This double-blind, placebo-controlled, four-way balanced design crossover study included hypertensive patients aged 60-85 years with mean office-measured sitting systolic blood pressure (SBP) 160-179 mm Hg and daytime SBP > or =135 mm Hg. After a 2-week run-in period, during which previous medications were discontinued, each patient received the following four treatments in randomized order for 4 weeks each: lercanidipine 10 mg (L), enalapril 20 mg (E), lercanidipine 10 mg plus enalapril 20 mg (L/E) and placebo (P). At the end of each treatment period, office trough blood pressure (BP) was measured and a 24-h Ambulatory Blood Pressure Monitoring (ABPM) was performed. Seventy-five patients (mean age 66 years, office BP 168/92 mm Hg, daytime SBP 151 mm Hg) were randomized and 62 completed the study with four valid post-baseline ABPMs. The administration of P, L, E and L/E was associated with a mean 24-h SBP of 144, 137, 133 and 127 mm Hg, respectively. All active treatments significantly reduced the mean 24-h SBP in comparison with placebo, but L/E was significantly more effective than L and E alone. Similarly, office SBP was significantly more reduced with L/E (-16.9 mm Hg) than with L (-5.0 mm Hg) or E (-5.9 mm Hg). A BP <140/90 mm Hg was recorded in 18% of patients with L, 19% with E and 45% with L/E. Two patients on P and two on L/E were withdrawn from the study due to adverse events. In conclusion, combination therapy with L/E has additive antihypertensive effects on both ambulatory and office BP in elderly patients and is well tolerated.

译文

:这项双盲,安慰剂对照,四向平衡设计交叉研究纳入了60-85岁,平均办公室测量的坐位收缩压(SBP)160-179 mm Hg和白天SBP>或= 135 mm的高血压患者汞经过2周的磨合期(在此期间以前的药物已停止使用),每位患者随机接受以下4种治疗,每组4周:乐卡地平10 mg(L),依那普利20 mg(E),乐卡地平10 mg加依那普利20毫克(L / E)和安慰剂(P)。在每个治疗期结束时,测量办公室低谷血压(BP)并进行24小时动态血压监测(ABPM)。将75名患者(平均年龄66岁,办公室BP 168/92毫米汞柱,白天SBP 151毫米汞柱)随机分组,其中62名患者接受了四个有效的基线后ABPM来完成研究。施用P,L,E和L / E的平均24小时SBP分别为144、137、133和127 mm Hg。与安慰剂相比,所有积极治疗均显着降低了平均24小时SBP,但L / E比单独使用L和E更有效。同样,使用L / E(-16.9 mm Hg)的办公室SBP明显比使用L(-5.0 mm Hg)或E(-5.9 mm Hg)的办公室SBP减少更多。在18%的L患者,19%的E患者和45%的L​​ / E患者中记录到BP <140/90 mm Hg。由于不良事件,两名P病人和L / E病人两名退出研究。总之,L / E联合疗法对老年患者的门诊和办公室BP都有加成的降压作用,并且耐受性良好。

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