Should we continue to indicate meglumine antimoniate as first-line treatment for cutaneous leishmaniasis in Tunisia

Abstract

Meglumine antimoniate compounds have been the mainstay of treatment for cutaneous leishmaniasis (CL) for decades. We propose to evaluate the place of these drugs in this indication in Tunisia. We retrospectively reviewed medical records of 67 patients treated for (CL) using meglumine antimoniate at a dose of 20 mg/kg/day for 15 day from 1998 to 2010. Clinical and laboratory data, tolerance, and outcome were precised. Side effects were recorded in 17 among 67 patients (25%). The average age was 44.4 years (2-86 years). Antimony intolerance events occurred in 11 patients, stibio-intoxication events in nine cases, and the both type of antimony adverse effects were observed in three patients. Fever was the most frequent complication of antimony intolerance (five cases), followed by cough (three cases), rash (two cases), injection site erythema (two cases), musculoskeletal pain (one case), asthenia (one case), and vomiting (one case). Signs of stibio-intoxication were asymptomatic elevation of amylase level (four cases), hepatic cytolysis (three cases), hematologic toxicity (three cases), and acute toxic kidney failure (one case). Meglumine antimoniate was stopped in 13 cases. Systemic administration of pentavalent antimonials in the treatment of CL has been associated with severe adverse effects. CL observed in Tunisia is a self-healing dermatosis that never induces sequela; therefore, other therapies such as topical treatment or cryotherapy should be considered.

Travelers With Cutaneous Leishmaniasis Cured Without Systemic Therapy

“…In a recent analysis of systemic antimony toxicity in 67 travelers without preexisting morbidity, close follow-up of laboratory data was key for a timely suspension of treatment in 6 patients [38]. Recent observations in Tunisia suggest that antimony-induced severe adverse events affecting the kidney or liver are not exceptional [39]. Taken together, these observations reinforce the current assertion that the benefit-risk ratio of systemic anti-leishmanial therapy for CL requires cautious evaluation in the general population of patients.…”

Immucillins Impair Leishmania (L.) infantum chagasi and Leishmania (L.) amazonensis Multiplication In Vitro

“…Taken as a whole, these results are promising, considering the increased incidence of human VL cases caused by parasites resistant to Glucantime [ 10 ] and the strong toxicity determined by this therapy in the sensitive cases [ 6 – 8 , 48 , 49 ].…”

Cutaneous Leishmaniasis in Travellers: a Focus on Epidemiology and Treatment in 2015

“…Mild to moderate adverse effects occur in most patients, including fatigue, arthralgia, gastrointestinal complaints, transaminitis, elevated lipase with symptoms of pancreatitis, mild thrombocytopenia, and ECG abnormalities [11,94,95]. Up to 25-65 % of patients require treatment interruptions [11,95]. Although most patients resume therapy within days, severe adverse events including more severe cytopenias, symptomatic arrhythmias, major cardiac repolarization abnormalities, acute tubular necrosis, and fulminant hepatitis can occur, primarily in patients over age 55 or with underlying co-morbidities [46].…”

“…Due to lack of FDA approval, US health insurance plans may not reimburse costs associated with intravenous treatment, and home antibiotic infusion programs are ill-equipped to handle administration and required monitoring [9•]. Mild to moderate adverse effects occur in most patients, including fatigue, arthralgia, gastrointestinal complaints, transaminitis, elevated lipase with symptoms of pancreatitis, mild thrombocytopenia, and ECG abnormalities [11,94,95]. Up to 25-65 % of patients require treatment interruptions [11,95].…”