EBM Research Center, Kyoto University Graduate School of Medicine, Yoshida-Konoechou, Sakyo-ku, Kyoto, 606-8501, Japan.
Clin Exp Nephrol. 2013 Apr;17(2):211-7. doi: 10.1007/s10157-012-0676-5. Epub 2012 Sep 6.
Since dyslipidemia has been shown to be an independent risk factor for the progression of chronic kidney disease (CKD), low-density lipoprotein cholesterol (LDL-C)-lowering therapy can be potentially associated with inhibition of CKD progression. The ASsessment of clinical Usefulness in CKD patients with Atorvastatin (ASUCA) trial was designed to determine whether atorvastatin has protective effects on renal function in patients with dyslipidemia and CKD.
We decided to carry out a prospective multi-center, open-labeled, randomized trial to compare the reno-protective effects between diet therapy alone and atorvastatin plus diet therapy in patients with dyslipidemia (LDL-C ≥ 140 mg/dL if not treated or LDL-C ≥ 100 mg/dL if treated with lipid-lowering drugs in subjects taking dyslipidemia-treating agents other than statins) and CKD [estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m(2)]. The primary endpoint is the change in eGFR (mL/min/1.73 m(2)) as calculated by the modified MDRD equation for Japanese after 2 years of treatment.
Enrollment began in April 2009 and was completed in March 2011. A total of 334 patients (213 male and 121 female) were randomly assigned to either diet therapy alone or atorvastatin plus diet therapy and included in an intent-to-treat population. In the atorvastatin and control groups, the mean ages were 63.2 and 63.1 years, mean eGFRs were 55.9 and 54.0 mL/min/1.73 m(2), and median urinary albumin/creatinine ratios were 24.9 and 29.1 mg/g, respectively.
This study distinguishes itself from similar studies by increasing statistical accuracy derived from its significantly larger sample size and longitudinal magnitude. The results of this study will help to determine whether atorvastatin has reno-protective effects in patients with dyslipidemia and CKD.
由于血脂异常已被证实是慢性肾脏病（CKD）进展的独立危险因素，因此降低低密度脂蛋白胆固醇（LDL-C）的治疗可能与抑制 CKD 进展有关。阿托伐他汀在伴有血脂异常的 CKD 患者中的临床应用评估（ASUCA）试验旨在确定阿托伐他汀是否对血脂异常和 CKD 患者的肾功能具有保护作用。
我们决定开展一项前瞻性、多中心、开放性、随机试验，比较单独饮食疗法与阿托伐他汀加饮食疗法在血脂异常（未治疗者 LDL-C≥140mg/dL，或服用他汀类药物以外的降脂药物治疗血脂异常的患者 LDL-C≥100mg/dL）和 CKD[估算肾小球滤过率（eGFR）＜60mL/min/1.73m²]患者中的肾脏保护作用。主要终点是治疗 2 年后改良 MDRD 方程计算的 eGFR（mL/min/1.73m²）变化。
入组于 2009 年 4 月开始，2011 年 3 月完成。共有 334 例患者（213 例男性，121 例女性）被随机分配至单独饮食疗法或阿托伐他汀加饮食疗法组，并纳入意向治疗人群。在阿托伐他汀组和对照组中，患者的平均年龄分别为 63.2 岁和 63.1 岁，平均 eGFR 分别为 55.9 和 54.0mL/min/1.73m²，中位数尿白蛋白/肌酐比值分别为 24.9 和 29.1mg/g。
本研究通过增加样本量和纵向幅度，提高了统计精度，从而与类似研究有所区别。本研究的结果将有助于确定阿托伐他汀是否对血脂异常和 CKD 患者具有肾脏保护作用。
