Efficacy of Miltefosine for Bolivian Cutaneous Leishmaniasis

Abstract

Oral miltefosine (2.5 mg/kg/d for 28 days) was compared with intramuscular antimony (20 mg/kg/d for 20 days) in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Palos Blancos, Bolivia. The cure rates with 6 months of follow-up were statistically similar: 36 of 41 evaluable miltefosine patients (88%) versus 15 of 16 (94%) evaluable antimony patients. However, antimony cured more rapidly, because, by 1 month after therapy, 31 of 44 miltefosine patients (70%) compared with 16 of 16 antimony patients (100%) had achieved cure. The two conclusions from this work are that oral miltefosine can be used for cutaneous disease in this part of Bolivia and that miltefosine was more effective for L. braziliensis in this region than for L. braziliensis in Guatemala. Chemotherapy needs to be evaluated in each endemic region, even if the "same" species of Leishmania causes disease in these locales.

Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil

“…This AE was never reported before in any patient treated with miltefosine. Although different in frequencies, the clinical-related AEs were also reported in the studies performed by Soto and others [6][7][8][9] except that "motion sickness" was not reported by any of our patients. Laboratory AEs were mainly related to the liver and kidneys.…”

“…No species identification was performed, although the authors stated that the main species in the study area was L. ( V. ) braziliensis . 9 On the basis of the efficacy results of these four trials, it is clear that miltefosine-induced cure rates for new world leishmaniasis vary according to both the species of leishmania causing disease and between the same species acquired from different endemic areas. This observation was indeed pointed out in two other studies conducted in Peru where leishmania species were associated with different antimonial treatment outcomes.…”

“…10,11 This variation in cure rates has also been demonstrated in patients infected with L. ( V. ) braziliensis and L. ( V. ) guyanensis in Brazil where antimonial cure rates are lower than the ones reported in Bolivia and Peru. 9,12,13 Despite the epidemiologic importance of L. ( V. ) guyanensis in the Brazilian Amazon, only one clinical trial addressing treatment response of this leishmania species to antimonials was performed in the past 10 years.…”

“…The evidence of its clinical efficacy for new world CL relies on four studies performed by Soto and others. [6][7][8][9] The first study was an open-label phase I/II dose escalation trial of miltefosine in 72 male Colombian soldiers (mean weight 67 kg) with CL. Doses varied from 50 mg/day/for 20 days to 150 mg/day for 28 days.…”

Leishmaniases in Bolivia: Comprehensive Review and Current Status

“…69 Another drug that has been tested for its efficacy in treating CL in Bolivia is miltefosine, with reported cure rates of 88-91% and 58-83% for LCL and ML, respectively. 70,71 Several anecdotal reports describe the use of folk medicine to treat the leishmaniases in Bolivian communities, 72 and many local Bolivia plants have been found to have anti-leishmanial activity in vitro [72][73][74] and in vivo . 74 However, to date, there has been no controlled study to establish whether these plants have a potential application in clinical medicine.…”