PMID- 27623681
OWN - NLM
STAT- Publisher
LR  - 20220408
IS  - 2567-689X (Electronic)
IS  - 0340-6245 (Linking)
VI  - 116
IP  - Suppl. 2
DP  - 2016 Sep 28
TI  - Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical 
      practice.
PG  - S13-S23
AB  - Randomised controlled trials (RCTs) are considered the gold standard of clinical 
      research as they use rigorous methodologies, detailed protocols, pre-specified 
      statistical analyses and well-defined patient cohorts. However, RCTs do not take 
      into account the complexity of real-world clinical decision-making. To tackle 
      this, real-world data are being increasingly used to evaluate the long-term 
      safety and effectiveness of a given therapy in routine clinical practice and in 
      patients who may not be represented in RCTs, addressing key clinical questions 
      that may remain. Real-world evidence plays a substantial role in supporting the 
      use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical 
      practice. By providing data on patient profiles and the use of anticoagulation 
      therapies in routine clinical practice, real-world evidence expands the current 
      awareness of NOACs, helping to ensure that clinicians are well-informed on their 
      use to implement patient-tailored clinical decisions. There are various issues 
      with current anticoagulation strategies, including under- or overtreatment and 
      frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use 
      is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the 
      FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of 
      rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and 
      non-central nervoUS system systemic embolism in patients with non-valvular atrial 
      fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the 
      latest updates in real-world evidence across a variety of methodologies, such as 
      non-interventional studies (NIS), registries and database analyses studies. It is 
      anticipated that these studies will provide valuable clinical insights into the 
      management of thromboembolism, and enhance the current knowledge on anticoagulant 
      use and outcomes for patients.
FAU - Beyer-Westendorf, Jan
AU  - Beyer-Westendorf J
AD  - Jan Beyer-Westendorf, Center for Vascular Medicine, University Hospital "Carl 
      Gustav Carus", Technical University Dresden, Fetscherstrasse 74, 01307 Dresden, 
      Germany, Tel.: +49 351 4583659, E-mail: jan.beyer@uniklinikum-dresden.de.
FAU - Camm, A John
AU  - Camm AJ
FAU - Coleman, Craig I
AU  - Coleman CI
FAU - Tamayo, Sally
AU  - Tamayo S
LA  - eng
PT  - Journal Article
DEP - 20160914
PL  - Germany
TA  - Thromb Haemost
JT  - Thrombosis and haemostasis
JID - 7608063
OTO - NOTNLM
OT  - Non-interventional study
OT  - database
OT  - registries
OT  - rivaroxaban
EDAT- 2016/09/15 06:00
MHDA- 2016/09/15 06:00
CRDT- 2016/09/15 06:00
PHST- 2016/06/29 00:00 [received]
PHST- 2016/07/10 00:00 [accepted]
PHST- 2016/09/15 06:00 [entrez]
PHST- 2016/09/15 06:00 [pubmed]
PHST- 2016/09/15 06:00 [medline]
AID - 16-06-0485 [pii]
AID - 10.1160/TH16-06-0485 [doi]
PST - ppublish
SO  - Thromb Haemost. 2016 Sep 28;116(Suppl. 2):S13-S23. doi: 10.1160/TH16-06-0485. 
      Epub 2016 Sep 14.