Effects of intensive versus mild lipid lowering by statins in patients with ischemic congestive heart failure: Korean Pitavastatin Heart Failure (SAPHIRE) study.

Abstract

BACKGROUND/AIMS: This study was designed to evaluate the dose-effect relationship

of statins in patients with ischemic congestive heart failure (CHF), since the

role of statins in CHF remains unclear. METHODS: The South koreAn Pitavastatin

Heart FaIluRE (SAPHIRE) study was designed to randomize patients with ischemic

CHF into daily treatments of 10 mg pravastatin or 4 mg pitavastatin. RESULTS: The

low density lipoprotein cholesterol level decreased by 30% in the pitavastatin

group compared with 12% in the pravastatin (p < 0.05) group. Left ventricular

systolic dimensions decreased significantly by 9% in the pitavastatin group and

by 5% in the pravastatin group. Left ventricular ejection fraction (EF) improved

significantly from 37% to 42% in the pitavastatin group and from 35% to 39% in

the pravastatin group. Although the extent of the EF change was greater in the

pitavastatin group (16% vs. 11%) than that in the pravastatin group, no

significant difference was observed between the groups (p = 0.386). Exercise

capacity, evaluated by the 6-min walking test, improved significantly in the

pravastatin group (p < 0.001), but no change was observed in the pitavastatin

group (p = 0.371). CONCLUSIONS: Very low dose/low potency pravastatin and high

dose/high potency pitavastatin had a beneficial effect on cardiac reverse

remodeling and improved systolic function in patients with ischemic CHF. However,

only pravastatin significantly improved exercise capacity. These findings suggest

that lowering cholesterol too much may not be beneficial for patients with CHF.