The direct renin inhibitor Aliskiren was first granted regulatory approval as anti-hypertensive therapy in 2007. The approval was granted on basis of aliskiren’s effectiveness through six, placebo-controlled, eight-week clinical trials involving more than 2,000 patients with mild to moderate hypertension. The anti-hypertensive effect was maintained for up to one year across all demographic subgroups.
Interim analysis of the ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) study has shown higher adverse event rate in these high-risk patients receiving aliskiren (Rasilez/Tekturna, Novartis) combined with standard care. Specifically, an increased incidence for nonfatal stroke, renal complications, hyperkalemia and hypotension among those who had received 18 to 24 months of treatment with aliskiren as well as standard therapy.
Another blockbuster drug bites the dust! We have had a few patients on Aliskiren and now all are off it! One of my patients said “What next doctor? I was on Rosiglitazone and was taken off it and now this?” Glad I had counseled my patients when starting a new drug. Well, at least Metformin continues to provide good news.