FDA approves 3-in-1 BP pill

We already have a 2-in-1 high blood pressure/high cholesterol drug on the market, called Caduet, but now the FDA has approved a 3 in 1, called Exforge HCT. The new pill is a combination of a calcium channel blocker, angiotensin receptor blocker and diuretic – so-called water pills.

Here is the press release issued by the manufacturer, Novartis:

FDA approves Exforge HCT(R) – the Only High Blood Pressure Treatment to Combine Three Medications in a Single Pill

EAST HANOVER, N.J., April 30 /PRNewswire/ — The US Food and Drug Administration (FDA) has approved Exforge HCT (amlodipine, valsartan, hydrochlorothiazide), the only blood pressure (BP) treatment to combine three medications in a single pill. Exforge HCT combines the number one prescribed calcium channel blocker, angiotensin receptor blocker, and diuretic in one pill, and is an important new option for patients who have tried taking dual combinations of these classes of blood pressure medications without success.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/exforge/38191/

“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 greater than or equal to 100 mmHg and <120 mmHg, MSSBP greater than or equal to 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 significantly greater reductions in systolic and diastolic blood pressures when compared to all dual combinations of its components at the same doses (valsartan/hydrochlorothiazide 320 mg/25 mg, amlodipine/valsartan 10 mg/320 mg, and amlodipine/hydrochlorothiazide 10 mg/25 mg), providing additional reductions of 18-29% in systolic blood pressure and 19-32% in diastolic blood pressure. The reductions in systolic/diastolic blood pressure with Exforge HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide. 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.

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 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.”

This FDA approval was based on a clinical trial of Exforge HCT of over 2,000 patients.

~~~

Image: Newscom