Reichman Marsha E, Wernecke Michael, Graham David J, Liao Jiemin, Yap John, Chillarige Yoganand, Southworth Mary Ross, Keeton Stephine, Goulding Margie R, Mott Katrina, Kelman Jeffrey A
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Acumen LLC, Burlingame, CA, USA.
Pharmacoepidemiol Drug Saf. 2017 Oct;26(10):1190-1196. doi: 10.1002/pds.4260. Epub 2017 Jul 19.
Assess angioedema risk with exposure to angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) compared with beta-blockers, by race/ethnicity.
New-user cohorts of Medicare beneficiaries 65 years or older initiating ACEI, ARB, or beta-blocker treatment from March 2007 to March 2014 were constructed. Angioedema incidence rates by drug and race/ethnicity were computed for 1-30 and 31-365 days of treatment. Cox proportional hazards regression was used to examine angioedema risk between cohorts.
Angioedema incidence rates (per 1000 person years) in beta-blocker users were 1.80 (whites), 4.11 (blacks), 1.89 (Asians), and 2.10 (Hispanics); in ACEI users, 4.03, 23.77, 2.94, and 4.27; and in ARB users, 1.73, 3.11, 1.10, and 1.90, respectively. Incidence rates were significantly higher in the first 30 days of exposure for all drug × race/ethnic groups. Overall, angioedema risk increased among ACEI users (hazard ratio, 2.91; 95% confidence interval, 2.75-3.07) but not ARB users (0.93, 0.85-1.02) versus beta-blocker users. Angioedema risk with ACEIs versus beta-blockers increased more in blacks (6.28, 5.44-7.24) than whites (2.33, 2.19-2.48), Hispanics (2.04, 1.36-3.07), and Asians (1.48, 0.94-2.35). Compared with white beta-blocker users, angioedema risk was increased 2.9-fold in whites, 20.2-fold in blacks, and 2.3-fold in other race/ethnic groups combined during the first 30 days of ACEI exposure.
There was significant effect modification of angioedema risk by race and ACEI use for blacks, but not for other race/ethnicity groups. Angioedema risk was significantly greater in the first 30 days of exposure for all, and highest among blacks.
按种族/民族评估与β受体阻滞剂相比，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）时发生血管性水肿的风险。
构建2007年3月至2014年3月开始使用ACEI、ARB或β受体阻滞剂治疗的65岁及以上医疗保险受益人的新用户队列。计算治疗1 - 30天和31 - 365天按药物和种族/民族划分的血管性水肿发病率。使用Cox比例风险回归分析各队列之间的血管性水肿风险。
β受体阻滞剂使用者的血管性水肿发病率（每1000人年）分别为：白人1.80、黑人4.11、亚洲人1.89、西班牙裔2.10；ACEI使用者分别为4.03、23.77、2.94、4.27；ARB使用者分别为1.73、3.11、1.10、1.90。所有药物×种族/民族组在暴露的前30天发病率显著更高。总体而言，与β受体阻滞剂使用者相比，ACEI使用者的血管性水肿风险增加（风险比，2.91；95%置信区间，2.75 - 3.07），而ARB使用者未增加（0.93，0.85 - 1.02）。与β受体阻滞剂使用者相比，ACEI使用者发生血管性水肿的风险在黑人中（6.28，5.44 - 7.24）比白人（2.33，2.19 - 2.48）、西班牙裔（2.04，1.36 - 3.07）和亚洲人（1.48，0.94 - 2.35）增加得更多。与白人β受体阻滞剂使用者相比，在ACEI暴露的前30天，白人血管性水肿风险增加2.9倍，黑人增加20.2倍，其他种族/民族组合计增加2.3倍。
种族和ACEI使用对黑人血管性水肿风险有显著的效应修正作用，但对其他种族/民族组没有。所有人群在暴露的前30天血管性水肿风险显著更高，且在黑人中最高。
