Efficacy/Safety of a Fixed‐Dose Amlodipine/Olmesartan Medoxomil–Based Treatment Regimen in Hypertensive Blacks and Non‐Blacks With Uncontrolled BP on Prior Antihypertensive Monotherapy

Abstract

In this secondary analysis of a dose-titration study of patients with hypertension uncontrolled on prior monotherapy, blacks (n=234) and non-blacks (n=765) were switched to amlodipine (AML)/olmesartan medoxomil (OM) 5/20 mg, with uptitration every 4 weeks to AML/OM 5/40 mg and then AML/OM 10/40 mg to achieve a seated cuff blood pressure (SeBP) of <120/70 mm Hg. Hydrochlorothiazide 12.5 and 25 mg could be added if SeBP was ! 125/75 mm Hg. The cumulative proportions of patients achieving systolic SeBP <140 mm Hg (<130 mm Hg if diabetic) at 12 weeks were 71.6% for blacks and 77.2% for non-blacks. Mean SeBP change from baseline in blacks (mean baseline BP: 153.0/ 93.7 mm Hg) ranged from À11.7/À6.1 mm Hg for AML/OM 5/20 mg to À23.6/À12.9 mm Hg for AML/OM 10/40 mg +hydrochlorothiazide 25 mg (all P<.0001). Antihypertensive efficacy was maintained throughout the 24-hour dosing interval. An AML/OM-based regimen was effective in blacks with hypertension uncontrolled on prior monotherapy. J Clin Hypertens (Greenwich) 2013;15:247-253. ª2013 Wiley Periodicals, Inc.

Efficacy and safety of olmesartan medoxomil‐amlodipine besylate tablet in Chinese patients with essential hypertension: A prospective, single‐arm, multi‐center, real‐world study

“…17 In A possible explanation might be that the SeSBP and SeDBP at baseline were numerically lower than those reported by previous studies. 18,20 Meanwhile, the proportion of patients who achieved SeSBP/SeDBP < 140/90 mmHg in this study was comparable to the previous randomized, controlled trial conducted in China. 14 Regarding the proportion of patients who achieved BP target by AHA criteria after treatment of OM-AML tablet, it was incomparable since no data is reported by previous studies.…”

“…For instance, after administrated with OM-AML tablet for 12 weeks, the mean change of SeSBP/SeDBP from baseline to week 12 is −11.7 (± 0.8)/−6.1 (± 0.5) mmHg in black and Although varied a little, the mean changes of SeSBP and SeDBP were in the range reported by previous studies. [18][19][20] Meanwhile, the mean change of SeSBP/SeDBP by OM-AML tablet in the current study is numerically greater than that by OM (−10.5/−9.6 mmHg) or AML (−9.1/−7.7 mmHg) monotherapy reported by the previous study. 14 The explanation might be that OM-AML tablet combined two antihypertensive drugs with different acting mechanisms, which exerts a superior effect on controlling BP.…”

“…Home measured SeSBP and SeDBP from W1 to W8 (A). Change of home measured SeSBP and SeDBP from W1 to W8 (B).−15.0 (± 0.5)/−8.2 (± 0.3) mmHg in non-black patients with essential hypertension 18. Another study conducted in the United States reports that the primary endpoint of SeSBP less than 140 mmHg is achieved in 71.6% of essential hypertensive patients with obesity and 80.2% in those without obesity after taking the OM-AML tablet 19.…”

A thorough QTc study demonstrates that olmesartan medoxomil does not prolong the QTc interval

“…The safety of OM for the treatment of hypertension, both as monotherapy and as part of combination therapy, has been demonstrated across multiple patient subgroups in numerous hypertension studies. [7][8][9][10][11][12][13][14][15][16][17] Importantly, the findings of increased rates of cardiovascular death in OM-treated patients in ROADMAP and ORIENT are not supported by more recent large-scale retrospective cohort analyses, which observed no difference in risk between patients initiating OM and those initiating other ARBs or angiotensin-converting enzyme inhibitors. [18][19][20][21] Some concern for increased risk was raised with the use of high-dose olmesartan for �6 months' duration in elderly patients with type 2 diabetes.…”

Olmesartan‐based monotherapy vs combination therapy in hypertension: A meta‐analysis based on age and chronic kidney disease status

“…OM has been shown to provide 24‐hour BP‐lowering coverage and has a safety profile similar to that of placebo when used as monotherapy or in combination therapy,6 including when used across a wide range of patient subgroups (obese, elderly, children, black, Hispanic, or those with diabetes mellitus) 7, 8, 9, 10, 11, 12, 13, 14, 15, 16. In light of the various recommendations from treatment guidelines and clinical trials, the current meta‐analysis sought to compare the efficacy and safety of OM single‐pill dual‐combination therapy with that of OM monotherapy.…”