Comments: Overall, the baseline demographic and disease characteristics were comparable between treatment groups in both the post-cut off dataset and the complete double-blind phase dataset, and were also comparable to those presented for the double-blind phase up to 25 May 2010. Although the efficacy results were not analysed for statistical significance, the results of the complete double-blind phase were generally comparable to those of the double-blind phase up to 25 May 2010. Table 3. Baseline demographic and disease characteristics, and main efficacy endpoints for double-blind phase up to 25 May 2010, post-cut off dataset, and complete phase dataset Double-blind phase up to 25 Post-cut off dataset Complete May 2010 phase dataset Eplerenone Placebo Eplerenone Placebo Eplerenone placebo N=1364 N=1373 N=1041 N=1006 N=1367 N=1376 Baseline demographic and disease characteristics (%) 77.3 78.1 76.4 78.2 77.4 78.1 White (%) 82.6 83.1 85.0 84.8 82.6 83.1 Mean age (SD) 68.7 68.6 68.3 68.3 68.7 68.6 (years) (7.7) (7.6) (7.5) (7.7) (7.7) (7.6) Ischaemic 69.7 68.1 67.4 66.9 NA NA aetiology of HF (%) Mean duration of 5.36 5.34 5.31 5.15 NA NA ischaemic HF (years) Primary efficacy 18.3% 25.9% 3.6% 3.4% 21.1% 28.5% endpoint - CV mortality or hospitalisation for HF Main secondary 19.8% 27.4% 3.7% 4.0% 22.8% 30.4% efficacy - all-cause mortality or HF hospitalisation Mortality secondary endpoints 12.5% 15.5% 3.1% 4.0% 15.0% 18.4% mortality CV mortality 10.8% 13.5% 2.8% 3.0% 13.0% 15.6%
Comments: Overall, the baseline demographic and disease characteristics were comparable between treatment groups in both the post-cut off dataset and the complete double-blind phase dataset, and were also comparable to those presented for the double-blind phase up to 25 May 2010. Although the efficacy results were not analysed for statistical significance, the results of the complete double-blind phase were generally comparable to those of the double-blind phase up to 25 May 2010. Table 3. Baseline demographic and disease characteristics, and main efficacy endpoints for double-blind phase up to 25 May 2010, post-cut off dataset, and complete phase dataset Double-blind phase up to 25 May 2010 Post-cut off dataset Complete phase dataset Eplerenone N=1364 Placebo N=1373 Eplerenone N=1041 Placebo N=1006 Eplerenone N=1367 placebo N=1376 Baseline demographic and disease characteristics (%) 77.3 78.1 76.4 78.2 77.4 78.1 White (%) 82.6 83.1 85.0 84.8 82.6 83.1 Mean age (SD) (years) 68.7 (7.7) 68.6 (7.6) 68.3 (7.5) 68.3 (7.7) 68.7 (7.7) 68.6 (7.6) Ischaemic aetiology of HF (%) 69.7 68.1 67.4 66.9 NA NA Mean duration of ischaemic HF (years) 5.36 5.34 5.31 5.15 NA NA Primary efficacy endpoint - CV mortality or hospitalisation for HF 18.3% 25.9% 3.6% 3.4% 21.1% 28.5% Main secondary efficacy - all-cause mortality or HF hospitalisation 19.8% 27.4% 3.7% 4.0% 22.8% 30.4% Mortality secondary endpoints mortality 12.5% 15.5% 3.1% 4.0% 15.0% 18.4% CV mortality 10.8% 13.5% 2.8% 3.0% 13.0% 15.6%