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. 2009 May 25;170(1):12–23. doi: 10.1093/aje/kwp115

Table 1.

Age-adjusted Incidence Rates for Selected Clinical Outcomes, According to Priora Use of Hormone Therapy and Use of Conjugated Equine Estrogens (Posthysterectomy Women) or Conjugated Equine Estrogens/Medroxyprogesterone Acetate (Women With Intact Uterus), in the Women's Health Initiative Hormone Therapy Clinical Trials and Corresponding Observational Study Subcohorts, 1993–2004

Clinical Trials
 Observational Study
No Prior HT Prior HT No Prior HT Prior HT
Women Without Uterus
Placebo
 CEE
 Placebo
 CEE
 Nonuser
 CEE
 Nonuser
 CEE
No. of women 1,977 1,952 2,659 2,541 5,106 8,677 4,429 1,905
Average age, years 64.1 63.8 63.4 63.6 65.0 63.4 65.7 64.2
Incidence rateb (no. of cases):
    Coronary heart disease 7.07 (98) 5.79 (83) 4.28 (79) 5.05 (89) 4.33 (171) 2.45 (147) 3.42 (123) 2.73 (38)
    Stroke 3.05 (43) 4.67 (68) 3.61 (67) 4.43 (78) 3.31 (122) 2.89 (171) 3.16 (117) 3.73 (52)
    Venous thromboembolism 2.49 (32) 2.70 (32) 2.04 (38) 3.31 (59) 2.23 (93) 1.68 (101) 1.97 (65) 1.23 (18)
    Invasive breast cancer 3.73 (49) 2.28 (30) 2.67 (50) 2.56 (46) 3.22 (122) 3.81 (235) 3.12 (99) 3.48 (51)
    Invasive colorectal cancer 1.52 (22) 1.65 (23) 1.21 (23) 1.47 (26) 1.31 (54) 0.73 (46) 0.86 (33) 1.66 (24)
    Hip fracture 1.89 (24) 1.53 (21) 1.95 (35) 0.95 (17) 1.38 (48) 0.96 (58) 1.28 (51) 1.66 (21)
    Death from other causes 4.78 (67) 5.51 (69) 4.52 (84) 4.79 (85) 6.58 (246) 4.57 (274) 6.23 (223) 4.63 (62)
    Global index 21.57 (300) 20.82 (285) 17.20 (320) 19.44 (345) 19.70 (753) 15.32 (928) 18.41 (650) 17.11 (237)
    Total invasive cancer 10.54 (148) 9.25 (131) 9.15 (171) 8.87 (158) 10.15 (386) 9.23 (571) 10.33 (348) 9.73 (138)
    Total mortality 8.50 (119) 8.17 (106) 6.70 (124) 7.93 (140) 9.29 (357) 6.38 (382) 9.11 (330) 6.55 (87)
Women With Uterus
Placebo
 CEE/MPA
 Placebo
 CEE/MPA
 Nonuser
 CEE/MPA
 Nonuser
 CEE/MPA
No. of women 5,427 5,450 2,082 2,229 18,526 5,710 5,660 1,046
Average age, years 63.6 63.7 63.0 62.6 64.7 60.7 64.8 64.3
Incidence rateb (no. of cases):
    Coronary heart disease 3.52 (198) 3.92 (116) 2.66 (31) 4.33 (52) 2.76 (306) 2.07 (50) 2.53 (92) 1.70 (10)
    Stroke 2.42 (74) 3.36 (96) 2.48 (27) 2.81 (34) 2.17 (245) 1.65 (37) 2.31 (84) 1.42 (8)
    Venous thromboembolism 1.58 (43) 3.62 (110) 2.04 (23) 3.32 (40) 1.64 (186) 2.35 (60) 1.72 (59) 1.00 (6)
    Invasive breast cancer 3.48 (105) 3.91 (114) 2.50 (28) 4.65 (58) 2.85 (291) 6.75 (199) 3.45 (110) 7.44 (43)
    Invasive colorectal cancer 1.64 (43) 1.00 (31) 1.53 (17) 0.70 (8) 0.97 (106) 1.08 (27) 1.06 (35) 0.72 (4)
    Invasive endometrial cancer 0.62 (19) 0.49 (12) 0.88 (10) 0.91 (10) 0.77 (79) 1.07 (30) 1.17 (40) 1.05 (6)
    Hip fracture 1.65 (48) 1.32 (39) 1.74 (19) 0.57 (7) 1.22 (140) 1.45 (23) 0.97 (37) 1.77 (10)
    Death from other causes 3.83 (108) 3.71 (110) 3.99 (46) 3.10 (36) 4.44 (476) 3.68 (86) 3.92 (141) 2.62 (15)
    Global index 16.47 (478) 18.47 (540) 15.69 (177) 17.32 (209) 15.36 (1,668) 18.04 (469) 15.63 (542) 17.38 (100)
    Total invasive cancer 10.26 (303) 9.79 (282) 10.02 (114) 11.70 (141) 9.01 (956) 13.32 (370) 9.38 (311) 12.38 (71)
    Total mortality 5.25 (150) 5.42 (156) 5.59 (64) 5.10 (60) 5.93 (640) 4.71 (112) 5.45 (198) 3.47 (20)

Abbreviations: CEE, conjugated equine estrogens; HT, hormone therapy; MPA, medroxyprogesterone acetate.

a

Prior HT was defined relative to Women's Health Initiative enrollment in the clinical trials and in the nonuser groups in the observational study. Prior HT in the user groups in the observational study was defined relative to the beginning of the ongoing HT episode at enrollment.

b

Incidence rate per 1,000 person-years, adjusted to the 5-year age distribution in the clinical trials.