Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong, China.
Shantou University Medical College, Shantou, Guangdong, China.
Am J Hypertens. 2024 Jul 15;37(8):612-620. doi: 10.1093/ajh/hpae038.
Optimal antihypertensive medication for chronic type B aortic dissection (AD) remains undecided. This study compared the efficacy and safety of sacubitril/valsartan with valsartan to determine suitable antihypertensive drug combinations.
In this single-center, open-label, randomized, controlled trial, patients with chronic Stanford type B AD and mild hypertension were randomized to receive sacubitril/valsartan 100/200 mg or valsartan 80/160 mg. The primary endpoint was the reduction in mean sitting systolic blood pressure (msSBP) at week 8 in patients with sacubitril/valsartan vs. valsartan. Key secondary endpoints included changes in (i) mean sitting diastolic blood pressure (msDBP); (ii) pulse pressure (PP); and (iii) mean ambulatory blood pressure (BP) for 24-hour, daytime, and nighttime. Safety assessments included adverse events (AEs) and serious AEs. This trial was registered with the Chinese Clinical Trial Registry, identifier: ChiCTR2300073399.
A total of 315 patients completed the study. Sacubitril/valsartan provided a significantly greater reduction in msSBP than valsartan at week 8 (between-treatment difference: -5.1 mm Hg [95% confidence interval -5.8 to -4.5], P < 0.001). Reductions in msSBP, msDBP, and PP as well as the mean ambulatory BP for 24-hour, daytime, and nighttime, were significantly greater in sacubitril/valsartan compared with valsartan (all P < 0.001). No excessive episodes of AEs occurred in the sacubitril/valsartan group.
Sacubitril/valsartan and valsartan reduced BP compared with baseline values. However, sacubitril/valsartan improved BP control to a greater extent than valsartan. It may offer a new treatment option for patients with mild hypertension and chronic type B AD.
慢性 B 型主动脉夹层（AD）的最佳降压药物仍未确定。本研究比较了沙库巴曲缬沙坦与缬沙坦的疗效和安全性，以确定合适的降压药物组合。
在这项单中心、开放标签、随机、对照试验中，将慢性 Stanford 型 B 型 AD 合并轻度高血压患者随机分为沙库巴曲缬沙坦 100/200mg 或缬沙坦 80/160mg 组。主要终点为沙库巴曲缬沙坦组与缬沙坦组患者 8 周时平均坐位收缩压（msSBP）的降低。次要终点包括（i）平均坐位舒张压（msDBP）的变化；（ii）脉压（PP）；以及（iii）24 小时、白天和夜间平均动态血压（BP）的变化。安全性评估包括不良事件（AE）和严重不良事件（SAE）。本试验在中国临床试验注册中心注册，注册号：ChiCTR2300073399。
共有 315 例患者完成了研究。沙库巴曲缬沙坦组较缬沙坦组在第 8 周时 msSBP 降低更显著（治疗间差异：-5.1mmHg [95%置信区间-5.8 至-4.5]，P<0.001）。沙库巴曲缬沙坦组较缬沙坦组 msSBP、msDBP 和 PP 以及 24 小时、白天和夜间平均动态血压降低更显著（均 P<0.001）。沙库巴曲缬沙坦组未发生 AE 过度事件。
沙库巴曲缬沙坦和缬沙坦均较基线降低血压，但沙库巴曲缬沙坦较缬沙坦更能改善血压控制。它可能为合并轻度高血压的慢性 B 型 AD 患者提供新的治疗选择。
