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

Parving, H H and Brenner, B M and McMurray, J J V and de Zeeuw, D and Haffner, S M and Solomon, S D and Chaturvedi, N and Persson, F and Desai, A S and Nicolaides, M and Richard, A and Xiang, Z and Brunel, P and Pfeffer, M A and Mohan, V (2012) Cardiorenal End Points in a Trial of Aliskiren for Type 2 Diabetes. New England Journal of Medicine, 367 (23). p. 2204. ISSN 0028-4793



Background This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 diabetes and chronic kidney disease, cardiovascular disease, or both. Methods In a double-blind fashion, we randomly assigned 8561 patients to aliskiren (300 mg daily) or placebo as an adjunct to an angiotensin-converting–enzyme inhibitor or an angiotensin-receptor blocker. The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation; nonfatal myocardial infarction; nonfatal stroke; unplanned hospitalization for heart failure; end-stage renal disease, death attributable to kidney failure, or the need for renal-replacement therapy with no dialysis or transplantation available or initiated; or doubling of the baseline serum creatinine level. Results The trial was stopped prematurely after the second interim efficacy analysis. After a median follow-up of 32.9 months, the primary end point had occurred in 783 patients (18.3%) assigned to aliskiren as compared with 732 (17.1%) assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98 to 1.20; P=0.12). Effects on secondary renal end points were similar. Systolic and diastolic blood pressures were lower with aliskiren (between-group differences, 1.3 and 0.6 mm Hg, respectively) and the mean reduction in the urinary albumin-to-creatinine ratio was greater (between-group difference, 14 percentage points; 95% CI, 11 to 17). The proportion of patients with hyperkalemia (serum potassium level, ≥6 mmol per liter) was significantly higher in the aliskiren group than in the placebo group (11.2% vs. 7.2%), as was the proportion with reported hypotension (12.1% vs. 8.3%) (P<0.001 for both comparisons). Conclusions The addition of aliskiren to standard therapy with renin–angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful. (Funded by Novartis; ALTITUDE number, NCT00549757.)

Item Type:Article
Official URL/DOI:
Uncontrolled Keywords:Cardiorenal; Type 2 Diabetes; ALTITUDE Investigators
Subjects:Diabetes Clinical Trials
Diabetology > Cardiovascular Diabetology
Divisions:Department of Diabetology
Department of Clinical Trials
ID Code:760
Deposited By:surendar radha
Deposited On:17 Oct 2013 10:00
Last Modified:17 Oct 2013 10:00

Repository Staff Only: item control page