Table 4.
Cardiovascular Endpoint Events and Hazard Ratios in ERN vs. Placebo Treated Stratified by Baseline CKD Status
| CKD | No CKD | |||||
|---|---|---|---|---|---|---|
| Clinical Event | Placebo (N = 251) |
Niacin (N = 254) |
Niacin vs. Placebo HR2 (95% CI) |
Placebo (N = 1444) |
Niacin (N = 1464) |
Niacin vs. Placebo HR (95% CI) |
| Exposure (pt-yr) | 748 | 737 | 4444 | 4477 | ||
| Primary Endpoint1 | 60 (23.9%) | 60 (23.6%) | 1.02 (0.71 – 1.45) | 214 (14.9%) | 222 (15.2%) | 1.03 (0.85 – 1.24) |
| Secondary Endpoints | ||||||
| First occurrence of CHD death, non-fatal MI, ischemic stroke or “high risk” acute coronary syndrome |
40 (15.9%) | 41 (16.1%) | 1.05 (0.68 −1.63) | 118 (8.2%) | 130 (8.9%) | 1.10 (0.85 – 1.41) |
| First occurrence of CHD death, non-fatal MI or ischemic stroke |
35 (13.9%) | 39 (15.4%) | 1.15 (0.73 – 1.82) | 103 (7.1%) | 117 (8.0%) | 1.13 (0.87 – 1.47) |
| Cardiovascular mortality | 12 (4.8%) | 19 (7.5%) | 1.62 (0.78 – 3.33) | 26 (1.8%) | 26 (1.8%) | 0.99 (0.57 – 1.70) |
| Overall Mortality | 23 (9.2%) | 39 (15.4%) | 1.73 (1.03 – 2.89)3 | 59 (4.1%) | 57 (3.9%) | 0.96 (0.67 – 1.38) |
| Cardiac | 12 (4.8%) | 16 (6.3%) | 1.35 (0.64 −2.86) | 22 (1.5%) | 22 (1.5%) | 0.99 (0.55 – 1.79) |
| Vascular, Non-cardiac | 0 (0.0%) | 3 (1.2%) | N/A | 4 (0.3%) | 4 (0.3%) | 0.99 (0.25 – 3.97) |
| Non-cardiovascular | 11 (4.4%) | 18 (7.1%) | 1.67 (0.79 – 3.53) | 32 (2.2%) | 29 (2.0%) | 0.90 (0.54 – 1.49) |
| Cardiovascular death or non-fatal MI | 30 (12.0%) | 34 (13.4%) | 1.16 (0.71 – 1.90) | 91 (6.3%) | 95 (6.5%) | 1.03 (0.78 – 1.38) |
1
Primary endpoint is defined as first occurrence of CHD death, non-fatal MI, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization.
2
Hazard ratios are based on model with baseline eGFR group.
3
P=0.038