Reproductive Endocrinology CE/CME ACCREDITED Watch Time: 51 mins

touchCONGRESS Scanning the horizon of pharmacological treatments for women experiencing vasomotor symptoms during menopause: What’s new in 2022?

Watch this two-part activity exploring the latest data on pharmacological treatments for vasomotor symptoms (VMS) associated with menopause. Filmed following the 2022 North American Menopause Society (NAMS) Annual Meeting and the International Menopause Society (IMS) 18th World Congress on Menopause.

Part 1: Watch menopause expert Prof. Steven Goldstein review key data from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause Watch Now

Part 2: Choose from leading menopause experts who discuss what these data may mean for clinical practice in the USA Select An Interview

  • Part 1: Data Review
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Introduction
Hormone therapy for VMS associated with menopause
Non-hormonal therapy for VMS associated with menopause
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Overview

Watch Prof. Steven Goldstein summarize and share his interpretation of the latest data from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause on pharmacological treatments for VMS associated with menopause. During the presentation, he considers:

  • Hormone therapy for VMS associated with menopause
  • Non-hormonal therapy for VMS associated with menopause

Steven R Goldstein is professor of obstetrics and gynaecology at the New York University Grossman School of Medicine in New York City, New York, USA. read more

Prof. Goldstein is a former president of the IMS (2021–2022) and past president and fellow of the American Institute of Ultrasound in Medicine. He is also a past president of the NAMS, past chairman of the American College of Obstetricians and Gynecologists, New York section, and an honorary fellow of the Royal College of Obstetricians and Gynaecologists.

Prof. Goldstein is one of the most highly recognized and regarded individuals in the field of vaginal probe ultrasound worldwide. He has been a guest faculty member, invited speaker, visiting professor or course director over 400 times throughout the USA and the world.

In 2016, Prof. Goldstein received the NAMS/Thomas B. Clarkson Outstanding Clinical and Basic Science Research Award, and in 2019, he received the Joseph H. Holmes Basic Science Pioneer Award from the American Institute of Ultrasound in Medicine. Prof. Goldstein has published seven books on women’s health, and has authored more than 60 chapters and over 140 original research articles.

Prof. Steven Goldstein discloses Advisory board or panel fees from Myovant Sciences and SCYNEXIS (relationships terminated). Consultancy fees from CooperSurgical (relationship terminated) and Cook Medical. Other financial or material support from GE Ultrasound.

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  • Part 2: Expert interviews
Prof. Steven Goldstein
Watch Time: 07:06 New York University Grossman School of Medicine, New York, NY, USA

Prof. Steven Goldstein considers the latest data from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause on pharmacological treatments for VMS associated with menopause, including the role of hormone therapy, and how emerging non-hormonal therapies are likely to impact clinical practice and patient outcomes, once approved.
 
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In this interview, Prof. Steven Goldstein answers the following questions:

  • How will recent data from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause shape conversations with patients on the use of hormone therapy in clinical practice?
  • How can key learnings from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause be integrated into clinical practice when choosing between hormone and non-hormonal therapy, once approved?
  • How is our understanding of the role of non-hormonal therapy for the treatment of VMS evolving in light of recent data, and what are the possible future clinical implications?
  • What are the unmet treatment needs for women experiencing VMS associated with menopause, and how will the approval of non-hormonal therapy drive individualized treatment decisions in future?

Steven R Goldstein is professor of obstetrics and gynaecology at the New York University Grossman School of Medicine in New York City, New York, USA. read more

Prof. Goldstein is a former president of the IMS (2021–2022) and past president and fellow of the American Institute of Ultrasound in Medicine. He is also a past president of the NAMS, past chairman of the American College of Obstetricians and Gynecologists, New York section, and an honorary fellow of the Royal College of Obstetricians and Gynaecologists.

Prof. Goldstein is one of the most highly recognized and regarded individuals in the field of vaginal probe ultrasound worldwide. He has been a guest faculty member, invited speaker, visiting professor or course director over 400 times throughout the USA and the world.

In 2016, Prof. Goldstein received the NAMS/Thomas B. Clarkson Outstanding Clinical and Basic Science Research Award, and in 2019, he received the Joseph H. Holmes Basic Science Pioneer Award from the American Institute of Ultrasound in Medicine. Prof. Goldstein has published seven books on women’s health, and has authored more than 60 chapters and over 140 original research articles.

Prof. Steven Goldstein discloses Advisory board or panel fees from Myovant Sciences and SCYNEXIS (relationships terminated). Consultancy fees from CooperSurgical (relationship terminated) and Cook Medical. Other financial or material support from GE Ultrasound.

Dr Samuel Lederman
Watch Time: 06:15 Women's Care Florida, West Palm Beach, FL, USA

Dr Samuel Lederman considers the latest data from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause on pharmacological treatments for VMS associated with menopause, including the role of hormone therapy, and how emerging non-hormonal therapies are likely to impact clinical practice and patient outcomes, once approved.
 
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In this interview, Dr Samuel Lederman answers the following questions:

  • How will recent data from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause shape conversations with patients on the use of hormone therapy in clinical practice?
  • How can key learnings from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause be integrated into clinical practice when choosing between hormone and non-hormonal therapy, once approved?
  • How is our understanding of the role of non-hormonal therapy for the treatment of VMS evolving in light of recent data, and what are the possible future clinical implications?
  • What are the unmet treatment needs for women experiencing VMS associated with menopause, and how will the approval of non-hormonal therapy drive individualized treatment decisions in future?

Samuel Lederman is the regional medical director at Women’s Care Florida and an assistant professor of obstetrics and gynaecology at the Schmidt College of Medicine, Florida Atlantic University College of Medicine in Boca Raton, Florida. He is also the medical director of Altus Research, a privately owned clinical research site in Florida, USA. read more

Dr Lederman holds several leadership positions at area hospitals and remains an active member of many professional and civic organizations. Dr Lederman is board certified by the American College of Obstetricians and Gynecologists. He was the founding member of Palm Beach Ob/Gyn, now a part of Women’s Care Florida private practice.

For the past 25 years, Dr Lederman has served as principal investigator in clinical trials in women’s health, obesity, osteoporosis, uterine fibroids, endometriosis, hormone therapy, family planning, urinary incontinence, vaccinations and many more.

Dr Samuel Lederman discloses Grants/research support from Aspira, Astellas Pharma, GSK, INOVIO Pharmaceuticals, Janssen Pharmaceuticals, Moderna, Mylan, Myovant Sciences, Parexel, Sebela Pharmaceuticals and Spruce Biosciences. Salary or contractual services from InMode. Speaker’s bureau fees from AbbVie and Mycovia Pharmaceuticals. Stock/shareholder (self-managed) fees from LabConnect.

Prof. JoAnn Pinkerton
Watch Time: 07:34 University of Virginia Health System, Charlottesville, VA, USA

Prof. JoAnn Pinkerton considers the latest data from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause on pharmacological treatments for VMS associated with menopause, including the role of hormone therapy, and how emerging non-hormonal therapies are likely to impact clinical practice and patient outcomes, once approved.
 
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In this interview, Prof. JoAnn Pinkerton answers the following questions:

  • How will recent data from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause shape conversations with patients on the use of hormone therapy in clinical practice?
  • How can key learnings from the 2022 NAMS Annual Meeting and the IMS 18th World Congress on Menopause be integrated into clinical practice when choosing between hormone and non-hormonal therapy, once approved?
  • How is our understanding of the role of non-hormonal therapy for the treatment of VMS evolving in light of recent data, and what are the possible future clinical implications?
  • What are the unmet treatment needs for women experiencing VMS associated with menopause, and how will the approval of non-hormonal therapy drive individualized treatment decisions in future?

JoAnn V Pinkerton is professor of obstetrics and gynaecology and division director of Midlife Health Center at the University of Virginia (UVA) Health System in Charlottesville, Virginia, USA. read more

Prof. Pinkerton is on the board of trustees for the NAMS and was president and vice president in 2009 and 2010, respectively. Prof. Pinkerton is also a fellow of the American College of Obstetricians and Gynecologists. In 2013, Prof. Pinkerton received the UVA Sharon L. Hostler Women in Medicine Leadership Award and she has featured annually on the Best Doctors in America® List from 2010 to 2020. She is also a recipient of the American Library Association Award for Understanding Midlife Health.

Prof. Pinkerton has published more than 90 peer-reviewed publications, 70 abstracts, 30 invited papers and 11 invited chapters. In addition, she has served as principal investigator for over 30 clinical trials on treatment of VMS with hormone and non-hormonal therapies. Prof. Pinkerton has developed five women’s midlife health festivals and has helped plan the biannual Midlife Community Educational Symposium since 2013.

Dr JoAnn Pinkerton discloses Grants/research support from Bayer.

Please Select A Video:
Prof. Steven Goldstein
 New York University Grossman School of Medicine, New York, NY, USA Watch Time: 07:06 Translations available:
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Dr Samuel Lederman
 Women's Care Florida, West Palm Beach, FL, USA Watch Time: 06:15 Translations available:
Watch Video
Prof. JoAnn Pinkerton
 University of Virginia Health System, Charlottesville, VA, USA Watch Time: 07:34 Translations available:
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Learning Objectives & Overview
Overview

In this two-part activity, explore the latest data on pharmacological hormone therapy and non-hormonal therapy for VMS associated with menopause. This activity was filmed following the 2022 NAMS Annual Meeting (12–15 October 2022) and the IMS 18th World Congress on Menopause (26–29 October 2022).

This activity is jointly provided by USF Health and touchIME. read more

Target Audience

This activity has been designed to meet the educational needs of gynaecologists, primary care physicians and endocrinologists involved in the management of menopause.

Disclosures

USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

Faculty

Prof. Steven Goldstein discloses Advisory board or panel fees from Myovant Sciences and SCYNEXIS (relationships terminated). Consultancy fees from CooperSurgical (relationship terminated) and Cook Medical. Other financial or material support from GE Ultrasound.

Dr Samuel Lederman discloses Grants/research support from Aspira, Astellas Pharma, GSK, INOVIO Pharmaceuticals, Janssen Pharmaceuticals, Moderna, Mylan, Myovant Sciences, Parexel, Sebela Pharmaceuticals and Spruce Biosciences. Salary or contractual services from InMode. Speaker’s bureau fees from AbbVie and Mycovia Pharmaceuticals. Stock/shareholder (self-managed) fees from LabConnect.

Dr JoAnn Pinkerton discloses Grants/research support from Bayer.

Content reviewer

Karen Bruder, MD has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Director

Katrina Lester has no financial interests/relationships or affiliations in relation to this activity.

USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

If you have questions regarding credit please contact cpdsupport@usf.edu.

Accreditations

Physicians

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

USF Health designates this enduring material for a maximum of 1.0 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 CreditTM into European CME credit (ECMEC) should contact the UEMS (www.uems.eu).

Advanced Practice Providers

Physician Assistants may claim a maximum of 1.0 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

Date of original release: 12 December 2022. Date credits expire: 12 December 2023.

If you have any questions regarding credit please contact cpdsupport@usf.edu.

Learning Objectives

After watching this activity, participants should be better able to:

  • Describe the benefits and risks of hormone therapy for vasomotor symptoms associated with menopause
  • Outline the rationale for non-hormonal therapy and mechanisms of action of emerging options for the treatment of vasomotor symptoms associated
    with menopause
  • Recall the latest data for emerging non-hormonal therapies for the treatment of vasomotor symptoms associated with menopause
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This Activity Is Funded By:

An independent medical education grant from Astellas.
This activity is jointly provided by USF Health and touchIME.

The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

This content is intended for healthcare professionals.

Date of original release: 12 December 2022. Date credits expire: 12 December 2023.

This content is intended for healthcare professionals only. Please confirm that you are a healthcare professional.

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Question 1/4
Your patient is a 55-year-old, non-hysterectomized woman experiencing menopause whose last menstrual period was 24 months ago. She is experiencing frequent severe hot flashes and sleep disturbance. Whilst discussing treatment options, your patient expresses a preference for a more natural HT. Based on data presented at the IMS 18th World Congress on Menopause and the 2022 NAMS Annual Meeting, what treatment do you recommend?

CEE, conjugated equine estrogen; E2, 17β‐estradiol; E4, estetrol; HT, hormone therapy;
IMS, International Menopause Society; MPA, medroxyprogesterone acetate; NAMS, North American Menopause Society; P4, progesterone.
 Correct

E2 and micronised P4 are bioidentical to natural estrogen and progesterone, respectively.1,2 MPA is synthetically modified.1,2 A progestogen should be given alongside estrogen for patients with a uterus.1 A retrospective, real-world analysis of US claims data, reported at the congresses, showed that E2/P4 was associated with a 30% lower risk of VTE vs CEE/MPA (HR: 0.70, p<0.05) in women aged ≥40 years with no prior VTE (N=36,061); however, further research is required to confirm these findings.2,3 E4 is approved as a contraceptive4 and is an emerging treatment for VMS.

Abbreviations

CEE, conjugated equine estrogen; E2, 17β‐estradiol; E4, estetrol; HR, hazard ratio; MPA, medroxyprogesterone acetate; P4, progesterone; VMS, vasomotor symptoms; VTE, venous thromboembolism.

References

  1. The 2022 Hormone Therapy Position Statement of The North American Menopause Society Advisory Panel. Menopause. 2022;29:767–94.
  2. Panay N, et al. Presented at: The IMS 18th World Congress of Menopause, Lisbon, Portugal.
    26–29 October 2022.
  3. Archer DF, et al. Presented at: The 2022 NAMS Annual Meeting, Atlanta, GA, USA. 12–15 October 2022. Abstr S-10.
  4. FDA. Estetrol PI. Available at: http://bit.ly/3Eqzk4N (accessed 21 November 2022).
Question 2/4
Your 50-year-old patient had her last menstrual period 14 months ago and has been experiencing severe VMS for the past 6 months. She has been reluctant to seek treatment with HT due to concerns about the risk of blood clots and breast cancer, despite having no personal or family history of these conditions. Based on the 2022 HT Position Statement of The NAMS, how would you advise her?

HT, hormone therapy; NAMS, North American Menopause Society; VMS, vasomotor symptoms.
 Correct

According to the 2022 HT Position Statement of The NAMS, HT is the most effective treatment for VMS.1,2 For women aged <60 years or within 10 years of menopause onset, the benefit–risk ratio of HT is favourable.1,2 Overall, the increased absolute risks for VTE and breast cancer associated with HT vs placebo are low (<10 events/10,000 women/year).1

Abbreviations

HT, hormone therapy; NAMS, North American Menopause Society; VMS, vasomotor symptoms;
VTE, venous thromboembolism.

References

  1. The 2022 Hormone Therapy Position Statement of The North American Menopause Society Advisory Panel. Menopause. 2022;29:767–94.
  2. Faubion S. Presented at: The 2022 NAMS Annual Meeting, Atlanta, GA, USA. 12–15 October 2022.
Question 3/4
Based on the pathophysiology of hot flashes associated with menopause, how might you explain the mechanism of action of emerging
non-hormonal KNDy-targeting agents for the treatment of VMS?

KNDy, Kiss, neurokinin B and dynorphin; NKB, neurokinin B; VMS, vasomotor symptoms.
 Correct

KNDy neurons project to the hypothalamic thermoregulatory centre; they are stimulated by NKB and inhibited by estrogens. When levels of estrogen decline due to menopause, uninhibited NKB signalling leads to overstimulation of KNDy neurons and increased stimulation of the thermoregulatory centre. This triggers heat dissipation effectors, thereby causing hot flashes.

Abbreviations

KNDy, Kiss, neurokinin B and dynorphin; NKB, neurokinin B; VMS, vasomotor symptoms.

Reference

Menown SJ, Tello JA. Adv Ther. 2021;38:5025–45.

Question 4/4
What did the results of the phase III SKYLIGHT 4 trial tell us about the safety profile of fezolinetant in women experiencing moderate-to-severe VMS associated with menopause?

VMS, vasomotor symptoms.
 Correct

Data from the SKYLIGHT 4 trial demonstrated that fezolinetant 30 mg (n=210) and 45 mg (n=203) met the primary endpoints for endometrial health (rates of endometrial hyperplasia or malignancy ≤1%). Both fezolinetant doses were well tolerated and rates of treatment-emergent adverse events were similar across all study groups.

Reference

Neal-Perry G, et al. Presented at: The 2022 NAMS Annual Meeting, Atlanta, GA, USA. 12–15 October 2022. Abstr S-11.

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