Harris Kevin P G, Wheeler David C, Chong Camilla C
Department of Nephrology, Leicester General Hospital, Leicester, England, United Kingdom.
Kidney Int. 2002 Apr;61(4):1469-74. doi: 10.1046/j.1523-1755.2002.00262.x.
Individuals with chronic renal disease are at high risk of cardiovascular morbidity and mortality, and therefore the management of dyslipidemia is particularly important in this patient population. This double-blind randomized study investigated the efficacy and safety of the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, atorvastatin, in continuous ambulatory peritoneal dialysis (CAPD) patients with dyslipidemia.
Following a two- to four-week baseline period, patients with low-density lipoprotein (LDL)-cholesterol > or =3.5 mmol/L (135 mg/dL) were randomized to receive either atorvastatin 10 mg (N = 82) or placebo (N = 95) for 16 weeks. If LDL-cholesterol remained > or =3.5 mmol/L, the dose of atorvastatin was titrated to 20 mg and 40 mg after four and eight weeks, respectively.
After four weeks a significantly greater proportion of patients receiving atorvastatin 10 mg had achieved the LDL-cholesterol goal < or =3.5 mmol/L compared with patients receiving placebo (85.4% vs. 16.0%; P < or = 0.001). The statistically significant difference between the two groups was maintained at week 8 and week 16 (P < or = 0.001 at both time points). At week 16, patients receiving atorvastatin had significantly greater reductions from baseline in LDL-cholesterol, total cholesterol, triglycerides and total cholesterol:HDL-cholesterol ratio (all P = 0.0001), and a significantly greater increase from baseline in HDL-cholesterol (P = 0.001) than patients receiving placebo. The overall adverse event profile for atorvastatin was similar to that observed with placebo.
Atorvastatin was effective in achieving target LDL-cholesterol levels in a high proportion of the dyslipidemic CAPD patients studied at doses that are well tolerated.
慢性肾病患者心血管发病和死亡风险较高，因此血脂异常的管理在该患者群体中尤为重要。这项双盲随机研究调查了3-羟基-3-甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂阿托伐他汀对持续性非卧床腹膜透析（CAPD）血脂异常患者的疗效和安全性。
在为期2至4周的基线期后，低密度脂蛋白（LDL）胆固醇≥3.5 mmol/L（135 mg/dL）的患者被随机分为两组，分别接受10 mg阿托伐他汀（N = 82）或安慰剂（N = 95）治疗16周。如果LDL胆固醇仍≥3.5 mmol/L，则分别在4周和8周后将阿托伐他汀剂量滴定至20 mg和40 mg。
4周后，接受10 mg阿托伐他汀治疗的患者中达到LDL胆固醇目标水平≤3.5 mmol/L的比例显著高于接受安慰剂治疗的患者（85.4%对16.0%；P≤0.001）。两组之间的统计学显著差异在第8周和第16周时得以维持（两个时间点均为P≤0.001）。在第16周时，接受阿托伐他汀治疗的患者与接受安慰剂治疗的患者相比，LDL胆固醇、总胆固醇、甘油三酯和总胆固醇与高密度脂蛋白胆固醇比值从基线的下降幅度显著更大（所有P = 0.0001），高密度脂蛋白胆固醇从基线的升高幅度也显著更大（P = 0.001）。阿托伐他汀的总体不良事件情况与安慰剂观察到的相似。
在研究的大部分血脂异常的CAPD患者中，阿托伐他汀在达到目标LDL胆固醇水平方面有效，且剂量耐受性良好。
