Van Mieghem W, Billiouw J M, Brohet C, Dupont A G, Gazagnes M D, Heller F, Krzesinski J M, Missault L, Persu A, Piérard L, Rottiers R, Vanhooren G, Vervaet P, Herman A G
Ziekenhuis Oost-Limburg, Genk Department of Cardiology Oude Postbaan, 60 B-3600 Genk.
Acta Clin Belg. 2010 Mar-Apr;65(2):107-14. doi: 10.1179/acb.2010.022.
The HOPE and EUROPA clinical studies have shown that treatment with the angiotensin-converting enzyme (ACE) inhibitors, ramipril and perindopril, may reduce the occurrence of major cardiovascular events in patients with proven atherosclerotic disease. The recently published results of the PRoFESS and TRANSCEND trials completed the much needed information concerning the use of an angiotensin receptor blocker for patients at high risk of cardiovascular events. PROFESS compared a therapy of telmisartan 80 mg daily with placebo in patients with a recent ischemic stroke. The difference in the primary outcome of first recurrent stroke was not statistically significant between telmisartan and placebo. The secondary outcome of major cardiovascular events showed a relative risk reduction (RRR) of 7% in favour of telmisartan. This tended to be significant (p = 0.06) despite a rather short follow-up period of only 28 months. In TRANSCEND 5926 patients at high risk for cardiovascular events were randomized to a treatment with telmisartan 80 mg daily or placebo for a mean duration of follow-up of 56 months. The primary composite outcome of cardiovascular death, myocardial infarction, stroke or hospitalization for heart failure showed a non-significant 8% RRR in favour of the telmisartan treated patients. The main secondary outcome of cardiovascular death and myocardial infarction or stroke as used in the HOPE trial showed a non-significant RRR of 13% in favour of telmisartan treated patients (p = 0.068 adjusted for multiplicity of comparisons). In comparing the Kaplan-Meier curves for the endpoint of major cardiovascular events used in HOPE, EUROPA, TRANSCEND and PRoFESS, the trends are similar. Results of most of the recently published trials have been neutral.This could partly be explained by major improvements in the optimal background therapy of the patients included. Nevertheless, the results of PRoFESS and TRANSCEND do not contradict the results from previous studies with theACE inhibitors ramipril and perindopril and the ARB telmisartan.
HOPE和EUROPA临床研究表明,使用血管紧张素转换酶(ACE)抑制剂雷米普利和培哚普利治疗,可能会降低已确诊动脉粥样硬化疾病患者发生重大心血管事件的几率。PRoFESS和TRANSCEND试验最近公布的结果完善了关于血管紧张素受体阻滞剂用于心血管事件高危患者的急需信息。PRoFESS在近期发生缺血性卒中的患者中,将每日80毫克替米沙坦治疗与安慰剂进行了比较。替米沙坦组和安慰剂组首次复发性卒中的主要结局差异无统计学意义。重大心血管事件的次要结局显示,替米沙坦组相对风险降低(RRR)7%。尽管随访期仅28个月,时间较短,但这一结果有趋于显著的倾向(p = 0.06)。在TRANSCEND试验中,5926例心血管事件高危患者被随机分配接受每日80毫克替米沙坦治疗或安慰剂治疗,平均随访期为56个月。心血管死亡、心肌梗死、卒中或因心力衰竭住院的主要复合结局显示,替米沙坦治疗组相对风险降低8%,但差异无统计学意义。HOPE试验中使用的心血管死亡和心肌梗死或卒中的主要次要结局显示,替米沙坦治疗组相对风险降低13%,差异无统计学意义(经多重比较校正后p = 0.068)。比较HOPE、EUROPA、TRANSCEND和PRoFESS中重大心血管事件终点的Kaplan-Meier曲线,趋势相似。最近公布的大多数试验结果均为中性。这部分可以通过纳入患者的最佳背景治疗有了重大改善来解释。然而,PRoFESS和TRANSCEND的结果与先前使用ACE抑制剂雷米普利和培哚普利以及ARB替米沙坦的研究结果并不矛盾。