Exte Extendin ing Use of Use of Horm Hormone Thera Therapy - PDF document

9/29/2016 Nams.translational HT 65 plus 9 9 16c Andrew M. Kaunitz: Disclosures Exte Extendin ing Use of Use of Horm Hormone Thera Therapy Beyond Age 65—Who & Beyond Age 65—Who & When? When? ● Clinical trial funding to University of Florida – Bayer, TherapeuticsMD ● Advisory Boards (contraception) NAMS 3 rd Utian Translational Symposium – Allergan, Bayer, Medicines360, Merck, Pfizer Andrew M. Kaunitz MD, FACOG, NCMP ● Consultant (GSM): Shionogi University of Florida Research Foundation Professor and Associate Chairman ● Royalties Department of Obstetrics and Gynecology University of Florida College of Medicine ‐ Jacksonville – UpToDate (contraception, abnormal uterine bleeding) Director, Menopause & GYN Ultrasound Services UF Southside Women’s Health Specialists Case: 80 ‐ year old health care Extended Use of HT: Overview and Objectives provider in good health, BMI 21 ● Because no RCT data available, providing • Presented for menopausal management guidance to patients regarding use of HT • Hysterectomy for benign indications 15 years earlier among women age >65 is controversial • In recent years, had been feeling well on oral estradiol 0.5 mg – However, clinicians commonly encounter this • Her former gynecologist, however, discontinued this issue in practice medication, and would not discuss alternative ● Objective: Provide guidance to clinicians treatments regarding extended duration HT use, based • Off estradiol, frequent and bothersome vasomotor on available evidence as well as personal symptoms reccurred… clinical experience 1

9/29/2016 Relevant Issues to Be Reviewed… How Long do VMS Persist? (I) ● Duration of VMS ● Penn Ovarian Aging study, population ‐ based ● EPT and breast cancer prospective cohort designed to assess ● Oral vs. transdermal estrogen therapy duration of VMS: – Median duration of bothersome VMS: 10.2 years ● HT and prevention of osteoporosis – Symptoms beginning during perimenopausal ● Beers list and insurance coverage of HT transition: > 11.25 years ● NAMS 2016 Position Statement Freeman EW, et al. Obstet Gynecol 2011 . How Long do VMS Persist? (II) How Long do VMS Persist? (III) ● A population ‐ based survey of 85 ‐ year old Swedish women ● Prospective cohort study of women with – 16% of respondents experienced VMS osteoporosis: – 10% of respondents were ‘very to moderately distressed’ by – Mean age 67 years; mean years since menopause 19 their VMS – 11.8% of women reported ‘clinically significant’ hot flushes at baseline; more than half of these Persistent bothersome VMS not unusual in • symptomatic women continued to report women > 65 years of age In many women, short ‐ term HT will not be bothersome symptoms 3 years subsequently • sufficient to control VMS Huang AJ, et al. Arch Intern Med 2008. Vikström J, et al. Climacteric 2013 2

9/29/2016 Counselling EPT Users regarding Breast Oral vs. Transdermal ET (TDE2) Cancer Risks ● Extended use of EPT increases breast cancer ● Although no RCT data, CVD safety profile of risk HT with TDE2 (particularly 0.05 mg or lower – Benefit: risk profile for extended use EPT less dose) appears more favorable than oral HT ● 7 observational studies : lower risk VTE w/TDE2 favorable than for ET – Clinicians should periodically review benefit: – One observational study: lower risk CVA risk profile of HT with users TDE2 particularly advisable if baseline CVD risk elevated: – Older age, obesity, hypertension, metabolic syndrome, smoking NAMS 2016 AM Kaunitz. Menopause June 2014. AM Kaunitz. Menopause June 2014. A Bergendal et al.; JA Simon et al. Menopause 2016 Standard dose ET prevents Lower dose ET also prevents osteoporosis osteoporosis – Weekly ultra ‐ low 0.014 mg patch (TDET): serum E2 levels remain in menopausal range; – Most estrogen formulations/doses – BMD maintained/enhanced in two year trial of approved for prevention of osteoporosis women (mean age 66; intact uterus) o No data address ultra ‐ low dose E2 patch’s impact on – Standard doses: fracture risk: no data available o Oral estradiol (E2) 1 mg – Proliferative changes more common in E2 group (8.5%) vs. placebo (1.1.%) o Oral conjugated equine estrogen (CEE) 0.625 mg In women using ultra ‐ low dose ET, consider use of o Transdermal (TD) E2 0.05 mg progestogen, or periodic endometrial monitoring NAMS. Menopause 2012. Ettinger B, et al. Obstet Gynecol 2004. NAMS. Menopause 2016. Kaunitz AM. Menopause June 2014. Johnson SR, et al. Obstet Gynecol 2005. Kaunitz AM. Menopause June 2014. 3

9/29/2016 Notice Received From Insurance Company NAMS 2016 HT Position Statement ● “Your patient is at least 65 years old and has evidence for ● “Prevention of bone loss and fracture may be an either an oral or transdermal estrogen containing preparation. indication for extended duration in selected These estrogen containing preparations should be avoided in women after appropriate counseling about risks older women due to the risk of thrombosis and cancer. If and benefits, recognizing rapid bone loss is seen your patient fits this clinical profile, and if not already done, upon discontinuation.” consider reassessment of risks/benefits of continuing estrogen.“ When HT is continued solely for the prevention of osteoporosis, lower than standard doses appropriate American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults: The American Geriatrics Society 2012 Beers Criteria Update Expert Panel 2012 J Am Geriatr Soc 2012; 60 (4): 616 ‐ 631. NAMS. 2016 Kaunitz AM. Menopause June 2014 Use of HT to Treat Menopausal Symptoms: Beers Criteria for Potentially Inappropriate ACOG Guidance Medication Use in Older Adults “ …ACOG recommends against routine discontinuation ● In 1991 the late geriatrician Mark Beers catalogued of systemic estrogen at age 65 years. As with younger medications that “… cause adverse drug events in women, use of HT and estrogen therapy should be older adults due to their pharmacologic properties individualized based on each woman’s risk–benefit and the physiologic changes of aging.” ratio and clinical presentation .” ● List includes systemic estrogens (oral and transdermal) with or without progestins http://www.americangeriatrics.org/files/documents/beers/PrintableBeersPocketCard.pdf ACOG. Practice Bulletin 141. Obstet Gynecol January, 2014. 4

9/29/2016 Back to the case…. NAMS 2016 HT Position Statement ● Patient counselled regarding nonhormonal treatments ● “The Beers Criteria recommendation to routinely discontinue systemic HT after age 65 is not as well as oral and transdermal ET supported by data.” – Elected to start estradiol 0.0375 mg patch ● “Decisions regarding whether or not to continue HT o Called 6 weeks later indicating symptom relief incomplete beyond the age of 60 should be made on an o Now doing well on 0.05 mg patch individual basis, after appropriate evaluation and counseling about potential benefits and risks and – Recent DXA: normal bone mineral density: spine and hip with ongoing surveillance. “ – Patient expressed concern regarding prior clinicians’ Some clinicians include NAMS statement when reluctance to Rx HT; she was enthusiastic regarding, and consented to her history being presented at professional responding to insurance notices denying meetings reimbursement for systemic HT in women age 65+ years NAMS 2016 Conclusion: NAMS 2016 HT Position Statement ● “Decisions about duration of HT require individualization, including consideration of personal preferences, balancing potential ongoing benefits and risks, and decisions to continue HT for preventative and/or quality of life purposes.” Shared decision making helps our patients make sound choices NAMS. 2016. Kaunitz AM. Menopause June 2014. 5