This randomised, double-blind, double-dummy, parallel group, multicentre study compared the efficacy and tolerability of lercanidipine with lacidipine. Elderly patients with isolated systolic hypertension (supine blood pressure >/=160/<95 mmHg) were enrolled and underwent a placebo run-in period of 14-27 days before random allocation to lercanidipine tablets 10 mg once daily (n=111) or lacidipine tablets 2 mg once daily (n=111) for the assessment period (112-160 days). Titration to lercanidipine 20 mg once daily (two 10 mg tablets) or lacidipine 4 mg once daily (two 2 mg tablets) was allowed after 8 weeks, if required. Both treatments decreased supine and standing systolic and diastolic blood pressure between the end of the run-in period and the end of the assessment period (P<0.0001). At the end of the assessment period, the estimated mean treatment difference (95% confidence intervals) in supine systolic blood pressure was -0.81 (-4.45, 2.84) mmHg. These confidence intervals were within the limits specified for equivalence, that is, (-5, 5) mmHg. Ambulatory blood pressure monitoring showed that the antihypertensive effects of both drugs lasted for the full 24-h dosing period and followed a circadian pattern. Both treatments were well tolerated with a low incidence of adverse drug reactions and a low withdrawal rate. Significantly fewer patients withdrew from treatment with lercanidipine (P=0.015). Neither treatment had any clinically significant effect on pulse rate or cardiac conduction. In conclusion, both treatments were equally effective in controlling supine systolic blood pressure in patients with isolated systolic hypertension.

译文

:这项随机,双盲,双虚拟,平行组,多中心研究比较了乐卡地平和拉西地平的疗效和耐受性。入选了患有单纯收缩期高血压(仰卧血压> / = 160 / <95 mmHg)的老年患者,并进行了14-27天的安慰剂磨合期,然后每天随机分配一次10 mg lercanidipine片(n = 111)或拉西平片2 mg每天一次(n = 111),用于评估期(112-160天)。如果需要,允许在8周后滴定至每天20 mg乐卡地平(两次10 mg片剂)或lacidipine 4 mg每天滴定(两次2 mg片剂)滴定。在磨合期结束和评估期结束之间,两种治疗均降低了仰卧位和站立时的收缩压和舒张压(P <0.0001)。在评估期结束时,仰卧收缩压的估计平均治疗差异(95%置信区间)为-0.81(-4.45,2.84)mmHg。这些置信区间在等效的指定限制内​​,即(-5,5)mmHg。动态血压监测表明,这两种药物的降压作用持续了整个24小时的服药期间,并遵循了昼夜节律模式。两种疗法均具有良好的耐受性,药物不良反应发生率低,停药率低。乐卡地平退出治疗的患者明显减少(P = 0.015)。两种疗法均未对脉搏率或心脏传导产生任何临床显着影响。总之,两种治疗方法在控制单纯收缩期高血压患者的仰卧收缩压方面均有效。

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