Efficacy and Safety of Dabigatran Etexilate vs. Warfarin in Asian RE-LY Patients According to Baseline Renal Function or CHADS₂ Score

Influence of Renal Function on the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Non–Vitamin K Antagonist Oral Anticoagulants

“…Relative efficacy and safety of dabigatran in renal function subgroups. 24,25,[27][28][29] Forest plots of hazard ratios and 95% CIs for (A) stroke and systemic embolism in atrial fibrillation (AF) clinical trials, 24,25,27 (B) major bleeding in AF clinical trials, 24,25 (C) total venous thromboembolism (VTE) and all-cause mortality in deep vein thrombosis (DVT) prophylaxis clinical trials, 28 and (D) major and clinically relevant nonmajor bleeding in VTE treatment clinical trials. 29 Data for Eriksson et al 28 are absolute risk differences (the difference in the proportion of patients with an event) rather than hazard ratios.…”

“…In the original assessment, wherein CrCL was estimated using the Cockcroft-Gault equation, the results for the primary efficacy and safety end points were consistent across renal function subgroups (Figure 2A and B). 24,25,27 However, a subsequent assessment, in which renal function was estimated using the 24,25,27 and data not shown). No interaction was found between treatment effects (either efficacy or safety) and renal function in a subsequent Asian subgroup analysis; however, CrCL was calculated using the Cockcroft-Gault equation in this analysis.…”

Safety of low-dose dabigatran in patients with atrial fibrillation and mild renal insufficiency

“…In fact, compared to non-Asian populations, DE has documented more significant reduction in the incidence of ICH compared with warfarin in Asian populations [28]. Recently, Hori et al reported the sub-analysis of RE-LY in Asian patients with renal dysfunction [32]. In this Asian subanalysis, DE did not show any differences in efficacy and safety endpoints independent of renal function compared with the warfarin group.…”

The Nephrological Aspects of the Use of Rivaroxaban and Other Direct Peroral Anticoagulants in Non-Valvular Atrial Fibrillation

“…В последующем вторичном анализе данных исследования RE-LY на азиатской популяции было показано отсутствие статистически значимых различий по риску развития инсульта или кровотечения в зависимости от дозы дабигатрана (150 или 110 мг 2 раза в сутки) у больных с Cl cr <50 или 50-80 мл / мин. Это служит обоснованием для принятия решения о сохранении дозы дабигатрана при Cl cr >30 мл / мин [14]. Вместе с тем в рекомендациях эксперты советуют снижать дозу дабигатрана до 110 мг 2 раза в сутки при Cl cr <50 мл / мин и высоком риске кровотечений [15].…”