Miltefosine to treat cutaneous leishmaniasis caused by<i>Leishmania tropica</i>

Killingley, Ben; Lamb, Lucy; Davidson, Robert N.

doi:10.1179/136485909x398177

Cited by 14 publications

(8 citation statements)

References 19 publications

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“…Our observational retrospective study showed that miltefosine is an effective treatment option in CL patients with PLOS NEGLECTED TROPICAL DISEASES contraindications to, or previously had failed antimonial treatment. The results of this study are comparable to the outcomes of miltefosine treatment in CL caused by L. major and in muco-cutaneous leishmaniasis [22,24,25,30,31,43,44]. We showed that the overall positive initial treatment response to miltefosine was 90.6% (95%CI: 80.7-96.5%) and the overall final cure rate 76.9% (95%CI: 63.2-87.5%).…”

Section: Discussionsupporting

confidence: 78%

“…Miltefosine is registered in Pakistan for use in leishmaniasis (produced and sold under the name Fosine). However, until now, only limited case studies have been conducted to evaluate the efficacy of miltefosine in CL caused by L. tropica which is generally considered to be less drug sensitive [24][25][26]. It is not (yet) included in the Pakistan national guidelines, although it is recommended by the WHO in the manual for case management of CL in the EMRO region (2014) as a second line treatment [27,28].…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of miltefosine in cutaneous leishmaniasis caused by Leishmania tropica in Pakistan after antimonial treatment failure or contraindications to first line therapy—A retrospective analysis

Kämink

Masih²,

Ali³

et al. 2021

PLoS Negl Trop Dis

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Background Cutaneous leishmaniasis (CL) is a neglected tropical skin disease, caused by Leishmania protozoa. In Pakistan, where CL caused by L. tropica is highly endemic, therapy with pentavalent antimonials is the standard of care, but has significant toxicity when used in systemic therapy, while are no evidence-based safer alternative treatment options for L. tropica. The efficacy of oral miltefosine has not been studied in CL caused by L. tropica. We evaluated effectiveness and tolerability of miltefosine in patients with previous treatment failure or with contraindications to systemic antimonial treatment. Methods A retrospective review was conducted of a cohort of CL patients who were treated with a 28-day course of miltefosine between December 2017 and August 2019, in urban Quetta, Pakistan, an area endemic for L. tropica. Descriptive analyses were performed, and effectiveness was assessed by initial response after treatment, and final cure at routine follow up visits, six weeks to three months post-treatment. Tolerability was assessed by routinely reported adverse events. Results Of the 76 CL patients in the cohort, 42 (55%) had contraindications to systemic antimonial treatment, and 34 (45%) had failure or relapse after antimonial treatment. Twelve patients defaulted during treatment and 12 patients were lost to follow up. In the remaining 52 patients, final cure rate was 77% (40/52). In those with contraindications to systemic antimonial treatment the final cure rate was 83% (24/29) and in the failure and relapse group 70% (16/23). Twenty-eight patients (40.0%) reported 39 mild to moderate adverse events with the main complaints being nausea (41.0%), general malaise (25.6%), and stomach pain (12.8%). Conclusion Results indicate that miltefosine is an effective second line treatment in CL in areas endemic for L. tropica. Prospective studies with systematic follow up are needed to obtain definitive evidence of effectiveness and tolerability, including identification of risk factors for miltefosine treatment failure.

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Section: Discussionsupporting

confidence: 78%

Section: Introductionmentioning

confidence: 99%

Effectiveness of miltefosine in cutaneous leishmaniasis caused by Leishmania tropica in Pakistan after antimonial treatment failure or contraindications to first line therapy—A retrospective analysis

Kämink

Masih²,

Ali³

et al. 2021

PLoS Negl Trop Dis

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“…Both oral miltefosine and liposomal intravenous amphotericin B were effective in a few L. tropica CL cases reported [16], [82]–[84], but controlled trials are still missing. In addition, the current prices for these medications essentially prohibit their use in Afghanistan.…”

Section: Discussionmentioning

confidence: 99%

Rapid Healing of Cutaneous Leishmaniasis by High-Frequency Electrocauterization and Hydrogel Wound Care with or without DAC N-055: A Randomized Controlled Phase IIa Trial in Kabul

et al. 2014

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BackgroundAnthroponotic cutaneous leishmaniasis (CL) due to Leishmania (L.) tropica infection is a chronic, frequently disfiguring skin disease with limited therapeutic options. In endemic countries healing of ulcerative lesions is often delayed by bacterial and/or fungal infections. Here, we studied a novel therapeutic concept to prevent superinfections, accelerate wound closure, and improve the cosmetic outcome of ACL.Methodology/Principal FindingsFrom 2004 to 2008 we performed a two-armed, randomized, double-blinded, phase IIa trial in Kabul, Afghanistan, with patients suffering from L. tropica CL. The skin lesions were treated with bipolar high-frequency electrocauterization (EC) followed by daily moist-wound-treatment (MWT) with polyacrylate hydrogel with (group I) or without (group II) pharmaceutical sodium chlorite (DAC N-055). Patients below age 5, with facial lesions, pregnancy, or serious comorbidities were excluded. The primary, photodocumented outcome was the time needed for complete lesion epithelialization. Biopsies for parasitological and (immuno)histopathological analyses were taken prior to EC (1st), after wound closure (2nd) and after 6 months (3rd). The mean duration for complete wound closure was short and indifferent in group I (59 patients, 43.1 d) and II (54 patients, 42 d; p = 0.83). In patients with Leishmania-positive 2nd biopsies DAC N-055 caused a more rapid wound epithelialization (37.2 d vs. 58.3 d; p = 0.08). Superinfections occurred in both groups at the same rate (8.8%). Except for one patient, reulcerations (10.2% in group I, 18.5% in group II; p = 0.158) were confined to cases with persistent high parasite loads after healing. In vitro, DAC N-055 showed a leishmanicidal effect on pro- and amastigotes.Conclusions/SignificanceCompared to previous results with intralesional antimony injections, the EC plus MWT protocol led to more rapid wound closure. The tentatively lower rate of relapses and the acceleration of wound closure in a subgroup of patients with parasite persistence warrant future studies on the activity of DAC N-055.Trial RegistrationClinicalTrails.gov NCT00947362

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“…So far, no vaccine approved for human use is available [3]. Various antileishmanial agents are readily available in the market although none of these chemotherapy drugs are free from harmful side effects and toxicity [4–7]. Currently, the development of new drugs against leishmaniasis is a need.…”

Section: Introductionmentioning

confidence: 99%

Activity of Cuban Plants Extracts againstLeishmania amazonensis

et al. 2012

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Natural products have long been providing important drug leads for infectious diseases. Leishmaniasis is a major health problem worldwide that affects millions of people especially in the developing nations. There is no immunoprophylaxis (vaccination) available for Leishmania infections, and conventional treatments are unsatisfactory; therefore, antileishmanial drugs are urgently needed. In this work, 48 alcoholic extracts from 46 Cuban plants were evaluated by an in vitro bioassay against Leishmania amazonensis. Furthermore, their toxicity was assayed against murine macrophage. The three most potent extracts against the amastigote stage of Leishmania amazonensis were from Hura crepitans, Bambusa vulgaris, and Simarouba glauca.

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Miltefosine to treat cutaneous leishmaniasis caused byLeishmania tropica

Cited by 14 publications

References 19 publications

Effectiveness of miltefosine in cutaneous leishmaniasis caused by Leishmania tropica in Pakistan after antimonial treatment failure or contraindications to first line therapy—A retrospective analysis

Effectiveness of miltefosine in cutaneous leishmaniasis caused by Leishmania tropica in Pakistan after antimonial treatment failure or contraindications to first line therapy—A retrospective analysis

Rapid Healing of Cutaneous Leishmaniasis by High-Frequency Electrocauterization and Hydrogel Wound Care with or without DAC N-055: A Randomized Controlled Phase IIa Trial in Kabul

Activity of Cuban Plants Extracts againstLeishmania amazonensis

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