Table 3.
Effect of Randomized Treatment Assignment on the Primary Outcome in Prespecified and Exploratory Subgroups.
| No. of Patients* | No. of Events (%)* | |||||
|---|---|---|---|---|---|---|
| Characteristic | Active | Placebo | Active | Placebo | RR (95% CI) | P-value for Interaction |
| Overall | 2721 | 2721 | 406 (14.9) | 390 (14.3) | 1.03 (0.90–1.19) | |
| Age (years) 40–54 |
582 | 584 | 50 (8.6) | 43 (7.4) | 1.17 (0.78–1.76) | |
| 55–64 | 990 | 970 | 119 (12.0) | 133 (13.7) | 0.85 (0.67–1.09) | 0.55 |
| 65+ | 1149 | 1167 | 237 (20.6) | 214 (18.3) | 1.12 (0.93–1.34) | |
| Prior Cardiovascular Disease† Yes |
1764 | 1728 | 329 (18.7) | 314 (18.2) | 1.03 (0.89–1.21) | 0.93 |
| No | 957 | 993 | 77 (8.1) | 76 (7.65) | 1.01 (0.73–1.39) | |
| Diabetes Yes |
570 | 574 | 142 (24.9) | 143 (24.9) | 0.99(0.78–1.24) | 0.67 |
| No | 2151 | 2147 | 264 (12.3) | 247 (11.5) | 1.06(0.89–1.26) | |
| Hypertension‡ Yes |
2360 | 2335 | 373 (15.8) | 363 (15.6) | 1.01 (0.87–1.16) | 0.30 |
| No | 361 | 386 | 33 (9.1) | 27 (7.0) | 1.32 (0.80–2.20) | |
| Elevated Cholesterol§ Yes |
2118 | 2150 | 340 (16.1) | 331 (15.4) | 1.03 (0.88–1.19) | 0.77 |
| No | 603 | 571 | 66 (11.0) | 59 (10.3) | 1.07 (0.76–1.52) | |
| Current Smoking Yes |
311 | 334 | 56 (18.0) | 70 (21.0) | 0.87 (0.61–1.24) | 0.34 |
| No | 2410 | 2387 | 350 (14.5) | 320 (13.4) | 1.07 (0.92–1.25) | |
| Parental History of MI|| Yes |
1056 | 1097 | 165 (15.6) | 167 (15.2) | 1.03(0.83–1.27) | 0.90 |
| No | 1656 | 1610 | 238 (14.4) | 219 (13.6) | 1.04 (0.87–1.26) | |
| BMI < 25kg/m2 |
616 | 566 | 100 (16.2) | 82 (14.5) | 1.12 (0.84–1.50) | |
| 25-< 30kg/m2 | 764 | 806 | 126 (16.5) | 127 (15.8) | 1.07 (0.84–1.37) | 0.41 |
| 30± kg/m2 | 1341 | 1349 | 180 (13.4) | 181 (13.4) | 0.97 (0.79–1.20) | |
| Alcohol Intake# < 1/month |
1494 | 1499 | 247 (16.5) | 234 (15.6) | 1.05 (0.88–1.26) | 0.73 |
| ≥ 1/month | 1227 | 1222 | 159 (13.0) | 156 (12.8) | 1.00 (0.80–1.25) | |
| Folate Intake# Below median (<= 432 ug/day) |
1322 | 1263 | 207 (15.7) | 183 (14.5) | 1.07 (0.87–1.30) | 0.88 |
| Above median (> 432 ug/day) | 1263 | 1323 | 181 (14.3) | 183 (13.8) | 1.04 (0.85–1.28) | |
| Aspirin** Yes |
1446 | 1385 | 270 (18.7) | 244 (17.6) | 1.07(0.90–1.28) | 0.37 |
| No | 1274 | 1336 | 136 (10.7) | 146 (10.9) | 0.93(0.73–1.17) | |
| Beta-Blockers Yes |
684 | 697 | 125 (18.3) | 123 (17.7) | 1.04 (0.81–1.34) | 0.93 |
| No | 1887 | 1883 | 263 (13.9) | 249 (13.2) | 1.03 (8.7–1.23) | |
| Lipid-lowering drugs Yes |
914 | 938 | 178 (19.5) | 171 (18.2) | 1.05 (0.85–1.30) | 0.83 |
| No | 1807 | 1783 | 228 (12.6) | 219 (12.3) | 1.02 (0.85–1.23) | |
| ACE inhibitors Yes |
627 | 668 | 102 (16.3) | 125 (18.7) | 0.81 (0.63–1.06) | 0.03 |
| No | 1957 | 1920 | 287 (14.7) | 247 (12.9) | 1.15 (0.97–1.36) | |
| Hormone-replacement therapy Yes |
1320 | 1329 | 172 (13.0) | 191 (14.4) | 0.89(0.72–1.09) | 0.05 |
| No | 1401 | 1392 | 234 (16.7) | 199 (14.3) | 1.18 (0.97–1.42) | |
| Multivitamins*** Yes |
616 | 631 | 94 (15.3) | 87 (13.8) | 1.09 (0.81–1.46) | 0.67 |
| No | 2105 | 2088 | 312 (14.8) | 302 (14.5) | 1.02 (0.87–1.19) | |
| Vitamin C Active |
1349 | 1356 | 213 (15.8) | 177 (13.1) | 1.21(0.99–1.48) | 0.03 |
| Placebo | 1372 | 1365 | 193 (14.1) | 213 (15.6) | 0.89(0.73–1.08) | |
| Vitamin E Active |
1364 | 1356 | 190(13.9) | 198 (14.6) | 0.94(0.77–1.15) | 0.22 |
| Placebo | 1357 | 1365 | 216(15.9) | 192 (14.1) | 1.12(0.93–1.37) | |
| Beta-Carotene Active |
1358 | 1349 | 199(14.7) | 203 (15.1) | 0.96(0.79–1.17) | 0.32 |
| Placebo | 1363 | 1372 | 207(15.2) | 187 (13.6) | 1.11(0.91–1.35) | |
Numbers do not always some to group totals due to missing information for some of the subgroup variables
Reported history of myocardial infarction, stroke, coronary revascularization, angina pectoris, transient ischemic attack, carotid endarterectomy, or peripheral artery surgery
Self-reported systolic blood pressure ≥ 140 mm Hg, diastolic blood pressure ≥ 90 mm Hg; self-reported physician-diagnosed hypertension; or reported treatment with medication for hypertension.
Self reported high cholesterol, cholesterol level ≥ 240 mg/dl; self-reported physician diagnosed, high cholesterol levels; or reported treatment with cholesterol lowering medication.
Parental history of myocardial infarction in father prior to age 60 or mother prior to age 65.
Estimated from the semiquantitative food frequency questionnaire
Aspirin use at least 4 times per month.
Any multivitamin use in the past month.