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.

中文翻译：

---

肾功能与高剂量或低剂量匹伐他汀治疗稳定型心绞痛患者中期预后的关系：REAL-CAD 亚研究。

背景尚未确定高剂量他汀类药物是否对患有稳定性冠状动脉疾病 (CAD) 和肾功能不全的患者的心血管事件产生有益影响。方法 REAL-CAD 研究是一项前瞻性、多中心、开放标签试验。作为一项子研究，我们根据估计的肾小球滤过率 (eGFR) 将患者分类如下：eGFR ≥ 60 (n = 7,768)；eGFR ≥45 且 <60（n = 3,176）；eGFR <45 mL/Min/1.73 m2 (n = 1,164)，他们被随机分配接受匹伐他汀 4mg 或 1mg 治疗。主要终点是心血管死亡、非致命性心肌梗死、非致命性缺血性中风或不稳定心绞痛的复合终点，并通过对数秩检验和 Cox 比例风险模型进行评估。结果 两组的基线特征和药物基本平衡。在所有 eGFR 类别中，高剂量和低剂量匹伐他汀组 6 个月时低密度脂蛋白胆固醇 (LDL-C) 降低的幅度相当。在中位随访 3.9 年期间，与低剂量匹伐他汀相比，高剂量匹伐他汀显着降低 eGFR ≥60 患者的心血管事件（风险比 (HR) 0.73；95% 置信区间 (CI) 0.58-0.91；P = . 006），并且对于 eGFR ≥ 45 和 <60 的患者（HR 0.85；95% CI，0.63-1.14；P = .27）或 eGFR <45 mL/Min/1.73 m2（HR 0.90；95%）降低但不显着CI 0.62-1.33；P = .61)。按 eGFR 类别进行的交互作用测试不显着（交互作用的 P 值 = .30）。结论 不论 eGFR 水平如何，高剂量匹伐他汀治疗可降低稳定型 CAD 患者的 LDL 水平和心血管事件，