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. Author manuscript; available in PMC: 2016 Mar 1.
Published in final edited form as: Ann Epidemiol. 2014 Nov 13;25(3):193–200. doi: 10.1016/j.annepidem.2014.11.004

Table 4.

Health outcomes in the overall study population in the Women’s Health Initiative hormone therapy trials during the intervention phasea

Estrogen-progestin trial Estrogen-alone trial
Outcome Ie Iu AR AR% HR (95% CI) p Ie Iu AR AR% HR (95% CI) p
Cardiovascular disease
 Coronary heart diseaseb 41 35 6 14.6 1.18 (0.95-1.45) 0.13 55 58 −3 −5.5 0.94 (0.78-1.14) 0.53
 Myocardial infarction 35 29 6 17.1 1.24 (0.98-1.56) 0.07 44 45 −1 −2.3 0.97 (0.79-1.21) 0.97
 Coronary revascularizationc 42 45 −3 7.1 0.95 (0.78-1.16) 0.64 68 67 1 1.5 1.00 (0.83-1.19) 0.96
 Stroke 33 24 9 27.2 1.37 (1.07-1.76) 0.01 45 34 11 24.4 1.35 (1.07-1.70) 0.01
 Pulmonary embolism 18 9 9 50.0 1.98 (1.36-2.87) <0.001 14 10 4 28.6 1.35 (0.89-2.05) 0.15
 Deep vein thrombosis 25 14 12 48.0 1.87 (1.37-2.54) <0.001 23 15 7 30.4 1.48 (1.06-2.07) 0.02
 All cardiovascular eventsd 170 152 19 11.2 1.13 (1.02-1.25) 0.02 251 224 27 10.8 1.11 (1.01-1.22) 0.03
Cancer
 Breast cancer 43 35 9 20.9 1.24 (1.01-1.53) 0.04 28 35 −7 25.0 0.79 (0.61-1.02) 0.07
 Colorectal cancer 10 17 −6 −60.0 0.62 (0.43-0.89) 0.009 17 15 2 11.8 1.15 (0.81-1.64) 0.44
 Endometrial cancer 6 7 −1 −16.7 0.83 (0.49-1.40) 0.49 NA NA NA NA NA NA
 All cancer typese 127 124 4 3.1 1.02 (0.91-1.15) 0.69 109 117 −8 −7.3 0.93 (0.81-1.07) 0.30
Other outcomes
 Hip fracture 11 17 −6 −54.5 0.67 (0.47-0.95) 0.03 13 19 −6 −46.2 0.67 (0.46-0.96) 0.03
 All fracture 161 212 −51 −31.7 0.76 (0.69-0.83) <0.001 153 214 −61 −39.9 0.72 (0.64-0.80) <0.001
 Diabetes 72 88 −16 −22.2 0.81 (0.70-0.94) 0.005 134 155 −21 −15.7 0.86 (0.76-0.98) 0.02
 Gallbladder disease 131 84 47 35.9 1.57 (1.36-1.80) <0.001 164 106 58 35.4 1.55 (1.34-1.79) <0.001
 Probable dementiaf 46 23 23 50.0 2.01 (1.19-3.42) 0.01 44 29 15 34.1 1.47 (0.85-2.52) 0.17
 All-cause mortality 52 53 −1 1.9 0.97 (0.81-1.16) 0.76 80 77 3 3.7 1.03 (0.88-1.21) 0.68
 Global indexg 189 168 20 10.6 1.12 (1.02-1.24) 0.02 208 204 4 1.9 1.03 (0.93-1.13) 0.63
a

Median length of randomized treatment was 5.6 years for estrogen-progestin and 7.1 years for estrogen alone.

b

Coronary heart disease is defined as nonfatal myocardial infarction or coronary death.

c

Coronary revascularization is defined as coronary artery bypass grafting or percutaneous coronary intervention.

d

All cardiovascular events is a composite outcome of MI, stroke, coronary revascularization, angina, heart failure, carotid artery disease, peripheral vascular disease, venous thromboembolism (pulmonary embolism, deep vein thrombosis), and cardiovascular death.

e

All cancer types except for non-melanoma skin cancer.

f

Probable dementia was assessed in women aged ≥65.

g

Global index=a composite outcome of coronary heart disease, stroke, pulmonary embolism, breast cancer, colorectal cancer, endometrial cancer (in the estrogen-progestin trial), hip fracture, and mortality.

Abbreviations: Ie, incidence in the exposed group (estrogen-progestin or estrogen alone), expressed as number of events per 10,000 person-years. Iu, incidence in the unexposed group (placebo), expressed as number of events per 10,000 person-years. AR, attributable risk, calculated as Ie - Iu (numbers may not add precisely due to rounding error). AR%, attributable risk percent, calculated as 100*(Ie – Iu)/Ie and computed from data provided in source document. HR, hazard ratio. CI, confidence interval. NA, not applicable due to hysterectomy.

Source: Manson JE et al. JAMA 2013;1353-68.