"004.008" . "Hypertenze\nV kontrolovan\u00FDch klinick\u00FDch studi\u00EDch u pacient\u016F s hypertenz\u00ED byl celkov\u00FD v\u00FDskyt ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F srovnateln\u00FD s placebem a odpov\u00EDd\u00E1 farmakologick\u00E9mu p\u016Fsoben\u00ED valsartanu. V\u00FDskyt ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F nevykazoval vztah k d\u00E1vce nebo trv\u00E1n\u00ED l\u00E9\u010Dby, a tak\u00E9 neuk\u00E1zal \u017E\u00E1dnou spojitost s pohlav\u00EDm, v\u011Bkem nebo rasou. \nNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky zaznamenan\u00E9 v klinick\u00FDch studi\u00EDch, po uveden\u00ED p\u0159\u00EDpravku na trh a laboratorn\u00ED n\u00E1lezy jsou uvedeny n\u00ED\u017Ee podle t\u0159\u00EDdy org\u00E1nov\u00FDch syst\u00E9m\u016F. \nNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky jsou \u0159azeny podle \u010Detnosti, nej\u010Detn\u011Bj\u0161\u00ED je uv\u00E1d\u011Bn jako prvn\u00ED, za pou\u017Eit\u00ED n\u00E1sleduj\u00EDc\u00ED klasifikace: velmi \u010Dast\u00E9 (>1/10); \u010Dast\u00E9 (>1/100 a\u017E <1/10); m\u00E9n\u011B \u010Dast\u00E9 (>1/1 000 a\u017E <1/100); vz\u00E1cn\u00E9 (>1/10 000 a\u017E <1/1 000); velmi vz\u00E1cn\u00E9 (<1/10 000), v\u010Detn\u011B izolovan\u00FDch p\u0159\u00EDpad\u016F. V ka\u017Ed\u00E9 skupin\u011B \u010Detnosti jsou ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky \u0159azeny dle klesaj\u00EDc\u00ED z\u00E1va\u017Enosti. \nU v\u0161ech ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F zaznamenan\u00FDch po uveden\u00ED p\u0159\u00EDpravku na trh a u laboratorn\u00EDch n\u00E1lez\u016F nen\u00ED mo\u017En\u00E9 pou\u017E\u00EDt \u017E\u00E1dnou \u010Detnost ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F, proto jsou v tabulce uvedeny s \u010Detnost\u00ED \u201Enen\u00ED zn\u00E1mo\u201C. \n\t\n\tVelmi \u010Dast\u00E9\n\t\u010Cast\u00E9\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tVz\u00E1cn\u00E9\n\tVelmi vz\u00E1cn\u00E9\n\tNen\u00ED zn\u00E1mo\n\tPoruchy krve a lymfatick\u00E9ho syst\u00E9mu\n\t\n\t\n\t\n\t\n\t\n\tSn\u00ED\u017Een\u00FD hemoglobin, sn\u00ED\u017Een\u00FD hematokrit, neutropenie, trombocytopenie\n\tPoruchy imunitn\u00EDho syst\u00E9mu\n\t\n\t\n\t\n\t\n\t\n\tHypersenzitivita v\u010Detn\u011B s\u00E9rov\u00E9 nemoci\n\tPoruchy metabolismu a v\u00FD\u017Eivy\n\t\n\t\n\t\n\t\n\t\n\tZv\u00FD\u0161en\u00E1 hladina drasl\u00EDku v s\u00E9ru\n\tPoruchy ucha a labyrintu\n\t\n\t\n\tZ\u00E1vrat\u011B\n\t\n\t\n\t\n\tC\u00E9vn\u00ED poruchy\n\t\n\t\n\t\n\t\n\t\n\tVaskulitida\n\tRespira\u010Dn\u00ED, hrudn\u00ED a mediastin\u00E1ln\u00ED poruchy\n\t\n\t\n\tKa\u0161el\n\t\n\t\n\t\n\tGastrointestin\u00E1ln\u00ED poruchy\n\t\n\t\n\tBolest b\u0159icha\n\t\n\t\n\t\n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest\n\t\n\t\n\t\n\t\n\t\n\tZv\u00FD\u0161en\u00ED hodnot jatern\u00EDch test\u016F v\u010Detn\u011B zv\u00FD\u0161en\u00E9 hladiny bilirubinu v s\u00E9ru\n\tPoruchy k\u016F\u017Ee a podko\u017En\u00ED tk\u00E1n\u011B\n\t\n\t\n\t\n\t\n\t\n\tAngioed\u00E9m, sv\u011Bd\u011Bn\u00ED, vyr\u00E1\u017Eka\n\tPoruchy pohybov\u00E9ho syst\u00E9mu a pojivov\u00E9 tk\u00E1n\u011B\n\t\n\t\n\t\n\t\n\t\n\tMyalgie\n\tPoruchy ledvin a mo\u010Dov\u00FDch cest\n\t\n\t\n\t\n\t\n\t\n\tSelh\u00E1n\u00ED a po\u0161kozen\u00ED ledvin, zv\u00FD\u0161en\u00E1 hladina kreatininu v s\u00E9ru\n\tCelkov\u00E9 a jinde neza\u0159azen\u00E9 poruchy a lok\u00E1ln\u00ED reakce po pod\u00E1n\u00ED\n\t\n\t\n\t\u00DAnava\n\t\n\t\n\t\nPediatrick\u00E1 populace \nHypertenze \nAntihypertenzivn\u00ED \u00FA\u010Dinek valsartanu byl hodnocen ve dvou randomizovan\u00FDch, dvojit\u011B zaslepen\u00FDch klinick\u00FDch studi\u00EDch u 561 pediatrick\u00FDch pacient\u016F ve v\u011Bku od 6 do 18 let. S v\u00FDjimkou ojedin\u011Bl\u00FDch gastrointestin\u00E1ln\u00EDch poruch (jako bolest b\u0159icha, nauzea, zvracen\u00ED) a z\u00E1vrati nebyly zji\u0161t\u011Bny relevantn\u00ED rozd\u00EDly z hlediska typu, frekvence a z\u00E1va\u017Enosti ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F mezi profilem bezpe\u010Dnosti u pediatrick\u00FDch pacient\u016F ve v\u011Bku od 6 do 18 let a profilem d\u0159\u00EDve zaznamenan\u00FDm u dosp\u011Bl\u00FDch pacient\u016F. \nNeurokognitivn\u00ED a v\u00FDvojov\u00E9 hodnocen\u00ED pediatrick\u00FDch pacient\u016F ve v\u011Bku od 6 do 18 let neodhalilo \u017E\u00E1dn\u00E9 celkov\u00E9 klinicky relevantn\u00ED ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky po l\u00E9\u010Db\u011B valsartanem po dobu a\u017E jednoho roku. \nVe dvojit\u011B zaslepen\u00E9, randomizovan\u00E9 studii 90 d\u011Bt\u00ED ve v\u011Bku od 1 roku do 6 let, kter\u00E9 byly sledov\u00E1ny v jednolet\u00E9m otev\u0159en\u00E9m prodlou\u017Een\u00ED studie, byly zaznamen\u00E1ny dva p\u0159\u00EDpady \u00FAmrt\u00ED a ojedin\u011Bl\u00E9 p\u0159\u00EDpady v\u00FDznamn\u00E9ho vzestupu jatern\u00EDch transamin\u00E1z. Tyto p\u0159\u00EDpady se vyskytly u populace se signifikantn\u00EDmi komorbiditami. P\u0159\u00ED\u010Dinn\u00E1 souvislost s valsartanem nebyla stanovena. Ve druh\u00E9 studii, v n\u00ED\u017E bylo randomizov\u00E1no 75 d\u011Bt\u00ED ve v\u011Bku od 1 roku do 6 let, nedo\u0161lo k signifikantn\u00EDmu vzestupu jatern\u00EDch transamin\u00E1z \u010Di \u00FAmrt\u00ED p\u0159i l\u00E9\u010Db\u011B valsartanem. \nHyperkal\u00E9mie byl \u010Dast\u011Bji pozorov\u00E1na u d\u011Bt\u00ED a mladistv\u00FDch ve v\u011Bku od 6 do 18 let s prim\u00E1rn\u00EDm chronick\u00FDm onemocn\u011Bn\u00EDm ledvin. \nBezpe\u010Dnostn\u00ED profil zaznamenan\u00FD v kontrolovan\u00FDch klinick\u00FDch studi\u00EDch u dosp\u011Bl\u00FDch pacient\u016F po infarktu myokardu a/nebo srde\u010Dn\u00EDm selh\u00E1n\u00ED se li\u0161\u00ED od celkov\u00E9ho bezpe\u010Dnostn\u00EDho profilu zaznamenan\u00E9ho u pacient\u016F s hypertenz\u00ED. Tato odli\u0161nost m\u016F\u017Ee souviset se z\u00E1kladn\u00EDm onemocn\u011Bn\u00EDm pacienta. Ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky, kter\u00E9 se vyskytly u dosp\u011Bl\u00FDch pacient\u016F po infarktu myokardu a/nebo srde\u010Dn\u00EDm selh\u00E1n\u00ED jsou uvedeny n\u00ED\u017Ee. \nStav po infarktu myokardu a/nebo srde\u010Dn\u00EDm selh\u00E1n\u00ED (studov\u00E1no pouze u dosp\u011Bl\u00FDch pacient\u016F) \n\t\n\tVelmi \u010Dast\u00E9\n\t\u010Cast\u00E9\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tVz\u00E1cn\u00E9\n\tVelmi vz\u00E1cn\u00E9\n\tNen\u00ED zn\u00E1mo\n\tPoruchy krve a lymfatick\u00E9ho syst\u00E9mu\n\t\n\t\n\t\n\t\n\t\n\tTrombocytopenie\n\tPoruchy imunitn\u00EDho syst\u00E9mu\n\t\n\t\n\t\n\t\n\t\n\tHypersenzitivita v\u010Detn\u011B s\u00E9rov\u00E9 nemoci\n\tPoruchy metabolismu a v\u00FD\u017Eivy\n\t\n\t\n\tHyperkal\u00E9mie\n\t\n\t\n\tZv\u00FD\u0161en\u00E1 hladina drasl\u00EDku v s\u00E9ru\n\tPoruchy nervov\u00E9ho syst\u00E9mu\n\t\n\tZ\u00E1vrat\u011B, postur\u00E1ln\u00ED z\u00E1vrat\u011B\n\tMdloby, bolest hlavy\n\t\n\t\n\t\n\tPoruchy ucha a labyrintu\n\t\n\t\n\tZ\u00E1vrat\u011B\n\t\n\t\n\t\n\tSrde\u010Dn\u00ED poruchy \n\t\n\t\n\tSrde\u010Dn\u00ED selh\u00E1n\u00ED\n\t\n\t\n\t\n\tC\u00E9vn\u00ED poruchy\n\t\n\tHypotenze, ortostatick\u00E1 hypotenze\n\t\n\t\n\t\n\tVaskulitida\n\tRespira\u010Dn\u00ED, hrudn\u00ED a mediastin\u00E1ln\u00ED poruchy\n\t\n\t\n\tKa\u0161e\n\t\n\t\n\t\n\tGastrointestin\u00E1ln\u00ED poruchy\n\t\n\t\n\tNauzea, pr\u016Fjem\n\t\n\t\n\t\n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest\n\t\n\t\n\t\n\t\n\t\n\tZv\u00FD\u0161en\u00ED hodnot jatern\u00EDch test\u016F\n\tPoruchy k\u016F\u017Ee a podko\u017En\u00ED tk\u00E1n\u011B\n\t\n\t\n\tAngioed\u00E9m\n\t\n\t\n\tSv\u011Bd\u011Bn\u00ED, vyr\u00E1\u017Eka\n\tPoruchy pohybov\u00E9ho syst\u00E9mu a pojivov\u00E9 tk\u00E1n\u011B\n\t\n\t\n\t\n\t\n\t\n\tMyalgie\n\tPoruchy ledvin a mo\u010Dov\u00FDch cest\n\t\n\tSelh\u00E1n\u00ED a po\u0161kozen\u00ED ledvin\n\tAkutn\u00ED selh\u00E1n\u00ED ledvin, zv\u00FD\u0161en\u00E1 hladina kreatininu v s\u00E9ru\n\t\n\t\n\tZv\u00FD\u0161en\u00E1 hladina dus\u00EDku mo\u010Doviny v krvi\n\tCelkov\u00E9 a jinde neza\u0159azen\u00E9 poruchy a lok\u00E1ln\u00ED reakce po pod\u00E1n\u00ED\n\t\n\t\n\tAst\u00E9nie, \u00FAnava\n\t\n\t\n\t\n"@cs . "4.8 Ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky "@cs . . . . . . . . . . . . . .