Safety of Dabigatran in an Elderly Population: Single Center Experience in Italy

Title:Safety of Dabigatran in an Elderly Population: Single Center Experience in Italy

Volume: 10 Issue: 2

Author(s): Paolo Verdecchia, Gabriella Molini, Claudia Bartolini, Valentina De Filippo, Francesca Valecchi, Stefania Martone, Adolfo Aita, Letizia di Giacomo, Fabio Angeli and Gianpaolo Reboldi

Affiliation:

Keywords: Atrial fibrillation, bleeding, dabigatran, mortality, observational studies, stroke, warfarin.

Abstract: 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.

Cite this article as:

Verdecchia Paolo, Molini Gabriella, Bartolini Claudia, Filippo De Valentina, Valecchi Francesca, Martone Stefania, Aita Adolfo, Giacomo di Letizia, Angeli Fabio and Reboldi Gianpaolo, Safety of Dabigatran in an Elderly Population: Single Center Experience in Italy, Current Drug Safety 2015; 10 (2) . https://dx.doi.org/10.2174/1574886309666141111102344