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2018 (v.26 no.3)

Translational and Clinical Pharmacology

Korean Society for Clinical Pharmacology and Therapeutics
Quarter
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

    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 ≤ 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.

    Keyword

    Fimasartan, Post marketing surveillance, Safety