Update in Women s Health Year In Review

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1 Update in Women s Health Year In Review Judith Walsh MD, MPH Professor of Medicine Division of General Internal Medicine And Epidemiology and Biostatistics I have no disclosures Disclosures 1

2 Plan for today Review of the literature for the annual Society of General Internal Medicine Meeting Brigid Dolan, MD, MEd Megan McNamara, MD, MS Bimla Schwarz, MD, MAS Review some of the most significant published advances in the Women s Health medical literature over the past year Top articles Key articles Guidelines Assess the strength and scope of the evidence presented in the selected literature Apply this new information to our clinical practice Take home points Process 16 Journals March 1, 2017 Feb 28, Independent reviewers: ranked 1 4 stars 2

3 Criteria How new/innovative is this information? Strength of the evidence? How will it change my practice? Issues for older women Osteoporosis Issues for Mid Life Women Menopause Female Sexual Function Cancer Screening Breast Cancer Screening Issues for Reproductive Aged Women Endometriosis Bacterial Vaginosis Contraception Topics 3

4 Issues for Older Women: Bone Health Background Practice guidelines recommend calcium and Vitamin D supplementation for fracture prevention in older adults with osteoporosis Meta analyses of association between calcium/vitamin D and fracture risk have been inconclusive Association between calcium/vitamin D supplementation may differ between community dwelling adults and those in institutions 4

5 Case: Bonnie Bony is a 65 year old woman who comes in for an annual exam. Her mother had osteoporosis and she is very concerned about her bone health. You order a DEXA. As you are about to leave the room, she asks what you think about calcium and Vitamin D. She wants to know if she should take supplements and if so, how much. What do you tell her? The News Association between calcium or Vitamin D supplementation and fracture incidence in community dwelling older adults: a systematic review and meta analysis. JG Zhao et al. JAMA 2017 Objective: To evaluate whether calcium and or Vitamin D supplements are associated with a lower fracture incidence in community dwelling older adults 5

6 Methods Meta analysis of RCTS comparing calcium, Vitamin D or both with placebo Enrolling community dwelling men and women age 50 and over Fracture outcomes Primary outcome: Hip fracture Secondary outcomes: Nonvertebral, vertebral and total fracture All studies evaluated using Risk of bias criteria Risk ratios, risk differences and CIs calculated using random effects model Subgroup analyses based on dose and frequency of administration Results 33 trials including 51,145 participants met criteria No association of calcium or Vitamin D with hip fracture Calcium: RR 1.53 (95% C.I ) Vitamin D: RR 1.21 (95% C.I ) No association of COMBINED calcium/vitamin D with hip fracture Ca/Vit D: RR 1.09 (95% C.I ) No association calcium, Vitamin D or both with nonvertebral, vertebral or total fracture Subgroup analyses showed similar results regardless of dose, sex, fracture history, dietary calcium intake and baseline 25 OH Vitamin D concentration 6

7 Conclusion In meta analysis of randomized controlled trials, use of supplements that included calcium, Vitamin D or both was not associated with a reduction in fracture risk in community dwelling men and women Trials did not select for osteoporosis risk Serum 25 OH Vitamin D only measured in some participants Impact for Practice The results of this study do not support routine use of calcium and Vitamin D supplements in community dwelling older adults, but it is possible that some individuals at risk for osteoporosis may still benefit 7

8 Case Bea Brittle is a 70 year old woman with osteoporosis. You prescribed alendronate a couple of years ago, but her grandson, a dentist, told her that she should NEVER take that drug because of the risk of osteonecrosis of the jaw. She wants to know if there are any other treatment options she could consider. What do you recommend? What do you recommend? PTH Abaloparatide Romosozumab Zolendronic Acid Your grandson should stick to dentistry. I recommend alendronate 8

9 Osteoporosis Treatments: Background Several agents, including bisphosphonates have been shown to decrease fracture risk compared with placebo Romosozumab is a monoclonal antibody that binds to and inhibits sclerostin, increases bone formation and decreases bone resportion There are few head to head studies of osteoporosis therapies with fracture endpoints Active Controlled Fracture Study in Postmenopausal Women with Osteoporosis at High Risk (ARCH) The News Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis Sung et al. NEJM 2017 Objective: To compare the effectiveness of a treatment regimen starting with romosozumab and transitioning to alendronate with alendronate treatment alone in reducing the risk of fracture in postmenopausal women with osteoporosis and a previous fracture 9

10 Methods (ARCH) 4093 women with osteoporosis and a fragility fracture randomized to receive monthly subcutaneous romosozumab (200 mg) or weekly oral alendronate (70 mg) for 12 months Stratified by age After RCT, all received open label alendronate until the end of the trial All received calcium and Vitamin D Outcomes Primary: new vertebral fracture at 24 months and cumulative incidence of clinical fracture at time of primary analysis Results (ARCH) Median age of women was 74 Reduction in new vertebral fracture with romosozumab 6.2% vs 11.9% (49% reduction: p<0.001) Reduction in clinical fracture with romosozumab 9.7% vs 13.0% (27% reduction: p<0.001) Reduction in hip fracture 2.0% vs 3.2% (38% reduction: p=0.02) No difference in overall adverse events More serious cardiovascular events during year 1 with romosozumab 2.5% vs 1.9% (NS) 10

11 Limitations Increased risk of cardiovascular events needs further study Very short term follow up (24 months) Long term effects not known Not currently FDA approved Conclusion In postmenopausal women with osteoporosis, romosozumab for one year followed by alendronate resulted in lower fracture risk than alendronate alone 11

12 Impact for Practice In women at high risk for osteoporosis, romosozumab compared with alendronate was associated with a lower fracture risk Increased risk of cardiovascular events needs further evaluation Long term benefits and risks of romosozumab not known To date romosozumab is not FDA approved. Quick Take Romosozumab vs teriparitide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomized open label phase 3 trial Langdahl et al, Lancet randomized to romosozumab vs teriparitide Median BMD increased more in romosozumab group after 12 months 2.6% vs 0.6% Although romosozumab led to greater increases in BMD, fractures were not assessed More studies with fracture endpoints needed Includes women often excluded from other trials 12

13 Quick Take Effecs of teriparatide and risedronate on new fractures in postmenopausal women with severe osteoporosis (VERO) Kendler et al Lancet, 2018 To compare anti fracture efficacy of teriparatide with risedronate in patients with severe osteoporosis 680 patients per group At 24 months, fewer fractures in teriparatide group Vertebral fractures, clinical fractures and non vertebral fractures Risk of new fractures significantly lower in those receiving teriparatide compared with those receiving risedronate New Osteoporosis Treatment Guidelines 13

14 Case After learning about all the new medications, Bea wants to start something for awhile and wants to know when you will check her bone density again. What do you tell her? a. We will check it in a year b. We will check it in two years c. We will check it in five years d. We will not check it while you are on active therapy ACP Guidelines Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update from the American College of Physicians Objective: To provide recommendations on treatment of low bone density and osteoporosis to prevent fractures in men and women Issued in May 2017 (updates the 2008 Guidelines) 14

15 ACP Guidelines Offer treatment with alendronate, risedronate, zolendronic acid or denosumab to reduce risk of hip and vertebral fractures in women with known osteoporosis Strong recommendation, High quality evidence Treat osteoporotic women with pharmacologic therapy for 5 years Weak recommendation, low quality evidence High risk patients may benefit from more than 5 years of treatment ACP Guidelines Offer pharmacologic treatment with bisphosphonates to reduce risk of vertebral fracture to men with clinically recognized osteoporosis Weak recommendation, low quality evidence No bone density monitoring in women during the 5 year treatment period Weak recommendation, low quality evidence 15

16 ACP Guidelines Recommends against using estrogen, estrogen/progestin or raloxifene for osteoporosis treatment in women Strong recommendation, moderate quality evidence Decisions about treating osteopenic women age 65 and older who are at high fracture risk should include patient preferences, fracture risk profile and benefits, harms and costs of medications Weak recommendation, low quality evidence Conclusions Although current evidence does not support routine use of calcium and Vitamin D supplements in community dwelling older adults, it is possible that some individuals at risk for osteoporosis may benefit New treatment options on the horizon, are not yet FDA approved and follow up has been short New Treatment Guidelines emphasize starting with bisphosphonate and not monitoring bone density during therapy 16

17 What do you recommend? PTH Abaloparatide Romosozumab Zolendronic Acid Your grandson should stick to dentistry. I recommend alendronate Let s ask the dog.. 17

18 Menopause 18

19 Minnie Pause is a 54 year old healthy woman whose LMP was 1.5 years ago. She has been struggling with hot flashes for two years. Her sister told her hormones can kill you! but she read that menopausal hormones are good. Minnie asks what she should do. You reply: a. Estrogen + Progestin increases cardiovascular mortality but estrogen does not. b. Estrogen + Progestin increases breast cancer mortality but estrogen does not. c. Estrogen + Progestin increases all cause mortality but estrogen does not. d. Estrogen ± Progestin does not increase mortality. Background Menopausal hormone therapy (MHT) remains the mainstay of treatment for women with bothersome vasomotor symptoms. While a number of outcomes had been previously reported from trials of MHT, longterm mortality associated with E+P or E alone treatment was unknown 19

20 The News Menopausal Hormone Therapy and Long term All Cause and Cause Specific Mortality: The Women s Health Initiative Randomized Trials. Manson et al, JAMA 2017 WHI Methods: Estrogen + Progestin vs Placebo 16,608 women with a uterus Randomized to 0.625mg conjugated equine estrogen + 2.5mg medroxyprogesterone acetate vs. placebo On therapy for a median 5.6 years before trial stopped July 2002 Estrogen only vs Placebo 10,739 women s/p hysterectomy Randomized to 0.625mg conjugated equine estrogen alone vs. placebo On therapy for a median 7.2 years before trial stopped February 2004 Outcome: All cause and cause specific mortality over three time periods: cumulative 18 year follow up, mortality during intervention phase, and mortality during the post intervention phase. Included all deaths reported as of 12/31/2014. Manson JE et al. JAMA. 2017;381(10):

21 Results: All Cause Mortality No differences in all cause mortality during cumulative 18 year follow up: Estrogen + Progestin 26.4% vs placebo 26.0% (HR 1.02, 95% CI ) Estrogen alone 28.3% vs placebo 30.0% (HR 0.94, 95% CI ) Pooled MHT 27.1% vs placebo 27.6% (HR 0.99, 95% CI ) No difference in all cause mortality during intervention or post intervention phases Manson JE et al. JAMA. 2017;381(10): Results: Cause Specific Mortality 18 year cumulative follow up Manson JE et al. JAMA. 2017;381(10):

22 Results: Breast Cancer Mortality 18 year cumulative follow up Manson JE et al. JAMA. 2017;381(10): MHT and Mortality: Take Home Points At 18 years of follow up, there is no difference in all cause OR cause specific mortality between women who took MHT and those who did not. Cancer mortality: no difference CVD: no difference. Women can be reassured that treating vasomotor symptoms of menopause with MHT is a safe option for those without contraindications. 22

23 Minnie Pause is a 54 year old healthy woman whose LMP was 1.5 years ago. She has been struggling with hot flashes for two years. Her sister told her hormones can kill you! Minnie asks what she should do. You reply: a. Estrogen + Progestin increases cardiovascular mortality but estrogen does not. b. Estrogen + Progestin increases breast cancer mortality but estrogen does not. c. Estrogen + Progestin increases all cause mortality but estrogen does not. d. Estrogen ± Progestin does not increase mortality. Minnie is reassured by this evidence and decides that she would like to start menopausal hormone therapy with estrogen + progesterone and asks if there s a difference in the different methods she s read about. You reply: a. It doesn t matter they have equivalent effects. b. Transdermal therapy may be more effective & have less cardiovascular risk. c. Oral therapy is more effective but has increased cardiovascular risk. d. Compounded or bioidentical hormones are the safest and best option. 23

24 The News Vasomotor symptoms resulting from natural menopause: a systematic review and network meta analysis of treatment effects from the National Institute for Health and Care Excellence guideline on menopause. Sarri et al, BJOG 2017 The 2017 hormone therapy position statement of The North American Menopause Society NAMS, Menopause 2017 National Institute for Health and Care Excellence Guideline Question: Which treatments are most clinically effective for the relief of vasomotor symptoms for women in natural menopause with an intact uterus? Population: 8326 women, age > 45, with a dx of natural menopause Intervention: 16 different treatment classes, including TD/oral E+P, tibolone, bioidenticals, raloxifene, SSRI/SNRIs, gabapentin, clonidine, isoflavones, herbals, relaxation, acupuncture, sham acupuncture, and multibotanicals. Comparison: Placebo Network meta analysis modeling then allowed comparisons between classes Outcomes: short term (no >26 weeks) outcomes considered only Efficacy: relief of hot flashes Adverse event outcomes: discontinuation of therapy and vaginal bleeding Type: Network meta analysis of 47 RCTs Sarri G et al. BJOG 2017; 124:

25 NICE guideline: Efficacy outcome Vasomotor Symptom Improvement: 12 treatment classes, included trials with 4165 women. Both transdermal estrogen + progesterone (MR 0.23, 95% CI ) and oral estrogen + progesterone (MR 0.52, 95% CI ) outperformed placebo Isoflavones and black cohosh were also better than placebo. In the network meta analysis, transdermal estrogen + progesterone outperformed the other treatments. Sarri G et al. BJOG 2017; 124: NICE Guideline: Adverse Event Outcomes Discontinuation 10 treatment classes, included trials with 4829 women. Transdermal estrogen + progesterone had the least discontinuation. Estrogen + bazedoxifene was also discontinued less than placebo SSRIs and SNRIs had the highest rate of discontinuation. Vaginal Bleeding: 5 treatment classes with 1367 women Inconclusive evidence Sarri G et al. BJOG 2017; 124:

26 NICE Guideline: Conclusions and Limitations Their conclusions: Both transdermal E+P and oral E+P have good efficacy and low discontinuation Transdermal E+P demonstrated the highest rating in the network meta analysis SSRIs and SNRIs have high discontinuation rates and efficacy not optimal Study limitations: Heterogeneity among doses, so all agents treated as class effect including SSRI/SNRI/gabapentin where prior data shows dose effect Limited number of studies reported all outcomes. Study only included women with a uterus and without a history of breast cancer. Sarri G et al. BJOG 2017; 124: Quick Take: NAMS 2017 Position Statement Vasomotor Symptoms Use MHT for women with symptomatic VMS at age <60 or within the first 10 years of menopause The lowest doses may take 6 8 weeks for symptoms to improve. Non oral routes of systemic therapy may have improved CV safety, but large, long term RCTs are lacking. Genitourinary Symptoms: Consider the local estrogen therapy (ET) when non hormonal therapies fail Discuss ET with treating oncologists before prescribing to women who take aromatase inhibitors; systemic absorption with low dose topical ET is higher than the levels that are typically present with AI use. 26

27 Minnie is reassured by this evidence and decides that she would like to start menopausal hormone therapy with estrogen + progesterone and asks if there s a difference in the different types she s read about. You reply: a. It doesn t matter all hormones seem to be the same. b. Transdermal E + oral P may be more effective & have less cardiovascular risk. c. Oral E+P may be more effective but has increased cardiovascular risk d. Compounded or bioidentical hormones are the safest and best option. Quick take: USPSTF Update: MHT for Chronic Disease Prevention? Question: Do benefits outweigh risks for use of MHT in chronic disease prevention? Systematic review of 18 RCTS reporting a number of health outcomes: cancer, CHD, dementia, diabetes, fractures, gallbladder disease, stroke, urinary incontinence, VTE, and all cause mortality Divided into Estrogen + progesterone or Estrogen alone Results: The risks of systemic MHT continue to prevent its use for primary prevention of diabetes, colorectal cancer, or other diseases in the absence of VMS. Gartlehner G et al JAMA 2017;318(22):

28 As you leave the office, your patient asks Oh, Doc, one more question is there anything I can take to help with libido? My husband said there s some drug known as female viagra that I could take. You cringe that your ROS did not include sexual function and say a. On second thought, let s go back to our discussion of MHT b. Testosterone is safe and effective in post menopausal women c. Flibanserin is the best option for post menopausal women d. There s no downside in trying sildenafil. Background Low estrogen levels can lead to vaginal dryness and dyspareunia in post menopausal women Estradiol modulates serotonergic function which may also lead to reduced sexual desire. Nearly a quarter of naturally menopausal women are distressed by their low sexual desire. Effective treatments are lacking Taylor et al JAMA Intern Med. 2017;177(10):

29 The News Effects of Oral vs Transdermal Estrogen Therapy on Sexual Function in Early Postmenopause Ancillary Study of the Kronos Early Estrogen Prevention Study (KEEPS) Taylor et al. JAMA Internal Medicine Question: What are the effects of transdermal or oral estrogen therapy on sexual function in recently postmenopausal women over time? Taylor et al JAMA Intern Med. 2017;177(10): KEEPS sexual function: Methods Population: 670 women, y/o, 6 36 months from LMP, no CV disease/dm/smoking. Baseline FSFI score of Intervention: either ORAL conjugated equine estrogen 0.45mg/day + oral micronized progesterone 200mcg on 12 of 28 days OR TRANSDERMAL 17b estradiol 50 mcg/day + oral micronized progesterone 200mcg on 12 of 28 days Comparison: Placebo pills and patches Outcomes: Female sexual function inventory (FSFI) and sex hormone binding globulin (SHBG) levels at baseline, 18, 36, and 48 months Type: RCT in 4:4:5 ratio Female sexual function inventory (FSFI) Domain Score Range Desire 0 5 Arousal 0 5 Lubrication 0 5 Orgasm 0 5 Satisfaction 0 5 Pain 0 5 Overall Score 0 36 Taylor et al JAMA Intern Med. 2017;177(10):

30 KEEPS sexual function: Results Small improvements in FSFI at 48 months with Transdermal MHT +2.6 (CI , p=0.002) Initial improvements in FSFI with oral MHT did not persist at 48 months At 48 months, pain and lubrication domains remained significant with transdermal MHT The impact was mostly in women with low baseline FSFI. JAMA Intern Med. 2017;177(10): doi: /jamainternmed Date of download: 3/20/2018 KEEPS sexual function: Limitations & Take Home Limitations: Did not measure patient s distress, so not a true trial of sexual dysfunction Did not use outcome measures that have been used in other trials, difficult to compare to other agents. Population was relatively homogenous mostly college educated, white, and income >$60K Take Home: Treatments for women experiencing sexual dysfunction are limited For early postmenopausal women with baseline low sexual function, transdermal MHT could be considered for healthy women without CV risk factors particularly if they experience VMS. Taylor et al JAMA Intern Med. 2017;177(10):

31 Quick take! Efficacy of Vaginal Estradiol or Vaginal Moisturizer vs. Placebo for Treating Postmenopausal Vulvovaginal Symptoms. A Randomized Controlled Trial. JAMA Internal Medicine post menopausal women (aged 61) with symptoms of pain with vaginal penetration or vulvovaginal dryness were randomized to vaginal 10mcg estradiol tablet + placebo vs. placebo + vaginal moisturizer vs. double placebo. All groups had similar reductions in symptoms over 12 weeks. There was no significant difference between the groups in female sexual function. Breast Cancer Screening To screen or not to screen? That is the question. 31

32 Case Ms. Bea Screen is a 48 year old female with a medical history significant for anxiety and depression who presents for routine primary care. She wants to know if she needs a mammogram this year. She had her first mammogram last year, and found it to be an uncomfortable experience. She was called back for additional images, and although the final mammography report was normal she had an increase in her anxiety for weeks. What do you tell her? New evidence Effectiveness of and overdiagnosis from mammography screening in the Netherlands: population based study. BMJ 2017; 359; j5224. Intervention: Dutch mammography screening program launched in 1988 Women aged were invited to attend biennial mammography screening Questions: 1. What is the estimate of breast cancer overdiagnosis related to this program? 2. How many breast cancer deaths were avoided because of screening? Remember: Overdiagnosis is the number of breast cancers that would have never been detected during a woman s lifetime in the absence of mammography screening. 32

33 Background Study rationale Effective screening should decrease the number of advanced cancers associated with poor prognosis This should be seen independent of treatment A decrease in advanced cancers should lead to a decrease in cancerspecific mortality What was known prior to this study 2004: Dutch National Evaluation Team reported reductions in the incidence of larger tumors with positive lymph nodes or distant metastases as a result of screening among women ages Methods Population: Dutch women from women ages were included since inception of the program in 1997 women aged also started to be invited Intervention/Exposure: biennial mammography digital mammography replaced film in 2006 Comparison: women age less than 50 and women age 75 or more (not invited to screening) Outcomes: stage specific age adjusted incidence of breast cancer from Type of study: population based observational study 33

34 Minimal change in the incidence of stage 2 4 cancers (ie advanced cancers) over time 1989: 168/100,000 Results Trends in age adjusted breast cancer incidence by stage in women aged 50 or more in the Netherlands, 1989 to : 166/100,000 Overdiagnosis: ~ 50% Higher after digital mammography introduced Philippe Autier et al. BMJ 2017;359:bmj.j5224 Trends in age adjusted in situ breast cancer incidence in women by age group in the Netherlands, 1989 to In 1997 women ages were invited to participate in screening In 2007 digital mammography was introduced Philippe Autier et al. BMJ 2017;359:bmj.j by British Medical Journal Publishing Group 34

35 Results Calculations: For 3 fewer stage 2 4 cancers there would be 2 fewer breast cancer deaths Expected increase in breast cancer mortality if mammography had not been introduced = 2% Parameter Decrease in stage 2 4 breast cancers (observed) Decrease in breast cancer mortality due to decreases in stage 2 4 cancers (calculated) Reduction in breast cancer mortality as a result of screening (calculated) Estimate 4% 3% 5% Conclusions Overdiagnosis is common, representing about 50% of in situ and stage I cancers The reduction in breast cancer mortality as a result of screening is 5% What does this mean for my patient? The benefits of screening may be less than previously thought and the possibility for overdiagnosis is significant. 35

36 Issues for Reproductive Aged Women Case 23 year old med student presents for her annual. Has had endometriosis and bacterial vaginosis for years Wonders if there are any new treatments available? Doesn t want to get pregnant until she finishes school, but is worried OC will give her breast cancer What do you tell her? 36

37 Background: Endometriosis Affects 6 10% of women of reproductive age Treatment options include: NSAIDs Hormonal Contraception (except for LNG IUDs) GnRH agonists (leuprolide) Surgery The News Treatment of Endometriosis Associated Pain with Elagolix, an Oral GnRH Antagonist. HS Taylor et al. NEJM double blind phase 3 RCTs with 6 month follow up 150 mg once daily vs 200mg twice daily N=872 randomized; n= 653 (75%) completed N=817 randomized; n=632 (77%) completed 37

38 Results: Elagolix Dysmenorrhea improved at 3 and 6 months By 1 point on a 10 point scale with high dose treatment Nonmenstrual pelvic pain improved at 3 and 6 months By 0.5 points on a 10 point scale Side effects: hot flashes, higher lipids, decreases in BMD FDA priority review since Oct 2017 Background: Bacterial Vaginosis Affects 29% of US women of reproductive age each year Treatment options include: Oral: Metronidazole 500mg po bid for 7 days ($10) Intravaginal: Metronidazole 0.75% gel for 5 days ($34 $80) Clindamycin 2% cream for 7 days ($43) 38

39 The News A phase 3, double blind, placebo controlled study of the effectiveness and safety of single oral doses of secnidazole 2g for the treatment of women with bacterial vaginosis. JR Schwebke et al. AJOG 2017 N=189 from 21 centers, randomized 2:1 vs. placebo Results: Secnidazole Clinical cure per FDA guidance: 64% vs 26% Side effects: 20% vs 11% Diarrhea 4% vs 2% Headache 4% vs 3% Nausea 5% vs 2% Vulvovaginal candidiasis 4% vs 3% FDA approved Solosec Sept 2017 (yours, now for only $275) 39

40 The News Dec 2017: Birth Control Pills Still Linked to Breast Cancer, Study Finds Danish national registries 1.8 million women Followed for 10 years, on average Morch et al NEJM 2018 Breast cancer diagnosis? Absolute increase in Breast CA DIAGNOSIS among current/recent users of any hormonal contraceptive? 13 (95% CI, 10 16)/100,000 person yrs 1 extra breast cancer Dx per 7690 women using hormonal contraception for 1 year. Morch et al NEJM

41 Results: Relative Risks Compared to Never use: 1 year of hormonal contraception RR=1.09 (95% CI, ) NOT SIGNIFICANT 10 years of hormonal contraception RR=1.38 (95% CI, ) Morch et al NEJM 2018 Results: Relative Risks Compared to Never use: Current/recent LNG IUD RR= 1.21 (95% CI, ) Morch et al NEJM

42 BUT IF this is a hormonal effect, WHY would IUD users be more likely than OC users to be Dx d with cancer? Systemic hormone exposure with IUD is 10% of COC May reflect more clinician contact Basaraba CN et al Contraception 2016 AND If you see a doctor to get an Rx (or IUD), you are more likely to get screened Early diagnosis allows early treatment This may be a good thing! Schwarz EB et al NEJM

43 In other news: A better designed recent study >100,000 U.S. women participating in the prospective NIH AARP Diet and Health Study Age at enrollment, years Followed for 15 years Controlled for family history of cancer Examined subgroups by smoking and obesity Michels KA et al JAMA Oncol 2018 Controlling for other factors After controlling for smoking, obesity, and family history of cancer: Breast cancer risk with OC use was negligible, Ovarian cancer risk decreased with OC use among all women, smokers, obese, or both. Endometrial cancer risk decreased with OC use among all women greatest risk reduction among smokers, obese, or both. Michels KA et al JAMA Oncol

44 Take Home Hormonal Contraceptives PROTECT women from several cancers, and reduce pain from endometriosis. Intrauterine (Liletta, Mirena, Kyleena, Skyla, ParaGard) and subdermal contraceptives (Nexplanon) are still the safest & most effective contraceptives available Questions? 44

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