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FDA approves Exforge HCT for treatment of hypertension
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The FDA recently approved a hypertension drug that combines a calcium antagonist, an angiotensin II receptor antagonist and a diuretic in one tablet.
According to a press release, the combination tablet of amlodipine besylate, valsartan and hydrochlorathiazide (Exforge HCT, Novartis) is approved for patients with moderate-to-severe hypertension (mean diastolic BP as ≥100 mm Hg and <120 mm Hg and mean systolic BP >145 mm Hg and <200 mm Hg). The combination of the three antihypertensive medications in one tablet can be used in patients whose BP is not adequately controlled by individual or dual combinations of components of the new drug. The pill is at present the only three-in-one FDA-approved hypertension treatment.
The approval was based in part on results from a double-blind clinical trial that included 2,271 patients with moderate to severe hypertension. According to the product label, patients were assigned different dual-combinations of amlodipine, valsartan and hydrochlorathiazide. At week eight, the triple combination therapy of amlodipine plus valsartan plus hydrochlorathiazide was associated with greater reductions in both systolic and diastolic BP vs. each of the dual-combination treatments (P<.0001 for all differences). In a subgroup of 268 patients whose ambulatory BP was monitored, the blood pressure-lowering effect from triple-combination therapy was maintained throughout the 24-hour monitoring period.
“The majority of people with hypertension will require more than one medication to control their BP and it is not uncommon for patients with severe hypertension and/or patients requiring stricter BP control to need three or more medications,” David A. Calhoun, MD, a professor of medicine at the University of Alabama at Birmingham, said in a press release. “With a triple combination option, appropriate patients may experience a simpler routine of a convenient, once-daily pill to help them control their high BP.”