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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">El insomnio constituye una afecci&#243;n com&#250;n en Europa&#44; con una prevalencia variable entre el 5&#44;7&#37; en Alemania y el 20&#44;8&#37; en Espa&#241;a<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">1&#8211;3</span></a>&#46; Para el tratamiento del insomnio se recomienda utilizar benzodiacepinas o agonistas de los receptores de las benzodiacepinas &#40;denominados hipn&#243;ticos-Z&#41;&#46; Tambi&#233;n se han incorporado al tratamiento del insomnio algunos antidepresivos&#44; entre los que se halla la trazodona<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">4</span></a>&#46; En estudios realizados en Mallorca &#40;Espa&#241;a&#41; el 53&#44;5&#37; de m&#233;dicos de atenci&#243;n primaria prescribe alguno de estos f&#225;rmacos&#44; siendo las benzodiacepinas las m&#225;s utilizadas&#44; seguidas por los hipn&#243;ticos Z y&#44; posteriormente&#44; por los antidepresivos<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">5</span></a>&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Entre los efectos adversos del tratamiento del insomnio se encuentran la aparici&#243;n de confusi&#243;n nocturna&#44; somnolencia diurna&#44; tolerancia&#44; dependencia e insomnio de rebote<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">1</span></a>&#46; Tambi&#233;n se relacionado el consumo de benzodiacepinas e hipn&#243;ticos Z con un mayor riesgo de ca&#237;das<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">6&#44;7</span></a>&#46; La incidencia de presentar alguna reacci&#243;n adversa aumenta en relaci&#243;n con la edad y con la polifarmacia<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">8</span></a>&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">En el presente estudio hemos querido establecer el perfil de seguridad de lormetazepam&#44; zolpidem y trazodona&#44; los f&#225;rmacos m&#225;s com&#250;nmente utilizados en Espa&#241;a para el tratamiento del insomnio<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">9</span></a>&#46; Para ello hemos analizado las notificaciones de reacciones adversas de la base de datos europea EudraVigilance &#40;<a href="http://www.adrreports.eu/">www&#46;adrreports&#46;eu</a>&#41; a fecha 27 de abril de 2020&#46; Las reacciones adversas fueron categorizadas en 4 grupos&#58; &#171;Des&#243;rdenes generales y condiciones del lugar de administraci&#243;n&#187;&#44; que se ha tomado como grupo control&#59; &#171;Da&#241;o&#44; intoxicaci&#243;n o complicaciones de procedimiento&#187;&#44; que incluye&#44; entre otros&#44; ca&#237;das y fracturas&#59; &#171;Des&#243;rdenes del sistema nervioso&#187;&#44; que incluye disminuci&#243;n del nivel de consciencia o coma y&#44; finalmente &#171;Des&#243;rdenes psiqui&#225;tricos&#187;&#44; que incluye estado de confusi&#243;n o delirium&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Como m&#233;todo de an&#225;lisis hemos calculado la raz&#243;n de notificaci&#243;n proporcional &#40;<span class="elsevierStyleItalic">Proportional Reporting Ratio</span> &#91;PRR&#93; en ingl&#233;s&#41; y su intervalo de confianza al 95&#37;&#46; La raz&#243;n de notificaci&#243;n proporcional es una medida que informa del riesgo de un efecto adverso para un determinado medicamento espec&#237;fico&#44; en comparaci&#243;n con la frecuencia con la que se informa el mismo efecto adverso en pacientes que toman otro medicamento &#40;o que toman cualquier medicamento de una clase espec&#237;fica de medicamentos&#41;&#46; Se han considerado cl&#237;nicamente relevantes los valores de PRR iguales o superiores a 2 seg&#250;n los criterios de EudraVigilance&#46; As&#237; mismo&#44; hemos realizado un an&#225;lisis de la base de datos por subgrupos de edad y sexo&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">El conjunto de reacciones adversas &#171;Des&#243;rdenes psiqui&#225;tricos&#187;&#44; que incluye estado confusional o delirium&#44; fue el que se report&#243; con m&#225;s frecuencia entre los efectos adversos analizados &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">tabla 1</a>&#41;&#46; Por f&#225;rmacos zolpidem mostr&#243; aumentar significativamente el riesgo de presentar efectos adversos de los grupos &#171;Da&#241;o&#44; intoxicaci&#243;n o complicaciones del procedimiento&#187;&#44; &#171;Des&#243;rdenes del sistema nervioso&#187; y &#171;Des&#243;rdenes psiqui&#225;tricos&#187;&#46; Trazodona mostr&#243; mayor riesgo de producir efecto adverso en las categor&#237;as &#171;Da&#241;o&#44; intoxicaci&#243;n o complicaciones de procedimiento&#187; y &#171;Des&#243;rdenes psiqui&#225;tricos&#187; y lormetazepam mostr&#243; incrementar el riesgo de reacci&#243;n adversa en el grupo &#171;Des&#243;rdenes psiqui&#225;tricos&#187;&#46; No hubo diferencias significativas en los valores de PRR de los diferentes hipn&#243;ticos seg&#250;n el sexo&#46; El an&#225;lisis por estratos de edad muestra que lormetazepam fue m&#225;s seguro que trazodona y zolpidem en individuos entre 18-64 a&#241;os&#46; Por el contrario&#44; trazodona mostr&#243; un menor riesgo de efectos adversos que lormetazepam y zolpidem en individuos de m&#225;s de 85 a&#241;os&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">Este trabajo es el primero que analiza una base de datos de farmacovigilancia europea para comparar la seguridad de los hipn&#243;ticos&#46; Hemos comprobado que lormetazepam es el f&#225;rmaco con mejor perfil de seguridad entre los comparados&#46; Al contrario que nuestro estudio&#44; un ensayo cl&#237;nico comparativo no mostr&#243; diferencias en t&#233;rminos de seguridad entre zolpidem y trazodona<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">10</span></a>&#46; Probablemente esta discrepancia se deba al escaso n&#250;mero de pacientes incluido en el ensayo cl&#237;nico y a la corta duraci&#243;n de dicho estudio<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">10</span></a>&#46; El aumento del riesgo de ca&#237;das en los pacientes tratados con zolpidem frente a los tratados con benzodiacepinas observado en nuestro estudio ya se ha publicado anteriormente<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">11</span></a>&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Como en otras series&#44; apreciamos un aumento progresivo del riesgo de reacci&#243;n adversa para todos los hipn&#243;ticos seg&#250;n la edad<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">6&#44;7</span></a>&#46; Sin embargo&#44; nuestro an&#225;lisis muestra que la trazodona&#44; con respecto a zolpidem y lormetazepam&#44; present&#243; un mejor perfil de seguridad entre los pacientes mayores de 85 a&#241;os&#46; Esta observaci&#243;n no se hab&#237;a notificado con anterioridad&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Respecto a las fortalezas y debilidades de nuestro trabajo destacaremos que EudraVigilance es una base de datos de reporte espont&#225;neo&#44; por lo que est&#225; sujeta a infranotificaci&#243;n de los efectos adversos&#46; En relaci&#243;n con el an&#225;lisis de los resultados la agrupaci&#243;n de las reacciones adversas en grandes apartados minimiza la importancia de reacciones adversas espec&#237;ficas y tiende a sesgar los valores de PRR hacia el valor nulo&#46; Ello implica que los valores de PRR iguales o superiores a 2 se interpreten como se&#241;ales robustas de asociaci&#243;n entre f&#225;rmaco y efecto adverso&#46; Finalmente&#44; EudraVigilance aporta una elevada validez interna y externa&#44; ya que recoge las notificaciones de reacciones adversas asociadas a f&#225;rmacos de todo el espacio com&#250;n europeo&#46; Los contenidos de la base de datos se revisan peri&#243;dicamente para reducir el riesgo de sesgos&#44; entre otros la duplicidad de reportes&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">A la vista de nuestros resultados consideramos que el lormetazepam podr&#237;a representar la alternativa m&#225;s segura&#44; en comparaci&#243;n con el zolpidem y la trazodona&#46; Sin embargo&#44; en sujetos mayores de 85 a&#241;os la trazodona es el f&#225;rmaco que mostr&#243; mejor perfil de seguridad&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Financiaci&#243;n</span><p id="par0050" class="elsevierStylePara elsevierViewall">La investigaci&#243;n a la que hacemos referencia no ha recibido ayudas espec&#237;ficas provenientes de agencias del sector p&#250;blico&#44; sector comercial o entidades sin &#225;nimo de lucro&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflictos de inter&#233;s</span><p id="par0055" class="elsevierStylePara elsevierViewall">Ninguno&#46;</p></span></span>"
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Des&#243;rdenes psiqui&#225;tricos</th></tr><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">PRR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">IC 95&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">PRR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">IC 95&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">PRR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">IC 95&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">PRR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">IC 95&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><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
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Lormetazepam&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">Hombre&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;43&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;25-0&#44;61&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;90&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;77-2&#44;03&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;95&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;85-2&#44;04&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">8&#44;53&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">8&#44;47-8&#44;58&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
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">Mujer&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;49&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;35-0&#44;62&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;74&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;64-1&#44;84&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;87&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;80-1&#44;95&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">6&#44;90&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">6&#44;85-6&#44;95&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
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">18-64 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;38&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;23-0&#44;54&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;55&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;44-1&#44;66&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;66&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;58-1&#44;74&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">6&#44;80&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">6&#44;76-6&#44;85&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
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">65-85 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;54&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;32-0&#44;76&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">2&#44;18&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">2&#44;02-2&#44;33&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;63&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;37-0&#44;89&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">9&#44;31&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">9&#44;21-9&#44;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
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">&#62;<span class="elsevierStyleHsp" style=""></span>85 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;54&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;13-0&#44;94&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">2&#44;46&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">2&#44;24-2&#44;68&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">2&#44;06&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;85-2&#44;27&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">9&#44;42&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">9&#44;23-9&#44;61&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
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Trazodona&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">Hombre&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;01&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">0&#44;95-1&#44;07&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">2&#44;29&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">2&#44;22-2&#44;35&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;90&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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&#44;84-1&#44;96&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">5&#44;91&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">5&#44;86-5&#44;95&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  " align="left" valign="\n
                  \t\t\t\t\ttop\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">2&#44;19-2&#44;35&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">2&#44;18&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&#44;11-2&#44;25&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">10&#44;65&#42;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \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">10&#44;59-10&#44;72&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
              ]
              "imagenFichero" => array:1 [
                0 => "xTab2501229.png"
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        ]
        "descripcion" => array:1 [
          "es" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Estudio comparativo por sexo y edad de los diferentes grupos de reacciones adversas medicamentosas notificadas para los hipn&#243;ticos incluidos en nuestro trabajo</p>"
        ]
      ]
    ]
    "bibliografia" => array:2 [
      "titulo" => "Bibliograf&#237;a"
      "seccion" => array:1 [
        0 => array:2 [
          "identificador" => "bibs0015"
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            0 => array:3 [
              "identificador" => "bib0060"
              "etiqueta" => "1"
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "European guideline for the diagnosis and treatment of insomnia"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "D&#46; Riemann"
                            1 => "C&#46; Baglioni"
                            2 => "C&#46; Bassetti"
                            3 => "B&#46; Bjorvatn"
                            4 => "L&#46;D&#46; Groselj"
                            5 => "J&#46;G&#46; Ellis"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1111/jsr. 12594"
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Reacciones adversas medicamentosas de los hipnóticos más utilizados en España
Adverse drug reactions among the most used hypnotic drugs in Spain
A.J. Pardo-Cabelloa,
Autor para correspondencia
alfredoj.pardo.sspa@juntadeandalucia.es

Autor para correspondencia.
, V. Manzano-Gamerob, J.D. Luna-del Castilloc
a Servicio de Medicina Interna, Hospital Universitario San Cecilio, Granada, España
b Servicio de Medicina Interna, Hospital Universitario Virgen de las Nieves, Granada, España
c Departamento de Bioestadística, Facultad de Medicina, Universidad de Granada, Granada, España
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">El insomnio constituye una afecci&#243;n com&#250;n en Europa&#44; con una prevalencia variable entre el 5&#44;7&#37; en Alemania y el 20&#44;8&#37; en Espa&#241;a<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">1&#8211;3</span></a>&#46; Para el tratamiento del insomnio se recomienda utilizar benzodiacepinas o agonistas de los receptores de las benzodiacepinas &#40;denominados hipn&#243;ticos-Z&#41;&#46; Tambi&#233;n se han incorporado al tratamiento del insomnio algunos antidepresivos&#44; entre los que se halla la trazodona<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">4</span></a>&#46; En estudios realizados en Mallorca &#40;Espa&#241;a&#41; el 53&#44;5&#37; de m&#233;dicos de atenci&#243;n primaria prescribe alguno de estos f&#225;rmacos&#44; siendo las benzodiacepinas las m&#225;s utilizadas&#44; seguidas por los hipn&#243;ticos Z y&#44; posteriormente&#44; por los antidepresivos<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">5</span></a>&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Entre los efectos adversos del tratamiento del insomnio se encuentran la aparici&#243;n de confusi&#243;n nocturna&#44; somnolencia diurna&#44; tolerancia&#44; dependencia e insomnio de rebote<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">1</span></a>&#46; Tambi&#233;n se relacionado el consumo de benzodiacepinas e hipn&#243;ticos Z con un mayor riesgo de ca&#237;das<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">6&#44;7</span></a>&#46; La incidencia de presentar alguna reacci&#243;n adversa aumenta en relaci&#243;n con la edad y con la polifarmacia<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">8</span></a>&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">En el presente estudio hemos querido establecer el perfil de seguridad de lormetazepam&#44; zolpidem y trazodona&#44; los f&#225;rmacos m&#225;s com&#250;nmente utilizados en Espa&#241;a para el tratamiento del insomnio<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">9</span></a>&#46; Para ello hemos analizado las notificaciones de reacciones adversas de la base de datos europea EudraVigilance &#40;<a href="http://www.adrreports.eu/">www&#46;adrreports&#46;eu</a>&#41; a fecha 27 de abril de 2020&#46; Las reacciones adversas fueron categorizadas en 4 grupos&#58; &#171;Des&#243;rdenes generales y condiciones del lugar de administraci&#243;n&#187;&#44; que se ha tomado como grupo control&#59; &#171;Da&#241;o&#44; intoxicaci&#243;n o complicaciones de procedimiento&#187;&#44; que incluye&#44; entre otros&#44; ca&#237;das y fracturas&#59; &#171;Des&#243;rdenes del sistema nervioso&#187;&#44; que incluye disminuci&#243;n del nivel de consciencia o coma y&#44; finalmente &#171;Des&#243;rdenes psiqui&#225;tricos&#187;&#44; que incluye estado de confusi&#243;n o delirium&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Como m&#233;todo de an&#225;lisis hemos calculado la raz&#243;n de notificaci&#243;n proporcional &#40;<span class="elsevierStyleItalic">Proportional Reporting Ratio</span> &#91;PRR&#93; en ingl&#233;s&#41; y su intervalo de confianza al 95&#37;&#46; La raz&#243;n de notificaci&#243;n proporcional es una medida que informa del riesgo de un efecto adverso para un determinado medicamento espec&#237;fico&#44; en comparaci&#243;n con la frecuencia con la que se informa el mismo efecto adverso en pacientes que toman otro medicamento &#40;o que toman cualquier medicamento de una clase espec&#237;fica de medicamentos&#41;&#46; Se han considerado cl&#237;nicamente relevantes los valores de PRR iguales o superiores a 2 seg&#250;n los criterios de EudraVigilance&#46; As&#237; mismo&#44; hemos realizado un an&#225;lisis de la base de datos por subgrupos de edad y sexo&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">El conjunto de reacciones adversas &#171;Des&#243;rdenes psiqui&#225;tricos&#187;&#44; que incluye estado confusional o delirium&#44; fue el que se report&#243; con m&#225;s frecuencia entre los efectos adversos analizados &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">tabla 1</a>&#41;&#46; Por f&#225;rmacos zolpidem mostr&#243; aumentar significativamente el riesgo de presentar efectos adversos de los grupos &#171;Da&#241;o&#44; intoxicaci&#243;n o complicaciones del procedimiento&#187;&#44; &#171;Des&#243;rdenes del sistema nervioso&#187; y &#171;Des&#243;rdenes psiqui&#225;tricos&#187;&#46; Trazodona mostr&#243; mayor riesgo de producir efecto adverso en las categor&#237;as &#171;Da&#241;o&#44; intoxicaci&#243;n o complicaciones de procedimiento&#187; y &#171;Des&#243;rdenes psiqui&#225;tricos&#187; y lormetazepam mostr&#243; incrementar el riesgo de reacci&#243;n adversa en el grupo &#171;Des&#243;rdenes psiqui&#225;tricos&#187;&#46; No hubo diferencias significativas en los valores de PRR de los diferentes hipn&#243;ticos seg&#250;n el sexo&#46; El an&#225;lisis por estratos de edad muestra que lormetazepam fue m&#225;s seguro que trazodona y zolpidem en individuos entre 18-64 a&#241;os&#46; Por el contrario&#44; trazodona mostr&#243; un menor riesgo de efectos adversos que lormetazepam y zolpidem en individuos de m&#225;s de 85 a&#241;os&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">Este trabajo es el primero que analiza una base de datos de farmacovigilancia europea para comparar la seguridad de los hipn&#243;ticos&#46; Hemos comprobado que lormetazepam es el f&#225;rmaco con mejor perfil de seguridad entre los comparados&#46; Al contrario que nuestro estudio&#44; un ensayo cl&#237;nico comparativo no mostr&#243; diferencias en t&#233;rminos de seguridad entre zolpidem y trazodona<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">10</span></a>&#46; Probablemente esta discrepancia se deba al escaso n&#250;mero de pacientes incluido en el ensayo cl&#237;nico y a la corta duraci&#243;n de dicho estudio<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">10</span></a>&#46; El aumento del riesgo de ca&#237;das en los pacientes tratados con zolpidem frente a los tratados con benzodiacepinas observado en nuestro estudio ya se ha publicado anteriormente<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">11</span></a>&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Como en otras series&#44; apreciamos un aumento progresivo del riesgo de reacci&#243;n adversa para todos los hipn&#243;ticos seg&#250;n la edad<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">6&#44;7</span></a>&#46; Sin embargo&#44; nuestro an&#225;lisis muestra que la trazodona&#44; con respecto a zolpidem y lormetazepam&#44; present&#243; un mejor perfil de seguridad entre los pacientes mayores de 85 a&#241;os&#46; Esta observaci&#243;n no se hab&#237;a notificado con anterioridad&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Respecto a las fortalezas y debilidades de nuestro trabajo destacaremos que EudraVigilance es una base de datos de reporte espont&#225;neo&#44; por lo que est&#225; sujeta a infranotificaci&#243;n de los efectos adversos&#46; En relaci&#243;n con el an&#225;lisis de los resultados la agrupaci&#243;n de las reacciones adversas en grandes apartados minimiza la importancia de reacciones adversas espec&#237;ficas y tiende a sesgar los valores de PRR hacia el valor nulo&#46; Ello implica que los valores de PRR iguales o superiores a 2 se interpreten como se&#241;ales robustas de asociaci&#243;n entre f&#225;rmaco y efecto adverso&#46; Finalmente&#44; EudraVigilance aporta una elevada validez interna y externa&#44; ya que recoge las notificaciones de reacciones adversas asociadas a f&#225;rmacos de todo el espacio com&#250;n europeo&#46; Los contenidos de la base de datos se revisan peri&#243;dicamente para reducir el riesgo de sesgos&#44; entre otros la duplicidad de reportes&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">A la vista de nuestros resultados consideramos que el lormetazepam podr&#237;a representar la alternativa m&#225;s segura&#44; en comparaci&#243;n con el zolpidem y la trazodona&#46; Sin embargo&#44; en sujetos mayores de 85 a&#241;os la trazodona es el f&#225;rmaco que mostr&#243; mejor perfil de seguridad&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Financiaci&#243;n</span><p id="par0050" class="elsevierStylePara elsevierViewall">La investigaci&#243;n a la que hacemos referencia no ha recibido ayudas espec&#237;ficas provenientes de agencias del sector p&#250;blico&#44; sector comercial o entidades sin &#225;nimo de lucro&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflictos de inter&#233;s</span><p id="par0055" class="elsevierStylePara elsevierViewall">Ninguno&#46;</p></span></span>"
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">Mujer&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  " align="left" valign="\n
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                  \t\t\t\t">65-85 a&#241;os&nbsp;\t\t\t\t\t\t\n
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                  """
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          "es" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Estudio comparativo por sexo y edad de los diferentes grupos de reacciones adversas medicamentosas notificadas para los hipn&#243;ticos incluidos en nuestro trabajo</p>"
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Información del artículo
ISSN: 00142565
Idioma original: Español
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