Novartis AG said its blood pressure drug Rasilez (aliskiren), the first-in-class direct renin inhibitor, was shown to be as effective in reducing left ventricular hypertrophy (LVH), a condition that often precedes heart disease, than the standard treatment.
Rasilez has shown clinically meaningful reductions in left ventricular hypertrophy(LVH), or abnormal thickening of the heart muscle, often results from high blood pressure, a proven predictor of heart disease, that are comparable to those seen with the current standard-of-care treatment. Affecting nearly a third of patients with high blood pressure, LVH decreases the heart's ability to work efficiently and more than doubles a patient's risk of premature cardiovascular events or death.
High blood pressure currently affects approximately one billion people worldwide and causes about 7.1 million deaths each year. The American Heart Association estimates that high blood pressure will cost the US economy $66.4 billion in 2008.
Late-breaking results were presented at the American College of Cardiology meeting in Chicago from the ALLAY study, part of the extensive Rasilez outcomes trial programme known as ASPIRE HIGHER.
The study showed that Rasilez alone reduced LVH as effectively as the angiotensin receptor blocker (ARB) losartan (-5.4 per cent vs -4.7 per cent respectively) after nine months of therapy, despite patients having very well-controlled baseline blood pressure. With regard to the study's primary endpoint, the combination of both medicines achieved a numerically greater reduction in LVH than losartan alone, but the result was not statistically significant. Alone and in combination, Rasilez was well-tolerated.
"ALLAY is our first proof that direct renin inhibition, and aliskiren in particular, reduces thickening of heart muscle which is a key risk factor for heart disease," said Dr Scott Solomon, lead investigator of ALLAY and Director of Non-Invasive Cardiology at Brigham and Women's Hospital, Boston, USA. "This is important because it provides doctors and patients with another LVH treatment alternative, while also providing effective blood pressure lowering."
The ALLAY study is the latest trial in the ASPIRE HIGHER program to highlight the organ protection potential of Rasilez, the first new kind of high blood pressure treatment in more than a decade. Other studies, including ALOFT, have highlighted the protective potential of Rasilez against heart and kidney diseases.
ALLAY, involving 460 overweight patients with high blood pressure and LVH from eight countries, investigated whether Rasilez reduced LVH as well as losartan, and whether a combination of the two medicines offered further LVH reductions over losartan alone. Patients were randomised to receive Rasilez or losartan alone, or both in combinations.
Professor Björn Dahlöf, Associate Professor in the Department of Medicine at Sahlgrenska University Hospital/Ostra, University of Gothenburg, Sweden, said, "We expect some LVH reductions simply by lowering the patient's blood pressure, but because patients in ALLAY had low baseline blood pressures, the degree of reduction with aliskiren was especially impressive."
ASPIRE HIGHER is the largest ongoing cardio-renal outcomes program and involves more than 35,000 patients in 14 trials, including three new mega-trials. ASPIRE HIGHER is studying Rasilez and direct renin inhibition in a variety of kidney and heart diseases, including diabetic kidney disease and heart failure.
Rasilez acts by directly inhibiting renin, an enzyme that triggers a process leading to high blood pressure. Rasilez is approved in more than 40 countries and is proven to provide blood pressure reductions that last beyond 24 hours. It was approved in the European Union in August 2007 and in the US in March 2007 under the trade name Tekturna. Tekturna HCT, the first single-dose combination involving Tekturna, was approved in the US in January 2008.