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 ).