Effectiveness and Safety of Standard- and Low-Dose Rivaroxaban in Asians With Atrial Fibrillation

Lin, Yi; Chien, Shu; Hsieh, Yi Chen; Shih, Chün Ming; Lin, Feng Yen; Tsao, Nai Wen; Chen, Chih‐Wei; Kao, Yung Ta; Chiang, Kuang Hsing; Chen, Wan‐Ting; Chien, Li‐Nien; Huang, Chun Yao

doi:10.1016/j.jacc.2018.04.084

Cited by 45 publications

(31 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Thus, the current results differ from recent real-world study results, in which reduced-dose NOAC treatment was associated with increased rates of thromboembolic and major haemorrhagic events, along with stroke/SE and myocardial infarction, in Japanese patients with NVAF 18 32. Of note, the proportions of patients initiated on reduced doses of NOACs were higher than those reported in studies conducted in the USA,33–35 Korea and Taiwan36–39 and in real-world studies in Japan 17 18 40. It is likely that the high rates of dose reduction observed in the current study were primarily attributable to the risk characteristics of the patient sample.…”

Section: Discussioncontrasting

confidence: 99%

Safety and effectiveness of non-vitamin K oral anticoagulants versus warfarin in real-world patients with non-valvular atrial fibrillation: a retrospective analysis of contemporary Japanese administrative claims data

et al. 2020

View full text Add to dashboard Cite

ObjectiveTo assess the safety (ie, risk of bleeding) and effectiveness (ie, risk of stroke/systemic embolism (SE)) separately for four non-vitamin K oral anticoagulants (NOACs; apixaban, dabigatran, edoxaban and rivaroxaban) versus warfarin in Japanese patients with non-valvular atrial fibrillation (NVAF), including those at high risk of bleeding and treated with reduced doses of NOACs.MethodsWe conducted a retrospective analysis of electronic health records and claims data from 372 acute care hospitals in Japan for patients with NVAF newly initiated on NOACs or warfarin. Baseline characteristics were balanced using inverse probability of treatment weighting with stabilised weights (s-IPTW). Bleeding risk and stroke/SE risk were expressed as HRs with 95% CIs. Two sensitivity analyses were conducted.ResultsA total of 73 989 patients were eligible for analysis. Notably, 52.8%–81.9% of patients received reduced doses of NOACs. After applying s-IPTW, patient characteristics were well balanced across warfarin/NOAC cohorts. The mean within-cohort age, CHADS2 score and CHA2DS2-VASc score were 76 years, 2.2–2.3 and 3.8, respectively. In all age categories, the majority of the HRs for major bleeding, any bleeding and stroke/SE were equal to or below 1 for all NOACs versus warfarin. Apixaban was the only NOAC associated with a significantly lower risk of any bleeding. There was a trend towards increased risk reduction with NOACs versus warfarin in patients with body weight ≥60 kg. In patients with renal disease, the HRs for apixaban versus warfarin were below 1 for major bleeding, any bleeding and stroke/SE, with statistical significance observed for the risk reduction in stroke/SE versus warfarin. In the sensitivity analysis, there were no large differences in HRs between the two observational periods.ConclusionsIn patients with NVAF primarily treated with reduced-dose NOACs, the risks of stroke/SE and major bleeding were significantly lower with NOACs versus warfarin.

show abstract

Section: Discussioncontrasting

confidence: 99%

Safety and effectiveness of non-vitamin K oral anticoagulants versus warfarin in real-world patients with non-valvular atrial fibrillation: a retrospective analysis of contemporary Japanese administrative claims data

et al. 2020

View full text Add to dashboard Cite

show abstract

“…However, these studies are still selective, namely regarding patient recruitment, so the extent of inappropriate dosing, in everyday clinical practice, may be underestimated . Another important point is that studies indicated that low‐dose rivaroxaban may be less effective than standard‐dose rivaroxaban without lowering the adverse effect of bleeding . However, this can be explained, in part, by clinicians not always prescribing according to the guidelines, introducing this reduced‐dose regimen in patients who should be receiving the standard dose.…”

Section: Discussionmentioning

confidence: 99%

“…11 Another important point is that studies indicated that low-dose rivaroxaban may be less effective than standard-dose rivaroxaban without lowering the adverse effect of bleeding. 86 However, this can be explained, in part, by clinicians not always prescribing according to the guidelines, introducing this reduced-dose regimen in patients who should be receiving the standard dose. Therefore, these patients become unintentionally undertreated, which increases their risk of thromboembolic complications.…”

Section: Discussionmentioning

confidence: 99%

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Santos

António

Rocha³

et al. 2020

Brit J Clinical Pharma

View full text Add to dashboard Cite

Aims Worldwide observational studies are evidencing discordance between guidelines and real‐world practice regarding direct oral anticoagulant drug (DOAC) doses. This systematic review summarizes and evaluate DOACs use in real‐world practice. Methods This review was performed following the preferred reporting items for systematic reviews and meta‐analyses (PRISMA) guidelines searching PubMed (MEDLINE) and Medscape databases. Results Data from 75 studies showed that most of the patients treated with DOACs for stroke prevention in atrial fibrillation received doses in accordance to the guidelines. However, a significant number of patients received off‐label doses (25–50% in most of the studies evaluated). DOAC overdosing was associated with increased all‐cause mortality and worse bleeding events while underdosing was associated with increased cardiovascular hospitalization and, particularly for apixaban, with a nearly 5‐fold increased risk of stroke. Conclusion Patients prescribed with off‐label DOAC doses did not receive the full benefit of anticoagulation and presented an increased risk of stroke, bleeding and/or adverse effects.

show abstract

“…Researchers from Taiwan have published several papers comparing the effectiveness and safety of NOACs and warfarin. 10) 41) Researchers in Korea have also published several studies comparing the effectiveness and safety of NOACs with warfarin. 42) 43) 44) 45) 46) Korean researchers have also analyzed special populations, such as patients with low body-weight and liver disease, which were not included in the pivotal RCTs of NOACs.…”

Section: Cardiovascular Researchers Using the National Health Informamentioning

confidence: 99%

Cardiovascular Research Using the Korean National Health Information Database

2020

View full text Add to dashboard Cite

The Korean National Health Information Database (NHID) contains nationwide claims data, including sociodemographic data, health care utilization, health screening data, and healthcare provider information. To compensate for the limitations of randomized clinical trials, real-world observational studies using claims data have emerged as a novel research tool. We summarized the structure of the Korean NHID and the recent researches conducted in the field of cardiovascular science. Epidemiological studies, prescription patterns, temporal trends, comparison of effectiveness and safety of treatments, variability index using laboratory data, and rare intractable disease constitute interesting topics of research in cardiovascular science using the NHID. The operational definition of covariates and clinical outcomes is important for researchers interested in using the NHID data as new tools to prove their hypothesis. A step-by-step approach adopted by a team of data scientists, epidemiologists, statisticians, and clinical researchers may be most effective while designing research studies. The ultimate direction of research using the NHID should aim to improve the welfare of the public by promoting public health, reducing medical costs, and guiding healthcare policies.

show abstract

Effectiveness and Safety of Standard- and Low-Dose Rivaroxaban in Asians With Atrial Fibrillation

Abstract: Compared to standard-dose rivaroxaban, low-dose rivaroxaban in Asian patients with AF was associated with similar risks of thromboembolism and bleeding except myocardial infarction.

Cited by 45 publications

References 28 publications

Safety and effectiveness of non-vitamin K oral anticoagulants versus warfarin in real-world patients with non-valvular atrial fibrillation: a retrospective analysis of contemporary Japanese administrative claims data

Safety and effectiveness of non-vitamin K oral anticoagulants versus warfarin in real-world patients with non-valvular atrial fibrillation: a retrospective analysis of contemporary Japanese administrative claims data

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Cardiovascular Research Using the Korean National Health Information Database

Contact Info

Product

Resources

About