| Single-Pill Combination of Telmisartan/Amlodipine Versus Amlodipine Monotherapy in Diabetic Hypertensive Patients: An 8-Week Randomized, Parallel-Group, Double-Blind Trial. | |
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MedLine Citation:
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PMID: 22386829 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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BACKGROUND: Hypertensive patients with diabetes often require combination therapy to achieve a blood pressure (BP) goal, and evidence suggests that time to BP goal is crucial to decrease cardiovascular risk. OBJECTIVE: The aim of the study was to investigate whether the single-pill combination of telmisartan and amlodipine was superior to amlodipine alone as initial antihypertensive therapy in patients with diabetes and hypertension. METHODS: An 8-week, randomized, parallel-group, double-blind international trial comparing the once-daily single-pill combination of telmisartan 80 mg and amlodipine 10 mg (T/A; n = 352) with once-daily amlodipine 10 mg (A; n = 354) in patients with type 2 diabetes mellitus and stage 1 or 2 hypertension (systolic BP [SBP] >150 mm Hg). RESULTS: Patient demographics were similar between treatment groups, with an mean (SD) age of 60.5 (10.1) years; 51.7% were male, the mean (SD) body mass index was 32.0 (6.1) and the mean (SD) duration of hypertension was 8.8 (7.9) years. After 8 weeks (primary end point) as well as after 1, 2, and 4 weeks (key secondary end points), significantly greater decreases in the in-clinic mean seated trough cuff SBP with T/A versus A were achieved (-29.0 mm Hg vs -22.9 mm Hg at 8 weeks; P < 0.0001). After 8 weeks, 71.4% versus 53.8% of patients achieved the BP goal (<140/90 mm Hg) with T/A versus A, with mean SBPs of 131.9 and 137.9 mm Hg, respectively. Similar results were observed in the obese (metabolic syndrome) subpopulation. The more stringent goal (<130/80 mm Hg) was achieved by 36.4% and 17.9% patients in the T/A and A groups, respectively. The most common adverse events were peripheral edema, headache, and dizziness. CONCLUSIONS: In this selected population of patients with diabetes and hypertension, T/A provided prompt and greater BP decreases compared with A monotherapy, with the majority of patients achieving the BP goal (<140/90 mm Hg). |
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Authors:
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Arya M Sharma; George Bakris; Joel M Neutel; Thomas W Littlejohn; Maureen Kobe; Naitee Ting; Ludwin Ley |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-3-1 |
Journal Detail:
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Title: Clinical therapeutics Volume: - ISSN: 1879-114X ISO Abbreviation: - Publication Date: 2012 Mar |
Date Detail:
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Created Date: 2012-3-5 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7706726 Medline TA: Clin Ther Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved. |
Affiliation:
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Professor of Medicine, Chair for Obesity Research & Management, University of Alberta, Edmonton, Alberta, Canada. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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