Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Department of Epidemiology, UNC Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Pharmacotherapy. 2018 Jan;38(1):29-41. doi: 10.1002/phar.2051. Epub 2017 Dec 11.
To assess the incidence of and risk factors associated with severe adverse events in elderly patients who used angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) after an acute myocardial infarction (AMI).
Retrospective cohort study.
Centers for Medicare & Medicaid Services Chronic Conditions Data Warehouse (Medicare service claims database), American Community Survey of the U.S. Census Bureau, and Multum Lexicon Drug database.
A total of 101,588 eligible Medicare fee-for-service beneficiaries 66 years or older, who were hospitalized for AMI between January 1, 2008, and December 31, 2009, and used ACEIs or ARBs within 30 days after discharge.
Primary outcomes were hospitalizations for acute renal failure (ARF) and hyperkalemia. The secondary outcome was discontinuation or suspension of ACEI/ARB therapy after a visit to a health care provider. The primary risk factors of interest were age, sex, race/ethnicity, and chronic kidney disease (CKD). Cumulative incidence curves and multivariable Fine-Gray proportional hazards models with 95% confidence intervals (CIs) were used with death as a competing risk in both intention-to-treat (ITT) and as-treated (AT) analyses. In the study cohort, 2.8% experienced ARF, 0.5% experienced hyperkalemia, and 63.7% discontinued ACEI/ARB therapy within 1 year after hospital discharge. Approximately half of the incidence of ARF and hyperkalemia occurred within 6 months after hospital discharge, but the cumulative incidence increased after 6 months. Patients older than 85 years had a higher rate of ARF (ITT hazard ratio [HR] 1.15, 95% CI 1.04-1.28) and hyperkalemia (ITT HR 1.33, 95% CI 1.05-1.68) compared with those aged 65-74 years. Patients with baseline CKD had higher rates of ARF (ITT HR 1.61, 95% CI 1.42-1.82), hyperkalemia (ITT HR 1.41, 95% CI 1.11-1.77), and ACEI/ARB therapy discontinuation or suspension (ITT HR 1.05, 95% CI 1.02-1.09).
We found a low incidence of ARF and hyperkalemia in elderly patients treated with ACEIs or ARBs after AMI hospitalization. However, a high rate of treatment discontinuation might prevent a higher rate of occurrence of these events. Long-term careful monitoring of severe adverse events and timely discontinuation of ACEIs or ARBs among elderly patients with advancing age and CKD after an AMI is warranted in clinical practice.
评估老年患者在急性心肌梗死(AMI)后使用血管紧张素转换酶抑制剂(ACEI)或血管紧张素 II 受体阻滞剂(ARB)后发生严重不良事件的发生率和相关风险因素。
回顾性队列研究。
医疗保险和医疗补助服务中心慢性病数据仓库(医疗保险服务索赔数据库)、美国人口普查局的美国社区调查以及 Multum Lexicon 药物数据库。
共有 101588 名符合条件的 66 岁或以上的 Medicare 收费服务受益人的住院患者,他们在 2008 年 1 月 1 日至 2009 年 12 月 31 日期间因 AMI 住院,并且在出院后 30 天内使用 ACEI 或 ARB。
主要结局为急性肾衰竭(ARF)和高钾血症的住院治疗。次要结局是在就诊后停止或暂停 ACEI/ARB 治疗。感兴趣的主要风险因素是年龄、性别、种族/民族和慢性肾脏病(CKD)。在意向治疗(ITT)和实际治疗(AT)分析中,使用累积发生率曲线和多变量 Fine-Gray 比例风险模型,以死亡为竞争风险,置信区间(CI)为 95%。在研究队列中,2.8%的患者发生 ARF,0.5%的患者发生高钾血症,63.7%的患者在出院后 1 年内停止 ACEI/ARB 治疗。大约一半的 ARF 和高钾血症的发生率发生在出院后 6 个月内,但累积发生率在 6 个月后增加。年龄大于 85 岁的患者发生 ARF(ITT 风险比 [HR] 1.15,95%CI 1.04-1.28)和高钾血症(ITT HR 1.33,95%CI 1.05-1.68)的比率高于 65-74 岁的患者。基线 CKD 的患者发生 ARF(ITT HR 1.61,95%CI 1.42-1.82)、高钾血症(ITT HR 1.41,95%CI 1.11-1.77)和 ACEI/ARB 治疗停药或停药的比率更高(ITT HR 1.05,95%CI 1.02-1.09)。
我们发现,在 AMI 住院后接受 ACEI 或 ARB 治疗的老年患者中,ARF 和高钾血症的发生率较低。然而,较高的治疗停药率可能会阻止这些事件的发生率更高。在临床实践中,对于年龄较大且患有 CKD 的老年患者,在 AMI 后需要长期密切监测严重不良事件,并及时停止 ACEI 或 ARB 的使用。