Incidence and Pattern of Aminotransferase Elevation During Anti-Hypertensive Therapy With Angiotensin-II Receptor Blockers
10.3346/jkms.2022.37.e255
- Author:
Won Joon CHOI
1
;
Gi-Ae KIM
;
Jaewon PARK
;
Sangmi JANG
;
Woo Jin JUNG
;
Jae-Jun SHIM
;
Yewan PARK
;
Gwang Hyeon CHOI
;
Jin-Wook KIM
;
Sook-Hyang JEONG
;
Eun Sun JANG
Author Information
1. Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
- Publication Type:Original Article
- From:Journal of Korean Medical Science
2022;37(33):e255-
- CountryRepublic of Korea
- Language:English
-
Abstract:
Background:Angiotensin type II receptor blockers (ARBs) are the most widely used antihypertensive drugs. This study aimed to elucidate the likelihood and pattern of ARB-induced liver injury in a hospital-based cohort.
Methods:Data of patients receiving fimasartan (n = 5,543), candesartan (n = 6,406), valsartan (n = 6,040), and losartan (n = 9,126) were retrieved from the clinical data warehouse of two tertiary hospitals. Patients with alanine aminotransferase (ALT) levels > 5 times the upper normal limit were assessed according to the Roussel Uclaf Causality Assessment Method (RUCAM).
Results:A total of 27,115 patients were enrolled, including 14,630 (54.0%) men, with a mean age of 64.6 years (standard deviation, 13.6). During 31,717 person-years of ARB therapy, serum ALT levels > 120 IU/L were found in 558 (2.1%) person-years, and levels > 200 IU/L were found in 155 (0.6%) person-years. The incidence of ALT elevation > 120 IU/L per 10 6cumulative defined daily doses was 6.6, 3.6, 3.9, and 4.0 in the fimasartan, candesartan, valsartan, and losartan groups, respectively (P = 0.002). An ALT level > 200 IU/L with RUCAM score ≥ 6 was found in 20 patients, suggesting probable drug-induced liver injury for 11 (0.2%) patients receiving fimasartan, five (0.1%) receiving candesartan, four (0.1%) receiving valsartan, and none receiving losartan (P < 0.001).
Conclusion:Approximately 2% of patients receiving ARB therapy had significant ALT elevation (4.24/10 6 cumulative defined daily doses [cDDDs]), which was associated with probable ARB-related liver injury in 0.07% of patients (0.15/10 6 cDDDs). Elevation of ALT was more commonly associated with fimasartan than the other ARBs. Clinicians should be aware of the possibility of ARB-related ALT elevation in patients with unexplained chronic abnormal ALT.
