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UPDATE IN WOMEN

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Title: UPDATE IN WOMEN


1
UPDATE IN WOMENS HEALTH 2009September 11, 2009
  • Eileen C. West, MD
  • Director, Internal Medicine Womens Health
  • Assoc. Professor of Internal Medicine, Obstetrics
    and Gynecology
  • University of Oklahoma Health Sciences Center

2
OVERVIEW
  • Review of literature from March, 2008 through
    February 2009
  • Journals, Cochrane, Medline search using medical
    subject heading sex factors
  • Criteria
  • Scientific rigor
  • Potential to impact clinical practice

3
OVERVIEW
  • CV Risk Reduction
  • Menopause and Hormone Therapy
  • Osteoporosis
  • Breast Health
  • Cervical Cancer Screening Guidelines

4
CARDIOVASCULAR DISEASE IN WOMEN
  • FOCUS ON RISK FACTOR
  • REDUCTION

5
CV Risk Reduction
  • Yvonne is a 56 y/o woman worried about her
    potential risk of CVD. She requests a CRP level.
    Your response is
  • A. Sure
  • B. Consider with lipids, glucose, TSH
  • C. Other non-lab tests are more important

6
Background
  • Lowering LDL cholesterol with statins in women
    and men leads to less CHD CVA most effective
    in those high risk
  • Statins also lower high-sensitivity CRP levels
  • JUPITER Trial
  • In healthy women and men with LDL lt 130 and
    hsCRP gt 2 mg/L will treatment with rosuvastatin
    decrease CVD events?

7
JUPITER Rosuvastatin Trial
  • Healthy women gt 60 men gt 50 yrs
  • Entry LDL lt 130 and hsCRP gt 2 mg/L
  • Participants were 38 female
  • Double-blind, placebo controlled multi-center
    trial in 26 countries
  • Primary Endpoint Non-fatal MI or CVA, arterial
    revascularization, admission for unstable angina
    or confirmed CV death

8
JUPITER Results at 1.9 yrs
MI, CVA or CVD Death
Primary Endpoint
All Death
9
JUPITER Primary Endpoints Subgroup Effects
But more DM
10
From here to Jupiter
  • Research Question How many NHANES 99-04 would
    qualify for statin therapy based on Jupiter?
  • Design Reviewed NHANES data
  • Results
  • Prior 58 statin indicated use 24
  • Additional 19 may become eligible
  • New pts female, older, obese, HTN, metabolic
    syndrome

Spatz 2008
11
Impact for Practice
  • Treatment with statins benefit High total
    cholesterol, LDL, low HDL, high-sensitivity CRP
    in addition to LDL
  • Under-treatment of lipids already occurs
  • DASH Diet also lowers hsCRP, weight BP
  • OTHER KEY RF - Weight - BMI - Abd girth
  • - Blood pressure - Physical activity level
  • - Glucose - Thyroid

12
DIABETES
13
Background
  • DM increases CVD risk in women
  • At time of DM diagnosis, lipids in women lower
    HDL than men
  • HTN treatment decreases CVD risk even more than
    glucose control
  • Hyperglycemia increases CVD risk

14
Framingham CVD Risk Impact of Weight in DM
  • Over 30 yrs CVD Risk
  • Overall original cohort CVD 39 women, 55 men
  • Overall offspring CVD 27 women and 40 men.
  • CVD 54 in DM women with nl weight
  • CVD 70 in DM women overweight
  • CVD 79 in DM obese women

Fox 2008
15
Framingham 30 yr CVD Risk

Fox 2008
16
Impact for Practice
  • DM increases CVD risk
  • Aggressive treatment of CV Risk Factors is
    indicated including statins, Renin-Angiotensin
    System drugs, and metformin
  • DM women who weigh less, have lower CVD rates

17
OBESITY
18
US Trends in Weight

Circ 2008 118 428
19
Obesity associated with higher mortality,
morbidity and
  • DM
  • CHD
  • CHD Risk Factors HTN, lipids, inflammatory
    markers, hypercoag
  • Stroke, DVT
  • Cancer Breast, colon, endometrial, renal,
    esophageal
  • Pulm Obstructive Sleep Apnea, hypoventilation,
    asthma

Circ 2008 118 (4) 428
20
Keeping the Weight Off
  • Iam Trying is completing a 6 month weight loss
    program where she has lost more than 15 lbs. What
    will help her maintain her lower weight the best?
  • A. Self control
  • B. Interactive computer system
  • C. Monthly personal contact

21
Maintaining Weight Loss
Phase 1 loss gt 4 kg then Circle self-directed,
Square computer, Triangle personal contact
22
Obesity Key Articles
  • BMI and abdominal girth correlate with
    complications
  • RN Health Study abd fat assoc with all-cause
    mortality, CVD cancer
  • RF Modification in Obesity Tobacco avoidance and
    increased activity
  • Makes a difference
  • Activity gt 275 min/week associated with sustained
    weight loss at 2 yrs

23
Obesity Impact for Practice
  • Overwt and obesity increases MULTIPLE health
    risks
  • Difficult to lose even 10 weight
  • Even more difficult to sustain weight loss more
    physical activity is key, focused brief
    counseling helps

24
MENOPAUSE AND HORMONE THERAPY
25
Vasomotor Symptoms
  • Minnie Pause is a 53 year old woman who had her
    last menstrual period 18 months ago. She is
    still having hot flashes and awakens at least
    twice a night with them. She is considering
    taking estrogen but wants to know how much longer
    this will last. What do you tell her?

26
When will they go away?
  1. Average duration is about 2 years and so they
    should be gone in about 6 months.
  2. Average duration is about 4 years
  3. They will never go away

27
Background
  • Treatment for menopausal symptoms is based on
    their transitory nature
  • Many clinical guidelines suggest that symptom
    duration is approximately 2 years
  • Many studies do not follow women more than 2
    years
  • Risks and benefits of hormone therapy depend on
    duration of use
  • Use lowest dose for shortest duration

28
Clinical Questions
  • What is the natural progression of vasomotor
    symptoms during the menopause transition?
  • How long is it safe to use hormone therapy?

29
Duration of Vasomotor Symptoms
  • Politi MC et al. Revisiting the duration of
    vasomotor symptoms of menopause a
    meta-analysis. JGIM 200823 1507-13
  • Objective to estimate the natural progression of
    menopausal symptoms

30
Vasomotor Symptoms
  • Rigorous meta-analysis included 10 studies with
    over 35,000 participants
  • Clear definition of vasomotor symptoms
  • Assessed prevalence of symptoms and bothersome
    symptoms

31
Results
  • Percent of women with symptoms increased in the
    two years before the final menstrual period (FMP)
    , peaked one year after the FMP and did not
    return to premenopausal levels until 8 years
    after the FMP
  • 50 of women had symptoms during the 4 years
    after FMP
  • 10 of women had symptoms up to 12 years after FMP

32
Results Bothersome Symptoms
33
Menopause Impact for Practice
  • Menopausal symptoms last about 4 years
  • Risks and benefits of hormone therapy must be
    considered within the longer period of use

34
Key articles
  • New evidence based guidelines for the use of
    hormone therapy
  • Risk defined as possibility or chance of harm
  • Put level of risk in perspective
  • HT should not be used as an anti-depressant
  • No data to support any particular route of
    administration or dosing regimen
  • Use greater caution in women over 60

NAMS, Menopause, 2008
35
Key Articles
  • Menopausal complaints are associated with a less
    favorable cardiovascular risk profile
  • Gast, 2009
  • Hormone therapy associated with an increased risk
    of GERD
  • Jacobson, 2008
  • Hormone therapy associated with an increased risk
    of stroke regardless of time of initiation
  • Grodstein, 2008

36
Key Articles
  • Hormone therapy is associated with improvement in
    some quality of life measures in women with
    vasomotor symptoms and may improve sexual
    function and vitality
  • - Hess, 2008 Welton, 2008
  • Hypnosis and exercise may improve vasomotor
    symptoms
  • - Elkins, 2008

37
OSTEOPOROSIS
38
OSTEOPOROSIS
  • Violet D. is a 69 year old woman who comes in for
    a health care maintenance exam. You order a
    bone mineral density test. She tells you she
    also wants a Vitamin D level checked. What do
    you do?

39
Vitamin D
  1. Order a Vitamin D level
  2. Dont order a Vitamin D level because you are not
    sure to do with the results
  3. Dont order it but start her on a calcium/Vitamin
    D supplement

40
Background
  • Vitamin D deficiency is common in older adults,
    homebound individuals and women admitted with hip
    fracture
  • Association between Vitamin D level and fracture
    risk is inconsistent
  • Association could be influenced by renal
    function, muscle strength and estrogen receptors

41
Clinical Questions
  • What is the association between Vitamin D level
    and fracture?
  • When should Vitamin D levels be checked?
  • When and how should Vitamin D supplementation be
    given?

42
Vitamin D and Fracture Risk
  • Cauley JA et al. Serum 25(OH) vitamin D
    concentrations and risk for hip fractures. Ann
    Intern Med 2008149 242-250.
  • Aim To determine whether serum 25 (OH) D
    concentration is associated with hip fracture in
    community dwelling older women

43
Methods
  • Nested case-control study within the Womens
    Health Initiative Observational Study
  • 400 cases and 400 controls followed for a median
    of 7.1 years
  • Women had no prior history of hip fracture, were
    not on estrogen or other bone active therapies

44
Results Hip Fracture Risk
Odds Ratios of Risk for Hip Fracture Odds Ratios of Risk for Hip Fracture Odds Ratios of Risk for Hip Fracture Odds Ratios of Risk for Hip Fracture Odds Ratios of Risk for Hip Fracture Odds Ratios of Risk for Hip Fracture Odds Ratios of Risk for Hip Fracture Odds Ratios of Risk for Hip Fracture Odds Ratios of Risk for Hip Fracture Odds Ratios of Risk for Hip Fracture Odds Ratios of Risk for Hip Fracture

25-Hydroxyvitamin D Level 25-Hydroxyvitamin D Level 25-Hydroxyvitamin D Level 25-Hydroxyvitamin D Level Unadjusted Odds Ratio (95 CI) Unadjusted Odds Ratio (95 CI) Adjusted Odds Ratio (95 CI) Adjusted Odds Ratio (95 CI) Adjusted Odds Ratio (95 CI) Adjusted Odds Ratio (95 CI)

Per 2.5-nmol/L decrease Per 2.5-nmol/L decrease 1.03 (1.01-1.05) 1.03 (1.01-1.05) 1.03 (1.01-1.05) 1.03 (1.01-1.05) 1.03 (1.01-1.05) 1.03 (1.01-1.05)
Per 25-nmol/L decrease Per 25-nmol/L decrease 1.30 (1.07-1.58) 1.30 (1.07-1.58) 1.33 (1.06-1.68) 1.33 (1.06-1.68) 1.33 (1.06-1.68) 1.33 (1.06-1.68)
Quartile (according to control group) Quartile (according to control group) Quartile (according to control group) Quartile (according to control group)
First (9.2-47.5 nmol/L) First (9.2-47.5 nmol/L) 1.73 (1.13-2.66) 1.73 (1.13-2.66) 1.71 (1.05-2.79) 1.71 (1.05-2.79) 1.71 (1.05-2.79) 1.71 (1.05-2.79)
Second (47.6-60.1 nmol/L) Second (47.6-60.1 nmol/L) Second (47.6-60.1 nmol/L) Second (47.6-60.1 nmol/L) 1.08 (0.72-1.63) 1.08 (0.72-1.63) 1.09 (0.70-1.71) 1.09 (0.70-1.71) 1.09 (0.70-1.71) 1.09 (0.70-1.71)
Third (60.2-70.6 nmol/L) Third (60.2-70.6 nmol/L) Third (60.2-70.6 nmol/L) Third (60.2-70.6 nmol/L) 0.78 (0.50-1.20) 0.78 (0.50-1.20) 0.82 (0.51-1.31) 0.82 (0.51-1.31) 0.82 (0.51-1.31) 0.82 (0.51-1.31)
Fourth (70.7-121.5 nmol/L) Fourth (70.7-121.5 nmol/L) Fourth (70.7-121.5 nmol/L) Fourth (70.7-121.5 nmol/L) 1.00 (reference) 1.00 (reference) 1.00 (reference) 1.00 (reference) 1.00 (reference) 1.00 (reference)
P for trend 0.009 for unadjusted and 0.015 for
adjusted models
45
HIP FRACTURE RISK
  • Association was linear
  • Dose response effect
  • No difference by age
  • Independent of geographic location

46
Impact for Practice
  • Low serum 25 (OH) vitamin D concentrations can
    help identify women at high risk for hip fracture
  • Perhaps we should consider Vitamin D level in
    decision making about anti-resorptive therapies

47
Background
  • Osteoporotic fractures are increasing as the
    population ages
  • Hip and vertebral fractures are associated with
    premature mortality

48
Clinical Questions
  • What is the mortality risk following an
    osteoporotic fracture?
  • Does degree of trauma matter?
  • Does subsequent fracture affect that risk?

49
Methods
  • Prospective cohort study from Dubbo Osteoporosis
    Epidemiology Study
  • Individuals who had a fracture between 1989 and
    2007
  • Age and sex specific standardized mortality
    ratios compared with general population for hip,
    vertebral, major and minor fractures

50
Results in Women
Fracture type Number of deaths Person-years SMR (95 C.I.)
Hip 89 509 2.53 (2.04-3.13)
Vertebral 93 994 1.76 (1.43- 2.17)
Major 48 591 1.60 (1.20-2.13)
Minor 76 1349 1.38 (1.10-1.74)
51
SUBSEQUENT FRACTURE AND MORTALITY
  • Subsequent fracture was associated with an
    increased risk of mortality in women
  • HR 1.53 (1.15, 2.04)

52
Key Articles
  • Any fracture is associated with an increased risk
    of 5-10 year mortality
  • A subsequent fracture is associated with an
    increased mortality risk for 5 more years
  • We should pay more attention to non-hip,
    non-vertebral fractures

53
Key Articles
  • FRAX WHO Fracture assessment
  • Calculate the 10 year probability of a hip
    fracture and the 10 year probability of any
    osteoporotic fracture
  • Includes femoral neck BMD and risk factors
  • Can be used only in previously untreated patients
  • Algorithm adapted for the U.S.

  • www.shef.ac.uk/FRAX

54
(No Transcript)
55
WHO Fracture Risk Algorithm
  • Most useful in identifying individuals in the
    osteopenic range who are most likely to benefit
    from treatment
  • Treat when there is a 10 year risk of hip
    fracture 3 or a 10 year risk of a major
    osteoporosis-related fracture that is 20 based
    on the U.S. adapted WHO algorithm
  • In the future some BMD machines may be able to
    provide a report with absolute fracture risk

56
BREAST HEALTH
57
Breast Screening and HT
  • Maggie Graham55 y/o, on HT x 5 yrs, no family hx
    of breast cancer
  • Started HT for symptoms and sx recur when she
    tries to stop
  • Abnormal mammo 2 years ago led to a biopsy
    (benign)
  • She read news articles about increased accuracy
    of screening ultrasound and MRI.

58
What would you recommend to increase screening
accuracy?
  1. Add ultrasound
  2. Add breast MRI
  3. Stop hormone therapy
  4. All of the above

59
Screening Breast Ultrasound
  • Question Does added screening U/S ? the
    diagnostic yield of mammography?
  • Design 21 site RCT
  • Population 2809 ? w/dense breasts
  • Results
  • Adding a single screening u/s to mammo will
    yield an additional 1.1 7.2 cancers per 1000
    high-risk women, but it will also substantially ?
    false positives (Approximately doubles false
    positives to roughly 10)

Berg, JAMA 08
60
Screening Breast MRI
  • Question Does added screening MRI ? the
    diagnostic accuracy of mammography?
  • Design Meta-analysis of 11 prospective,
    non-randomized studies
  • Results Assuming a 2 prior prob
  • Negative MRI/mammo 0.3
  • Negative mammo alone 1.4
  • Limitations Heterogeneity, few non-familial
    risk pts, no data on recurrence or survival,
    criteria for suspicious lesions varied across
    studies

Warner, Annals 08
61
Chlebowski Archives 08
30
20
10
0
62
Chlebowski Archives 08
63
Summary Breast Health
  • Screening breast ultrasound and MRI may improve
    sensitivity, but result in more false positives
  • Hormone Therapy use results in more abnormal
    mammograms and biopsies
  • Stopping Hormone Therapy reduces abnormal
    mammograms and biopsies
  • There is a cause-effect relationship between
    stopping Hormone Therapy and decreasing breast
    cancer risk

64
CERVICAL CANCER SCREENING
  • 2008 update

65
ACOG Screening Guidelines When to Start
  • Three yrs after onset of intercourse no later
    than age 21
  • Annual Pap 21-30 with reflex HPV if abnormal
  • PAPHPV screen every 3 yrs 30-? Unless
  • new partner
  • Immunocompromised
  • DES exposure
  • chronic steroid use


66
ACOG Screening Guidelines When to Stop
  • Difficult to set an upper age limit
  • ACS Guideline Discontinue After Age 70
  • USPSTF Guideline Discontinue After Age 65
  • Cervical cancer in older women almost entirely
    among unscreened underscreened
  • Continue routine screening if
  • Remains sexually active w/ multiple partners
  • Has previous hx of abnormal pap smears

67
ACOG Screening Guidelines When to Stop
  • Prior to cessation of screening consider a HPV
    plus Pap for double negative at 64 years of age.

68
ACOG Screening Guidelines After Hysterectomy
  • PAP not indicated after total hysterectomy
    (includes removal of cervix) for benign
    gynecologic disease
  • 663 vaginal paps needed to detect one case of
    vaginal dysplasia2

69
ACOG Screening Guidelines After Hysterectomy
  • BUT
  • CIN 2/3 prior to or at time of hysterectomy,
    screen annually until 3 consecutive normal smears
  • w/ history DES exposure or cervical cancer,
    screen indefinitely while in reasonably good
    health
  • Increased risk for vaginal cancer
  • Err on side of screening if accurate information
    unavailable

70
HPV
  • Seattle, Washington college students
  • 36 month cumulative risk of CIN2-3
  • Any incident HPV 10
  • Incident HPV 16/18 27
  • Median time to detection of CIN2-3 was only 14 mo
    after HPV detection

From Winer, et al. J Inf Diseases 2005
71
ASCCP 2008
72
  • TUBAL LIGATION, ENDOMETRIAL ABLATION,
    CONTRACEPTION
  • do not negate the need for a PAP smear.

73
QUESTIONSCV Risk Reduction
  • Yvonne is a 56 y/o woman worried about her
    potential risk of CVD. She requests a CRP level.
    Your response is
  • A. Sure
  • B. Consider with lipids, glucose, TSH
  • C. Other non-lab tests are more important

74
Keeping the Weight Off
  • Iam Trying is completing a 6 month weight loss
    program where she has lost more than 15 lbs. What
    will help her maintain her lower weight the best?
  • A. Self control
  • B. Interactive computer system
  • C. Monthly personal contact

75
Vasomotor Symptoms
  • Minnie Pause is a 53 year old woman who had her
    last menstrual period 18 months ago. She is
    still having hot flashes and awakens at least
    twice a night with them. She is considering
    taking estrogen but wants to know how much longer
    this will last. What do you tell her?

76
When will they go away?
  1. Average duration is about 2 years and so they
    should be gone in about 6 months.
  2. Average duration is about 4 years
  3. They will never go away

77
OSTEOPOROSIS
  • Violet D. is a 69 year old woman who comes in for
    a health care maintenance exam. You order a
    bone mineral density test. She tells you she
    also wants a Vitamin D level checked. What do
    you do?

78
Vitamin D
  1. Order a Vitamin D level
  2. Dont order a Vitamin D level because you are not
    sure to do with the results
  3. Dont order it but start her on a calcium/Vitamin
    D supplement

79
Breast Screening and HT
  • Maggie Graham55 y/o, on HT x 5 yrs, no family hx
    of breast cancer
  • Started HT for symptoms and sx recur when she
    tries to stop
  • Abnormal mammo 2 years ago led to a biopsy
    (benign)
  • She read news articles about increased accuracy
    of screening ultrasound and MRI.

80
What would you recommend to increase screening
accuracy?
  1. Add ultrasound
  2. Add breast MRI
  3. Stop hormone therapy
  4. All of the above

81
THANK YOU FOR YOUR ATTENTION
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