阿托伐他汀强化降脂治疗冠心病合并糖尿病及慢性肾脏病患者

Intensive lipid lowering with atorvastatin in patients with coronary artery disease, diabetes, and chronic kidney disease.

作者信息

Shepherd James, Kastelein John P, Bittner Vera A, Carmena Rafael, Deedwania Prakash C, Breazna Andrei, Dobson Stephen, Wilson Daniel J, Zuckerman Andrea L, Wenger Nannette K

机构信息

University of Glasgow, United Kingdom.

出版信息

Mayo Clin Proc. 2008 Aug;83(8):870-9.

PMID:18674471

Abstract

OBJECTIVE

To investigate the effect of intensive lipid lowering with high-dose atorvastatin on the incidence of major cardiovascular events compared with low-dose atorvastatin in patients with coronary artery disease and type 2 diabetes, with and without chronic kidney disease (CKD).

PATIENTS AND METHODS

Following 8 weeks' open-label therapy with atorvastatin (10 mg/d), 10,001 patients with coronary artery disease were randomized to receive double-blind therapy with either 80 mg/d or 10 mg/d of atorvastatin between July 1, 1998, and December 31, 1999. Of 1501 patients with diabetes, renal data were available for 1431. Patients with CKD were defined as having a baseline estimated glomerular filtration rate (eGFR) below 60 mL/min per 1.73 m2, using the Modification of Diet in Renal Disease equation.

RESULTS

After a median follow-up of 4.8 years, 95 (17.4%) of 546 patients with diabetes and CKD experienced a major cardiovascular event vs 119 (13.4%) of 885 patients with diabetes and normal eGFRs (hazard ratio [HR], 1.32; 95% confidence interval [CI], 1.00-1.72; P<.05). Compared with 10 mg of atorvastatin, 80 mg of atorvastatin reduced the relative risk of major cardiovascular events by 35% in patients with diabetes and CKD (20.9% [57/273] vs 13.9% [38/273]; HR, 0.65; 95% CI, 0.43-0.98; P=.04) and by 10% in patients with diabetes and normal eGFR (14.1% [62/441] vs 12.8% [57/444]; HR, 0.90; 95% CI, 0.63-1.29; P=.56). The absolute risk reduction in patients with diabetes and CKD was substantial, yielding a number needed to treat of 14 to prevent 1 major cardiovascular event over 4.8 years. Both treatments were well tolerated.

CONCLUSION

Patients with diabetes, stable coronary artery disease, and mild to moderate CKD experience marked reduction in cardiovascular events with intensive lipid lowering, in contrast to previous observations in patients with diabetes and end-stage renal disease.

TRIAL REGISTRATION

clinicaltrials.gov identifier: NCT00327691.

摘要

目的

研究与低剂量阿托伐他汀相比，高剂量阿托伐他汀强化降脂对合并或不合并慢性肾脏病（CKD）的冠心病和2型糖尿病患者主要心血管事件发生率的影响。

患者与方法

在接受8周的阿托伐他汀（10毫克/天）开放标签治疗后，10001例冠心病患者于1998年7月1日至1999年12月31日被随机分配接受80毫克/天或10毫克/天阿托伐他汀的双盲治疗。在1501例糖尿病患者中，有1431例可获得肾脏数据。使用肾脏病饮食改良公式，CKD患者被定义为基线估计肾小球滤过率（eGFR）低于60毫升/分钟/1.73平方米。

结果

中位随访4.8年后，546例合并糖尿病和CKD的患者中有95例（17.4%）发生主要心血管事件，而885例糖尿病且eGFR正常的患者中有119例（13.4%）发生主要心血管事件（风险比[HR]为1.32；95%置信区间[CI]为1.00 - 1.72；P<0.05）。与10毫克阿托伐他汀相比，80毫克阿托伐他汀使合并糖尿病和CKD的患者主要心血管事件的相对风险降低35%（20.9%[57/273]对13.9%[38/273]；HR为0.65；95%CI为0.43 - 0.98；P = 0.04），使糖尿病且eGFR正常的患者主要心血管事件的相对风险降低10%（14.1%[62/441]对12.8%[57/444]；HR为0.90；95%CI为0.63 - 1.29；P = 0.56）。合并糖尿病和CKD的患者绝对风险降低幅度很大，4.8年内预防1例主要心血管事件所需治疗人数为14。两种治疗耐受性均良好。