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

Lee HY, Cho HJ, Kim HY, Jeon HK, Shin JH, Kang SM, Baek SH - Korean J. Intern. Med. (2014)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.

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.

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Related in: MedlinePlus

Study design.
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Figure 1: Study design.

Mentions: The clinical trial was conducted at five clinical research centers and hospitals. All patients provided written informed consent prior to participation. Subjects who satisfied all inclusion/exclusion criteria were randomized either to the pravastatin group or the pitavastatin group. The pravastatin group was administered 10 mg pravastatin once daily and the pitavastatin group 2 mg pitavastatin once daily. If no AEs were determined by the investigators after 4 weeks, the pitavastatin dose was doubled to 4 mg once daily regardless of the serum cholesterol level, and the patients were treated for 52 weeks. The study design is summarized in Fig. 1.


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

Lee HY, Cho HJ, Kim HY, Jeon HK, Shin JH, Kang SM, Baek SH - Korean J. Intern. Med. (2014)

Study design.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4219965&req=5

Figure 1: Study design.
Mentions: The clinical trial was conducted at five clinical research centers and hospitals. All patients provided written informed consent prior to participation. Subjects who satisfied all inclusion/exclusion criteria were randomized either to the pravastatin group or the pitavastatin group. The pravastatin group was administered 10 mg pravastatin once daily and the pitavastatin group 2 mg pitavastatin once daily. If no AEs were determined by the investigators after 4 weeks, the pitavastatin dose was doubled to 4 mg once daily regardless of the serum cholesterol level, and the patients were treated for 52 weeks. The study design is summarized in Fig. 1.

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.

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.

Show MeSH
Related in: MedlinePlus