Design and baseline characteristics of the Xarelto Post‐Authorization Safety &amp; Effectiveness Study in Japanese Patients with Atrial Fibrillation (<scp>XAPASS</scp>)

Ogawa, Satoshi; Minematsu, Kazuo; Ikeda, Takanori; Kitazono, Takanari; Nakagawara, Jyoji; Miyamoto, Susumu; Murakawa, Yuji; Ohashi, Yohei; Takeichi, Makiko; Okayama, Yutaka; Yamanaka, Satoshi; Inuyama, Lyo

doi:10.1002/joa3.12034

Cited by 13 publications

(32 citation statements)

References 25 publications

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“…Before the propensity matching, patients receiving apixaban were older (mean age, 76.7 vs 72.3‐74.4 years) and had reduced renal function (comorbid renal dysfunction, 4.9% vs 2.4%‐3.3%) compared with those receiving dabigatran or rivaroxaban . These findings were consistent with the present study in comparison with the PMS studies of rivaroxaban and dabigatran in terms of higher mean age (74.5 vs 73.1 and 70.8 years) and reduced CrCl (62.2 vs 67.7 and 72.8 mL/min) in patients receiving apixaban.…”

Section: Discussionsupporting

confidence: 90%

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study

Inoue

Umeyama

Yamada

et al. 2019

Journal of Arrhythmia

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Background Apixaban, a non‐vitamin K oral anticoagulant ( NOAC ), was approved in Japan in 2012 for the prevention of thromboembolic events in patients with nonvalvular atrial fibrillation ( NVAF ). However, the safety and effectiveness of apixaban in clinical practice have not yet been elucidated thoroughly among Japanese NVAF patients. Methods A postmarketing surveillance study was conducted to determine the safety and effectiveness of apixaban. Patients were followed‐up for 104 weeks. Outcome events included adverse drug reactions ( ADR s), hemorrhages, and thromboembolic events (ischemic stroke, systemic embolism [ SE ], and transient ischemic attack [ TIA ]). Results Among 6306 NVAF patients in the safety analysis set (age, 74.5 ± 10.1 years; women, 41.1%; and CHADS 2 score, 2.0 ± 1.4), 3600 patients (57.1%) received the standard dose (5 mg twice daily) and 2694 (42.7%) received a reduced dose (2.5 mg twice daily) of apixaban. ADR s occurred in 604 patients (9.58%), with the most common being epistaxis (0.86%), subcutaneous hemorrhage (0.67%), and hematuria (0.57%). Incidence rate of any hemorrhages and major hemorrhage was 5.52% per year and 2.36% per year, respectively. Incidence rate of ischemic stroke/ SE / TIA was 1.00% per year among 6286 patients in the effectiveness analysis set. Among three subgroups (3106 apixaban initiators, 2038 patients switched from warfarin, and 1118 patients switched from other NOAC s), incidence rates of major hemorrhage ( P = 0.221 for trend) and ischemic stroke/ SE / TIA ( P = 0.686 for trend) were comparable. Conclusions No new safety signals of apixaban were identified in Japanese NVAF patients. Safety and effectiveness of apixaban were consistent with those in the ARISTOTLE study.

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Section: Discussionsupporting

confidence: 90%

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study

Inoue

Umeyama

Yamada

et al. 2019

Journal of Arrhythmia

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“…Two recent reports, XAPASS (Xarelto Post‐Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation) and J‐dabigatran surveillance, are of interest because both described independent surveillance data targeting Japanese patients with NVAF. The mean age, mean CLcr, and mean CHADS 2 score were 73.1 years, 67.7 mL/min, and 2.2 in the XAPASS, and 70.8 years, 72.8 mL/min, and 1.8, in the J‐dabigatran surveillance, respectively.…”

Section: Discussionmentioning

confidence: 99%

Postmarketing surveillance on clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA‐AF‐Japan): Three‐month interim analysis results

Yamashita

Koretsune

Ishikawa

et al. 2018

Journal of Arrhythmia

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BackgroundDirect oral anticoagulants are the first‐line drugs for anticoagulation therapy in nonvalvular atrial fibrillation (NVAF). However, a real‐world, large‐scale, clinical study on edoxaban has not been performed. Our ongoing postmarketing surveillance, ETNA‐AF‐Japan (Edoxaban Treatment in routiNe clinical prActice in patients with non‐valvular Atrial Fibrillation; UMIN000017011), was designed to collect such data.MethodsEnrollment started on 13 April 2015 and ended on 30 September 2017. Eligible patients were those diagnosed with NVAF who were to receive edoxaban for the first time and provided written consent for study participation. Baseline patient characteristics and adverse events (AEs) were collected.ResultsA total of 11 569 patients were enrolled. Data for 8157 patients in the first 3 months were analyzed. Mean age, body weight, creatinine clearance (CLcr), and CHADS 2 score were 74.2 ± 10.0 years, 60.0 ± 12.6 kg, 64.0 ± 25.6 mL/min, and 2.2 ± 1.3, respectively. Female patients, and patients with age ≥75 years, body weight ≤60 kg, and CLcr <30 mL/min constituted 40.7%, 52.4%, 54.6%, and 4.7%, respectively. Patients with paroxysmal, persistent, and permanent AF constituted 46.1%, 38.7%, and 15.1%, respectively. Most patients (85.3%) received dosages according to the prescribing information, and 90.8% continued the medication for 3 months. Bleeding AEs occurred in 3.29%, including major bleeding in 0.29%.ConclusionsThe majority (90.8%) of patients continued medication and no significant safety concerns related to edoxaban were reported during the first 3 months of treatment. Clearer safety and efficacy profiles of edoxaban await data analyses after the 2‐year follow‐up period.

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“…The XAPASS was conducted to evaluate the real-world safety and effectiveness of rivaroxaban in patients with NVAF [8]. The 1-year follow-up results in 9578 patients demonstrated low incidences of bleeding and thromboembolic events, suggesting that rivaroxaban is safe and effective for stroke prevention in daily clinical practice [9].…”

Section: Discussionmentioning

confidence: 99%

“…The XAPASS (Clinicaltrials.gov: NCT01582737) is a realworld, prospective, open-label, single-arm, observational, post-authorization cohort study conducted in Japan. The study design has been described previously [8]. Briefly, the standard observation period for each patient is 2 years with data collection at 6 months, 1 year, and 2 years after the initiation of rivaroxaban treatment.…”

Section: Methodsmentioning

confidence: 99%

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Impact of body mass index on real-world outcomes of rivaroxaban treatment in Japanese patients with non-valvular atrial fibrillation

et al. 2020

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This sub-analysis of the XAPASS, a prospective, single-arm, observational study, aimed to evaluate relationships between body mass index (BMI) and safety (major bleeding and all-cause mortality) and effectiveness [stroke/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI)] outcomes in Japanese patients with non-valvular atrial fibrillation (NVAF) receiving rivaroxaban. Patients were categorized according to BMI (kg/m 2 ) as underweight (< 18.5), normal weight (18.5 to < 25), overweight (25 to < 30), or obese (≥ 30). In total, 9578 patients with NVAF completed the 1-year follow-up and were evaluated; of these, 7618 patients had baseline BMI data. Overall, 542 (5.7%), 4410 (46.0%), 2167 (22.6%), and 499 (5.2%) patients were underweight, normal weight, overweight, and obese, respectively. Multivariable Cox regression analysis demonstrated that none of the BMI categories were independent predictors of major bleeding whereas being underweight was independently associated with increased all-cause mortality [hazard ratio (HR) 3.56, 95% confidence interval (CI) 2.40-5.26, p < 0.001]. The incidence of stroke/non-CNS SE/MI was higher in patients who were underweight than in those of normal weight (HR 2.11, 95% CI 1.20-3.70, p = 0.009). However, in multivariable analyses, being underweight was not identified as an independent predictor of stroke/non-CNS SE/MI (HR 1.64, 95% CI 0.90-2.99, p = 0.104). In conclusion, the high incidence of thromboembolic events and all-cause mortality in patients who were underweight highlights that thorough evaluation of disease status and comorbidities may be required in this population.

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Design and baseline characteristics of the Xarelto Post‐Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS)

Cited by 13 publications

References 25 publications

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study

Postmarketing surveillance on clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA‐AF‐Japan): Three‐month interim analysis results

Impact of body mass index on real-world outcomes of rivaroxaban treatment in Japanese patients with non-valvular atrial fibrillation

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