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GYN
CMECNE

PCOS: Targeting Treatments to Improve Reproductive Outcomes and Reduce CVD

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Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Compare treatment options for menstrual disorders in women who are not trying to conceive and for those who are attempting to become pregnant
2. Relate how to reduce cardiovascular and diabetes risk in women not attempting conception

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Dec 31 2017 through Dec 31 2021, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Read Disclaimer & Fine Print

Polycystic ovary syndrome (PCOS) is poorly understood and is characterized by varying degrees of hyperandrogenism, ovarian dysfunction and polycystic ovaries.  Due to insulin resistance, women with PCOS are at increased risk for metabolic syndrome and consequent diabetes and cardiovascular events.  Unopposed estrogen may result in endometrial cancer. Once identified, women need to be counseled and treated appropriately to reduce their risk of these health problems.

CLINICAL ACTIONS:

Treatment for Menstrual Disorders

Women with PCOS who are not attempting to conceive:

  • Combined oral contraceptives suppress luteinizing hormone secretion, ovarian androgen secretion and increase circulating sex hormone binding globulin (SHBG)
    • Recommended for primary treatment of menstrual disorders
    • May also be used to treat hirsutism
  • Progestin-only contraceptives or progestin containing IUDs protect the endometrium but lead to abnormal bleeding patterns in over 50% of patients
  • Insulin sensitizing agents, including biguanides (metformin) and thiazolidinediones (pioglitazone, rosiglitazone)
    • The use of insulin sensitizers are associated with decrease in androgen levels, improved ovulation, improved glucose tolerance
    • Important to discuss contraception
    • The insulin sensitizing agents are not currently approved by the FDA for the treatment of PCOS
      • Metformin, according to ACOG has the “safest risk-benefit ratio”
      • The International Guideline recommends metformin for those women with metabolic features of glucose intolerance/ insulin resistance

Treatment for Hirsutism

Women with PCOS can be treated with the following:

  • Spironolactone, a diuretic, aldosterone antagonist, androgen receptor antagonist: 25-100 mg twice daily
    • May take up to 6 months to be effective
  • Flutamide, an androgen-receptor antagonist 125-250 mg/day: Teratogenic
  • Finasteride, a 5-alpha-reductase inhibitor, 1-5 mg/day: Teratogenic
  • Topical eflornithine, an inhibitor of ornithine decarboxylase, twice daily application for facial hair
  • Mechanical hair removal (electrolysis, laser vaporization, shaving, plucking, waxing, depilatory creams)

Treatment to Reduce Cardiovascular and Diabetes Risks

Women with PCOS who are not attempting to conceive:

  • Lifestyle modification (e.g. regular exercise and weight loss)
    • Weight loss is the primary therapy in PCOS: As little as 5% reduction in weight can restore regular menses and improve response to fertility medications
  • Insulin sensitizing agents such as metformin can delay development of diabetes in those at risk
    • Data currently insufficient to recommend insulin-sensitizing agents prophylactically for women at higher risk of diabetes due to PCOS
  • Statins lower testosterone, total and LDL cholesterol levels but do not improve menses, hirsutism or acne
  • No evidence that combined hormonal contraceptives or progestins will increase the risk of diabetes or CVD in women with PCOS

Treatment for Women with PCOS Planning to Conceive

First-Line Interventions

  • Letrozole
    • Letrozole (aromatase inhibitor) is considered a first-line treatment due to data demonstrating increased ovulation rates, clinical pregnancy rates and live-birth rate vs clomiphene citrate
    • Counsel patients that letrozole is not approved by the FDA for ovulation induction
    • Letrozole starting dose is 2.5 mg/day for 5 days starting day 3, 4 or 5 of cycle and increase to 5 mg/day for 5 days with a maximum dosage of 7.5 mg/day if ovulation does not occur at lower, initial dose
  • Clomiphene Citrate
    • ‘Traditional’ first-line treatment with improved performance compared to metformin alone or placebo
    • Over 50% of those who conceive do so on 50 mg/day dose and 20% on 100 mg/day dose
    • Most pregnancies occur within 6 months

Second-Line Interventions

  • If clomiphene citrate or letrozole fails
    • Gonadotropins
    • Laparoscopy with ovarian drilling

Third-Line Intervention 

  • The International Guideline considers IVF to be a third line intervention for PCOS

Diabetes Assessment

Screening for Diabetes

  • Assess glycemic status at baseline in all women at time of PCOS diagnosis and repeat every 1 to 3 years depending on other risk factors
  • To assess glycemic status, use one of the following tests
    •  Oral glucose tolerance test (OGTT)
    • Fasting plasma glucose
    • HbA1c
  • OGTT is recommended in women with PCOS and risk factors
    • BMI > 25 kg/m2
    • Asians > 23 kg/m2
    • History of impaired fasting glucose
    • Impaired glucose tolerance or gestational diabetes
    • Family history of diabetes mellitus type 2
    • Hypertension
    • High-risk ethnicity

Women considering fertility treatment or preconception planning 

  • Prior to fertility treatment and/or preconception planning
    • Offer all women a 75-g OGTT
  • In pregnancy
    • If not performed preconception, offer OGTT<20 weeks
    • Offer all pregnant women with PCOS an OGTT at 24-28 weeks gestation

SYNOPSIS:

Once diagnosed, treatment of PCOS should be tailored to patient’s risk factors and desires.  Lifestyle modifications including weight reduction and regular exercise have been shown to decrease the metabolic and hormonal effects of PCOS. Treatment regimens are based on protecting the endometrium from the effects of unopposed estrogen, reestablishing a regular menstrual cycle, preventing the metabolic syndrome and cardiovascular sequelae of PCOS, and providing support for ovulatory dysfunction in those anticipating pregnancy.

KEY POINTS:

  • ACOG Practice Bulletin updated based on recent data that letrozole outperforms clomiphene citrate for ovulation induction
    • Higher live-birth rate: 27.5% vs 10.1% (P=0.007) with odds ratio of 1.64 (95% CI, 1.32-2.04)
    • Higher ovulation rate: 61.7% vs 48.3% (P<0.001)
    • Higher clinical pregnancy rate: Odds ratio of 1.40 (95% CI, 1.18-1.65)
  • Before starting medical/surgical ovulation induction therapies, counsel about lifestyle modification including
    • Stop smoking
    • Reduce weight and increase exercise especially in setting of overweight/obesity
    • Reduce alcohol consumption
  • Neither letrozole or clomiphene citrate are contraindicated in pregnancy

Learn More – Primary Sources:

ACOG Practice Bulletin No. 194: Polycystic ovary syndrome

Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome

EJE: MANAGEMENT OF ENDOCRINE DISEASE: Morbidity in polycystic ovary syndrome

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ANDROGEN EXCESS AND PCOS SOCIETY DISEASE STATE CLINICAL REVIEW: GUIDE TO THE BEST PRACTICES IN THE EVALUATION AND TREATMENT OF POLYCYSTIC OVARY SYNDROME–PART 1

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ANDROGEN EXCESS AND PCOS SOCIETY DISEASE STATE CLINICAL REVIEW: GUIDE TO THE BEST PRACTICES IN THE EVALUATION AND TREATMENT OF POLYCYSTIC OVARY SYNDROME – PART 2

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OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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