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In patients with type 2 diabetes and uncontrolled hypertension while on antihypertensive monotherapy, more than one half had their blood pressure controlled after switching to a fixed-dose combination of amlodipine/olmesartan, said Shawna D Nesbitt, MD.
In patients with type 2 diabetes and uncontrolled hypertension while on antihypertensive monotherapy, more than one half had their blood pressure controlled after switching to a fixed-dose combination of amlodipine/olmesartan, said Shawna D Nesbitt, MD.
She presented the results from the subpopulation of patients with type 2 diabetes who were enrolled in an open-label, dose-titration trial known as BP-CRUSH (Blood Pressure Control in All Subgroups with Hypertension).
The overall study included 999 patients with uncontrolled hypertension despite drug monotherapy. For the subset of 192 patients with diabetes, “uncontrolled hypertension” was defined as mean systolic blood pressure (SBP) between 130 mmHg and 179 mmHg and mean diastolic blood pressure 110 mmHg or lower. The primary endpoint was achievement of goal blood pressure (seated SBP <130 mmHg for patients with diabetes).
After discontinuation of previous antihypertensive therapy without a washout period, the 20-week active treatment period consisted of consecutive 4-week intervals during which dosages of amlodipine/olmesartan could be up-titrated from 5/20 mg to 5/40 mg to 10/40 mg; hydrochlorothiazide, 12.5 mg or 25 mg, could be added to amlodipine/olmesartan if goal blood pressure was still not achieved.
At week 12, 57.9% of the diabetes population in this study achieved their seated SBP goal of less than 130 mmHg, said Nesbitt, Associate Professor of Medicine at University of Texas Southwestern Medical Center.
Some 50% achieved a cumulative blood pressure goal of less than 130/80 mmHg by week 12; this percentage improved to 65.3% at week 20.
Ambulatory blood pressure monitoring revealed that blood pressure reductions from baseline were maintained throughout the 24-hour dosing interval. The combination regimen was well tolerated: 15.3% to 25.8% of the diabetes subgroup had a treatment-emergent adverse event.