Comparison of meglumine antimoniate versus miltefosine in the treatment of new world cutaneous leishmaniasis: a systematic review and meta-analysis.

BACKGROUND

Cutaneous leishmaniasis (CL) affects up to 1.2 million people annually, mainly in resource-limited regions. Meglumine antimoniate, the standard treatment, is limited by systemic toxicity, injectable administration, and increasing resistance. Miltefosine, an oral alternative, offers practical advantages, although comparative efficacy and safety data remain inconsistent.

OBJECTIVE

To compare the efficacy and safety of miltefosine versus meglumine antimoniate for New World CL.

METHODS

The authors systematically searched PubMed, Embase, Scopus, and the Cochrane Library for randomized controlled trials directly comparing miltefosine and meglumine antimoniate. Risk Ratios (RRs) with 95% Confidence Intervals (95% CIs) were calculated using random-effects models. Heterogeneity was assessed with the I² statistic. Risk of bias was evaluated using the Cochrane RoB-2 tool. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach.

RESULTS

Eight trials involving 898 patients (502 treated with miltefosine, 396 with meglumine antimoniate) were included. Miltefosine showed significantly higher cure rates at two months (RR = 0.83; 95% CI: 0.71-0.98; I2 = 0%). Differences at six months were not statistically significant. Gastrointestinal side effects were more frequent with miltefosine, whereas hepatic enzyme elevations, arthralgia (RR = 10.08; 95% CI: 2.36-43.12), and fever (RR = 2.98; 95% CI: 1.53-5.80) were more common with meglumine antimoniate.

STUDY LIMITATIONS: High heterogeneity, short follow-up, small sample sizes, and interstudy variability may limit precision.

CONCLUSION

Miltefosine shows superior early response and a safer systemic profile. However, the certainty of evidence, as assessed by GRADE, ranged from very low to high across outcomes, and long-term data remain limited, highlighting the need for further high-quality studies with extended follow-up.