Rivaroxaban vs. Warfarin in Japanese Patients With Atrial Fibrillation

Hori, Masatsugu; Matsumoto, Masayasu; Tanahashi, Norio; Momomura, Shin‐ichi; Uchiyama, Shinichiro; Goto, Shinya; Izumi, Tohru; Koretsune, Yukihiro; Kajikawa, Mariko; Kato, Masahiro; Ueda, Hitoshi; Iwamoto, Kazuya; Tajiri, Masahiro

doi:10.1253/circj.cj-12-0454

Cited by 579 publications

(475 citation statements)

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“…Eight eligible RCTs were identified and included in this review ( Figure 1). [2][3][4][5][6][24][25][26] Study Participants and Interventions Table 2 summarizes the characteristics of the included studies and participants. Of the eight included studies, four compared rivaroxaban with vitamin K antagonists (two compared rivaroxaban with warfarin, 2,4 two compared rivaroxaban with acenocoumarol 3,25 ), three studies compared dabigatran with warfarin, 1,6,24 and one study compared apixaban with warfarin.…”

Section: Resultsmentioning

confidence: 99%

“…Eight studies reported on the outcome of major bleeding or the combined bleeding endpoint in patients with CKD (CrCl#50 ml/min) ( Figure 3A, Table 3). [2][3][4][5][6]24,25 Of these eight studies, two reported major bleeding and combined bleeding events, 4,5 three reported only combined bleeding events, 2,3,25 and three reported only major bleeding events. 6,24 All studies compared one of the NOACs with a VKA (n=10,616).…”

Section: Adverse Eventsmentioning

confidence: 99%

“…Furthermore, they have demonstrated similar or greater efficacy and safety in relation to conventional anticoagulants in large trials. [1][2][3][4][5][6] NOACs differ from traditional oral VKAs mechanistically and pharmacokinetically.…”

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confidence: 99%

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Comparisons between Novel Oral Anticoagulants and Vitamin K Antagonists in Patients with CKD

Harel¹,

Sholzberg

Shah³

et al. 2014

Journal of the American Society of Nephrology

100

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Novel oral anticoagulants (NOACs) (rivaroxaban, dabigatran, apixaban) have been approved by international regulatory agencies to treat atrial fibrillation and venous thromboembolism in patients with kidney dysfunction. However, altered metabolism of these drugs in the setting of impaired kidney function may subject patients with CKD to alterations in their efficacy and a higher risk of bleeding. This article examined the efficacy and safety of the NOACs versus vitamin K antagonists (VKAs) for atrial fibrillation and venous thromboembolism in patients with CKD. A systematic review and meta-analyses of randomized controlled trials were conducted to estimate relative risk (RR) with 95% confidence interval (95% CIs) using a random-effects model. MEDLINE, Embase, and the Cochrane Library were searched to identify articles published up to March 2013. We selected published randomized controlled trials of NOACs compared with VKAs of at least 4 weeks' duration that enrolled patients with CKD (defined as creatinine clearance of 30-50 ml/min) and reported data on comparative efficacy and bleeding events. Eight randomized controlled trials were eligible. There was no significant difference in the primary efficacy outcomes of stroke and systemic thromboembolism (four trials, 9693 participants; RR, 0.64 [95% CI, 0.39 to 1.04]) and recurrent thromboembolism or thromboembolism-related death (four trials, 891 participants; RR, 0.97 [95% CI, 0.43 to 2.15]) with NOACs versus VKAs. The risk of major bleeding or the combined endpoint of major bleeding or clinically relevant nonmajor bleeding (primary safety outcome) (eight trials, 10,616 participants; RR 0.89 [95% CI, 0.68 to 1.16]) was similar between the groups. The use of NOACs in select patients with CKD demonstrates efficacy and safety similar to those with VKAs. Proactive postmarketing surveillance and further studies are pivotal to further define the rational use of these agents.

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Section: Resultsmentioning

confidence: 99%

Section: Adverse Eventsmentioning

confidence: 99%

See 1 more Smart Citation

Comparisons between Novel Oral Anticoagulants and Vitamin K Antagonists in Patients with CKD

Harel¹,

Sholzberg

Shah³

et al. 2014

Journal of the American Society of Nephrology

100

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show abstract

“…The optimal dose of NOACs to be used specifically in Asians remains uncertain due to their different body size, pharmacokinetics, and underlying comorbidities as compared with non‐Asians. The J‐ROCKET AF trial (Japanese Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) showed that the pharmacokinetic profiles of a 15‐mg dose of rivaroxaban in Japanese patients was similar to the 20‐mg dose in white patients, indicating that low‐dose rivaroxaban with 15/10 mg is adequate for stroke prevention in AF patients 35. Chan et al also reported that low‐dose dabigatran was associated with the lowest risk of ischemic stroke and ICH compared with warfarin with a variety of quality controls in elderly Chinese with AF 36, 37, 38.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Apixaban, Dabigatran, Rivaroxaban, and Warfarin in Asians With Nonvalvular Atrial Fibrillation

Chan

See

et al. 2018

JAHA

118

100

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BackgroundWhether non–vitamin K antagonist oral anticoagulants (NOACs) are superior to warfarin among Asians with nonvalvular atrial fibrillation remains unclear.Methods and ResultsIn this nationwide retrospective cohort study collected from Taiwan National Health Insurance Research Database, there were 5843, 20 079, 27 777, and 19 375 nonvalvular atrial fibrillation patients taking apixaban, dabigatran, rivaroxaban and warfarin, respectively, from June 1, 2012 to December 31, 2016. Propensity‐score weighting was used to balance covariates across study groups. Patients were followed until the first occurrence of any efficacy or safety outcome or the end date of study. Hazard ratios (95% confidence intervals) comparing apixaban, dabigatran, and rivaroxaban with warfarin were: ischemic stroke/systemic embolism (IS/SE), 0.55 (0.43–0.69), 0.82 (0.68–0.98), and 0.81 (0.67–0.97); major bleeding, 0.41 (0.31–0.53), 0.65 (0.53–0.80), and 0.58 (0.46–0.72); and all‐cause mortality, 0.58 (0.51–0.66), 0.61 (0.54–0.68), and 0.57 (0.51–0.65). A total of 3623 (62%), 17 760 (88%), and 26 000 (94%) patients were taking low‐dose apixaban (2.5 mg twice daily), dabigatran (110 mg twice daily), and rivaroxaban (10–15 mg once daily), respectively. Similar to all‐dose NOACs, all low‐dose NOACs had lower risk of IS/SE, major bleeding, and mortality when compared with warfarin. In contrast to other standard‐dose NOACs, apixaban was associated with lower risks of IS/SE (0.45 [0.31–0.65]), major bleeding (0.29 [0.18–0.46]), and mortality (0.23 [0.17–0.31]) than warfarin.ConclusionsAll NOACs were associated with lower risk of IS/SE, major bleeding, and mortality compared with warfarin in the largest real‐world practice among Asians with nonvalvular atrial fibrillation. All low‐dose NOACs had lower risk of IS/SE, major bleeding, and mortality when compared with warfarin. Standard‐dose apixaban caused a lower risk of IS/SE, major bleeding, and mortality compared with warfarin.

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“…This finding will also affect other Asian countries where the dose of prasugrel that is normally chosen is identical to that in Europe and the USA. With regard to rivaroxaban, a novel oral anticoagulant, the dose set in Japan differs from that in Europe and the USA 6) . There has been much discussion over the years regarding racial and ethnic differences in response to medicines in the development of drugs [7][8][9] .…”

Section: Disclosuresmentioning

confidence: 99%

Are There Any Racial and Ethnic Differences in Response to Medicines in Japanese Patients?

Nakagawa

2015

JAT

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Rivaroxaban vs. Warfarin in Japanese Patients With Atrial Fibrillation

Cited by 579 publications

References 11 publications

Comparisons between Novel Oral Anticoagulants and Vitamin K Antagonists in Patients with CKD

Comparisons between Novel Oral Anticoagulants and Vitamin K Antagonists in Patients with CKD

Efficacy and Safety of Apixaban, Dabigatran, Rivaroxaban, and Warfarin in Asians With Nonvalvular Atrial Fibrillation

Are There Any Racial and Ethnic Differences in Response to Medicines in Japanese Patients?

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