Table 5.
Venous thromboembolism outcomes and the effect of calcium plus vitamin D in subgroups of participants defined by baseline characteristics.
| Calcium plus Vitamin D |
Placebo (N=18,106) |
HR 1 (95% CI) |
Interaction P-value |
|||
|---|---|---|---|---|---|---|
| n VTE | Annualized risk (%) |
n VTE | Annualized risk (%) |
|||
| Age at screening, y | 0.85 | |||||
| 50-59 | 81 | (0.16%) | 80 | (0.16%) | 1.04 (0.76, 1.42) | |
| 60-69 | 157 | (0.28%) | 177 | (0.31%) | 0.88 (0.71, 1.10) | |
| 70-79 | 82 | (0.39%) | 91 | (0.43%) | 0.89 (0.66, 1.21) | |
| Race/ethnicity | 0.68 | |||||
| White | 282 | (0.27%) | 300 | (0.28%) | 0.95 (0.81, 1.12) | |
| Black | 25 | (0.22%) | 34 | (0.30%) | 0.69 (0.41, 1.16) | |
| Hispanic | 8 | (0.15%) | 7 | (0.14%) | 1.07 (0.35, 3.31) | |
| History of VTE | 0.76 | |||||
| No | 284 | (0.23%) | 303 | (0.25%) | 0.93 (0.79, 1.09) | |
| Yes | 36 | (0.94%) | 45 | (1.09%) | 0.84 (0.54, 1.31) | |
| Diabetes | 0.41 | |||||
| No | 294 | (0.24%) | 326 | (0.27%) | 0.91 (0.77, 1.06) | |
| Yes | 26 | (0.37%) | 22 | (0.32%) | 1.21 (0.68, 2.16) | |
| Current smoker | 0.21 | |||||
| No | 299 | (0.26%) | 317 | (0.27%) | 0.94 (0.81, 1.11) | |
| Yes | 17 | (0.17%) | 27 | (0.29%) | 0.57 (0.30, 1.06) | |
| Body mass index, kg/m2 | 0.82 | |||||
| <25 | 49 | (0.15%) | 45 | (0.13%) | 1.11 (0.74, 1.66) | |
| 25 - <30 | 95 | (0.21%) | 109 | (0.24%) | 0.85 (0.64, 1.12) | |
| >=30 | 176 | (0.37%) | 193 | (0.42%) | 0.91 (0.74, 1.11) | |
| Anticoagulant use | 0.28 | |||||
| No | 308 | (0.24%) | 343 | (0.27%) | 0.90 (0.78, 1.06) | |
| Yes | 12 | (1.32%) | 5 | (0.73%) | 1.84 (0.63, 5.39) | |
| Aspirin use ≥ 75 mg | 0.32 | |||||
| No | 256 | (0.25%) | 268 | (0.26%) | 0.96 (0.81, 1.14) | |
| Yes | 64 | (0.27%) | 80 | (0.35%) | 0.81 (0.58, 1.13) | |
| Hormone use status 2 | 0.72 | |||||
| None/past | 148 | (0.24%) | 160 | (0.27%) | 0.91 (0.72, 1.13) | |
| Current E-alone | 82 | (0.26%) | 98 | (0.31%) | 0.87 (0.65, 1.17) | |
| Current E+P | 90 | (0.26%) | 90 | (0.26%) | 1.02 (0.76, 1.38) | |
| Hormone Therapy Trial (HT) assignment | 0.86 | |||||
| No | 180 | (0.25%) | 194 | (0.27%) | 0.92 (0.75, 1.12) | |
| E-alone placebo | 24 | (0.23%) | 27 | (0.25%) | 0.91 (0.52, 1.59) | |
| E-alone active | 31 | (0.29%) | 42 | (0.40%) | 0.76 (0.48, 1.21) | |
| E+P placebo | 33 | (0.19%) | 34 | (0.21%) | 0.94 (0.58, 1.52) | |
| E+P active | 52 | (0.30%) | 51 | (0.29%) | 1.05 (0.71, 1.55) | |
| HT trial participant | 0.92 | |||||
| No | 180 | (0.25%) | 194 | (0.27%) | 0.92 (0.75, 1.12) | |
| Yes | 140 | (0.25%) | 154 | (0.28%) | 0.92 (0.73, 1.16) | |
| Diet Modification Trial participant | 0.76 | |||||
| No | 89 | (0.23%) | 100 | (0.27%) | 0.88 (0.66, 1.18) | |
| Yes | 231 | (0.26%) | 248 | (0.28%) | 0.94 (0.78, 1.12) | |
| Supplemental vitamin D use | 0.61 | |||||
| No | 177 | (0.26%) | 184 | (0.27%) | 0.95 (0.77, 1.17) | |
| Yes | 143 | (0.24%) | 164 | (0.28%) | 0.86 (0.69, 1.08) | |
| Total vitamin D intake (diet, supplements), IU/d 3 | 0.62 | |||||
| <200 | 117 | (0.24%) | 126 | (0.27%) | 0.89 (0.69, 1.14) | |
| 200 - <400 | 73 | (0.31%) | 69 | (0.29%) | 1.09 (0.78, 1.53) | |
| 400 - <600 | 67 | (0.23%) | 78 | (0.26%) | 0.83 (0.60, 1.15) | |
| >= 600 | 59 | (0.25%) | 72 | (0.31%) | 0.80 (0.57, 1.14) | |
| Total calcium intake (diet, supplements, meds), mg/d | 0.38 | |||||
| <800 | 94 | (0.22%) | 115 | (0.27%) | 0.79 (0.60, 1.04) | |
| 800 - <1200 | 102 | (0.31%) | 88 | (0.27%) | 1.12 (0.84, 1.49) | |
| >= 1200 | 120 | (0.25%) | 142 | (0.29%) | 0.87 (0.68, 1.11) | |
| Plasma 25-hydroxyvitamin D categories, nmol/L 4 | 0.82 | |||||
| <25.0 | 5 | (0.22%) | 12 | (0.55%) | 0.27 (0.09, 0.88) | |
| 25.0 - <50.0 | 27 | (0.36%) | 24 | (0.31%) | 1.20 (0.68, 2.10) | |
| 50.0 - < 75.0 | 19 | (0.38%) | 27 | (0.51%) | 0.76 (0.42, 1.40) | |
| ≥75.0 | 4 | (0.17%) | 7 | (0.31%) | 0.65 (0.17, 2.46) | |
1
Values are from Cox proportional hazard models stratified on age, history of VTE and randomization arms in the HT and DM trial
2
Values reflect hormone therapy use during year 1 of the clinical trial, including exposure in the Hormone Therapy trials.
3
Values reflect intake during year 1 of the clinical trial
4
Among a subgroup of 4,868 women (2,404 randomized to Calcium/Vitamin and 2,464 randomized to placebo), 25-OHD measured at baseline.
Abbreviations: HR = hazard ratio, E = estrogen, P = progestin