Optimal dose of dabigatran for the prevention of thromboembolism with minimal bleeding risk in Korean patients with atrial fibrillation

Lee, Ki Hong; Park, Hyung Wook; Lee, Nuri; Hyun, Dae Young; Won, Jumin; Oh, Sung Sik; Park, Hyuk Jin; Kim, Yongcheol; Cho, Jae Yeong; Kim, Min Chul; Sim, Doo Sun; Yoon, Hwi Joong; Yoon, Nam Sik; Kim, Kye Hun; Hong, Young Joon; Kim, Ju Han; Ahn, Youngkeun; Jeong, Myung Ho; Park, Jong Chun; Cho, Jeong Gwan

doi:10.1093/europace/eux247

Cited by 31 publications

(32 citation statements)

References 14 publications

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“…61 Regarding the optimal dose in Asians, a retrospective study to determine the optimal dose of dabigatran in Korean patients with NVAF suggested a fixed dose of 110 mg might be sufficient regardless of dose-reduction criteria based on the comparable efficacy and favorable safety of the 110-mg dose to 150-mg dose. 62 This finding in Korea is consistent with the observational study of realworld data in Taiwan that did not show a benefit of the 150-mg dose over the 110-mg dose. 63 Also, those results support the real-world clinical practice for dabigatran in Asia that the 110-mg dose is preferred because of a concern about bleeding risk in Asian patients with a higher dose.…”

Section: Dabigatransupporting

confidence: 87%

“…63 Also, those results support the real-world clinical practice for dabigatran in Asia that the 110-mg dose is preferred because of a concern about bleeding risk in Asian patients with a higher dose. 62,63 The recommendation for dabigatran dose reduction to 110 mg in fragile patients is supported by real-world clinical data as well as the RE-LY study. However, clinical data on the optimal dabigatran dose in Asian patients with NVAF are not sufficient.…”

Section: Dabigatranmentioning

confidence: 99%

“…The smaller body size and lower renal clearance in Asians compared to non-Asians, as well as ethnic differences in pharmacokinetic and pharmacodynamic features, render physicians to prefer reduced-dose NOACs for their patients. 62,63,65 Mirroring that tendency, especially among Asians, reduced-dose rivaroxaban has been used more frequently than the full-dose in patients without dosereduction criteria (eg, renal dysfunction). 65,66 However, concerns remain about the insufficient net clinical benefit of off-label underdosing and the optimal dose of rivaroxaban for Asian NVAF patients.…”

Section: Rivaroxabanmentioning

confidence: 99%

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<p>Using non-vitamin K oral anticoagulants in specific patient populations: a study of Korean cases</p>

Cho¹

2019

TCRM

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Non-vitamin K oral anticoagulants (NOACs) are increasingly used as alternatives to conventional therapies and have considerable accumulated real-world clinical data in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE). However, it is not easy to make a complete changeover to NOACs in real-world clinical practice because NOACs still have challenges in specific patient populations (eg, Asian patients, NVAF patients presenting with acute coronary syndrome [ACS], dialysis patients with NVAF, patients with cancer-associated VTE, etc.). Clinical data on the optimal dose of NOACs in Asian patients with NVAF are not sufficient. The intensity of NOAC and antiplatelet treatment and the duration of antiplatelet treatment should be adjusted according to the bleeding and thrombotic risk profiles of the individual NVAF patient presenting with ACS. Increased bleeding risk and unclear efficacy of NOACs in dialysis patients with NVAF should be considered when making decisions on whether to give NOACs for these patients. If dialysis patients with NVAF require anticoagulant for stroke prevention, then apixaban could be considered while awaiting more clinical efficacy and safety data. Additional studies are needed to determine the utility of continuing treatment with reduced-dose NOACs for long-term therapy after VTE. We have enough experiences in using NOACs in cancer patients showing the benefit of antithrombotic treatment counterbalanced the bleeding risk; however, some challenges of cancer-associated VTE management exist due to differences in cancer types or chemotherapy regimens and comorbidities. Different dosing regimens among NOACs may impact on medication adherence; thus, individual patient preference should be considered in choosing a particular NOAC. A significant proportion of patients remain on warfarin because of the high price of NOACs and variability in reimbursement coverage. To compensate clinical-evidence and achieve optimal use of NOACs, we should pay attention to the outcomes of ongoing studies and evaluate more real-world data.

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Section: Dabigatransupporting

confidence: 87%

Section: Dabigatranmentioning

confidence: 99%

Section: Rivaroxabanmentioning

confidence: 99%

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<p>Using non-vitamin K oral anticoagulants in specific patient populations: a study of Korean cases</p>

Cho¹

2019

TCRM

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“…Dabigatran 110 mg was associated with lower risk of major bleeding (HR, 0.19 [0.07–0.55]). In this study, the number of patients in dabigatran 150 mg was 294 compared with 550 in dabigatran 110 mg group and 990 in warfarin group, which may undermine the safety profile of dabigatran 150 mg. 67) …”

Section: Effectiveness and Safety Of Oral Anticoagulation In Asian Pomentioning

confidence: 99%

Stroke Prevention in Atrial Fibrillation: Focus on Asian Patients

Lee

Choi

et al. 2018

Korean Circ J

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Atrial fibrillation (AF) is the most common arrhythmia conferring a fivefold increased risk of stroke. Stroke prevention is the cornerstone of management of patients with AF. Asians have a generally higher incidence of AF-related risks of stroke and bleeding (particularly intracranial bleeding), compared with non-Asians. Despite the well-documented efficacy and relative safety of oral anticoagulation for stroke prevention among Asians, the suboptimal use of oral anticoagulation remains common. The current narrative review aims to provide a summary of the available evidence on stroke prevention among patients with AF focused on the Asia region, regarding stroke and bleeding risk evaluation, the performance of oral anticoagulation, and current use of thromboprophylaxis.

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“…Therefore, NOACs might be more attractive treatment options for Asian AF patients. Consequently, several large scale real-world studies of NOACs also support better efficacy and safety of NOACs compared to warfarin in Asian AF patients 714151617. Nonetheless, there have been few studies in Korean non-valvular AF patients.…”

Section: Introductionmentioning

confidence: 99%

Real World Comparison of Rivaroxaban and Warfarin in Korean Patients with Atrial Fibrillation: Propensity Matching Cohort Analysis

et al. 2019

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Rivaroxaban has emerged as a potential alternative to warfarin for the prevention of thromboembolism in patients with atrial fibrillation (AF). However, there has been concern for the risk of major bleeding, especially in Asian patients. We investigated the efficacy and safety of rivaroxaban compared to warfarin in Korean real world practice. A total of 2,208 consecutive non-valvular AF patients were divided into the Warfarin group (n=990) and the Rivaroxaban group (n=1218). Propensity matched 1-year clinical outcomes were compared (Warfarin, n=804; Rivaroxaban, n=804). The efficacy outcome was defined as stroke/systemic embolism (SE). The safety outcome was major bleeding. The primary net clinical benefit (NCB) was defined as the composite of stroke/SE, major bleeding, and all-cause mortality. Secondary, NCB was defined as the composite of stroke, SE, and major bleeding. Rivaroxaban had the similar efficacy in terms of thromboembolic event prevention [hazard ratio (HR) 0.69, 95% confidence interval (CI) 0.37–1.32, p=0.266] compared to warfarin. Rivaroxaban significantly lowered the risk of major bleeding [HR 0.41, 95% CI 0.22–0.76, p=0.004]. Primary NCB was significantly low in the rivaroxaban group [HR 0.54, 95% CI 0.36–0.81, p=0.003]. Secondary NCB was also low in the rivaroxaban group [HR 0.62, 95% CI 0.40–0.99, p=0.041]. Both rivaroxaban 15 mg and 20 mg groups had similar efficacy and significantly lower risks of major bleeding as well as primary and secondary NCB compared to the warfarin group. In patients with non-valvular AF, rivaroxaban had a similar efficacy to warfarin in Korean real world practice. However, rivaroxaban had better safety and net clinical outcomes compared to warfarin.

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Optimal dose of dabigatran for the prevention of thromboembolism with minimal bleeding risk in Korean patients with atrial fibrillation

Cited by 31 publications

References 14 publications

<p>Using non-vitamin K oral anticoagulants in specific patient populations: a study of Korean cases</p>

<p>Using non-vitamin K oral anticoagulants in specific patient populations: a study of Korean cases</p>

Stroke Prevention in Atrial Fibrillation: Focus on Asian Patients

Real World Comparison of Rivaroxaban and Warfarin in Korean Patients with Atrial Fibrillation: Propensity Matching Cohort Analysis

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