RESUMO
BACKGROUND: Fimasartan (Kanarb; Boryung Pharmaceutical Co., Ltd., Seoul, Republic of Korea) is a non-protein angiotensin II receptor blocker that selectively blocks the AT1 receptor. No prior large-scale study has investigated the impact of demographics, disease, treatment, and clinical characteristics on medication satisfaction and quality of life in Korean hypertensive patients. Additionally, it is unclear whether increased medication compliance affects the achievement of hypertension treatment objectives. METHODS: This was a multicenter, non-interventional, open-label and 8-week switching study. This study was divided into 2 steps. STEP I was a cross-sectional study composed entirely of hypertensive patients undergoing treatment and STEP II was a prospective observational study of hypertensive patients switching to fimasartan. A total of 12,244 and 2023 patients were analyzed in the STEP I and STEP II groups, respectively. In STEP I, we investigated demographics, clinical, disease, and treatment characteristics at the registration point and then analyzed medication satisfaction, patient compliance, and quality of life. In STEP II, the patients who switched to fimasartan were followed up for 8 weeks, and the data analyzed included changes in medication effects, satisfaction, compliance, and adverse events. RESULTS: Some baseline characteristics, such as sex, body mass index, region of residence, educational level, and income level, affected the quality of life and medication duration in hypertensive patients. At 4 and 8 weeks, 62.5 and 69.9% of patients, respectively, reached their target blood pressure. The medication satisfaction scores were increased 4.0 ± 1.2, 5.1 ± 1.1, and 5.4 ± 1.0 at baseline, 4 weeks, and 8 weeks, respectively, and the difference was statistically significant (p < 0.0001). Most patients (76.4%) who changed from prior antihypertensive drug to fimasartan were not satisfied with conventional antihypertensive drugs (e.g., lack of efficacy). Among 2183 patients, 234 adverse events occurred in 151 (6.9%) and 50 adverse drug reactions occurred in 39 (1.8%). CONCLUSION: The demographic, clinical, disease, and treatment characteristics of hypertensive patients were investigated in this study. After switching to fimasartan, blood pressure was significantly decreased and patient satisfaction was improved. Fimasartan treatment was well tolerated and safe in hypertensive patients in Korea.Trial registration. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: (NCT02394392).
RESUMO
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.
