title: Predictors of venous thromboembolism recurrence and the bleeding events identified using a Japanese healthcare database.
abstract: BACKGROUND
  Treatment to prevent the recurrence of venous thromboembolism (VTE) and prevent bleeding events should be given to patients with VTE in an appropriate balance in relation to relevant predictors. We elucidated the current medical care in a real world setting and quantified predictors using a Japanese healthcare database.
  
  
  METHODS
  The study included 3578 patients who were diagnosed with VTE between April 2008 and September 2013 at a Japanese acute-care hospital and included in the hospital database. Twenty-four patients who had a VTE event during the 180-day period after enrollment were excluded. We analyzed the incidence of recurrent VTE, incidence of bleeding events, and predictors in VTE patients. Events were defined by disease, medication, imaging, and laboratory testing, among other factors.
  
  
  RESULTS
  The rate of recurrence of VTE events was 7.2 per 100 patient-years. The incidence rate of bleeding events was 8.3 per 100 patient-years. The presence of malignant disease, antipsychotic drugs, and nonsteroidal anti-inflammatory drugs increased the risk for recurrent VTE. The predictors for bleeding events were malignant disease, central venous catheterization, cancer chemotherapy, stroke, and diabetes.
  
  
  CONCLUSIONS
  These findings obtained from healthcare database suggest predictors either for recurrent VTE and bleeding that should be considered when selecting treatment to reduce the risk of recurrent VTE and mitigate bleeding.
authors.affiliation: Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan. Electronic address: mashio@clin.medic.mie-u.ac.jp.
authors.forename: Mashio
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan.
authors.forename: Norikazu
authors.initials: N
authors.lastname: Yamada
authors.affiliation: Medical TOUKEI Corporation, Tokyo, Japan.
authors.forename: Eisei
authors.initials: E
authors.lastname: Oda
authors.affiliation: Medical Data Vision Co., Ltd., Tokyo, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Matsubayashi
authors.affiliation: Medical Data Vision Co., Ltd., Tokyo, Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Ota
authors.affiliation: Department of Corporate Planning, Linical Co., Ltd., Osaka, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kobayashi
authors.affiliation: EU Biostatistics & Data Management, Daiichi Sankyo Europe GmbH, Munich, Germany.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Matsushita
authors.affiliation: Medical Science Department, Daiichi Sankyo Co Ltd., Tokyo, Japan.
authors.forename: Jumpei
authors.initials: J
authors.lastname: Kaburagi
authors.affiliation: Medical Science Department, Daiichi Sankyo Co Ltd., Tokyo, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Ibusuki
authors.affiliation: Safety and Risk Management Department, Daiichi Sankyo Co Ltd., Tokyo, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Takita
authors.affiliation: Medical Science Department, Daiichi Sankyo Co Ltd., Tokyo, Japan.
authors.forename: Mikio
authors.initials: M
authors.lastname: Iwashita
authors.affiliation: Division of Biostatistics, Tohoku University Graduate School of Medicine, Miyagi, Japan.
authors.forename: Takuhiro
authors.initials: T
authors.lastname: Yamaguchi
mesh_terms: D000368:Aged; D016208:Databases, Factual; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D007564:Japan; D008297:Male; D012008:Recurrence; D012307:Risk Factors; D054556:Venous Thromboembolism / Q000453:epidemiology*
keywords: Bleeding event; Deep vein thrombosis; Healthcare database; Pulmonary embolism; Venous thromboembolism