Relation of renal function to mid-term prognosis of stable angina patients with high- or low-dose pitavastatin treatment: REAL-CAD substudy.

Abstract

BACKGROUND:

It has not yet been established whether higher-dose statins have beneficial effects on cardiovascular events in patients with stable coronary artery disease (CAD) and renal dysfunction.

METHODS:

The REAL-CAD study is a prospective, multicenter, open-label trial. As a substudy, we categorized patients by an estimated glomerular filtration rate (eGFR) as follows: eGFR ≥60 (n = 7,768); eGFR ≥45 and <60 (n = 3,176); and eGFR <45 mL/Min/1.73 m2 (n = 1,164), who were randomized to pitavastatin 4mg or 1mg therapy. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or unstable angina, and was assessed by the log-rank test and Cox proportional hazards model.

RESULTS:

The baseline characteristics and medications were largely well-balanced between two groups. The magnitude of low-density lipoprotein cholesterol (LDL-C) reduction at 6 months in high- and low-dose pitavastatin groups was comparable among all eGFR categories. During a median follow-up of 3.9 years, high- compared with low-dose pitavastatin significantly reduced cardiovascular events in patients with eGFR ≥60 (hazard ratio (HR) 0.73; 95% confidence interval (CI) 0.58-0.91; P = .006), and reduced but not significant for patients with eGFR ≥45 and <60 (HR 0.85; 95% CI, 0.63-1.14; P = .27) or eGFR <45 mL/Min/1.73 m2 (HR 0.90; 95% CI 0.62-1.33; P = .61). An interaction test of treatment by eGFR category was not significant (P value for interaction = .30).

CONCLUSION:

Higher-dose pitavastatin therapy reduced LDL levels and cardiovascular events in stable CAD patients irrespective of eGFR level, although the effect on events appeared to be numerically lower in patients with lower eGFR.

• Authors: Mitsuru Abe, Yukio Ozaki, Hiroshi Takahashi, Mitsuru Ishii, Nobutoyo Masunaga, Tevfik F Ismail, Satoshi Iimuro, Retsu Fujita, Hiroshi Iwata, Ichiro Sakuma, Yoshihisa Nakagawa, Kiyoshi Hibi, Takafumi Hiro, Yoshihiro Fukumoto, Seiji Hokimoto, Katsumi Miyauchi, Hisao Ogawa, Hiroyuki Daida, Hiroaki Shimokawa, Yasushi Saito, Masunori Matsuzaki, Masaharu Akao, Takeshi Kimura, Ryozo Nagai
• Journal: American heart journal (Am Heart J) Vol. 240 Pg. 89-100 (10 2021) ISSN: 1097-6744 [Electronic] United States
• PMID: 34174217 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021. Published by Elsevier Inc.

Chemical References

• Cholesterol, LDL
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Lipids
• Quinolines
• C-Reactive Protein
• pitavastatin

Topics

• Aged
• Angina, Stable (blood, complications, drug therapy, physiopathology)
• C-Reactive Protein (metabolism)
• Cardiovascular Diseases (prevention & control)
• Cholesterol, LDL (blood)
• Coronary Artery Disease (blood, complications, drug therapy, physiopathology)
• Female
• Glomerular Filtration Rate
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (administration & dosage)
• Lipids (blood)
• Male
• Middle Aged
• Prospective Studies
• Quinolines (administration & dosage)
• Treatment Outcome