title: Risks of thromboembolism associated with hormonal contraceptives related to body mass index and aging in Japanese women.
abstract: OBJECTIVE
  The aim of this study is to estimate the risk of thromboembolism related to body mass index (BMI) and aging among users of hormonal contraceptives in Japan.
  
  
  METHODS
  A case-control study of the risk of obesity and a descriptive study of the risk of age were conducted. We used the Pharmaceuticals and Medical Devices Agency database, and extracted thromboembolic events of combined oral contraceptive (COC) products. Control data were from the National Health and Nutrition Survey in Japan. Denominator of descriptive study was from IMS Health, JPM.
  
  
  RESULTS
  A total of 306 thromboembolic events and 6423 controls were analyzed. The odds ratios (95% confidence interval) of the obesity groups (BMI ≥ 25) were 2.32 (1.71-3.15) for venous thromboembolism (VTE), 1.16 (0.62-2.18) for arterial embolism and thrombosis (ATE), and 1.83 (1.38-2.43) for overall thromboembolic events compared with the standard group (BMI of 18.5-24.9) as a reference. The estimated incidence rates of VTE, ATE and overall thromboembolic events per 10,000 person-years in users of therapeutic remedies for dysmenorrhea (35 μg ethinylestradiol combined with norethisterone, 20 μg ethinylestradiol combined with drospirenone and dienogest) among women aged 10-59 years from 2009 to 2013 were 2.38 (2.08-2.74), 0.63 (0.48-0.82), and 3.17 (2.81-3.57), respectively. This tendency was not seen for dienogest.
  
  
  CONCLUSIONS
  The risk of VTE in the obesity group among COC users was more than 2 times higher than in the standard group. The incidence rates of VTE in Japanese users of all remedies for dysmenorrhea except dienogest were as high as in people in Western countries.
authors.affiliation: Department of Reproductive Health Nursing/Midwifery, Nagoya City University Graduate School of Nursing, Nagoya, Japan; Department of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan. Electronic address: sugiura@med.nagoya-cu.ac.jp.
authors.forename: Kazuko
authors.initials: K
authors.lastname: Sugiura
authors.affiliation: Department of Obstetrics and Gynecology, Hamamatsu Medical Center, Hamamatsu, Japan. Electronic address: tkoba@hmedc.or.jp.
authors.forename: Takao
authors.initials: T
authors.lastname: Kobayashi
authors.affiliation: Department of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan. Electronic address: ojima@hama-med.ac.jp.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Ojima
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D015992:Body Mass Index; D016022:Case-Control Studies; D002648:Child; D015897:Comorbidity; D003267:Contraception / Q000706:statistics & numerical data*; D003278:Contraceptives, Oral, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D008875:Middle Aged; D009765:Obesity / Q000453:epidemiology*; D018570:Risk Assessment; D054556:Venous Thromboembolism / Q000139:chemically induced / Q000453:epidemiology*; D016387:Women's Health / Q000706:statistics & numerical data*; D055815:Young Adult
chemical_list: D003278:Contraceptives, Oral, Hormonal
keywords: Aging; Arterial embolism and thrombosis; Hormonal contraceptives; Obesity; Venous thromboembolism