Borghi Claudio, Ambrosioni Ettore, Omboni Stefano, Cicero Arrigo Fg, Bacchelli Stefano, Esposti Daniela Degli, Novo Salvatore, Vinereanu Dragos, Ambrosio Giuseppe, Reggiardo Giorgio, Zava Dario
Unit of Internal Medicine, Policlinico S Orsola, University of Bologna, Bologna, Italy.
Clinicoecon Outcomes Res. 2013 Jul 8;5:317-25. doi: 10.2147/CEOR.S43138. Print 2013.
In SMILE-4 (the Survival of Myocardial Infarction Long-term Evaluation 4 study), zofenopril + acetylsalicylic acid (ASA) was superior to ramipril + ASA in reducing the occurrence of major cardiovascular events in patients with left ventricular dysfunction following acute myocardial infarction. The present post hoc analysis was performed to compare the cost-effectiveness of zofenopril and ramipril.
In total, 771 patients with left ventricular dysfunction and acute myocardial infarction were randomized in a double-blind manner to receive zofenopril 60 mg/day (n = 389) or ramipril 10 mg/day (n = 382) + ASA 100 mg/day and were followed up for one year. The primary study endpoint was the one-year combined occurrence of death or hospitalization for cardiovascular causes. The economic analysis was based on evaluation of cost of medications and hospitalizations and was applied to the intention-to-treat population (n = 716). Cost data were drawn from the National Health Service databases of the European countries participating in the study. The incremental cost-effectiveness ratio was used to quantify the cost per event prevented with zofenopril versus ramipril.
Zofenopril significantly (P = 0.028) reduced the risk of the primary study endpoint by 30% as compared with ramipril (95% confidence interval, 4%-49%). The number needed to treat to prevent a major cardiovascular event with zofenopril was 13 less than with ramipril. The cost of drug therapies was higher with zofenopril (328.78 Euros per patient per year, n = 365) than with ramipril (165.12 Euros per patient per year, n = 351). The cost related to the occurrence of major cardiovascular events requiring hospitalization averaged 4983.64 Euros for zofenopril and 4850.01 Euros for ramipril. The incremental cost-effectiveness ratio for zofenopril versus ramipril was 2125.45 Euros per event prevented (worst and best case scenario in the sensitivity analysis was 3590.09 and 3243.96 Euros, respectively).
Zofenopril is a viable and cost-effective treatment for managing patients with left ventricular dysfunction after acute myocardial infarction.
在SMILE-4（心肌梗死长期评估4研究）中，对于急性心肌梗死后左心室功能不全的患者，佐芬普利+乙酰水杨酸（ASA）在降低主要心血管事件发生率方面优于雷米普利+ASA。进行本次事后分析以比较佐芬普利和雷米普利的成本效益。
总共771例左心室功能不全和急性心肌梗死患者以双盲方式随机分组，接受60毫克/天的佐芬普利（n = 389）或10毫克/天的雷米普利（n = 382）+100毫克/天的ASA，并随访一年。主要研究终点是心血管原因导致的死亡或住院的一年综合发生率。经济分析基于对药物和住院费用的评估，并应用于意向性治疗人群（n = 716）。成本数据来自参与研究的欧洲国家的国民健康服务数据库。增量成本效益比用于量化佐芬普利与雷米普利预防每个事件的成本。
与雷米普利相比，佐芬普利显著（P = 0.028）降低了30%的主要研究终点风险（95%置信区间，4%-49%）。使用佐芬普利预防主要心血管事件所需的治疗人数比雷米普利少13人。佐芬普利的药物治疗成本（每年每位患者328.78欧元，n = 365）高于雷米普利（每年每位患者165.12欧元，n = 351）。因需要住院的主要心血管事件发生而产生的成本，佐芬普利平均为4983.64欧元，雷米普利平均为4850.01欧元。佐芬普利与雷米普利相比的增量成本效益比为预防每个事件2125.45欧元（敏感性分析中的最差和最佳情况分别为3590.09和3243.96欧元）。
佐芬普利是治疗急性心肌梗死后左心室功能不全患者的一种可行且具有成本效益的治疗方法。
