SUPPLEMENTAL MATERIAL

Transcription

1 SUPPLEMENTAL MATERIAL Supplemental Table 1. Distribution of Participants Characteristics by Treatment Group at Baseline - The Vitamin D and calcium (CaD) Trial of the Women s Health Initiative (WHI) Study, Baseline characteristics Vitamin D and calcium (N=18,023) (N=17,960) No. (%) with data Age (years) Race/Ethnicity White Black Hispanic Other Education None/grade school High school/some college College Beyond college Income ($) <25, , , ,000 70, , , >100, Region by Solar Irradiance High Cholesterol requiring pills ever BMI (kg/m 2 ) > Alcohol intake None Past drinker Less than 1 drink/month Less than 7 drinks/week More than 7 drinks/week Physical activity level (total METs/week) Low Moderate High Systolic blood pressure, mean (SD), mmhg 126 (17) 126 (17) Diastolic blood pressure, mean (SD), mmhg 75 (9) 75 (9)

2 Supplemental Table 1 (ct d). Distribution of Participants Characteristics by Treatment Group at Baseline - The Vitamin D and calcium (CaD) Trial of the Women s Health Initiative (WHI) Study, No. (%) with data Smoking status None Past Current Multivitamin use Daily calcium (supplements + diet), mg/day Mean (SD) 1142 (669) 1144 (670) < , , Daily vitamin D (supplements + diet), IU/day Mean (SD) < > Ever received hormone replacement therapy History of hypertension Never Untreated Treated History of CVD History of diabetes History of CHD Family history of CVD Dietary modification trial assignment Not randomized Intervention Control Hormone therapy trial assignment Not randomized Estrogen alone intervention Estrogen alone control Estrogen + progesterone intervention Estrogen + progesterone control Abbreviations: SD, standard deviation; BMI, body mass index; MET, metabolic equivalent of task; CVD, cardiovascular disease; CHD, coronary heart disease.

3 Supplemental Table 2. Baseline Characteristics of Participants Stratified by Baseline Risk Status of Heart Failure and by Treatment Group - the Vitamin D and Calcium (CaD) Trial of the Women s Health Initiative (WHI) Study, Baseline Risk Status Low-risk group High-risk group Baseline characteristics CaD (n = 9,307) (N = 18,534) (n = 9,227) CaD (n = 8,716) (N = 17,449) (n = 8,733) No. (%) with data Age (years) Race/Ethnicity White Black Hispanic Other Education None/grade school High school/some college College Beyond college Income ($) <25, , , ,000 70, , , >100, Region by Solar Irradiance High Cholesterol requiring pills ever BMI (kg/m 2 ) > Alcohol intake None Past drinker Less than 1 drink/month Less than 7 drinks/week More than 7 drinks/week Abbreviations: SD, standard deviation; BMI, body mass index; MET, metabolic equivalent of task; CVD, cardiovascular disease.

4 Supplemental Table 2 (ct d). Baseline Characteristics of Participants Stratified by Baseline Risk Status of Heart Failure and by Treatment Group - the Vitamin D and Calcium (CaD) Trial of the Women s Health Initiative (WHI) Study, Baseline Risk Status Low-risk group High-risk group Baseline characteristics CaD (n = 9,307) (N = 18,534) (n = 9,227) CaD (n = 8,716) (N = 17,449) (n = 8,733) No. (%) with data Physical activity level (total METs/week) Low Moderate High Smoking status None Past Current Multivitamin use Daily calcium (supplements + diet), mg/day Mean (SD) 1170 (680) 1167 (660) 1113 (656) 1120 (680) < , Personal calcium (alone) supplements Daily vitamin D (supplements + diet), IU/day Mean (SD) 368 (273) 368 (268) 365 (268) 367 (265) < > Personal vitamin D (alone) supplements Ever received hormone replacement therapy Family history of CVD Dietary modification trial assignment Not randomized Intervention Control Hormone therapy trial assignment Not randomized Estrogen alone intervention Estrogen alone control Estrogen + progestin intervention Estrogen + progestin control Abbreviations: SD, standard deviation; BMI, body mass index; MET, metabolic equivalent of task; CVD, cardiovascular disease.

5 Supplemental Table 3. Results of Sensitivity Analysis Estimating the Association between CaD Supplementation and Heart Failure Incidence - The Vitamin D and calcium (CaD) Trial of the Women s Health Initiative (WHI) Study, Study population *IPCW method (N = 35,983) Total HR (95% CI) P Overall Control 17, CaD 18, ( ) 0.49 Low-risk Control 9, CaD 9, ( ) 0.14 High-risk Control 8, CaD 8, ( ) 0.67 Abbreviations: CaD, calcium plus vitamin D trial; HR, hazard ratio; CI, confidence interval; IPCW, Inverse Probability of Censored Weights; CI, confidence interval; P, P value *Analysis are based on entire baseline population (N = 35,983) adjusted for age, education, use of personal calcium, vitamin D or multivitamin supplements, history of heart failure risk factors (hypertension, CVD, CHD/coronary events, or diabetes), family history of CVD, and enrollment in other clinical trials

6 Supplemental Table 4. Distribution of Baseline Mean Concentrations of Total Calcium and Vitamin D Intakes and Measured Serum 25-Hydroxyvitamin D Levels by Heart Failure Incidence Cohorts - The Vitamin D and calcium (CaD) Trial of the Women s Health Initiative (WHI) Study, Study population Mean baseline levels Total (diet + supplements) calcium, mean (SD), mg/day Total (diet + supplements) vitamin D, mean (std), IU/day *Serum 25(OH)D, mean (std), ng/ml HF (n = 736) (697.16) (273.70) (6.29) Overall CaD (n=35,633) Low risk (n=18,339) High risk (n=17,295) No HF (n = 34,897) (724.15) (270.5) (9.18) P HF (n = 155) (687.91) (300.74) (6.20) No HF (n = 18,184) (731.21) (271.32) (9.24) P HF (n = 581) (700.08) (266.29) No HF (n = 16,714) (715.94) (269.54) P (6.42) (9.04) 0.43 Abbreviations: HF, heart failure; P, P value; SD, standard deviation * Values reported are based on data from a random sample of 2,012 participants with measured serum 25(OH)D levels at baseline.

7 Supplemental Table 5. Interaction between cardiovascular disease medications and calcium and vitamin D supplements. Cardiovascular disease medications Users of cardiovascular disease medications, n (%) P-value for interaction between baseline use of CVD medications and CaD ACE inhibitors 5,554 (31.8) 0.62 Angiotensin II receptor blockers 1,934 (11.1) 0.04 Statins 5,731 (32.8) 0.74 Betablockers 876 (5.0) 0.44 Calcium blockers 5,691 (32.6) 0.29 Composite 9,501 (54.5) 0.35

8 Supplemental Figure 1: Schoenfeld residual plots to evaluate the Cox proportional hazards assumption