Table 2.
Estrogen-progestin trial | Estrogen-alone trial | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
E+P | Placebo | E alone | Placebo | |||||||
Outcome | # events per 10,000 PY | # events per 10,000 PY | Differenceb per 10,000 PY | RR (95% CI) | p | # events per 10,000 PY | # events per 10,000 PY | Differenceb per 10,000 PY | RR (95% CI) | p |
Cardiovascular disease | ||||||||||
Coronary heart diseasec | ||||||||||
50–59 y | 23 | 17 | 5 | 1.34 (0.82 – 2.19) | 0.81 | 17 | 28 | −11 | 0.60 (0.35 – 1.04) | 0.08 |
60–69 y | 37 | 37 | 0 | 1.01 (0.73 – 1.39) | 61 | 63 | −3 | 0.95 (0.72 – 1.24) | ||
70–79 y | 82 | 63 | 19 | 1.31 (0.93 – 1.84) | 97 | 90 | 7 | 1.09 (0.80 – 1.49) | ||
Myocardial infarction | ||||||||||
50–59 y | 19 | 15 | 4 | 1.32 (0.77 – 2.25) | 0.55 | 14 | 25 | −11 | 0.55 (0.31 – 1.00) | 0.02 |
60–69 y | 33 | 31 | 2 | 1.05 (0.74 – 1.47) | 46 | 48 | −2 | 0.95 (0.69 – 1.30) | ||
70–79 y | 69 | 47 | 21 | 1.46 (1.00 – 2.15) | 83 | 69 | 14 | 1.24 (0.88 – 1.75) | ||
Coronary revascularizationd | ||||||||||
50–59 y | 20 | 20 | 0 | 1.03 (0.63 – 1.68) | 0.67 | 24 | 41 | −17 | 0.56 (0.35 – 0.88) | 0.06 |
60–69 y | 43 | 52 | −9 | 0.85 (0.64 – 1.13) | 79 | 69 | 11 | 1.13 (0.88 – 1.46) | ||
70–79 y | 75 | 70 | +5 | 1.08 (0.77 – 1.51) | 107 | 102 | 5 | 1.07 (0.79 – 1.43) | ||
Stroke | ||||||||||
50–59 y | 15 | 10 | 5 | 1.51 (0.81 – 2.82) | 0.50 | 16 | 17 | −1 | 0.99 (0.53 – 1.85) | 0.77 |
60–69 y | 34 | 23 | 11 | 1.45 (1.00 – 2.11) | 51 | 33 | 18 | 1.55 (1.10 – 2.16) | ||
70–79 y | 63 | 50 | 13 | 1.22 (0.84 – 1.79) | 77 | 59 | 17 | 1.29 (0.90 – 1.86) | ||
Pulmonary embolism | ||||||||||
50–59 y | 11 | 5 | 6 | 2.05 (0.89 – 4.71) | 0.61 | 10 | 6 | 3 | 1.53 (0.63 – 3.75) | 0.28 |
60–69 y | 19 | 11 | 8 | 1.69 (1.01 – 2.85) | 17 | 10 | 7 | 1.72 (0.94 – 3.14) | ||
70–79 y | 30 | 12 | 18 | 2.54 (1.27 – 5.09) | 14 | 16 | −2 | 0.85 (0.39 – 1.84) | ||
All cardiovascular eventse | ||||||||||
50–59 y | 82 | 67 | 14 | 1.19 (0.92 – 1.53) | 0.92 | 108 | 123 | −16 | 0.84 (0.66–1.06) | 0.06 |
60–69 y | 176 | 161 | 15 | 1.10 (0.94 – 1.28) | 280 | 236 | 44 | 1.18 (1.03 – 1.36) | ||
70–79 y | 321 | 280 | 41 | 1.14 (0.96 – 1.35) | 410 | 350 | 60 | 1.17 (0.99 – 1.37) | ||
Cancer | ||||||||||
Breast cancer | ||||||||||
50–59 y | 33 | 27 | 6 | 1.21 (0.81 – 1.80) | 0.68 | 24 | 29 | −5 | 0.82 (0.50 – 1.34) | 0.89 |
60–69 y | 45 | 38 | 8 | 1.20 (0.89 – 1.62) | 28 | 39 | −10 | 0.73 (0.51 – 1.07) | ||
70–79 y | 56 | 41 | 15 | 1.37 (0.90 – 2.07) | 32 | 27 | −5 | 0.86 (0.52 – 1.43) | ||
Colorectal cancer | ||||||||||
50–59 y | 4 | 5 | −1 | 0.79 (0.29 – 2.18) | 0.66 | 7 | 10 | −3 | 0.71 (0.30 – 1.67) | 0.02 |
60–69 y | 13 | 21 | −8 | 0.61 (0.37 – 0.99) | 16 | 19 | −2 | 0.88 (0.53 – 1.47) | ||
70–79 y | 16 | 28 | −11 | 0.58 (0.31 – 1.08) | 33 | 15 | 19 | 2.24 (1.16 – 4.30) | ||
All cancerf | ||||||||||
50–59 y | 83 | 84 | −1 | 0.97 (0.76 – 1.23) | 0.77 | 71 | 79 | −8 | 0.89 (0.66 – 1.19) | 0.39 |
60–69 y | 142 | 128 | 15 | 1.11 (0.93 – 1.31) | 114 | 129 | −15 | 0.89 (0.73 – 1.08) | ||
70–79 y | 171 | 182 | −11 | 0.94 (0.75 – 1.17) | 152 | 147 | 6 | 1.04 (0.81 – 1.33) | ||
Other outcomes | ||||||||||
All fracture | ||||||||||
50–59 y | 120 | 145 | −25 | 0.82 (0.68 – 1.00) | 0.83 | 133 | 149 | −16 | 0.90 (0.72 – 1.11) | 0.33 |
60–69 y | 160 | 226 | −66 | 0.70 (0.61 – 0.81) | 139 | 218 | −80 | 0.63 (0.53 – 0.75) | ||
70–79 y | 236 | 300 | −65 | 0.79 (0.66 – 0.95) | 208 | 297 | −90 | 0.71 (0.58 – 0.87) | ||
Diabetes | ||||||||||
50–59 y | 74 | 85 | −11 | 0.85 (0.66 – 1.09) | 0.10 | 131 | 158 | −26 | 0.83 (0.67 – 1.04) | 0.99 |
60–69 y | 61 | 99 | −38 | 0.61 (0.49 – 0.77) | 144 | 159 | −15 | 0.91 (0.76 – 1.09) | ||
70–79 y | 95 | 70 | +24 | 1.35 (0.98 – 1.88) | 119 | 114 | −27 | 0.82 (0.62 – 1.07) | ||
Total mortality | ||||||||||
50–59 y | 21 | 31 | −10 | 0.67 (0.43 – 1.04) | 0.20 | 29 | 40 | −11 | 0.70 (0.46 – 1.09) | 0.04 |
60–69 y | 51 | 47 | 5 | 1.07 (0.81 – 1.41) | 78 | 77 | 0 | 1.01 (0.79 – 1.29) | ||
70–79 y | 106 | 102 | 3 | 1.03 (0.87 – 1.36) | 155 | 129 | 26 | 1.21 (0.95 – 1.56) | ||
Global indexg | ||||||||||
50–59 y | 103 | 91 | 12 | 1.12 (0.89 – 1.40) | >0.99 | 98 | 117 | −19 | 0.84 (0.66 – 1.07) | 0.02 |
60–69 y | 189 | 167 | 22 | 1.13 (0.97 – 1.31) | 210 | 211 | −1 | 0.99 (0.85 – 1.15) | ||
70–79 y | 342 | 303 | 38 | 1.12 (0.95 – 1.32) | 367 | 316 | 51 | 1.17 (0.99 – 1.39) |
Median length of randomized treatment was 5.6 years for estrogen-progestin and 7.2 years for estrogen alone.
Difference = # events per 10,000 women per year in the hormone therapy group - # events per 10,000 women per year in the placebo group. Numbers may not add precisely due to rounding error.
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.
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: CI, confidence interval; PY, person-years; RR, relative risk. Data from: Manson JE, et al. JAMA 2013;310:1353–68.