Pedersen Terje R, Cater Nilo B, Faergeman Ole, Kastelein John J P, Olsson Anders G, Tikkanen Matti J, Holme Ingar, Larsen Mogens Lytken, Lindahl Christina, Szarek Michael
Center for Preventive Medicine, Oslo University Hospital, and University of Oslo, Norway.
Am J Cardiol. 2010 Aug 1;106(3):354-9. doi: 10.1016/j.amjcard.2010.03.033.
Previous studies have demonstrated that benefits of intensive statin therapy compared to standard statin therapy begin shortly after an acute event and are continued up to 2 years of follow-up. However, whether efficacy and safety of intensive statin therapy in patients with a recent cardiac event are maintained in longer-term follow-up has not been evaluated. We conducted a post hoc analysis of a subgroup of 999 patients who had a first acute myocardial infarction (MI) <2 months before randomization in a prospective, open-label, blinded end-point evaluation trial of 8,888 patients with a history of MI that compared intensive statin therapy (atorvastatin 80 mg) to standard statin therapy (simvastatin 20 to 40 mg) over approximately 5 years of follow-up. We analyzed the same composite end point used in the Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE IT) trial (death, MI, hospitalization for unstable angina, revascularization, and stroke). Rates of the composite end point were 44.7% (n = 226) in the simvastatin group and 37.9% (n = 187) in the atorvastatin group (hazard ratio 0.82, 95% confidence interval 0.67 to 0.99, p = 0.04). Although statistical power was smaller than that of the PROVE IT trial, the relative risk decrease observed at 5 years is consistent with that in the 2-year follow-up in PROVE IT. The 2 treatment regimens were well tolerated. In conclusion, our analysis provides support for the strategy of placing patients with recent MI on intensive statin therapy and maintaining the high dose over the long term, beyond 2 years.
既往研究表明,与标准他汀类药物治疗相比,强化他汀类药物治疗的益处于急性事件后不久即开始显现,并持续至2年的随访期。然而,近期发生心脏事件的患者接受强化他汀类药物治疗的疗效和安全性在长期随访中是否得以维持,尚未得到评估。我们对999例患者的亚组进行了事后分析,这些患者在一项纳入8888例有心肌梗死病史患者的前瞻性、开放标签、盲终点评估试验中,于随机分组前不到2个月发生了首次急性心肌梗死(MI)。该试验比较了强化他汀类药物治疗(阿托伐他汀80mg)与标准他汀类药物治疗(辛伐他汀20至40mg),随访期约5年。我们分析了普伐他汀或阿托伐他汀评价与感染治疗(PROVE IT)试验中使用的相同复合终点(死亡、心肌梗死、因不稳定型心绞痛住院、血运重建和卒中)。辛伐他汀组复合终点发生率为44.7%(n = 226),阿托伐他汀组为37.9%(n = 187)(风险比0.82,95%置信区间0.67至0.99,p = 0.04)。尽管统计效能低于PROVE IT试验,但5年时观察到的相对风险降低与PROVE IT试验2年随访时一致。两种治疗方案耐受性良好。总之,我们的分析支持对近期发生心肌梗死的患者采用强化他汀类药物治疗策略,并长期维持高剂量治疗,时间超过2年。