Single-Pill Combination Olmesartan/Amlodipine/Hydrochlorothiazide Safety and Effectiveness in Older Patients with Hypertension: Pooled Analysis of Post-Approval Observational Studies

INTRODUCTION: Despite needing intensive blood pressure (BP) control, elderly patients with hypertension may be undertreated because of concern about potential hypotension-related adverse events (AEs). Many older patients need combination therapy to achieve BP targets. This study investigated whether single-pill combination (SPC) antihypertensive therapy may benefit such patients. METHODS: This study analyzed pooled data from patients treated with olmesartan/amlodipine/hydrochlorothiazide (O/A/H) SPC therapy in three multicenter, prospective, observational studies (RESOLVE, RESOLVE-PRO and RESOLVE-INT) in South Korea. The primary endpoint was the incidence of hypotension-related AEs (hypotension/orthostatic hypotension, dizziness/postural dizziness, syncope, falls/fractures), stratified by age: < 65 years (non-elderly), 65‒79 years (elderly), and ≥ 80 years (very elderly). Secondary endpoints included hypotension-related AEs stratified by O/A/H dose and by baseline systolic BP (SBP) and diastolic BP (DBP), and SBP change from baseline to Week 24, and at Weeks 8, 16 and 24, stratified by age. RESULTS: From 16,646 pooled participants, 10,948 met the inclusion criteria and received ≥ 1 dose of O/A/H (safety set): 5892 were < 65 years old, 4143 were 65-79, and 911 were aged ≥ 80 years (two had missing age data). The effectiveness set comprised 9292 with complete BP data. Hypotension-related AEs occurred in 4.82% (95% CI 4.29, 5.40) of non-elderly patients, 4.44% (95% CI 3.83, 5.11) of elderly patients, and 4.61% (95% CI 3.34, 6.18) of the very elderly group, with no statistically significant difference in relative risk between age groups. There was no difference in relative risk of hypotension-related AEs with increased O/A/H dosage in patients aged > 65 years and stratified by baseline SBP or DBP. All groups achieved effective BP reductions, with mean BP < 140/90 mmHg at 24 weeks. CONCLUSION: The O/A/H single-pill combination is well tolerated and effective in elderly and very elderly Korean patients with hypertension, offering a safe and practical therapeutic option for achieving BP control in the aging hypertensive population. TRIAL REGISTRATION: Clinical Research Information Service-Republic of Korea, KCT0010343 ( https://cris.nih.go.kr/cris/search/detailSearch.do?seq=29557&search_page=L ).