TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
J Am Coll Cardiol. 2009 Dec 15;54(25):2358-62. doi: 10.1016/j.jacc.2009.10.005.
In addition to reducing first events in patients after an acute coronary syndrome (ACS), we hypothesized that high-dose atorvastatin 80 mg would also reduce recurrent cardiovascular events, and therefore total events, compared with pravastatin 40 mg during the 2-year follow-up.
In the PROVE IT-TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis In Myocardial Infarction 22) trial, more intensive lipid lowering with high-dose atorvastatin reduced the first occurrence of the primary end point (death, myocardial infarction, unstable angina requiring rehospitalization, stroke, or revascularization > or = 30 days) compared with moderate lipid lowering with pravastatin.
Poisson regression analysis was performed to compare the number of occurrences of the primary end point between high-dose atorvastatin and pravastatin in the PROVE IT-TIMI 22 trial.
As previously reported, first primary end point events were reduced by 16% with atorvastatin 80 mg versus pravastatin 40 mg (n = 464 vs. n = 537, respectively; p = 0.005). Additional events were also reduced by 19% with atorvastatin 80 mg (n = 275 vs. n = 340, respectively; p = 0.009). Overall, there were 138 fewer primary efficacy events with atorvastatin 80 mg versus pravastatin 40 mg (n = 739 vs. n = 877, respectively; rate ratio: 0.85, 95% confidence interval: 0.77 to 0.94, p = 0.001).
Although analytic techniques commonly used in clinical outcomes trials censor patients who experience a component of the primary composite end point, total cardiovascular events are important to patients, clinicians, and health care payers. Maintaining low levels of low-density lipoprotein cholesterol is central to preventing additional atherosclerotic development and subsequent cardiovascular events. Atorvastatin 80 mg, a more intensive low-density lipoprotein cholesterol lowering agent, reduced both first and subsequent primary end point events compared with pravastatin 40 mg after ACS.
除了降低急性冠脉综合征（ACS）后患者的首发事件外，我们假设高剂量阿托伐他汀 80mg 与普伐他汀 40mg 相比，在 2 年随访期间还可减少复发性心血管事件，从而减少总事件。
在 PROVE IT-TIMI 22（普伐他汀或阿托伐他汀评价及感染治疗-心肌梗死 22 试验）试验中，与中等强度降脂的普伐他汀相比，高强度阿托伐他汀降低了首发终点（死亡、心肌梗死、需要再住院的不稳定型心绞痛、卒中和血管重建术>或=30 天）的首次发生。
采用泊松回归分析比较 PROVE IT-TIMI 22 试验中高剂量阿托伐他汀和普伐他汀的首发终点事件数量。
如前所述，阿托伐他汀 80mg 组与普伐他汀 40mg 组的首发主要终点事件减少 16%（分别为 464 例和 537 例；p=0.005）。阿托伐他汀 80mg 组还额外减少了 19%的事件（分别为 275 例和 340 例；p=0.009）。总体而言，阿托伐他汀 80mg 组比普伐他汀 40mg 组有 138 例首发疗效事件减少（分别为 739 例和 877 例；发生率比：0.85，95%置信区间：0.77 至 0.94，p=0.001）。
尽管临床结局试验中常用的分析技术对经历主要复合终点部分的患者进行了删失，但总心血管事件对患者、临床医生和医疗保健支付者都很重要。维持低水平的低密度脂蛋白胆固醇是预防动脉粥样硬化进一步发展和随后发生心血管事件的关键。阿托伐他汀 80mg 是一种更强效的降低低密度脂蛋白胆固醇的药物，与普伐他汀 40mg 相比，可降低 ACS 后的首发和随后的首发终点事件。
