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

Research output: Contribution to journalArticle

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

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Amlodipine
Antihypertensive Agents
Blood Pressure
Hypertension
Safety
Losartan
olmesartan
Korea

Keywords

  • Amlodipine
  • blood pressure
  • combination
  • efficacy
  • olmesartan

ASJC Scopus subject areas

  • Internal Medicine
  • Physiology

Cite this

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

In: Clinical and Experimental Hypertension, Vol. 37, No. 6, 18.08.2015, p. 482-489.

Research output: Contribution to journalArticle

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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 na{\"i}ve 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 na{\"i}ve (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.",
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AU - Kim, Kwang Il

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AU - Bae, Jang Ho

AU - Kim, Cheol Ho

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