OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.