Successful therapeutic response of resistant cases of mucocutaneous leishmaniasis to a very low dose of antimony

Oliveira-Neto, Manoel P.; Mattos, Marise

doi:10.1590/s0037-86822006000400011

Cited by 4 publications

(4 citation statements)

References 16 publications

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“…Since the mid-1980s, low dose regimen has been employed at our institution in Rio de Janeiro, Brazil, to treat patients with cutaneous and mucosal leishmaniasis [15–21, 24, 30, 34]. The rationale behind it is intuitively attractive and relies on its expected non-inferior effectiveness, less toxicity, improved compliance and reduced costs [26].…”

Section: Discussionmentioning

confidence: 99%

“…Although previous studies have suggested that low dose regimen is apparently effective, evidence was scarce and based mainly on case reports and observational studies [16, 18–24]. High dose of antimony is the current standard of care for most patients with ACL.…”

Section: Discussionmentioning

confidence: 99%

“…On this account, a few observational studies have suggested that alternative antimonial treatment regimens such as low dose (5 mg Sb 5+ /kg/day), intermittent and intralesional therapies are safer, more cost-efficient and could be as effective as the standard high dose therapy for treating CL [15–24]. Other studies have shown that alternative antimonial regimens could be used in the aforementioned subgroup of patients with CL who, otherwise, would not get any treatment due to the high toxicity of the drugs [21].…”

Section: Introductionmentioning

confidence: 99%

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Low versus high dose of antimony for American cutaneous leishmaniasis: A randomized controlled blind non-inferiority trial in Rio de Janeiro, Brazil

et al. 2017

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BackgroundAlthough high dose of antimony is the mainstay for treatment of American cutaneous leishmaniasis (ACL), ongoing major concerns remain over its toxicity. Whether or not low dose antimony regimens provide non-inferior effectiveness and lower toxicity has long been a question of dispute.MethodsA single-blind, non-inferiority, randomized controlled trial was conducted comparing high dose with low dose of antimony in subjects with ACL treated at a referral center in Rio de Janeiro, an endemic area of Leishmania (Viannia) braziliensis transmission. The primary outcome was clinical cure at 360 days of follow-up in the modified-intention-to-treat (mITT) and per-protocol (PP) populations. Non-inferiority margin was 15%. Secondary objectives included occurrence of epithelialization, adverse events and drug discontinuations. This study was registered in ClinicalTrials.gov: NCT01301924.ResultsOverall, 72 patients were randomly assigned to one of the two treatment arms during October 2008 to July 2014. In mITT, clinical cure was observed in 77.8% of subjects in the low dose antimony group and 94.4% in the high dose antimony group after one series of treatment (risk difference 16.7%; 90% CI, 3.7–29.7). The results were confirmed in PP analysis, with 77.8% of subjects with clinical cure in the low dose antimony group and 97.1% in the high dose antimony group (risk difference 19.4%; 90% CI, 7.1–31.7). The upper limit of the confidence interval exceeded the 15% threshold and was also above zero supporting the hypothesis that low dose is inferior to high dose of antimony after one series of treatment. Nevertheless, more major adverse events, a greater number of adverse events and major adverse events per subject, and more drug discontinuations were observed in the high dose antimony group (all p<0.05). Interestingly, of all the subjects who were originally allocated to the low dose antimony group and were followed up after clinical failure, 85.7% achieved cure after a further treatment with local therapy or low dose of antimony.ConclusionsCompared with high dose, low dose of antimony was inferior at the pre-specified margin after one series of treatment of ACL, but was associated with a significantly lower toxicity. While high dose of antimony should remain the standard treatment for ACL, low dose antimony treatment might be preferred when toxicity is a primary concern.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Low versus high dose of antimony for American cutaneous leishmaniasis: A randomized controlled blind non-inferiority trial in Rio de Janeiro, Brazil

et al. 2017

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“…Different doses have been evaluated, and doses other than the recommended dose are occasionally used; however, the decision to use a different dose must be based on structured studies within the same area and with the same Leishmania species. 48,49 The cure rate after treatment using pentavalent antimonials varies from 30% to 90%. 50 Because some reports using liposomal amphotericin B formulations for the treatment of ML have shown excellent results, liposomal amphotericin B can be an alternative treatment; however, the optimal doses for the treatment of ML have not been completely defined.…”

Section: MLmentioning

confidence: 99%

Review of the current treatments for leishmaniases

Lindoso

Costa

Queiroz

et al. 2012

RRTM

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Leishmaniases are vector-borne zoonotic diseases that are prevalent in tropical and subtropical areas in the world, with two million new cases occurring yearly. Visceral and tegumentary forms of leishmaniasis are known. The latter form may present as localized cutaneous or mucosal forms, disseminated, diffuse forms, or leishmaniasis recidiva cutis. Visceral leishmaniasis is caused by parasites of the species Leishmania (Leishmania) donovani and L. (L.) infantum, and tegumentary leishmaniasis is caused by 15 other species, with distinct distributions in the Old and New World. The varied clinical manifestations, the multitude of Leishmania species, and the increasing incidence of HIV coinfection make the diagnosis and treatment of leishmaniases complex. Since there are no solid data relating clinical manifestations, treatment outcomes and Leishmania species the decision regarding the best therapeutic option is almost entirely based on clinical manifestations. Because most of the literature is focused on leishmaniasis in the Old World, in this review we present data on the treatment of New World leishmaniasis in more detail. Ranked therapeutic options, clinical trials, and also observations, even with a restricted number of subjects, on treatment outcome of visceral and different forms of tegumentary leishmaniasis, are presented. Treatment for leishmaniasis in HIVcoinfected patients is addressed as well. Some of these data strongly suggest that the differences in the outcome of the treatment are related to the Leishmania species. Therefore, although it is not possible at most points of care to identify the species causing the infection-a process that requires a well equipped laboratory-the infecting species should be identified whenever possible. More recent approaches, such as the use of immunomodulators and immunotherapy, and the lines for development of new candidate drugs are mentioned.

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