The effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: An uncontrolled clinical trial

Abstract

Background Recent circumstantial evidence suggests increasing number of Iranian patients with cutaneous leishmaniasis (CL) who are unresponsive to meglumine antimoniate (MA), the first line of treatment in Iran. Oral meltifosine was previously reported to be effective in visceral leishmaniasis as well CL. The current study is designed to determine efficacy and safety of oral miltefosine for the treatment of anthroponotic cutaneous leishmaniasis (ACL) cases who were refractory to MA in Iran. Methodology/Principal findings Miltefosine was orally administered for 27 patients with MA resistant ACL with approved L.tropica infection, at a dosage of ∼2.5 mg/kg daily for 28 days. Patients were evaluated on day 14 and 28, as well as 3, 6 and 12 month post treatment follow up sessions. Laboratory data were performed and repeated at each visit. Data were analyzed using SPSS version 17. Twenty-seven patients including 16 men (59.25%) and 11 women (40.74%) with mean age of 28.56 ± 4.8 (range 3–54 years old) were enrolled. Total number of lesions were 42 (1–4 in each patient). Most of lesions were on face (76.19%). Mean lesions’ induration size was 2.38 ± 0.73 cm at the base-line which significantly decreased to1.31 ± 0.58 cm and 0.61 ±0.49 cm after 14 and 28 days of therapy, respectively (p value <0.05). At 12-months follow-up post treatment, 22 patients had definite/partial cure (81.48%) including 17 definitely cured patients, corresponding to a cure rate of 68% on per protocol analysis, and 62.96% according to intention to treat analysis. Recurrence of lesion was only occurred in one patient (3.70%). Nausea was the most subjective complication during the therapy (33.33%). Conclusion Oral miltefosine could be an effective alternative for the treatment of MA-resistant ACL.

Comparison of Efficacy of Miltefosine Versus Meglumine Antimonate in the Treatment of Cutaneous Leishmaniasis

“…We found Miltefosine an effective drug for CL with prolong duration (p<0.023) and multiple lesions (p <0.001), emphasizing its coverage of all strains in KPK. Our results are endorsed by Ware JM et al and Tayyabi M et al 12,13 Ware JM concluded that miltefosine was effective (77℅) against all strains of leishmania, while Tayyab M et al found it effective (82℅) against MA-resistant cases of CL. Mann S et al reported successful treatment of two cases of L. panamensis, which is also consistent with our study results of our study.…”

Antileishmanial potential of immunomodulator gallic acid against experimental murine visceral leishmaniasis

“…Miltefosine is also useful for drug-resistant cases of antimonials. 34 The therapeutic effects of oral drug miltefosine are comparable with other injectable therapies against leishmaniasis. 35 Therefore, in the case of leishmaniasis, the possibility of oral therapy is considerable.…”

Treatment of Cutaneous Leishmaniasis with Allopurinol Plus Itraconazole in Iran

“…Old World cutaneous leishmaniasis (OWCL) is mainly seen in two clinical forms: zoonotic (rural type), which is caused by the Leishmania major species, and anthroponotic (urban type), which is caused by the Leishmania tropica species. 1 Although meglumine antimoniate (MA) remains the main treatment choice of OWCL, many patients are categorized as MA resistant. 1 Up to now, many therapeutic options have been explored in the treatment of MA-resistant CL.…”

“…1 Although meglumine antimoniate (MA) remains the main treatment choice of OWCL, many patients are categorized as MA resistant. 1 Up to now, many therapeutic options have been explored in the treatment of MA-resistant CL. In this article, the therapeutic outcome of allopurinol plus itraconazole (API) was evaluated in 27 patients (56 lesions) with anthroponotic CL who were resistant to previous treatment with MA.…”