College of Pharmacy and Graduate School of Pharmaceutical Sciences, Ewha Womans University, 52 Ewhayeodae-gil, Seodaemun-gu, Seoul, 03760, Korea.
Sci Rep. 2024 Sep 3;14(1):16408. doi: 10.1038/s41598-024-67050-5.
This study aimed to evaluate the association between sacubitril/valsartan and dementia-related adverse events (AEs) in geographical subpopulations using subgroup disproportionality analysis. Cases from the FDA adverse event reporting system involving patients aged 60 or older with sacubitril/valsartan or angiotensin receptor blockers (ARBs) were analyzed. The adjusted reporting odds ratios (RORs) for dementia-related AEs were calculated for each continent. A total of 61,518 AEs associated with sacubitril/valsartan or ARBs were identified. Among these, 1441 were dementia-related AEs. In Asia, Europe, and Africa, the reporting risk of dementia-related AEs associated with sacubitril/valsartan was lower compared to ARBs (adjusted ROR, 0.57 [95% CI 0.31-1.01]; adjusted ROR, 0.89 [95% CI 0.69-1.14]; adjusted ROR, 0.40 [95% CI 0.27-0.61], respectively). In Latin America and Oceania, the reporting risk of dementia-related AEs associated with sacubitril/valsartan was similar to that associated with ARBs (adjusted ROR, 1.04 [95% CI 0.75-1.44]; adjusted ROR, 1.02 [95% CI 0.31-3.37], respectively). On the contrary, in North America, the reporting risk associated with sacubitril/valsartan was higher compared to ARBs (adjusted ROR, 1.29 [95% CI 1.10-1.53]). Although the ROR value did not meet the criteria for signal detection, the significantly greater than 1 ROR observed in North America suggests that caution may be warranted regarding potential dementia-related adverse events associated with sacubitril/valsartan.
本研究旨在使用亚组不均衡分析评估沙库巴曲缬沙坦在地理亚人群中与痴呆相关不良事件（AE）的关联。从 FDA 不良事件报告系统中分析了涉及沙库巴曲缬沙坦或血管紧张素受体阻滞剂（ARB）的年龄在 60 岁或以上的患者的病例。为每个大陆计算了与痴呆相关的 AE 的调整后报告比值比（ROR）。确定了 61518 例与沙库巴曲缬沙坦或 ARB 相关的 AE。其中，1441 例为痴呆相关 AE。在亚洲、欧洲和非洲，与沙库巴曲缬沙坦相关的痴呆相关 AE 的报告风险低于 ARB（调整后 ROR，0.57 [95%CI 0.31-1.01]；调整后 ROR，0.89 [95%CI 0.69-1.14]；调整后 ROR，0.40 [95%CI 0.27-0.61]）。在拉丁美洲和大洋洲，与沙库巴曲缬沙坦相关的痴呆相关 AE 的报告风险与 ARB 相似（调整后 ROR，1.04 [95%CI 0.75-1.44]；调整后 ROR，1.02 [95%CI 0.31-3.37]）。相反，在北美，与沙库巴曲缬沙坦相关的报告风险高于 ARB（调整后 ROR，1.29 [95%CI 1.10-1.53]）。尽管 ROR 值未达到信号检测标准，但在北美观察到显著大于 1 的 ROR 值表明，对于沙库巴曲缬沙坦相关的潜在痴呆相关不良事件，可能需要谨慎。
