New clinical data presented show first-in-class direct renin inhibitor Rasilez (aliskiren), known as Tekturna in the US, provides significantly greater blood pressure reductions in patients with high blood pressure aged 65 and over, compared to the angiotensin-converting enzyme (ACE) inhibitor ramipril.
Results from the AGELESS study, presented at the American Heart Association (AHA) 2008 scientific sessions, showed that Rasilez/Tekturna provides an additional reduction in systolic blood pressure of 2.3 mmHg in patients aged 65 and over compared to the ACE inhibitor ramipril after the primary endpoint of 12 weeks of treatment.
Seventy per cent of people aged over 60 have high blood pressure. Increased systolic blood pressure (the pressure of blood flow when the heart beats) is the most frequent type of uncontrolled high blood pressure in the elderly and is associated with an increased risk of cardiovascular events including stroke, myocardial infarction and heart failure.
"High blood pressure becomes more prevalent and challenging to treat with age," said Professor Daniel Duprez, lead author of the AGELESS study and Director of Research at the Rasmussen Center for Cardiovascular Disease Prevention, University of Minnesota. "The elderly population is expected to more than double over the next thirty years. Therefore, it is important to have effective therapies such as aliskiren to treat a range of patients, including the elderly."
The AGELESS study conducted in 900 patients with systolic hypertension aged 65 and over showed that Rasilez/Tekturna (150 mg daily increased to 300 mg daily) lowered systolic blood pressure by 13.6 mmHg compared to a reduction of 11.3 mmHg in patients taking ramipril (5 mg daily increased to 10 mg daily) after 12 weeks of treatment (p< 0.0001). A greater reduction of diastolic blood pressure (pressure between heart beats) was also achieved after 12 weeks of treatment with Rasilez/Tekturna compared to ramipril (-4.8 mmHg vs. -3.5 mmHg, respectively) (p< 0.0001). In the study, Rasilez was well tolerated. The most frequently reported adverse events in this study for Rasilez/Tekturna included headache, dizziness, diarrhoea, upper respiratory tract infection, cough, nasopharyngitis and nausea.
"AGELESS is the third study to show that Rasilez lowers blood pressure more effectively than the ACE inhibitor ramipril," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "Rasilez provides effective blood pressure lowering that lasts beyond 24 hours in a range of patients. Through the ASPIRE HIGHER program we hope to further demonstrate significant blood pressure lowering in special populations as well as examine the organ protection potential of Rasilez."
AGELESS is part of the landmark ASPIRE HIGHER program, the largest ongoing cardio-renal outcomes program worldwide involving more than 35,000 patients in 14 trials. In addition to hypertension studies in specific patient populations, the ASPIRE HIGHER program is investigating the potential heart and kidney protection benefits of Rasilez/Tekturna.
The AGELESSS data adds to the findings from three of the 14 studies in the ASPIRE HIGHER program that have also been reported. The AVOID study, published recently in The New England Journal of Medicine, showed that Rasilez/Tekturna reduced albuminuria, a key indicator of kidney disease, by an additional 20% in type 2 diabetic patients with kidney disease and high blood pressure who were already taking the maximum standard treatment.
The ALOFT study, recently published in Circulation: Heart Failure, showed that the addition of Rasilez/Tekturna to standard heart failure treatments resulted in nearly five times greater reductions in brain natriuretic protein (BNP), a marker of heart failure severity, than placebo. The ALLAY study demonstrated that Rasilez/Tekturna reduced left ventricular hypertrophy (LVH), a marker of cardiac damage associated with an increased risk of cardiovascular events. In ALLAY, Rasilez/Tekturna reduced LVH as effectively as the angiotensin receptor blocker (ARB) losartan, the gold standard in reducing LVH in hypertensive patients. The combination of Rasilez/Tekturna and losartan achieved a numerically greater reduction in LVH than losartan alone, but the result was not statistically significant.
Rasilez/Tekturna is approved in more than 57 countries. Tekturna was approved in the US in March 2007, and in the European Union in August 2007 under the trade name Rasilez. Tekturna HCT, the first single-pill combination involving Tekturna, was approved in the US in January 2008. Rasilez HCT was approved in Switzerland in October 2008 and a European Commission decision is expected for the single-pill combination in early 2009.
Novartis is focused on improving the lives of the hundreds of millions of people with cardiovascular and metabolic diseases. As a global leader in cardiovascular and metabolic health for nearly 50 years, Novartis provides innovative therapies and support programs to treat high blood pressure and diabetes - both major public health issues.