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FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent
Date:7/20/2009

approvals of Tekturna HCT were based on a clinical trial program involving over 6,200 patients and evaluated more than 2,700 patients exposed to combinations of Tekturna and hydrochlorothiazide. The safety and efficacy of Tekturna HCT were evaluated in patients with mild-to-moderate hypertension in an 8-week, randomized, double-blind, placebo-controlled, parallel-group, 15-arm factorial trial (n=2762). Patients were randomized to receive various combinations of Tekturna (75 mg to 300 mg) plus hydrochlorothiazide (6.25 mg to 25 mg) once daily (without titrating up from monotherapy) and followed for blood pressure response. The combination of Tekturna and hydrochlorothiazide resulted in additive placebo-adjusted decreases in systolic and diastolic blood pressure at trough of 10-14/5-7 mmHg at doses of 150-300 mg/12.5-25 mg, compared to 5-8/2-3 mmHg for Tekturna 150 mg to 300 mg and 6-7/2-3 mmHg for hydrochlorothiazide 12.5 mg to 25 mg alone. Blood pressure reductions with the combinations were greater than the reductions with the monotherapies. The safety and efficacy of Tekturna HCT as initial therapy was evaluated in this trial. All patients randomized to the combination groups received the combination treatment of Tekturna HCT at assigned doses as initial therapy without titration from monotherapy. The antihypertensive effect of Tekturna HCT were largely manifested within 1 week. The maximum antihypertensive effect was generally attained after about 4 weeks of therapy.

About Tekturna and Tekturna HCT

TEKTURNA and TEKTURNA HCT are prescription medications for adults used to treat high blood pressure. TEKTURNA and TEKTURNA HCT may be used alone or in combination with other high blood pressure medications. It is not known whether additive effects are present when TEKTURNA or TEKTURNA HCT are used in combination with types of medications called ACE inhibitors or beta-blockers. TEKTURNA HCT can be used first if your doc
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SOURCE Novartis Pharmaceuticals Corporation
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