Lacourcière Y, Poirier L, Dion D, Provencher P
Hypertension Research Unit, Centre Hospitalier Université, Laval, Quebec, Canada.
Am J Cardiol. 1990 Feb 15;65(7):467-72. doi: 10.1016/0002-9149(90)90812-f.
The antihypertensive efficacy of sustained-release isradipine administered once daily compared to the immediate-release formulation administered twice daily was assessed by ambulatory blood pressure (BP) monitoring in a double-blind randomized crossover study in 76 mild-to-moderate hypertensive patients. Conventional BP and heart rate parameters were evaluated after a 4-week placebo period and patients qualified for entry if sitting diastolic BP was between 95 and 114 mm Hg. Ambulatory BP monitoring was measured at baseline and after active treatment with both formulations. The 2 regimens induced a significant and almost identical reduction (p less than 0.001) in the mean 24-hour BP without affecting heart rate. Isradipine was more effective in patients whose clinical hypertension was confirmed by ambulatory BP monitoring (35) than in patients who remained normotensive by ambulatory BP monitoring criteria (41). The isradipine-treated ambulatory hypertensive group experienced significantly greater decreases in BP during 24-hour, work, awake and sleep periods than did the ambulatory normotensive group. These data suggest that sustained-release isradipine has a sustained antihypertensive effect throughout 24 hours comparable to that of isradipine given twice daily and may improve compliance with long-term treatment. In addition, the results confirm the usefulness of ambulatory BP monitoring in determining truly hypertensive patients likely to respond to drug administration.
在一项针对76例轻至中度高血压患者的双盲随机交叉研究中，通过动态血压监测评估了每日给药一次的缓释伊拉地平与每日给药两次的速释制剂相比的降压疗效。在为期4周的安慰剂期后评估常规血压和心率参数，若坐位舒张压在95至114 mmHg之间，则患者符合入组条件。在基线以及两种制剂进行积极治疗后测量动态血压。两种治疗方案均使24小时平均血压显著降低且降低幅度几乎相同（p<0.001），且未影响心率。通过动态血压监测确诊为临床高血压的患者（35例）使用伊拉地平治疗比根据动态血压监测标准血压仍正常的患者（41例）更有效。与动态血压正常组相比，伊拉地平治疗的动态高血压组在24小时、工作、清醒和睡眠期间血压下降幅度显著更大。这些数据表明，缓释伊拉地平在24小时内具有持续的降压作用，与每日给药两次的伊拉地平相当，且可能提高长期治疗的依从性。此外，结果证实了动态血压监测在确定可能对药物治疗有反应的真正高血压患者方面的有用性。
