Novartis Stops ALTITUDE Trial of Aliskiren added to ACE or ARB in patients with diabetes and concurrent kidney disease
This week, Novartis announced that its trial (ALTITUDE) of aliskiren in addition to an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in diabetic patients with concurrent kidney disease has been stopped because of increased numbers of adverse events including renal events, hyperkalemia, hypotension, and stroke. A complete analysis of the trials outcomes and events has not yet been provided by Novartis and a separate evaluation of the trial by FDA has not been made available. Novartis will no longer be promoting aliskiren in combination with an ACE or an ARB, and specifically will not promote its product Valturna. AACE recommends, as a preliminary precaution, that physicians transition away from the use of aliskiren in combination with ACEI or ARB's in patients with diabetes and chronic kidney disease. AACE will issue further updates as more data on details of the trial become available and after the FDA review of the data. To read the media release from Novartis, click here.