METHODS: The median follow-up was 21 (10-33) months. Of the 2737 patients included, 623 (23%) had non-
insulin-treated diabetes, 236 (9%) had
insulin-treated diabetes and 1878 did not have diabetes. Patients with
insulin-treated diabetes were younger, more often women, with higher body mass index, waist circumference, more frequent ischemic
heart failure cause, impaired kidney function, and longer diabetes duration. Compared with patients without diabetes, those with
insulin-treated diabetes had a 2-fold higher risk of having a primary outcome event. The hazard ratio (95% CI) for the effect of
eplerenone, compared with placebo, on the primary outcome was 0.31 (0.19-0.50) in
insulin-treated diabetes, 0.69 (0.50-0.93) in non-
insulin-treated diabetes, and 0.72 (0.58-0.88) in patients without diabetes; interaction P=0.007. The annualized number needed-to-treat-to-benefit with regards to the primary outcome was 3 (95% CI, 3-4) in patients with
insulin-treated diabetes, 16 (13-19) in patients with diabetes not receiving
insulin, and 26 (24-28) in patients without diabetes.
CONCLUSIONS: Patients with
insulin-treated diabetes experienced a greater benefit from
eplerenone than those with diabetes not treated with
insulin and people without diabetes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00232180.