Results:

After a median follow-up of 32.9 months, the primary cardiorenal composite outcome had occurred in 783 participants in the aliskiren group (18.3%), as compared to 732 (17.1%) assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98-1.20; p = 0.12). This overall lack of benefit was observed across all predefined subgroups. The trial was terminated prematurely based on the independent Data and Safety Monitoring Committee’s assessment that the excess risk of adverse events in the aliskiren group could not be countered by a reduction in cardiovascular and renal events. Compared to placebo, the addition of aliskiren was associated with an increased number of adverse events. In particular, the proportion of patients with hyperkalemia (serum potassium level ≥6 mmol/L) was significantly higher in the aliskiren group than in the placebo group (11.2% vs. 7.2%).