Table 4.
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 |
Median length of randomized treatment was 5.6 years for estrogen-progestin and 7.1 years for estrogen alone.
Coronary heart disease is defined as nonfatal myocardial infarction or coronary death.
Coronary revascularization is defined as coronary artery bypass grafting or percutaneous coronary intervention.
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.
All cancer types except for non-melanoma skin cancer.
Probable dementia was assessed in women aged ≥65.
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.