August 31, 2023Advances in TherapyOpen Access

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

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Why the study?

Hypertensive patients with cardiovascular risk factors require more intensive blood pressure control, and single-pill combinations may benefit them by improving adherence.

Does a single-pill combination of olmesartan/amlodipine/hydrochlorothiazide improve blood pressure control in Korean patients with hypertension and cardiovascular risk factors?

Structured PICO

Does a single-pill combination of olmesartan/amlodipine/hydrochlorothiazide improve blood pressure control in Korean patients with hypertension and cardiovascular risk factors?

Population

South Korean patients with hypertension and cardiovascular risk factors (including 46.3% with diabetes mellitus)

Intervention

Single-pill combination (SPC) containing olmesartan, amlodipine, and hydrochlorothiazide (O/A/H)

Outcome

Blood pressure control rates (intensive: SBP < 130 mmHg and DBP < 80 mmHg; standard: < 140 mmHg and < 90 mmHg) and changes in SBP and DBP from baseline to week 24surrogate

A single-pill combination of olmesartan, amlodipine, and hydrochlorothiazide provides rapid and sustained blood pressure reduction in hypertensive patients with cardiovascular risk factors.

Implication

Supports real-world SPC use for adherence in high-risk hypertension; leaves open need for outcome RCTs.

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: (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 ).