Wang Kang-Ling, Fang Chih-Yuan, Lai Wen-Ter, Wang Tzung-Dau, Ueng Kwo-Chang, Wang Kuo-Yang, Wang Ji-Hung, Shyu Kou-Gi, Chiang Chern-En
General Clinical Research Center, Taipei Veterans General Hospital.
School of Medicine, National Yang-Ming University, Taipei.
Acta Cardiol Sin. 2021 Mar;37(2):186-194. doi: 10.6515/ACS.202103_37(2).20200914B.
Immediate-release carvedilol requires twice-daily dosing and may have low treatment compliance. We assessed the efficacy of a new formulation of once-daily extended-release carvedilol (carvedilol ER) on systolic blood pressure (SBP) and diastolic blood pressure (DBP) among patients with hypertension in this double-blind, randomized, placebo-controlled trial.
A total of 134 patients with untreated or uncontrolled hypertension were randomly assigned in a 1:1:1 ratio to receive placebo, low-dose carvedilol ER, or high-dose carvedilol ER for 8 weeks. The primary endpoint was the reduction in office SBP at 8 weeks. Secondary endpoints included the reduction in office DBP and the proportion of patients with blood pressure (BP) < 140/90 mm Hg.
In the intention-to-treat population, placebo-adjusted changes in SBP/DBP were -2.9 mm Hg [95% confidence interval (CI), -9.6 to 3.7]/-1.7 mm Hg (95% CI, -5.6 to 2.3) and -4.9 mm Hg (95% CI, -11.5 to 1.7)/-3.4 mm Hg (95% CI, -7.3 to 0.5) for low-dose carvedilol ER and high-dose carvedilol ER, respectively. In the per-protocol population, high-dose carvedilol ER was associated with a significant DBP reduction [placebo-adjusted difference, -4.7 mm Hg (95% CI, -8.8 to -0.5); adjusted p = 0.026]. There was a gradational improvement in BP control with carvedilol ER (25%, 37%, and 48% for placebo, low-dose carvedilol ER, and high-dose carvedilol ER, respectively; linear-by-linear association p = 0.028). There were no differences in safety among the three groups.
Carvedilol ER, though well tolerated, did not result in a greater reduction in either SBP or DBP compared with placebo.
速释型卡维地洛需要每日给药两次，治疗依从性可能较低。在这项双盲、随机、安慰剂对照试验中，我们评估了一种新型每日一次的缓释卡维地洛（卡维地洛 ER）制剂对高血压患者收缩压（SBP）和舒张压（DBP）的疗效。
总共 134 例未经治疗或血压控制不佳的高血压患者按 1:1:1 的比例随机分组，接受安慰剂、低剂量卡维地洛 ER 或高剂量卡维地洛 ER 治疗 8 周。主要终点是 8 周时诊室 SBP 的降低情况。次要终点包括诊室 DBP 的降低以及血压（BP）<140/90 mmHg 的患者比例。
在意向性分析人群中，低剂量卡维地洛 ER 和高剂量卡维地洛 ER 的 SBP/DBP 相对于安慰剂调整后的变化分别为-2.9 mmHg [95%置信区间（CI），-9.6 至 3.7] / -1.7 mmHg（95%CI，-5.6 至 2.3）和-4.9 mmHg（95%CI，-11.5 至 1.7）/ -3. mmHg（95%CI，-7.3 至 0.5）。在符合方案人群中，高剂量卡维地洛 ER 与显著的 DBP 降低相关[相对于安慰剂调整后的差异，-4.7 mmHg（95%CI，-8.8 至-0.5）；调整后 p = 0.026]。卡维地洛 ER 在血压控制方面有逐步改善（安慰剂组、低剂量卡维地洛 ER 组和高剂量卡维地洛 ER 组分别为 25%、37%和 48%；线性趋势分析 p = 0.028）。三组在安全性方面无差异。
卡维地洛 ER 耐受性良好，但与安慰剂相比，在降低 SBP 或 DBP 方面并未有更大幅度的下降。
