Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause stroke, need to take blood thinners to prevent it. It is important to prescribe the correct dose of blood thinners to the right patients to ensure the treatment works however avoiding complications. In the recent years, new blood thinners have been available; they require less laboratory tests and fewer visits to a doctor compared to older therapies. This study will look at how the general practitioners in the UK prescribe blood thinners according to the instructions given by the product manufacturer. We will use primary care data that is routinely collected by the general practitioners about their patients but without any possibility to identify individual patients. The results will help us to understand the magnitude of deviation from instructions in order to ensure that the patients benefit from the treatment.
Background
There is a limited data on prescription and usage patterns of direct oral anticoagulants (DOACs) (rivaroxaban, dabigatran, apixaban) in routine care for stroke prevention in non-valvular atrial fibrillation (NVAF). Monitoring the usage patterns of DOACs is essential to study compliance with labelling information.
Objectives
This population-based descriptive study will characterize first-time users of three DOACs in NVAF patients for stroke prevention including those renal impaired. Additionally, it will assess patterns of drug utilization in routine general practice in the UK.
Methods
This is a retrospective cohort study designed to assess the characteristics of patients and patterns of drug utilization in new users of DOACs in the UK by merging the Clinical Practice Research Datalink (CPRD) and The Health Improvement Network (THIN). The enrollment period extends from January 2011 up to last available database extraction.
All patients 18+ years of age with first prescription of DOAC during the study period and diagnosed with NVAF (any time prior index date or within the 2 weeks after the index date).
Data Analysis
Following variables will be analysed: age, gender, co-medications, comorbidities, risk scores, lifestyle factors, healthcare utilization, dose, posology, duration of study drugs. Descriptive statistics will be applied including frequencies and percentages, means (+/-standard deviations), proportions, medians (quartiles) as well as minimum and maximum values.
Primary outcomes: 1. baseline characteristics of NVAF patients in the UK prescribed any of the three direct oral anticoagulants (DOACs) (rivaroxaban, dabigatran and apixaban) for the first time for stroke prevention 2. daily dose, dose posology, naive status, treatment duration of DOACs for stroke prevention in NVAF patients including those with renal impairment Secondary outcomes: 1. time-trends in the characteristics of first-time use of DOACs in NVAF patients
Gunnar Brobert - Chief Investigator - Bayer AG
Gunnar Brobert - Corresponding Applicant - Bayer AG
Ana Ruigomez - Collaborator - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )
Kiliana Suzart-Woischnik - Collaborator - Bayer AG
Luis Alberto Garcia Rodriguez - Collaborator - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )
Luke Roberts - Collaborator - Bayer AG
Martin Homering - Collaborator - Bayer AG
Montse Soriano Gabarro - Collaborator - Bayer AG
Pareen Vora - Collaborator - Bayer AG
Yanina Lenz - Collaborator - Bayer AG