Objective: To evaluate the efficacy and safety of two different strengths of single-pill combinations of the angiotensin II receptor blocker telmisartan 40 or 80 mg (T40 or T80) and the calcium channel blocker amlodipine 10 mg (A10) compared with that of A10 monotherapy in a hypertensive patient population whose blood pressure was not controlled by A10.
Research Design And Methods: An 8-week, randomized, double-blind, controlled study to compare the efficacy and safety of single-pill combinations of T40/A10 or T80/A10 versus A10 monotherapy in 947 patients with uncontrolled hypertension (diastolic blood pressure [DBP] ≥90 mmHg after 6 weeks' A10).
Main Outcome Measures: The primary end point was change from baseline in seated in-clinic trough cuff DBP after 8 weeks. Secondary efficacy end points included change from baseline in seated in-clinic trough cuff systolic blood pressure (SBP), and the proportion of patients achieving SBP/DBP response (<140/90 mmHg or ≥10/15 mmHg reduction) and SBP/DBP goal (<140/90 mmHg) after 8 weeks' treatment. Adverse events were recorded throughout.
Results: In a patient population who had failed to achieve DBP goal with A10, T40/A10 and T80/A10 resulted in significantly greater (P < 0.0001) reductions in seated trough SBP/DBP versus A10 (-3.7/-2.8 mmHg; -3.9/-2.8 mmHg), significantly higher SBP/DBP goal rates versus A10 (58.8/63.7% and 60.3/66.5% vs. 50.2/51.1%), and significantly higher SBP/DBP response rates with T40-80/A10 versus A10 (64.7/66.0% and 65.8/68.7% vs. 54.1/53.4%). T40-80/A10 were well tolerated. Rates of peripheral edema adverse events were low (6.7-8.5%) and not significantly different between the treatment groups; however, patients were pre-screened for intolerance to A10.
Conclusions: Switching patients who fail to achieve blood pressure goal with A10 to a single-pill combination of T40/A10 or T80/A10 results in superior SBP/DBP reductions, and SBP/DBP goal and response rates.
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