Borghi Claudio, Omboni Stefano, Reggiardo Giorgio, Bacchelli Stefano, Degli Esposti Daniela, Ambrosioni Ettore
a Unit of Internal Medicine, Policlinico S. Orsola , University of Bologna , Bologna , Italy.
b Clinical Research Unit , Italian Institute of Telemedicine , Varese , Italy.
Blood Press. 2017 Aug;26(4):211-219. doi: 10.1080/08037051.2017.1281712. Epub 2017 Feb 3.
The four SMILE studies demonstrated that early administration of zofenopril following acute myocardial infarction is prognostically beneficial compared to placebo or other angiotensin-converting enzyme (ACE) inhibitors. In the present retrospective pooled analysis of individual SMILE studies, we evaluated the efficacy of zofenopril on cardiovascular (CV) outcomes in 1880 hypertensive and 1662 normotensive patients.
Four hundred and forty-nine hypertensives and 486 normotensives were treated with placebo, 980 and 786 with zofenopril 30-60 mg daily, 252 and 259 with lisinopril 5-10 mg daily, 199 and 131 with ramipril 10 mg daily, for 6 to 48 weeks.
The 1-year risk of death or hospitalization for CV causes was significantly reduced with zofenopril and lisinopril vs. placebo in both hypertensive (HR: 0.65; 95%CI: 0.48-0.86; p = .003 and .60, .36-.99; p = .049, respectively) and normotensive patients (0.56, 0.42-0.75; p = .0001 and .51, .28-.90; p = .020), whereas this was not the case for ramipril (hypertensives: 1.02, 0.69-1.52; p = .918; normotensives: 0.91, 0.59-1.41; p = .670). Zofenopril significantly reduced the risk of CV outcomes vs. the other two ACE-inhibitors pooled together in hypertensive (0.76; 0.58-0.99; p = .045), but not in normotensive patients (0.77; 0.55-1.10; p = .150).
In cardiac patients of the SMILE studies with arterial hypertension treatment with the ACE-inhibitor zofenopril was beneficial in reducing the 1-year risk of CV events as compared to placebo and ramipril. An efficacy similar to that of zofenopril was observed with lisinopril.
四项SMILE研究表明，急性心肌梗死后早期服用佐芬普利与安慰剂或其他血管紧张素转换酶（ACE）抑制剂相比，在预后方面具有益处。在本次对SMILE研究个体进行的回顾性汇总分析中，我们评估了佐芬普利对1880例高血压患者和1662例血压正常患者心血管（CV）结局的疗效。
449例高血压患者和486例血压正常患者接受安慰剂治疗，980例和786例患者每日服用30 - 60毫克佐芬普利，252例和259例患者每日服用5 - 10毫克赖诺普利，199例和131例患者每日服用10毫克雷米普利，治疗6至48周。
在高血压患者（HR：0.65；95%CI：0.48 - 0.86；p = 0.003和0.60，0.36 - 0.99；p = 0.049）和血压正常患者（0.56，0.42 - 0.75；p = 0.0001和0.51，0.28 - 0.90；p = 0.020）中，与安慰剂相比，佐芬普利和赖诺普利显著降低了心血管病因导致的死亡或住院1年风险，而雷米普利则不然（高血压患者：1.02，0.69 - 1.52；p = 0.918；血压正常患者：0.91，0.59 - 1.41；p = 0.670）。与其他两种ACE抑制剂联合使用相比，佐芬普利在高血压患者中显著降低了心血管结局风险（0.76；0.58 - 0.99；p = 0.045），但在血压正常患者中未降低（0.77；0.55 - 1.10；p = 0.150）。
在SMILE研究中的心脏病合并动脉高血压患者中，与安慰剂和雷米普利相比，使用ACE抑制剂佐芬普利有利于降低心血管事件的1年风险。观察到赖诺普利与佐芬普利疗效相似。
