Leonetti G
Center of Clinical Physiology and Hypertension, Hospital Policlinic, Milan, Italy.
J Cardiovasc Pharmacol. 1991;17 Suppl 4:S31-4. doi: 10.1097/00005344-199117041-00007.
The aim of this study was to compare the antihypertensive efficacy and tolerability of lacidipine, a new dihydropyridine calcium antagonist, and slow-release nifedipine (SR) in patients with mild-to-moderate essential hypertension. After a 1-month placebo run-in period, 435 patients were randomized into a double-blind, parallel-group study to receive either 4 mg of lacidipine once daily (n = 220) or 20 mg of nifedipine twice daily (n = 215). After 4 weeks, the doses for "nonresponders" were increased to 6 mg of lacidipine once daily (n = 82) and to 40 mg of nifedipine SR twice daily (n = 62). After 4 weeks, 50 mg of atenolol once daily was added to the regimens of patients still uncontrolled by lacidipine (n = 32) and nifedipine SR (n = 23) as monotherapy. Sitting blood pressure and heart rate were measured at 22-24 h after lacidipine and 10-12 h after nifedipine SR. Both calcium antagonists similarly and significantly reduced the blood pressure at rest (sitting) and on exercise, while the heart rate did not change significantly. The nature and incidence of side effects and withdrawals also did not differ between the two. In conclusion, lacidipine once daily is as effective and well tolerated as nifedipine SR twice daily in patients with mild-to-moderate essential hypertension.
本研究旨在比较新型二氢吡啶类钙拮抗剂拉西地平与缓释硝苯地平在轻至中度原发性高血压患者中的降压疗效及耐受性。经过1个月的安慰剂导入期后,435例患者被随机分为一项双盲、平行组研究,分别接受每日一次4 mg拉西地平(n = 220)或每日两次20 mg硝苯地平(n = 215)治疗。4周后,“无反应者”的剂量分别增至每日一次6 mg拉西地平(n = 82)和每日两次40 mg缓释硝苯地平(n = 62)。4周后,对于单药治疗仍未得到控制的拉西地平组患者(n = 32)和缓释硝苯地平组患者(n = 23),在其治疗方案中添加每日一次50 mg阿替洛尔。在服用拉西地平后22 - 24小时及服用缓释硝苯地平后10 - 12小时测量坐位血压和心率。两种钙拮抗剂均能相似且显著地降低静息(坐位)血压及运动时血压,而心率无显著变化。两组间副作用及撤药的性质和发生率也无差异。总之,对于轻至中度原发性高血压患者,每日一次拉西地平与每日两次缓释硝苯地平的疗效相当且耐受性良好。