Disclosures. Objec7ves 9/9/15. What Exactly are bio- iden7cal hormones and what should I tell my pa7ents? Christy Blanco, DNP, RN, WHNP- BC.

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1 What Exactly are bio- iden7cal hormones and what should I tell my pa7ents? Christy Blanco, DNP, RN, WHNP- BC Disclosures None Objec7ves Discuss terminology of bio- iden7cal, synthe7c and natural hormones. Iden7fy the risks and benefits of hormone replacement therapy and the latest evidence about treatment of menopausal symptoms. What should you tell your pa7ents about bio- iden7cal hormones. 1

2 Menopause Cessa7on of menses for one year Average age 51 Due to cessa7on of ovarian func7on and diminished levels of estrogen 6,000 women reach menopause daily 10- year anniversary of the first report from the WHI History of HRT 1970 s- recogni7on estrogen increased uterine cancer, added proges7n to obviate risk Popularity of growing evidence might prevent coronary artery disease Animal studies suggested estrogen slowed rates of atherogenesis Epidemiologic studies found decrease risk CHD History (Con t) 1990 s CEE + MPA most widely used combina7on HT for women in the U.S. No full- scale trial with CHD as outcomes had been done HERS started early 1990s WHI started 1990 s 2

3 Before WHI A Clinical Trial of Estrogen- Replacement Therapy a]er Ischemic Stroke New England Journal of Medicine, 2001 Women s Estrogen for Stroke Trial RCT, 90 days a]er stroke or TIA Mean age 71 Background July 2002: Women s Health Ini7a7ve suspended the estrogen- proges7n trial Feb 2004: Women s Health Ini7a7ve with estrogen- only trial ended early Recommenda7ons The North American Menopause Society 2012 posi7on statement on hormone therapy. Individualiza7on is key in decision to use HT and should incorporate a woman s health and quality of life priori7es as well as her personal risk factors, such as risk of venous thrombosis, CHD, stroke, and breast cancer risk. 3

4 NAMS Recommenda7ons (con t) Recommenda7on for dura7on of therapy differs for EPT and ET. For EPT, dura7on is limited by the increased risk of breast cancer and breast cancer mortality associated with 3 to 5 years of use; for ET, a more favorable benefit- risk profile was observed during a mean of 7 years of use and 4 years of follow- up, a finding that allows more flexibility in dura7on of use. NAMS Recommenda7ons (con t) ET is the most effec7ve treatment of symptoms of vulvar and vaginal atrophy; low- doses, local vaginal ET is advised when only vaginal symptoms are present. Women with premature or early menopause who are otherwise appropriate candidates for HT can use HT at least un7l the median age of natural menopause (age 51). Longer dura7on of treatment can be considered if needed for symptom management. NAMS Recommenda7on (Con t) Although ET did not increase breast cancer risk in the WHI, there is a lack of safety data suppor7ng the use of ET in breast cancer survivors, and one RCT reported a higher increase in breast cancer recurrence rates. Both transdermal and low- dose oral estrogen have been associated with lower risks of VTE and stroke than standard doses of oral estrogen, but RCT evidence is not yet available. 4

5 WHI Women years Average age 63.6 years With uterus: mg conjugated equine estrogen mg medroxyprogesterone acetate Without uterus: mg conjugated equine estrogen WHI CHD Increase 8/10,000 year EPT Decrease 3/10,000 year ET VTE Increase 18/10,000 year EPT Increase 7/10,000 year ET Stroke Increase 8/10,000 year EPT Increase 11/10,000 year ET WHI CHD by Age- Estrogen only 5

6 Studies Problems with WHI Only one dose One form of route Different 7ming Same risk factor if you suffer from vasomotor symptoms Timing of HRT Kronos Early Estrogen Preven7on Study (KEEPS) RCT, 4 year, double blinded, placebo- controlled, low- dose oral, or transdermal estrogen and cyclic monthly progesterone Healthy women 42 to 59 (mean age of 52) Within 3 years a]er menopause 727 par7cipants, randomized to 3 groups KEEPS Trial One group 0.45 mg/ day of Premarin (conjugated equine estrogen) Second group 50 mcg of transdermal estradiol, Climara patch Third group placebo 200 mg of micronized progesterone (Prometrium) for 12 days each month 6

7 KEEPS Trial (con t) Trial did not include women with evidence of CVD Coronary artery calcium score of 50 or higher Level of plasma cholesterol or triglycerides that would normally be treated with lipid- lowering drugs Severe obesity Heavy smoking habit KEEPS Trial (Con t) Small numbers, there was a trend toward less progression of CAC in the two HT groups Neither HT significantly affected systolic or diastolic blood pressure Oral HT was associated with increase in HDL cholesterol and decrease in LDL, increased triglyceride Transdermal route improved glucose levels and insulin sensi7vity, with neutral effects on biomarkers KEEPS Trial (Con t) No sta7s7cally significant differences in rates of breast cancer, endometrial cancer, myocardial infarc7on, TIA, stroke, or venous thromboembolic disease between three groups. 7

8 Route of Administra7on Transdermal vs. oral Found many studies, no RCTs Renoux et al (2010), case control study n=59,958 Bypass hepa7c- first pass metabolism estrone Ac7vates the coagula7on cascade, increasing thrombo7c risk Cochrane Review, 2010 Cochrane review 23 studies 41,830 women 70% data from WHI, HERS 1998 Review of Literature EPT Increased risk of coronary event a]er one year 4 per 1000 Venous thrombo- embolism a]er one year 7 per 1000 Stroke a]er 3 years 18 per 1000 ET Increased risk of venous thrombo- embolism 1-2 years of use (5 per 1000) Stroke a]er 7 years (32 per 1000) 8

9 Why Worry Let s tell all women NO to hormones! They are bad They cause cancer Symptoms of Menopause Hot flashes Night sweats Vaginal dryness Anxiety Mood swings Irritability Insomnia Depression Symptoms of Menopause (con t) Loss of sexual interest Hair growth on face Painful intercourse Panic anacks Weird dreams Urinary tract infec7ons Vaginal itching Bloa7ng 9

10 Symptoms of Menopause (con t) Flatulence Indiges7on Osteoporosis Aching ankles, knees, wrists, shoulders, heels Hair loss Frequent urina7on Sore breasts Symptoms of Menopause (con t) Palpita7ons Varicose veins Urinary leakage Dizzy spells Skin feeling crawly Migraine headaches Memory lapses Weight gain Estrogens Estrogen has 400 func7ons in the body E1 called estrone E2 called estradiol E3 called estriol 10

11 Estrone (E1) Predominant estrogen in menopause Weakest of all estrogens Secreted from ovary and adipose 7ssue Estradiol (E2) 10 7mes more potent than E1 and 80 7mes more potent than estriol Predominate estrogen during reproduc7ve years Estriol (E3) 80 7mes weaker than E2, so lesser s7mulatory effect Does not have the bone, heart, or brain protec7on of estradiol Primary estrogen during pregnancy The controversy of bio- iden7cal hormone replacement therapy 11

12 Bioiden7cal What does this mean? Acts in body just like hormones we produce May be natural, but not bio- iden7cal Bio- iden7cal estradiol can be monitored and treatment individualized Synthe7c & Natural Synthe7c hormones: Not created structurally the same as human hormones Natural hormones: Not defined by FDA, however considered not ar7ficial or synthe7c (including all color addi7ves regardless of source). Estrogens Conjugated equine estrogens (CEE), Premarin Pregnant mares urine Mixture of sodium estrone sulfate and sodium equilin sulfate Sodium sulfate conjugates 17a- dihydroequilin 17a- estradiol 17B- dihydroequilin 12

13 Estrogens Synthe7c conjugated estrogens Plant based Cenes7n, Enjuivia Pills Estrogens Esterified estrogens Pregnant mare s urine Menest Pill Estrogens 17- beta- estradiol Plant based Alora, climara, esclim, estraderm, vivelle (patches) Estrogel (transdermal gel), estrasorb (topical cream), estrace (vaginal cream), estring (vaginal ring) All are bio- iden7cal 13

14 Estropipate/Plant Modified estrone Ortho- Est, Ogen (pills) Ogen (cream) Estradiol Acetate Femring Vaginal ring Bio- iden7cal Estradiol Hemihydrate Vagifem Vaginal tablet Bio- iden7cal 14

15 Ethinyl Estradiol Es7nyl Pill Progesterones Low progesterone symptoms Anxiety Depression Irritability mood swings Insomnia Decreased libido Nervousness Excessive menstrua7on Medroxyprogesterone Acetate Amen, Cycrin, Provera Pill 15

16 Micronized Progesterone Prometrium (pill) Prochieve 4% (vaginal gel) Plant- based Bio- iden7cal Norgestrel Ovrene Pill Norethindrone Micronor, Nor- QD Pill 16

17 Norethindrone Acetate Ayges7n Pill What to tell the pa7ents? Let them know what you know and let them make their own decisions It does not cause breast cancer MenoPro, free app from NAMS Ques7ons? 17

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