PDF(Pubmed)
Abstract：
New approaches are needed to lower blood pressure (BP) given persistently low control rates. QUARTET USA sought to evaluate the effect of four-drug, quarter-dose BP lowering combination in patients with hypertension. QUARTET USA was a randomized (1:1), double-blinded trial conducted in federally qualified health centers among adults with hypertension. Participants received either a quadpill of candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg or candesartan 8 mg for 12 weeks. If BP was >130/>80 mm Hg at 6 weeks in either arm, then participants received open label add-on amlodipine 5 mg. The primary outcome was mean change in systolic blood pressure (SBP) at 12 weeks, controlling for baseline BP. Secondary outcomes included mean change in diastolic blood pressure (DBP), and safety included serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. Among 62 participants randomized between August 2019-May 2022 (n = 32 intervention, n = 30 control), mean (SD) age was 52 (11.5) years, 45% were female, 73% identified as Hispanic, and 18% identified as Black. Baseline mean (SD) SBP was 138.1 (11.2) mmHg, and baseline mean (SD) DBP was 84.3 (10.5) mmHg. In a modified intention-to-treat analysis, there was no significant difference in SBP (-4.8 mm Hg [95% CI: -10.8, 1.3, p = 0.123] and a -4.9 mmHg (95% CI: -8.6, -1.3, p = 0.009) greater mean DBP change in the intervention arm compared with the control arm at 12 weeks. Adverse events did not differ significantly between arms. The quadpill had a similar SBP and greater DBP lowering effect compared with candesartan 8 mg. Trial registration number: NCT03640312.
摘要：
由于控制率持续较低，因此需要新的方法来降低血压（BP）。QUARTETUSA试图评估四种药物的效果，四分之一剂量降血压联合治疗高血压患者。QUARTETUSA是随机的（1：1），在联邦合格的健康中心对患有高血压的成人进行双盲试验.参与者接受了坎地沙坦2毫克的四粒药，氨氯地平1.25毫克，茚达帕胺0.625毫克，和比索洛尔2.5mg或坎地沙坦8mg，持续12周。如果两臂6周时血压>130/>80mmHg，然后参与者接受开放标签添加氨氯地平5mg.主要结果是12周时收缩压（SBP）的平均变化，控制基线BP。次要结果包括舒张压（DBP）的平均变化，安全性包括严重不良事件，相关药物不良反应，和电解质异常。在2019年8月至2022年5月期间随机分组的62名参与者中(n=32，n=30控制)，平均（SD）年龄为52（11.5）岁，45%是女性,73%的人被认定为西班牙裔，18%的人被认定为黑人。基线平均（SD）SBP为138.1（11.2）mmHg，基线平均（SD）DBP为84.3（10.5）mmHg。在修改后的意向治疗分析中，与对照组相比,干预组12周时的SBP变化无显著差异(-4.8mmHg[95%CI:-10.8,1.3,p=0.123]和-4.9mmHg(95%CI:-8.6,-1.3,p=0.009)。两组之间的不良事件没有显着差异。与8mg坎地沙坦相比，四药具有相似的SBP和更大的DBP降低作用。试验注册号：NCT03640312。
