Management of Hypertension in Patients With Diabetes Using an Amlodipine-, Olmesartan Medoxomil-, and Hydrochlorothiazide-Based Titration Regimen - 06/08/11
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Résumé |
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.
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This study was supported by Daiichi Sankyo, Inc., Parsippany, New Jersey. |
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C.V. Ram is a member of the speakers' and/or consultants' bureaus for AHM, Advanced Health Media (Bridgewater, New Jersey), and The Peer Group, Inc. (Edison, New Jersey), which conduct educational and interactive programs for various pharmaceutical and medical devices companies. R. Sachson is a member of the speakers' bureaus for Abbott Laboratories (Abbott Park, Illinois), Amgen (Thousand Oaks, California), Amylin Pharmaceuticals (San Diego, California), Eli Lilly (Indianapolis, Indiana), Genentech (South San Francisco, California), GlaxoSmithKline (Research Triangle Park, North Carolina), Novartis (Basel, Switzerland), Novo Nordisk (Princeton, New Jersey), Solvay (Brussels, Belgium), and Takeda Pharmaceuticals (Deerfield, Illinois). T. Littlejohn has nothing to disclose. C. Qian, A. Shojaee, and K.A. Stoakes are all employees of Daiichi Sankyo, Inc (Parsippany, New Jersey). J.M. Neutel is a member of the speakers' bureau for Boehringer Ingelheim (Ridgefield, Connecticut), Daiichi Sankyo, Inc. (Parsippany, New Jersey), Forest (New York, New York), Novartis (Basel, Switzerland), Pfizer (New York, New York), and Sanofi-aventis/Bristol-Myers Squibb (Bridgewater, New Jersey and Princeton, New Jersey). |
Vol 107 - N° 9
P. 1346-1352 - mai 2011 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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