title: Rationale and design of a study to evaluate effects of pitavastatin on Japanese patients with chronic heart failure: the pitavastatin heart failure study (PEARL study).
abstract: BACKGROUND
  HMG-CoA reductase inhibitors (statins) are known to have pleiotropic effects in addition to their lipid-lowering effect. Many studies have suggested cardioprotective effects of statins, however, recent large-scale clinical trials using rosuvastatin, a hydrophilic statin, have failed to show beneficial effects on cardiovascular events in patients with severe heart failure. We have designed the study to evaluate the effects of pitavastatin, a lipophilic statin, on Japanese patients with mild to moderate heart failure.
  
  
  RESULTS
  Five hundred seventy-seven patients with chronic heart failure were enrolled. We used a prospective, randomized, open-label, and blinded-endpoint evaluation (PROBE) design. Patients aged 20-79 years old with symptomatic (NYHA functional class II or III) heart failure and a left ventricular ejection fraction of ≤ 45% were randomly allocated to either receive pitavastatin (2mg/day) or not in addition to conventional therapy for heart failure by using the minimization method. Follow-up will be continued until March 2011. The primary endpoint is a composite of cardiac death and hospitalization for worsening heart failure.
  
  
  CONCLUSIONS
  The PEARL study will provide important data on the role of pitavastatin in the treatment of Japanese patients with mildly symptomatic heart failure (UMIN-ID: UMINC000000428).
authors.affiliation: Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Mizuma
authors.forename: Teruo
authors.initials: T
authors.lastname: Inoue
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Takano
authors.forename: Satoshi
authors.initials: S
authors.lastname: Shindo
authors.forename: Toru
authors.initials: T
authors.lastname: Oka
authors.forename: Daisuke
authors.initials: D
authors.lastname: Fujimatsu
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Kuwabara
authors.forename: Koichi
authors.initials: K
authors.lastname: Node
authors.forename: Issei
authors.initials: I
authors.lastname: Komuro
mesh_terms: D000368:Aged; D044466:Asian People / Q000208:ethnology*; D002908:Chronic Disease; D003643:Death; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000208:ethnology* / Q000401:mortality; D006760:Hospitalization / Q000639:trends; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011804:Quinolines / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; C108475:pitavastatin