Zhang Shuang, Yin Zheng, Li Zhi-Fan, Zhang Wen-Jia, Sui Yong-Gang, Xu Yan-Lu, Zhang Hai-Tao, Liu Xiao-Ning, Qiu Hong, Zhao Jing-Lin, Li Jian-Jun, Dou Ke-Fei, Qian Jie, Wu Na-Qiong
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No 167 BeiLiShi Road, XiCheng District, Beijing, 100037, China.
Cardiovasc Drugs Ther. 2024 Dec;38(6):1349-1358. doi: 10.1007/s10557-023-07509-1. Epub 2023 Oct 13.
Given the beneficial effects of sacubitril/valsartan on blood pressure generally, this study investigates its antihypertension effects in diabetes mellitus (DM) patients with primary hypertension specifically, and the effect of sacubitril/valsartan on glycolipid metabolism.
We conducted a randomized, open-label, active-controlled study to compare the antihypertension effects of sacubitril/valsartan in DM individuals with primary hypertension. The primary end point was reduction in mean systolic blood pressure (SBP) from baseline with sacubitril/valsartan vs. olmesartan at week 8. The secondary endpoints included the changes in diastolic blood pressure (DBP), daytime SBP/DBP, nighttime SBP/DBP, BP achievement (office sitting BP < 130/80 mmHg), and lipid profile. The trial was registered with chictr.org.cn (ChiCTR2200066428) on Dec 22, 2022.
A total of 124 patients were included in the final analysis. SBP decreased to a greater extent in the sacubitril/valsartan group from baseline to 8 weeks [between-treatment difference: 3.51 mm Hg, 95% confidence interval (95% CI) 0.41 to 6.62 mm Hg, P = 0.03]. Furthermore, more patients achieved the blood pressure goal with sacubitril/valasartan (74.60% vs. 54.70%, P = 0.03). Multiple logistical regression analysis showed that sacubitril/valsartan was associated with BP achievement [odds ratio (OR) 0.33, 95% CI 0.14-0.73, P = 0.007], but the difference in SBP, DBP, day time SBP/DBP, and night time SBP/DBP reduction did not approach statistical significance. HbA1C1, total cholesterol, and low-density lipoprotein-cholesterol were lower than baseline in both groups (P < 0.05); however, there was no difference in the effects on glucose and lipid metabolism from sacubitril/valsartan compared to olmesartan.
Sacubitril/valsartan not only provided superior BP reduction compared to olmesartan, it did so without adverse effects on glycemic control and lipid parameters in DM patients with primary hypertension.
鉴于沙库巴曲缬沙坦总体上对血压有益,本研究专门调查其在原发性高血压糖尿病(DM)患者中的降压效果,以及沙库巴曲缬沙坦对糖脂代谢的影响。
我们进行了一项随机、开放标签、活性对照研究,以比较沙库巴曲缬沙坦在原发性高血压DM个体中的降压效果。主要终点是在第8周时,沙库巴曲缬沙坦与奥美沙坦相比,平均收缩压(SBP)从基线的降低情况。次要终点包括舒张压(DBP)、日间SBP/DBP、夜间SBP/DBP的变化、血压达标情况(诊室坐位血压<130/80 mmHg)以及血脂谱。该试验于2022年12月22日在chictr.org.cn(ChiCTR2200066428)注册。
共有124例患者纳入最终分析。从基线到8周,沙库巴曲缬沙坦组的SBP下降幅度更大[组间差异:3.51 mmHg,95%置信区间(95%CI)0.41至6.62 mmHg,P = 0.03]。此外,使用沙库巴曲缬沙坦达到血压目标的患者更多(74.60%对54.70%,P = 0.03)。多元逻辑回归分析显示,沙库巴曲缬沙坦与血压达标相关[比值比(OR)0.33,95%CI 0.14 - 0.73,P = 0.007],但SBP、DBP、日间SBP/DBP和夜间SBP/DBP降低的差异未达到统计学意义。两组的糖化血红蛋白、总胆固醇和低密度脂蛋白胆固醇均低于基线(P < 0.05);然而,与奥美沙坦相比,沙库巴曲缬沙坦对糖脂代谢的影响没有差异。
与奥美沙坦相比,沙库巴曲缬沙坦不仅能更有效地降低血压,而且对原发性高血压DM患者的血糖控制和血脂参数没有不良影响。