Effects of pitavastatin on Japanese patients with chronic heart failure: a subanalysis of the PEARL

Abstract

Purpose: HMG-CoA reductase inhibitors (statins) are known to have pleiotropic effects in addition to their lipid-lowering effect. Many studies have suggested car-dioprotective 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 performed the study to evaluate the effects of pitavastatin, a lipophilic statin, on Japanese patients with heart failure and reported the results (Takano H, et al. Circ J. 2013). In this subanalysis of the PEARL, we evaluated the effects of pitavastatin on Japanese patients with dilated cardiomyopathy (DCM). Methods: The PEARL study is a multi-center, prospective, randomized, open-label, blinded-endpoint (PROBE) trial being carried out in Japan. Patients with stable and symptomatic heart failure (NYHA class II-III) with systolic dysfunction were eligible. After consent by the document, patients were randomly allocated to either the pitavastatin group (2 mg/day) or the control group (no statin) by using the minimization method. The primary outcome was a composite of cardiac death and hospitalization for worsening heart failure. The secondary outcomes were all-cause death, cardiac death, hospitalization for worsening heart failure, myocardial infarction, unstable angina, stroke, percutaneous coronary intervention, and surgical therapy for worsening heart failure. Results: In the PEARL study, a total of 574 Japanese patients with chronic heart failure were randomly assigned to the pitavastatin group (n=288) or the control group (n=286). The median duration of follow-up was 35.5 months. There were no significant differences in baseline characteristics between the two groups. The patients had a mean age of 62.6 years and 86.2% of them were older than 50 years. The mean LVEF was 34.0% and 89.7% of the patients were classified to NYHA class II. In this subanalysis, the patients with DCM (n=310) were analyzed. Of those patients, 149 were assigned to the pitavastatin group and 161 to the control group. There was no significant difference in the primary outcome and the secondary outcomes between the two groups. We did not note any significant differences in the adverse events between the two groups. Conclusions: Pitavastatin did not reduce cardiac death and hospitalization for worsening heart failure in the patients with DCM.