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To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL).
PLoS One. 2017; 12(3):e0174497.Plos

Abstract

BACKGROUND

Post kala-azar dermal leishmaniasis (PKDL) is a skin disorder that usually occurs among patients with a past history of visceral leishmaniasis (VL). Cases are also reported without a history of VL. There is no satisfactory treatment regimen available at present. We aimed to compare the efficacy and safety of amphotericin B in two different doses (0.5mg/kg vs 1mg/kg) in a prospective randomized trial in 50 PKDL patients.

METHODS

In this open label study 50 patients with PKDL, aged between 5-60 years were randomized in two groups. Group A received amphotericin B in the dose of 0.5 mg/kg in 5% dextrose, daily for 20 infusions for 3 courses at an interval of 15 days between each course and Group B received amphotericin B in the dose of 1mg/kg in 5% dextrose on alternate days, 20 infusions for 3 courses an interval of 15 days between each course and followed up for one year.

RESULTS

A total of 50 patients were enrolled, 25 in each of group A and group B. Two patients lost to follow up and three patients withdrew consent due to adverse events. The initial cure rate was 92% in group A and 88% in group B by intention to treat analysis and final cure rate by per protocol analysis was 95.65% and 95.45% in group A and group B respectively. Two patients each from either group relapsed. Nephrotoxicity was the most common adverse event occurring in both the groups.

CONCLUSION

The lower dose appears to have fewer adverse events however, nephrotoxicity remains a problem in both regimens. The 0.5mg/kg regimen may be considered instead of the higher dosage however safer treatments remain critical for PKDL treatment.

Authors+Show Affiliations

Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.Department of Biostatistics, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India.Department of Biochemistry, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.Department of Pathology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.Department of Molecular Biology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.Department of Molecular Biology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28355259

Citation

Rabi Das, Vidya Nand, et al. "To Evaluate Efficacy and Safety of Amphotericin B in Two Different Doses in the Treatment of Post Kala-azar Dermal Leishmaniasis (PKDL)." PloS One, vol. 12, no. 3, 2017, pp. e0174497.
Rabi Das VN, Siddiqui NA, Pal B, et al. To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL). PLoS One. 2017;12(3):e0174497.
Rabi Das, V. N., Siddiqui, N. A., Pal, B., Lal, C. S., Verma, N., Kumar, A., Verma, R. B., Kumar, D., Das, P., & Pandey, K. (2017). To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL). PloS One, 12(3), e0174497. https://doi.org/10.1371/journal.pone.0174497
Rabi Das VN, et al. To Evaluate Efficacy and Safety of Amphotericin B in Two Different Doses in the Treatment of Post Kala-azar Dermal Leishmaniasis (PKDL). PLoS One. 2017;12(3):e0174497. PubMed PMID: 28355259.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL). AU - Rabi Das,Vidya Nand, AU - Siddiqui,Niyamat Ali, AU - Pal,Biplab, AU - Lal,Chandra Shekhar, AU - Verma,Neena, AU - Kumar,Ashish, AU - Verma,Rakesh Bihari, AU - Kumar,Dhirendra, AU - Das,Pradeep, AU - Pandey,Krishna, Y1 - 2017/03/29/ PY - 2016/06/25/received PY - 2017/03/08/accepted PY - 2017/3/30/entrez PY - 2017/3/30/pubmed PY - 2017/8/26/medline SP - e0174497 EP - e0174497 JF - PloS one JO - PLoS One VL - 12 IS - 3 N2 - BACKGROUND: Post kala-azar dermal leishmaniasis (PKDL) is a skin disorder that usually occurs among patients with a past history of visceral leishmaniasis (VL). Cases are also reported without a history of VL. There is no satisfactory treatment regimen available at present. We aimed to compare the efficacy and safety of amphotericin B in two different doses (0.5mg/kg vs 1mg/kg) in a prospective randomized trial in 50 PKDL patients. METHODS: In this open label study 50 patients with PKDL, aged between 5-60 years were randomized in two groups. Group A received amphotericin B in the dose of 0.5 mg/kg in 5% dextrose, daily for 20 infusions for 3 courses at an interval of 15 days between each course and Group B received amphotericin B in the dose of 1mg/kg in 5% dextrose on alternate days, 20 infusions for 3 courses an interval of 15 days between each course and followed up for one year. RESULTS: A total of 50 patients were enrolled, 25 in each of group A and group B. Two patients lost to follow up and three patients withdrew consent due to adverse events. The initial cure rate was 92% in group A and 88% in group B by intention to treat analysis and final cure rate by per protocol analysis was 95.65% and 95.45% in group A and group B respectively. Two patients each from either group relapsed. Nephrotoxicity was the most common adverse event occurring in both the groups. CONCLUSION: The lower dose appears to have fewer adverse events however, nephrotoxicity remains a problem in both regimens. The 0.5mg/kg regimen may be considered instead of the higher dosage however safer treatments remain critical for PKDL treatment. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/28355259/To_evaluate_efficacy_and_safety_of_amphotericin_B_in_two_different_doses_in_the_treatment_of_post_kala_azar_dermal_leishmaniasis__PKDL__ L2 - https://dx.plos.org/10.1371/journal.pone.0174497 DB - PRIME DP - Unbound Medicine ER -