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No evidence for cardiotoxicity of miltefosine
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Dorlo" "autores" => array:1 [ 0 => array:4 [ "nombre" => "Thomas P.C." "apellidos" => "Dorlo" "email" => array:1 [ 0 => "thomasdorlo@gmail.com" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital/Netherlands Cancer Institute, Amsterdam, The Netherlands" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Department of Pharmacy, Uppsala University, Uppsala, Sweden" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In a recent article, Barroso et al.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> reported on the comparison of cardiotoxicity between N-methyl glucamine antimoniate, better known as meglumine antimoniate, and miltefosine. As the authors indicate, antimonial compounds are notorious for their extensive toxicity, particularly cardiotoxicity, leading to pronounced prolongation of corrected QT interval (QTc) and risk of developing abnormal heart rhythms that can cause sudden death.</p><p id="par0010" class="elsevierStylePara elsevierViewall">The only significant result the authors report is a decreased relative risk in QTc > 440 msec for meglumine antimoniate (<span class="elsevierStyleItalic">n</span>=38) compared to miltefosine (<span class="elsevierStyleItalic">n</span>=15) on day 7 of treatment. Looking at it longitudinally for the miltefosine-regimen, the proportion of patients with QTc > 440 msec appeared to increase in the first week of treatment, but thereafter completely disappeared: 1/15, 5/15, 0/15, 0/15, for day 0, 7, 14, and 21, respectively, while it steadily increased in the meglumine antimoniate-treated group, culminating to 35.3% of patients with an abnormal QTc. Instead of looking at relative risk at each of the measured time points, assessing longitudinal changes within treatment groups would potentially have been a more relevant way of analyzing and interpreting these data.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The authors suggest that the cardiotoxicity of miltefosine has been described before, but to the best of my knowledge, this is not the case. The phase 3 study<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> to which the authors refer reports no abnormalities in electrocardiography, with a 14 msec increase in QTc from baseline during miltefosine. Such a clinically non-relevant increase in QTc is seen for many anti-infective drugs, also for those not exhibiting cardiotoxicity, probably due to recovery from infection and waning of fever, which can have a prolonging effect itself on QTc.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">From a pharmacokinetic angle, there is little rationale for a QTc prolongation only in the first treatment week. Miltefosine keeps accumulating during the 28-day treatment regimen, reaching a steady state in the last week of treatment.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Maximal drug concentrations in the first week are < 50% of those expected in the fourth week of treatment. Moreover, no mechanisms of cardiotoxicity are known from pre-clinical and clinical pharmacological research on miltefosine. Recently, a dedicated study investigating the effect of miltefosine on QTc in 42 Bolivian mucocutaneous leishmaniasis patients was concluded. While results remain to be published, the updated FDA miltefosine label mentions no evidence of QTc prolongation or increases >20 msec from baseline were observed in this study.</p><p id="par0025" class="elsevierStylePara elsevierViewall">The conclusion should be that there is no convincing evidence nor pharmacokinetic-pharmacodynamic rationale that miltefosine causes cardiotoxicity.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Financial support</span><p id="par0030" class="elsevierStylePara elsevierViewall">None declared.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Author’ contributions</span><p id="par0035" class="elsevierStylePara elsevierViewall">Thomas P.C. Dorlo: Preparation and writing of the manuscript; study conception and planning; approval of the final version of the manuscript.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflicts of interest</span><p id="par0040" class="elsevierStylePara elsevierViewall">None declared.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Financial support" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Author’ contributions" ] 2 => array:2 [ "identificador" => "sec0015" "titulo" => "Conflicts of interest" ] 3 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2022-01-25" "fechaAceptado" => "2022-03-25" "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Study conducted at the Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital/Netherlands Cancer Institute, Amsterdam, The Netherlands.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:4 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Comparison of cardiotoxicity between N-methyl-glucamine and miltefosine in the treatment of American cutaneous leishmaniasis" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "D.H. 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Saralamba" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1371/journal.pmed.1003040" "Revista" => array:5 [ "tituloSerie" => "PLoS Med" "fecha" => "2020" "volumen" => "17" "paginaInicial" => "e1003040" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/32134952" "web" => "Medline" ] ] ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0020" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Miltefosine: a review of its pharmacology and therapeutic efficacy in the treatment of leishmaniasis" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "T.P.C. Dorlo" 1 => "M. Balasegaram" 2 => "J.H. 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