Single-Pill First-Line Combo Drugs for High BP Cleared

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The FDA has approved two single-pill combination drugs, Diovan HCT (valsartan and hydrochlorothiazide) and Exforge (amlodipine and valsartan), as first-line treatments in patients likely to need multiple drugs to manage hypertension.

Approval of these products, both marketed by Novartis, for first-line use reinforces current U.S. guideline recommendations to start appropriate patients on combination therapy. Up to 80% of patients may need multiple medications to achieve BP goals, research suggests.

Using single-pill combo drugs first-line will eliminate the added steps of starting on a single medication, increasing the dose, and then adding another medication.

These approvals were based on clinical trials in which both products demonstrated efficacy and tolerability in patients with mild-to-severe hypertension.

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