Cardiovascular Disease Center, The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Enshi Clinical College of Wuhan University, Enshi, Hubei, China.
Front Endocrinol (Lausanne). 2024 Mar 8;15:1335531. doi: 10.3389/fendo.2024.1335531. eCollection 2024.
Vericiguat, the newest soluble guanylate cyclase (sGC) drug, is potentially beneficial in treating heart failure (HF). However, most studies have only confirmed the significant impact of sGC in patients with reduced left ventricular ejection fraction (LVEF). Therefore, the main objective of this meta-analysis was to comparatively analyze the effects of Vericiguat in the entire LVEF range based on previous studies. According to PubMed, Web of Science, Cochrane, and Embase databases, randomized controlled studies in the full LVEF stage range were screened, and two extensive clinical studies on Vericiguat, namely VICTORIA (LVEF<45%) and VITALITY-HFpEF (LVEF≥45%) were identified for analysis and systematic evaluation. We separately assessed the rates of primary outcomes, cardiovascular death, and serious adverse events in both studies. The results of our research confirmed that although the criteria for the primary outcome were not the same in the two extensive studies, it was evident that there was no difference in the primary outcome between the experimental Vericiguat group and the placebo group in the VITALITY-HFpEF (LVEF≥45%) (P=0.45), whereas the primary outcome of VICTORIA (LVEF<45%) was significantly improved with the administration of Vericiguat showing a significant improvement (RR 0.93; 95% CI 0.87 to 1.00), but the effect of Vericiguat on cardiovascular mortality was not significant across the full range of LVEF (RR 0.97; 95% CI 0.86 to 1.09), and the incidence of total serious adverse events did not differ significantly between the two studies (RR 0.96; 95% CI 0.89 to 1.03). Surprisingly, partial subgroups analysis of serious adverse events found that vericiguat treatment reduced the incidence of all-cause death, Cardiac disorders, Hypotension, and Hypertension in patients with LVEF<45%, with a particular effect on the incidence of Cardiac disorders. Taken together, Vericiguat had a significant benefit in HF patients with LVEF<45%, especially in patients with LVEF<24%; it had a less pronounced effect in HF patients with LVEF ≥45%, but no adverse effects were observed.
维立西呱是一种新型可溶性鸟苷酸环化酶（sGC）药物，有望用于心力衰竭（HF）的治疗。然而，大多数研究仅证实了 sGC 在左心室射血分数（LVEF）降低的患者中的显著作用。因此，本荟萃分析的主要目的是基于既往研究比较分析维立西呱在整个 LVEF 范围内的作用。根据 PubMed、Web of Science、Cochrane 和 Embase 数据库，筛选出全 LVEF 阶段范围的随机对照研究，并对维立西呱的两项大型临床试验 VICTORIA（LVEF<45%）和 VITALITY-HFpEF（LVEF≥45%）进行分析和系统评价。我们分别评估了这两项研究中主要结局、心血管死亡和严重不良事件的发生率。我们的研究结果证实，尽管两项大型研究的主要结局标准不同，但维立西呱组与安慰剂组在 VITALITY-HFpEF（LVEF≥45%）（P=0.45）中的主要结局没有差异，而 VICTORIA（LVEF<45%）的主要结局则明显改善，维立西呱组显著改善（RR 0.93；95%CI 0.87 至 1.00），但维立西呱对全 LVEF 范围内心血管死亡率的影响并不显著（RR 0.97；95%CI 0.86 至 1.09），且两项研究之间总严重不良事件的发生率没有显著差异（RR 0.96；95%CI 0.89 至 1.03）。令人惊讶的是，严重不良事件的亚组分析发现，维立西呱治疗降低了 LVEF<45%患者的全因死亡、心脏疾病、低血压和高血压的发生率，对心脏疾病的发生率有特殊影响。综上所述，维立西呱对 LVEF<45%的心力衰竭患者有显著获益，尤其是 LVEF<24%的患者；对 LVEF≥45%的心力衰竭患者的作用不明显，但无不良事件发生。
