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

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 naive 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 naive (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 +/- 7.8mmHg (103.3 +/- 3.0 to 80.2 +/- 8.1mmHg) in group 1, 14.3 +/- 8.2mmHg (94.6 +/- 5.1 to 80.3 +/- 8.6mmHg) in group 2, and 15.7 +/- 6.8mmHg (94.6 +/- 4.8 to 78.9 +/- 7.0mmHg) 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.