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【medical-news】ONTARGET研究:ARB是否与AECI 疗效相当

ONTARGET: Is an ARB as good as an ACE?
N Engl J Med 2008;358:1547–59.
To provide clinically relevant data, trials evaluating angiotensin II receptor blockers (ARBs) must include proven doses of ACE inhibitors either as a background treatment or as a comparator. The ONTARGET (Ongoing Telmisartan Alone and in Combination with Ramipril Global End-point Trial) evaluated whether the ARB telmisartan was non-inferior to the ACE inhibitor ramipril and whether using the two drugs in combination was better than ramipril alone as a treatment to prevent vascular events in high-risk patients who had cardiovascular disease or diabetes mellitus but did not have heart failure.

A total of 29 019 patients entered a single blind run in period of 3 weeks; during this period, drug doses were uptitrated. Of these patients 3399 (11.7%) were excluded from the study. After this run-in period 25 620 patients underwent double-blind randomisation: 8576 were assigned to receive 10 mg of ramipril daily, 8542 assigned to receive 80 mg telmisartan daily and 8502 patients assigned to receive both drugs (combination therapy). The primary composite end point was death from cardiovascular causes, myocardial infarction, stroke or hospitalisation for heart failure.

Mean blood pressure was lower in both the telmisartan group (0.9/0.6 mm Hg greater reduction) and in the combination therapy group (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 (16.5%) in the ramipril group compared with 1423 patients in the telmisartan group (16.7%, relative risk 1.01, 95% 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 both groups (0.2%). In the combination therapy group the primary outcome occurred in 1386 patients (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).

This study demonstrates that telmisartan at a dose of 80 mg daily preserved 94% of the benefit of ramipril 10 mg daily as reported in the Heart Outcomes Prevention Evaluation (HOPE) trial. Therefore in the patient population studied, doctors can now choose between either an ACE inhibitor or an ARB as first-line treatment. However, what is also clear is that the use of combination therapy was of no clinical benefit—despite the additional effect on blood pressure lowering—and indeed there was a strong trend towards dialysis in the combination group. 本人已认领该文编译,48小时后若未提交译文,请其他战友自由认领。 ONTARGET: Is an ARB as good as an ACE?
ONTARGET:ARB与ACEI一样有效吗?

N Engl J Med 2008;358:1547–59.
N Engl J Med 2008;358:1547–59.

To provide clinically relevant data, trials evaluating angiotensin II receptor blockers (ARBs) must include proven doses of ACE inhibitors either as a background treatment or as a comparator. The ONTARGET (Ongoing Telmisartan Alone and in Combination with Ramipril Global End-point Trial) evaluated whether the ARB telmisartan was non-inferior to the ACE inhibitor ramipril and whether using the two drugs in combination was better than ramipril alone as a treatment to prevent vascular events in high-risk patients who had cardiovascular disease or diabetes mellitus but did not have heart failure.
为了提供临床的相关数据,评估血管紧张素II受体拮抗剂(ARBs)的试验必须包括ACEI用量作为背景组或对照组。ONTARGET(正在进行的单用替米沙坦和合用雷米普利全球终点试验)评价在预防高危患者发生心血管事件,高危患者是指有心血管疾病或糖尿病但是无心衰ARB替米沙坦是否不劣于ACEI雷米普利,是否两药合用优于单用雷米普利。

A total of 29 019 patients entered a single blind run in period of 3 weeks; during this period, drug doses were uptitrated. ONTARGET:ARB与ACEI一样有效吗?

N Engl J Med 2008;358:1547–59.
为了提供临床的相关数据,评估血管紧张素II受体拮抗剂(ARBs)的试验必须包括ACEI用量作为背景组或对照组。ONTARGET(正在进行的单用替米沙坦和合用雷米普利全球终点试验)评价在预防高危患者发生心血管事件,高危患者是指有心血管疾病或糖尿病但是无心衰ARB替米沙坦是否不劣于ACEI雷米普利,是否两药合用优于单用雷米普利。

29019例患者进入3周的单盲期,在此期间,药物剂量uptitrated.其中3399 (11.7%)从研究中排除。此期后,25620例患者经历随机双肓试验:8576例患者每天服用10mg雷米普利,8542例患者每天服用80mg替米沙坦,8502例患者两种药物均服用(联合治疗)。主要复合终点是心血管原因而死亡,心肌梗死,中风或因心衰入院。

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作者:admin@医学,生命科学    2011-04-20 05:14
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