FDA Approves Novartis's Diovan HCT to Lower Hypertension

Diovan HCT has been approved for second-line treatment of hypertension.

Diovan HCT is a combination of an angiotensin II receptor blocker (ARB)--a first line treatment that lowers blood pressure with an overall incidence of side effects comparable to placebo--and a diuretic, which is commonly used with other therapies to provide additional blood pressure lowering.

The United States Food and Drug Administration has granted marketing approval to Novartis Pharmaceuticals Corp.’s Diovan HCT(TM) (valsartan and hydrochlorothiazide) for second-line treatment of hypertension.
Diovan HCT is a combination of an angiotensin II receptor blocker (ARB) -- a first-line treatment that lowers blood pressure with an overall incidence of side effects comparable to placebo -- and a diuretic, which is commonly used with other therapies to provide additional blood pressure lowering.
Diovan (valsartan) and Diovan HCT offer physicians a range of options for first and second-line treatment of hypertensive patients. For initial monotherapy, once-daily Diovan 80 mg is effective for the majority of patients. If additional antihypertensive effect is required, physicians can either increase the dosage to 160 mg once-daily, or choose Diovan HCT, which will be available in once-daily doses of 80 mg or 160 mg valsartan and 12.5 mg hydrochlorothiazide.

Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension.

Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy.

Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.

The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks.