Charlon V, Kobrin I
Hoffmann-LaRoche, Clinical Research Department, Nutley, NJ, USA.
Int J Clin Pract. 1998 Jun;52(4):257-64.
The pool of controlled clinical studies on mibefradil, a new selective T-type calcium channel blocker, for the treatment of chronic stable angina pectoris was analysed to determine the effects in subgroups of patients defined by age, gender, body weight and common co-existing conditions. Total exercise tolerance test duration increased similarity in all subgroups, both at 50 mg (range 8.9-17.3%; n = 383) and 100 mg mibefradil (range 23.6-30.8%; n = 235). The increases in time to onset of angina and 1 mm ST-segment depression were similarly comparable. Safety and tolerability was similar to placebo for subgroups at 50 mg, but the incidence of adverse events was slightly higher in females, older, and lower weight patients at the 100 mg dose, particularly in reported leg oedema (7.9% in females vs 1.0% in males and 5.1% in older vs 0% in younger patients). Mibefradil proved a safe, well tolerated, and effective antianginal agent that can be used regardless of demographic factors or of frequently coexisting clinical conditions.
对新型选择性T型钙通道阻滞剂米贝拉地尔治疗慢性稳定型心绞痛的对照临床研究进行分析,以确定在按年龄、性别、体重和常见并存疾病定义的患者亚组中的疗效。在所有亚组中,50毫克(范围8.9 - 17.3%;n = 383)和100毫克米贝拉地尔(范围23.6 - 30.8%;n = 235)时,总运动耐量试验持续时间的增加相似。心绞痛发作时间和ST段压低1毫米的增加同样具有可比性。50毫克亚组的安全性和耐受性与安慰剂相似,但在100毫克剂量时,女性、老年和体重较轻患者的不良事件发生率略高,尤其是报告的腿部水肿(女性为7.9%,男性为1.0%;老年患者为5.1%,年轻患者为0%)。米贝拉地尔被证明是一种安全、耐受性良好且有效的抗心绞痛药物,可用于任何人口统计学因素或常见临床并存疾病的患者。