Miltefosine for new world cutaneous leishmaniasis

Area of Science:

• Infectious Diseases
• Tropical Medicine
• Pharmacology

Background:

• Miltefosine is an oral treatment with a high cure rate for visceral leishmaniasis in India.
• Cutaneous leishmaniasis remains a significant health concern in tropical regions, requiring effective therapeutic options.

Purpose of the Study:

• To evaluate the efficacy and tolerability of miltefosine for treating cutaneous leishmaniasis in Colombia and Guatemala.
• To compare miltefosine's effectiveness against specific Leishmania species prevalent in these regions.

Main Methods:

• A large, placebo-controlled study involving miltefosine therapy (2.5 mg/kg/day for 28 days).
• Patient populations were stratified by geographic region and prevalent Leishmania species (L. v. panamensis, L. v. braziliensis, L. m. mexicana).
• Per-protocol cure rates were assessed and compared to historical data for antimony treatment.

Main Results:

• In Colombia, miltefosine achieved a 91% cure rate against L. v. panamensis, comparable to historical antimony efficacy.
• In Guatemala, miltefosine showed a 53% cure rate against L. v. braziliensis and L. m. mexicana, which was lower than historical antimony cure rates (>90%).
• Miltefosine was generally well-tolerated in both study populations.

Conclusions:

• Miltefosine is a viable oral treatment for cutaneous leishmaniasis caused by L. v. panamensis in Colombia.
• Miltefosine demonstrated insufficient efficacy for treating cutaneous leishmaniasis caused by L. v. braziliensis and L. m. mexicana in Guatemala.
• Treatment outcomes for cutaneous leishmaniasis vary significantly depending on the causative Leishmania species and geographic location.