Therapeutic and adverse effects of standard-dose and low-dose meglumine antimoniate during systemic treatment of Syrian cutaneous leishmaniasis patients

Abstract

Objective To evaluate therapeutic and adverse effects of meglumine antimoniate (MA) during systemic treatment of Syrian cutaneous leishmaniasis (CL) patients. Methods In this randomized study, of 70 Syrian clinically suspected CL patients referred to the Aleppo University Hospital Clinic, 60 patients with the clinical and parasitological diagnosis of CL were recruited and were randomly divided into two treatment groups of 30 subjects each. The first group was treated with 60 mg/kg/day/IM of MA (standard dose) and the second group received 30 mg/kg/day/IM of MA (low-dose). The duration of treatment was 3 weeks for both groups. The effectiveness of the treatment was classified in three levels as complete response, partial response and no response. Data were analyzed by SPSS 19 using Chi square, Mann-Whitney, Kaplan-Mayer and ANOVA tests. Results There were 38 males (63.4%) and 22 females (36.6%) among Syrian CL patients and the mean age of the patients was 25.7±12 years. At the end of the study (12 weeks), rate of complete response was (91.1%) in first group and (78.3%) in second group, respectively. The most common side effect was skin hypersensitivity and urticaria, fever, swelling without increased WBC count which was more seen in those received 60 mg/kg/day/IM MA, (40% in comparison with 23.3% in second group). Signs of stibio-intoxication were asymptomatic, cardiac toxicity ‘QT prolongation’ occurred in 8 (13.3%) patients in both groups during the third week of treatment for which finally their medication was discontinued and was switched to another group of drugs. No hepatic or renal complication was observed. Conclusions Our results showed that complete response rate was higher (91.1%) for the group treated with standard-dose of systemic MA. Adverse effects of systemic MA were relatively frequent in our study. Skin hypersensitivity and urticaria, musculoskeletal pain, nausea and vomiting were not severe and disappeared when the treatment was stopped. Stibio-intoxication cases, cardiac toxicity (QT prolongation) were serious. Therefore, other therapies such as topical treatment or cryotherapy should be considered in any patient who develops suspicious symptoms.