Efficacy of ketoconazole in cutaneous leishmaniasis

Weinrauch, Louis; Livshin, R; Even‐Paz, Z.; El‐On, Joseph

doi:10.1007/bf00417211

Cited by 52 publications

(15 citation statements)

References 5 publications

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“…6 In the treatment of cutaneous leishmaniasis caused by various species, the clinical effectiveness of the azole drugs has been varied. [7][8][9][10][11][12][13][14][15] Data are limited on the clinical efficacy against leishmania of fluconazole, a triazole antifungal agent available for oral and parenteral administration. 16,17 Its excellent safety profile and pharmacokinetic properties make it a suitable alternative therapy for cutaneous leishmaniasis.…”

Section: Resultsmentioning

confidence: 99%

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Fluconazole for the Treatment of Cutaneous Leishmaniasis Caused byLeishmania major

et al. 2002

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Section: Resultsmentioning

confidence: 99%

“…Several uncontrolled studies in which ketoconazole was used had mixed results. 7,8,32 Only one randomized, double-blind, placebo-controlled study examined the effect of itraconazole on cutaneous leishmaniasis. 15 In that study, Momeni et al randomly assigned 131 patients to receive itraconazole or placebo for three weeks.…”

Section: Discussionmentioning

confidence: 99%

Fluconazole for the Treatment of Cutaneous Leishmaniasis Caused byLeishmania major

et al. 2002

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“…Azole drugs (ketoconazole, fluconazole and itraconazole) have been applied in the treatment of cutaneous and mucocutaneous leishmaniasis [31]–[39] although their efficacy is still debated [36]. Recent papers suggest that doses might not have been adequate [40], [41].…”

Section: Methodsmentioning

confidence: 99%

Species-Directed Therapy for Leishmaniasis in Returning Travellers: A Comprehensive Guide

et al. 2014

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BackgroundLeishmaniasis is increasingly reported among travellers. Leishmania species vary in sensitivity to available therapies. Fast and reliable molecular techniques have made species-directed treatment feasible. Many treatment trials have been designed poorly, thus developing evidence-based guidelines for species-directed treatment is difficult. Published guidelines on leishmaniasis in travellers do not aim to be comprehensive or do not quantify overall treatment success for available therapies. We aimed at providing comprehensive species-directed treatment guidelines.Methodology/Principal FindingsEnglish literature was searched using PubMed. Trials and observational studies were included if all cases were parasitologically confirmed, the Leishmania species was known, clear clinical end-points and time points for evaluation of treatment success were defined, duration of follow-up was adequate and loss to follow-up was acceptable. The proportion of successful treatment responses was pooled using mixed effects methods to estimate the efficacy of specific therapies. Final ranking of treatment options was done by an expert panel based on pooled efficacy estimates and practical considerations. 168 studies were included, with 287 treatment arms. Based on Leishmania species, symptoms and geography, 25 clinical categories were defined and therapy options ranked. In 12/25 categories, proposed treatment agreed with highest efficacy data from literature. For 5/25 categories no literature was found, and in 8/25 categories treatment advise differed from literature evidence. For uncomplicated cutaneous leishmaniasis, combination of intralesional antimony with cryotherapy is advised, except for L. guyanensis and L. braziliensis infections, for which systemic treatment is preferred. Treatment of complicated (muco)cutaneous leishmaniasis differs per species. For visceral leishmaniasis, liposomal amphotericin B is treatment of choice.Conclusions/SignificanceOur study highlights current knowledge about species-directed therapy of leishmaniasis in returning travellers and also demonstrates lack of evidence for treatment of several clinical categories. New data can easily be incorporated in the presented overview. Updates will be of use for clinical decision making and for defining further research.

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“…With use first proposed in the 1980s [43], fluconazole, ketoconazole and itraconazole have since been indicated for the treatment of TL in many, generally small studies of poor methodological quality [15–17,23–56]. In addition, many case reports and series with fewer than ten patients that explored the efficacy and safety of this class of medications have also been published [57–62]. In this context, most of the studies included in this systematic review were not randomized.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of azole therapy for tegumentary leishmaniasis: A systematic review and meta-analysis

2017

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BackgroundSeveral controlled and uncontrolled studies addressing azole antifungal drugs for cutaneous and mucosal leishmaniasis have been published with inconclusive results. We conducted a systematic literature review of studies evaluating the efficacy and toxicity associated with azole therapy for tegumentary leishmaniasis.MethodologyPRISMA guidelines for systematic reviews and the Cochrane manual were followed, and the review methodology was registered (PROSPERO; CRD42016048668). Sources included the EMBASE, Web of Science, MEDLINE, LILACS, and IBECS databases along with a manual search of references from evaluated studies. Additional resources such as Google Scholar and clinicaltrials.gov were also searched. We included all studies reporting cure rate after cutaneous or mucosal leishmaniasis treatment with systemic azole drugs, regardless of their design. R software was used to estimate global rates of success and adverse events with each drug. The main outcome of interest was clinical cure, defined as complete re-epithelialization of all lesions.ResultsA total of 37 studies involving 1259 patients that reported outcomes after fluconazole (9), ketoconazole (14) and itraconazole (15) treatments were included. Only 14 (38%) were randomized controlled trials (RCT). The pooled azole final efficacy rate was 64% (CI95%: 57–70%) for all studies and 60% (CI95%: 50–70%) (p = 0.41) if only RCTs studies were considered. Twenty-four studies were conducted in the Old World and 13 studies in the Americas. The final efficacy rate according to New and Old World were 62% (CI95%: 43–77%) and 66% (CI95%: 58–73%), respectively. The final efficacy rate of azoles according to species were 89% (CI95%: 50–98%) for L. mexicana; 88% for L. infantum (CI95%: 27–99%); 80% for L. donovani; 53% (CI95%: 29–76%) for L. major; 49% for L. braziliensis (CI95%: 21–78%); and 15% (CI95%: 1–84%) for L. tropica. The cure rates were similar among the fluconazole, ketoconazole and itraconazole group arms (p = 0.89), specifically 61% (CI95%: 48–72%), 64% (CI95%: 44–80%) 65% (CI95%: 56–72%), respectively. Adverse events during fluconazole, itraconazole and ketoconazole therapy were reported in 7% (CI95%: 3–14%), 12% (CI95% 8–19%) and 13% (CI95%: 6–29%) of treated patients, respectively, without difference among them (p = 0.35). This systematic review included studies with small samples and both non-comparative and non-randomized studies and the main limitation was the low quality of the available studies.ConclusionsAvailable evidence suggests that fluconazole, ketoconazole and itraconazole have similar and modest efficacy rates for tegumentary leishmaniasis treatment. There is insufficient evidence to support the exclusive use of azole therapy as a single agent for leishmaniasis treatment.

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Efficacy of ketoconazole in cutaneous leishmaniasis

Cited by 52 publications

References 5 publications

Fluconazole for the Treatment of Cutaneous Leishmaniasis Caused byLeishmania major

Fluconazole for the Treatment of Cutaneous Leishmaniasis Caused byLeishmania major

Species-Directed Therapy for Leishmaniasis in Returning Travellers: A Comprehensive Guide

Efficacy of azole therapy for tegumentary leishmaniasis: A systematic review and meta-analysis

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