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Correspondence
No evidence for cardiotoxicity of miltefosine
Thomas P.C. Dorloa,b,
Autor para correspondência
thomasdorlo@gmail.com

Corresponding author.
a Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital/Netherlands Cancer Institute, Amsterdam, The Netherlands
b Department of Pharmacy, Uppsala University, Uppsala, Sweden
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In a recent article&#44; Barroso et al&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> reported on the comparison of cardiotoxicity between N-methyl glucamine antimoniate&#44; better known as meglumine antimoniate&#44; and miltefosine&#46; As the authors indicate&#44; antimonial compounds are notorious for their extensive toxicity&#44; particularly cardiotoxicity&#44; leading to pronounced prolongation of corrected QT interval &#40;QTc&#41; and risk of developing abnormal heart rhythms that can cause sudden death&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The only significant result the authors report is a decreased relative risk in QTc&#160;&#62;&#160;440&#160;msec for meglumine antimoniate &#40;<span class="elsevierStyleItalic">n</span>&#61;38&#41; compared to miltefosine &#40;<span class="elsevierStyleItalic">n</span>&#61;15&#41; on day 7 of treatment&#46; Looking at it longitudinally for the miltefosine-regimen&#44; the proportion of patients with QTc&#160;&#62;&#160;440&#160;msec appeared to increase in the first week of treatment&#44; but thereafter completely disappeared&#58; 1&#47;15&#44; 5&#47;15&#44; 0&#47;15&#44; 0&#47;15&#44; for day 0&#44; 7&#44; 14&#44; and 21&#44; respectively&#44; while it steadily increased in the meglumine antimoniate-treated group&#44; culminating to 35&#46;3&#37; of patients with an abnormal QTc&#46; Instead of looking at relative risk at each of the measured time points&#44; assessing longitudinal changes within treatment groups would potentially have been a more relevant way of analyzing and interpreting these data&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The authors suggest that the cardiotoxicity of miltefosine has been described before&#44; but to the best of my knowledge&#44; this is not the case&#46; 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&#44; with a 14&#160;msec increase in QTc from baseline during miltefosine&#46; Such a clinically non-relevant increase in QTc is seen for many anti-infective drugs&#44; also for those not exhibiting cardiotoxicity&#44; probably due to recovery from infection and waning of fever&#44; which can have a prolonging effect itself on QTc&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">From a pharmacokinetic angle&#44; there is little rationale for a QTc prolongation only in the first treatment week&#46; Miltefosine keeps accumulating during the 28-day treatment regimen&#44; reaching a steady state in the last week of treatment&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Maximal drug concentrations in the first week are &#60; 50&#37; of those expected in the fourth week of treatment&#46; Moreover&#44; no mechanisms of cardiotoxicity are known from pre-clinical and clinical pharmacological research on miltefosine&#46; Recently&#44; a dedicated study investigating the effect of miltefosine on QTc in 42 Bolivian mucocutaneous leishmaniasis patients was concluded&#46; While results remain to be published&#44; the updated FDA miltefosine label mentions no evidence of QTc prolongation or increases &#62;20&#160;msec from baseline were observed in this study&#46;</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&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Financial support</span><p id="par0030" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Author&#8217; contributions</span><p id="par0035" class="elsevierStylePara elsevierViewall">Thomas P&#46;C&#46; Dorlo&#58; Preparation and writing of the manuscript&#59; study conception and planning&#59; approval of the final version of the manuscript&#46;</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&#46;</p></span></span>"
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