Preliminary Observations on the Antihypertension Action of Dabigatran Etexilate in Patients With Nonvalvular Atrial Fibrillation: A Prospective Multicenter Single-Arm Interventional Study

Abstract

Background:In Japan, the number of patients with atrial fibrillation continues to grow with the aging of the population. Prevention of cardiogenic cerebral embolism is extremely important in patients with atrial fibrillation. While warfarin has long played a major role for this purpose, a new oral anticoagulant, dabigatran etexilate (dabigatran), has demonstrated superior efficacy and safety in recent years. We conducted a multicenter prospective interventional study to examine whether dabigatran could demonstrate superiority over warfarin in practical clinical situation. Methods: Among outpatients attending Fukuoka University ChikushiHospital or clinics registered with the Chikushi Cardiovascular Disease Clinical Research Network (Chikushi-JRN), 143 patients with nonvalvular atrial fibrillation (NVAF) were enrolled in this study and followed up for 12 months after initiation of dabigatran therapy. The primary endpoint was occurrence of cerebral embolism or systemic embolism, while secondary endpoints were: 1) Bleeding events; 2) Changes in the activated partial thromboplastin time (aPTT); 3) Adverse events; and 4) Changes in blood pressure and pulse rate. Results:During the follow-up period, none of the patients developed cerebral or systemic embolism (the primary endpoint). In addition, there were no bleeding events or other adverse events (the secondary endpoints). aPTT remained stable throughout the 12-month observation period. A significant decrease in systolic blood pressure was observed at 1 month after initiation of dabigatran therapy, and blood pressure was reduced up to 12 months. Blood pressure showed a significant decrease in patients with paroxysmal atrial fibrillation, but not in patients with chronic atrial fibrillation. Conclusions:Dabigatran showed a stable anticoagulant effect, and its safety was confirmed. Dabigatran also reduced blood pressure, which may help to explain why it causes fewer major bleeding events than warfarin.