TREATMENT OF AMBULATORY HYPERTENSIVES WITH NEBIVOLOL OR HYDROCHLOROTHIAZIDE ALONE AND IN COMBINATION - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FACTORIAL-DESIGN TRIAL
TREATMENT OF AMBULATORY HYPERTENSIVES WITH NEBIVOLOL OR HYDROCHLOROTHIAZIDE ALONE AND IN COMBINATION - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FACTORIAL-DESIGN TRIAL
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DOI：
10.1093/ajh/7.2.137
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发表时间：
1994-02-01
影响因子：
3.2
通讯作者：
ARNOTT, A
中科院分区：
文献类型：
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作者：
LACOURCIERE, Y;LEFEBVRE, J;ARNOTT, A
这项安慰剂对照多因素设计试验评估了奈比洛尔（一种具有血管舒张特性的新型心脏选择性β(1)受体阻滞剂）与氢氯噻嗪单药及联合治疗的降压效果。在4周的安慰剂期后，240名平均日间动态血压大于或等于90mmhg的白人患者被随机分配接受安慰剂、纳比洛尔（1,5或10mg）、氢氯噻嗪（12.5或25mg），或纳比洛尔和氢氯噻嗪的六种可能组合中的一种，持续12周。每一种药物单独治疗和两种药物联合治疗，临床和动态血压均有剂量相关的降低。5毫克和10毫克剂量的奈比洛尔比氢氯噻嗪对临床血压和24小时间隔的影响更大。此外，联合剂量具有显著的抗高血压作用，持续整个24小时，并且观察到高剂量联合的效果更大。10mg奈比洛尔联合25mg氢氯噻嗪可将血压负荷（清醒时血压百分比为140/90 mm Hg，睡眠时血压百分比为120/80 mm Hg）降低至11.5%，进一步证实了动态血压的降低。奈比洛尔和氢氯噻嗪耐受性良好。我们提供的证据表明，奈比洛尔单药治疗或与低剂量氢氯噻嗪合用，可有效降低动态高血压患者的临床和24小时动态血压。该结果为在研究新的抗高血压药物时使用动态血压监测和因子设计提供了进一步的证据。
This placebo-controlled multifactorial design trial assessed the antihypertensive efficacy of nebivolol, a novel cardioselective beta(1)-blocker with vasodilating properties, and hydrochlorothiazide monotherapy and in combination. After a 4-week placebo period, 240 white patients with a mean daytime ambulatory blood pressure of greater than or equal to 90 mm Hg were randomized to receive either placebo, nebivolol (1, 5, or 10 mg), hydrochlorothiazide (12.5 or 25 mg), or one of the six possible combinations of nebivolol and hydrochlorothiazide for 12 weeks. A dose-related reduction in clinic and ambulatory blood pressure was demonstrated for each drug as monotherapy and for the two drugs in combination. Nebivolol, 5- and 10-mg doses, showed a larger effect than hydrochlorothiazide doses on clinic blood pressure and over the 24-h interval. Moreover, the combination doses had substantial antihypertensive effects that were sustained over the entire 24-h profile with a greater effect observed with the higher dose combinations. The reduction in ambulatory blood pressure was further substantiated by the reduction of blood pressure loads (% of BP > 140/90 mm Hg awake and > 120/80 mm Hg asleep) to as low as 11.5% with 10 mg of nebivolol combined with 25 mg of hydrochlorothiazide. Nebivolol and hydrochlorothiazide were well tolerated. We provided evidence that nebivolol, given as monotherapy or in combination with low dose of hydrochlorothiazide, is effective in reducing clinic and 24-h ambulatory blood pressure in patients with ambulatory hypertension. The results provided further evidence for the use of ambulatory blood pressure monitoring and factorial designs when investigating new antihypertensive agents.