Glucantime side effects in leishmaniasis not worse in children

By David Douglas

NEW YORK (Reuters Health) - Cutaneous leishmaniasis treatment with systemic meglumine antimoniate (Glucantime, Sanofi Aventis) is generally fairly well tolerated in children and the rate of adverse events is similar to that seen in adults, according to Iranian researchers.

In an April 3 online paper in the Journal of the Pediatric Infectious Diseases Society, Dr. Toktam Moghiman of Mashhad University of Medical Sciences and colleagues note that cutaneous leishmaniasis is one of the most common endemic diseases in their part of the country and is mainly due to Leishmania tropica.

Children are among those at highest risk and have only recently been included in clinical trials. They've also shown a significantly lower response rate and significantly higher elimination rate of antimony compared to adults. Moreover, reports covering side effects in children have been limited.

To investigate further, the researchers prospectively studied 70 children with a mean age of 5.39 years. A full medical history was taken and a thorough physical examination was performed to rule out other underlying diseases.

Children were given intramuscular injections of the agent at a dosage of 20 mg of pentavalent antimony/kg per day for 20 days. Laboratory tests were performed before, during, and after treatment.

Sixty patients received a single treatment course and 10 went on to have another course. Overall, 31 patients (44.3%) experienced no adverse effects.

Fourteen patients experienced clinical adverse effects with erythema of the injection site (18.6%) and protracted pain (10%) being the most common. "A few" patients also experienced inflammation, myalgia, anorexia, and fever.

No significant changes were observed in mean white blood cell counts, platelet counts, hemoglobin, serum blood urea nitrogen, and other measures before and after treatment. No observed changes in other markers were considered to be clinically relevant.

The findings on side effects in other studies involving both adults and children were comparable to those in the current study of children alone, say the investigators.

Although the drug appears to be reasonably well tolerated, they conclude, "continued monitoring of renal, hepatic, and pancreatic function during and immediately after antimonial treatment is prudent." Use of electrocardiograms may also be an option.

Commenting on the findings by email, Dr. Abhay R. Satoskar of The Ohio State University in Columbus told Reuters Health, "It is encouraging that the children did not develop more severe systemic side effects with antimony therapy. More studies will be needed from other regions to validate the observations."

"However, there are also other alternatives which could be better for treatment of cutaneous leishmaniasis in children," continued Dr. Satoskar, who has conducted research in the field. "One of such treatment is FDA-approved topical radio frequency induced heat therapy. This requires to be administered only once in most patients locally for 30-60 seconds and hence has better patient compliance. Among other alternatives are intralesional injections of antimony which has no systemic side effects but they are painful."

Dr. Moghiman did not respond to requests for comment. The study was funded by the Research Council of Mashhad University of Medical Sciences.

SOURCE: http://bit.ly/1khn5p0

J Ped Infect Dis 2014.

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