Abstract

This 12-wk, randomized, double-blind, forced-titration study compared the antihypertensive efficacy of OLM with VAL and LOS across all recommended doses and dosing regimens. Pts with stage 2 hypertension (HTN; N=723; 79% non-black, 21% black) were randomized to OLM 20mg (n=207), VAL 80mg (n=203), LOS 50mg (n=207) or placebo (n=106) once daily. At wk 4, doses were titrated to OLM 40mg, VAL 160mg and LOS 100mg, once daily. At wk 8, pts taking OLM remained at 40 mg once daily (maximum recommended dose) for an additional 4 wks, pts taking VAL were titrated to 320mg daily, and pts taking LOS were given a divided dose of 50mg twice daily. The primary endpoint was mean change in cuff seated diastolic blood pressure (SeDBP) from baseline to wk 8. Secondary efficacy variables included mean change in cuff seated systolic BP (SeSBP). Wk 12 analysis was designed to show equivalence of the treatments. A secondary analysis was performed to determine BP goal rates. Angiotensin II receptor blockers (ARBs) are usually given to black pts with HTN in combination with a thiazide diuretic, as about two-thirds have low plasma renin levels, resulting in reduced response to RAAS blocking agents. The data from black pts were analyzed to assess the efficacy of ARB monotherapy. In the intention-to-treat cohort, 152/707 pts were black (mean baseline BP 155/104 mmHg). OLM 40mg (n=40), VAL 160mg (n=38) or LOS 100mg (n=45) resulted in significant mean reductions in SeDBP and SeSBP from baseline (P < 0.001) at wk 8. For the primary efficacy variable, mean reduction in SeDBP with OLM (−9.6 mmHg) was numerically greater than LOS (−7.7 mmHg; P = NS) and VAL (−9.0 mmHg; P = NS). Mean reduction in SeSBP with OLM (−11.9 mmHg) was also numerically greater than LOS (−7.9 mmHg; P = NS) and VAL (−11.0 mmHg; P = NS). The BP differences allowed twenty-five percent more pts to achieve the BP goal of <140/90 mmHg with OLM compared with VAL (35.0% vs 28.9%; P = NS) and twice as many to achieve this goal with OLM compared with LOS (35.0% vs 15.6%; P < 0.05) at wk 8. At wk 12, similar changes from baseline in mean SeSBP and SeDBP were observed for all treatments. Although the small number of black pts is a limiting factor, the results suggest that ARB monotherapy may be effective in certain black pts with HTN. A large-scale trial will be needed to confirm these initial results.