OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE (OM/HCTZ) 40/25MG PROVIDES GREATER AMBULATORY BLOOD PRESSURE-LOWERING VS OM/HCTZ 20/25MG IN MODERATE-TO-SEVERE PATIENTS UNCONTROLLED BY OM: PP.5.207

Abstract

Objective: To compare the efficacy of OM/HCTZ 40/25 mg versus 20/25 mg in terms of 24-h, daytime and night-time BP lowering, as assessed by ambulatory BP monitoring (ABPM), in patients whose BP was inadequately controlled by OM 40 mg. Design and Methods: This was a 16-week study in patients aged >/=18 years. The study consisted of 2 periods, each 8 weeks long. Eligible patients (N=1404) received 8 weeks' open-label OM 40 mg (Weeks 0–8). At Week 8 (baseline), patients with inadequate BP control (mean trough seated BP [SeBP] 140–180/90–115 mmHg, mean 24-h diastolic BP [DBP] >/=80 mmHg and >/=30% of daytime DBP readings >85 mmHg) were randomised to a further 8 weeks' double-blind treatment with OM/HCTZ 40/25 mg (N=502) or OM/HCTZ 20/25 mg (N=508) (Weeks 8–16). Changes in mean 24-h, daytime and night-time ABPM from Week 8 to Week 16, were measured as secondary parameters using a Spacelabs90207 device. Analyses were performed on the FAS (LOCF) using an ANCOVA model. Results: At baseline, mean patient age was 54.6 years and mean SeBP was 153.4/96.9 mmHg. By Week 16, significantly greater reductions in mean 24-h, daytime and night-time ambulatory DBP and SBP were achieved with OM/HCTZ 40/25 mg compared with OM/HCTZ 20/25 mg (Treatment differences for DBP reductions were: –1.6, –1.6 and –1.5 mmHg, respectively, in favour of OM/HCTZ 40/25 mg; p = 0.0016, 0.0031 and 0.0073, respectively. Treatment differences for SBP reductions were: –2.3, –2.3 and –2.0 mmHg, respectively, in favour of OM/HCTZ 40/25 mg; p = 0.0021, 0.0031 and 0.0104, respectively; Figure). Both doses of OM/HCTZ were well tolerated. Conclusions: ABPM provides reliable information on 24-h BP and is an accurate predictor of cardiovascular risk. In patients with moderate-to-severe hypertension, OM/HCTZ 40/25 mg produced further incremental significantly greater reductions in 24-h, daytime and night-time ambulatory BP compared with OM/HCTZ 20/25 mg, which may be of clinical relevance. A significant reduction in night-time BP is important to avoid stroke in the early morning hours.