Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008–2015): A cross‐national drug utilization study

Abstract

AimsTo estimate the incidence of direct oral anticoagulant drug (DOAC) use in patients with nonvalvular atrial fibrillation and to describe user and treatment characteristics in 8 European healthcare databases representing 6 European countries.MethodsLongitudinal drug utilization study from January 2008 to December 2015. A common protocol approach was applied. Annual period incidences and direct standardisation by age and sex were performed. Dose adjustment related to change in age and by renal function as well as concomitant use of potentially interacting drugs were assessed.ResultsA total of 186 405 new DOAC users (age ≥18 years) were identified. Standardized incidences varied from 1.93–2.60 and 0.11–8.71 users/10 000 (2011–2015) for dabigatran and rivaroxaban, respectively, and from 0.01–8.12 users/10 000 (2012–2015) for apixaban. In 2015, the DOAC incidence ranged from 9 to 28/10 000 inhabitants in SIDIAP (Spain) and DNR (Denmark) respectively. There were differences in population coverage among the databases. Only 1 database includes the total reference population (DNR) while others are considered a population representative sample (CPRD, BIFAP, SIDIAP, EGB, Mondriaan). They also varied in the type of drug data source (administrative, clinical). Dose adjustment ranged from 4.6% in BIFAP (Spain) to 15.6% in EGB (France). Concomitant use of interacting drugs varied between 16.4% (SIDIAP) and 70.5% (EGB). Cardiovascular comorbidities ranged from 25.4% in Mondriaan (The Netherlands) to 82.9% in AOK Nordwest (Germany).ConclusionOverall, apixaban and rivaroxaban increased its use during the study period while dabigatran decreased. There was variability in patient characteristics such as comorbidities, potentially interacting drugs and dose adjustment. (EMA/2015/27/PH).

An Exploratory Association Analysis of ABCB1 rs1045642 and ABCB1 rs4148738 with Non-Major Bleeding Risk in Atrial Fibrillation Patients Treated with Dabigatran or Apixaban

“…Furthermore, clinicians are reluctant to prescribe these drugs to frail patients or those at high risk of bleeding due to the lack of routine monitoring of the anticoagulant effect; they strictly follow the guidelines recommendations regarding the dosing regimen and monitor more often NOACs-treated patients. This unwillingness to prescribe NOACs is also reported in real-world studies in recent years [53,54]. Periodic monitoring of patients greatly improves treatment compliance.…”

“…Even minor or non-major bleeding episodes are important in the evolution of patients because they affect their quality of life [ 7 ] and are often followed by discontinuation of anticoagulant therapy which in turn increases the risk of mortality. In real-world studies, it was estimated that less than 50% of patients resume anticoagulant treatment after a bleeding episode [ 53 , 54 ].…”

Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP): A data resource for pharmacoepidemiology in Spain

“…Lipid modifying agents (C10) Indication 40,41 Topical calcineurin inhibitors (D11A) Impact of RMM 42 Estrogens (G03C, G03F) Trends 43…”

International Collaboration in Real‐World Evidence Generation for Direct Acting Oral Anti‐Coagulants

“…Collectively, the studies provide information on real‐world safety and effectiveness of DOACs. Real‐world data studies on DOACs are important because the DOACs are widely used 3 and studies have shown that they prevent deaths and serious disability from thrombosis and embolism 4 . However, it is well known from pivotal clinical trials that all anticoagulants and antiplatelet agents increase the risk of bleeding, including serious bleeding and death; these adverse drug reactions constitute one of the most common causes of drug‐induced harm 5 .…”