Safety and effectiveness of amphotericin B deoxycholate for the treatment of visceral leishmaniasis in Uganda

Abstract

Between September 2003 and April 2004, the supply of antimonial drugs to Amudat Hospital, in north-eastern Uganda, was interrupted and all cases of visceral leishmaniasis presenting at the hospital could only be treated with amphotericin B deoxycholate (AmB). This allowed the safety and effectiveness of the AmB to be evaluated, in comparison with an historical cohort of patients treated, at the same hospital, with meglumine antimoniate (Sb(V)). Demographic and clinical data were collected before and after treatment. Adverse effects were recorded passively in all the subjects, and actively, using a standardized questionnaire, in a sub-group of the patients given AmB. The in hospital case-fatality 'rates' were 4.8% [95% confidence interval (CI) = 2.4%-8.8%] among the 210 patients treated with AmB and 3.7% (CI = 1.4%-7.9%) among the 161 patients treated with Sb(V) (P>0.20). Adverse effects requiring treatment interruption were rare in both cohorts. Treatment failures (i.e. non-responses or relapses) were observed in 2.9% (CI = 1.2%-6.4%) of the patients treated with AmB and 1.2% (CI = 0.1%-4.4%) of the patients treated with Sb(V) (P>0.20). For the treatment of visceral leishmaniasis in Uganda, AmB therefore had a similar effectiveness and safety profile to that of meglumine antimoniate.

Clinical Epidemiology, Diagnosis and Treatment of Visceral Leishmaniasis in the Pokot Endemic Area of Uganda and Kenya

“…Amphotericin B deoxycholate (1 mg/kg administered on alternate days for 15 days) was temporarily used as first-line treatment in Amudat during a stock-out of antimonials, with no difference in outcome compared with antimonials 11. In a retrospective analysis of patients treated between 2000 and 2006, patients with a high risk of death during treatment with antimonials were identified,12 leading to recommend amphotericin B deoxycholate and later AmBisome as the first-line treatment of vulnerable patients (human immunodeficiency virus [HIV] co-infected patients, pregnant women, patients > 45 years of age, and patients in very poor general health).…”

Risk factors for in‐hospital mortality of visceral leishmaniasis patients in eastern Uganda

“…Severe adverse effects such as anaphylactic reactions, renal insufficiency or hypokalemia may occur. Whereas ampB deoxycholate was found to be effective and relatively safe in Indian rural hospitals (Thakur & Ahmed 2001), it did not perform better than SbV in Uganda (Mueller et al. 2008).…”

A Probabilistic Risk Assessment for Deployed Military Personnel After the Implementation of the "Leishmaniasis Control Program" at Tallil Air Base, Iraq

“…The side effects of amphotericin B deoxycholate are back pain, sweating, headache, diarrhea, itching, shivering, respiratory distress, and/or cardiac arrhythmia, which have been observed in Ͻ40% of patients , Mueller et al 2008. Treatment with amphotericin B deoxycholate has a cure rate of Ϸ92% after 6 mo (Sundar et al 1997, Mueller et al 2008. Despite frequent applications and multipathway exposures, our probabilistic estimates of exposure to lambda-cyhalothrin, bifenthrin, and chlorpyrifos exceeded the RQ LOC but did not exceed their respective NOAELs.…”

“…Amphotericin B deoxycholate has been approved by the U.S. Food and Drug Adminstration for the treatment of leishmaniasis (Herwaldt 1999). The side effects of amphotericin B deoxycholate are back pain, sweating, headache, diarrhea, itching, shivering, respiratory distress, and/or cardiac arrhythmia, which have been observed in Ͻ40% of patients , Mueller et al 2008. Treatment with amphotericin B deoxycholate has a cure rate of Ϸ92% after 6 mo (Sundar et al 1997, Mueller et al 2008.…”