The WHI 12 Years Later: What Have We Learned about Postmenopausal HRT?

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1 AACE 23 rd Annual Scientific and Clinical Congress (2014) Syllabus Materials: The WHI 12 Years Later: What Have We Learned about Postmenopausal HRT? JoAnn E. Manson, MD, DrPH, FACP, FACE Chief, Division of Preventive Medicine Brigham and Women's Hospital Principal Investigator, Boston site of the WHI Professor of Medicine and the Michael and Lee Bell Professor of Women s Health Harvard Medical School, Boston, Massachusetts Take Home Points : Menopausal hormone therapy (HT) continues to have an important clinical role in the management of menopausal symptoms. Current evidence does not support the use of HT for the prevention of cardiovascular disease or other chronic diseases. The best candidates for systemic HT tend to be recently menopausal and symptomatic women who are in generally good health, due to their low absolute risks of adverse events and greater potential for quality-of-life benefits. Risk stratification and a personalized approach to HT decision making is recommended. Summary and Tables: Menopausal hormone therapy (HT) has complex biological effects but continues to have an important clinical role in the management of vasomotor and other menopausal symptoms. Findings from the Women s Health Initiative (WHI), which led to a dramatic reduction in HT use, are summarized in Table 1 (overall study population) and stratified by by age group in Table 2. WHI and other randomized clinical trials have helped to clarify the benefits and risks of HT and provided insights to improve decision making. Several clinical characteristics have utility in identifying women for whom benefits of HT are likely to outweigh the risks. Age and time since menopause are strong predictors of health outcomes and absolute risks on HT, especially for estrogen alone. In the Women s Health Initiative trial of conjugated equine estrogens (CEE) alone, younger women (50-59 years) had more favorable results for all-cause mortality, myocardial infarction, and the global index (P values for trend by age <0.05), but not for stroke and venous thrombosis. Age trends were less clear for CEE+MPA, due to increased risks of breast cancer, stroke, and venous thrombosis in all age groups. Absolute risks of adverse events were lower in younger than older women in both trials, however. Other predictors of lower risk from HT include favorable lipid status and absence of the metabolic syndrome (Table 3). Transdermal administration may be associated with lower risks of venous thrombosis and stroke, but additional research is needed. The use of risk stratification and personalized risk assessment offers promise for improved benefit:risk profile and safety of HT. 1

2 Table 1. Benefits and risks (absolute risks per 10,000 women per yr, rate differences, and relative risks) of postmenopausal hormone therapy on chronic disease outcomes in the overall study population of women aged 50 to 79 years in the Women s Health Initiative (WHI) estrogen-progestin and estrogen-alone trials a Outcome Estrogen-progestin trial (n=16,608) Estrogen-alone trial (n=10,739) Number of cases per 10,000 women per year Number of cases per 10,000 women per year E+P Placebo Difference b RR (95% CI) b ET Placebo Difference b RR (95% CI) b Benefits (not including vasomotor sx) Hip fracture ( ) ( ) Type 2 diabetes ( ) ( ) Risks Stroke ( ) ( ) Pulmonary embolism ( ) ( ) Deep vein thrombosis ( ) ( ) Breast cancer c ( ) ( ) Gallbladder disease ( ) ( ) Neutral or uncertain risks and benefits d Coronary heart disease e ( ) ( ) Myocardial infarction ( ) ( ) Ovarian cancer ( ) Not available Colorectal cancer ( ) ( ) Dementia (age 65) ( ) ( ) Total mortality ( ) ( ) Global index d,f ( ) ( ) a. The estrogen-progestin arm of the WHI assessed 5.6 years of conjugated equine estrogen (0.625 mg/d) plus medroxyprogesterone acetate (2.5 mg/d) versus placebo. The estrogen-alone arm of the WHI assessed 7.1 years of conjugated equine estrogen (0.625 mg/d) versus placebo. b. RR, relative risk; CI, confidence interval. c. Divergent results for the two interventions. d. Also includes outcomes with divergent results for the two interventions. e. Coronary heart disease is defined as nonfatal myocardial infarction or coronary death. f. The global index is a composite outcome representing the first event for each participant from among the following: coronary heart disease, stroke, pulmonary embolism, breast cancer, colorectal cancer, endometrial cancer (estrogenprogestin trial only), hip fracture, and death. Because participants can experience more than one type of event, the global index cannot be derived by a simple summing of the component events. Source: Manson JE, Chlebowski RT, Stefanick ML, et al. JAMA 2013; 310(13):

3 Table 2. Effects of postmenopausal hormone therapy on cardiovascular outcomes in the Women s Health Initiative estrogen-progestin and estrogen-alone trials, according to age at study entry Intervention phase (5.6 years of randomized treatment) Outcome Estrogen-progestin Estrogen alone RR (95% CI) P RR (95% CI) P Coronary heart disease * y 1.34 ( ) ( ) y 1.01 ( ) 0.95 ( ) y 1.31 ( ) 1.09 ( ) Myocardial infarction y 1.32 ( ) ( ) y 1.05 ( ) 0.95 ( ) y 1.46 ( ) 1.24 ( ) Stroke y 1.51 ( ) ( ) y 1.45 ( ) 1.55 ( ) y 1.22 ( ) 1.29 ( ) Pulmonary embolism y 2.05 ( ) ( ) y 1.69 ( ) 1.72 ( ) y 2.54 ( ) 0.85 ( ) RR, relative risk; CI, confidence interval. *Coronary heart disease is defined as nonfatal myocardial infarction or coronary death. Source: Manson JE, Chlebowski RT, Stefanick ML, et al. JAMA 2013; 310(13):

4 Table 3. CHD risk in the Women s Health Initiative estrogen-progestin and estrogen-alone trials, according to baseline levels of selected markers Marker OR (95% CI) for HT treatment effect P for interaction LDL cholesterol (mg/dl) < ( ) ( ) LDL/HDL cholesterol ratio < ( ) ( ) C-reactive protein < ( ) ( ) Metabolic syndrome * No 0.97 ( ) 0.03 Yes 2.26 ( ) Waist circumference 88 cm 1.03 ( ) 0.12 >88 cm 1.93 ( ) OR, odds ratio; CI, confidence interval. * Metabolic syndrome was defined as having three or more of the following: waist size >88 cm (>80 cm for Asians and Native Americans); systolic blood pressure >130 mm/hg or diastolic blood pressure >85 mm Hg; fasting glucose >100 mg/dl; HDL cholesterol <50 mg/dl; triglycerides >150 mg/dl. Sources: Bray PF et al. Am J Cardiol 2008;101: , and Wild RA et al. Menopause 2013;20:

5 References/Suggested Readings Santen RJ, Allred DC, Ardoin SP, et al. Postmenopausal hormone therapy: an Endocrine Society scientific statement. J Clin Endocrinol Metab 2010;95:S1-S66. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA 2013;310: Rossouw JE, Prentice RL, Manson JE, et al. Effects of postmenopausal hormone therapy on cardiovascular disease by age and years since menopause. JAMA 2007;297: Manson JE, Hsia J, Johnson KC, et al. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med 2003;349: Hsia J, Langer RD, Manson JE, et al. Conjugated equine estrogens and the risk of coronary heart disease: the Women's Health Initiative. Arch Intern Med 2006;166: Manson JE, Bassuk SS. The menopause transition and postmenopausal hormone therapy. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jamison JL, Loscalzo J, eds. Harrison's Principles of Internal Medicine: McGraw-Hill; Rossouw JE, Cushman M, Greenland P, et al. Inflammatory, lipid, thrombotic, and genetic markers of coronary heart disease risk in the Women's Health Initiative trials of hormone therapy. Arch Intern Med 2008;168: Wassertheil-Smoller S, Hendrix SL, Limacher M, et al. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative: a randomized trial. JAMA 2003;289: Bray PF, Larson JC, Lacroix AZ, Manson J, Limacher MC, Rossouw JE, Lasser NL, Lawson WE, Stefanick ML, Langer RD, Margolis KL. Usefulness of baseline lipids and C-reactive protein in women receiving menopausal hormone therapy as predictors of treatment-related coronary events. Am J Cardiol 2008;101: Wild RA, Wu C, Curb JD, Martin LW, Phillips L, Stefanick M, Trevisan M, Manson JE. Coronary heart disease events in the Women's Health Initiative hormone trials: effect modification by metabolic syndrome: a nested case-control study within the Women's Health Initiative randomized clinical trials. Menopause 2013;20: Manson JE. The role of personalized medicine in identifying appropriate candidates for menopausal estrogen therapy. Metabolism 2013;62 Suppl 1:S Rossouw J, Bray P, Liu J, Kooperberg C, Hsia J, Lewis C, Cushman M, Bonds D, Hendrix S, Papanicolaou G, Howard T, Herrington D. Estrogen receptor polymorphisms and the vascular effects of hormone therapy. Arterioscler Thromb Vasc Biol 2011;31:

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