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HERS
Heart and Estrogen/progestin Replacement Study
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Author(s) |
(a) Schrott HG, Bittner V, Vittinghoff E, Herrington D, Hulley S
(b) Grady D, Applegate W, Bush T, Furberg C, Riggs B, Hulley S
(c) Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B, Vittinghoff E
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Title(s) |
(a) Adherence to National Cholesterol Education Program treatment goals in postmenopausal women with heart disease. The Heart and Estrogen/progestin Replacement Study (HERS)
(b) Heart and Estrogen/progestin Replacement Study (HERS): design, methods, and baseline characteristics
(c) Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women
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Reference(s) |
(a) JAMA 1997;277:1281-6
(b) Control Clin Trials 1998;19:314-35
(c) JAMA 1998;280:605-13
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Disease |
Coronary heart disease
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Purpose |
To assess the cardioprotective effect and safety of combined hormone replacement therapy (HRT) with oestrogen and progestin in women with documented coronary heart disease
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Study design |
Randomised, double-blind, placebo-controlled
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Follow-up |
Mean 4.1 years
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Patients |
2763 postmenopausal women (1380 HRT, 1383 placebo), mean age 66.7 ± 6.7 years, with a coronary heart disease event > 6 months before entry
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Treatment regimen |
Conjugated oestrogens, 0.625 mg, plus medroxyprogesterone acetate, 2.5 mg, or placebo once daily
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Concomitant therapy |
Antihypertensive agents, antianginal agents, lipid-lowering drugs and ASA or other anticoagulants at the discretion of the physician
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Results |
Coronary risk factors included past or current smoking (62%), hypertension (59%), and diabetes (23%), and LDL cholesterol ≥ 100 mg/dl. The 1993 treatment goal of the NCEP (LDL cholesterol < 100 mg/dl) failed to be met by 91% of participants, though 47% took lipid-lowering medication. The incidence of fatal coronary heart disease events and nonfatal MI was similar in the two groups (33.1/1000 women/year vs 33.6/1000 women/year, relative hazard 0.99; p = 0.91) despite an 11% lower LDL cholesterol (p < 0.001) and 10% higher HDL cholesterol (p < 0.001) in the HRT group. There was a significant time trend, with more coronary heart disease events in the HRT group than in the placebo group in year 1 and fewer in years 4 and 5. More women in the HRT group experienced venous thromboembolism (relative hazard 2.89; p = 0.002) and gall bladder disease (relative hazard 1.38; p = 0.05). There were no significant differences between groups in any of the other cardiovascular outcomes assessed
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Comments |
This study has been the basis for a number of publications. A selection of references:
Atherosclerosis
– Byington RP et al, Arterioscler Thromb Vasc Biol 2002;22:1692–7
Cognitive function
– Grady D et al, Am J Med 2002;113:543–8
Fractures
– Cauley JA et al, Am J Med 2001;110:442–50
Lipids
– Shlipak MG et al, Am Heart J 2003;146:870–5
Quality of life
– Hlatky MA et al, JAMA 2002;287:591–7
Serum uric acid
– Simon JA et al, Ann Epidemiol 2006;16:138–45
Statins
– Herrington DM et al, Circulation 2002;105:2962–7
– Pellegrini CN et al, Heart 2009;95:704–8
Stroke
– Simon JA et al, Circulation 2001;103:638–42
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