ts† 0.95 (0.79-1.16) 56 53
Nonfatal MI† 0.91 (0.73-1.14) 43 40
CHD death† 1.01 (0.71-1.43) 16 16
Stroke†
Ischemic† 1.37 (1.09 -1.73)
1.55 (1.19-2.01) 33
25 45
38
Deep vein thrombosis†‡ 1.47 (1.06-2.06) 15 23
Pulmonary embolism† 1.37 (0.90-2.07) 10 14
Invasive breast cancer† 0.80 (0.62-1.04) 34 28
Colorectal cancer§ 1.08 (0.75-1.55) 16 17
Hip fracture§ 0.61 (0.41-0.91) 17 11
Vertebral fractures§‡ 0.62 (0.42-0.93) 17 11
Total fractures§‡ 0.70 (0.63-0.79) 195 139
Death due to other causes§¶ 1.08 (0.88-1.32) 50 53
Overall Mortality§‡ 1.04 (0.88-1.22) 78 81
Global index§# 1.01 (0.91-1.12) 190 192
For those outcomes included in the WHI “global index” that reached statistical significance, the absolute excess risk per 10,000 women-years in the group treated with CE alone was 12 more strokes, while the absolute risk reduction per 10,000 women-years was 6 fewer hip fractures. The absolute excess risk of events included in the "global index" was a nonsignificant 2 events per 10,000 women-years. There was no difference between the groups in terms of all-cause mortality. (See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.)
Final centrally adjudicated results for CHD events and centrally adjudicated results for invasive breast cancer incidence from the estrogen alone substudy, after an average follow-up of 7.1 years, reported no overall difference for primary CHD events (nonfatal MI, silent MI and CHD death) and invasive breast cancer incidence in women receiving CE alone compared with placebo (see Table 2).
The estrogen plus progestin substudy was also stopped early. According to the predefined stopping rule, after an average follow-up of 5.2 years of treatment, the increased risk of breast cancer and cardiovascular events exceeded the specified benefits included in the “global index.” The absolute excess risk of events included in the “global index” was 19 per 10,000 women-years (relative risk [RR] 1.15, 95% nCI, 1.03-1.28).
For those outcomes included in the “global index,” that reached statistical significance after 5.6 years of follow-up, the absolute excess risks per 10,000 women-years in the group treated with CE/MPA were 6 more CHD events, 7 more strokes, 10 more PEs, and 8 more invasive breast cancers, while the absolute risk reductions per 10,000 women-years were 7 fewer colorectal cancers and 5 fewer hip fractures. (See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.)
Results of the estrogen plus progestin substudy, which included 16,608 women (average age of 63 years, range 50-79; 83.9 percent White, 6.8 percent Black, 5.4 percent Hispanic, 3.9 percent Other), are presented in Table 3.
TABLE 3 Relative and Absolute Risk Seen in the Estrogen Plus Progestin Substudy of WHI at an Average of 5.6 Years * *
Results are based on centrally adjudicated data. Mortality data was not part of the adjudicated data: however, data at 5.2 years of follow-up showed no difference between the groups in terms of all-cause mortality (RR 0.98, 95% nCI, 0.82-1.18).
Nominal confidence intervals unadjusted for multiple looks and multiple comparisons.
Includes metastatic and non-metastatic br |
