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KOMPARATIVNA ANALIZA KARAKTERISTIKA NOAK-A KROZ NAJVAŽNIJE KLINIČKE STUDIJE I PODATKE IZ SVAKODNEVNE KLINIČKE PRAKSE /

COMPARATIVE ANALYSIS OF NOACS' CHARACTERISTICS: THE MOST IMPORTANT CLINICAL STUDIES AND DATA FROM EVERYDAY CLINICAL PRACTICE

Authors

 

Milena S Pandrc1 , Danijela Vraneš1 , Vanja Kostovski2 , Nenad Zornić3 , Zlatko Perišić4

1KKlinika za kardiologiju i urgentnu internu medicinu, Vojnomedicinska akademija, Beograd
2 Klinika za grudnu i kardijalnu hirurgiju, Vojnomedicinska akademija, Beograd
3 Odeljenje anesteziologije, Medicinski fakultet, Kragujevac
4 Odeljenje opšte i digestivne hirurgije, Urgentni Centar, Klinički Centar Srbije, Beograd

 

UDK: 615.273.06


The paper was received / Rad primljen: 05.07.2020.

Accepted / Rad prihvaćen: 26.07.2020.

 


Correspondence to:


Milena S. Pandrc,
MD; Department of Cardiology and Urgent Internal Medicine,
Military Medical Academy,
Crnotravska 17, 11000 Belgrade, Serbia;
phone number: +381-64-291-6310
e-mail: pandrcmilena@yahoo.com

 

 

Sažetak

 

Prilikom uvođenja antikoagulantne terapije u svakodnevnoj  kliničkoj  praksi se   javilo nekoliko otežavajućih okolnosti, a koje se odnose na merenje nivoa antikoagulacije. Imajući u vidu da FVII ima zanemarljiv efekat na nastanak trombina, koji je uglavnom determinisan faktorima II i X, te da je protrombinsko vreme (PT) produženo prilikom smanjenja koncentracije u plazmi svakog od vitamin K zavisnih faktora koagulacije (FII, VII i X) javila se potreba za savremenijim i preciznijim testovima, kojim bi se prevazišao tzv. antikoagulacioni varijabilitet. Prethodno navedene nedostatke VKAs u celini prevazilaze novi antikoagulantni lekovi podeljeni u dve grupe: oralni direktni inhibitori trombina i oralni inhibitori faktora Xa. Optimizovani ishod lečenja antikoagulansom se definiše kao prevencija ishemijskog i hemoragijskog moždanog udara   uz minimalan rizik za nastanak krvarenja. Rezulati studija ukazuju da NOAC-i kod pacijenata sa AF u poređenju sa varfarinom pokazuju povoljan profil bezbednosti (intrakranijalna hemoragija, velika krvavljenja, gastrointestinalno krvavljenje) i efikasnosti (moždani udar, sistemski embolizam, sveukupni mortalitet). Dabigatran je prvi odobreni NOAK koji je promenio dosadašnju paradigmu u antikoagulantnom lečenju. Brojne analize iz svakodnevne kliničke prakse konzistentno pokazuju bolji sigurnosni profil dabigatrana u poređenju sa VKA.  Javljanje velikih krvavljenja je u 83% analiza bilo značajno manje u pacijenata lečenih dabigatran eteksilatom u poređenju sa VKA.  Devet analiza na više od 210 000 pacijenata su pokazali da je u 78% analiza javljanje velikih krvarenja značajno manje u lečenih dabigatranom u poređenju sa lečenim rivaroksaban. 11 analiza na više od 170 000 pacijenata su pokazala da su velika krvarenja u lečenih dabigatranom u poređenju sa apikasabanom bila slična u 82% analiza. Podaci iz svakodnevne kliničke prakse pokazuju da je rivaroxaban pođednako bezbedan kao VKA, dok je bezbednost dabigatrana za ICH bolja nego kod rivaroksabana

 

 

 

Ključne reči:

varfarin, novi antikoagulantni lekovi, dabigatran eteksilat

 

 

Abstract

 

During the introduction of anticoagulant therapy into clinical practice, several aggravating circumstances have arisen, which relate to the measurement of anticoagulation levels. Given that FVII has a negligible effect on thrombin formation, which is mainly determined by factors II and X, and that prothrombin time (PT) is prolonged when the plasma concentration of each of the vitamin K-dependent coagulation factors (mostly FII, VII and X) decreases there is a need for more modern and precise tests, which would overcome the so-called anticoagulant variability. The aforementioned deficiencies of VKAs are generally overcome by new anticoagulant drugs divided into two groups: oral direct thrombin inhibitors and oral factor Xa inhibitors. Optimized anticoagulant treatment outcome is defined as the prevention of ischemic and hemorrhagic stroke with minimal risk of bleeding. The results of the study indicate that NOACs in patients with AF show a favorable safety profile (intracranial hemorrhage, major bleeding, gastrointestinal bleeding) and efficacy (stroke, systemic embolism, overall mortality) compared to warfarin. Dabigatran is the first approved NOAK that changed the current paradigm in anticoagulant treatment. Numerous analyzes from everyday clinical practice consistently show a better safety profile of dabigatran compared to VKA. The occurrence of major bleeding was significantly lower in 83% of analyzes in patients treated with dabigatran etexilate compared with VKA. Nine analyzes with more than 210,000 patients showed that in 78% of the analyzes, the occurrence of major bleeding was significantly lower in dabigatran-treated compared with rivaroxaban-treated. Eleven analyzes with more than 170,000 patients showed that major bleeding in dabigatran-treated patients was similar to apixaban in 82% of the analyzes. Data from everyday clinical practice show that rivaroxaban is as safe as VKA, while the safety of dabigatran for ICH is better than that of rivaroxaban.

 

 

Key words:

warfarin, new anticoagulant drugs, dabigatran etexilate

 

 

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PDF Pandrc S. M. et al • MD-Medical Data 2020;12(3): 143-147

 

 

 

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