title: Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study.
abstract: BACKGROUND
  Drugs that inhibit the renin-angiotensin-aldosterone system benefit patients at risk for or with existing cardiovascular disease. However, evidence for this effect in Asian populations is scarce. We aimed to investigate whether addition of an angiotensin receptor blocker, valsartan, to conventional cardiovascular treatment was effective in Japanese patients with cardiovascular disease.
  
  
  METHODS
  We initiated a multicentre, prospective, randomised controlled trial of 3081 Japanese patients, aged 20-79 years, (mean 65 [SD 10] years) who were undergoing conventional treatment for hypertension, coronary heart disease, heart failure, or a combination of these disorders. In addition to conventional treatment, patients were assigned either to valsartan (40-160 mg per day) or to other treatment without angiotensin receptor blockers. Our primary endpoint was a composite of cardiovascular morbidity and mortality. Analysis was by intention to treat. The study was registered at clintrials.gov with the identifier NCT00133328.
  
  
  RESULTS
  After a median follow-up of 3.1 years (range 1-3.9) the primary endpoint was recorded in fewer individuals given valsartan than in controls (92 vs 149; absolute risk 21.3 vs 34.5 per 1000 patient years; hazard ratio 0.61, 95% CI 0.47-0.79, p=0.0002). This difference was mainly attributable to fewer incidences of stroke and transient ischaemic attack (29 vs 48; 0.60, 0.38-0.95, p=0.028), angina pectoris (19 vs 53; 0.35, 0.20-0.58, p<0.0001), and heart failure (19 vs 36; 0.53, 0.31-0.94, p=0.029) in those given valsartan than in the control group. Mortality or tolerability did not differ between groups.
  
  
  CONCLUSIONS
  The addition of valsartan to conventional treatment prevented more cardiovascular events than supplementary conventional treatment. These benefits cannot be entirely explained by a difference in blood pressure control.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan. Electronic address: m_seibu@jikei.ac.jp.
authors.forename: Seibu
authors.initials: S
authors.lastname: Mochizuki
authors.affiliation: Institute of Medicine, Department of Emergency and Cardiovascular Medicine, Sahlgrenska University Hospital/Östra, Göteborg, Sweden.
authors.forename: Björn
authors.initials: B
authors.lastname: Dahlöf
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Mitsuyuki
authors.initials: M
authors.lastname: Shimizu
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Katsunori
authors.initials: K
authors.lastname: Ikewaki
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Yoshikawa
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Ikuo
authors.initials: I
authors.lastname: Taniguchi
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Ohta
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Taku
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Ogawa
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Kanae
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Kawai
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Seki
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Fumiko
authors.initials: F
authors.lastname: Okazaki
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Taniguchi
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Yoshida
authors.affiliation: Division of Diabetes, Metabolism, and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Tajima
mesh_terms: D000328:Adult; D000368:Aged; D057911:Angiotensin Receptor Antagonists; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D003327:Coronary Disease / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D023381:Endpoint Determination / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D007564:Japan; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068756:Valsartan
chemical_list: D057911:Angiotensin Receptor Antagonists; D000959:Antihypertensive Agents; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine