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Efficacy of ketoconazole against Leishmania braziliensis panamensis cutaneous leishmaniasis.
Am J Med. 1990 Aug; 89(2):147-55.AJ

Abstract

PURPOSE, PATIENTS, AND METHODS

The classic agent for cutaneous leishmaniasis is pentavalent antimony. However, there are no reports of the efficacy of antimony versus placebo or of the efficacy of any alternative therapy versus either antimony or placebo. In the present report, the oral antifungal agent ketoconazole (600 mg/day for 28 days) was compared to a recommended regimen of intramuscular Pentostam (20 mg antimony/kg, with a maximum of 850 mg antimony/day, for 20 days) in a randomized study of the treatment of Panamanian cutaneous leishmaniasis due to Leishmania braziliensis panamensis. A separate group of patients with this disease was administered placebo.

RESULTS

Ketoconazole clinically cured 16 of 21 (76%) patients. The lesions on nine patients healed by 1 month after therapy, and the lesions healed by 3 months after therapy on the other seven patients. Side effects were limited to a 27% incidence of mild, reversible hepatocellular enzyme elevation and an asymptomatic, reversible, approximately 70% decrease in serum testosterone in all patients. Pentostam cured 13 of 19 (68%) patients; the lesions on seven patients healed by the end of therapy, and the lesions on four other patients healed by 1 month after the end of therapy. Side effects were a 47% incidence of mild, reversible hepatocellular enzyme elevation and the morbidity due to 20 intramuscular injections in almost all patients. The placebo group of 11 patients had a 0% cure rate. By 1 month after therapy, all placebo-treated patients demonstrated new lesions or one lesion that was 23% to 875% larger than before therapy.

CONCLUSION

Both ketoconazole and Pentostam were more effective than placebo against L. braziliensis panamensis cutaneous leishmaniasis. Oral ketoconazole is comparable in efficacy to this parenteral Pentostam regimen and can be recommended as initial treatment for this disease.

Authors+Show Affiliations

Gorgas Memorial Institute, Panama City, Republic of Panama.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

2166429

Citation

Saenz, R E., et al. "Efficacy of Ketoconazole Against Leishmania Braziliensis Panamensis Cutaneous Leishmaniasis." The American Journal of Medicine, vol. 89, no. 2, 1990, pp. 147-55.
Saenz RE, Paz H, Berman JD. Efficacy of ketoconazole against Leishmania braziliensis panamensis cutaneous leishmaniasis. Am J Med. 1990;89(2):147-55.
Saenz, R. E., Paz, H., & Berman, J. D. (1990). Efficacy of ketoconazole against Leishmania braziliensis panamensis cutaneous leishmaniasis. The American Journal of Medicine, 89(2), 147-55.
Saenz RE, Paz H, Berman JD. Efficacy of Ketoconazole Against Leishmania Braziliensis Panamensis Cutaneous Leishmaniasis. Am J Med. 1990;89(2):147-55. PubMed PMID: 2166429.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of ketoconazole against Leishmania braziliensis panamensis cutaneous leishmaniasis. AU - Saenz,R E, AU - Paz,H, AU - Berman,J D, PY - 1990/8/1/pubmed PY - 1990/8/1/medline PY - 1990/8/1/entrez SP - 147 EP - 55 JF - The American journal of medicine JO - Am J Med VL - 89 IS - 2 N2 - PURPOSE, PATIENTS, AND METHODS: The classic agent for cutaneous leishmaniasis is pentavalent antimony. However, there are no reports of the efficacy of antimony versus placebo or of the efficacy of any alternative therapy versus either antimony or placebo. In the present report, the oral antifungal agent ketoconazole (600 mg/day for 28 days) was compared to a recommended regimen of intramuscular Pentostam (20 mg antimony/kg, with a maximum of 850 mg antimony/day, for 20 days) in a randomized study of the treatment of Panamanian cutaneous leishmaniasis due to Leishmania braziliensis panamensis. A separate group of patients with this disease was administered placebo. RESULTS: Ketoconazole clinically cured 16 of 21 (76%) patients. The lesions on nine patients healed by 1 month after therapy, and the lesions healed by 3 months after therapy on the other seven patients. Side effects were limited to a 27% incidence of mild, reversible hepatocellular enzyme elevation and an asymptomatic, reversible, approximately 70% decrease in serum testosterone in all patients. Pentostam cured 13 of 19 (68%) patients; the lesions on seven patients healed by the end of therapy, and the lesions on four other patients healed by 1 month after the end of therapy. Side effects were a 47% incidence of mild, reversible hepatocellular enzyme elevation and the morbidity due to 20 intramuscular injections in almost all patients. The placebo group of 11 patients had a 0% cure rate. By 1 month after therapy, all placebo-treated patients demonstrated new lesions or one lesion that was 23% to 875% larger than before therapy. CONCLUSION: Both ketoconazole and Pentostam were more effective than placebo against L. braziliensis panamensis cutaneous leishmaniasis. Oral ketoconazole is comparable in efficacy to this parenteral Pentostam regimen and can be recommended as initial treatment for this disease. SN - 0002-9343 UR - https://www.unboundmedicine.com/medline/citation/2166429/Efficacy_of_ketoconazole_against_Leishmania_braziliensis_panamensis_cutaneous_leishmaniasis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/0002-9343(90)90292-L DB - PRIME DP - Unbound Medicine ER -