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APPROACH研究:罗格列酮对有心血管病史的2型糖尿病患者动脉粥样硬化进展的干预研究
Assessment on Prevention of Progression by Rosiglitazone on Atherosclerosis in Type 2 Diabetes Patient with Cardiovascular History
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 关键字:APPROACH试验 罗格列酮 

试验设计:糖尿病患者被随机分成逐渐增加至每天8 mg的罗格列酮组(n=333)和逐渐增加至每天15 mg的格列吡嗪组(n=339)。在起始和18个月时行血管内超声检查。

结果
    ● 粥样斑块变化百分比:罗格列酮组-0.21%,格列吡嗪组0.43% (P=0.12)。
    ● 粥样斑块总体积变化:分别为-3.9  mm3和1.2  mm3(P=0.04)。
    ● 病死率:分别为2.4%和2.1%。
    ● 心肌梗死:分别为2.1%和1.8%。

结论
    ● 在2型糖尿病患者中,与应用格列吡嗪相比,罗格列酮没有减少粥样斑块变化的百分比。
    ● 应用罗格列酮后,粥样斑块总体积减少。
    ● 两组心血管事件结果相似(本研究样本量小,不足以显示预后终点差别,预后也不是本研究的主要终点)。
    ● 两组的心血管死亡率和心血管住院率(P=0.14),6分钟步行距离(P=0.26)相似,但运动训练组峰值氧耗量增加。
    ● 两组的严重不良反应相似。

结论 
    ● 优化治疗方案的基础上,给予收缩性慢性心力衰竭患者运动训练是安全和有效的。
    ● 更加支持目前指南关于慢性心力衰竭患者运动建议的证据。

APPROACH试验摘要(研究设计及患者基线特征):

BACKGROUND: Rosiglitazone, a thiazolidinedione, has effects on insulin sensitivity and cardiovascular risk factors that may favorably impact the progression of coronary atherosclerosis.

METHODS: APPROACH is a double-blind randomized clinical trial comparing the effects of the insulin sensitizer rosiglitazone with the insulin secretagogue glipizide on the progression of coronary atherosclerosis. Patients with type 2 diabetes and coronary artery disease undergoing clinically indicated coronary angiography or percutaneous coronary intervention are randomized to receive rosiglitazone or glipizide for 18 months using a titration algorithm designed to provide comparable glycemic control between treatment groups. The primary end point is change in percent atheroma volume from baseline to study completion in a nonintervened coronary artery, as measured by intravascular ultrasound. Cardiovascular events are adjudicated by an end point committee.

RESULTS: A total of 672 patients were randomized. The mean age was 61 years, hemoglobin A(1c) (HbA(1c)) 7.2%, body mass index 29.5 kg/m(2), and median duration of diabetes 4.8 years. At baseline, approximately half of the participants were receiving oral antidiabetic monotherapy (53.9%) with 27.5% receiving dual combination therapy and 17.9% treated with diet and exercise alone. Approximately two thirds of the participants (68%) had dyslipidemia, 79.9% hypertension, and 24% prior myocardial infarction.

CONCLUSIONS: APPROACH has fully enrolled a high-risk patient population and will compare the glucose-independent effects of rosiglitazone and glipizide on the progression of coronary atherosclerosis, as well as provide additional data on the cardiovascular safety of rosiglitazone in patients with type 2 diabetes and coronary artery disease.


 

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