December 20th, 2011

ALTITUDE Study of Aliskiren Terminated Early by Novartis

Novartis announced today the early termination of the ALTITUDE trial, which was testing the effect of the direct renin inhibitor aliskiren (Tekturna, Rasilez) in patients with type 2 diabetes and renal impairment at high risk for cardiovascular and renal events. The action was based on the recommendation of the independent Data Monitoring Committee, after it found an increased risk for nonfatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after 18-24 months. Patients in ALTITUDE were randomized to receive aliskiren or placebo in addition to an ACE inhibitor or an angiotensin receptor blocker (ARB).

The company is also recommending that physicians not prescribe drugs containing aliskiren with either an ACE inhibitor or an ARB. Patients who are already taking a combination pill should be switched to an alternative antihypertensive regimen, according to the company.

The action represents a major setback for a drug that was once believed to have blockbuster potential. Novartis said it was immediately ceasing all promotion of products containing aliskiren for use in combination with an ACE inhibitor or ARB, and said it was talking with health authorities about the implications of the findings.

Aliskiren was first approved in 2007 for the treatment of hypertension. Novartis said that total sales for Tekturna and Rasilez were $449 million for the first 9 months of 2011.

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