Electronico

Am. J. Trop. Med. Hyg., 78(2), 2008, pp. 210–211
Copyright © 2008 by The American Society of Tropical Medicine and Hygiene

Short Report: Efficacy of Miltefosine for Bolivian Cutaneous Leishmaniasis
Jaime Soto, Jaime Rea, Margarita Balderrama, Julia Toledo, Paula Soto, Luis Valda, and Jonathan D. Berman*
Fundación FADER, Bogota, Colombia; Puesto de Salud, Campamento OSCAR, Palos Blancos,Bolivia; Hospital de Clínicas,
La Paz, Bolivia; and AB Foundation, Rockville, Maryland

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 41evaluable 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 miltefosinewas
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.
Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Because the disease
generally self-cures in 2–15 months depending on theendemic
region in which it was obtained,1 parenteral therapy is inherently unattractive, and the primary chemotherapeutic need is
an effective oral or, if appropriate, topical regimen. Miltefosine is an oral agent, originally shown to be > 95% curative for
Indian visceral leishmaniasis,2 which underwent evaluation
for cutaneous and mucosal disease of the New World. A 91%
cure rate forLeishmania panamensis disease in Colombia
compared with a 38% cure rate for placebo led to the registration of this drug in Colombia.3 However, miltefosine was
not impressively effective in Guatemala, in which the infecting species are L. braziliensis and L. mexicana. In Guatemala,
50% of the miltefosine group were cured compared with 20%
of the placebo group, and for patients with documented L.braziliensis disease, only 5 of 15 patients (33%) cured in the
miltefosine group compared with 1 of 12 cases (8%) in the
placebo group.3 In contrast, antimony routinely cures > 90%
of patients in Guatemala, and it seemed as if miltefosine
should not be recommended for L. braziliensis cutaneous disease.
The possibility that L. braziliensis in Guatemala is unusual
in its low response to miltefosineled us to study miltefosine
for Bolivian leishmaniasis, 94% of which is caused by L. braziliensis.4 We first studied mucosal leishmaniasis. In a singlegroup trial, the cure rate for miltefosine was similar to that of
historic values for antimony.5 It could be argued, however,
that antimony might have been superior had a randomized
study been performed, and that at any rate, the mucosal datamight not pertain to cutaneous leishmaniasis, which is by far
the most prevalent presentation. To directly evaluate the relative efficacy of miltefosine to antimony for L. braziliensis
cutaneous disease in this region of Bolivia, we compared the
drugs in a randomized study of cutaneous leishmaniasis at the
same site at which we had conducted the mucosal trial.
Our study patients lived in thesame Bolivian provinces of
Beni or La Paz from which we recruited mucosal patients5
and were treated at the community clinic of Palos Blancos.
The inclusion/exclusion criteria for this cutaneous study were
similar to that used in the Colombian/Guatemalan cutaneous
study3: a skin ulcer confirmed to be caused by leishmania by
visualization of parasites in lesion material by Giemsa stain-...