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Seated cuff blood pressure-lowering efficacy of an olmesartan medoxomil-based treatment regimen in patients with type 2 diabetes mellitus.

Kereiakes DJ, Neutel JM - Drugs R D (2011)

Bottom Line: Endpoints evaluated in this analysis were the change from baseline in mean seated cuff BP (SeBP), proportions of patients achieving SeBP goals, and distribution of SeBP reductions.Mean SeBP was 158.1/90.0 mmHg at baseline.The mean ± standard error of BP reductions at 12 weeks for systolic and diastolic BP were 21.3 ± 1.1 mmHg and 9.8 ± 0.6 mmHg, respectively (p < 0.0001 for each).

View Article: PubMed Central - PubMed

Affiliation: The Christ Hospital Heart and Vascular Center/The Carl and Edyth Lindner Center for Research and Education, Cincinnati, OH 45219, USA. lindner@thechristhospital.com

ABSTRACT

Background: Hypertension is a common co-morbidity in patients with type 2 diabetes mellitus, and well tolerated, effective therapies are needed to achieve guideline-recommended blood pressure (BP) goals in these patients.

Objective: The aim of this study was to present the results of a prespecified analysis of key secondary endpoints from a 12-week, open-label, single-arm study evaluating the efficacy and safety of olmesartan medoxomil plus hydrochlorothiazide (HCTZ) in patients with hypertension and type 2 diabetes.

Study design and methods: After a placebo run-in period, 192 patients received olmesartan medoxomil 20 mg/day for 3 weeks. If BP remained ≥ 120/70 mmHg, patients were uptitrated at 3-week intervals to olmesartan medoxomil 40 mg/day, olmesartan medoxomil/HCTZ 40/12.5 mg/day, and olmesartan medoxomil/HCTZ 40/25 mg/day.

Main outcome measure: Endpoints evaluated in this analysis were the change from baseline in mean seated cuff BP (SeBP), proportions of patients achieving SeBP goals, and distribution of SeBP reductions.

Results: Mean SeBP was 158.1/90.0 mmHg at baseline. The mean ± standard error of BP reductions at 12 weeks for systolic and diastolic BP were 21.3 ± 1.1 mmHg and 9.8 ± 0.6 mmHg, respectively (p < 0.0001 for each). At the end of the study, the proportion of patients with diabetes achieving the recommended SeBP goal of <130/80 mmHg was 41.1%.

Conclusions: An olmesartan medoxomil ± HCTZ treatment regimen significantly reduced BP from baseline in patients with hypertension and type 2 diabetes.

Clinical trials registration: ClinicalTrials.gov identifier: NCT00403481.

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Related in: MedlinePlus

Change from baseline in seated cuff blood pressure (SeBP) at week 12/last observation carried forward for the total cohort, patients with stage 1 hypertension, and patients with stage 2 hypertension. Data are mean ± standard error of the mean. p < 0.0001 for all reductions vs baseline. HCTZ = hydrochlorothiazide; OM = olmesartan medoxomil; SeDBP = seated cuff diastolic blood pressure; SeSBP = seated cuff systolic blood pressure; *p < 0.0001, **p < 0.001, *** p < 0.01, **** p-value not significant vs preceding treatment regimen.
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Fig1: Change from baseline in seated cuff blood pressure (SeBP) at week 12/last observation carried forward for the total cohort, patients with stage 1 hypertension, and patients with stage 2 hypertension. Data are mean ± standard error of the mean. p < 0.0001 for all reductions vs baseline. HCTZ = hydrochlorothiazide; OM = olmesartan medoxomil; SeDBP = seated cuff diastolic blood pressure; SeSBP = seated cuff systolic blood pressure; *p < 0.0001, **p < 0.001, *** p < 0.01, **** p-value not significant vs preceding treatment regimen.

Mentions: Mean SeSBP was significantly decreased from baseline by week 12 for each treatment regimen, with reductions ranging from −9.5 ± 1.0 mmHg to −21.8 ± 1.2 mmHg (figure 1). Mean SeDBP also significantly decreased, with reductions ranging from −4.0 ± 0.6 mmHg to −9.9 ± 0.7 mmHg (figure 1).


Seated cuff blood pressure-lowering efficacy of an olmesartan medoxomil-based treatment regimen in patients with type 2 diabetes mellitus.

Kereiakes DJ, Neutel JM - Drugs R D (2011)

Change from baseline in seated cuff blood pressure (SeBP) at week 12/last observation carried forward for the total cohort, patients with stage 1 hypertension, and patients with stage 2 hypertension. Data are mean ± standard error of the mean. p < 0.0001 for all reductions vs baseline. HCTZ = hydrochlorothiazide; OM = olmesartan medoxomil; SeDBP = seated cuff diastolic blood pressure; SeSBP = seated cuff systolic blood pressure; *p < 0.0001, **p < 0.001, *** p < 0.01, **** p-value not significant vs preceding treatment regimen.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3585768&req=5

Fig1: Change from baseline in seated cuff blood pressure (SeBP) at week 12/last observation carried forward for the total cohort, patients with stage 1 hypertension, and patients with stage 2 hypertension. Data are mean ± standard error of the mean. p < 0.0001 for all reductions vs baseline. HCTZ = hydrochlorothiazide; OM = olmesartan medoxomil; SeDBP = seated cuff diastolic blood pressure; SeSBP = seated cuff systolic blood pressure; *p < 0.0001, **p < 0.001, *** p < 0.01, **** p-value not significant vs preceding treatment regimen.
Mentions: Mean SeSBP was significantly decreased from baseline by week 12 for each treatment regimen, with reductions ranging from −9.5 ± 1.0 mmHg to −21.8 ± 1.2 mmHg (figure 1). Mean SeDBP also significantly decreased, with reductions ranging from −4.0 ± 0.6 mmHg to −9.9 ± 0.7 mmHg (figure 1).

Bottom Line: Endpoints evaluated in this analysis were the change from baseline in mean seated cuff BP (SeBP), proportions of patients achieving SeBP goals, and distribution of SeBP reductions.Mean SeBP was 158.1/90.0 mmHg at baseline.The mean ± standard error of BP reductions at 12 weeks for systolic and diastolic BP were 21.3 ± 1.1 mmHg and 9.8 ± 0.6 mmHg, respectively (p < 0.0001 for each).

View Article: PubMed Central - PubMed

Affiliation: The Christ Hospital Heart and Vascular Center/The Carl and Edyth Lindner Center for Research and Education, Cincinnati, OH 45219, USA. lindner@thechristhospital.com

ABSTRACT

Background: Hypertension is a common co-morbidity in patients with type 2 diabetes mellitus, and well tolerated, effective therapies are needed to achieve guideline-recommended blood pressure (BP) goals in these patients.

Objective: The aim of this study was to present the results of a prespecified analysis of key secondary endpoints from a 12-week, open-label, single-arm study evaluating the efficacy and safety of olmesartan medoxomil plus hydrochlorothiazide (HCTZ) in patients with hypertension and type 2 diabetes.

Study design and methods: After a placebo run-in period, 192 patients received olmesartan medoxomil 20 mg/day for 3 weeks. If BP remained ≥ 120/70 mmHg, patients were uptitrated at 3-week intervals to olmesartan medoxomil 40 mg/day, olmesartan medoxomil/HCTZ 40/12.5 mg/day, and olmesartan medoxomil/HCTZ 40/25 mg/day.

Main outcome measure: Endpoints evaluated in this analysis were the change from baseline in mean seated cuff BP (SeBP), proportions of patients achieving SeBP goals, and distribution of SeBP reductions.

Results: Mean SeBP was 158.1/90.0 mmHg at baseline. The mean ± standard error of BP reductions at 12 weeks for systolic and diastolic BP were 21.3 ± 1.1 mmHg and 9.8 ± 0.6 mmHg, respectively (p < 0.0001 for each). At the end of the study, the proportion of patients with diabetes achieving the recommended SeBP goal of <130/80 mmHg was 41.1%.

Conclusions: An olmesartan medoxomil ± HCTZ treatment regimen significantly reduced BP from baseline in patients with hypertension and type 2 diabetes.

Clinical trials registration: ClinicalTrials.gov identifier: NCT00403481.

Show MeSH
Related in: MedlinePlus