Ogihara Toshio, Fujimoto Akira, Nakao Kazuwa, Saruta Takao
Osaka General Medical Center, Osaka, Japan.
Expert Rev Cardiovasc Ther. 2008 Oct;6(9):1195-201. doi: 10.1586/14779072.6.9.1195.
The Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) trial was a comparative study of the angiotensin II receptor blocker (ARB), candesartan, and a calcium channel blocker (CCB), amlodipine, regarding the incidence of cardiovascular events in high-risk Japanese hypertensive patients. The study design was a prospective, multicenter, randomized, open-label, active-controlled, two-arm, parallel-group comparison study with a response-dependent dose titration and blinded assessment of the end point. The CASE-J trial enrolled 4728 patients, with a mean age of 63.8 years and a mean BMI of 24.6 kg/m(2), who were randomly assigned to either candesartan- or amlodipine-based treatment regimens. Blood pressure was well controlled to the level of less than 140/80 mmHg in both of the treatment regimens. During 3.2 years of follow-up, primary cardiovascular events occurred in 134 patients in each of the two treatment-based regimens, resulting in no significant difference in the incidence of cardiovascular events between them (hazard ratio: 1.01; 95% confidence interval: 0.79-1.28; p = 0.969). In 404 patients with left ventricular hypertrophy, a significantly larger decrease in left ventricular mass index 3 years after enrollment was observed in candesartan-based (n = 205) than amlodipine-based (n = 199) regimens (-22.9 vs -13.4 g/m(2), respectively; p = 0.023). Furthermore, new-onset diabetes occurred in fewer patients taking candesartan than in those taking amlodipine, resulting in a 36% relative risk reduction (p = 0.030). The CASE-J trial demonstrated that both an ARB, candesartan, and a CCB, amlodipine, equally suppressed the incidence of cardiovascular events. The ARB may confer more beneficial effects to hypertensive patients with left ventricular hypertrophy or for those at-risk of diabetes than CCB.
日本坎地沙坦抗高血压生存评估（CASE-J）试验是一项关于血管紧张素II受体阻滞剂（ARB）坎地沙坦与钙通道阻滞剂（CCB）氨氯地平在高危日本高血压患者心血管事件发生率方面的对比研究。研究设计为前瞻性、多中心、随机、开放标签、活性对照、双臂、平行组比较研究，采用反应依赖性剂量滴定并对终点进行盲法评估。CASE-J试验纳入了4728例患者，平均年龄63.8岁，平均体重指数24.6kg/m²，这些患者被随机分配至基于坎地沙坦或氨氯地平的治疗方案。两种治疗方案的血压均得到良好控制，降至140/80mmHg以下。在3.2年的随访期间，两种基于治疗方案的每组中均有134例患者发生原发性心血管事件，两者之间心血管事件发生率无显著差异（风险比：1.01；95%置信区间：0.79 - 1.28；p = 0.969）。在404例左心室肥厚患者中，与基于氨氯地平的治疗方案（n = 199）相比，基于坎地沙坦的治疗方案（n = 205）在入组3年后观察到左心室质量指数有显著更大幅度的下降（分别为-22.9 vs -13.4g/m²；p = 0.023）。此外，服用坎地沙坦的患者中新发糖尿病的发生率低于服用氨氯地平的患者，相对风险降低了36%（p = 0.030）。CASE-J试验表明，ARB坎地沙坦和CCB氨氯地平均能同等程度地抑制心血管事件的发生率。与CCB相比，ARB可能对左心室肥厚的高血压患者或有糖尿病风险的患者具有更多有益作用。
