Wang Yining, Ren Qidong, Luo HuiTing, Chen Gang, Zhao Bin, Li Xuemei
Nephrology Department, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, 100730 Beijing, China.
Pharmacy Department, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, 100730 Beijing, China.
Rev Cardiovasc Med. 2023 Apr 13;24(4):107. doi: 10.31083/j.rcm2404107. eCollection 2023 Apr.
The widely used Renin-angiotensin-aldosterone system inhibitor (RASI) may increase the risk of hyperkalemia and acute kidney injury (AKI). We aimed to analyze the RASI-related AKI or hyperkalemia reported in the Food and Drug Administration's Adverse Event Reporting System (FAERS) database to optimize patients' treatment and provide a reference for a clinically safe and rational prescription.
We obtained data in FAERS recorded from January 2004 to December 2020. Disproportionality analysis and Bayesian analysis were used in data mining to screen the suspected AKI or hyperkalemia after RASI. The time to onset, hospitalization, and prognosis of RASI-associated AKI or hyperkalemia were also investigated.
We identified 11,301 RASI-related adverse events (AEs) of hyperkalemia and AKI in the FAERS database; 4997 were due to Angiotensin-converting enzyme inhibitors (ACEIs), 5658 were due to angiotensin receptor blockers (ARBs), and 646 were due to the combination of ACEI and ARB. AKI was more commonly reported in patients with ARB (78.42%) than ACEI users (57.27%). Hyperkalemia cases were reported more in ACEI users (28.70%) than ARB users (14.14%). The median time to onset of RAS-associated AKI was 135.0 (17.0-620.0) days. RASI-associated hyperkalemia occurred relatively later in ACEI users, with a median onset time of 261.0 (43.0-1097.7) days, compared with that of 200.5 (52.0-636.0) days in ARB users ( 0.001). Among all AEs, 72.39% of cases received hospitalization. Death occurred in 6.3% of the renal AE cases. The elderly and heart failure were potential risk factors for death in patients who developed RASI-associated renal AEs, with an increased Odds Ratio (OR) compared with younger age (OR = 1.32) and hypertension patients (OR = 2.55). Based on the criteria of the four algorithms, the ACEI and ARB combination further increased the incidence of AKI and hyperkalemia, demonstrating the highest Reporting Odds Ratios (RORs), Proportional Reporting Ratios (PRRs) and Empirical Bayesian Geometric Average (EBGMs).
Patients who indicated RASI for heart failure demonstrated a higher death risk when AEs occurred. ACEI combined with ARB can increase the incidence of hyperkalemia and AKI. Careful and individualized management is necessary.
广泛使用的肾素 - 血管紧张素 - 醛固酮系统抑制剂（RASI）可能会增加高钾血症和急性肾损伤（AKI）的风险。我们旨在分析美国食品药品监督管理局不良事件报告系统（FAERS）数据库中报告的与RASI相关的AKI或高钾血症，以优化患者治疗，并为临床安全合理用药提供参考。
我们获取了FAERS中2004年1月至2020年12月记录的数据。数据挖掘中采用不成比例分析和贝叶斯分析来筛选RASI使用后疑似的AKI或高钾血症。还调查了RASI相关的AKI或高钾血症的发病时间、住院情况及预后。
我们在FAERS数据库中识别出11301例与RASI相关的高钾血症和AKI不良事件（AE）；4997例由血管紧张素转换酶抑制剂（ACEI）引起，5658例由血管紧张素受体阻滞剂（ARB）引起，646例由ACEI与ARB联合使用引起。与ACEI使用者（57.27%）相比，ARB使用者中AKI报告更为常见（78.42%）。ACEI使用者中高钾血症病例报告（28.70%）多于ARB使用者（14.14%）。RAS相关AKI的中位发病时间为135.0（17.0 - 620.0）天。ACEI使用者中RASI相关高钾血症发生相对较晚，中位发病时间为261.0（43.0 - 1097.7）天，而ARB使用者为200.5（52.0 - 636.0）天（P = 0.001）。在所有AE中，72.39%的病例接受了住院治疗。6.3%的肾脏AE病例发生了死亡。老年患者和心力衰竭是发生RASI相关肾脏AE患者死亡的潜在危险因素，与年轻患者（比值比[OR]=1.32）和高血压患者（OR = 2.55）相比，死亡风险增加。基于四种算法的标准，ACEI与ARB联合使用进一步增加了AKI和高钾血症的发生率，显示出最高的报告比值比（ROR）、比例报告比（PRR）和经验贝叶斯几何均值（EBGM）。
因心力衰竭使用RASI的患者在发生AE时死亡风险较高。ACEI与ARB联合使用会增加高钾血症和AKI的发生率。需要谨慎进行个体化管理。
