565 STRONG SAFETYAND EFFICACY OFA NEW ANGIOTENSIN RECEPTOR BLOCKER FIMASARTAN, INPATIENTSWITHARTERIALHYPERTENSION

Abstract

Objective: To determine whether age, gender, concomitant disease and current antihypertensive medication affect the safety and efficacy offimasartan in the treatment of arterial hypertension. Study Design and Methods: This is a large-scale, open-label observational study to see the safety and efficacy of a newly-released antihypertensive drug, fimasartan, in patients with hypertension. Patients were recruited who was treated for more than 2 months with fimasartan (60–120 mg once daily) and data was systematically collected using electronic case report forms. Written consent form was received in all patients. Results: Atotalof14,151 patients (50.7%males,meanage59 ± 12years)were evaluated, of whom 37.9, 53.5, and 8.5%, respectively, were never-treated, added with and switched to fimasartan. Overall, fimasartan reduced systolic blood pressure from 145.4 ± 18.1mmHg to126.8 ± 12.6 mmHg and diastolic blood pressure from88.7 ± 11.8mmHgto79.0 ± 8.6mmHg (all p < 0.001). Pulse rate was also decreased from 74.4 ± 10.3 to 71.8 ± 9.2 (p < 0.001). Reductions were similar between genders, age groups and patients with and without comorbidities, and not dependent on prior or concomitant treatment with other antihypertensive drugs. Adverse effects were reported in 3.14% (overall) and 2.3% (drug-related) of patients, and there was no dose-difference. The most frequent adverse events were dizziness (49%), which is probably due to a strong blood pressure reduction. Global drug compliance rated as excellent, very good, good, and poor was respectively, 68.1%, 26.9%, 3.4% and 1.7% of patients. Conclusion: The safety, efficacy and compliance of fimasartan were found excellent in a large patient's population, including patients potentially at higher risk for adverse events.