Krishna Pandey1, Biplab Pal2, Niyamat Ali Siddiqui3, Chandra Shekhar Lal4, Vahab Ali5, Sanjiva Bimal6, Ashish Kumar7, Neena Verma8, Vidya Nand Rabi Das1, Shubhankar Kumar Singh5, Roshan Kamal Topno9, Pradeep Das7. 1. Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Patna, Bihar, India. 2. Department of Pharmacology, Lovely Professional University, Phagwara, Punjab. 3. Department of Biostatistics, Lovely Professional University, Phagwara, Punjab. 4. Department of Biochemistry, Lovely Professional University, Phagwara, Punjab. 5. Department of Microbiology, Lovely Professional University, Phagwara, Punjab. 6. Department of Immunology, Lovely Professional University, Phagwara, Punjab. 7. Department of Molecular Biology, Lovely Professional University, Phagwara, Punjab. 8. Department of Pathology, Lovely Professional University, Phagwara, Punjab. 9. Department of Epidemiology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Patna, Bihar, India.
Abstract
BACKGROUND: Treatment of post-kala-azar dermal leishmaniasis cases is of paramount importance for kala-azar elimination; however, limited treatment regimens are available as of now. AIM: To compare the effectiveness of liposomal amphotericin B vs miltefosine in post-kala-azar dermal leishmaniasis patients. METHODOLOGY: This was a randomized, open-label, parallel-group study. A total of 100 patients of post kala azar dermal leishmaniasis, aged between 5 and 65 years were recruited, 50 patients in each group A (liposomal amphotericin B) and B (miltefosine). Patients were randomized to receive either liposomal amphotericin B (30 mg/kg), six doses each 5 mg/kg, biweekly for 3 weeks or miltefosine 2.5 mg/kg or 100 mg/day for 12 weeks. All the patients were followed at 3rd, 6th and 12th months after the end of the treatment. RESULTS: In the liposomal amphotericin B group, two patients were lost to follow-up, whereas four patients were lost to follow-up in the miltefosine group. The initial cure rate by "intention to treat analysis" was 98% and 100% in liposomal amphotericin B and miltefosine group, respectively. The final cure rate by "per protocol analysis" was 74.5% and 86.9% in liposomal amphotericin B and miltefosine, respectively. Twelve patients (25.5%) in the liposomal amphotericin B group and six patients (13%) in the miltefosine group relapsed. None of the patients in either group developed any serious adverse events. LIMITATIONS: Quantitative polymerase chain reaction was not performed at all the follow-up visits and sample sizes. CONCLUSION: Efficacy of miltefosine was found to be better than liposomal amphotericin B, hence, the use of miltefosine as first-line therapy for post-kala-azar dermal leishmaniasis needs to be continued. However, liposomal amphotericin B could be considered as one of the treatment options for the elimination of kala-azar from the Indian subcontinent.
RCT Entities:
BACKGROUND: Treatment of post-kala-azar dermal leishmaniasis cases is of paramount importance for kala-azar elimination; however, limited treatment regimens are available as of now. AIM: To compare the effectiveness of liposomal amphotericin B vs miltefosine in post-kala-azar dermal leishmaniasispatients. METHODOLOGY: This was a randomized, open-label, parallel-group study. A total of 100 patients of post kala azar dermal leishmaniasis, aged between 5 and 65 years were recruited, 50 patients in each group A (liposomal amphotericin B) and B (miltefosine). Patients were randomized to receive either liposomal amphotericin B (30 mg/kg), six doses each 5 mg/kg, biweekly for 3 weeks or miltefosine 2.5 mg/kg or 100 mg/day for 12 weeks. All the patients were followed at 3rd, 6th and 12th months after the end of the treatment. RESULTS: In the liposomal amphotericin B group, two patients were lost to follow-up, whereas four patients were lost to follow-up in the miltefosine group. The initial cure rate by "intention to treat analysis" was 98% and 100% in liposomal amphotericin B and miltefosine group, respectively. The final cure rate by "per protocol analysis" was 74.5% and 86.9% in liposomal amphotericin B and miltefosine, respectively. Twelve patients (25.5%) in the liposomal amphotericin B group and six patients (13%) in the miltefosine group relapsed. None of the patients in either group developed any serious adverse events. LIMITATIONS: Quantitative polymerase chain reaction was not performed at all the follow-up visits and sample sizes. CONCLUSION: Efficacy of miltefosine was found to be better than liposomal amphotericin B, hence, the use of miltefosine as first-line therapy for post-kala-azar dermal leishmaniasis needs to be continued. However, liposomal amphotericin B could be considered as one of the treatment options for the elimination of kala-azar from the Indian subcontinent.
Authors: Krishna Pandey; V N R Das; Dharmendra Singh; Sushmita Das; C S Lal; N Verma; S Bimal; R K Topno; N A Siddiqui; R B Verma; P K Sinha; Pradeep Das Journal: J Clin Microbiol Date: 2012-01-25 Impact factor: 5.948
Authors: Shyam Sundar; J Chakravarty; V K Rai; N Agrawal; S P Singh; V Chauhan; Henry W Murray Journal: Clin Infect Dis Date: 2007-07-23 Impact factor: 9.079