Translational and Clinical Pharmacology

  • 제26권3호
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  • Pages.118-127
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  • 2018
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  • 2289-0882(pISSN)
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  • 2383-5427(eISSN)
대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
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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.)
  • 투고 : 2018.06.29
  • 심사 : 2018.08.14
  • 발행 : 2018.09.15
⟨ 이전 논문 다음 논문 ⟩

초록

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.

키워드

과제정보

연구 과제 주관 기관 : Boryung Pharmaceutical Co., Ltd.

참고문헌

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