Clinical characteristics and satisfaction with the fimasartan in Korean hypertensive patients: a prospective, cross-sectional and open-label, 8-week switching study (Kanarb-hypertension epidemiology medication satisfaction study; K-HEMS study)

Oh, Dong Joo; Han, Su Eun; Jeong, Seung Hee; Hong, Myung Sook; Choe, Seong Choon

Abstract

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).