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Efficacy of olmesartan medoxomil (OLM), losartan potassium (LOS) and valsartan (VAL) in a non-black patient (PT) cohort

2005; Oxford University Press; Volume: 18; Issue: 5 Linguagem: Inglês

10.1016/j.amjhyper.2005.03.145

1941-7225

Steven G. Chrysant, An Wang, Michael Jones,

Cardiac, Anesthesia and Surgical Outcomes

This 12-wk, randomized, double-blind, forced-titration study compared the antihypertensive efficacy of the angiotensin II receptor blocker (ARB) OLM with VAL and LOS across all recommended doses and dosing regimens. Pts with stage 2 hypertension (N=723; 79% non-black, 21% black) were randomized to OLM 20mg (n=207), VAL 80mg (n=203), LOS 50mg (n=207) or placebo (PLA; n=106), once daily. At wk 4, doses were titrated to: OLM 40mg, VAL 160mg and LOS 100mg, once daily for 4 wks. At wk 8, pts taking OLM remained at 40mg once daily (maximum recommended dose) for an additional 4 wks, pts taking VAL were titrated to 320mg daily, and pts taking LOS were titrated to 50mg twice daily. The primary endpoint was the mean change in cuff seated diastolic blood pressure (SeDBP) from baseline to wk 8. Secondary efficacy variables included the 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 (<140/90 mmHg). The efficacy of ARBs in black pts is known to be lower, due to low plasma renin levels. Thus, non-black cohort data from this study were analyzed to assess the efficacy of these ARBs. Five hundred fifty-five pts were non-black (mean baseline BP 155/103 mmHg). Daily administration of OLM 40mg (n=146), VAL 160mg (n=148) or LOS 100mg (n=144) resulted in significant mean reductions in SeDBP and SeSBP from baseline (P<0.001) and vs PLA (P<0.01) at wk 8. For the primary efficacy variable, mean reduction in SeDBP with OLM (−14.0 mmHg) was greater than LOS (-10.1 mmHg; P<0.001) and VAL (−12.3 mmHg; P<0.05). The mean reduction in SeSBP achieved with OLM (−16.2 mmHg) was also greater than LOS (−11.9 mmHg; P<0.01) and VAL (−13.2 mmHg; P<0.05). These BP differences translated into forty-five percent more pts achieving the BP goal of <140/90 mmHg with OLM compared with VAL (41.8% vs 28.4%; P<0.05) and almost twice as many pts achieving this BP goal with OLM compared with LOS (41.8% vs 21.5%; P<0.001) at wk 8. At wk 12, similar changes from baseline in mean SeSBP and SeDBP were observed for all treatments. Thus, OLM is an effective antihypertensive agent in pts most likely to receive ARB monotherapy and is associated with more pts achieving BP goals compared with VAL and LOS.