Exforge®, a single-tablet combination of two of the world's most commonly prescribed high blood pressure medicines3,4, has been shown in new clinical data to have helped nine out of 10 non-diabetic patients to reach their treatment goals after having previously failed to do so with single medicines1.

The results showed patients taking Exforge experienced on average an additional 20 mmHg drop in systolic blood pressure compared to reductions seen with their previous medication1. The data from this trial involving 894 patients were presented today at the Annual Scientific Meeting of the American Society of Hypertension (ASH) in Chicago.

The efficacy of Exforge, which combines the angiotensin receptor blocker (ARB) valsartan (Diovan®) and the calcium channel blocker (CCB) amlodipine in one tablet, was again demonstrated in this trial, even in patients considered to be more difficult to treat such as the elderly or those with type 2 diabetes1. Exforge was well-tolerated at the doses used in this trial1.

The study - designed to assess the use of Exforge in a real-life treatment environment - showed that patients who had failed to reach the recommended blood pressure goal of 140/90 mmHg (systolic/diastolic pressure) on a range of single therapies could be effectively treated to this goal with Exforge, regardless of previous treatment.

In patients with type 2 diabetes in the same study, Exforge helped an impressive five out of 10 achieve a more aggressive treatment goal of reducing blood pressure to 130/80 mmHg.

"Most patients will require two or more medications to achieve optimal sustained blood pressure control," said Dr. Joseph Izzo, the lead investigator from the Department of Medicine at the State University of New York in Buffalo. "These data show that using Exforge in a real-life setting can get patients who were previously uncontrolled to a healthy blood pressure goal."

Following Swiss and European Union approval in early 2007, Exforge is currently available in Germany, Switzerland and the UK and is planned to be launched in the rest of the EU in 2007/2008. The US Food and Drug Administration (FDA) granted tentative approval for Exforge in December 2006, and this medicine is expected to become available in the US later in 2007 following the expiration of market exclusivity for Norvasc®† (amlodipine).

"Exforge is a very exciting addition to our cardiovascular portfolio," said Dr. James Shannon, Global Head of Development at Novartis Pharma AG. "The fact that nearly 70% of people with high blood pressure still do not have this potentially fatal condition under control demonstrates the need for powerful and more effective therapies."

High blood pressure and its consequences is the world's No. 1 cause of death5. This condition, also called hypertension, is when the blood in the body moves through the blood vessels at a higher pressure than normal and causes damage to the arteries, kidneys, brain and other vital organs that can ultimately lead to heart failure6. At present, high blood pressure is estimated to affect about one in four of all adults in the US, while approximately one billion people worldwide suffer from the condition. The number of people with high blood pressure is expected to reach nearly 1.6 billion by 20257.

Study details

This trial was a randomized, double-blind, multicenter study that compared the efficacy and safety of two doses of Exforge in patients with high blood pressure who had not reached goals with a single medicine. A total of 894 patients, of whom 145 (16%) had type 2 diabetes, were randomized to either Exforge (valsartan/amlodipine) 160/5 mg (n=443) or Exforge 160/10 mg (n=451). The majority of patients had previously taken either a calcium channel blocker (CCB), angiotensin receptor blocker (ARB), angiotensin-converting enzyme inhibitor (ACE), beta blocker or diuretic. The primary endpoint measured the proportion of patients after eight and 16 weeks who reached the recommended treatment goals of blood pressure of