Veliko opservacijsko ispitivanje istraživača iz američke FDA je pokazalo da je dabigatran (150 mg dvaput dnevno) povezan s nižim stopama intrakranijalnog krvarenja i velikog ekstrakranijalnog krvarenja, uključujući veliko gastrointestinalno krvarenje naspram rivaroksabana (20 mg jedanput dnevno) u bolesnika s atrijskom fibrilacijom (AF).1 Ispitivanje predstavlja, do danas, najveće opservacijsko ispitivanje koje uspoređuje dva lijeka, a analizirani podaci dobiveni su na više od 118 000 bolesnika s AF-om.1 Na osnovi podataka objavljenih u magazinu JAMA Internal Medicine, popratna napomena urednika Parksa i Redberga sugerira da bi liječnici trebali “propisivati dabigatran prije nego rivaroksaban za bolesnike s atrijskom fibrilacijom.”2

U ispitivanju, čiji su autori Graham i njegovi suradnici iz Uprave za lijekove (FDA) u SAD-u, su retrospektivno uspoređivali rizike od moždanog udara, krvarenja i smrtnosti na 118 891 bolesnika s AF-om, najčešćim poremećajem nepravilnog srčanog ritma. Ključni ishodi su sljedeći1:

U ispitivanju, čiji su autori Graham i njegovi suradnici iz Uprave za lijekove (FDA) u SAD-u, su retrospektivno uspoređivali rizike od moždanog udara, krvarenja i smrtnosti na 118 891 bolesnika s AF-om, najčešćim poremećajem nepravilnog srčanog ritma. Ključni ishodi su sljedeći1:

“Ova posljednja analiza jasno ističe povoljan profil sigurnosti dabigatrana i koristi koje se nude širokom spektru bolesnika s AF-om u redovnoj kliničkoj praksi,” izjavio je profesor Jörg Kreuzer, dopredsjednik za medicinska pitanja, zadužen za kardiovaskularno terapijsko područje, u Boehringer Ingelheimu. “Ispitivanje nudi vrijedne informacije liječnicima, s ciljem podrške u odabiru liječenja za maksimalnu korist bolesnika. Potvrđuje rezultate drugih ispitivanja provedenih u stvarnoj kliničkoj praksi koji su objavljeni u prethodnom razdoblju ove godine, te se nadovezuje na obilje podataka koji podupiru pozitivan profil sigurnoti i djelotvornosti dabigatrana.”

Pozitivan profil sigurnosti dabigatrana, koji je izvorno utemeljen u ispitivanju RE-LY®l3,4, se opetovano potvrđuje u kliničkoj praksi stvarnog okruženja putem određenog broja ispitivanja iz različitih izvora.5-18 Nadalje, dabigatran je jedini oralni antikoagulans koji ne pripada antagonistima vitamina K, a koji ima odobren i široko dostupan specifični antagonist namijenjen primjeni u hitnim situacijama, kada se zahtijeva trenutno poništavanje antikoagualcije.19,20 Radi se o Idarucizumabu (Praxbind®) koji je u značajnoj mjeri dostupan u više od 5 500 bolnica širom svijeta, uključujući više od 2 500 bolnica u Europi.21

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http://archinte.jamanetwork.com/article.aspx?articleid=2560376

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