The US Food and Drug Administration (FDA) has approved Exforge HCT, the only single pill to combine the three most prescribed high blood pressure treatments in their classes in the US: the calcium channel blocker amlodipine, the angiotensin receptor blocker valsartan, and the diuretic hydrochlorothiazide.

Exforge HCT is an important new option for patients who have tried taking dual combinations of these classes of blood pressure medications without success.

"The majority of people with hypertension will require more than one medication to control their blood pressure and it's not uncommon for patients with severe hypertension and/or patients requiring stricter blood pressure control to need three or more medications," said David A. Calhoun, MD, Professor of Medicine, Vascular Biology and Hypertension Program, University of Alabama at Birmingham. "With a triple combination option, appropriate patients may experience a simpler routine of a convenient, once-daily pill to help them control their high blood pressure."

Exforge HCT provides proven efficacy in patients with moderate to severe hypertension (MSDBP 100 mmHg and <120 mmHg, MSSBP 145 mmHg and <200 mmHg). In a clinical trial, the maximum dose of Exforge HCT (amlodipine/valsartan/ hydrochlorothiazide 10 mg/320 mg/25 mg) demonstrated additional reductions of 18-29% in systolic blood pressure and 19-32% in diastolic blood pressure when compared to all dual combinations of its components at the same doses. The reductions in systolic/diastolic blood pressure with Exforge HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide 320 mg/25 mg; 6.2/3.3 mmHg greater than with amlodipine/valsartan 10mg/320 mg; and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide 10 mg/25 mg. These results also include a placebo effect of unknown size. Ambulatory blood pressure monitoring showed that the blood pressure lowering effect of Exforge HCT was maintained throughout the 24-hour period.
High blood pressure affects approximately 74 million adults in the US and one in four adults worldwide. If high blood pressure is not treated, it can lead to heart attack and stroke. Exforge HCT is not indicated for the treatment or prevention of heart attack or stroke.

Research suggests that up to 85% of patients may need multiple medications and many need three or more to help control their blood pressure. Patients may find treatment more convenient with one single pill rather than separate pills.

Exforge HCT contains three effective medicines that work in three different ways. A patient may be switched to the single pill combination Exforge HCT if blood pressure is not adequately controlled on any two of the following anti-hypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. The full blood pressure lowering effect was achieved two weeks after being on the maximal dose of Exforge HCT.

"This approval of Exforge HCT as the only single blood pressure pill combining the efficacy of three of the most-prescribed treatments in their classes represents a significant milestone toward reducing the burden of unmet need in hypertension," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "Novartis remains confident in the important role of single pill combination medications to help appropriate patients achieve their blood pressure targets, while providing physicians with a range of powerful yet flexible combinations of doses to effectively manage high blood pressure in different patients."

Exforge and Exforge HCT will be offered at the same price in the US on a dose equivalent basis, essentially providing the added diuretic in Exforge HCT at no additional cost. Since Exforge HCT combines three medications in a single pill, patients may benefit from reduced insurance co-payments.

This FDA approval was based on a clinical trial of Exforge HCT of over 2,000 patients. Exforge HCT is currently under review in the EU.