The Women s Health Initiative: The Role of Hormonal Therapy in Disease Prevention

Size: px
Start display at page:

Download "The Women s Health Initiative: The Role of Hormonal Therapy in Disease Prevention"

Transcription

1 The Women s Health Initiative: The Role of Hormonal Therapy in Disease Prevention Robert B. Wallace, MD, MSc Departments of Epidemiology and Internal Medicine University of Iowa College of Public Health Iowa City, IA The Women s Health Initiative (WHI) clinical trials on hormone therapy (HT) in postmenopausal women have changed clinical thinking on estrogen therapy in substantial ways, and have clarified clinical guidelines on disease prevention in post-menopausal women. These trials (1,2,3), along with the HERS Trial (4), a secondary prevention trial of HT and coronary artery disease, have been to date the only randomized, double-blind trials of estrogen therapy with sufficient statistical power to explore a broad range of important disease outcomes in post-menopausal women. WHI HT findings have been widely discussed and at times controversial (5), perhaps in part because their findings have been inconsistent with established clinical lore and practice, particularly with respect to the impact of HT on atherosclerotic diseases. Also, WHI findings also caused some reconsideration of basis research programs predicated on the notion that HT was cardio- and neuro-protective in animal models. However, WHI methods and findings have stood up to substantial scrutiny and have in my view become the standard for complex, long-term trials of hormonal intervention in older women. WHI comprised two HT trials: estrogen plus progestin (Prempro ) for women with an intact uterus (E+P); and estrogen alone (E-alone) (Premarin ) for women with prior hysterectomy. They were not intended to explore treatment of menopausal symptoms.

2 Rather, they addressed the value of long-term HT in the prevention of major chronic conditions of women after menopause. The primary outcomes were all-cause mortality, coronary mortality and several major conditions: coronary disease, stroke, breast cancer, hip and other fractures, pulmonary embolism and colo-rectal cancer. As well, there was a global index of these disease outcomes (2). In execution and interpretation, the WHI HT trials were complex, with too much detail for this presentation. Basic WHI HT trial findings are briefly summarized in the table. Major outcomes, primary and secondary, were defined before trial initiation. An ancillary study of dementia outcomes [WHIMS: the WHI Memory Study (6,7)] began within two years of study onset. In general, the findings were similar across the age spectrum under study (50-79 years at entry), although there was some variation. As the table shows, some conditions were increased by HT, and others were decreased. Neither intervention had an impact on total mortality. Coronary disease, breast cancer and pulmonary embolism rates were significantly increased by E+P, but this was not seen with E-alone. Both interventions caused an increase in stroke rates and a decrease in hip fracture rates. E+P caused a decrease in colon cancer rates, but this was not seen with E-alone. Dementia rates were increased with E+P; a similar trend was seen with E-alone, but it was not statistically significant. There was a significant overall increase in dementia outcome rates when the findings from both trials were combined. When there were differential effects between E +P and E-alone, it has been suggested that the progestin (medroxyprogesterone acetate) may be responsible for some of these

3 differences. This may be correct, but the issue will require further study, particularly since the two trial populations were dissimilar in some respects. For example, the E-alone participants had a higher mean body mass index and more years of prior exposure to HT than E + P participants, so interpretation of trial differences must be cautious. Many of the findings were consistent with prior observational epidemiologic studies, with the most important exception being the cardio-vascular outcomes. Also of note, in the E+P trial after one year, there very few differences between intervention and placebo groups in a variety of quality-of-life measures (8), suggesting that in this population there were no important effects in the variety of physical and behavioral domains studied. The WHI has made critically important contributions to our knowledge of disease prevention in post-menopausal women, and has challenged current clinical practice and prevention policies. Given that some types of HT will likely cause some excess morbidity, a particular problem emerges in the treatment of menopausal symptoms, since few other effective treatments exist. Also, many women seek advice on the value of HT at the time of menopause, and provision of counseling is now more complex. Perhaps most importantly, WHI has hopefully changed the decision process related to HT use at the time of menopause, and refocused attention on a very important issue: the best regimen for disease prevention in the patient s next thirty years of life. The U.S. Preventive Services Task Force has recommended against HT for chronic disease prevention in post-menopausal women (9), reinforcing the need for an overall prevention focus.

4 More detailed analyses of WHI HT findings will be forthcoming. Additionally, two other WHI trials are not yet complete: long-term interventions with calcium/vitamin D, and low fat diet. The WHI will continue to help guide our clinical preventive strategies and policies for several years to come. Keywords: women s health, estrogen, progestin, hormone therapy, chronic disease

5 Summary of Findings from the Women s Health Initiative Hormone Therapy Trials Intervention Trial Clinical Outcome E + P E Alone All-cause mortality 0 0 Coronary Heart Disease + 0 Stroke + + Breast cancer + 0 Hip fracture - - Colo-rectal cancer - 0 Pulmonary embolism + 0 Global Index ~ + 0 Dementia = no significant change compared with placebo + = statistically significantly higher rates in the hormone intervention group versus placebo - = statistically significant lower rates in the hormone intervention group versus placebo ~ = global index consisting of cumulative events including non-fatal myocardial infarction and CHD death, stroke, pulmonary embolism, invasive breast cancer, hip fracture, colo-rectal cancer, endometrial cancer and death due to other causes.

6 References 1. Women's Health Initiative Study Group. Design of the Women's Health Initiative clinical trial and observational study. The Control Clin Trials. 1998;19: Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288: Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004;291: Grady D. Herrington D. Bittner V. Blumenthal R. et al. HERS Research Group. Cardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA. 2002;288: Goldman JA. The Women s Health Initiative 2004 Review and Critique. Medscape Ob/Gyn & Women s Health. 2004;6(3). 6. Shumaker SA. Legault C. Rapp SR. et al. WHIMS Investigators. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women's Health Initiative Memory Study: a randomized controlled trial. JAMA. 2003;289: Shumaker SA. Legault C. Kuller L. et al. Conjugated equine estrogens and incidence of probable dementia and mild cognitive impairment in postmenopausal women: Women's Health Initiative Memory Study. JAMA. 2004;291: Hays J. Ockene JK. Brunner RL. et al. Women's Health Initiative Investigators. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med. 2003;348: U. S. Preventive Services Task Force. Chemoprevention for hormone replacement therapy. (Release Date: 2002)

7 [Dr. Wallace is the site principal investigator for the Women s Health Initiative at the University of Iowa. The opinions are solely those of the author and not the Women s Health Initiative investigators, the National Institutes of Health, the American College of Preventive Medicine or any other organization or association]

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

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

More information

The Women s Health Initiative where are we a decade later?

The Women s Health Initiative where are we a decade later? The Women s Health Initiative where are we a decade later? Henry G. Burger MIMR-PHI Institute & Jean Hailes for Women s Health, Melbourne, Australia Disclosures: Henry Burger Sources of Funding Pharmaceutical

More information

Executive Summary and Questions and Answers

Executive Summary and Questions and Answers Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phase of the Women s Health Initiative Randomized Trials (Manson et al., 2013) Table of Contents Executive

More information

(212) 733-2324 mackay.jimeson@pfizer.com

(212) 733-2324 mackay.jimeson@pfizer.com For immediate release: July 9, 2012 Media Contacts: MacKay Jimeson (212) 733-2324 mackay.jimeson@pfizer.com Pfizer Recognizes 10 th Anniversary Of The Women s Health Initiative: A Modern Day Perspective

More information

Hormone therapy and breast cancer: conflicting evidence. Cindy Farquhar Cochrane Menstrual Disorders and Subfertility Group

Hormone therapy and breast cancer: conflicting evidence. Cindy Farquhar Cochrane Menstrual Disorders and Subfertility Group Hormone therapy and breast cancer: conflicting evidence Cindy Farquhar Cochrane Menstrual Disorders and Subfertility Group The world of hormone therapy in the 1990 s Throughout the 1970s, 1980s and 1990s

More information

Hormone Replacement Therapy : The New Debate. Susan T. Hingle, M.D.

Hormone Replacement Therapy : The New Debate. Susan T. Hingle, M.D. Hormone Replacement Therapy : The New Debate Susan T. Hingle, M.D. Background Hormone replacement therapy (HRT) is extensively used in the United States, especially for: *treatment of menopausal symptoms

More information

Post Menopausal Hot Flashes Medical Insights Market Opportunity. Tro Kalayjian Physician Chimera Research Group

Post Menopausal Hot Flashes Medical Insights Market Opportunity. Tro Kalayjian Physician Chimera Research Group Post Menopausal Hot Flashes Medical Insights Market Opportunity Tro Kalayjian Physician Chimera Research Group Outline Introduction & Presentation Epidemiology Comorbidities Pathophysiology Women s Health

More information

Neal Rouzier responds to the JAMA article on Men and Testosterone

Neal Rouzier responds to the JAMA article on Men and Testosterone Neal Rouzier responds to the JAMA article on Men and Testosterone On the first day the JAMA article was released I received 500 emails from physicians and patients requesting my opinion of the article

More information

Randomized trials versus observational studies

Randomized trials versus observational studies Randomized trials versus observational studies The case of postmenopausal hormone therapy and heart disease Miguel Hernán Harvard School of Public Health www.hsph.harvard.edu/causal Joint work with James

More information

Learning Objectives. Is FSH testing helpful in diagnosing perimenopause? Issues for the peri menopausal woman. Presenter Disclosure Information

Learning Objectives. Is FSH testing helpful in diagnosing perimenopause? Issues for the peri menopausal woman. Presenter Disclosure Information 5 5:45 pm Managing Menopause: Before, During and After Presenter Disclosure Information The following relationships exist related to this presentation: Jane S. Sillman, MD: No financial relationships to

More information

ABSTRACT. Home Current Issue All Issues Online First Specialties & Topics CME Multimedia Quizzes For Authors Subscribe

ABSTRACT. Home Current Issue All Issues Online First Specialties & Topics CME Multimedia Quizzes For Authors Subscribe SIGN IN (Create a Free Personal Account) Journals > Specialties & Topics Store Physician Jobs About Mobile Search The JAMA Network Search JAMA Advanced Search Home Current Issue All Issues Online First

More information

Use of Hormone Replacement Therapy in the Asymptomatic Postmenopausal Woman: What is the Current Evidence?

Use of Hormone Replacement Therapy in the Asymptomatic Postmenopausal Woman: What is the Current Evidence? CPD Paper 5 605 Use of Hormone Replacement Therapy in the Asymptomatic Postmenopausal Woman: What is the Current Evidence? F H Loh,*FAMS, MRCOG (Lond), M Med (O & G) Abstract The publication of the Women

More information

Case Study 11: Hormone Replacement Therapy

Case Study 11: Hormone Replacement Therapy Case Study 11: Hormone Replacement Therapy October 2000 Scenario Ann McDonnald is a successful 55 year old business executive She starts her first consult with you by saying I m getting hot flushes It

More information

THE WOMEN S HEALTH INITIAtive

THE WOMEN S HEALTH INITIAtive ORIGINAL CONTRIBUTION JAMA-EXPRESS Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women Principal Results From the Women s Health Initiative Randomized Controlled Trial Writing

More information

WHOLE HEALTH: CHANGE THE CONVERSATION. Hormone Replacement Therapy Clinical Tool

WHOLE HEALTH: CHANGE THE CONVERSATION. Hormone Replacement Therapy Clinical Tool Advancing Skills in the Delivery of Personalized, Proactive, Patient-Driven Care Hormone Replacement Therapy Clinical Tool This document has been written for clinicians. The content was developed by the

More information

Hormone Replacement Therapy: An Update

Hormone Replacement Therapy: An Update DOI 10.1007/s13224-012-0269-y EDITORIAL Hormone Replacement Therapy: An Update Khadilkar Suvarna Published online: 21 August 2012 Ó Federation of Obstetric & Gynecological Societies of India 2012 Ever

More information

Hormone Restoration: Is It Right for You? Patricia A. Stafford, M.D. Founder, Wellness ReSolutions

Hormone Restoration: Is It Right for You? Patricia A. Stafford, M.D. Founder, Wellness ReSolutions Hormone Restoration: Is It Right for You? Patricia A. Stafford, M.D. Founder, Wellness ReSolutions IMPORTANCE OF HORMONE BALANCE Importance of Hormone Balance Help you live a long, healthy life Help you

More information

February 1, 2014 RESTORING STRENGTH AND VITALITY THROUGH HORMONES FACTS, FANTASIES, POSSIBILITIES, AND PITFALLS

February 1, 2014 RESTORING STRENGTH AND VITALITY THROUGH HORMONES FACTS, FANTASIES, POSSIBILITIES, AND PITFALLS February 1, 2014 RESTORING STRENGTH AND VITALITY THROUGH HORMONES FACTS, FANTASIES, POSSIBILITIES, AND PITFALLS Calvin Hirsch, MD Professor of Clinical Internal Medicine (Geriatrics) UC Davis School of

More information

The Women s Health Initiative (WHI) Clinical Trial of Estrogen plus Progestin in Postmenopausal Women

The Women s Health Initiative (WHI) Clinical Trial of Estrogen plus Progestin in Postmenopausal Women The Women s Health Initiative (WHI) Clinical Trial of Estrogen plus Progestin in Postmenopausal Women Funded by the National Heart, Lung, and Blood Institute Bethesda, Maryland Conducted by 40 Clinical

More information

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

Endocrinology & Women s Health + Adult Immunizations Exotic Asia CME Cruise June 15 24, 2015. Menopause & Osteoporosis update 2015. Menopause and Osteoporosis Update 2015 Post WHI-Update CCFP, MHSc, FRCP,FCFP,, NAMS Accredited Menopause Expert Associate Professor University of Toronto www.seacourses.com 1 Canadian Population Pyramid:

More information

Position Statement on Chemoprevention updated June 2011

Position Statement on Chemoprevention updated June 2011 Position Statement on Chemoprevention updated June 2011 Position Women need more information on the potential risks and benefits of taking tamoxifen, raloxifene, and aromatase inhibitors for breast cancer

More information

Promoting the Fountain of Youth: Low-T and Estrogen Deficiency

Promoting the Fountain of Youth: Low-T and Estrogen Deficiency Promoting the Fountain of Youth: Low-T and Estrogen Deficiency Adriane Fugh-Berman MD Georgetown University Medical Center ajf29@georgetown.edu Hormone Therapy in Women Animal glandulars became popular

More information

The U.S. Preventive Services Task Force (USPSTF) makes

The U.S. Preventive Services Task Force (USPSTF) makes Annals of Internal Medicine Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions: U.S. Preventive Services Task Force Recommendation Statement Virginia A. Moyer, MD, MPH, on behalf

More information

Getting Started: The Anatomy and Physiology of Clinical Research

Getting Started: The Anatomy and Physiology of Clinical Research Getting Started: The Anatomy and Physiology of Clinical Research Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings This chapter introduces clinical research from two viewpoints, setting up themes

More information

Dr.Deepak V. Chaturvedi,

Dr.Deepak V. Chaturvedi, Dr.Deepak V. Chaturvedi, M.B.B.S; M.D.(Medicine) Metabolic Physician, Diabetologist, Antiaging, Obesity & Hormones Specialist. Specializing in Bio Identical Hormone Replacement Therapy Evolution from TREATMENT

More information

Hormones and cardiovascular disease, what the Danish Nurse Cohort learned us

Hormones and cardiovascular disease, what the Danish Nurse Cohort learned us Hormones and cardiovascular disease, what the Danish Nurse Cohort learned us Ellen Løkkegaard, Clinical Associate Professor, Ph.d. Dept. Obstetrics and Gynecology. Hillerød Hospital, University of Copenhagen

More information

PROMISE & PITFALLS OF OUTCOMES RESEARCH USING EMR DATABASES. Richard L. Tannen, M.D., Mark Weiner, Dawei Xie

PROMISE & PITFALLS OF OUTCOMES RESEARCH USING EMR DATABASES. Richard L. Tannen, M.D., Mark Weiner, Dawei Xie PROMISE & PITFALLS OF OUTCOMES RESEARCH USING EMR DATABASES Richard L. Tannen, M.D., Mark Weiner, Dawei Xie GOALS OF STUDY Determine Whether Studies Using EMR Database Yield Valid Outcome Assessment Major

More information

SSE/EFI Working Paper Series in Economics and Finance, No 571. December Abstract

SSE/EFI Working Paper Series in Economics and Finance, No 571. December Abstract A reassessment of the cost-effectiveness of hormone replacement therapy in Sweden results based on the Women s Health Initiative randomised controlled trial Niklas Zethraeus 1, Fredrik Borgström 2, Bengt

More information

Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study

Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study DOI 10.1007/s00198-012-2224-2 ORIGINAL ARTICLE Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study R. L. Prentice & M. B. Pettinger

More information

What is an Evidence-Based, Value-Based Health Care System? (Part 1)

What is an Evidence-Based, Value-Based Health Care System? (Part 1) Evidence-Based Medicine What is an Evidence-Based, Value-Based Health Care System? (Part 1) By Sheri Strite and Michael E. Stuart, MD IN THIS ARTICLE The two biggest issues facing health care organizations

More information

PROVERA (medroxyprogesterone acetate) Product Monograph Page 34 of 38

PROVERA (medroxyprogesterone acetate) Product Monograph Page 34 of 38 PART III: CONSUMER INFORMATION PR PROVERA* (medroxyprogesterone acetate) This leaflet is part III of a three-part "Product Monograph" published when PROVERA was approved for sale in Canada and is designed

More information

The menopausal transition usually has three parts:

The menopausal transition usually has three parts: The menopausal transition usually has three parts: Perimenopause begins several years before a woman s last menstrual period, when the ovaries gradually produce less estrogen. In the last 1-2 years of

More information

The U.S. Preventive Services Task Force (USPSTF) makes

The U.S. Preventive Services Task Force (USPSTF) makes Annals of Internal Medicine Clinical Guideline Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions: U.S. Preventive Services Task Force Recommendation Statement Virginia A. Moyer,

More information

Sunday, May 6. Power Surge: History and Current Treatment Options for Hot Flashes 3/28/2012

Sunday, May 6. Power Surge: History and Current Treatment Options for Hot Flashes 3/28/2012 Power Surge: History and Current Treatment Options for Hot Flashes 2012 Regional Osteopathic Medical Education (ROME ) Southeast Conference Sunday, May 6 Power Surge: History and Current Treatment Options

More information

Coronary heart disease in menopausal women: Implications of primary and secondary prevention trials of hormones

Coronary heart disease in menopausal women: Implications of primary and secondary prevention trials of hormones Maturitas 51 (2005) 51 63 Coronary heart disease in menopausal women: Implications of primary and secondary prevention trials of hormones Jacques E. Rossouw National Heart, Lung, and Blood Institute, National

More information

Outline Introduction Oidti Oxidative damage Antioxidants properties Antioxidants and antiaging interventions Hormonal therapy Benefits of DHEA, testos

Outline Introduction Oidti Oxidative damage Antioxidants properties Antioxidants and antiaging interventions Hormonal therapy Benefits of DHEA, testos Anti-Aging Aging g Medications What is the Evidence? Sixth Annual Family Medicine Conference Crown Plaza November 11, 2007 Presented by : Jad J. Sakr, Pharm.D. Outline Introduction Oidti Oxidative damage

More information

POSTMENOPAUSAL ESTROGEN REPLACEMENT THERAPY

POSTMENOPAUSAL ESTROGEN REPLACEMENT THERAPY POSTMENOPAUSAL ESTROGEN REPLACEMENT THERAPY Dorie W. Schwertz, PhD (2/01) University of Illinois at Chicago Hormone Replacement Therapy (HRT) and Estrogen Replacement Therapy (ERT) Menopause - loss of

More information

New Cholesterol Guidelines: Carte Blanche for Statin Overuse Rita F. Redberg, MD, MSc Professor of Medicine

New Cholesterol Guidelines: Carte Blanche for Statin Overuse Rita F. Redberg, MD, MSc Professor of Medicine New Cholesterol Guidelines: Carte Blanche for Statin Overuse Rita F. Redberg, MD, MSc Professor of Medicine Disclosures & Relevant Relationships I have nothing to disclose No financial conflicts Editor,

More information

Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes

Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes U.S. Department of Health and Human Services Food and Drug Administration Center

More information

The Menopause. Nicola Clarke 4th year, Univesity of Leeds

The Menopause. Nicola Clarke 4th year, Univesity of Leeds The Menopause Definition The menopause in it s literal definition means the end of monthly cycles ; from the Greek word paussis (cessation) and the root men- (month) 1. This definition, however, refers

More information

With Big Data Comes Big Responsibility

With Big Data Comes Big Responsibility With Big Data Comes Big Responsibility Using health care data to emulate randomized trials when randomized trials are not available Miguel A. Hernán Departments of Epidemiology and Biostatistics Harvard

More information

Case studies of bias in real life epidemiologic studies. Bias File 1. The Rise and Fall of Hormone Replacement Therapy

Case studies of bias in real life epidemiologic studies. Bias File 1. The Rise and Fall of Hormone Replacement Therapy Case studies of bias in real life epidemiologic studies Bias File 1. The Rise and Fall of Hormone Replacement Therapy Compiled by Madhukar Pai, MD, PhD Jay S Kaufman, PhD Department of Epidemiology, Biostatistics

More information

Hormone replacement therapy:

Hormone replacement therapy: www.bpac.org.nz keyword: hrt Hormone replacement therapy: latest evidence and treatment recommendations Key advisor: Dr Helen Roberts, Senior Lecturer, Department of Obstetrics and Gynaecology, Faculty

More information

Hormone Replacement Therapy (HRT) a is the term used for the. Hormone Replacement Therapy: Real Concerns and False Alarms REVIEW ARTICLE

Hormone Replacement Therapy (HRT) a is the term used for the. Hormone Replacement Therapy: Real Concerns and False Alarms REVIEW ARTICLE REVIEW ARTICLE Hormone Replacement Therapy: Real Concerns and False Alarms Avrum Z. Bluming, MD, and Carol Tavris, PhD Abstract: From 2002 to 2008, reports from the Women s Health Initiative (WHI) claimed

More information

TITLE: Oral Progesterone for the Treatment of Menopausal Symptoms: A Review of the Clinical Evidence

TITLE: Oral Progesterone for the Treatment of Menopausal Symptoms: A Review of the Clinical Evidence TITLE: Oral Progesterone for the Treatment of Menopausal Symptoms: A Review of the Clinical Evidence DATE: 29 April 2014 CONTEXT AND POLICY ISSUES Menopause is the cessation of menses caused by progressively

More information

Randomised trials on the long-term effects of hormone replacement therapy: Criticism of Women s Health Initiative Study

Randomised trials on the long-term effects of hormone replacement therapy: Criticism of Women s Health Initiative Study HIPPOKRATIA 2002, 6, 2: 51-56 HIPPOKRATIA 2002, 6, 2 51 EDITORIAL COMMENTS Randomised trials on the long-term effects of hormone replacement therapy: Criticism of Women s Health Initiative Study Panidis

More information

Hormone Therapy: The Pendulum Swings Finding the Right Balance

Hormone Therapy: The Pendulum Swings Finding the Right Balance Hormone Therapy: The Pendulum Swings Finding the Right Balance by Dr. Diana Hoppe Menopause is a time of great change and confusion! Not only can menopausal symptoms be incredibly challenging, but so can

More information

Natural Hormone Therapy

Natural Hormone Therapy Natural Hormone Therapy Dr. Helen Roberts MB, MPH Associate Professor Women s Health Department Obstetrics and Gynaecology University of Auckland h.roberts@auckland.ac.nz Research Advisor Family Planning

More information

Not All Clinical Trials Are Created Equal Understanding the Different Phases

Not All Clinical Trials Are Created Equal Understanding the Different Phases Not All Clinical Trials Are Created Equal Understanding the Different Phases This chapter will help you understand the differences between the various clinical trial phases and how these differences impact

More information

ABOUT XARELTO CLINICAL STUDIES

ABOUT XARELTO CLINICAL STUDIES ABOUT XARELTO CLINICAL STUDIES FAST FACTS Xarelto (rivaroxaban) is a novel, oral direct Factor Xa inhibitor. On September 30, 2008, the European Commission granted marketing approval for Xarelto for the

More information

Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial

Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial Connie N. Hess, MD, MHS, Stefan James, MD, PhD, Renato D. Lopes, MD, PhD, Daniel M. Wojdyla,

More information

Komorbide brystkræftpatienter kan de tåle behandling? Et registerstudie baseret på Danish Breast Cancer Cooperative Group

Komorbide brystkræftpatienter kan de tåle behandling? Et registerstudie baseret på Danish Breast Cancer Cooperative Group Komorbide brystkræftpatienter kan de tåle behandling? Et registerstudie baseret på Danish Breast Cancer Cooperative Group Lotte Holm Land MD, ph.d. Onkologisk Afd. R. OUH Kræft og komorbiditet - alle skal

More information

Systolic Blood Pressure Intervention Trial (SPRINT) Principal Results

Systolic Blood Pressure Intervention Trial (SPRINT) Principal Results Systolic Blood Pressure Intervention Trial (SPRINT) Principal Results Paul K. Whelton, MB, MD, MSc Chair, SPRINT Steering Committee Tulane University School of Public Health and Tropical Medicine, and

More information

Chapter 6. Conclusions

Chapter 6. Conclusions Chapter 6 Conclusions Contents Page DETERMINING THE RELATIONSHIP BETWEEN THE MENOPAUSE AND DISEASES OF AGING....*.*...**...,..****,...*.**.* 101 RANDOMIZED CLINICAL TRIALS ARE NEEDED..............................

More information

Dr. Friedman s Guide to Estrogen Replacement

Dr. Friedman s Guide to Estrogen Replacement Dr. Friedman s Guide to Estrogen Replacement There are risks and benefits with all medicines and estrogen replacement is no exception. In fact, estrogen replacement is one of the most controversial topics

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE 1 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Guideline title SCOPE Hypertension: clinical management of primary hypertension in adults 1.1 Short title Hypertension (partial update) 2 The remit

More information

Main Effect of Screening for Coronary Artery Disease Using CT

Main Effect of Screening for Coronary Artery Disease Using CT Main Effect of Screening for Coronary Artery Disease Using CT Angiography on Mortality and Cardiac Events in High risk Patients with Diabetes: The FACTOR-64 Randomized Clinical Trial Joseph B. Muhlestein,

More information

The benefits of oestrogen following menopause: why hormone replacement therapy should be offered to postmenopausal women

The benefits of oestrogen following menopause: why hormone replacement therapy should be offered to postmenopausal women The benefits of oestrogen following menopause: why hormone replacement therapy should be offered to postmenopausal women Barry G Wren For over 70 years, women have used oestrogen-based hormone replacement

More information

Medications to Prevent and Treat Osteoporosis

Medications to Prevent and Treat Osteoporosis Medications to Prevent and Treat Osteoporosis National Institutes of Health Osteoporosis and Related Bone Diseases ~ National Resource Center 2 AMS Circle Bethesda, MD 20892-3676 Tel: (800) 624-BONE or

More information

University of Ulsan College of Medicine, Asan Medical Center on behalf of the REAL-LATE and the ZEST-LATE trial

University of Ulsan College of Medicine, Asan Medical Center on behalf of the REAL-LATE and the ZEST-LATE trial Duration of Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation A Pooled Analysis of the REAL-LATE and the ZEST-LATE Trial Seung-Jung Park MD PhD Seung-Jung Park, MD, PhD, University of Ulsan

More information

LIVING WATERS MEDICAL SPA AND WELLNESS CENTER

LIVING WATERS MEDICAL SPA AND WELLNESS CENTER November 2014 LIVING WATERS MEDICAL SPA AND WELLNESS CENTER Contents Benefits and Risks of Hormone Replacement 1-3 Liposuction Pictures 4-6 Remember to get your Botox before Christmas! Menopause and male

More information

Pfizer Medical Education Group. Appropriate use of Hormone Therapy in Postmenopausal Women. Request for Proposals.

Pfizer Medical Education Group. Appropriate use of Hormone Therapy in Postmenopausal Women. Request for Proposals. Pfizer Medical Education Group Appropriate use of Hormone Therapy in Postmenopausal Women Request for Proposals December 12, 2012 Background: The mission of the Pfizer Medical Education Group is to accelerate

More information

Study Design for Chemoprevention. Cancer Epidemiology, Prevention and Control Workshop Shanghai, March 12, 2008

Study Design for Chemoprevention. Cancer Epidemiology, Prevention and Control Workshop Shanghai, March 12, 2008 Study Design for Chemoprevention Cancer Epidemiology, Prevention and Control Workshop Shanghai, March 12, 2008 I. INTRODUCTION Experimental studies are conducted to assess the effect of a treatment using

More information

ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes

ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes Effects of a fixed combination of the ACE inhibitor, perindopril,

More information

Bayer Initiates Rivaroxaban Phase III Study to Support Dose Selection According to Individual Benefit-Risk Profile in Long- Term VTE Prevention

Bayer Initiates Rivaroxaban Phase III Study to Support Dose Selection According to Individual Benefit-Risk Profile in Long- Term VTE Prevention Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Long-term prevention of venous blood clots (VTE): Bayer Initiates Rivaroxaban

More information

DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study

DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study National Diabetes Information Clearinghouse U.S. Department of Health and Human Services NATIONAL INSTITUTES OF HEALTH What

More information

Does Diabetes Control Matter?

Does Diabetes Control Matter? Does Diabetes Control Matter? Laurence Kennedy, MD, FRCP Endocrinology Department Cleveland Clinic, OH Disclosures None Does Diabetes Control Matter? Generality of patients Relative Risk Complications

More information

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors News Release For use outside the US and UK only Bayer Pharma AG 13342 Berlin Germany Tel. +49 30 468-1111 www.bayerpharma.com Bayer s Xarelto Approved in the EU for the Prevention of Stroke in Patients

More information

Observational studies, clinical trials, and the women s health initiative

Observational studies, clinical trials, and the women s health initiative Lifetime Data Anal (2007) 13:449 462 DOI 10.1007/s10985-007-9047-z Observational studies, clinical trials, and the women s health initiative Ross L. Prentice Received: 5 July 2007 / Accepted: 16 July 2007

More information

Menopause Guidance on management and prescribing HRT for GPs based on NICE guidance 2015

Menopause Guidance on management and prescribing HRT for GPs based on NICE guidance 2015 PRIMARY CARE WOMEN S HEALTH FORUM GUIDELINES Menopause Guidance on management and prescribing HRT for GPs based on NICE guidance 2015 Written by Dr Imogen Shaw This guidance is designed to support you

More information

ECONOMIC COSTS OF PHYSICAL INACTIVITY

ECONOMIC COSTS OF PHYSICAL INACTIVITY ECONOMIC COSTS OF PHYSICAL INACTIVITY This fact sheet highlights the prevalence and health-consequences of physical inactivity and summarises some of the key facts and figures on the economic costs of

More information

CASE A1 Hypoglycemia in an Elderly T2DM Patient with Heart Failure

CASE A1 Hypoglycemia in an Elderly T2DM Patient with Heart Failure Hypoglycemia in an Elderly T2DM Patient with Heart Failure 1 I would like to introduce you to Sophie, an elderly patient with long-standing type 2 diabetes, who has a history of heart failure, a common

More information

Statins and Risk for Diabetes Mellitus. Background

Statins and Risk for Diabetes Mellitus. Background Statins and Risk for Diabetes Mellitus Kevin C. Maki, PhD, FNLA Midwest Center for Metabolic & Cardiovascular Research and DePaul University, Chicago, IL 1 Background In 2012 the US Food and Drug Administration

More information

About the RECORD Clinical Trial Program

About the RECORD Clinical Trial Program About the RECORD Clinical Trial Program Fast facts RECORD was a global program of four trials in more than 12,500 patients, comparing Xarelto (rivaroxaban) and enoxaparin in the prevention of venous thromboembolism

More information

DUAL ANTIPLATELET THERAPY. Dr Robert S Mvungi, MD(Dar), Mmed (Wits) FCP(SA), Cert.Cardio(SA) Phy Tanzania Cardiac Society Dar es Salaam Tanzania

DUAL ANTIPLATELET THERAPY. Dr Robert S Mvungi, MD(Dar), Mmed (Wits) FCP(SA), Cert.Cardio(SA) Phy Tanzania Cardiac Society Dar es Salaam Tanzania DUAL ANTIPLATELET THERAPY Dr Robert S Mvungi, MD(Dar), Mmed (Wits) FCP(SA), Cert.Cardio(SA) Phy Tanzania Cardiac Society Dar es Salaam Tanzania DUAL ANTIPLATELET THERAPY (DAPT) Dual antiplatelet regimen

More information

BREAST CANCER RISK ASSESSMENT AND PRIMARY PREVENTION FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 1

BREAST CANCER RISK ASSESSMENT AND PRIMARY PREVENTION FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 1 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 1 Hello, my name is Rachel Jankowitz, I m an assistant professor of medicine in the Division of Hematology Oncology at the University of Pittsburgh

More information

Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs

Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs Jay S. Skyler, MD, MACP Division of Endocrinology, Diabetes, and Metabolism and Diabetes Research Institute University of Miami Miller

More information

Always Start with PECO

Always Start with PECO Goals of This Course Be able to understand a study design (very basic concept) Be able to understand statistical concepts in a medical paper Be able to perform a data analysis Understanding: PECO study

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 13 October 2005 Doc. Ref. EMEA/CHMP/021/97 Rev. 1 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE

More information

Testosterone; What s all the hype? KRISTEN WYRICK, LTCOL,USAFR, MC USUHS, FAMILY MEDICINE JOINT BASE LANGLEY-EUSTIS

Testosterone; What s all the hype? KRISTEN WYRICK, LTCOL,USAFR, MC USUHS, FAMILY MEDICINE JOINT BASE LANGLEY-EUSTIS Testosterone; What s all the hype? KRISTEN WYRICK, LTCOL,USAFR, MC USUHS, FAMILY MEDICINE JOINT BASE LANGLEY-EUSTIS The faces of Low Testosterone What your patients are seeing Pharmacy Industry Testosterone

More information

Success factors in Behavioral Medicine

Success factors in Behavioral Medicine Success factors in Behavioral Medicine interventions post myocardial infarction Depression Gunilla post myocardial Burell, PhD infarction Department of Public Health, Uppsala University, Sweden XIII Svenska

More information

DRAFT COPY: PERSONAL USE ONLY

DRAFT COPY: PERSONAL USE ONLY Climacteric medicine: European Menopause and Andropause Society (EMAS) 2004/2005 positions statements on peri- and postmenopausal hormone replacement therapy Skouby S.O. Al-Azzawi F. Barlow D. Calaf-Alsina

More information

The intent of The North American Menopause Society

The intent of The North American Menopause Society Menopause: The Journal of The North American Menopause Society Vol. 19, No. 3, pp. 257/271 DOI: 10.1097/gme.0b013e31824b970a * 2012 by The North American Menopause Society POSITION STATEMENT The 2012 Hormone

More information

BMC Med 7/19/2007; Simvastatin linked to reduced incidence of dementia, Parkinson s disease.

BMC Med 7/19/2007; Simvastatin linked to reduced incidence of dementia, Parkinson s disease. March 3, 2012 BD Response to FDA statement regarding Statins The Food and Drug Administration announced on Tuesday (February 28, 2012) the changes to the safety information on the labels of statins regarding

More information

Perimenopause and hormones

Perimenopause and hormones Doctors have been contradicting themselves for so many years now that not unexpectedly many women are suspicious and wonder what is the truth about hormones. The problem was highlighted in 2002 with the

More information

NHS outcomes framework and CCG outcomes indicators: Data availability table

NHS outcomes framework and CCG outcomes indicators: Data availability table NHS outcomes framework and CCG outcomes indicators: Data availability table December 2012 NHS OF objectives Preventing people from dying prematurely DOMAIN 1: preventing people from dying prematurely Potential

More information

PCHC FACTS ABOUT HEALTH CONDITIONS AND MOOD DIFFICULTIES

PCHC FACTS ABOUT HEALTH CONDITIONS AND MOOD DIFFICULTIES PCHC FACTS ABOUT HEALTH CONDITIONS AND MOOD DIFFICULTIES Why should mood difficulties in individuals with a health condition be addressed? Many people with health conditions also experience mood difficulties

More information

Postmenopausal Hormone Replacement Therapy and Cardiovascular Disease

Postmenopausal Hormone Replacement Therapy and Cardiovascular Disease This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or a basis for reimbursement and coverage policies. AHRQ

More information

Expert Commentary. A response to the recent JAMA meta analysis on omega 3 supplementation and cardiovascular events

Expert Commentary. A response to the recent JAMA meta analysis on omega 3 supplementation and cardiovascular events Expert Commentary A response to the recent JAMA meta analysis on omega 3 supplementation and cardiovascular events Dr. Bruce J. Holub, Ph.D., Professor Emeritus, University of Guelph Expert Commentary:

More information

Treatment of Menopausal Symptoms in Family Medicine Settings following the Women s Health Initiative Findings

Treatment of Menopausal Symptoms in Family Medicine Settings following the Women s Health Initiative Findings Treatment of Menopausal Symptoms in Family Medicine Settings following the Women s Health Initiative Findings The Florida Behavioral Health Research Consortium; Mary Ann Burg, LCSW, PhD, Kathryn Fraser,

More information

Hôpitaux Universitaires de Genève Lipides, métabolisme des hydrates de carbonne et maladies cardio-vasculaires

Hôpitaux Universitaires de Genève Lipides, métabolisme des hydrates de carbonne et maladies cardio-vasculaires Hôpitaux Universitaires de Genève Lipides, métabolisme des hydrates de carbonne et maladies cardio-vasculaires Prof. J. Philippe Effect of estrogens on glucose metabolism : Fasting Glucose, HbA1c and C-Peptide

More information

NICE Pathways bring together all NICE guidance, quality standards and other NICE information on a specific topic.

NICE Pathways bring together all NICE guidance, quality standards and other NICE information on a specific topic. Benefits and risks of hormone replacement therapy bring together all NICE guidance, quality standards and other NICE information on a specific topic. are interactive and designed to be used online. They

More information

Aging Well - Part V. Hormone Modulation -- Growth Hormone and Testosterone

Aging Well - Part V. Hormone Modulation -- Growth Hormone and Testosterone Aging Well - Part V Hormone Modulation -- Growth Hormone and Testosterone By: James L. Holly, MD (The Your Life Your Health article published in the December 4th Examiner was a first draft. It was sent

More information

patient education Fact Sheet PFS003: Hormone Therapy APRIL 2015

patient education Fact Sheet PFS003: Hormone Therapy APRIL 2015 patient education Fact Sheet PFS003: Hormone Therapy APRIL 2015 Hormone Therapy Menopause is the time in a woman s life when she naturally stops having menstrual periods. Menopause marks the end of the

More information

Stress is linked to exaggerated cardiovascular reactivity. 1) Stress 2) Hostility 3) Social Support. Evidence of association between these

Stress is linked to exaggerated cardiovascular reactivity. 1) Stress 2) Hostility 3) Social Support. Evidence of association between these Psychosocial Factors & CHD Health Psychology Psychosocial Factors 1) Stress 2) Hostility 3) Social Support Evidence of association between these psychosocial factors and CHD Physiological Mechanisms Stress

More information

COULD IT BE LOW TESTOSTERONE?

COULD IT BE LOW TESTOSTERONE? COULD IT BE LOW TESTOSTERONE? By Dr. Lauren M. Bramley For thousands of years women have been recognized for their sensitivity to hormones. PMS, post partum depression, menopause have long been plights

More information

Listen to your heart: Good Cardiovascular Health for Life

Listen to your heart: Good Cardiovascular Health for Life Listen to your heart: Good Cardiovascular Health for Life Luis R. Castellanos MD, MPH Assistant Clinical Professor of Medicine University of California San Diego School of Medicine Sulpizio Family Cardiovascular

More information

Now, there are multiple risk factors that may increase the risk for contralateral second primary breast cancers. Women diagnosed at a young age with a

Now, there are multiple risk factors that may increase the risk for contralateral second primary breast cancers. Women diagnosed at a young age with a Hello. My name is Suzanne Day. I am a nurse practitioner at The University of Texas MD Anderson Cancer Center. I m here today to talk about assessing risk and preventing second primary breast cancers.

More information

Investor News. Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint. Not intended for U.S.

Investor News. Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint. Not intended for U.S. Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint

More information

Mediterranean diet: A heart-healthy eating plan Source: mayoclinic.org/mediterranean-diet

Mediterranean diet: A heart-healthy eating plan Source: mayoclinic.org/mediterranean-diet Mediterranean diet: A heart-healthy eating plan Source: mayoclinic.org/mediterranean-diet The heart-healthy Mediterranean is a healthy eating plan based on typical foods and recipes of Mediterranean-style

More information