Real-World Effectiveness and Safety of a Single-Pill Combination of Olmesartan/Amlodipine/Hydrochlorothiazide in Korean Patients with Hypertension and Cardiovascular Risk Factors

Abstract

Introduction: Patients with hypertension and additional cardiovascular risk factors pose a challenge by requiring more intensive blood pressure (BP) control. Single-pill combination (SPC) therapy can benefit these patients by improving medication adherence.

Methods: This prospective, multicenter observational study assessed the real-world safety and effectiveness of an SPC containing olmesartan, amlodipine, and hydrochlorothiazide (O/A/H) in South Korean patients with hypertension and cardiovascular risk factors. BP control rates, defined as the percentage of patients achieving systolic BP (SBP) < 130 mmHg and diastolic BP (DBP) < 80 mmHg for intensive BP control, and < 140 mmHg and < 90 mmHg, respectively, for standard BP control, were investigated across various cardiovascular risk groups, along with changes in SBP and DBP from baseline to week 24.

Results: The most prevalent cardiovascular risk factor was age (≥ 45 years in men, ≥ 55 years in women, 86.1%), followed by cardiovascular diseases (64.4%), dyslipidemia (53.7%), body mass index ≥ 25 kg/m² (53.5%), and diabetes mellitus (DM) (46.3%). Switching to O/A/H showed significant BP reduction, with a mean change of - 17.8 mmHg/- 9.3 mmHg in SBP/DBP within 4 weeks. The intensive BP control rate was 41.4% (95% confidence interval [CI] 39.5, 43.4), and the standard BP control rate was 73.3% (95% CI 71.5, 75.1), with better control rates in the risk age group (43.1% and 74.1%, respectively) and cardiovascular disease group (42.0% and 73.8%, respectively). The DM group had relatively lower control rates (37.5% for intensive control and 69.4% for standard control). Common adverse drug reactions included dizziness (2.91%), hypotension (1.51%), and headaches (0.70%).

Conclusion: The SPC therapy of O/A/H caused a rapid and sustained reduction in SBP/DBP in patients' hypertension and additional cardiovascular risk factors. The therapy was safe and well tolerated.

Study registration number: KCT0003401 ( https://cris.nih.go.kr/cris/search/detailSearch.do/20795 ).

Keywords: Olmesartan-based combination therapy; Patients with hypertension and additional cardiovascular risk factors; Real-world effectiveness of blood pressure control; Single-pill combination.

Fig. 1

Patient selection process. DBP diastolic blood pressure, SBP systolic blood pressure

Fig. 2

Blood pressure control rates according to a the standard criteria or b intensive criteria. BMI body mass index, CI confidence interval, CKD chronic kidney disease, CVD cardiovascular disease, DM diabetes mellitus

Fig. 3

Subgroup analysis for mean change in BP at week 24 from baseline. a Subgroups are based on the number of classes of previous antihypertensive agents. b Subgroups are based on the combinations of classes of antihypertensive agents taken prior to the study. c Mean BP change in the subgroup of patients using the triple combination of ARB, CCB, and DU before the study is presented. *ARB, CCB refers to the subgroup of patients using ARB, CCB combination treatment before the study. ^†ARB, DU refers to the subgroup of patients using ARB, DU combination treatment before the study. ^‡ARB, CCB, BB refers to the subgroup of patients using ARB, CCB, BB combination treatment before the study. ^§ARB, CCB, DU refers to the subgroup of patients using ARB, CCB, DU combination treatment before the study. ^‖ARB, DU, BB refers to the subgroup of patients using ARB, DU, BB combination treatment before the study. ^¶Three-pill for ARB, CCB, DU refers to the subgroup of patients using three individual pills for ARB, CCB, and DU combination treatment before the study. ^◊Two-pill for ARB, CCB, DU refers to the subgroup of patients using two individual pills for ARB, CCB, and DU combination treatment before the study. ^↓A single-asterisk sign (*) indicates P < 0.05 versus the baseline and a double-asterisk sign (**) indicates P < 0.05 versus the comparator group. ARB angiotensin receptor blocker, BB beta-blocker, BP blood pressure, CCB calcium channel blocker, DU diuretic, DBP diastolic blood pressure, SBP systolic blood pressure