Ogihara Toshio, Nakao Kazuwa, Fukui Tsuguya, Fukiyama Kohshiro, Ueshima Kenji, Oba Koji, Sato Tosiya, Saruta Takao
Osaka University Graduate School of Medicine, Osaka, Japan.
Hypertension. 2008 Feb;51(2):393-8. doi: 10.1161/HYPERTENSIONAHA.107.098475. Epub 2008 Jan 2.
The Candesartan Antihypertensive Survival Evaluation in Japan Trial was designed to compare the long-term effects of the angiotensin II receptor blocker candesartan and the calcium channel blocker amlodipine on the incidence of cardiovascular events, represented as a composite of sudden death and cerebrovascular, cardiac, renal, and vascular events in high-risk Japanese hypertensive patients. We conducted a prospective, randomized, open-label study with blinded assessment of the end point in 4728 Japanese hypertensive patients (mean age: 63.8 years; mean body mass index: 24.6 kg/m(2)). Patients were followed for an average of 3.2 years. Blood pressure was well controlled with both treatment-based regimens (systolic blood pressure/diastolic blood pressure: 136.1/77.3 mm Hg for candesartan-based regimens and 134.4/76.7 mm Hg for amlodipine-based regimens after 3 years). Primary cardiovascular events occurred in 134 patients with both the candesartan- and amlodipine-based regimens. The 2 treatment-based regimens produced no significant differences in cardiovascular morbidity or mortality in the high-risk Japanese hypertensive patients (hazard ratio: 1.01; 95% CI: 0.79 to 1.28; P=0.969). In each primary end point category, there was no significant difference between the 2 treatment-based regimens. New-onset diabetes occurred in fewer patients taking candesartan (8.7/1000 person-years) than in those taking amlodipine (13.6/1000 person-years), which resulted in a 36% relative risk reduction (hazard ratio: 0.64; 95% CI: 0.43 to 0.97; P=0.033). We disclosed that candesartan-based and amlodipine-based regimens produced no statistical differences in terms of the primary cardiovascular end point, whereas candesartan prevented new-onset diabetes more effectively than amlodipine.
日本坎地沙坦抗高血压生存评估试验旨在比较血管紧张素II受体阻滞剂坎地沙坦与钙通道阻滞剂氨氯地平对高危日本高血压患者心血管事件发生率的长期影响，心血管事件以猝死以及脑血管、心脏、肾脏和血管事件的综合情况表示。我们开展了一项前瞻性、随机、开放标签研究，对4728例日本高血压患者（平均年龄：63.8岁；平均体重指数：24.6kg/m²）的终点进行盲法评估。患者平均随访3.2年。两种基于治疗的方案均能良好控制血压（3年后，基于坎地沙坦的方案收缩压/舒张压为136.1/77.3mmHg，基于氨氯地平的方案为134.4/76.7mmHg）。使用基于坎地沙坦和氨氯地平的方案时，均有134例患者发生原发性心血管事件。在高危日本高血压患者中，两种基于治疗的方案在心血管发病率或死亡率方面无显著差异（风险比：1.01；95%CI：0.79至1.28；P=0.969）。在每个主要终点类别中，两种基于治疗的方案之间均无显著差异。服用坎地沙坦的患者发生新发糖尿病的人数（8.7/1000人年）少于服用氨氯地平的患者（13.6/1000人年），相对风险降低了36%（风险比：0.64；95%CI：0.43至0.97；P=0.033）。我们发现，基于坎地沙坦和氨氯地平的方案在原发性心血管终点方面无统计学差异，而坎地沙坦预防新发糖尿病的效果比氨氯地平更有效。
