In clinical practice, adherence to drugs and their safety may differ from randomised
controlled trial settings. This study was undertaken to investigate the adherence to dabigatran, a direct
thrombin inhibitor, and its safety in a real-world setting. We studied a prospective cohort of 114
elderly consecutive patients with non valvular atrial fibrillation (AF) who were treated with dabigatran
150 mg twice-daily (N=39) or 110 mg twice-daily (N=76). These patients were studied at baseline and
after an average of 6 months. Mean age was 80 years and 53% were women. At entry, the average CHA2DS2VASc score
was 4 and the HAS-BLED score was 2. AF was permanent in 49% of patients, persistent in 30%, paroxysmal in 12% and
new-onset in 24%. In the follow-up clinical visit we ascertained vital status, adherence to treatment according to refill
prescription orders, and side effects. Adherence was ≥80% in 76.5% of patients. Heartburn, the most frequent adverse
effect, was reported by 25 patients (22%). Major and minor bleedings were experienced by 2 (1.8%) and 9 (7.9%)
patients, respectively. Permanent discontinuation occurred in 18 patients (16%). The most frequent cause of permanent
discontinuation was heartburn (10 patients). This real-life study suggests that safety of dabigatran and adherence to this
drug in an elderly cohort of AF patients at high or very high risk of thromboembolism are generally good. Heartburn is the
main cause of treatment discontinuation.
Keywords: Atrial fibrillation, bleeding, dabigatran, mortality, observational studies, stroke, warfarin.
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