Teo Koon, Yusuf Salim, Sleight Peter, Anderson Craig, Mookadam Farouk, Ramos Barbara, Hilbrich Lutz, Pogue Janice, Schumacher Helmut
McMaster University Medical Centre, 1200 Main Street West, Hamilton, Ontario, Canada L8N 3Z5.
Am Heart J. 2004 Jul;148(1):52-61. doi: 10.1016/j.ahj.2004.03.020.
Angiotensin-converting enzyme (ACE) inhibitors reduce mortality, myocardial infarction, stroke, heart failure, need for revascularization, nephropathy, and diabetes and its complications. Although angiotensin-II receptor blockers (ARBs) have been less extensively evaluated, theoretically they may have "protective" effects similar to those of ACE inhibitors, but with better tolerability. Currently, there is uncertainty about the role of ARBs when used alone or in combination with an ACE inhibitor in high-risk populations with controlled hypertension.
Primary objectives of the ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET) are to determine if the combination of the ARB telmisartan and the ACE inhibitor ramipril is more effective than ramipril alone, and if telmisartan is at least as effective as ramipril. The Telmisartan Randomized AssessmeNt Study in aCE iNtolerant subjects with cardiovascular Disease (TRANSCEND) will determine if telmisartan is superior to placebo in patients who are intolerant of ACE inhibitors. The primary outcome for both trials is the composite of cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure.
High-risk patients with coronary, peripheral, or cerebrovascular disease or diabetes with end-organ damage are being recruited and followed for 3.5 to 5.5 years in 2 parallel, randomized, double-blind clinical trials.
Recruitment from 730 centers in 40 countries for ONTARGET (n = 25,620) was completed in July 2003. For TRANSCEND, 5776 patients (out of a projected total of 6000) have been recruited (by May 10, 2004). Baseline patient characteristics are comparable to the Heart Outcomes Prevention Evaluation (HOPE) trial, the basis of the design of the current study, confirming that patients are at high-risk.
血管紧张素转换酶（ACE）抑制剂可降低死亡率、心肌梗死、中风、心力衰竭、血管再通需求、肾病以及糖尿病及其并发症的发生风险。尽管血管紧张素II受体拮抗剂（ARB）的评估不如ACE抑制剂广泛，但理论上它们可能具有与ACE抑制剂相似的“保护”作用，且耐受性更好。目前，对于ARB单独使用或与ACE抑制剂联合用于高血压已得到控制的高危人群时的作用尚不确定。
正在进行的替米沙坦单药及与雷米普利联合应用的全球终点试验（ONTARGET）的主要目的是确定ARB替米沙坦与ACE抑制剂雷米普利联合使用是否比单独使用雷米普利更有效，以及替米沙坦是否至少与雷米普利一样有效。替米沙坦在不能耐受ACE抑制剂的心血管疾病患者中的随机评估研究（TRANSCEND）将确定替米沙坦在不能耐受ACE抑制剂的患者中是否优于安慰剂。两项试验的主要结局均为心血管死亡、心肌梗死、中风或因心力衰竭住院的复合终点。
在两项平行、随机、双盲临床试验中，招募患有冠状动脉、外周或脑血管疾病或伴有靶器官损害的糖尿病的高危患者，并对其进行3.5至5.5年的随访。
ONTARGET研究（n = 25,620）于2003年7月完成了来自40个国家730个中心的招募工作。对于TRANSCEND研究，截至2004年5月10日，已招募5776例患者（计划共招募6000例）。患者的基线特征与本研究设计所依据的心脏结局预防评估（HOPE）试验相当，证实患者处于高危状态。
