Purpose

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.

Methods

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.

Results

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.

Conclusions

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.

中文翻译：

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沙库巴曲/缬沙坦与奥美沙坦对糖尿病合并原发性高血压患者血压和糖脂代谢的影响

目的

鉴于沙库巴曲/缬沙坦对血压的总体有益作用，本研究专门研究了其对患有原发性高血压的糖尿病（DM）患者的抗高血压作用，以及沙库巴曲/缬沙坦对糖脂代谢的影响。

方法

我们进行了一项随机、开放、主动对照研究，以比较沙库巴曲/缬沙坦对患有原发性高血压的糖尿病患者的抗高血压作用。主要终点是第 8 周时沙库巴曲/缬沙坦与奥美沙坦相比，平均收缩压 (SBP) 较基线降低。次要终点包括舒张压 (DBP)、白天 SBP/DBP、夜间 SBP/DBP 的变化、血压成绩（办公室血压<130/80 mmHg）和血脂状况。该试验于2022年12月22日在chictr.org.cn（ChiCTR2200066428）注册。

结果

最终分析共有124例患者。沙库巴曲/缬沙坦组的 SBP 从基线到 8 周下降幅度更大 [治疗间差异：3.51 mm Hg，95% 置信区间 (95% CI) 0.41 至 6.62 mm Hg，P = 0.03 ]  。此外，更多的患者使用沙库巴曲/缬沙坦达到了血压目标（74.60% vs. 54.70%，P  = 0.03）。多元逻辑回归分析显示，沙库巴曲/缬沙坦与血压实现相关[比值比 (OR) 0.33，95% CI 0.14–0.73，P  = 0.007]，但 SBP、DBP、白天 SBP/DBP 和夜间的差异收缩压/舒张压降低时间并未达到统计学显着性。两组 HbA1C1、总胆固醇、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/缬沙坦对葡萄糖和脂质代谢的影响没有差异。

结论

与奥美沙坦相比，沙库巴曲/缬沙坦不仅能提供更好的降压效果，而且对患有原发性高血压的糖尿病患者的血糖控制和血脂参数没有不良影响。