A multicenter, non-comparative study to evaluate the efficacy and safety of fixed-dose olmesartan/amlodipine in Korean patients with hypertension who are naïve or non-responders to anti-hypertensive monotherapy (ACE-HY study)

Hee Won Jung, Kwang Il Kim, Chang Gyu Park, Duk Hyun Kang, Youngkeun Ahn, Jang Ho Bae, Cheol Ho Kim

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    Abstract

    The purpose of this study was to evaluate the efficacy of a fixed-dose combination (FDC) of olmesartan and amlodipine in Korean hypertensive patients who were naïve to or uncontrolled by amlodipine or losartan monotherapy. This was a prospective, open-label, multi-center, non-comparative study with a planned treatment period of 12 weeks. The primary outcome was changed in seated diastolic blood pressure (SeDBP) from baseline to week 12. Secondary outcomes were changed in seated systolic blood pressure (SeSBP), the proportion of patients achieving target blood pressure (BP), and 24-h ambulatory BP. Safety and tolerability were also evaluated. A total of 376 patients were enrolled from 20 centers in Korea. The age of the patients was 52.4 ± 11.7 years, and 224 (59.6%) were male. Full analysis set included 110 naïve (group 1), 132 previously amlodipine-treated (group 2) and 134 previously losartan-treated (group 3) patients. The SeDBP decreased at 12 weeks in all three groups: by 23.1 ± 7.8 mm Hg (103.3 ± 3.0 to 80.2 ± 8.1 mm Hg) in group 1, 14.3 ± 8.2 mm Hg (94.6 ± 5.1 to 80.3 ± 8.6 mm Hg) in group 2, and 15.7 ± 6.8 mm Hg (94.6 ± 4.8 to 78.9 ± 7.0 mm Hg) in group 3 (all p < 0.001). Furthermore, the SeSBP and 24-h ambulatory BP decreased significantly in all three groups, and > 80% of patients achieved their target BP. Overall, the olmesartan/amlodipine FDC was well tolerated, and there were no serious adverse events associated with medication. In conclusion, the olmesartan/amlodipine FDC showed efficacy and safety in Korean patients with hypertension, who had never been treated or were uncontrolled with monotherapy.

    Original languageEnglish
    Pages (from-to)482-489
    Number of pages8
    JournalClinical and Experimental Hypertension
    Volume37
    Issue number6
    DOIs
    Publication statusPublished - 2015 Aug 18

    Keywords

    • Amlodipine
    • blood pressure
    • combination
    • efficacy
    • olmesartan

    ASJC Scopus subject areas

    • Internal Medicine
    • Physiology

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