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Previous Volume 347:1739-1746 November 28, 2002 Number 22 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Murray, H. W. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited Related Article by Jacobs, S. PubMed Citation

ABSTRACT

Background There are 500,000 cases per year of visceral leishmaniasis, which occurs primarily in the Indian subcontinent. Almost all untreated patients die, and all the effective agents have been parenteral. Miltefosine is an oral agent that has been shown in small numbers of patients to have a favorable therapeutic index for Indian visceral leishmaniasis. We performed a clinical trial in India comparing miltefosine with the most effective standard treatment, amphotericin B.

Methods The study was a randomized, open-label comparison, in which 299 patients 12 years of age or older received orally administered miltefosine (50 or 100 mg [approximately 2.5 mg per kilogram of body weight] daily for 28 days) and 99 patients received intravenously administered amphotericin B (1 mg per kilogram every other day for a total of 15 injections).

Results The groups were well matched in terms of age, weight, proportion with previous failure of treatment for leishmaniasis, parasitologic grade of splenic aspirate, and splenomegaly. At the end of treatment, splenic aspirates were obtained from 293 patients in the miltefosine group and 98 patients in the amphotericin B group. No parasites were identified, for an initial cure rate of 100 percent. By six months after the completion of treatment, 282 of the 299 patients in the miltefosine group (94 percent [95 percent confidence interval, 91 to 97]) and 96 of the 99 patients in the amphotericin B group (97 percent) had not had a relapse; these patients were classified as cured. Vomiting and diarrhea, generally lasting one to two days, occurred in 38 percent and 20 percent of the patients in the miltefosine group, respectively.

Conclusions Oral miltefosine is an effective and safe treatment for Indian visceral leishmaniasis. Miltefosine may be particularly advantageous because it can be administered orally. It may also be helpful in regions where parasites are resistant to current agents.

Source Information

From the Institutes of Medical Sciences, Banaras Hindu University, Varanasi (S.S.); the Kala-azar Research Center, Brahmpura, Muzaffarpur (T.K.J.); and Balaji Utthan Sanastan, Patna (C.P.T.) — all in India; Zentaris–Asta Medica, Frankfurt am Main, Germany (J.E., H.S., C.F., K.J.); the London School of Hygiene and Tropical Medicine, London (A.B.); and the Walter Reed Army Institute of Research, Silver Spring, Md. (J.B.).

Address reprint requests to Dr. Berman at the National Center for Complementary and Alternative Medicine, 6707 Democracy Blvd., Ste. 401, Bethesda, MD 20892, or at bermanjo{at}mail.nih.gov.

Full Text of this Article

Related Letters:

Miltefosine for Indian Visceral Leishmaniasis
Agarwal P. K., Roca B., Sundar S., Berman J.
Extract | Full Text | PDF  
N Engl J Med 2003; 348:857-858, Feb 27, 2003. Correspondence

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