By Professor Juan Tamargo, Madrid, Spain
The European Medicines Agency is planning to review the use of aliskiren-containing medicines after the ALTITUDE trial, which was terminated prematurely, found no apparent benefit among patients randomized to aliskiren (Rasilez in the EU/Tekturna in the U.S., Novartis) but an increasein the incidence of stroke, renal complications, hyperkalemia and hypotension in patients who received aliskiren compared with patients who received a placebo.
ALTITUDE assesed the efficacy and safety of aliskiren on top of ACE-inhibitor or angiotensin-receptor-blocker (ARB) therapy in patients with type 2 diabetes and renal impairment who are at high risk of cardiovascular and renal events compared with a placebo add-on.
Novartis is recommending that ALTITUDE investigators remove Rasilez/Tekturna-based products from their patients’ treatment regimen and review their high blood pressure medication (http://www.novartis.com). Novartis is also reviewing the findings with DMCs of other clinical studies involving Rasilez/Tekturna-based products and combination therapies.
Rasilez/Tekturna-based products include Rasilez®/Tekturna®; Rasilez HCT®/Tekturna HCT®; Valturna®; Rasilamlo®/Tekamlo®; Rasitrio®/Amturnide