Orange County Research Center, Tustin, CA, USA.
Curr Med Res Opin. 2010 Mar;26(3):721-8. doi: 10.1185/03007990903553556.
The BENIFICIARY (BENIcar safety and efFICacy evaluatIon: An open-label, single-ARm, titration study in patients with hypertension and tYpe 2 diabetes) study was conducted to evaluate the efficacy and safety of olmesartan medoxomil (OM) plus hydrochlorothiazide (HCTZ) in patients with hypertension and type 2 diabetes.
After a placebo run-in period, 192 patients received OM 20 mg/day for 3 weeks. If blood pressure (BP) remained > or =120/70 mm Hg, patients were up-titrated to OM 40 mg/day for 3 weeks and subsequently (in 3-week intervals) to OM/HCTZ 40/12.5 mg/day, then OM/HCTZ 40/25 mg/day as necessary. Blood pressure was evaluated by mean 24-hour ambulatory BP monitoring (ABPM). The primary efficacy endpoint was the change in mean 24-hour ambulatory systolic BP (SBP) from baseline to Week 12. Secondary endpoints included: change in ambulatory diastolic BP (DBP) from baseline to Week 12; changes in ambulatory SBP and DBP during daytime, nighttime, and the last 2, 4, and 6 hours of the dosing interval; and achievement of prespecified ambulatory BP targets. CLINICAL TRIALS REGISTRY NUMBER: NCT00403481.
Mean 24-hour ambulatory SBP and DBP decreased by 20.4 mm Hg and 11.1 mm Hg, respectively (both P < 0.0001 to baseline), and 61.6%, 47.1%, and 39.0% of patients reached the ambulatory BP targets of <130/80 mm Hg, <125/75 mm Hg, and <120/80 mm Hg, respectively. The study medication was well tolerated with few adverse events: 67/192 patients (34.9%) experienced a treatment-emergent adverse event (TEAE) while 15/192 (7.8%) experienced a drug-related TEAE.
In this open-label ABPM study, an OM +/- HCTZ based treatment regimen safely and significantly reduced BP in patients with hypertension and type 2 diabetes when assessed by 24-hour ABPM.
BENIFICIARY（贝尼卡降压和疗效评估：一项开放性、单臂、滴定研究，纳入高血压和 2 型糖尿病患者）研究旨在评估奥美沙坦酯（OM）加氢氯噻嗪（HCTZ）治疗高血压和 2 型糖尿病患者的疗效和安全性。
在安慰剂导入期后，192 例患者接受 OM 20 mg/天治疗 3 周。如果血压（BP）仍>或=120/70mmHg，患者将被滴定至 OM 40 mg/天治疗 3 周，随后（每 3 周间隔）滴定至 OM/HCTZ 40/12.5mg/天，必要时滴定至 OM/HCTZ 40/25mg/天。血压通过 24 小时动态血压监测（ABPM）评估。主要疗效终点为从基线到第 12 周的平均 24 小时动态收缩压（SBP）变化。次要终点包括：从基线到第 12 周的动态舒张压（DBP）变化；日间、夜间和给药间隔的最后 2、4 和 6 小时的动态 SBP 和 DBP 变化；以及达到预设的动态血压目标。临床试验注册号：NCT00403481。
平均 24 小时动态 SBP 和 DBP 分别下降 20.4mmHg 和 11.1mmHg（均 P<0.0001 至基线），分别有 61.6%、47.1%和 39.0%的患者达到动态血压目标<130/80mmHg、<125/75mmHg 和<120/80mmHg。研究药物耐受性良好，仅有少数不良事件：192 例患者中有 67 例（34.9%）发生治疗中出现的不良事件（TEAE），192 例患者中有 15 例（7.8%）发生与药物相关的 TEAE。
在这项开放性 ABPM 研究中，奥美沙坦酯加或不加氢氯噻嗪的治疗方案通过 24 小时 ABPM 评估，可安全显著降低高血压合并 2 型糖尿病患者的血压。
