The decision by the Swiss Agency for Therapeutic Products (Swissmedic) means that Diovan, an angiotensin II receptor blocker (ARB), can now be used not only for the treatment of hypertension but also for heart failure a widespread condition. Diovan is approved for use in patients with heart failure who cannot tolerate angiotensin-converting enzyme (ACE) inhibitors. Heart failure, the most rapidly growing cardiovascular disorder in the world, involves a progressive weakening of the cardiac muscle, with a loss of the heart's ability to pump blood effectively to the rest of the body. In Switzerland, about 100 000 patients suffer from heart failure, with around 20000 new cases diagnosed each year.

New indication based on convincing results from Val-HeFT study: The main basis for the extension of the indication was the Val-HeFT study, which involved 5 010 patients with heart failure in 16 countries. The overall results of this placebo-controlled study show that in patients already taking other heart failure treatments prescribed by their physicians, Diovan leads to a reduction in morbidity and slows down the progression of disease associated with heart failure. All-cause mortality was comparable in the group treated with Diovan and the group receiving placebo. In the Val-HeFT study, the best results with Diovan were obtained in patients who were not receiving ACE inhibitors. Among these patients, a relative reduction of 33 per cent was observed for mortality, 44 per cent for combined mortality/morbidity, and 53 per cent for hospitalizations due to heart failure, compared with placebo.

Guidelines issued by the Swiss Society of Cardiology support the use of Diovan to treat patients with heart failure who cannot tolerate ACE inhibitors2 Although the benefits offered by ACE inhibitors in heart failure are well known, these drugs cannot be given to certain patients on account of poor tolerance or for other reasons (e.g. cough).

Theodor Sproll, CEO of Novartis Pharma Switzerland, commented: "Diovan is already regarded by physicians as a reliable and effective agent for controlling hypertension. Now they can also prescribe Diovan to improve the condition and alleviate the suffering of their patients with heart failure. This important new indication for Diovan is a result of our major clinical development program, which is designed to help patients throughout the course of cardiovascular disease."

With Diovan, Novartis is conducting the world's largest clinical endpoint studies involving an ARB, with more than 43 000 patients included in the program. Besides Val-HeFT, trials examining the effects of Diovan beyond the hypertension indication include Value (high-risk patients with hypertension), Valiant (post-myocardial infarction patients), and Navigator (patients with impaired glucose tolerance - also called pre-diabetes - at high risk for cardiovascular events).

Worldwide and in the US, Diovan is the leading antihypertensive in the ARB class. Diovan has already been approved in other countries including the US for the heart failure indication in patients who cannot tolerate ACE inhibitors.