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Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension: results fromthe PREVER-treatment randomized trial

机译:氯噻酮/阿米洛利与氯沙坦在I期高血压患者中的有效性:PREVER治疗随机试验的结果

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Objectives:To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of stage I hypertension.Methods:In a randomized, double-blind, controlled trial, 655 participants were followed for 18 months in 21 Brazilian academic centers. Trial participants were adult volunteers aged 30-70 years with stage I hypertension (BP 140-159 or 90-99mmHg) following 3 months of a lifestyle intervention. Participants were randomized to 12.5/2.5mg of chlorthalidone/amiloride (N=333) or 50mg of losartan (N=322). If BP remained uncontrolled after 3 months, study medication dose was doubled, and if uncontrolled after 6 months, amlodipine (5 and 10mg) and propranolol (40 and 80mg twice daily) were added as open-label drugs in a progressive fashion. At the end of follow-up, 609 (93%) participants were evaluated.Results:The difference in SBP during 18 months of follow-up was 2.3 (95% confidence interval: 1.2 to 3.3)mmHg favoring chlorthalidone/amiloride. Compared with those randomized to diuretic, more participants allocated to losartan had their initial dose doubled and more of them used add-on antihypertensive medication. Levels of blood glucose, glycosilated hemoglobin, and incidence of diabetes were no different between the two treatment groups. Serum potassium was lower and serum cholesterol was higher in the diuretic arm. Microalbuminuria tended to be higher in patients with diabetes allocated to losartan (28.540.4 versus 16.226.7mg, P=0.09).Conclusion:Treatment with a combination of chlorthalidone and amiloride compared with losartan yielded a greater reduction in BP.Clinical trials registration number:NCT00971165.
机译:目的:比较氯噻酮/阿米洛利联合滴丸与氯沙坦在I期高血压初始治疗期间降低血压(BP)的功效。方法:在一项随机,双盲,对照试验中,有655名参与者被随访,共18次。在21个巴西学术中心工作了几个月。经过3个月的生活方式干预,试验参与者为年龄30-70岁,患有I期高血压(BP 140-159或90-99mmHg)的成年志愿者。参与者被随机分为12.5 / 2.5mg氯噻酮/阿米洛利(N = 333)或50mg氯沙坦(N = 322)。如果3个月后血压仍然不受控制,则研究药物剂量加倍;如果6个月后血压不受控制,则以渐进方式添加氨氯地平(5和10mg)和普萘洛尔(每天40和80mg两次)作为开放标签药物。在随访结束时,对609名(93%)参与者进行了评估。结果:在18个月的随访中,SBP的差异为2.3(95%可信区间:1.2至3.3)mmHg,而利于氯噻酮/阿米洛利。与随机分配给利尿剂的参与者相比,更多分配给氯沙坦的参与者的初始剂量增加了一倍,并且更多的人使用了附加的降压药。两个治疗组之间的血糖水平,糖基化血红蛋白水平和糖尿病发生率无差异。利尿剂组的血钾降低,血清胆固醇升高。分配给氯沙坦的糖尿病患者的微量白蛋白尿倾向较高(28.540.4比16.226.7mg,P = 0.09)。结论:氯沙酮和阿米洛利联合治疗比氯沙坦治疗可使BP降低更大。临床试验注册号:NCT00971165。

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