Punzi Henry A
Trinity Hypertension and Metabolic Research Institute, Punzi Medical Center, 1932 Walnut Plaza, Carrollton, TX 75006, USA.
Ther Adv Cardiovasc Dis. 2014 Feb;8(1):12-21. doi: 10.1177/1753944713520062.
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.
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.
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<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 < 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 < 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 < 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 < 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 < 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 < 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 < 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 < 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 < 0.0001).
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.
评估每日一次奥美沙坦酯（OM）/苯磺酸氨氯地平（AM）/氢氯噻嗪（HCTZ）40/10/25mg 对单药、双药或三药治疗未达目标的高血压患者的疗效和安全性。
这是一项单中心、前瞻性、开放标签、盲终点研究。在进行为期1周的筛查访视后，40例患者入组研究，并在患者接受原治疗方案的基线动态血压监测（ABPM）后，给予每日一次的OM/AM/HCTZ治疗。主要终点是在使用40/10/25mg的OM/AM/HCTZ治疗第一天后，24小时平均ABPM[收缩压（SBP）]相对于基线的变化。次要终点包括在使用40/10/25mg的OM/AM/HCTZ治疗第一天后，24小时平均ABPM[舒张压（DBP）]相对于基线的变化；第1天卧位谷值SBP（SeSBP）以及第1、2、3和4周的SeSBP相对于基线的平均变化；第1天卧位谷值DBP（SeDBP）以及第1、2、3和4周的SeDBP相对于基线的平均变化；以及达到24小时、日间和夜间ABPM血压目标的受试者百分比。
基线配对t检验收缩压ABPM为134.0±2.77mmHg，第1天为128.6±2.47mmHg，治疗差异为-5.55±1.3mmHg（p<0.0001）。在第1周时，配对t检验ABPM SBP降低至117.7±2.0mmHg，治疗差异为-16.5±1.8mmHg（p<0.0001）。在第2周时，配对t检验ABPM SBP降低至115.8±1.8mmHg，治疗差异为-18.4±2.0mmHg（p<0.0001）。在第3周时，配对t检验ABPM SBP降低至115.5±1.9mmHg，治疗差异为-18.6±2.0mmHg（p<0.0001）。在第4周时，配对t检验ABPM SBP降低至115.5±1.8mmHg，治疗差异为-18.6±2.2mmHg（p<0.0001）。基线配对t检验SeSBP为142±2.43mmHg，第1天为132±2.59mmHg，治疗差异为-9.78±1.51mmHg（p<0.0001）。在第1周时，配对t检验SeSBP降低至124.0±1.6mmHg，治疗差异为-17.9±1.8mmHg（p<0.0001）。在第2周时，配对t检验SeSBP降低至120.3±1.7mmHg，治疗差异为-21.5±2.1mmHg（p<0.0001）。在第3周时，配对t检验SeSBP降低至118.5±1.8mmHg，治疗差异为-23.3±1.7mmHg（p<0.0001）。在第4周时，配对t检验SeSBP降低至119.6±1.7mmHg，治疗差异为-22.2±1.9mmHg（p<0.0001）。
与单药、双药或三药治疗相比，OM/AM/HCTZ治疗在降低（SBP）ABPM方面效果更佳，使所有患者均达到收缩压ABPM目标，且未记录到ABPM相关的低血压情况。
