Clinical Research Center for Rare Diseases Aldo & Cele Daccò, Mario Negri Institute for Pharmacological Research, Bergamo, Italy.
Diabetes Care. 2010 Sep;33(9):1954-6. doi: 10.2337/dc10-0320. Epub 2010 Jun 21.
To assess the effects of inhibited gastrointestinal cholesterol absorption in statin-treated dyslipidemic patients.
In a multicenter prospective randomized double-blind placebo-controlled trial, we primarily compared by ANCOVA the effect of 2-month ezetimibe (10 mg/day) or placebo therapy on LDL cholesterol serum levels in 108 type 2 diabetic patients with albuminuria <200 microg/min and total cholesterol concentrations >135 mg/dl despite simvastatin treatment (40 mg/day).
Unlike placebo, ezetimibe decreased LDL cholesterol from 99 +/- 31 to 66 +/- 22 mg/dl, total cholesterol from 162 +/- 36 to 124 +/- 30 mg/dl, and apolipoprotein B from 83 +/- 22 to 64 +/- 18 mg/dl (P < 0.0001 for all changes versus placebo). A total of 72 and 17% of patients on ezetimibe or placebo achieved LDL levels <70 mg/dl, respectively (P < 0.0001). Treatment was well tolerated.
Adding ezetimibe to simvastatin therapy helps to improve the pro-atherogenic lipoprotein profile in type 2 diabetic patients who fail to reach recommended lipid targets with statin therapy alone.
评估抑制胃肠道胆固醇吸收对他汀类药物治疗血脂异常患者的影响。
在一项多中心前瞻性随机双盲安慰剂对照试验中，我们主要通过 ANCOVA 比较了 108 例 2 型糖尿病合并白蛋白尿 <200μg/min 和总胆固醇浓度 >135mg/dl 的患者，在他汀类药物（辛伐他汀 40mg/天）治疗的基础上加用 2 个月的依折麦布（10mg/天）或安慰剂治疗对 LDL 胆固醇血清水平的影响。
与安慰剂相比，依折麦布使 LDL 胆固醇从 99±31 降至 66±22mg/dl，总胆固醇从 162±36 降至 124±30mg/dl，载脂蛋白 B 从 83±22 降至 64±18mg/dl（与安慰剂相比，所有变化均 P<0.0001）。分别有 72%和 17%的依折麦布和安慰剂组患者的 LDL 水平<70mg/dl（P<0.0001）。治疗耐受性良好。
在单独使用他汀类药物治疗未能达到推荐血脂目标的 2 型糖尿病患者中，加用依折麦布可改善致动脉粥样硬化脂蛋白谱。
