Efficacy of Zofenopril Compared With Placebo and Other Angiotensin-converting Enzyme Inhibitors in Patients With Acute Myocardial Infarction and Previous Cardiovascular Risk Factors: A Pooled Individual Data Analysis of 4 Randomized, Double-blind, Controlled, Prospective Studies.
Efficacy of Zofenopril Compared With Placebo and Other Angiotensin-converting Enzyme Inhibitors in Patients With Acute Myocardial Infarction and Previous Cardiovascular Risk Factors: A Pooled Individual Data Analysis of 4 Randomized, Double-blind, Controlled, Prospective Studies.
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DOI：
10.1097/fjc.0000000000000440
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发表时间：
2017-01
影响因子：
3
通讯作者：
Ambrosioni E
中科院分区：
文献类型：
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作者：
Borghi C;Omboni S;Reggiardo G;Bacchelli S;Degli Esposti D;Ambrosioni E
在心肌梗死长期存活期评估(SMILE)1、3和4项研究中，与安慰剂或雷米普利相比，急性心肌梗死早期使用佐芬普利对预后有利。SMILE-2显示佐芬普利和赖诺普利都是安全的，在主要心血管(CV)并发症的发生率方面没有显著差异。在这项对SILE研究的个人数据的综合分析中，我们评估了佐芬普利在具有≥1CV风险因素(CV+，n=2962)的患者中是否也保持了与CV−(n=668)相比的优越疗效。主要研究终点设定为1年内因心血管疾病死亡或住院的综合事件。与安慰剂相比，在CV+(−37%；风险比：0.63；95%可信区间：0.51-0.78；P=0.0001)或在CV−组(−55%；风险比：0.45；0.26-0.78；P=0.004)中，佐非普利显著降低了心血管事件的风险。此外，其他血管紧张素转换酶抑制剂降低了主要心血管疾病结局的风险，尽管与安慰剂相比，这种降低在统计学上没有显著意义(CV+：0.78；0.58-1.05；P=0.107；CV−：0.71；0.36-1.41；P=0.334)。与其他血管紧张素转换酶抑制剂相比，佐芬普利治疗的患者获益更大，CV+(0.79；0.63-0.99；P=0.039)与CV−(0.62；0.37-1.06；P=0.081)的差异有统计学意义。综上所述，无论患者的心血管风险状况如何，急性心肌梗死后患者应用佐芬普利对预后有积极影响。
In the Survival of Myocardial Infarction Long-term Evaluation (SMILE) 1, 3, and 4 studies, early administration of zofenopril in acute myocardial infarction showed to be prognostically beneficial versus placebo or ramipril. The SMILE-2 showed that both zofenopril and lisinopril are safe and showed no significant differences in the incidence of major cardiovascular (CV) complications. In this pooled analysis of individual data of the SMILE studies, we evaluated whether the superior efficacy of zofenopril is maintained also in patients with ≥1 CV risk factor (CV+, n = 2962) as compared to CV− (n = 668). The primary study end point was set to 1-year combined occurrence of death or hospitalization for CV causes. The risk of CV events was significantly reduced with zofenopril versus placebo either in the CV+ (−37%; hazard ratio: 0.63; 95% confidence interval: 0.51–0.78; P = 0.0001) or in the CV− group (−55%; hazard ratio: 0.45; 0.26–0.78; P = 0.004). Also, the other angiotensin-converting enzyme inhibitors reduced the risk of major CV outcomes, though the reduction was not statistically significant versus placebo (CV+: 0.78; 0.58–1.05; P = 0.107; CV−: 0.71; 0.36–1.41; P = 0.334). The benefit was larger in patients treated with zofenopril than other angiotensin-converting enzyme inhibitors, with a statistically significant difference for CV+ (0.79; 0.63–0.99; P = 0.039) versus CV− (0.62; 0.37–1.06; P = 0.081). In conclusion, zofenopril administered to patients after acute myocardial infarction has a positive impact on prognosis, regardless of the patient's CV risk profile.
影响因子：
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作者：
Mitrovic PM;Stefanovic B;Vasiljevic Z;Radovanovic M;Radovanovic N;Krljanac G;Novakovic A;Ostojic M
通讯作者：
Ostojic M