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Treating cutaneous leishmaniasis in Brazil: good news from new trial

28 Jan 2011

Paul Chinnock

Source: PLoS Neglected Tropical Diseases (see original article or PDF)

Citation: Machado PR, Ampuero J, Guimarães LH, Villasboas L, Rocha AT et al. (2010). Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis in Brazil: A Randomized and Controlled Trial. PLoS Negl Trop Dis 4(12): e912.

The parasitic disease leishmaniasis comes in several different forms. Visceral leishmaniasis (VL) is the most severe of these, causing death – if untreated – within two years. Cutaneous leishmaniasis (CL) causes unpleasant sores on the skin which are often self- healing but some 3–5% of CL cases develop into the more serious mucocutaneous or disseminated forms of the disease. It is therefore important that patients with CL should be given effective treatment.

This is particularly the case in Brazil, one of the six countries in which 90% of the world’s CL cases occur. (The other five countries are Afghanistan, Iran, Peru, Saudi Arabia and Syria.) A recent clinical trial in Brazil has found encouraging results using the treatment drug miltefosine.

For many years the standard treatment for CL in Brazil has been pentavalent antimony (Sbv) but strains of the parasite Leishmania braziliensis (the most common species causing CL in this country) have emerged that are resistant to Sbv. Cure rates have therefore fallen. Sbv in any case has many drawbacks; the drug is moderately toxic and needs to be administered intramuscularly or intravenously, which is not easy in the rural areas where most cases are to be found.

Meanwhile, miltefosine – a drug which is given orally – has come into use as a treatment for visceral leishmaniasis in India. Trials of this drug for CL have taken place in Colombia and Guatemala with promising but variable results [1], and it is also reported to have been used effectively in Bolivia [2]. Till now, however, there has been no data on the use of miltefosine against L. braziliensis in Brazil.

The researchers conducted a randomized, open-label, controlled clinical trial in patients with CL caused by Leishmania braziliensis in Bahia, Brazil. A total of 90 patients were enrolled in the trial; 60 were assigned to receive miltefosine and 30 to receive Sbv. All of the patients were able to complete the treatment and only three were lost to follow-up at six months.

Six months after treatment the definitive cure rate was 53.3% in the Sbv group and 75% in the miltefosine group; the difference is statistically significant (95% CI 0.08% to 42.7%, p = 0.04). There was no difference in effectiveness between the two treatments in the 32 patients who were children, but with such a small number of individuals it would not be appropriate to draw too many conclusions from this.

Adverse effects of treatment occurred in around three-quarters of the patients in both groups. The effects in question differed: mainly nausea, vomiting and abdominal pain in the miltefosine group; whereas arthralgias, mialgias and fever were the most common problems with Sbv.

This is a small trial but it has demonstrated that miltefosine therapy is more effective than standard Sbv, and safe, for the treatment of CL caused by Leishmania braziliensis in this location. Given the greater ease of administration of miltefosine, it will be possible to treat more CL patients, with the more effective drug. This is good news but better treatments with higher cure rates and fewer adverse effects are still needed.

References

1. Soto J, Arana BA, Toledo J, Rizzo N, Vega JC, et al. (2004). Miltefosine for New World Cutaneous Leishmaniasis. Clin Infect Dis; 38:1266-1272. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15127339

2. Soto J, Rea J, Balderrama M, Toledo J, Soto P, et al. (2008). Short Report: Efficacy of Miltefosine for Bolivian Cutaneous Leishmaniasis. Am J Trop Med Hyg; 78:210-211. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18256415

2010 Machado et al

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