Höglund C, Cifkova R, Mimran A, Tenczer J, Watt A, Wilkins M R, Lindberg E
Stockholm Heart Center, Sweden.
Cardiology. 1998 May;89(4):263-70. doi: 10.1159/000006798.
This study was designed to compare the effect of mibefradil, a selective T-type calcium channel antagonist, with the beta-blocker atenolol on regression of left ventricular (LV) hypertrophy in hypertensive patients.
In this multicenter, double-blind, active-controlled, randomized, parallel-group comparison, 66 patients with mild-to-moderate hypertension (sitting diastolic blood pressure, SDBP, 95-114 mm Hg) and LV mass index > 102 g/m2 for males and > 88 g/m2 for females were randomized to an initial treatment with 50 mg of either mibefradil or atenolol for 4 weeks. Doses were increased to 100 mg/day if blood pressure was not normalized to < or = 90 mm Hg, and, if needed, 25 mg of hydrochlorothiazide was added. Treatment continued for a total of 24 weeks. LV hypertrophy was assessed by echocardiography, and trough SDBP and adverse events were recorded.
Treatment with mibefradil or atenolol resulted in decreases from baseline in LV mass index of 11.1% (p < 0.001) and 9.1% (p < 0.001), respectively. The treatment difference (mibefradil vs. atenolol) was not statistically significant. Reductions in SDBP with mibefradil and atenolol were 14.3 and 10.7 mm Hg, respectively, again not statistically significant. Both drugs were well tolerated; however, overall there were more potentially drug-related adverse events reported with atenolol (48.5%) than with mibefradil (24.2%).
The reductions in LV hypertrophy and blood pressure achieved with mibefradil were larger but statistically equivalent to those with atenolol, but a lower overall incidence of treatment-related adverse events was seen in the mibefradil-treated patients.
本研究旨在比较选择性T型钙通道拮抗剂米贝拉地尔与β受体阻滞剂阿替洛尔对高血压患者左心室(LV)肥厚消退的影响。
在这项多中心、双盲、活性对照、随机、平行组比较研究中,66例轻度至中度高血压患者(坐位舒张压,SDBP,95 - 114 mmHg),男性LV质量指数>102 g/m²,女性>88 g/m²,被随机分为初始治疗组,分别给予50 mg米贝拉地尔或阿替洛尔,治疗4周。如果血压未恢复正常至≤90 mmHg,则剂量增加至100 mg/天,如有需要,添加25 mg氢氯噻嗪。治疗持续共24周。通过超声心动图评估LV肥厚情况,并记录谷值SDBP和不良事件。
米贝拉地尔或阿替洛尔治疗后,LV质量指数分别较基线下降了11.1%(p < 0.001)和9.1%(p < 0.001)。治疗差异(米贝拉地尔与阿替洛尔)无统计学意义。米贝拉地尔和阿替洛尔使SDBP分别降低了14.3和10.7 mmHg,同样无统计学意义。两种药物耐受性良好;然而,总体而言,阿替洛尔报告的潜在药物相关不良事件(48.5%)比米贝拉地尔(24.2%)更多。
米贝拉地尔使LV肥厚和血压降低的幅度更大,但在统计学上与阿替洛尔相当,不过米贝拉地尔治疗的患者中与治疗相关的不良事件总体发生率较低。