This first pooled analysis from phase II/III studies was presented by Novartis at the World Congress of Cardiology in Barcelona, Spain. Pooled data were available from over 7,000 patients with mild-to-moderate hypertension treated with Rasilez over six to 52 weeks.
Speedel said Rasilez (also known as SPP100) provided a highly effective and consistent blood pressure (BP) lowering with placebo placebo-like tolerability in a broad range of patients with mild-to-moderate hypertension.
The analysis showed that Rasilez provides dose-dependant BP reductions at doses of up to 300mg, with the drug candidate’s anti-hypertensive effects proving consistent across the placebo-controlled studies.
In addition, the data show that 75mg to 600mg doses provide effective and comparable BP reductions in elderly and young patients and in both sexes, while the addition of Rasilez to other classes of anti-hypertensive therapy consistently provides additional BP reductions.
Investigators also presented data from phase III clinical trials of Rasilez in monotherapy and in co-administration therapy with a diuretic (HCTZ), a calcium channel blocker (amlodipine), and an ACE inhibitor (ramipril).
These data show that Rasilez is well tolerated and has sustained BP-lowering effects alone or in combination with HCTZ during long-term (52 weeks) treatment of hypertension.