Transl Clin Pharmacol.  2018 Sep;26(3):118-127. 10.12793/tcp.2018.26.3.118.

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

• Han SE
• Jeong SH
• Kang HJ
• Hong MS
• Paek E
• Cho H
• Choe SC

• KMID: 2420294
• DOI: http://doi.org/10.12793/tcp.2018.26.3.118

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

MeSH Terms

Blood Pressure
Dizziness
Drug-Related Side Effects and Adverse Reactions
Follow-Up Studies
Humans
Hypertension*
Hypotension
Korea*
Marketing*
Prospective Studies

Figure

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  Figure 1 Subject disposition. *Reason for exclusion: (1)=Administered prior to informed consent, (2)=Not administered fimasartan, (3)=Prohibited from receiving fimasarrtan, (4)=Lost to follow-up, (5)=Administration for < 8 weeks, (6)=Efficacy assessment not performed. **Reason for discontinuation: (7)=Poor response, (8)=Adverse events, (9)=No visit, (10)=Others.

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