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Original Research

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

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Pages 1341-1349 | Published online: 03 Apr 2020

References

  • WHO. Global Brief on Hypertension: Silent Killer, Global Public Health Crisis; 2013.
  • WheltonPK, CareyRM, AronowWS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018;71(19):e127–e248. doi:10.1016/j.jacc.2017.11.00629146535
  • LeeH, ParkS, KimHC. Temporal and geospatial trends of hypertension management in Korea: a nationwide study 2002–2016. Korean Circ J. 2019;49(6):514–527. doi:10.4070/kcj.2018.035830808085
  • ShahSJ, StaffordRS. Current trends of hypertension treatment in the United States. Am J Hypertens. 2017;30(10):1008–1014. doi:10.1093/ajh/hpx08528531239
  • KimHC, ChoMC; Korean Society H, Hypertension Epidemiology Research Working G. Korea hypertension fact sheet 2018. Clin Hypertens. 2018;24:13. doi:10.1186/s40885-018-0098-030288297
  • KimI, ParkCS, LeeHY. Angiotensin II Type 1 receptor blocker, fimasartan, reduces vascular smooth muscle cell senescence by Inhibiting the CYR61 signaling pathway. Korean Circ J. 2019;49(7):615–626. doi:10.4070/kcj.2018.037931074217
  • LeeHY, OhBH. Fimasartan: a new angiotensin receptor blocker. Drugs. 2016;76(10):1015–1022. doi:10.1007/s40265-016-0592-127272555
  • KimJH, LeeJH, PaikSH, KimJH, ChiYH. Fimasartan, a novel angiotensin II receptor antagonist. Arch Pharm Res. 2012;35(7):1123–1126. doi:10.1007/s12272-012-0700-z22864732
  • LeeHY, KimCH, SongJK, et al. 24-Hour blood pressure response to lower dose (30 mg) fimasartan in Korean patients with mild to moderate essential hypertension. Korean J Intern Med. 2017;32(6):1025–1036. doi:10.3904/kjim.2016.09429032666
  • LeeH, YangHM, LeeHY, et al. Efficacy and tolerability of once-daily oral fimasartan 20 to 240 mg/d in Korean patients with hypertension: findings from Two Phase II, randomized, double-blind, placebo-controlled studies. Clin Ther. 2012;34(6):1273–1289.22608107
  • LeeSE, KimYJ, LeeHY, et al. Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, compared with losartan (50/100 mg): a 12-week, Phase III, multicenter, prospective, randomized, double-blind, parallel-group, dose escalation clinical trial with an optional 12-week extension phase in adult Korean patients with mild-to-moderate hypertension. Clin Ther. 2012;34(3):552–568, 568 e551–e559. doi:10.1016/j.clinthera.2012.01.024
  • ChiYH, LeeH, PaikSH, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of fimasartan following single and repeated oral administration in the fasted and fed states in healthy subjects. Am J Cardiovasc Drugs. 2011;11(5):335–346. doi:10.2165/11593840-000000000-0000021910510
  • ParkDH, YunGY, EunHS, et al. Fimasartan-induced liver injury in a patient with no adverse reactions on other types of angiotensin II receptor blockers: a case report. Medicine (Baltimore). 2017;96(47):e8905. doi:10.1097/MD.000000000000890529382024
  • LeeHY, ShinJ, KimGH, et al. 2018 Korean Society of Hypertension Guidelines for the management of hypertension: part II-diagnosis and treatment of hypertension. Clin Hypertens. 2019;25:20. doi:10.1186/s40885-019-0124-x31388453
  • KimHC, IhmSH, KimGH, et al. 2018 Korean Society of Hypertension guidelines for the management of hypertension: part I-epidemiology of hypertension. Clin Hypertens. 2019;25:16. doi:10.1186/s40885-019-0121-031388451
  • HoofnagleJH, BjörnssonES. Drug-induced liver injury — types and phenotypes. N Engl J Med. 2019;381(3):264–273. doi:10.1056/NEJMra181614931314970
  • Robles-DiazM, LucenaMI, KaplowitzN, et al. Use of Hy’s law and a new composite algorithm to predict acute liver failure in patients with drug-induced liver injury. Gastroenterology. 2014;147(1):109–118 e105. doi:10.1053/j.gastro.2014.03.05024704526
  • United States. Congress. Office of Technology Assessment. Postmarketing Surveillance of Prescription Drugs. Washington, D.C.: Congress of the United States For sale by the Supt. of Docs., U.S. G.P.O.; 1982.
  • YounJC, IhmSH, BaeJH, et al. Efficacy and safety of 30-mg fimasartan for the treatment of patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, phase III clinical study. Clin Ther. 2014;36(10):1412–1421. doi:10.1016/j.clinthera.2014.07.00425092393
  • AndradeRJ, LucenaMI, FernandezMC, et al. Cholestatic hepatitis related to use of irbesartan: a case report and a literature review of angiotensin II antagonist-associated hepatotoxicity. Eur J Gastroenterol Hepatol. 2002;14(8):887–890. doi:10.1097/00042737-200208000-0001412172412
  • Lammel-LindemannJA, Flores-VillalbaE, MartagonAJ, DeObeso-GonzalezE, Puente-GallegosF. Noncholestatic acute hepatocellular injury following candesartan administration. Br J Clin Pharmacol. 2018;84(1):204–207. doi:10.1111/bcp.v84.128841231
  • VisserLE, StrickerBH, van der VeldenJ, PaesAH, BakkerA. Angiotensin converting enzyme inhibitor associated cough: a population-based case-control study. J Clin Epidemiol. 1995;48(6):851–857. doi:10.1016/0895-4356(94)00231-E7769416
  • CaldeiraD, DavidC, SampaioC. Tolerability of angiotensin-receptor blockers in patients with intolerance to angiotensin-converting enzyme inhibitors: a systematic review and meta-analysis. Am J Cardiovasc Drugs. 2012;12(4):263–277. doi:10.1007/BF0326183522587776
  • GilesTD, OparilS, SilfaniTN, WangA, WalkerJF. Comparison of increasing doses of olmesartan medoxomil, losartan potassium, and valsartan in patients with essential hypertension. J Clin Hypertens (Greenwich). 2007;9(3):187–195. doi:10.1111/j.1524-6175.2007.06395.x17341994
  • BurkeTA, SturkenboomMC, LuSE, WentworthCE, LinY, RhoadsGG. Discontinuation of antihypertensive drugs among newly diagnosed hypertensive patients in UK general practice. J Hypertens. 2006;24(6):1193–1200. doi:10.1097/01.hjh.0000226211.95936.f516685222
  • WilliamsB, ManciaG, SpieringW, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J. 2018;39(33):3021–3104.30165516
  • GuptaAK, ArshadS, PoulterNR. Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a meta-analysis. Hypertension. 2010;55(2):399–407. doi:10.1161/HYPERTENSIONAHA.109.13981620026768
  • VrijensB, VinczeG, KristantoP, UrquhartJ, BurnierM. Adherence to prescribed antihypertensive drug treatments: longitudinal study of electronically compiled dosing histories. BMJ. 2008;336(7653):1114–1117. doi:10.1136/bmj.39553.670231.2518480115
  • CurbJD, BorhaniNO, BlaszkowskiTP, ZimbaldiN, FotiuS, WilliamsW. Long-term surveillance for adverse effects of antihypertensive drugs. JAMA. 1985;253(22):3263–3268. doi:10.1001/jama.1985.033504600630223999311
  • NygaardB, StrandgaardS. Marked hepatotoxicity associated with losartan treatment. Blood Press. 1996;5(3):190–191. doi:10.3109/080370596090621288790930
  • TabakF, MertA, OzarasR, et al. Losartan-induced hepatic injury. J Clin Gastroenterol. 2002;34(5):585–586. doi:10.1097/00004836-200205000-0002211960076
  • ReneJM, BuenestadoJ, SeseE, MinanaJM. [Acute hepatitis induced by valsartan]. Med Clin (Barc). 2001;117(16):637–638. doi:10.1016/s0025-7753(01)72204-x