Table 1.
CV outcomes in the WHI hormone therapy trials during the intervention and extended follow‐up phase
| CEE + MPA Arm | CEE‐Only Arm | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. of Events (annualized %) | No. of Events (annualized %) | |||||||||
| CEE + MPA, n = 8506 | Placebo, n = 8102 | Difference/10 000 PY | HR (95% CI) | P Value | CEE, n = 5310 | Placebo, n = 5429 | Difference/10 000 PY | HR (95% CI) | P Value | |
| Intervention | ||||||||||
| CHD | 196 (0.41) | 159 (0.35) | 6 | 1.18 (0.95‐1.45) | 0.13 | 204 (0.55) | 222 (0.58) | –3 | 0.94 (0.78‐1.14) | 0.53 |
| Total MI | 168 (0.35) | 129 (0.29) | 6 | 1.24 (0.98‐1.56) | 0.07 | 164 (0.44) | 173 (0.45) | –1 | 0.97 (0.79‐1.21) | 0.81 |
| CABG or PCI | 198 (0.42) | 200 (0.45) | –3 | 0.95 (0.78‐1.16) | 0.64 | 249 (0.68) | 255 (0.67) | 0 | 1.00 (0.83‐1.19) | 0.96 |
| All CV events | 786 (1.70) | 663 (1.52) | 19 | 1.13 (1.02‐1.25) | 0.02 | 877 (2.51) | 813 (2.24) | 27 | 1.11 (1.01‐1.22) | 0.03 |
| CV deaths | 79 (0.16) | 70 (0.15) | 1 | 1.05 (0.76‐1.45) | 0.77 | 109 (0.29) | 112 (0.29) | 0 | 1.00 (0.77‐1.31) | 0.98 |
| All‐cause mortality | 250 (0.52) | 238 (0.53) | –1 | 0.97 (0.81‐1.16) | 0.76 | 301 (0.80) | 299 (0.77) | 3 | 1.03 (0.88‐1.21) | 0.68 |
| Extended follow‐up | ||||||||||
| CHD | 487 (0.48) | 430 (0.45) | 3 | 1.09 (0.96‐1.24) | 0.19 | 487 (0.48) | 430 (0.45) | 3 | 0.94 (0.82‐1.09) | 0.43 |
| Total MI | 389 (0.39) | 324 (0.34) | 5 | 1.15 (0.99‐1.34) | 0.06 | 285 (0.47) | 288 (0.47) | 1 | 1.01 (0.86‐1.19) | 0.90 |
| CABG or PCI | 506 (0.50) | 471 (0.50) | 1 | 1.04 (0.92‐1.18) | 0.50 | 405 (0.68) | 396 (0.65) | 3 | 1.03 (0.90‐1.19) | 0.65 |
| All CV events | 1606 (1.70) | 1446 (1.60) | 10 | 1.08 (1.00‐1.15) | 0.05 | 1267 (2.30) | 1227 (2.15) | 15 | 1.06 (0.98‐1.15) | 0.12 |
| CV deaths | 293 (0.28) | 286 (0.29) | –1 | 0.97 (0.83‐1.14) | 0.73 | 243 (0.39) | 257 (0.41) | –1 | 0.97 (0.82‐1.16) | 0.75 |
| All‐cause mortality | 1011 (0.98) | 966 (0.99) | –1 | 0.99 (0.91‐1.08) | 0.87 | 403 (1.66) | 426 (1.73) | –7 | 0.99 (0.90‐1.10) | 0.92 |
Abbreviations: CABG, coronary artery bypass grafting; CEE, conjugated equine estrogens; CHD, coronary heart disease (defined as nonfatal MI and CHD death); CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MI, myocardial infarction; MPA, medroxyprogesterone acetate; PCI, percutaneous coronary intervention; PY, person‐years; WHI, Women's Health Initiative. Data from Manson et al.25