Efficacy and tolerability profile of nebivolol vs atenolol in mild-to-moderate essential hypertension: results of a double-blind randomized multicentre trial.

Blood pressure. Supplement Pub Date : 2003-12-01
Guido Grassi, Fosca Quarti Trevano, Annalisa Facchini, Torakis Toutouzas, Bernard Chanu, Giuseppe Mancia
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Abstract

The objective of this 12-week double-blind randomized multicentre study was to compare the efficacy and tolerability of nebivolol, a recently developed beta-blocking agent with vasodilating properties, to the classical beta-blocker atenolol. After a placebo run-in phase, 205 mild-to-moderate middle-age essential hypertensives were randomized to either nebivolol 5 mg daily (n = 105) or atenolol 100 mg daily (n = 100) over a period of 12 weeks. The primary endpoint of the study was the change in sitting systolic and diastolic blood pressure (SBP and DBP respectively) from baseline to week 12 of treatment. The two drugs induced similar significant antihypertensive effects, the SBP and DBP reduction amounting to -18.2 +/-14.0 and -14.6 +/-7.9 mmHg (mean +/- SD) for atenolol and -19.1 +/-12.9 and -14.8 +/- 7.1 for nebivolol (p < 0.01 for all). This was the case also for standing blood pressure. Sitting and standing heart rate values were significantly reduced by both drugs, the bradicardic response induced by nebivolol treatment being significantly less than atenolol. Distribution of responders and non- responders was similar for nebivolol and atenolol, while the former drug showed a better tolerability profile and a lower incidence of side-effects. These data provide evidence, that, for the same antihypertensive effects, nebivolol shows a better tolerability profile than atenolol and a lower incidence of adverse effects.

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纳比洛尔与阿替洛尔治疗轻至中度原发性高血压的疗效和耐受性:一项双盲随机多中心试验的结果
这项为期12周的双盲随机多中心研究的目的是比较nebivolol(一种最近开发的具有血管舒张特性的β受体阻滞剂)与经典β受体阻滞剂阿替洛尔的疗效和耐受性。在安慰剂磨合期后,205名轻中度中年原发性高血压患者被随机分配到每天5毫克的奈比洛尔(n = 105)或每天100毫克的阿替洛尔(n = 100),为期12周。该研究的主要终点是从基线到治疗第12周坐位收缩压和舒张压(分别为收缩压和舒张压)的变化。两种药物的降压效果相似,阿替洛尔的收缩压和舒张压降低幅度分别为-18.2 +/-14.0和-14.6 +/-7.9 mmHg(平均+/- SD),奈比洛尔的收缩压和舒张压降低幅度分别为-19.1 +/-12.9和-14.8 +/- 7.1 (p < 0.01)。站立血压也是如此。两种药物均显著降低坐姿和站立心率值,奈比洛尔治疗引起的心动过缓反应明显小于阿替洛尔。奈比洛尔和阿替洛尔的应答者和无应答者分布相似,前者耐受性较好,副作用发生率较低。这些数据提供的证据表明,对于相同的降压作用,奈比洛尔比阿替洛尔表现出更好的耐受性和更低的不良反应发生率。
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