Newly-released clinical data show that Rasilez (aliskiren), the first orally effective direct renin inhibitor, provided superior reductions in systolic blood pressure over the ACE inhibitor ramipril in people with diabetes and hypertension.

The data, presented at 16th Scientific Meeting of the European Society of Hypertension (ESH) in Madrid, also show that the combination of Rasilez and ramipril improved blood pressure control over the use of either medication alone.

Other information presented at ESH show that Rasilez provided sustained and persistent blood pressure reductions over 24 hours in people with diabetes. Sustained 24-hour control is important because blood pressure often surges during early morning hours.

"It is particularly important for people with both diabetes and high blood pressure to gain control over both of these diseases," said Dr. James Shannon, MD, Head of Development at Novartis Pharma AG. "These new data demonstrate that using Rasilez in combination with commonly-used hypertension medicines, such as ramipril, can help patients achieve significantly better blood pressure control than with ramipril alone."

The US submission of Rasilez was completed in April 2006, while the European submission remains on track for the end of 2006.

High blood pressure, and its consequences, is the world's No. 1 killer, affecting one in four adults - or approximately one billion people globally. The risk of cardiovascular complications is two to four times higher in people with diabetes than those without the disease, so the International Diabetes Federation recommends tight blood pressure control.4 Despite extensive use of current therapies, about 70 per cent of people with high blood pressure - and nearly 90 per cent with both diabetes and high blood pressure - have not reached their target blood pressure levels.

"People with diabetes and high blood pressure need stringent 24-hour blood pressure control," said Dr. Hans-Henrik Parving, MD, of the Steno Diabetes Center in Denmark. "This study showed that aliskiren enhanced renin system suppression and resulted in greater blood pressure reductions."

This eight-week study involved 837 people with diabetes and high blood pressure. The results showed that Rasilez alone reduced mean sitting systolic blood pressure (MSSBP) by 14.7 mmHg compared to 12.0 mmHg with ramipril alone. However, adding aliskiren to ramipril lowered MSSBP by 16.6 mmHg, which was significantly more effective than ramipril alone (p<0.005). Also, responder rates - the number of people reaching the goal for mean sitting diastolic blood pressure (MSDBP) - were higher in people receiving aliskiren.

The most common adverse events were cough and headache, whose frequencies were highest in the ramipril group (4.7 per cent and 6.1 per cent, respectively). Cough and headache were less commonly seen when aliskiren was added to ramipril (1.8 per cent and 2.9 per cent, respectively) than with ramipril alone.

Throughout the clinical program, Rasilez - at doses up to 300 mg (within the expected therapeutic dose range) - has consistently shown tolerability similar to placebo. Rasilez has also been well tolerated when used with other common cardiovascular as well as anti-diabetic medicines.

If approved, Rasilez, which was developed with Speedel, will represent the first new treatment approach for people with high blood pressure in more than a decade. It acts within the Renin System, which 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).