Document Detail

Management of hypertension in patients with diabetes using an amlodipine-, olmesartan medoxomil-, and hydrochlorothiazide-based titration regimen.
MedLine Citation:
PMID:  21497211     Owner:  NLM     Status:  MEDLINE    
The safety and efficacy of an amlodipine/olmesartan medoxomil (OM)-based titration regimen was assessed in patients with type 2 diabetes mellitus and hypertension. After a 2- to 3-week placebo run-in period, 207 patients received amlodipine 5 mg and were uptitrated to amlodipine/OM 5/20, 5/40, and 10/40 mg and then amlodipine/OM 10/40 mg plus hydrochlorothiazide 12.5 and 25 mg in a step-wise manner at 3-week intervals if the seated blood pressure (BP) remained ≥120/70 mm Hg. The primary end point was the change from baseline in the mean 24-hour ambulatory systolic BP after 12 weeks of treatment. The baseline mean ± SD seated cuff systolic/diastolic BP was 158.8 ± 13.1/89.1 ± 10.1 mm Hg and the mean ± SD 24-hour ambulatory systolic/diastolic BP was 144.4 ± 11.7/81.6 ± 9.8 mm Hg. At week 12, the change from baseline in the mean ± SEM 24-hour ambulatory systolic/diastolic BP was -19.9 ± 0.8/-11.2 ± 0.5 mm Hg (p<0.0001 vs baseline), and 70% of patients had achieved a 24-hour ambulatory BP target of <130/80 mm Hg. At the end of 18 weeks of active treatment in patients uptitrated to amlodipine/OM 10/40 mg plus hydrochlorothiazide 25 mg, the change from baseline in the mean ± SEM seated BP was -28.0 ± 1.5/-13.7 ± 1.0 mm Hg (p<0.0001 vs baseline), with 62% of patients reaching the guideline-recommended seated BP goal of <130/80 mm Hg. Drug-related treatment-emergent adverse events occurred in 19.3% of patients. The most frequent events were peripheral edema (6%), dizziness (3%), and hypotension (2%). In conclusion, this amlodipine/OM-based titration regimen was well tolerated and effectively lowered BP throughout the 24-hour dosing interval in patients with hypertension and type 2 diabetes.
C Venkata Ram; Richard Sachson; Thomas Littlejohn; Chunlin Qian; Ali Shojaee; Kathy A Stoakes; Joel M Neutel
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The American journal of cardiology     Volume:  107     ISSN:  1879-1913     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-04-18     Completed Date:  2011-06-21     Revised Date:  2013-08-15    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1346-52     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2011 Elsevier Inc. All rights reserved.
University of Texas Southwestern Medical School, Dallas, Texas, USA.
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MeSH Terms
Aged, 80 and over
Amlodipine / therapeutic use
Antihypertensive Agents / therapeutic use*
Diabetes Mellitus, Type 2*
Diabetic Angiopathies*
Drug Combinations
Drug Therapy, Combination
Hydrochlorothiazide / therapeutic use
Hypertension / drug therapy*
Imidazoles / therapeutic use
Middle Aged
Tetrazoles / therapeutic use
Treatment Outcome
Reg. No./Substance:
0/Antihypertensive Agents; 0/Drug Combinations; 0/Imidazoles; 0/Tetrazoles; 58-93-5/Hydrochlorothiazide; 6M97XTV3HD/olmesartan medoxomil; 88150-42-9/Amlodipine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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