强化他汀治疗对老年患者肾功能的改善和血尿酸的降低：SAGE 试验的事后分析。
Improvement in Renal Function and Reduction in Serum Uric Acid with Intensive Statin Therapy in Older Patients: A Post Hoc Analysis of the SAGE Trial.
机构信息
Cardiology Division, UCSF School of Medicine, 5th Floor, 2823 Fresno Street, Fresno, CA, 93703, USA.
Brigham and Women's Hospital, Boston, MA, USA.
出版信息
Drugs Aging. 2015 Dec;32(12):1055-65. doi: 10.1007/s40266-015-0328-z.
BACKGROUND
Improvement in renal function and decreases in serum uric acid (SUA) have been reported following prolonged high-intensity statin (HMG-CoA reductase inhibitor) therapy. This post hoc analysis of the SAGE trial examined the effect of intensive versus less intensive statin therapy on renal function, safety, and laboratory parameters, including SUA, in elderly coronary artery disease (CAD) patients (65-85 years) with or without chronic kidney disease (CKD).
METHODS
Patients were randomized to atorvastatin 80 mg/day or pravastatin 40 mg/day and treated for 12 months. Patients were stratified using Modification of Diet in Renal Disease (MDRD) estimated glomerular filtration rates (eGFRs) in CKD (eGFR <60 mL/min/1.73 m(2)) and non-CKD populations.
RESULTS
Of the 893 patients randomized, 858 had complete renal data and 418 of 858 (49%) had CKD (99% Stage 3). Over 12 months, eGFR increased with atorvastatin and remained stable with pravastatin (+2.38 vs. +0.18 mL/min/1.73 m(2), respectively; p < 0.0001). MDRD eGFR improved significantly in both CKD treatment arms; however, the increased eGFR in patients without CKD was significantly greater with atorvastatin (+2.08 mL/min/1.73 m(2)) than with pravastatin (-1.04 mL/min/1.73 m(2)). Modest reductions in SUA were observed in both treatment arms, but a greater fall occurred with atorvastatin than with pravastatin (-0.52 vs. -0.09 mg/dL, p < 0.0001). Change in SUA correlated negatively with changes in eGFR and positively with changes in low-density lipoprotein cholesterol. Reports of myalgia were rare (3.6% CKD; 5.7% non-CKD), and there were no episodes of rhabdomyolysis. Elevated serum alanine and aspartate transaminase to >3 times the upper limit of normal occurred in 4.4% of atorvastatin- and 0.2% of pravastatin-treated patients.
CONCLUSION
Intensive management of dyslipidemia in older patients with stable coronary heart disease may have beneficial effects on renal function and SUA.
背景
长期高强度他汀类药物（HMG-CoA 还原酶抑制剂）治疗后，肾功能改善和血清尿酸（SUA）降低。SAGE 试验的这一事后分析检查了强化与非强化他汀类药物治疗对肾功能、安全性和实验室参数（包括 SUA）的影响，这些参数包括老年冠心病（CAD）患者（65-85 岁）和/或慢性肾脏病（CKD）患者。
方法
患者随机分为阿托伐他汀 80mg/天或普伐他汀 40mg/天，并治疗 12 个月。使用慢性肾脏病（CKD）（eGFR <60mL/min/1.73m(2)）和非 CKD 人群的改良肾脏病饮食研究（MDRD）估计肾小球滤过率（eGFR）对患者进行分层。
结果
在 893 名随机患者中，858 名患者有完整的肾功能数据，418 名（858 名中的 49%）患者患有 CKD（99%为 3 期）。阿托伐他汀治疗 12 个月后 eGFR 增加，普伐他汀治疗后 eGFR 保持稳定（分别为+2.38 与+0.18mL/min/1.73m(2)，p<0.0001）。在 CKD 治疗组中，MDRD eGFR 均显著改善；然而，无 CKD 患者的 eGFR 增加明显大于普伐他汀（+2.08mL/min/1.73m(2)），而普伐他汀则为-1.04mL/min/1.73m(2)）。两种治疗方案均观察到 SUA 适度降低，但阿托伐他汀比普伐他汀下降更明显（-0.52 与-0.09mg/dL，p<0.0001）。SUA 的变化与 eGFR 的变化呈负相关，与低密度脂蛋白胆固醇的变化呈正相关。肌肉疼痛的报告很少（CKD 为 3.6%；非 CKD 为 5.7%），无横纹肌溶解症发作。阿托伐他汀治疗患者中有 4.4%出现血清丙氨酸和天冬氨酸转氨酶升高至正常上限的 3 倍以上，而普伐他汀治疗患者中则有 0.2%出现这种情况。
结论
稳定型冠心病老年患者血脂异常的强化治疗可能对肾功能和 SUA 有益。
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