Endocrinology & Women s Health + Adult Immunizations Exotic Asia CME Cruise June 15 24, Menopause & Osteoporosis update 2015.

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1 Menopause and Osteoporosis Update 2015 Post WHI-Update CCFP, MHSc, FRCP,FCFP,, NAMS Accredited Menopause Expert Associate Professor University of Toronto 1

2 Canadian Population Pyramid: The Silver Tsunami Age 55 In 2009 Source: Statistics Canada Catalogue no , Annual Demographic Statistics 2005, page 6 2

3 What s Not New in the Update Lifestyle counseling is essential to reduce risks of chronic conditions (CVD, cancer) HT remains the single most effective treatment for distressing VMS The primary indication for systemic HT is for relief of moderate to severe VMS Systemic HT may and topical HT will relieve symptoms of UGA HT will prevent or alleviate somatic pain associated with loss of estrogen 3

4 What s Not New in the Update HT will reduce the rate of osteoporotic fractures, colorectal cancer (EPT), and metabolic syndrome but is not solely recommended to prevent these conditions. HT is not recommended for prevention of CVD or dementia HT increases the risk for VTE, ischemic stroke, GB disease, and breast cancer Potential benefits and potential risks need to be placed into perspective in the discussion about use of HT for QOL issues 4

5 What is New in the Update Evidence suggests that most CAM therapies for VMS are little more than placebo Safety data on CAMs is lacking and in the face of accumulating evidence of drug interactions and toxicity these should not be recommended for VMS 5

6 What is New in the Update There is no convincing evidence for an increase in the risk of CAD in newly menopausal women starting hormone therapy..women should be reassured about this! The absolute risk of breast cancer with short term exposure is small and compares favourably to risk related to common lifestyle choices women omen can be reassured ed about this! To reduce the small risk of stroke in women taking HT risk factors should be addressed Use lowest effective dose but no absolute time limit 6

7 Other Messages to Reinforce Women with premature menopause should be advised to stay on HT until the natural age of menopause There is no evidence that this will increase their risk of breast cancer and it will decrease both bone loss and coronary artery calcium deposition HT may alleviate depression in the perimenopausal transition but not at later stages of menopause 7

8 The Women s Health Initiative The largest single study ever conducted by the NIH..cost over $625 million Primary endpoints of HT arms: Effects of HT on CHD (non fatal MI and death) with breast cancer as the primary adverse outcome 8

9 The Women s Health Initiative EPT arm stopped prematurely in May 2002 at 5.2 yrs instead of the planned 8 yrs due to unexpected adverse effects (MI, stroke, breast cancer) E alone arm stopped prematurely in Feb 2004 at 6.8 yrs due to increased stroke risk 9

10 The WHI: The Chosen Methodology Instead the investigators recruited women in their 50 s, 60 s and 70 s Largest, most expensive study ever conducted by the NIH in the USA RCTs in two groups (16,000 women with a uterus and 10, women after hysterectomy) assessed effects of HT on CVD and breast cancer 10

11 2002 WHI Results Appeared to Counter Prevailing Opinion First reports stated that that HT increased heart attack and stroke Subsequent reports emphasized increased risks of breast cancer, dementia Unable to assess the benefits for vasomotor symptoms because most of the older population were not having hot flushes to start with Confirmed the effectiveness of HT for reduction in osteoporotic fractures, DM, and colorectal cancer 11

12 What the WHI Told the World About HT ( ) 2006) DOES NOT improve QOL PROTECTS bone and prevents fractures Ca AND VIT D SUPPLEMENTS DO NOT PREVENT FRACTURES LOW FAT DIET DOES NOT REDUCE CVD INCREASES MI STROKE INCREASES breast cancer risk INCREASES cognitive impairment and dementia INCREASES urinary incontinence 12

13 Media Commentary in July 2002 Results of the WHI E&P Arm: Results were cited in the in the media as relative risks: 29% increased risk of CHD 41% increased risk of stroke 26% increased risk of breast cancer Women and their health care providers were alarmed Widespread discontinuation of HT 13

14 Estrogen Alone Media Reports from 2004 WHI Results were again cited in the in the media as relative risks: 39% increased risk in stroke The Data and Safety Monitoring Board concluded that the study should be stopped prematurely because the risks exceeded benefits without addressing the fact that most women in the study did not have hot flashes Reinforced the negative messages from the E&P arm 14

15 Different Ways to Express Breast Cancer for HT users in WHI Relative risk (RR) Ratio of risk between users and non users 1.24 means a 24% increase above baseline Absolute risk Baseline risk x the RR 30/ 10, x 1.24 = 38/10, Attributable risk 8 8 cancers per 10,000 women = 0.08% per year after 5 years of exposure 15

16 Putting Risks into Perspective The WHO Terminology for Adverse Event Rates Very common Common Uncommon Rare Very rare >1/10 1 to 10/100 1 to 10/1, /10, <1/10,000 Council for International Organizations of Medical Sciences (CIOMS). Guidelines for preparing core clinical-safety information on drugs. 2 nd edition. Geneva:CIOMS:

17 WHI E+P: Results Absolute Risks & Benefits No /Yr/10, CEE/MPA Placebo More Cases in E+P Group No Significant Difference in # of Cases Fewer Cases in E+P Group CHD* Stroke Breast Cancer VTE PE Endometrial Cancer Total Deaths Colorectal Cancer Hip Fractures Women's Health Initiative Steering Committee. JAMA 2004;291: Attrib Risk/10,000/yr 17

18 WHI E Arm: Absolute Risks & Benefits 90 No /Yr/10, More Cases in E Group CEE Placebo No Significant Difference in # of Cases Fewer Cases in E Group Strokes VTE CHD Breast Cancer PE Colorectal Cancer Total Deaths Hip Fractures Women's Health Initiative Steering Committee. JAMA 2004;291: Attrib Risk/10,000/yr 18

19 Why So Much Confusion? Average age was 63.6 years Data from an older menopausal population may not apply to younger, newly menopausal women Results were not widely presented as absolute or attributable risks Results were not put into perspective with other risks s that many women take 19

20 Menopause & Osteoporosis update 2015 Alarming g News Accounts 20

21 The Media has a Pervasive Impact on Public Perceptions of Risk Research has shown that strong beliefs about risk, once formed, change very slowly l and are extraordinarily persistent in the face of contrary evidence Vincent Convello, Centre for Risk Communication, Columbia University 21

22 Consequences of the Initial WHI Reports Both doctors and patients became fearful of HT Many doctors advised discontinuation of HT and 50% of users stopped. Fueled a multi-billion dollar market in alternative and complementary products for the relief of menopausal vasomotor symptoms As many as a 25% of those who stopped HT returned to their doctors for permission i to resume treatment 22

23 What is the Association between HT and MI? 23

24 Critical Examination of the WHI Results: Did the Advanced Age of Participants Influence Results? Characteristic Age at screening CEE/MPA n = 8506 Placebo n = years 2839 (33.4) 2683 (33.1) years 3853 (45.3) 3657 (45.1) years 1814 (21.3) 1762 (21.7) 24

25 Critique of WHI Interpretation of CHD Results: 2002 By analogy, if the WHI had sought to test whether vigorous exercise was useful for primary prevention of CHD, and had used the same study population, it is likely that an excess of heart attacks in the older age groups assigned to exercise might have led to the conclusion that exercise initiated at the time of menopause was not helpful from primary protection from CHD Reid RL. Editorial: Translating the Latest Scientific Advances into Clinical Practice. JOGC

26 Age Does Matter Women in their 50 s have half the (baseline) risk of women in their 60 s and one quarter the risk of women in their 70 s Hulley SB, Grady D. Editorial. JAMA 2004;291(14):

27 Secondary Analysis of WHI Data Rossouw J, et al JAMA 2007;297(13):

28 WHI HT Trials: Absolute Risk of CHD by Age Age group Cases / 100 person-yrs CHD Combined Trials* PBO ** CEE+MPA PBO ** Absolute Risk per 10,000 Person-Years **P<0.05 vs 50 to 59 yrs 28

29 HT Can Precipitate Coronary Events in Older Women Good evidence of a small increase in risk of MI from both HERS and WHI Any consideration of initiation of HT in older women should require appropriate counselling and careful assessment and management of CV risks 29

30 WHI HT Trials: Total Mortality by Age HR (95% CI) Unopposed CEE y 0.71 (0.46 to 1.11) y 1.02 (0.80 to 1.30) y 1.20 (0.93 to 1.55) CEE+MPA y 0.69 (0.44 to 1.07) y 1.09 (0.83 to 1.44) y 1.06 (0.80 to 1.41) Both arms* y 0.70 (0.51 to 0.96) y 1.05 (0.87 to 1.26) y 1.14 (0.94 to 1.37) Hazard Ratio for Mortality 30

31 Hormone Therapy Redeemed By Alice Park, April 5, 2007 If women start hormone therapy within the first 10 years after onset of menopause to treat hot flashes and night sweats, and remain on the hormones for no more than four to five years, they can take the fear of heart disease out of the question. Dr. Jacques Rossouw, lead author of WHI studies 31

32 WHI re-analysis: 7.4 yrs treatment and 1.3 yrs post trial CT Scans of Heart Coronary Artery Calcification in yo CEE Placebo Score OR < >300 (67.7%) 71 (18.3%) 29 (7.5%) (54.3%) 78 (22.2%) 45 (12.8%) (6.5%) (10.8%) 1.00 (referent) 0.67 ( ) 0.43 ( ) 0.80) ( ) 0.73) Manson JE et al. NEJM 2007;356:

33 Hormone Therapy After Oophorectomy Lowers CAC WHI secondary analysis in 2008 After hysterectomy: BSO and no HT: OR 2.0 for elevated CAC vs no BSO BSO and HT: OR 1.0 for elevated CAC vs no BSO Conclusion: HT within 5 years of BSO protective Allison MA et al. for the WHI. Menopause (4):

34 HT After Premature Loss of Ovarian Function Findings are consistent with the thesis that the estrogen deficiency associated with bilateral oophorectomy is related to an increased burden of calcified plaque in the coronary arteries that can be countered by HT Allison MA et al. for the WHI. Menopause (4):

35 Is HT Cardioprotective in Newly Menopausal Women? We will probably never get the answer To demonstrate at 10% reduction in cardiovascular mortality in normal women aged ,000 women would have to remain compliant with hormones or placebo for 10 years Depypere HT et al.. Climacteric 2007; 10:

36 What Happened After Reports from the WHI: Management of Hot Flushes? Put up with it advice ignored the fact that symptoms can be extremely disruptive, affect 65% of menopausal women 20% seek medical help may last for 5-7 years in 15% even longer! Reluctance to prescribe HT caused many women to turn to CAMs 36

37 CAMs: Where s the Evidence? Systematic review.. Although individual trials suggest benefits from certain therapies, data are insufficient to support the effectiveness of any complementary and alternative therapy in the management of menopausal symptoms. * *1) Nedrow et al. Arch Intern Med 2006; 166(14): ) Speroff L. Intern J Fertility & Womens Medicine 2005; 50(3): ) Kronenberg F,et al. Ann Intern Med 2002; 137: ) Huntley ALet al..menopasue 2003; 10(5): ) NAMS. Menopause 2003: 11(1):

38 Menopausal Hot Flushes Remain the Primary Indication for HT If hot flushes are mild and not distressing lifestyle changes may reduce the frequency and severity of symptoms For moderate to severe vasomotor symptoms: Complementary medicines not recommended No treatment is as effective as HT If HT unacceptable try SNRIs Other non hormonal therapies may be tried (gabapentin, clonidine, bellergal etc) 38

39 Urogenital Ageing Bladder Urgency Frequency Recurrent UTI Vagina Dryness Painful intercourse Recurrent infection 39

40 Risks of HT Keeping perspective p 40

41 HT and Cardiovascular Disease in Women The definitive study on CVD benefits/ risks is lacking.. no RCT has recruited sufficient i numbers of newly menopausal women and followed them long term HT does not increase risk of CAD in newly menopausal women when started on HT within the first 10 years after menopause Women with premature menopause may be less likely to develop CVD if maintained on HT until the usual age of menopause Healthy life choices and the use of established medications for CVD prevention should remain the mainstay of strategies to reduce CVD in our aging population 41

42 HT and Risk of Stroke WHI reported an increased risk of stroke : 73% of women in WHI were in Framingham medium high risk for stroke (obese, smokers, hypertensive) The absolute risk for the entire population was 0.8/1000 (CEE) and 1.2/1000 woman-years (CEE/MPA) Other research found no increased risk of stroke Lobo (2004) stroke risk was decreased eased in 6681 newly menopausal women started on HT Wisdom Trial in UK (2007): no increased stroke in 2196 women on HT compared to placebo Always important to address stroke risk factors: Obesity, hypertension, smoking, etc 42

43 Dementia and HT: Re-Analysis of the WHIMS study Prior hormone users experienced significantly lower risks of Alzheimer s disease and all-cause dementia during WHIMS trials. Whereas hormone therapy initiated after age 65 increases dementia risk, these new findings support the need for further research on cognitive consequences of hormone initiation at earlier ages. Henderson VW, Espeland MA, Hogan PE, Rapp SR, Stefanick ML,et al. Prior Use of Hormone Therapy and Incident Alzheimer,s Disease in the Women s Health Initiative Memory Study Neurology 68 [suppl.1]:a205,

44 HT and Risk of VTE Menopausal HT very slightly increases the risk of a blood clot (2-3 additional cases per 10, users) The risk is greatest in the first year of use Age is greater risk factor: risk doubles risk quadruples Weight Overweight 1.96 ( ) Obese 3.09 ( ) Risk is reduced with lower doses and transdermal HT 44

45 Hormone Therapy and Breast Cancer Lifetime exposure to hormones linked to hormone receptor positive breast cancer Early menarche, late menopause Late first pregnancy Breast feeding Numerous studies indicate a small increase in risk of breast cancer with longer term HT (more so for combined EPT than ET alone) 45

46 WHI CEE/MPA : Overall HR and Attributable Risks/ Benefits Health Event CHD Stroke Breast cancer VTE Colorectal cancer Hip fractures Overall Hazard Ratio Confidence Interval Nominal 95% Adjusted 95% Attributable Risk per 10,000 Women/Year Attributable Benefit per 10,000 Women/Year Total fractures Writing Group for the Women's Health Initiative Investigators. JAMA. 2002;288:

47 WHI: Breast Cancer Results EPT Arm: Women with no prior hormone exposure: HR 1.09 (CI ) <5yrs prior use HR 1.70 (CI ) >5 yrs prior use HR (CI ) E Arm: No increased risk during 7 years HR 0.77 (CI ) 74% 74% had no prior HT exposure Chlebowski RT et al. JAMA 2000; (24):

48 Breast Cancer: Risks of developing or dying per decade Age Cases of Br Ca /1,000 Br Ca Deaths /1,000 All cause Deaths /1, Fletcher SW, Elmore JG. NEJM 2003; 348(17):

49 Editorial 2006 Collins JA Obstet Gynecol 2006;108(6):

50 Breast Cancer: Keeping Perspective When menopausal women present with distressing vasomotor symptoms, they can be reassured that short term (less than 5 years) use of either combined EPT or E alone will have little appreciable effect on their personal breast cancer risk. Longer use of combined EPT undeniably increases their breast cancer risk likely to a greater extent than exposure to E alone. However, the level of risk remains similar to risks that many women accept through lifestyles that expose them to daily alcohol ingestion, lack of regular exercise and postmenopausal obesity. Collins JA Obstet Gynecol 2006;108(6):

51 HT Risks Exaggerated by the Media A recent comprehensive analysis of breast cancer news in leading media outlets found that articles on breast cancer risk factors tended to focus on HT while ignoring equally important modifiable risk factors that could have a major impact on breast cancer rates in developing countries. Atkin CK et al. A Comprehensive Analysis of Breast Cancer News Coverage in Leading Media Outlets Focusing on Environmental Risks and Prevention J Health Communication 2008; 13:

52 Lifestyle contributions to Breast Cancer Risk Analysis of modifiable risk factors that could be altered after menopause has been attained suggest that a substantial fraction of postmenopausal breast cancers (34%) may be avoided by purposeful changes in lifestyle lf l later in life (Sprague 2008) Sprague BL et al. Proportion of invasive breast cancer attributable to risk factors modifiable after menopause. Am J Epidemiol2008; 168(4):

53 Comparison of HT and other Factors as Risks for Breast Cancer EPT > 5 yrs use 1.3 Early menarche 1.3 Late menopause Late ae first peg pregnancy Chest radiation Postmenopausal obesity 1.2 Alcohol use Age > First degree relative Br Ca > First degree relative Br Ca < BRAC gene mutation 200 Singletary SE. Ann Surg 2003; 237:

54 Risk Factors for Breast Cancer affected relatives Obesity Risk Relative Young menarche HRT>5 years 1 st child >age 30 1 year post HRT 5 years post HRT Alcohol Exercise Menopause < years oophx 0 54

55 Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy LaCroix et al JAMA April Health Event CHD MI Deaths MI Attributable Risk per 10,000 Women/Year Overall reduction in Breast Cancer was 27% over the placebo group Deaths Attributable Benefit per 10,000 Women/Year Writing Group for the Women's Health Initiative Investigators. JAMA. 2002;288:

56 Hormone Therapy: What can we say with reasonable confidence in 2015? Nothing is as effective as HT for vasomotor symptoms and most CAM act as placebos HT will relieve joint pain and prevent bone loss when used for vasomotor symptoms Systemic HT may, and intra-vaginal estrogen will, relieve urogenital atrophy HT used at menopause does not increase risk of CAD and used for 5 years or less has little appreciable effect on breast cancer risk 56

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