Fimasartan-induced liver injury in a patient with no adverse reactions on other types of angiotensin II receptor blockers

Abstract

Rationale:Angiotensin II receptor blockers (ARBs) are widely used for patients with hypertension, and fimasartan is a recently approved ARBs. Fimasartan can cause headache, dizziness, itching, and coughing. There have been several reports of hepatotoxicity in ARBs. However, there have not yet been published reports of the hepatotoxicity of fimasartan.Patient concerns:A 73-year-old man with hypertension experienced liver injury after fimasartan administration. He had a previous history of taking 3 types of ARBs each for more than 2 years before taking fimasartan, and there were no side effects on ARBs except for fimasartan.Diagnoses:Other factors that could cause liver injury were excluded in diagnostic tests, and fimasartan was suspected to be the causative agent.Intervention:Fimasartan was immediately discontinued and the patient was managed with supportive care via hepatotonics.Diagnoses:Other factors that could cause liver injury were excluded in diagnostic tests, and fimasartan was suspected to be the causative agent.Outcome:The liver injury due to fimasartan was confirmed by histology and accidental redosing.Lessons:We emphasize that liver function should be monitored during fimasartan administration because fimasartan may cause hepatotoxicity in patients who have no side effects with other types of ARBs. And fimasartan-induced liver injury may appear later than other ARBs.

<p>Long-Term Safety of a Novel Angiotensin Receptor Blocker, Fimasartan, According to the Absence or Presence of Underlying Liver Disease in Korean Hypertensive Patients: A Prospective, 12-Month, Observational Study</p>

“…Furthermore, there have been concerns that fimasartan might be related to liver toxicity due to its predominant hepatobiliary excretion. 13,20,21 The results of this prospective study provide reliable evidence that fimasartan could be a safe choice for long-term treatment of HTN, regardless of underlying liver disease.…”

“…32 Fimasartan has also been reported to have caused liver damage in a patient who had tolerated previous ARB use. 13 According to previous Figure 2 The risk of adverse events according to chronic liver disease is not significantly different between exploratory subgroups. Abbreviations: OR, odds ratio; CI, confidence interval.…”

“…In patients with chronic liver disease, serum AST and total bilirubin levels were significantly higher at baseline (Table 1), and the difference persisted throughout the study period (Table 4). During follow-up, liver function enzyme abnormalities were more frequently observed in patients with chronic liver disease (10.8% [13] vs 3.6% [16], p=0.001). In detail, there were 7 cases of hepatocellular injury, 1 case of cholestatic injury, and 5 cases of mixed type injury observed in the chronic liver disease group, whereas 14 cases of hepatocellular injury, 1 case of cholestatic injury, and 1 case of mixed type injury were observed in the normal liver function group.…”

“…Furthermore, clinicians have also expressed concerns that long-term use of fimasartan may be associated with increased risk of liver injury, especially in patients with underlying liver disease. 13 However, previous studies have only been performed for limited periods, and most studies excluded patients with chronic liver disease.…”

Incidence and Pattern of Aminotransferase Elevation During Anti-Hypertensive Therapy With Angiotensin-II Receptor Blockers

“…To date, few case reports have described ARB-induced liver injury. 9 10 11 12 Most cohort studies have not reported detailed liver injury incidence and outcomes related to ARB-related DILI, instead only the overall, severe adverse drug-related reaction rates have been reported. 8 …”