Safety and effectiveness of apixaban in comparison to warfarin in patients with nonvalvular atrial fibrillation: a propensity-matched analysis from Japanese administrative claims data

Shun Kosaka, Jun Katada, Kumiko Saito, Yasuo Terayama

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objective: To investigate the risk of bleeding events and stroke/systemic embolism (SE) among Japanese patients with nonvalvular atrial fibrillation (NVAF), focusing on the initial dosage of apixaban and patient age. Methods: This retrospective cohort study used de-identified electronic health records based claims data from 314 acute-care hospitals in Japan. NVAF patients newly initiated on warfarin or apixaban, with no prescription during the 180-day blanking period, were eligible. Patients were allocated to receive warfarin or 5 or 2.5 mg twice daily (BID) apixaban. One-to-one propensity-score matching was used to balance patient characteristics between apixaban and warfarin. Results: Among 31,006 eligible patients, 11,972 matched pairs were identified for apixaban versus warfarin. Mean age ± standard deviation was 77.7 ± 10.0 and 77.6 ± 10.0 years and CHADS2 score was 2.2 ± 1.4 and 2.2 ± 1.4 for warfarin and apixaban, respectively. In the apixaban cohort, 39.4% of patients received the standard dose (5 mg BID) and 60.6% received the reduced dose (2.5 mg BID). Incidence rates (events per 100 person-years) of major bleeding, any bleeding and stroke/SE were 3.7, 23.1 and 3.1, and 2.5, 18.6 and 2.0 for warfarin and apixaban cohorts, respectively. Apixaban was associated with a significantly lower risk of any bleeding (hazard ratio [HR] 0.809, 95% confidence interval [CI] 0.731–0.895; p < .001), major bleeding (HR 0.655, 95% CI 0.505–0.849; p = .001) and stroke/SE (HR 0.637, 95% CI 0.478–0.850; p = .002). Conclusions: Our observational data from clinical practice broadly confirms the safety and efficacy results of pivotal randomized controlled trials of apixaban for stroke prevention among NVAF patients.

Original languageEnglish
Pages (from-to)1-8
Number of pages8
JournalCurrent Medical Research and Opinion
DOIs
Publication statusAccepted/In press - 2018 May 30

Fingerprint

Warfarin
Atrial Fibrillation
Safety
Hemorrhage
Embolism
Stroke
Confidence Intervals
apixaban
Propensity Score
Electronic Health Records
Prescriptions
Japan
Cohort Studies
Randomized Controlled Trials
Retrospective Studies
Incidence

Keywords

  • apixaban
  • Bleeding
  • nonvalvular atrial fibrillation
  • novel oral anticoagulants
  • stroke
  • warfarin

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{8c3fc9ab54f04d44acbe902d8acd30a2,
title = "Safety and effectiveness of apixaban in comparison to warfarin in patients with nonvalvular atrial fibrillation: a propensity-matched analysis from Japanese administrative claims data",
abstract = "Objective: To investigate the risk of bleeding events and stroke/systemic embolism (SE) among Japanese patients with nonvalvular atrial fibrillation (NVAF), focusing on the initial dosage of apixaban and patient age. Methods: This retrospective cohort study used de-identified electronic health records based claims data from 314 acute-care hospitals in Japan. NVAF patients newly initiated on warfarin or apixaban, with no prescription during the 180-day blanking period, were eligible. Patients were allocated to receive warfarin or 5 or 2.5 mg twice daily (BID) apixaban. One-to-one propensity-score matching was used to balance patient characteristics between apixaban and warfarin. Results: Among 31,006 eligible patients, 11,972 matched pairs were identified for apixaban versus warfarin. Mean age ± standard deviation was 77.7 ± 10.0 and 77.6 ± 10.0 years and CHADS2 score was 2.2 ± 1.4 and 2.2 ± 1.4 for warfarin and apixaban, respectively. In the apixaban cohort, 39.4{\%} of patients received the standard dose (5 mg BID) and 60.6{\%} received the reduced dose (2.5 mg BID). Incidence rates (events per 100 person-years) of major bleeding, any bleeding and stroke/SE were 3.7, 23.1 and 3.1, and 2.5, 18.6 and 2.0 for warfarin and apixaban cohorts, respectively. Apixaban was associated with a significantly lower risk of any bleeding (hazard ratio [HR] 0.809, 95{\%} confidence interval [CI] 0.731–0.895; p < .001), major bleeding (HR 0.655, 95{\%} CI 0.505–0.849; p = .001) and stroke/SE (HR 0.637, 95{\%} CI 0.478–0.850; p = .002). Conclusions: Our observational data from clinical practice broadly confirms the safety and efficacy results of pivotal randomized controlled trials of apixaban for stroke prevention among NVAF patients.",
keywords = "apixaban, Bleeding, nonvalvular atrial fibrillation, novel oral anticoagulants, stroke, warfarin",
author = "Shun Kosaka and Jun Katada and Kumiko Saito and Yasuo Terayama",
year = "2018",
month = "5",
day = "30",
doi = "10.1080/03007995.2018.1478282",
language = "English",
pages = "1--8",
journal = "Current Medical Research and Opinion",
issn = "0300-7995",
publisher = "Informa Healthcare",

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TY - JOUR

T1 - Safety and effectiveness of apixaban in comparison to warfarin in patients with nonvalvular atrial fibrillation

T2 - a propensity-matched analysis from Japanese administrative claims data

AU - Kosaka, Shun

AU - Katada, Jun

AU - Saito, Kumiko

AU - Terayama, Yasuo

PY - 2018/5/30

Y1 - 2018/5/30

N2 - Objective: To investigate the risk of bleeding events and stroke/systemic embolism (SE) among Japanese patients with nonvalvular atrial fibrillation (NVAF), focusing on the initial dosage of apixaban and patient age. Methods: This retrospective cohort study used de-identified electronic health records based claims data from 314 acute-care hospitals in Japan. NVAF patients newly initiated on warfarin or apixaban, with no prescription during the 180-day blanking period, were eligible. Patients were allocated to receive warfarin or 5 or 2.5 mg twice daily (BID) apixaban. One-to-one propensity-score matching was used to balance patient characteristics between apixaban and warfarin. Results: Among 31,006 eligible patients, 11,972 matched pairs were identified for apixaban versus warfarin. Mean age ± standard deviation was 77.7 ± 10.0 and 77.6 ± 10.0 years and CHADS2 score was 2.2 ± 1.4 and 2.2 ± 1.4 for warfarin and apixaban, respectively. In the apixaban cohort, 39.4% of patients received the standard dose (5 mg BID) and 60.6% received the reduced dose (2.5 mg BID). Incidence rates (events per 100 person-years) of major bleeding, any bleeding and stroke/SE were 3.7, 23.1 and 3.1, and 2.5, 18.6 and 2.0 for warfarin and apixaban cohorts, respectively. Apixaban was associated with a significantly lower risk of any bleeding (hazard ratio [HR] 0.809, 95% confidence interval [CI] 0.731–0.895; p < .001), major bleeding (HR 0.655, 95% CI 0.505–0.849; p = .001) and stroke/SE (HR 0.637, 95% CI 0.478–0.850; p = .002). Conclusions: Our observational data from clinical practice broadly confirms the safety and efficacy results of pivotal randomized controlled trials of apixaban for stroke prevention among NVAF patients.

AB - Objective: To investigate the risk of bleeding events and stroke/systemic embolism (SE) among Japanese patients with nonvalvular atrial fibrillation (NVAF), focusing on the initial dosage of apixaban and patient age. Methods: This retrospective cohort study used de-identified electronic health records based claims data from 314 acute-care hospitals in Japan. NVAF patients newly initiated on warfarin or apixaban, with no prescription during the 180-day blanking period, were eligible. Patients were allocated to receive warfarin or 5 or 2.5 mg twice daily (BID) apixaban. One-to-one propensity-score matching was used to balance patient characteristics between apixaban and warfarin. Results: Among 31,006 eligible patients, 11,972 matched pairs were identified for apixaban versus warfarin. Mean age ± standard deviation was 77.7 ± 10.0 and 77.6 ± 10.0 years and CHADS2 score was 2.2 ± 1.4 and 2.2 ± 1.4 for warfarin and apixaban, respectively. In the apixaban cohort, 39.4% of patients received the standard dose (5 mg BID) and 60.6% received the reduced dose (2.5 mg BID). Incidence rates (events per 100 person-years) of major bleeding, any bleeding and stroke/SE were 3.7, 23.1 and 3.1, and 2.5, 18.6 and 2.0 for warfarin and apixaban cohorts, respectively. Apixaban was associated with a significantly lower risk of any bleeding (hazard ratio [HR] 0.809, 95% confidence interval [CI] 0.731–0.895; p < .001), major bleeding (HR 0.655, 95% CI 0.505–0.849; p = .001) and stroke/SE (HR 0.637, 95% CI 0.478–0.850; p = .002). Conclusions: Our observational data from clinical practice broadly confirms the safety and efficacy results of pivotal randomized controlled trials of apixaban for stroke prevention among NVAF patients.

KW - apixaban

KW - Bleeding

KW - nonvalvular atrial fibrillation

KW - novel oral anticoagulants

KW - stroke

KW - warfarin

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