A calcium antagonist vs a non-calcium antagonist hypertension treatment strategy for patients with coronary artery disease - The International Verapamil-Trandolapril Study (INVEST): A randomized controlled trial
A calcium antagonist vs a non-calcium antagonist hypertension treatment strategy for patients with coronary artery disease - The International Verapamil-Trandolapril Study (INVEST): A randomized controlled trial
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DOI：
10.1001/jama.290.21.2805
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发表时间：
2003-12-03
影响因子：
120.7
通讯作者：
Parmley, WW
中科院分区：
文献类型：
--
作者：
Pepine, CJ;Handberg, EM;Parmley, WW
尽管有证据表明抗高血压药物治疗高血压患者有效，但抗高血压药物治疗冠状动脉疾病（CAD）的安全性和有效性仅从大型试验的亚组分析中得以识别。目的比较钙拮抗剂（CAS）和非钙拮抗剂（NCAS）治疗高血压合并冠心病患者的死亡率和发病率。设计、环境和参与者：1997年9月至2003年2月，在14个国家的862个地点进行了一项随机、开放标签、盲法终点研究，研究对象为22576名年龄在50岁及以上的高血压冠心病患者。干预措施患者被随机分配到CAS（维拉帕米缓释）或NCAS（阿替洛尔）。策略，指定剂量和额外的药物方案。根据高血压预防、检测、评估和治疗联合国家委员会（JNC VI）第六次报告的指南，给予Trandolapril和/或氢氯噻嗪以达到血压目标：小于140毫米汞柱（收缩压）和小于90毫米汞柱（舒张压）；如果存在糖尿病或肾功能损害，则小于130毫米汞柱（收缩压）和小于85毫米汞柱（舒张压）。曲多普利也被推荐用于心力衰竭、糖尿病或肾功能损害的患者。主要结局指标：首次死亡（全因）、非致死性心肌梗死或非致死性卒中；其他：心血管死亡、心绞痛、不良经历、住院和24个月时血压控制。结果24个月时，CAS组有6391例（81.5%）患者服用维拉帕米缓释片；4934例（62.9%）在服用trump olapril；服用氢氯噻嗪3430例（43.7%）。NCAS组6083例（77.5%）患者服用阿替洛尔；服用氢氯噻嗪4733例（60.3%）；有4113例（52.4%）在服用trump olapril。随访61835患者-年（平均2.7年/例），2269例患者出现主要结局事件，治疗策略间差异无统计学意义（CAS组9.93%，NCAS组10.17%；相对风险[RR]，0.98； 95%可信区间[CI]， 0.90-1.06）。两组之间两年的血压控制情况相似。JNC VI血压目标在CAS患者中分别达到65.0%（收缩压）和88.5%（舒张压），在NCAS患者中分别达到64.0%（收缩压）和88.1%（舒张压）。71.7%的CAS患者和70.7%的NCAS患者收缩压低于140 mm Hg，舒张压低于90 mm HA。结论以维拉帕米-曲多拉普利为基础的治疗高血压CAD患者的临床疗效与阿替洛尔-氢氯噻嗪相同。
Context Despite evidence of efficacy of anti hypertensive agents in treating hypertensive patients, safety and efficacy of anti hypertensive agents for coronary artery disease (CAD) have been discerned only from subgroup analyses in large trials.Objective To compare mortality and morbidity outcomes in patients with hypertension and CAD treated with a calcium antagonist strategy (CAS) or a non-calcium antagonist strategy (NCAS).Design, Setting, and Participants Randomized, open label, blinded end point study of 22576 hypertensive CAD patients aged 50 years or older, which was conducted September 1997 to February 2003 at 862 sites in 14 countries.Interventions Patients were randomly assigned to either CAS (verapamil sustained release) or NCAS (atenolol). Strategies specified dose and additional drug regimens. Trandolapril and/or hydrochlorothiazide was administered to achieve blood pressure goals according to guidelines from the sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) of less than 140 mm Hg (systolic) and less than 90 mm Hg (diastolic); and less than 130 mm Hg (systolic) and less than 85 mm Hg (diastolic) if diabetes or renal impairment was present. Trandolapril was also recommended for patients with heart failure, diabetes, or renal impairment.Main Outcome Measures Primary: first occurrence of death (all cause), nonfatal myocardial infarction, or nonfatal stroke; other: cardiovascular death, angina, adverse experiences,, hospitalizations, and blood pressure control at 24 months.Results At 24 months, in the CAS group, 6391 patients (81.5%) were taking verapamil sustained release; 4934 (62.9%) were taking trandolapril; and 3430 (43.7%) were taking hydrochlorothiazide. In the NCAS group, 6083 patients (77.5%) were taking atenolol; 4733 (60.3%) were taking hydrochlorothiazide; and 4113 (52.4%) were taking trandolapril. After a follow-up of 61835 patient-years (mean, 2.7 years per patient), 2269 patients had a primary outcome event with no statistically significant difference between treatment strategies (9.93% in CAS and 10.17% in NCAS; relative risk [RR],0.98; 95% confidence interval [CI], 0.90-1.06). Two-year blood pressure control was similar between groups. The JNC VI blood pressure goals were achieved by 65.0% (systolic) and 88.5% (diastolic) of CAS and 64.0% (systolic) and 88.1% (diastolic) of NCAS patients. A total of 71.7% of CAS and 70.7% of,NCAS patients achieved a systolic blood pressure of less than 140 mm Hg And diastolic blood pressure of less than 90 mm HA.Conclusion The verapamil-trandolapril-based strategy was as clinically effective as the atenolol-hydrochlorothiazide-based strategy in hypertensive CAD patients.