Translational and Clinical Pharmacology

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
권호 표지
DOI QR코드

DOI QR Code

Safety and efficacy of fimasartan with essential hypertension patients in real world clinical practice: data from a post marketing surveillance in Korea

  • Han, Su-Eun (Seoul Research Institute, Boryung Pharmaceutical Co., Ltd.) ;
  • Jeong, Seung Hee (Seoul Research Institute, Boryung Pharmaceutical Co., Ltd.) ;
  • Kang, Hye Jeong (Seoul Research Institute, Boryung Pharmaceutical Co., Ltd.) ;
  • Hong, Myung Sook (Seoul Research Institute, Boryung Pharmaceutical Co., Ltd.) ;
  • Paek, Eunah (Seoul Research Institute, Boryung Pharmaceutical Co., Ltd.) ;
  • Cho, Hijung (Seoul Research Institute, Boryung Pharmaceutical Co., Ltd.) ;
  • Choe, Seong Choon (Seoul Research Institute, Boryung Pharmaceutical Co., Ltd.)
  • Received : 2018.06.29
  • Accepted : 2018.08.14
  • Published : 2018.09.15
⟨ Previous Next ⟩

Abstract

The safety and efficacy of fimasartan have been evaluated through post-marketing surveillance in real world clinical practice. The multi-center, prospective, open-label and non-interventional study. A total of 3,945 patients (3,729 patients for safety assessment and 3,473 patients for efficacy assessment) were screened in patients with essential hypertension in 89 study centers from 9 September 2010 through 8 September 2016. Among the total patients, 2,893 patients (77.6%) were administered fimasartan for 24 weeks or longer and were classified as 'patients with long-term follow-up', and the additional safety and efficacy analysis were performed. The improvement was defined as systolic blood pressure (SBP) controlled to ${\leq}140mmHg$ or decreased SBP differences ${\geq}20mmHg$ after treatment or diastolic blood pressure (DBP) controlled to ${\leq}90mmHg$ or decreased DBP differences ${\geq}10mmHg$ after treatment. Adverse drug reactions (ADRs) were reported in 3.8% patients; dizziness, and hypotension were the most frequently reported ADRs in total patients. The results of patients with long-term follow-up were comparable with total patients. The overall improvement rate in all efficacy assessment at the last visit was 87.1% (3,025/3,473 patients). The overall improvement rate of the patients with long-term follow-up was 88.9%. Fimasartan was well tolerated, with no new safety concerns identified and an effective treatment in the real world clinical practice for Korean patients with hypertension.

Keywords

Acknowledgement

Supported by : Boryung Pharmaceutical Co., Ltd.

References

  1. Lawes CM, Vander Hoorn S, Rodgers A, International Society of Hypertension. Global burden of blood-pressure-related disease, 2001. Lancet 2008;371:1513-1518. doi: 10.1016/S0140-6736(08)60655-8.
  2. Han MK, Huh Y, Lee SB, Park JH, Lee JJ, Choi EA, et al. Prevalence of stroke and transient ischemic attack in Korean elders: findings from the Korean Longitudinal Study on Health and Aging (KLoSHA). Stroke 2009;40:966-969. doi: 10.1161/STROKEAHA.108.524983.
  3. Choi CU, Park CG. Estimating the probability of stroke in Korean hypertensive patients visiting tertiary hospitals using a risk profile from the Framingham study. BMC Neurol 2009;9:16. doi: 10.1186/1471-2377-9-16.
  4. Shin CY, Yun KE, Park HS. Blood pressure has a greater impact on cardiovascular mortality than other components of metabolic syndrome in Koreans. Atherosclerosis 2009;205:614-619. doi: 10.1016/j.atherosclerosis.2009.01.014.
  5. Murray CJL, Lopez AD.The global burden of disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Boston, MA: Harvard University Press, 1996, ISBN: 0-9655466-0-8
  6. Antonaccio MJ, Wright JJ. Enzyme inhibitors of the renin-angiotensin system. Prog Drug Res 1987;31:161-191.
  7. Wood SM, Mann RD, Rawlins MD. Angio-oedema and urticaria associated with angiotensin converting enzyme inhibitors. Br Med J (Clin Res Ed) 1987;294:91-92. https://doi.org/10.1136/bmj.294.6564.91
  8. Gravras H, Gravras I. Angiotensin converting enzyme inhibitors. Properties and side effects. Hypertension 1998;11:II37-II41.
  9. Lee HY, Oh BH. Fimasartan: A new angiotensin receptor blocker. Drugs 2016;76:1015-1022. doi: 10.1007/s40265-016-0592-1.
  10. Lee H, Yang HM, Lee HY, Kim JJ, Choi DJ, Seung KB, 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;34:1273-1289. doi: 10.1016/j.clinthera.2012.04.021.
  11. Lee H, Kim KS, Chae SC, Jeong MH, Kim DS, Oh BH. Ambulatory blood pressure response to once-daily fimasartan: an 8-week, multicenter, randomized, double-blind, active-comparator, parallel-group study in Korean patients with mild to moderate essential hypertension. Clin Ther 2013;35:1337-1349. doi: 10.1016/j.clinthera.2013.06.021.
  12. Lee SE, Kim YJ, Lee HY, Yang HM, Park CG, Kim JJ, 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 mildto-moderate hypertension. Clin Ther 2012;34:552-568, 568.e1-9. doi:10.1016/j.clinthera.2012.01.024.
  13. Lee JH, Yang DH, Hwang JY, Hur SH, Cha TJ, Kim KS, et al. A randomized, Double-blind, Candesartan-controlled, Parallel group comparison clinical trial to evaluate the antihypertensive efficacy and safety of fimasartan in patients with mild to moderate essential hypertension. Clin Ther 2016;38:1485-1497. doi: 10.1016/j.clinthera.2016.04.005.
  14. Naritomi H, Fujita T, Ito S, Ogihara T, Shimada K, Shimamoto K,, et al. Efficacy and safety of long-term losartan therapy demonstrated by a prospective observational study in Japanese patients with hypertension: The Japan Hypertension Evaluation with Angiotensin II Antagonist Losartan Therapy (J-HEALTH) study. Hypertens Res 2008;31:295-304. doi: 10.1291/hypres.31.295.
  15. Park JB, Sung KC, Kang SM, Cho EJ. Safety and efficacy of fimasartan in patients with arterial hypertension (Safe-KanArb study): an open-label observational study. Am J Cardiovasc Drugs 2013;13:47-56. doi: 10.1007/s40256-013-0004-9.
  16. Youn JC, Ihm SH, Bae JH, Park SM, Jeon DW, Jung BC, et al. Efficacy and safety of 30-mg fimasartan for the treatment of patients with mild to moderate hypertension: an 8-week, multicenter, randomized, doubleblind, phase III clinical study. Clin Ther 2014;36:1412-1421. doi: 10.1016/j.clinthera.2014.07.004.
  17. Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, 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: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension 2018;71:1269-1324.doi: 10.1161/HYP.0000000000000066.