Safety and efficacy of fimasartan with essential hypertension patients in real world clinical practice: data from a post marketing surveillance in Korea
10.12793/tcp.2018.26.3.118
- Author:
Su Eun HAN
1
;
Seung Hee JEONG
;
Hye Jeong KANG
;
Myung Sook HONG
;
Eunah PAEK
;
Hijung CHO
;
Seong Choon CHOE
Author Information
1. Seoul Research Institute, Boryung Pharmaceutical Co., Ltd., Seoul 03127, Republic of Korea. scchoejr@gmail.com
- Publication Type:Multicenter Study
- Keywords:
Fimasartan;
Post marketing surveillance;
Safety
- MeSH:
Blood Pressure;
Dizziness;
Drug-Related Side Effects and Adverse Reactions;
Follow-Up Studies;
Humans;
Hypertension;
Hypotension;
Korea;
Marketing;
Prospective Studies
- From:Translational and Clinical Pharmacology
2018;26(3):118-127
- CountryRepublic of Korea
- Language:English
-
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.
