Novartis announced new data showing that its direct renin inhibitor Rasilez (aliskiren) demonstrates long-term and sustained blood pressure control without risk of rebound high blood pressure. The data were presented by investigators at the 15th World Congress of Cardiology in Barcelona, Spain.
These data add to the growing body of evidence that suggest direct renin inhibition is an effective means of controlling high blood pressure. As a direct renin inhibitor, Rasilez would represent the first new treatment approach for high blood pressure in more than a decade.
The clinical trial results presented today highlight the power of Rasilez to maintain its blood pressure lowering effect over one year of therapy. Patients in the study taking Rasilez alone or in combination with diuretic hydrochlorothiazide lowered their blood pressure substantially (-17.4/-13.3 mmHg and -18.7/-12.1 mmHg, respectively).
These reductions were sustained over 24 hours - an important treatment consideration because many high blood pressure medicines fail to provide 24-hour control. True 24-hour blood pressure control can reduce the risk of heart attacks and strokes.
Interestingly, the study investigators also concluded that people in the study taking Rasilez avoided rebound high blood pressure, a potentially dangerous condition. After 11 months on Rasilez, some patients were switched to placebo. Despite this switch, their blood pressures rose only gradually toward baseline over the following month with no evidence of rebound.
"Normally we'd expect blood pressure to quickly return to pre-treatment levels when a medicine is stopped," said Dr. Domenic Sica, Professor of Medicine and Pharmacology at the Medical College of Virginia Commonwealth University in Richmond, Virginia. "However, our study showed that this does not occur with aliskiren. This may be a benefit of directly inhibiting renin to control blood pressure."
Throughout the clinical program including this trial, Rasilez has consistently shown tolerability comparable to placebo at doses up to 300 mg daily (i.e. within the expected therapeutic dose range). Rasilez has also been well-tolerated when used alone or with other common cardiovascular and anti-diabetic medicines.
Rasilez, which was developed in collaboration with Speedel, acts within the renin system that is central to blood pressure regulation. By directly inhibiting the renin system's point of activation - renin - Rasilez decreases the system's activity, as measured by plasma renin activity (PRA) .
The US submission of Rasilez was completed in April 2006, while the European submission is expected before for the end of 2006.