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afectada de 35 &#40;20&#8211;62&#44;25&#41;&#46; En cuanto a las medidas del resultado reportadas por el paciente&#44; los valores de media<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RIC para la escala num&#233;rica &#40;NRS&#41; del prurito m&#225;ximo y de DLQI fueron de 6&#44;50 &#40;5&#44;25&#8211;8&#41; y 18 &#40;13&#8211;21&#41;&#44; respectivamente&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">EASI75 &#40;&#8805;75&#37; reducci&#243;n desde el valor de EASI basal&#41; fue logrado por el 90&#44;9&#44; el 81&#44;8 y el 81&#44;8&#37; de los pacientes en las semanas 4&#44; 12 y 24&#44; respectivamente&#46; Las puntuaciones IGA-AD de 0&#8211;1 fueron logradas por el 81&#44;8&#44; 72&#44;7 y 72&#44;7&#37; de los pacientes en las semanas 4&#44; 12 y 24&#44; respectivamente&#46; Los valores medios de DLQI durante el seguimiento fueron de 4&#44; 2&#44; y 2 en las semanas 4&#44; 12 y 24&#44; respectivamente&#46; La eficacia del tratamiento durante el seguimiento se muestra en la <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">En cuanto a las AA&#44; los pacientes presentaron al menos una AA leve&#46; Anal&#237;ticamente&#44; todos los pacientes presentaron incrementos ligeros de los niveles de creatina quinasa en alg&#250;n momento del seguimiento&#46; Otros hallazgos fueron hipercolesterolemia &#40;54&#44;5&#37;&#41;&#44; hipertrigliceridemia &#40;18&#44;2&#37;&#41; e incremento leve de las transaminasas hep&#225;ticas &#40;9&#44;1&#37;&#41;&#46; En cuanto a trastornos infecciosos&#44; 1&#47;12 &#40;9&#44;1&#37;&#41; experimentaron un episodio de herpes z&#243;ster multimetam&#233;rico&#46; No se registraron AA cl&#237;nicos o anal&#237;ticos graves&#46; Todos los AA reportados se muestran en la <a class="elsevierStyleCrossRef" href="#tbl0010">Tabla 2</a>&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">Los ensayos cl&#237;nicos MEASURE UP 1 y 2 lograron un valor EASI75 en el 76&#44;3&#37; de los pacientes en la 16&#170; semana de seguimiento&#44; mientras que nosotros observamos un valor EASI75 ligeramente mejor en las semanas 12 y 24 &#40;81&#44;8&#37; en ambas&#41;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">1</span></a>&#46; En estudios previos sobre la pr&#225;ctica cl&#237;nica real con muestras de mayor tama&#241;o&#44; Pereyra-Rodriguez et al&#46; reportaron un valor de respuestas EASI75 e IGA-AD en la 16&#170; semana del 76&#44;7 y 62&#44;8&#37;&#44; respectivamente &#40;muestra de 43 pacientes&#41;&#44; lo cual es inferior a nuestros hallazgos<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">2</span></a>&#46; Por otro lado&#44; Chiricozzi et al&#46; reportaron resultados m&#225;s altos en t&#233;rminos de EASI75 en la 16&#170; semana &#40;97&#44;5&#37;&#41; en una muestra de 43 pacientes<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">3</span></a>&#46; Centr&#225;ndonos en los estudios que incluyen &#250;nicamente pacientes con DA refractaria&#44; como el nuestro &#40;inefectividad de dupilumab o JAKi&#41;&#44; Feraru et al&#46; encontraron una respuesta IGA-AD similar a la de nuestro estudio en la semana 24&#170; de seguimiento en 12 adultos &#40;75&#37;&#41;&#44; mientras que De Greef et al&#46; reportaron una respuesta IGA-AD ligeramente menor &#40;71&#44;4&#37;&#41; durante el seguimiento a largo plazo<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">4&#44;5</span></a>&#46; En los estudios con seguimientos m&#225;s breves&#44; Dal Bello et al&#46; lograron un resultado EASI75 en los 10 pacientes con DA refractaria incluidos en el estudio en la 8<span class="elsevierStyleHsp" style=""></span>&#170; semana de seguimiento&#44; mientras que Napolitano et al&#46; reportaron un valor EASI75 del 75&#37; &#40;16 pacientes incluidos&#41; en la 16&#170; semana de seguimiento<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">6&#44;7</span></a>&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Debemos mencionar el excelente control del prurito logrado por upadacitinib en nuestra serie &#40;72&#44;7&#37; de los pacientes frente al 60&#37; reportado en los ensayos cl&#237;nicos&#41;&#44; y el breve periodo de tiempo transcurrido hasta la remisi&#243;n del prurito de los pacientes &#40;mediana&#44; 4 d&#237;as&#41;&#44; variable no considerada en estudios previos y que debe ser de inter&#233;s&#44; dado que el prurito representa el s&#237;ntoma principal relacionado con la DA&#44; y tiene un impacto directo en la calidad de vida del paciente&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">En conclusi&#243;n&#44; nuestros hallazgos sobre eficacia son consistentes con los reportados tanto en ensayos cl&#237;nicos como en informes de la pr&#225;ctica cl&#237;nica previos&#46; Seg&#250;n nuestra experiencia&#44; upadacitinib es una opci&#243;n fiable cuando las circunstancias del paciente demandan un r&#225;pido alivio del prurito&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">La fortaleza de nuestro estudio es que se trat&#243; de una experiencia en la pr&#225;ctica cl&#237;nica real de los pacientes con DA refractaria a m&#250;ltiples tratamientos&#46; Las limitaciones principales del estudio incluyen el peque&#241;o tama&#241;o de la muestra y la recopilaci&#243;n retrospectiva de los datos&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicto de intereses</span><p id="par0055" class="elsevierStylePara elsevierViewall">Los autores declaran la ausencia de conflicto de intereses&#46;</p></span></span>"
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">11 &#40;100&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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Cartas científico-clínicas
Experiencia en práctica clínica real con upadacitinib en adolescentes y adultos con dermatitis atópica refractaria: un estudio retrospectivo de 24 semanas
Real-world Experience With Upadacitinib in Adolescents and Adults With Refractory Atopic Dermatitis: A 24-week Retrospective Study
J. Naharro-Rodríguez
Corresponding author
jorgenrmed@gmail.com

Autor para correspondencia.
, E. Berná-Rico, F.J. Pérez-Bootello, B. Pérez-García
Dermatology Department, Ramón y Cajal University Hospital, IRYCIS, Madrid, España
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    "titulo" => " Experiencia en pr&#225;ctica cl&#237;nica real con upadacitinib en adolescentes y adultos con dermatitis at&#243;pica refractaria&#58; un estudio retrospectivo de 24 semanas"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Upadacitinib es un inhibidor oral de la quinasa Janus &#40;JAKi&#41;&#44; aprobado para tratar la dermatitis at&#243;pica &#40;DA&#41; de moderada a grave de los pacientes &#8805;<span class="elsevierStyleHsp" style=""></span>12 a&#241;os&#46; Su perfil de eficacia y seguridad en comparaci&#243;n con el placebo ya ha sido demostrado en ensayos cl&#237;nicos<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">1</span></a>&#44; y se est&#225;n comenzando a reportar datos de la vida real en la literatura m&#233;dica cient&#237;fica&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Realizamos un estudio de cohorte retrospectivo recopilando datos de adolescentes y adultos con dermatitis at&#243;pica refractaria grave tratados diariamente con 30<span class="elsevierStyleHsp" style=""></span>mg de upadacitinib desde mayo de 2022 a abril de 2023 en la Unidad de Dermatolog&#237;a del Hospital Universitario Ramon y Cajal&#44; Madrid&#44; Espa&#241;a&#46; Su efectividad fue medida utilizando la escala IGA-AD &#40;Investigator Global Assessment for Atopic Dermatitis&#41; validada &#40;puntuaciones de 0 o 1 con reducci&#243;n &#8805;<span class="elsevierStyleHsp" style=""></span>2 grados con respecto al valor basal&#41;&#44; y el logro por parte de los pacientes de un valor 75 en la escala EASI &#40;Eczema Area and Severity Index&#41; en las semanas 4&#44; 12 y 24&#46; Se recopilaron todos los acontecimientos adversos &#40;AA&#41; relacionados con el tratamiento&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Se incluyeron once pacientes&#44; con edades que oscilaron de 13 a 52 a&#241;os &#40;mediana&#44; 29&#41;&#46; Todos ellos hab&#237;an sido tratados insatisfactoriamente con corticosteroides t&#243;picos y orales y ciclosporina&#44; 10&#47;11 &#40;90&#44;9&#37;&#41; segu&#237;an tratamiento de dupilumab&#44; y 1&#47;11 &#40;9&#44;1&#37;&#41; segu&#237;an tratamiento de baricitinib&#44; sin lograr un control de la enfermedad aceptable&#46; Las caracter&#237;sticas basales se reflejan en la <a class="elsevierStyleCrossRef" href="#tbl0005">Tabla 1</a>&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0020" class="elsevierStylePara elsevierViewall">En cuanto a la efectividad&#44; todos los pacientes reportaron alivio r&#225;pido del prurito&#44; que fue absoluto en el 72&#44;7&#37; de los pacientes&#59; en dichos pacientes&#44; el tiempo de media<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>rango intercuart&#237;lico &#40;RIC&#41; para el control fue de 4 d&#237;as &#40;2&#44;5&#8211;5&#41;&#46; Al inicio&#44; los valores de media<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RIC para EASI e IGA-AD fueron de 28 &#40;25&#44;50&#8211;34&#44;25&#41; y 4 &#40;3&#8211;4&#41;&#44; respectivamente&#44; el valor del &#237;ndice SCORAD fue de 58 &#40;51&#8211;60&#41;&#44; y el del &#225;rea de superficie corporal &#40;BSA&#41; afectada de 35 &#40;20&#8211;62&#44;25&#41;&#46; En cuanto a las medidas del resultado reportadas por el paciente&#44; los valores de media<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RIC para la escala num&#233;rica &#40;NRS&#41; del prurito m&#225;ximo y de DLQI fueron de 6&#44;50 &#40;5&#44;25&#8211;8&#41; y 18 &#40;13&#8211;21&#41;&#44; respectivamente&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">EASI75 &#40;&#8805;75&#37; reducci&#243;n desde el valor de EASI basal&#41; fue logrado por el 90&#44;9&#44; el 81&#44;8 y el 81&#44;8&#37; de los pacientes en las semanas 4&#44; 12 y 24&#44; respectivamente&#46; Las puntuaciones IGA-AD de 0&#8211;1 fueron logradas por el 81&#44;8&#44; 72&#44;7 y 72&#44;7&#37; de los pacientes en las semanas 4&#44; 12 y 24&#44; respectivamente&#46; Los valores medios de DLQI durante el seguimiento fueron de 4&#44; 2&#44; y 2 en las semanas 4&#44; 12 y 24&#44; respectivamente&#46; La eficacia del tratamiento durante el seguimiento se muestra en la <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">En cuanto a las AA&#44; los pacientes presentaron al menos una AA leve&#46; Anal&#237;ticamente&#44; todos los pacientes presentaron incrementos ligeros de los niveles de creatina quinasa en alg&#250;n momento del seguimiento&#46; Otros hallazgos fueron hipercolesterolemia &#40;54&#44;5&#37;&#41;&#44; hipertrigliceridemia &#40;18&#44;2&#37;&#41; e incremento leve de las transaminasas hep&#225;ticas &#40;9&#44;1&#37;&#41;&#46; En cuanto a trastornos infecciosos&#44; 1&#47;12 &#40;9&#44;1&#37;&#41; experimentaron un episodio de herpes z&#243;ster multimetam&#233;rico&#46; No se registraron AA cl&#237;nicos o anal&#237;ticos graves&#46; Todos los AA reportados se muestran en la <a class="elsevierStyleCrossRef" href="#tbl0010">Tabla 2</a>&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">Los ensayos cl&#237;nicos MEASURE UP 1 y 2 lograron un valor EASI75 en el 76&#44;3&#37; de los pacientes en la 16&#170; semana de seguimiento&#44; mientras que nosotros observamos un valor EASI75 ligeramente mejor en las semanas 12 y 24 &#40;81&#44;8&#37; en ambas&#41;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">1</span></a>&#46; En estudios previos sobre la pr&#225;ctica cl&#237;nica real con muestras de mayor tama&#241;o&#44; Pereyra-Rodriguez et al&#46; reportaron un valor de respuestas EASI75 e IGA-AD en la 16&#170; semana del 76&#44;7 y 62&#44;8&#37;&#44; respectivamente &#40;muestra de 43 pacientes&#41;&#44; lo cual es inferior a nuestros hallazgos<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">2</span></a>&#46; Por otro lado&#44; Chiricozzi et al&#46; reportaron resultados m&#225;s altos en t&#233;rminos de EASI75 en la 16&#170; semana &#40;97&#44;5&#37;&#41; en una muestra de 43 pacientes<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">3</span></a>&#46; Centr&#225;ndonos en los estudios que incluyen &#250;nicamente pacientes con DA refractaria&#44; como el nuestro &#40;inefectividad de dupilumab o JAKi&#41;&#44; Feraru et al&#46; encontraron una respuesta IGA-AD similar a la de nuestro estudio en la semana 24&#170; de seguimiento en 12 adultos &#40;75&#37;&#41;&#44; mientras que De Greef et al&#46; reportaron una respuesta IGA-AD ligeramente menor &#40;71&#44;4&#37;&#41; durante el seguimiento a largo plazo<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">4&#44;5</span></a>&#46; En los estudios con seguimientos m&#225;s breves&#44; Dal Bello et al&#46; lograron un resultado EASI75 en los 10 pacientes con DA refractaria incluidos en el estudio en la 8<span class="elsevierStyleHsp" style=""></span>&#170; semana de seguimiento&#44; mientras que Napolitano et al&#46; reportaron un valor EASI75 del 75&#37; &#40;16 pacientes incluidos&#41; en la 16&#170; semana de seguimiento<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">6&#44;7</span></a>&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Debemos mencionar el excelente control del prurito logrado por upadacitinib en nuestra serie &#40;72&#44;7&#37; de los pacientes frente al 60&#37; reportado en los ensayos cl&#237;nicos&#41;&#44; y el breve periodo de tiempo transcurrido hasta la remisi&#243;n del prurito de los pacientes &#40;mediana&#44; 4 d&#237;as&#41;&#44; variable no considerada en estudios previos y que debe ser de inter&#233;s&#44; dado que el prurito representa el s&#237;ntoma principal relacionado con la DA&#44; y tiene un impacto directo en la calidad de vida del paciente&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">En conclusi&#243;n&#44; nuestros hallazgos sobre eficacia son consistentes con los reportados tanto en ensayos cl&#237;nicos como en informes de la pr&#225;ctica cl&#237;nica previos&#46; Seg&#250;n nuestra experiencia&#44; upadacitinib es una opci&#243;n fiable cuando las circunstancias del paciente demandan un r&#225;pido alivio del prurito&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">La fortaleza de nuestro estudio es que se trat&#243; de una experiencia en la pr&#225;ctica cl&#237;nica real de los pacientes con DA refractaria a m&#250;ltiples tratamientos&#46; Las limitaciones principales del estudio incluyen el peque&#241;o tama&#241;o de la muestra y la recopilaci&#243;n retrospectiva de los datos&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicto de intereses</span><p id="par0055" class="elsevierStylePara elsevierViewall">Los autores declaran la ausencia de conflicto de intereses&#46;</p></span></span>"
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">1 &#40;9&#44;1&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">6 &#40;54&#44;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">2 &#40;18&#44;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1 &#40;9&#44;1&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Nivel elevado de CK&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">11 &#40;100&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Infecciosos</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">11 &#40;100&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Herpes z&#243;ster&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 &#40;9&#44;1&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">3 &#40;27&#44;3&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Reactivaci&#243;n de herpes simplex&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">4 &#40;36&#44;4&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Episodios cardiovasculares&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0 &#40;0&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Episodios tromboemb&#243;licos&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0 &#40;0&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Cualquier EA</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">11 &#40;100&#41;&nbsp;\t\t\t\t\t\t\n
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Article information
ISSN: 00017310
Original language: Spanish
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Idiomas
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