Objectives: To assess the efficacy and tolerability of aminosidine compared with sodium stibogluconate for treating visceral leishmaniasis.
Design: Randomised, unblinded, controlled trial with 180 day follow up.
Setting: Kala-Azar Research Centre, Brahmpura, Muzaffarpur, Bihar, India.
Subjects: People of either sex aged 6-50 years with symptoms and signs suggestive of visceral leishmaniasis (fever, loss of appetite, enlarged spleen) with leishmania amastigotes detected in Giemsa stained aspirates of spleen or bone marrow.
Interventions: Aminosidine at three daily doses (12, 16, and 20mg/kg) for 21 days and sodium stibogluconate 20mg/kg/day for 30 days.
Main outcome measures: Laboratory measures of efficacy: parasite count, haemoglobin concentration, white cell count, platelet count, serum albumin concentration. Clinical measures of efficacy: spleen size, fever, body weight, and liver size. Measures of safety: liver and renal function tests, reports of adverse events.
Results: Of the 120 patients enrolled (30 per treatment arm), 119 completed treatment and follow up. Cure at end of follow up was achieved in 23 (77%), 28 (93%), and 29 (97%) patients treated with 12, 16, and 20mg aminosidine/kg/day respectively, and in 19 (63%) patients given sodium stibogluconate. At 16 and 20mg/kg/day, aminosidine was significantly more active than sodium stibogluconate in both clinical and laboratory measures of efficacy. No significant clinical or laboratory toxicity occurred in any treatment group.
Conclusions: A 21 day course of aminosidine 16 or 20mg/kg/day should be considered as first line treatment for visceral leishmaniasis in Bihar.
- Bihar in north east India accounts for about half the annual worldwide cases of visceral leishmaniasis, and resistance to standard treatment with sodium stibogluconate has been increasing
- We compared the safety and efficacy of three doses of aminosidine with standard regimen of sodium stibogluconate for treating visceral leishmaniasis in Bihar
- Aminosidine given at 16 or 20mg/kg/day for 21 days was significantly more effective in producing final cure than sodium stibogluconate 20mg/kg/day for 30 days
- Aminosidine had a low incidence of adverse reactions, including ototoxicity and renal toxicity, and was well tolerated
- Intramuscular injection of aminosidine 16mg/kg/day for 21 days should be considered as a new first line treatment for visceral leishmaniasis in Bihar