Safety and efficacy of fimasartan with essential hypertension patients in real world clinical practice: data from a post marketing surveillance in Korea
Translational and Clinical Pharmacology
; : 118-127, 2018.
Article
in En
| WPRIM
| ID: wpr-742413
Responsible library:
WPRO
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.
Key words
Full text:
1
Index:
WPRIM
Main subject:
Blood Pressure
/
Prospective Studies
/
Follow-Up Studies
/
Marketing
/
Dizziness
/
Drug-Related Side Effects and Adverse Reactions
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Hypertension
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Hypotension
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Korea
Type of study:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Screening_studies
Limits:
Humans
Country/Region as subject:
Asia
Language:
En
Journal:
Translational and Clinical Pharmacology
Year:
2018
Type:
Article