-15.8-16.3 Stage 1 Stage 2 Stage 1 Stage 2 Greathouse a 0 ) H g -5 m (m-10 P B-15 n i eg-20 n ah-25 c an-30 e M -35 0 ) g H -5 m (m-10 P B-15 n i e-20 g n ah-25 c an-30 e M-35 SBP -29.3 -24.8 -32.7 DBP -16.1 c d SBP DBP 83.2 69.3 140/90 mm HG 130/85 mm Hg 93.7 75 88.6 54 140/90 mm HG 130/85 mm HG b ) (%100 P 90 lB 80 a o 70 g g 60 in 50 v ie 40 ch 30 a ts 20 en 10 ita 0 P 90 )%80 ( PB70 l ao60 g g50 n i iev40 h ac30 s tn20 e i ta10 P 0 Figure 1 Antihypertensive efficacy of olmesartan medoxomil/HCTZ in patients with Stage 1 (SBP 140–159 mmHg or DBP 90–99 mmHg) and Stage 2 (SBP ≥160 mmHg or DBP ≥100 mmHg) hypertension. Data are from an open-label study (n=201) in which a stepwise treatment algorithm was followed, with titration at 4-weekly intervals until goal BP was achieved, when patients withdrew from the study (Neutel et al 2004, 2006). Eight weeks of monotherapy with olmesartan medoxomil 20–40 mg/day was followed by 8 weeks of combination therapy with olmesartan medoxomil/HCTZ 40/12.5–25 mg/day. Reduction in BP and rate of attainment of BP goals (≤140/90 mmHg and an aggressive goal of ≤130/85 mmHg) after 16 weeks are shown. (a) Mean BP reduction for patients in the combined Stage 1/Stage 2 population treated with olmesartan medoxomil/HCTZ 40/12.5–25 mg/day (n=123) (Neutel et al 2004); (b) Cumulative goal attainment rates for the combined Stage 1/Stage 2 population (Neutel et al 2004); (c) Cumulative mean BP reduction according to baseline stage of hypertension (Neutel et al 2006); (d) Cumulative goal attainment rates according to baseline stage of hypertension (Neutel et al 2006). Cumulative results are based on the intent-to-treat population using last observation carried forward, and include data for patients treated only with olmesartan medoxomil monotherapy as well as those treated with dual combination therapy. Abbreviations: DBP, diastolic BP; HCTZ, hydrochlorothiazide; SBP, systolic BP. starting doses of each ARB (olmesartan medoxomil 20 mg/ An indirect comparison of olmesartan medoxomil/HCTZ day [n=308] or losartan 50 mg/day [n=305]) plus HCTZ with several other ARB/HCTZ combinations was performed 12.5 mg/day for 12 weeks. Mean BP reductions and BP in a review of randomized, double-blind, placebo-controlled control rates (<140/90 mmHg) were compared after 1, 2, 4, factorial studies of similar design in hypertensive patients 8, and 12 weeks of therapy; the primary endpoint was change with a DBP of 95–115 mmHg (Ram 2004). At maximum in DBP from baseline to 12 weeks. Olmesartan medoxomil/ US and European approved dosages, olmesartan HCTZ and losartan/HCTZ produced similar mean medoxomil/HCTZ compared favorably with irbesartan/ reductions in DBP (–17.6 and –16.5 mmHg, respectively; HCTZ, telmisartan/HCTZ, and valsartan/HCTZ, with each Figure 2). The mean reduction in SBP was 29.3 mmHg for combination producing double-digit reductions (not olmesartan medoxomil/HCTZ compared with 24.9 mmHg placebo-adjusted) in both SBP and DBP (Table 1) (Ram for losartan/HCTZ (p≤0.0003). A significantly higher 2004). DBP response rates (DBP<90 mmHg or a ≥10 mmHg percentage of olmesartan medoxomil/HCTZ recipients reduction from baseline) were numerically greater with achieved BP control (<140/90 mmHg) at week 12 compared olmesartan medoxomil/HCTZ than telmisartan/HCTZ or with losartan/HCTZ recipients (43.2% vs 32.1%, p=0.002) (Rump et al 2006). valsartan/HCTZ (eg, 92% vs 79% vs 81%; value not reported for irbesartan) (Ram 2004). 404 Vascular Health and Risk Management 2006:2(4)