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2018 (v.26 no.3)

Translational and Clinical Pharmacology

Korean Society for Clinical Pharmacology and Therapeutics
ISSN: 2289-0882

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

    Su-Eun Han, Seung Hee Jeong,, Hye Jeong Kang, Myung Sook Hong, Eunah Paek, Hijung Cho, Seong Choon Choe

    TCP | v.26, no.3, pp.118-127, Sep, 2018


    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 ≤ 140 mmHg or decreased SBP differences ≥
    20 mmHg after treatment or diastolic blood pressure (DBP) controlled to ≤ 90 mmHg or decreased
    DBP differences ≥ 10 mmHg 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.


    Fimasartan, Post marketing surveillance, Safety