November 4, 2012

Cardiorenal End Points in a Trial of Aliskiren for Type 2 Diabetes

As we originally reported towards the end of 2011, the ALTITUDE trial was terminated early.  The data from this trial was reported on November 3, 2012 at the American Society of Nephrology Kidney Week by Dr. Parving and simultaneously published online by the New England Journal of Medicine.

In ALTITUDE, a double-blind, randomized controlled trial, patients were randomly assigned aliskiren 300 mg daily or placebo in addition to therapy with an angiotensin-converting–enzyme inhibitor or an angiotensin-receptor blocker.

The trial was stopped prematurely after interim efficacy analysis suggested futility and possible harm from the therapy.

The intervention group reached the primary end point in 18.3% as compared with 17.1% assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98 to 1.20; P=0.12). The primary end point was a composite of the time to cardiovascular death or cardiac arrest with resuscitation, myocardial infarction, nonfatal stroke, hospitalization for heart failure, end-stage renal disease, death attributable to kidney failure, renal-replacement therapy or doubling of creatinine.

While effects on secondary renal end points were similar, there was a trend to higher cardiovascular composite outcome in the aliskiren group, HR 1.11 (0.99–1.25) p = 0.09.  Hyperkalemia and hypotension were more common in the aliskiren group.


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