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Efficacy of an olmesartan medoxomil-based treatment algorithm in patients stratified by age, race, or sex.

ABSTRACT: Demographic factors are known to influence the prevalence of hypertension, and evidence suggests that they may also influence the response of patients with hypertension to blood pressure (BP)-lowering therapies. To determine the effect of demographic factors on the efficacy and safety of an olmesartan medoxomil (OM)-based treatment regimen, we performed a prespecified subgroup analysis of a 12-week, randomized, placebo-controlled, titrate-to-goal study in patients with hypertension, stratifying patients into treatment groups according to age, sex, or race. After 12 weeks, OM-based therapy significantly reduced BP from baseline in blacks, non-blacks, men, women, and patients younger than 65 or 65 years and older compared with placebo, and enabled 51.9% to 79.5% of patients to achieve a BP goal of <140/90 mm Hg. The differences in BP-lowering efficacy of OM-based therapy between subgroups were not clinically significant, and treatment was generally well tolerated in all groups. This study demonstrates that an OM-based treatment algorithm is an effective and safe option for achieving recommended BP goal in patients with hypertension including blacks, non-blacks, men, women, and patients younger than 65 or 65 years and older.

SUBMITTER: Oparil S

PROVIDER: S-EPMC8673424 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5).In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ?100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP >140/90 mmHg or msSBP/msDBP >130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period.A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were -9.50 (8.46) mmHg in the OM/AML/HCTZ group and -4.23 (7.41) mmHg in the OM/HCTZ group (both p < 0.0001 vs. baseline; p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated.In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).

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Efficacy of an olmesartan medoxomil-based treatment algorithm in patients stratified by age, race, or sex.

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