Telmisartan, ramipril, or both in patients at high risk for vascular events
Telmisartan, ramipril, or both in patients at high risk for vascular events
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DOI：
10.1016/j.jvs.2008.06.009
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发表时间：
2008
期刊：
影响因子：
--
通讯作者：
J. Marin-Neto
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文献类型：
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作者：
J. Marin-Neto
血管紧张素转换酶（ACE）抑制剂可降低心血管疾病或高危糖尿病患者的死亡率和发病率，但血管紧张素受体阻滞剂（ARB）在这类患者中的作用尚不清楚。我们比较了血管紧张素转换酶抑制剂雷米普利，血管紧张素受体拮抗剂替米沙坦，以及两种药物的组合在血管疾病或高危糖尿病患者中的作用。MethodsAfter a 3-week，single blind run-in period，patients experienced double blind randomization，8576分配接受10 mg雷米普利每天，8542分配接受80 mg替米沙坦每天，8502被分配接受两种药物（联合治疗）。主要的复合终点是心血管原因，心肌梗死，中风，或住院治疗heartfailure.ResultsMean血压较低的替米沙坦组（0.9/0.6毫米汞柱更大的减少）和联合治疗组（2.4/1.4毫米汞柱更大的减少）比在雷米普利组。在中位随访56个月时，雷米普利组有1412例患者（16.5%）发生主要结局，而替米沙坦组有1423例患者（16.7%;相对风险，1.01; 95%置信区间[CI]，0.94 - 1.09）。与雷米普利组相比，替米沙坦组咳嗽（1.1% vs. 4.2%，P<0.001）和血管性水肿（0.1% vs. 0.3%，P=0.01）的发生率较低，水肿症状的发生率较高（2.6% vs. 1.7%，P<0.001）;两组晕厥的发生率相同（0.2%）。在联合治疗组中，1386名患者发生了主要结局（16.3%;相对危险度0.99; 95%CI 0.92 ~ 1.07）;与雷米普利组相比，（4.8%vs.1.7%，P<0.001）、晕厥（0.3%vs.0.2%，P=0.03）和肾功能不全（13.5%vs.10.2%，P<0.001）。两种药物的联合使用与更多的不良事件相关，而没有增加获益。（ClinicalTrials.gov编号，NCT 00153101。）
BackgroundIn patients who have vascular disease or high-risk diabetes without heart failure, angiotensin-converting–enzyme (ACE) inhibitors reduce mortality and morbidity from cardiovascular causes, but the role of angiotensin-receptor blockers (ARBs) in such patients is unknown. We compared the ACE inhibitor ramipril, the ARB telmisartan, and the combination of the two drugs in patients with vascular disease or high-risk diabetes.MethodsAfter a 3-week, single-blind run-in period, patients underwent double-blind randomization, with 8576 assigned to receive 10 mg of ramipril per day, 8542 assigned to receive 80 mg of telmisartan per day, and 8502 assigned to receive both drugs (combination therapy). The primary composite outcome was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure.ResultsMean blood pressure was lower in both the telmisartan group (a 0.9/0.6 mm Hg greater reduction) and the combination-therapy group (a 2.4/1.4 mm Hg greater reduction) than in the ramipril group. At a median follow-up of 56 months, the primary outcome had occurred in 1412 patients in the ramipril group (16.5%), as compared with 1423 patients in the telmisartan group (16.7%; relative risk, 1.01; 95% confidence interval [CI], 0.94 to 1.09). As compared with the ramipril group, the telmisartan group had lower rates of cough (1.1% vs. 4.2%, P<0.001) and angioedema (0.1% vs. 0.3%, P=0.01) and a higher rate of hypotensive symptoms (2.6% vs. 1.7%, P<0.001); the rate of syncope was the same in the two groups (0.2%). In the combination-therapy group, the primary outcome occurred in 1386 patients (16.3%; relative risk, 0.99; 95% CI, 0.92 to 1.07); as compared with the ramipril group, there was an increased risk of hypotensive symptoms (4.8% vs. 1.7%, P<0.001), syncope (0.3% vs. 0.2%, P=0.03), and renal dysfunction (13.5% vs. 10.2%, P<0.001).ConclusionsTelmisartan was equivalent to ramipril in patients with vascular disease or high-risk diabetes and was associated with less angioedema. The combination of the two drugs was associated with more adverse events without an increase in benefit. (ClinicalTrials.gov number, NCT00153101.)