Novartis said it was immediately ceasing all promotion of products containing aliskiren and was talking with health authorities about the implications of the findings.
Therefore healthcare professionals should switch patients who are on Tekturna or any aliskiren-based products, in combination with an ACE or an ARB, to an alternative anti-hypertension regimen.
The action was based on the recommendation of the independent Data Monitoring Committee (DMC), after it found an increased risk for non-fatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after 18-24 months.
Novartis announced today the early termination of the ALTITUDE trial, which was testing the effect of the direct renin inhibitor aliskiren (Rasilez, Tekturna) in type 2 diabetics at high risk for cardiovascular and renal events.