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Tenth%20International%20Symposium%20HEART%20FAILURE%20

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Tenth International Symposium HEART FAILURE & Co. CARDIOLOGY SCIENCE UPDATE FEMALE DOCTORS SPEAKING ON FEMALE DISEASES Milano 9 - 10 aprile 2010 S. HUNT – PowerPoint PPT presentation

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Title: Tenth%20International%20Symposium%20HEART%20FAILURE%20


1

Tenth International Symposium HEART FAILURE
Co. CARDIOLOGY SCIENCE UPDATE FEMALE DOCTORS
SPEAKING ON FEMALE DISEASES Milano 9 - 10 aprile
2010
S. HUNT
2
Tenth International SymposiumHEART FAILURE
Co.Milano 9-10 Abrille 2010
  • Sex Specific Guidelines for Cardiovascular
    Disease Management
  • How Close Are We?
  • Sharon A. Hunt, MD
  • Stanford University, California

3
Why create guidelines?
  • Because Knowledge about HF and many other
    conditions is accumulating so rapidly that
    individual clinicians may be unable to synthesize
    new information into effective principles of
    patient care. Trial data, though valuable, often
    do not give adequate direction for individual
    patient management.
  • Adams KF et al HFSA 2006 Guideline
    Executive Summary

4
in turn leading to
  • Over- and under-use of technology and drugs
  • Wide regional practice variations

5
further leading, in turn, to
  • A move to create published clinical guidelines
    over past 10 years with purpose of
  • (a) codifying and
  • (b) promoting implementation of evidence-based
    advances in diagnosis and therapy

6
Basic GL Principles Include
  • GLs should be evidence based
  • GLs should be consistent with other GLs
    (ACC/AHA, ESC, others)
  • GLs focus on information already published in
    peer-reviewed literature

7
Guidelines should in theory also
  • Acknowledge specific subsets of the population
    for whom evidence suggests differing
    effectiveness of various forms of therapy.

8
In CV disease this isnt often possible because
  • Subset analyses usually rely on
  • Meta-analyses
  • Post-hoc analyses

AND BOTH ARE FLAWED METHODS
9
There is a severe lack of data in all types of
trials in CV medicine that enroll adequate
numbers of women to allow significant subset
analyses.
  • This is despite the fact (in the US) that the NIH
    established a policy for the inclusion of women
    in clinical research in1986 that was passed into
    law when Congress approved the NIH Revitalization
    Act of 1993.

10
Having said that, the reality is
  • Guidelines arent always consistent with one
    another
  • Many recommendations are really based on expert
    consensus because there simply is no evidence
    base

11
There is, in fact, increasing consciousness of
the need to provide guidance for management of
important subsets of patients
  • This consciousness is perhaps best attributed to
    the data suggesting that improvements in outcomes
    over time are not evenly distributed between the
    sexes.

12
Temporal Trends in 5-Year Mortality After the
Diagnosis of Heart Failure, Data Stratified by
Sex (From analysis of Olmsted County population)
Roger, V. L. et al. JAMA 2004292344-350.
13
Such data led to investigations to determine
whether evidence based therapies are being used
equally.
  • Several very large studies have
  • now been done.

14
IMPROVE-HF
  • A prospective cohort study designed to
    characterize current management of patients with
    diagnosed HF and LVSD (or prior MI associated
    with LVSD) in outpatient cardiology practices.
  • Analyzed 15,381 patients in 167 outpatient
  • practices in the US
  • Yancy et al. Am Heart J 2009157754.

15
.
  • .

Patients receiving recommended HF therapy by
sex Yancy et al Am Heart J 2009157754
16
Thus, in IMPROVE-HFstudy of Guideline-recommended
Rx
  • The use of ACEI or ARB and beta blockers was
    remarkably similar for men and women
  • Women less likely to receive ICD/CRT-D implants
    or HF education

17
OPTIMIZE-HF A prospective registry and
performance improvement program of hospitalized
patients with HF
  • Evaluated differences in medical care and patient
    outcomes by age and gender in 48,612 patients
    from 259 hospitals in US
  • Fonarow et al Am J Cardiol 2009104107

18
In OPTIMIZE-HF registry
  • Length of stay was similar for men and women
  • Both groups experienced similarly high
    postdischarge mortality and readmission rate.

19
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20
Thus, in OPTIMIZE-HF registry
  • Appropriate ACEI/ARB and beta blocker use were
    similar between men and women.
  • Fewer women had
  • Aldo antagonists
  • Warfarin for AF
  • Discharge instructions

21
This is in contrast to recent UK study and others
which have shown lower HF treatment rates in
women.
  • .

22
Retrospective survey Of gt9,000 hospital Admissions
for HF In 2005-6 in UK. Women
significantly Less likely to be Prescribed HF
meds On discharge
Nicol et al Heart 200894172
23
Why the differences in IMPROVE-HF and OPTIMIZE-HF
from UK study?
  • Not completely clear, but possibly
  • Data were collected for outpatients in
    IMPROVE-HF, inpatients in others
  • There was a greater awareness of guideline
    recommendations in US
  • There was selection bias in the analyzed
    outpatient practices and hospitals in
    IMPROVE-HF and OPTIMIZE-HF

24
In any case
  • For the moment, Guidelines assign a Class I
    recommendation that groups of patients, including
    women, even if underrepresented in clinical
    trials, should, in the absence of specific
    evidence to treat otherwise, have clinical
    screening and therapy in a manner identical to
    that provided to the broader HF population

25
CONCLUSIONS
  • Our current HF guidelines are not sex specific
    because of insufficient data
  • Review of published reports raises concern that
    sex differences might exist regarding the degree
    of benefit of any given therapy for HF.
  • There continues to be a low rate of sex-specific
    reporting in CV trials

26
THIS NEEDS TO CHANGE
  • although who should accept this responsibility
    and how it should be enforced remain
    controversial.

27
.
  • it is important to stress that being male or
    female is a variable that should be dealt with in
    both basic science and clinical research
    differences are unlikely to be due only to sex
    hormones (but also to differences in gene
    expression on X and Y chromosomes)
  • Piro M et al. JACC 2010551057-65
  • Rome, Italy

28
How close are we to gender-specific guidelines?
  • I thinkonly as close as we are to designing
    clinical trials that include sufficient numbers
    of women to analyze.
  • That may not be very close.
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