Ofili Elizabeth O, Cable Greg, Neutel Joel M, Saunders Elijah
Morehouse School of Medicine, Atlanta, Georgia 30310, USA.
J Womens Health (Larchmt). 2008 Jul-Aug;17(6):931-8. doi: 10.1089/jwh.2008.0499.
This post hoc analysis of the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial evaluated the efficacy and safety of irbesartan/hydrochlorothiazide (HCTZ) in a diverse population of hypertensive women.
INCLUSIVE was a multicenter, prospective, open-label, single-arm trial. Adult subjects had uncontrolled systolic blood pressure (SBP 140-159 mm Hg; 130-159 mm Hg for those with type 2 diabetes mellitus [T2DM]) after > or =4 weeks of antihypertensive monotherapy. Treatment was sequential: placebo (4-5 weeks), HCTZ 12.5 mg (2 weeks), irbesartan/HCTZ 150/12.5 mg (8 weeks), and irbesartan/HCTZ 300/25 mg (8 weeks). Mean changes from baseline to treatment end in SBP and diastolic blood pressure (DBP), BP goal attainment, and safety were assessed.
Treatment with irbesartan/HCTZ was associated with significant mean reductions in BP (intent-to-treat population, n = 370; SBP/DBP: -22.9/-10.3 +/- 14.7/8.8 mm Hg). Improvements in SBP were observed in all subgroups (p < 0.001): Caucasian (n = 207) -23.5 +/- 13.5 mm Hg; African American (n = 93) -21.0 +/- 17.2 mm Hg; Hispanics/Latino (n = 66) -23.6 +/- 14.3 mm Hg; age <65 years (n = 281) -22.5 +/- 14.7 mm Hg; age > or =65 years (n = 89) -24.3 +/- 14.5 mm Hg; T2DM (n = 97) -19.0 +/- 15.1 mm Hg; and metabolic syndrome (n = 187) -22.1 +/- 14.6 mm Hg. Overall, 82% (95% confidence interval [CI] 78%-86%) of women achieved their SBP goal, 86% (95% CI 83%-90%) achieved their DBP goal, and 76% (95% CI 71%-80%) achieved their dual SBP/DBP goal. Treatments were well tolerated in all groups.
Irbesartan/HCTZ treatment was effective and well tolerated in a diverse population of women whose BP was previously uncontrolled on monotherapy.
本对厄贝沙坦/氢氯噻嗪在不同患者群体中降低血压（INCLUSIVE）试验的事后分析，评估了厄贝沙坦/氢氯噻嗪（HCTZ）在不同高血压女性群体中的疗效和安全性。
INCLUSIVE是一项多中心、前瞻性、开放标签、单臂试验。成年受试者在接受≥4周的抗高血压单药治疗后，收缩压未得到控制（收缩压140 - 159 mmHg；2型糖尿病[T2DM]患者为130 - 159 mmHg）。治疗是分阶段进行的：安慰剂（4 - 5周）、氢氯噻嗪12.5 mg（2周）、厄贝沙坦/氢氯噻嗪150/12.5 mg（8周），以及厄贝沙坦/氢氯噻嗪300/25 mg（8周）。评估了从基线到治疗结束时收缩压和舒张压（DBP）的平均变化、血压目标达成情况以及安全性。
厄贝沙坦/氢氯噻嗪治疗与血压的显著平均降低相关（意向性治疗人群，n = 370；收缩压/舒张压：-22.9/-10.3±14.7/8.8 mmHg）。在所有亚组中均观察到收缩压的改善（p < 0.001）：白种人（n = 207）-23.5±13.5 mmHg；非裔美国人（n = 93）-21.0±17.2 mmHg；西班牙裔/拉丁裔（n = 66）-23.6±14.3 mmHg；年龄<65岁（n = 281）-22.5±14.7 mmHg；年龄≥65岁（n = 89）-24.3±14.5 mmHg；T2DM（n = 97）-19.0±15.1 mmHg；以及代谢综合征（n = 187）-22.1±14.6 mmHg。总体而言，82%（95%置信区间[CI] 78% - 86%）的女性实现了收缩压目标，86%（95% CI 83% - 90%）实现了舒张压目标，76%（95% CI 71% - 80%）实现了收缩压/舒张压双重目标。所有组的治疗耐受性良好。
厄贝沙坦/氢氯噻嗪治疗在先前单药治疗血压未得到控制的不同女性群体中有效且耐受性良好。
