Electrocardiographic and biochemical adverse effects of meglumine antimoniate (MA) during treatment of Syrian cutaneous leishmaniasis patients
Keywords:
Adverse effects, cutaneous leishmaniasis, meglumine antimoniate, EKG, SyriaAbstract
Objective To evaluate the effect of meglumine antimoniate (MA) on EKG and some liver, kidney, and pancreas function tests among Syrian cutaneous leishmaniasis (CL) patients. Patients and methods In this prospective study, of 80 Syrian clinically suspected CL patients referred to the Aleppo University Hospital Clinic, 50 patients were randomly selected and after the diagnosis of CL was made by tissue smear and skin biopsy, EKG and blood samples were taken to evaluate liver, kidney, and pancreas function tests before and after treatment with intramuscular injections of MA at a dose of 20 mg Sb5+/kg/day equivalent to 60 mg/kg/day for 21 days. Informed consent was obtained from all the cases. Data were analyzed by use of paired t test and p values <0.05 were considered as significant. Results There were 33 (66%) males and 17 females (34%) among Syrian (CL) patients and the mean age of the patients was 28.3±11 years. The mean±SEM QTc progressively increased from 382±2.8 msec to 402±2.5 msec during 21 days of treatment and the QTc reached the threshold for potential cardiac toxicity among 6 (12%) patients during the third week of treatment. ST depression occurred in 3% the patients and inverted T was observed in 4% the patients. Mean serum levels of blood urea nitrogen, creatinine, sodium, potassium, total and direct bilirubin, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase significantly increased after treatment, although most of them were within normal ranges. There were no significant differences in serum levels of amylase and lipase before and after treatment, none developed clinical pancreatitis or hepatitis and treatment modification was not required. Conclusion Our results showed that one course of treatment with 20 mg Sb5+/kg/day equivalent to 60 mg/kg/day (MA) for 21 days does not significantly alter the liver, kidney and pancreas function tests. Treatment with systemic (MA) can induce many ECG changes as QT prolongation, a significant risk. Identification of factors before and during treatment that may increase the risk of QTc prolongation and arrhythmias is important. Systemic (MA) can be used safely in this population with adequate monitoring and the need for treatment interruption is uncommon.References
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