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Objective:   To assess the efficacy and safety of once daily olmesartan medoxomil (OM)/amlodipine besylate (AM)/hydrochlorothiazide (HCTZ) 40/10/25 mg in patients with hypertension not at goal with mono, dual or triple drug therapy.Methods:   This was a single-center, prospective, open-label, blinded-endpoint study. After a 1-week screening visit, 40 patients were enrolled into the study and given once daily treatment with OM/AM/HCTZ after the patients underwent baseline ambulatory blood pressure monitoring (ABPM) on their original therapy. The primary endpoint was changes from baseline in mean 24 h ABPM [systolic blood pressure (SBP)] after the first day of therapy with OM/AM/HCTZ 40/10/25 mg. Secondary endpoints were changes from baseline in mean 24 h ABPM [diastolic blood pressure (DBP)] after the first day of therapy with OM/AM/HCTZ 40/10/25 mg; mean changes from baseline in trough seated SBP (SeSBP) at day 1 and SeSBP at weeks 1, 2, 3 and 4; mean changes from baseline in trough seated DBP (SeDBP) at day 1 and SeDBP at weeks 1, 2, 3 and 4; and the percentage of subjects achieving mean 24 h, daytime and night-time ABPM BP goals.Results:   The baseline paired t-test systolic ABPM was 134.0 ± 2.77 mmHg and day 1 was 128.6 ± 2.47 mmHg with a treatment difference of −5.55 ± 1.3 mmHg ( p&lt;0.0001). At week 1, paired t-test ABPM SBP reduction was 117.7 ± 2.0 mmHg with a treatment difference of −16.5 ± 1.8 mmHg ( p &lt; 0.0001). At week 2, paired t-test ABPM SBP reduction was 115.8 ± 1.8 mmHg with a treatment difference of −18.4 ± 2.0 mmHg ( p &lt; 0.0001). At week 3, paired t-test ABPM SBP reduction was 115.5 ± 1.9 mmHg with a treatment difference of −18.6 ± 2.0 mmHg ( p &lt; 0.0001). At week 4, paired t-test ABPM SBP reduction was 115.5 ± 1.8 mmHg with a treatment difference of −18.6 ± 2.2 mmHg ( p &lt; 0.0001). The baseline paired t-test SeSBP was 142 ± 2.43 mmHg and day 1 was 132 ± 2.59 mmHg with a treatment difference of −9.78 ± 1.51 mmHg ( p &lt; 0.0001). At week 1, paired t-test SeSBP reduction was 124.0 ± 1.6 mmHg with a treatment difference of −17.9 ± 1.8 mmHg ( p &lt; 0.0001). At week 2, paired t-test SeSBP reduction was 120.3 ± 1.7 mmHg with a treatment difference of −21.5 ± 2.1 mmHg ( p &lt; 0.0001). At week 3, paired t-test SeSBP reduction was 118.5 ± 1.8 mmHg with a treatment difference of −23.3 ± 1.7 mmHg ( p &lt; 0.0001). At week 4, paired t-test SeSBP reduction was 119.6 ± 1.7 mmHg with a treatment difference of −22.2 ± 1.9 mmHg ( p &lt; 0.0001).Conclusion:   Treatment with OM/AM/HCTZ achieved superior (SBP) ABPM reductions compared with mono, dual or triple drug therapy, resulting in all patients achieving systolic ABPM goal without ABPM documented hypotension.

therapeutic advances in cardiovascular disease

Efficacy and safety of olmesartan/amlodipine/hydrochlorothiazide in patients with hypertension not at goal with mono, dual or triple drug therapy: results of the CHAMPiOn study