.6%, respectively.
Financial support: This work was supported by NVBDCP/World Bank (grant no. 3-87/2008-09/NVBDCP/WB/RMRI/Pharmaco).
Authors' addresses: Krishna Pandey, Vidyanand Ravidas, Niyamat A. Siddiqui, Sanjay K. Sinha, Rakesh B. Verma, and Pradeep Das, Rajendra Memorial Research Institute of Medical Sciences, Indian Council of Medical Research, Patna, India, E-mails: email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, and firstname.lastname@example.org. Tripurari P. Singh, Sadar Hospital, East Champaran, Bihar, India, E-mail: email@example.com. A. C. Dhariwal and R. K. Das Gupta, Directorate of National Vector Borne Disease Control Programme (NVBDCP), Delhi, India, E-mails: firstname.lastname@example.org and email@example.com.