title: Rationale, design, and baseline data of the Japanese Primary Prevention Project (JPPP)-a randomized, open-label, controlled trial of aspirin versus no aspirin in patients with multiple risk factors for vascular events.
abstract: BACKGROUND
  Prevention of atherosclerotic disease has become an important public health priority in Japan due to the aging of the population and changes in diet and lifestyle factors.
  
  
  METHODS
  The Japanese Primary Prevention Project (JPPP) is a multicenter, open-label, randomized, parallel-group trial that is evaluating primary prevention with low-dose aspirin in Japanese patients aged 60 to 85 years with hypertension, dyslipidemia, or diabetes mellitus. The study cohort will be followed for a mean of 4 years. The primary end point is a composite of death from cardiovascular causes (including fatal myocardial infarction [MI], fatal stroke, and other cardiovascular death), nonfatal stroke (ischemic or hemorrhagic), and nonfatal MI. Key secondary end points include a composite of cardiovascular death, nonfatal stroke, nonfatal MI, transient ischemic attack, angina pectoris, or arteriosclerotic disease requiring surgery or intervention; each component of the primary end point; noncerebrovascular and noncardiovascular death; and extracranial hemorrhage requiring transfusion or hospitalization. End point assessment is done by a central adjudication committee that is blinded to treatment assignments.
  
  
  RESULTS
  Enrollment began in March 2005 and was completed in June 2007. A total of 14,466 patients were randomly allocated to receive enteric-coated aspirin, 100 mg/d, or no aspirin. At randomization, the study cohort had a mean (SD) age of 70.6 (6.2) years; 57.8% were women, 85.0% had hypertension, 71.7% had dyslipidemia, and 33.9% had diabetes. In the study cohort, 80.4% of patients had > or =3 risk factors.
  
  
  CONCLUSIONS
  The JPPP is the largest primary prevention trial of aspirin in a Japanese population that is investigating whether the benefit of aspirin in reducing risk of vascular events outweighs any bleeding risk in elderly patients with multiple risk factors.
authors.affiliation: Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan. ttera@med.teikyo-u.ac.jp
authors.forename: Tamio
authors.initials: T
authors.lastname: Teramoto
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimada
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Uchiyama
authors.forename: Masahiro
authors.initials: M
authors.lastname: Sugawara
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Goto
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Yamada
authors.forename: Shinichi
authors.initials: S
authors.lastname: Oikawa
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Ando
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishizuka
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Yamazaki
authors.forename: Kenji
authors.initials: K
authors.lastname: Yokoyama
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Murata
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ikeda
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D003920:Diabetes Mellitus / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D050171:Dyslipidemias / Q000188:drug therapy; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D012107:Research Design; D012307:Risk Factors; D014652:Vascular Diseases / Q000208:ethnology / Q000209:etiology* / Q000517:prevention & control*
chemical_list: D010975:Platelet Aggregation Inhibitors; D001241:Aspirin