Table 3.
Primary and secondary outcomes according to n-3 supplementation in the Alpha Omega trial*
| EPA-DHA (N = 2404) | Placebo or ALA Only (N = 2433) | |||||
|---|---|---|---|---|---|---|
| Outcome | no. (%) | rate/1000 patient-yr | no. (%) | rate/1000 patient-yr | Hazard Ratio (95% Cl)† | P Value |
| Primary outcome: major cardiovascular events‡ | 336 (14.0) | 46.0 | 335 (13.8) | 45.7 | 1.01 (0.87–1.17) | .93 |
| Secondary outcomes | ||||||
| Incident cardiovascular disease | 170 (7.1) | 22.4 | 185 (7.6) | 24.3 | 0.92 (0.75–1.13) | .43 |
| Death from cardiovascular disease | 80 (3.3) | 10.3 | 82 (3.4) | 10.5 | 0.98 (0.72–1.33) | .89 |
| Death from coronary heart disease | 67 (2.8) | 8.7 | 71 (2.9) | 9.1 | 0.95 (0.68–1.32) | .75 |
| Ventricular–arrhythmia–related events§ | 67 (2.8) | 8.7 | 74 (3.0) | 9.6 | 0.90 (0.65–1.26) | .55 |
| Death from any cause | 186 (7.7) | 24.0 | 184 (7.6) | 23.7 | 1.01 (0.82–1.24) | .92 |
| ALA (N = 2409) | Placebo or EPA–DHA Only (N = 2428) | |||||
| no. (%) | rate/1000 patient-yr | no. (%) | rate/1000 patient-yr | Hazard Ratio (95% Cl)† | P Value | |
| Primary outcome: major cardiovascular events | 319 (13.2) | 43.6 | 352 (14.5) | 48.1 | 0.91 (0.78–1.05) | .20 |
| Secondary outcomes | ||||||
| Incident cardiovascular disease | 168 (7.0) | 22.1 | 187 (7.7) | 24.5 | 0.90 (0.73–1.11) | .34 |
| Death from cardiovascular disease | 78 (3.2) | 10.1 | 84 (3.5) | 10.8 | 0.94 (0.69–127) | .67 |
| Death from coronary heart disease | 66 (2.7) | 8.6 | 72 (3.0) | 9.2 | 0.92 (0.66–1.29) | .64 |
| Ventricular–arrhythmia–related events§ | 62 (2.6) | 8.1 | 79 (3.3) | 10.2 | 0.79 (0.57–1.10) | .16 |
| Death from any cause | 182 (7.6) | 23.5 | 188 (7.7) | 24.1 | 0.97 (0.79–1.19) | .80 |
ALA, alpha-linolenic acid; CI, confidence interval; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid.
The two groups that received EPA + DHA were combined and compared with the two groups that did not receive EPA + DHA (ie, the groups that received either placebo or only ALA). Similarly, the two groups that received ALA were combined and compared with the two groups that did not receive ALA (ie, the groups that received either placebo or only EPA + DHA).
The hazard ratios and 95% confidence intervals were calculated with the use of Cox proportional-hazards models.
Major cardiovascular events comprised fatal and nonfatal cardiovascular events and the cardiac interventions percutaneous coronary intervention and coronary-artery bypass grafting.
Ventricular-arrhythmia-related events comprised sudden death, fatal and nonfatal cardiac arrest, and placement of implantable cardioverter defibrillators.
Permission to reuse table granted by New England Journal of Medicine, Massachusetts Medical Society.79