ALTITUDE Trial and Dual RAS Blockade: The Alluring but Soft Science of the Surrogate End Point

On December 20, 2011, the large, landmark Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE) was terminated on the basis of the recommendations of the Data and Safety Monitoring Board. The ALTITUDE was designed to evaluate the effects of aliskiren versus placebo on top of an angiotensin receptor blocker or an angiotensin-converting enzyme inhibitor in more than 8000 patients with type II diabetes and renal impairment. An increased incidence of hypotension, hyperkalemia, renal complications, and nonfatal stroke (HR = 1.25; 95% CI 0.98-1.60; P = .07) was observed in the aliskiren arm during the follow-up of approximately 2 years. No benefit of aliskiren over placebo could be documented. As a consequence, Novartis (Basel, Switzerland) immediately suspended all promotional educational programs related to aliskiren and its combinations.
Source: The American Journal of Medicine - Category: Journals (General) Authors: Tags: Commentary Source Type: research