Table 3. Incidence and Relative Hazards of AF Among Participants Randomized to Vitamin D3 vs Placebo.
End points | Vitamin D3 (n = 12 553) | Placebo (n = 12 566) | Vitamin D3 vs placebo | ||||||
---|---|---|---|---|---|---|---|---|---|
No. of events | Total person-years | Events per 1000 person-years | No. of events | Total person-years | Events per 1000 person-years | Difference in events per 1000 person-years (95% CI) | Hazard ratio (95% CI)a | P value | |
Primary end point | |||||||||
All incident AF | 469 | 65 046 | 7.2 | 431 | 65 137 | 6.6 | 0.6 (−0.3 to 1.5) | 1.09 (0.96-1.25) | .19 |
Sensitivity analyses of primary end point | |||||||||
AF events excluding those with symptoms preceding randomization | 438 | 64 948 | 6.7 | 404 | 65 046 | 6.2 | 0.5 (−0.3 to 1.4) | 1.09 (0.95-1.25) | .22 |
AF events excluding those detected by CMS linkage data alone | 373 | 64 727 | 5.8 | 361 | 64 919 | 5.6 | 0.2 (−0.6 to 1.0) | 1.04 (0.90-1.20) | .60 |
AF events excluding atrial flutter alone and postoperative AFb | 404 | 64 815 | 6.2 | 380 | 64 962 | 5.8 | 0.4 (−0.5 to 1.2) | 1.07 (0.93-1.23) | .36 |
AF events excluding those confirmed by medical record aloneb | 343 | 64 671 | 5.3 | 313 | 64 790 | 4.8 | 0.5 (−0.3 to 1.2) | 1.10 (0.95-1.28) | .22 |
On-treatment analysisc | 383 | 50 540 | 7.6 | 336 | 48 640 | 6.9 | 0.7 (−0.4 to 1.7) | 1.09 (0.94-1.27) | .24 |
Secondary end points | |||||||||
Paroxysmal AF | 267 | 65 046 | 4.1 | 259 | 65 137 | 4.0 | 0.1 (−0.6 to 0.8) | 1.03 (0.87-1.23) | .71 |
Nonparoxysmal AF | 188 | 65 046 | 2.9 | 158 | 65 137 | 2.4 | 0.5 (−0.1 to 1.0) | 1.20 (0.97-1.48) | .10 |
Abbreviations: AF, atrial fibrillation; CMS, Centers for Medicare & Medicaid Services.
The hazard ratio for each intervention was estimated in Cox models using indicators for treatment group, controlling for the second intervention, age, and sex.
Post hoc analyses.
Adherence-based analyses that censored follow-up data when a participant discontinued trial capsules or began taking more than 800 IU/d of nonstudy vitamin D3.