title: Effects of pitavastatin in Japanese patients with chronic heart failure: the Pitavastatin Heart Failure Study (PEARL Study).
abstract: BACKGROUND
  Recent clinical trials using rosuvastatin, a hydrophilic statin, did not show beneficial effects on cardiovascular events in patients with heart failure. We examined the cardioprotective effects of pitavastatin, a lipophilic statin, on Japanese patients with chronic heart failure (CHF).
  
  
  RESULTS
  A total of 574 Japanese patients with CHF were randomly assigned to the pitavastatin group (n=288) or the control group (n=286). There was no significant difference between the 2 groups for the primary outcome, which was a composite of cardiac death and hospitalization for worsening HF (adjusted hazard ratio (aHR): 0.922, 95% confidence interval (CI): 0.632-1.345, P=0.672). A strongly significant statistical interaction between the effect of pitavastatin and left ventricular ejection fraction (LVEF) was found (P=0.004). In patients with LVEF ≥30%, a significant reduction in the primary outcome (aHR: 0.525, 95% CI: 0.308-0.896, P=0.018) was observed in the pitavastatin group. Pitavastatin did not show any effects on the primary outcome (aHR: 1.582, 95% CI: 0.890-2.813, P=0.118) in the subgroup of patients with LVEF <30%.
  
  
  CONCLUSIONS
  Pitavastatin did not reduce cardiac death or hospitalization for worsening HF in Japanese patients with CHF. (UMIN-ID: UMINC000000428).
authors.affiliation: Department of Molecular Cardiovascular Pharmacology, Graduate School of Pharmaceutical Sciences, Chiba University, Chiba, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Takano
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Mizuma
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Kuwabara
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Sato
authors.forename: Satoshi
authors.initials: S
authors.lastname: Shindo
authors.forename: Norihiko
authors.initials: N
authors.lastname: Kotooka
authors.forename: Daisuke
authors.initials: D
authors.lastname: Fujimatsu
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Kobayashi
authors.forename: Teruo
authors.initials: T
authors.lastname: Inoue
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; D002316:Cardiotonic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D013318:Stroke Volume / Q000187:drug effects
chemical_list: D002316:Cardiotonic Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; C108475:pitavastatin