Kereiakes Dean J, Neutel Joel
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, 2123 Auburn Avenue, Suite 424, Cincinnati, OH 45219, USA.
Ther Adv Cardiovasc Dis. 2010 Oct;4(5):285-93. doi: 10.1177/1753944710378675. Epub 2010 Aug 27.
Secondary, prespecified analysis of a single-arm, open-label study evaluating the efficacy of olmesartan medoxomil (OM) plus hydrochlorothiazide (HCTZ) in patients with hypertension and type 2 diabetes.
After placebo run-in, 192 patients received OM 20 mg/day for 3 weeks. If blood pressure (BP) remained ≥120/70 mmHg, patients were uptitrated every 3 weeks to OM 40 mg/day, OM/HCTZ 40/12.5 mg/day, and OM/HCTZ 40/25 mg/day. Efficacy was evaluated by 24-hour ambulatory BP monitoring. Secondary endpoints included changes in ambulatory systolic BP (SBP) and diastolic BP (DBP) during daytime (08:00 to 16:00) and nighttime (22:00 to 06:00), as well as achievement of prespecified ambulatory BP targets in the total cohort and subgroups based on gender, race, hypertension severity, and age (≥65 or <65 years). Dipper status (nocturnal decrease in BP ≥10% of mean daytime BP) was assessed.
At baseline, mean ambulatory BP was 151.2 ± 12.7/87.6 ± 9.0 mmHg during the daytime and 140.3 ± 13.1/78.1 ± 8.6 mmHg during the nighttime. Mean daytime and nighttime ambulatory BP was reduced from baseline by 22.3 ± 13.7/12.0 ± 8.9 mmHg and 18.8 ± 12.4/ 10.2 ± 7.2 mmHg, respectively. The reduction in daytime ambulatory SBP was 24.4 ± 11.8 mmHg in Blacks, 21.7 ± 14.2 mmHg in non-Blacks, 23.6 ± 12.3 mmHg in females, 21.2 ± 14.8 mmHg in males, 23.4 ± 11.6 mmHg in patients aged ≥65 years, and 21.9 ± 14.4 mmHg in those aged <65 years. Ambulatory BP targets of <130/80, <125/75, and <120/80 mmHg were reached by 51.7%, 36.0%, and 32.6% of patients during the daytime and 69.8%, 60.5%, and 50.6% of patients during the nighttime. After 12 weeks of treatment, 36.4% of baseline nondippers converted to dippers.
OM ± HCTZ effectively lowered ambulatory BP in patients with type 2 diabetes and hypertension, enabling them to achieve ambulatory BP targets during both the daytime and nighttime.
对一项单臂、开放标签研究进行二次预设分析，该研究评估奥美沙坦酯（OM）加氢氯噻嗪（HCTZ）对高血压合并2型糖尿病患者的疗效。
在安慰剂导入期后，192例患者接受每日20 mg的OM治疗3周。如果血压（BP）仍≥120/70 mmHg，则患者每3周递增剂量至每日40 mg的OM、OM/HCTZ 40/12.5 mg/日和OM/HCTZ 40/25 mg/日。通过24小时动态血压监测评估疗效。次要终点包括白天（08:00至16:00）和夜间（22:00至06:00）动态收缩压（SBP）和舒张压（DBP）的变化，以及整个队列和基于性别、种族、高血压严重程度和年龄（≥65岁或<65岁）的亚组中预设动态血压目标的达成情况。评估杓型状态（夜间血压下降≥白天平均血压的10%）。
基线时，白天动态血压平均为151.2±12.7/87.6±9.0 mmHg，夜间为140.3±13.1/78.1±8.6 mmHg。白天和夜间动态血压平均值分别较基线降低22.3±13.7/12.0±8.9 mmHg和18.8±12.4/10.2±7.2 mmHg。黑人白天动态SBP降低24.4±11.8 mmHg，非黑人降低21.7±14.2 mmHg，女性降低23.6±12.3 mmHg，男性降低21.2±14.8 mmHg，≥65岁患者降低23.4±11.6 mmHg，<65岁患者降低21.9±14.4 mmHg。白天动态血压目标<130/80 mmHg、<125/75 mmHg和<120/80 mmHg的患者比例分别为51.7%、36.0%和32.6%，夜间分别为69.8%、60.5%和50.6%。治疗12周后，36.4%的基线非杓型患者转变为杓型患者。
OM±HCTZ可有效降低2型糖尿病和高血压患者的动态血压，使他们在白天和夜间均能达到动态血压目标。
