In a subgroup of high-risk Asians, telmisartan was non-inferior to ramipril and better tolerated in the prevention of cardiovascular events.
In a subgroup of high-risk Asians, telmisartan was non-inferior to ramipril and better tolerated in the prevention of cardiovascular events.
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DOI：
10.1371/journal.pone.0013694
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发表时间：
2010-12-21
期刊：
影响因子：
3.7
通讯作者：
Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial Investigators
中科院分区：
文献类型：
--
作者：
Dans AL;Teo K;Gao P;Chen JH;Jae-Hyung K;Yusoff K;Chaithiraphan S;Zhu J;Lisheng L;Yusuf S;Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial Investigators
最近发表的ONTARGET研究（正在进行的替米沙坦单药治疗和与雷米普利联合治疗全球终点试验）的结果显示，在减少心血管事件方面，替米沙坦（80 mg/天）不劣于雷米普利（10 mg/天）。亚洲的临床医生怀疑患者对这些剂量的耐受性。因此，我们分析了本研究和一项平行研究TRANSCEND（在患有心血管疾病的ACE不耐受受试者中进行的替米沙坦随机评估研究）的数据。我们的目的是比较亚洲人和非亚洲人在以下方面的差异：1）替米沙坦与雷米普利在减少心血管事件方面的有效性; 2）达到替米沙坦、雷米普利或安慰剂全剂量的比例; 3）总体停药和因不良反应停药的比例。 ONTARGET研究将25，620例有心血管事件风险的患者随机分配至雷米普利、替米沙坦或其组合。主要复合终点为心血管疾病导致的死亡、急性MI、卒中和充血性心力衰竭导致的住院治疗。TRANSCEND将5926例有ACE抑制剂不耐受史的高危患者随机分配至替米沙坦组或安慰剂组。主要结局相同。在该子研究中，我们比较了亚洲人和非亚洲人对替米沙坦（在两项研究中给予）和雷米普利（在ONTARGET中给予）的耐受性。1)在降低亚洲人的主要终点方面，替米沙坦非劣效于雷米普利（RR = 0. 92; 95% CI：0. 74，1. 13）; 2）更多亚洲人达到任一药物的全剂量; 3）更少退出（总体）;和4）更少因不良反应退出。 此外，替米沙坦的耐受性优于雷米普利。这一优势在亚洲人中更为明显。虽然亚洲人的BMI比非亚洲人低，但亚洲人对这两种药物的耐受性更好。监管机构要求按种族报告安全性和有效性数据，但很少有人遵守这一要求。这项研究表明，种族亚组的安全性数据可以帮助评估结果对特定人群的适用性。ClinicalTrials.gov NCT00153101
Results of the recently published ONTARGET study (The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) showed that telmisartan (80 mg/day) was non-inferior to ramipril (10 mg/day) in reducing cardiovascular events. Clinicians in Asia doubt tolerability of these doses for their patients. We therefore analyzed data from this study and a parallel study TRANSCEND (Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease). Our objectives were to compare Asians and non-Asians with respect to the following: 1) Effectiveness of telmisartan vs. ramipril in reducing cardiovascular events; 2) Proportions who reached the full dose of telmisartan, ramipril or placebo; and 3) Proportions of overall discontinuations, and discontinuations due to adverse effects. The ONTARGET study randomized 25,620 patients at risk of cardiovascular events to ramipril, telmisartan, or their combination. The primary composite endpoint was death caused by cardiovascular disease, acute MI, stroke, and hospitalization because of congestive heart failure. TRANSCEND randomized 5926 high-risk patients with a history of intolerance to ACE-inhibitors to telmisartan or placebo. The primary outcome was the same. In this substudy, we compared Asians and non-Asians as to how well they tolerated telmisartan (given in both studies) and ramipril (given in ONTARGET). 1) Telmisartan was non-inferior to ramipril in lowering the primary endpoint among Asians (RR = 0.92; 95% CI: 0.74, 1.13); 2) more Asians achieved the full dose of either drug; 3) less withdrew (overall); and 4) less withdrew for adverse effects. Furthermore, telmisartan was better tolerated than ramipril. This advantage was greater among Asians. Although Asians had lower BMI than non-Asians, Asians tolerated both drugs better. Regulatory agencies require reporting of safety and effectiveness data by ethnicity, but few comply with this requirement. This study shows that safety data in ethnic subgroups can help assess applicability of results to specific populations. ClinicalTrials.gov NCT00153101
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DOI：
10.1056/nejmoa0804593
发表时间：
2008-09-18
期刊：
The New England journal of medicine
影响因子：
--
作者：
Yusuf S;Diener HC;Sacco RL;Cotton D;Ounpuu S;Lawton WA;Palesch Y;Martin RH;Albers GW;Bath P;Bornstein N;Chan BP;Chen ST;Cunha L;Dahlöf B;De Keyser J;Donnan GA;Estol C;Gorelick P;Gu V;Hermansson K;Hilbrich L;Kaste M;Lu C;Machnig T;Pais P;Roberts R;Skvortsova V;Teal P;Toni D;VanderMaelen C;Voigt T;Weber M;Yoon BW;PRoFESS Study Group
通讯作者：
PRoFESS Study Group
影响因子：
158.5
作者：
Yusuf, Salim;Teo, Koon K.;Anderson, Craig
通讯作者：
Anderson, Craig
影响因子：
19.6
作者：
So, WY;Ma, RCW;Chan, JCN
通讯作者：
Chan, JCN
影响因子：
120.7
作者：
Dans, AL;Dans, LF;Guyatt, GH
通讯作者：
Guyatt, GH
影响因子：
7.2
作者：
Corbie-Smith, G;St George, DMM;Ransohoff, DF
通讯作者：
Ransohoff, DF