The objective of this study was to determine the safety and efficacy of fimasartan in elderly patients (age ≥60 year-old) with hypertension by measuring clinic and home blood pressure and compare with non-elderly patients.Design and Method:
K-MetS study was a nation-wide prospective observational study including primary care clinic to tertiary care hospital about antihypertensive treatment including fimasartan. Among the 6,399 study population, elderly patients (age ≥60 year-old) who were treated for 1 year with fimasartan (30–120 mg daily) were recruited, and the data were systematically collected using electronic case report forms. Written informed consent forms were obtained from all patients.Results:
A total of 2,363 elderly patients [1,109 (46.9%) males; mean age 67.3 ± 5.7 years] were evaluated. Overall, fimasartan reduced systolic blood pressure (SBP) from 144.15 ± 17.25 to 127.75 ± 12.87 mmHg and diastolic blood pressure (DBP) from 85.10 ± 10.41 to 76.84 ± 8.36 mmHg (all p < 0.0001). The heart rate was reduced from 72.65 ± 10.25 to 71.55 ± 9.2 beats/min within 1-year fimasartan-including antihypertensive treatment (p < 0.0001). This efficacy of fimasartan was consistent regardless of patient's sex, underlying medical condition or co-morbidities in elderly patients. Adverse events were reported in 37 (0.016%) patients. There were no dose dependencies for adverse events. Non-of these events lead to drug discontinuation. The goal achievement rate (combined SBP/DBP < 140/ 90 mmHg) and the responder rate (DBP to <90 mmHg or a reduction of ≥10 mmHg) were 1,914 subjects (81.0%) and 2253 subjects (95.3%), respectively without differences from none-elderly patients. 1-year fimasartan treatment efficacy was gradually progress over 1-year treatment especially for SBP reduction in home BP data.Conclusions:
1-year treatment of fimasartan in eldely patients reduced clinic and home BP to normal level. There were no serious adverse events that lead to drug discontinuation. The safety and efficacy of fimasartan were found to be excellent beyond the target BP achievement in a large elderly patient population.