Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study (Retracted Article)
Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study (Retracted Article)
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DOI：
10.1016/s0140-6736(07)60669-2
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发表时间：
2007-04-01
期刊：
影响因子：
168.9
通讯作者：
Tajima, Naoko
中科院分区：
文献类型：
--
作者：
Mochizuki, Seibu;Dahloef, Bjorn;Tajima, Naoko
背景抑制肾素-血管紧张素-醛固酮系统的药物使有心血管疾病风险或患有心血管疾病的患者受益。然而，在亚洲人群中证明这一效应的证据很少。我们旨在研究在日本心血管疾病患者常规治疗的基础上加用血管紧张素受体阻滞剂valsartan是否有效。方法我们启动了一项多中心、前瞻性、随机对照试验，研究对象为3081名年龄在20-79岁(平均65岁，10岁)的日本患者，他们正在接受高血压、冠心病、心力衰竭或这些疾病的联合治疗。除了常规治疗外，患者还被分配到valsartan(每天40-160 mg)或其他没有血管紧张素受体阻滞剂的治疗中。我们的主要终点是心血管发病率和死亡率的综合指标。分析采用意向治疗。这项研究在Clintrials.gov上注册，标识为NCT0013328。经过3.1年(范围1-3.9年)的中位数随访后，服用valsartan的患者中记录的主要终点比对照组少(92vs149；每1000人年绝对风险21.3vs34.5；危险比0.61，95%CL0.47-0.79，p=0.0002)。这一差异主要是由于与对照组相比，服用valsartan的患者发生中风和短暂性脑缺血发作(29vs48；0.600.38-0.95p=0.028)、心绞痛(19vs53；0.350.20-0.58p<；0.0001)和心力衰竭(19vs36；0.530.31-0.94p=0.029)。死亡率或耐受性在不同组之间没有差异。解释说，在常规治疗的基础上加用valsartan预防的心血管事件比辅助传统治疗更多。这些好处不能完全用血压控制的不同来解释。
Background Drugs that inhibit the renin-angiotensin-aldosterone system benefit patients at risk for or with existing cardiovascular disease. However, evidence for this effect in Asian populations is scarce. We aimed to investigate whether addition of an angiotensin receptor blocker, valsartan, to conventional cardiovascular treatment was effective in Japanese patients with cardiovascular disease.Methods We initiated a multicentre, prospective, randomised controlled trial of 3081 Japanese patients, aged 20-79 years, (mean 65 [SD 10] years) who were undergoing conventional treatment for hypertension, coronary heart disease, heart failure, or a combination of these disorders. In addition to conventional treatment, patients were assigned either to valsartan (40-160 mg per day) or to other treatment without angiotensin receptor blockers. Our primary endpoint was a composite of cardiovascular morbidity and mortality. Analysis was by intention to treat. The study was registered at clintrials.gov with the identifier NCT00133328.Findings After a median follow-up of 3.1 years (range 1-3.9) the primary endpoint was recorded in fewer individuals given valsartan than in controls (92 vs 149; absolute risk 21.3 vs 34.5 per 1000 patient years; hazard ratio 0.61, 95% Cl 0.47-0.79, p=0.0002). This difference was mainly attributable to fewer incidences of stroke and transient ischaemic attack (29 vs 48; 0.60, 0.38-0.95, p=0.028), angina pectoris (19 vs 53; 0.35, 0.20-0.58, p < 0.0001), and heart failure (19 vs 36; 0.53, 0.31-0.94, p=0.029) in those given valsartan than in the control group. Mortality or tolerability did not differ between groups.Interpretation The addition of valsartan to conventional treatment prevented more cardiovascular events than supplementary conventional treatment. These benefits cannot be entirely explained by a difference in blood pressure control.