Quantitative Safety and Epidemiology, Novartis Pharma AG, WSJ-027.3.021, Postfach, 4002, Basel, Switzerland.
Health Economics and Outcomes Research, Quintiles IMS, One IMS Drive, Plymouth Meeting, PA, 19462, USA.
Am J Cardiovasc Drugs. 2017 Dec;17(6):465-474. doi: 10.1007/s40256-017-0242-3.
A non-interventional study suggested that use of angiotensin-converting enzyme inhibitors (ACEIs) or aliskiren was associated with an angioedema risk three times that of beta-blockers (BBs).
The aim was to assess angioedema incidence rates (IRs) and the relative angioedema risk of aliskiren compared to other antihypertensive drugs (AHDs).
A cohort study in hypertensive patients with an AHD prescription between 2007 and 2012 was conducted using data from the US PharMetrics Plus™ claims database. Angioedema was identified using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9CM) code 995.1. Additionally, a nested case-control analysis was conducted to assess the relative angioedema risk of aliskiren or other AHDs versus BBs.
A total of 3,090,114 patients were included (aliskiren n = 30,720). There were 15,744 angioedema events (IR 2.28/1000 person-years; 95% confidence interval (CI) 2.24-2.32). Aliskiren IRs were: any aliskiren 2.58 (2.08-3.17), aliskiren monotherapy 1.71 (0.74-3.37), aliskiren fixed-dose combination (FDC) 1.27 (0.41-2.96), and aliskiren free-standing combination (FSC) 2.93 (2.31-3.66). The case-control analysis included 15,100 angioedema cases and 60,400 controls; the angioedema risk for both aliskiren monotherapy and FDC was not significantly different from BBs [adjusted odds ratio (adjOR) 0.99 (95% CI 0.45-2.20) and 1.06 (0.40-2.76)]; aliskiren FSC was associated with an increased angioedema risk [adjOR 3.29 (2.42-4.48)], mainly driven by concomitant ACEI use [adjOR 7.03 (4.10-12.05)].
The IR and risk of angioedema in patients with aliskiren monotherapy or FDC are comparable to BBs. The higher IR and risk of angioedema identified in the aliskiren FSC group may largely be driven by the concomitant use of ACEIs.
一项非干预性研究表明，血管紧张素转换酶抑制剂（ACEI）或阿利克仑的使用与血管性水肿风险是β受体阻滞剂（BB）的三倍。
旨在评估阿利克仑与其他抗高血压药物（AHD）相比的血管性水肿发生率（IR）和相对血管性水肿风险。
使用美国 PharMetrics Plus™索赔数据库中的数据，对 2007 年至 2012 年间有 AHD 处方的高血压患者进行了队列研究。血管性水肿使用国际疾病分类，第九修订版，临床修正（ICD-9CM）代码 995.1 进行识别。此外，还进行了嵌套病例对照分析，以评估阿利克仑或其他 AHD 与 BB 相比的相对血管性水肿风险。
共纳入 3090114 名患者（阿利克仑 n=30720）。共有 15744 例血管性水肿事件（IR 2.28/1000人年；95%置信区间（CI）2.24-2.32）。阿利克仑 IRs 为：任何阿利克仑 2.58（2.08-3.17），阿利克仑单药治疗 1.71（0.74-3.37），阿利克仑固定剂量复方（FDC）1.27（0.41-2.96），和阿利克仑游离复方（FSC）2.93（2.31-3.66）。病例对照分析包括 15100 例血管性水肿病例和 60400 例对照；阿利克仑单药治疗和 FDC 的血管性水肿风险与 BB 无显著差异[校正比值比（adjOR）0.99（95%CI 0.45-2.20）和 1.06（0.40-2.76）]；阿利克仑 FSC 与血管性水肿风险增加相关[adjOR 3.29（2.42-4.48）]，主要由同时使用 ACEI 引起[adjOR 7.03（4.10-12.05）]。
阿利克仑单药治疗或 FDC 的患者的 IR 和血管性水肿风险与 BB 相当。在阿利克仑 FSC 组中观察到的更高的 IR 和血管性水肿风险可能主要是由同时使用 ACEI 引起的。
