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FDA approves antihypertensive combination pills as first-line therapy
Many physicians have prescribed this combination therapy for some time.
The FDA has approved two single-pill combination drugs for use as initial therapy for patients with hypertension.
Valsartan plus hydrochlorothiazide (Diovan HCT, Novartis) and amlodipine plus valsartan (Exforge, Novartis) were both approved as first-line therapies.
“These approvals provide flexibility and confidence to physicians to use well-proven and well-accepted therapies as first-line treatment,” Kenneth Jamerson, MD, professor of medicine at the University of Michigan, said in a press release. “Patients may also benefit by getting their BP effectively and quickly under control with a single pill and fewer co-pays.”
The approval was based on a review of the results from a clinical trial of 2,000 patients and a clinical trial of 3,500 patients that suggested both drugs were efficacious and well tolerated in patients with mild-to-severe hypertension, according to the release. Valsartan plus hydrochlorothiazide, a diuretic-based therapy, was approved as a second-line therapy in 1998.
Amlodipine plus valsartan, which was the first angiotensin II receptor antagonist and calcium antagonist combination, was approved in 2007. – by Eric Raible
The FDA has been fairly trigger-happy to approve diuretic-based combinations for first-line therapy. The first diuretic-based combination, bisoprolol plus hydrochlorothiazide [Ziac, Duramed], was approved around 1995. Ever since then, several diuretic-based combinations got the seal of approval, and valsartan plus hydrochlorothiazide is the latest one. What is completely new is the FDA’s nod of approval for a calcium channel blocker/AII receptor antagonist combination. It may be considered a major advantage that we can now “officially” prescribe one of the best-known fixed combinations for initial therapy. Many physicians have been doing so for quite some time. They started to use benazepril plus amlodipine [Lotrel, Novartis] as initial therapy, and a good percentage of physicians have more recently been using amlodipine plus valsartan as initial therapy, regardless of its FDA status. So the FDA has essentially given a belated blessing to the way some physicians have been using fixed combinations such as amlodipine plus valsartan.
– Franz H. Messerli, MD
Cardiology Today Editorial Board member