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Published on 20 June 2008

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Cardio-renal clinical trial expands

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Pharmaceutical firm Novartis has announced details of two new long-term outcome studies in its landmark ASPIRE HIGHER clinical trial programme, which has expanded to involve more than 35,000 patients in 14 trials.

The series of trials that comprise ASPIRE HIGHER now form the largest and most far-reaching cardio-renal outcomes program worldwide.

The newly-launched studies will evaluate the organ protection potential of the direct renin inhibitor Rasilez, known as Tekturna® in the US, for the treatment of heart failure and prevention of cardiovascular disease in the elderly, a patient segment that is predicted to more than double between 2000 and 2030.

A third “megatrial” already under way is studying cardio-renal outcomes in diabetes. High blood pressure is a sign that many organs in the body could be under threat.

Rasilez/Tekturna works by directly inhibiting renin, an enzyme that triggers a process leading to high blood pressure and organ damage. By inhibiting renin at the point of activation, Rasilez/Tekturna provides effective blood pressure reductions and may also afford greater protection against complications such as organ damage.

“Patients with hypertension, diabetes, kidney disease and heart failure continue to experience adverse clinical events despite current best treatment,” said Professor John McMurray of the British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Scotland.

“The ASPIRE HIGHER program of clinical trials aims to build upon exciting proof of concept studies with aliskiren to evaluate the role of this new agent in reducing morbidity and mortality in these very common and important disease states.”

Novartis



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