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Internal Medicine Update 2008

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Colon cancer screening. The periodic health exam. The Health Outcomes and Reduced Incidence with ... Colon cancer screening. The periodic health exam ... – PowerPoint PPT presentation

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Title: Internal Medicine Update 2008


1
Internal Medicine Update 2008
  • Michael Adams, M.D., FACP
  • Associate Professor of Medicine
  • Georgetown University Hospital

2
Credits
  • ACP Annual Session (permission received)
  • Robert Cato, M.D., FACP
  • Jack Ende, M.D., FACP
  • Individual authors

3
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

4
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

5
The Health Outcomes and Reduced Incidence
with Zoledronic Acid Once Yearly (Horizon) trial
6
Background / Methods
  • 45 of women non compliant with oral
    bisphosphonates at one year
  • Zoledronic acid is once-yearly, IV infusion
  • Decreases bone turnover and improves BMD
  • Fracture trial
  • 7000 women with osteoporosis
  • Multi center RCT, 3 year follow up
  • Primary endpoints spine / hip fractures
  • Secondary endpoints BMD

7
Horizon - results
NNT (hip fx) 91 NNT (vertebral fx via X-ray)
13 NNT (clinical vertebral fx) 48
8
Horizon
  • Fracture outcomes independent of bisphosphonate
    use
  • BMD improved 5-8 (placebo 1-2 decrease)
  • Temporary side effects noted day of infusion
  • Serious atrial fibrillation higher in
    Zoledronic acid patients (1.3 vs. 0.5)
  • Increased creatinine (1.2 vs. 0.4) - transient
  • No mortality differences
  • Jaw osteonecrosis 1 per group

9
Horizon Conclusions
  • Zoledronic acid increases BMD and reduces fx at
    similar rates to oral bisphosphonates
  • Not a comparison trial
  • Hurdles
  • Infusion
  • Concern for a fib

Bottom line Zoledronic acid offers another
option to treat postmenopausal osteoporosis after
oral therapy has been tried. Head-to-head trial
is needed plus investigation into atrial
fibrillation side effect.
10
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

11
Obesity surgery
12
Bariatric surgery
  • 2000 obese (BMI 34 for men, 38 for women) who
    underwent surgery in Sweden 1987-2001
  • Cohort analysis, non-randomized
  • No standardization of care, few exclusions
  • 99.9 follow up (vital status)

13
Results weight loss
Controls 1 Surgical -18
14
Results mortality
15
Results causes of mortality
16
Bariatric surgery trial Conclusions
  • Surgery patients had reduced weight, mortality
    from CV causes and cancer (Causal?)
  • Non-randomized
  • Most surgery was gastric banding (not bypass)
  • No specific follow up in control group (selection
    bias? More participation in health care in
    surgery group?)
  • BMIs used dont correspond to definition of
    obesity

17
Bariatric surgery
Bottom line Despite some study limitations,
this is the first trial to show a mortality
benefit from weight loss or obesity surgery.
Careful patient selection is crucial. More study
is needed to try to ascertain if this was a
simple association or cause effect.
18
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

19
Cancer risk from CT scans
JAMA 2007 298(3)317-23.
20
Background / Methods
  • Computer model to determine lifetime risk of
    cancer from a CT coronary angiogram
  • Lung / breast
  • Calculated age-specific LARs (lifetime
    attributable risk)
  • Delineated by sex
  • Estimated risk using dose reduction strategies

21
CTCA - results
22
CTCA results - LARs
Highest organ LARs lung / breast
23
CTCA - conclusion
  • CT angiography carries a non-negligible risk of
    cancer
  • Worse in younger women
  • May be reduced by modifying radiation techniques

Bottom line CTCA for identifying patients with
CAD should not be done indiscriminately.
24
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

25
Nephrogenic Systemic Fibrosis (Nephrogenic
Fibrosing Dermopathy)
26
Background / Methods
  • To determine if NSF is associated with
    gadolinium
  • Case-control study conducted by CDC after
    nephrologist reported a cluster of NSF cases
  • Controlled for other radiologic contrast agents
    and erythropoeitin
  • 4-year data collection

27
NSF - results
N 25
28
NSF - results
NSF rate 4.6 cases per 100 PD patients, 0.61
per 100 HD patients
29
Gadolinium and NSF - conclusion
  • Patients with stage IV/V chronic kidney disease
    are at risk of NSF, especially PD patients.
  • Time to onset ranges from days to years (median
    76 days)

Bottom line Gadolinium should be avoided if GFR
should be used, or HD should be done ASAP post
gadolinium.
30
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

31
Circulation. 2007116894-900.
32
Background / Methods
  • Physicians Health Study component
  • 51,000 men (91 Caucasian)
  • Association between gout, death, CHD
  • Multivariate analysis to adjust for other risk
    factors
  • 12 year follow up

33
Gout and CHD - results
34
Gout and CHD - results
35
Gout and CHD - conclusion
  • Men with gout had an approximately 25 increase
    in cardiovascular disease and cardiac mortality
  • Association with uric acid and CVD
  • Renin-angiotensin system activation
  • Chronic inflammation
  • Direct effect of uric acid on endothelium
  • Associated risk factors for gout

Bottom line Gout may be an indicator of
coronary heart disease. The present findings
provide support for aggressive management of
cardiovascular risk factors in patients with
gout.
36
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

37
Circulation. 2007116894-900.
Clinical Outcomes Utilizing Revascularization and
Aggressive Drug Evaluation (COURAGE)
38
Background / Methods
  • Optimal medical management (OMM) recommended
    for stable CAD
  • In 2004, 85 of all PCI procedures were elective
    and in stable CAD patients
  • Aim to determine if PCI reduces mortality and/or
    events in this population
  • 2,000 patients PCI (OMM) versus OMM alone
  • 5 years

39
PCI for stable CAD - results
  • Similar use of medications (ASA, beta blocker,
    statin, ACE) 71-95
  • BP similar
  • LDL 71
  • Short term improvements seen in angina in PCI
    group (similar to previous studies), but this
    disappeared by year 5

40
PCI for stable CAD - results
41
PCI for stable CAD - conclusion
  • Elective PCI for patients with stable CAD has
    not been shown to reduce future coronary events
    or mortality.
  • This group had better medical management than
    usual care
  • Study done prior to DES

Bottom line Medical management should be
initiated first for patients with stable CAD,
while PCI should be reserved for patients with
progressive, limiting angina despite medical
therapy.
42
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

43
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44
Background / Methods
  • Aim To determine if rosiglitazone has an effect
    on cardiovascular outcomes
  • Meta analysis
  • Excluded studies with zero events
  • 40 studies which lasted 6 months or more
  • Outcomes reviewed MI, cardiovascular death

45
Rosiglitazone - results
46
Rosiglitazone - results
47
Rosiglitazone - results
  • All cause mortality unchanged
  • Risk of MI higher with rosiglitazone use when
    compared with other diabetic drugs combined (but
    not individually)
  • Insulin
  • Metformin
  • Sulfonylurea
  • Overall event rates were very low (0.5)

48
Rosiglitazone questions raised
  • Is this a class effect?
  • All TZDs are not alike (pioglitzaone better on
    lipid profile, rosiglitazone may increase LDL)
  • Was the effect related to LDL levels alone?
  • CHF (TZDs may precipitate heart failure)
  • Is this a function of patients who have harder to
    control diabetes?
  • Typical CHD combined endpoints were not studied
  • Inherent limitations of meta analysis

49
Rosiglitazone - conclusion
  • NEJM authors Our data suggest a cardiovascular
    risk associated with the use of rosiglitazone.
  • ACP reviewers

Bottom line Inconclusive. One ongoing study
(RECORD) is not showing CV events with
rosiglitzaone, and pioglitazone may reduce events
(meta analysis). Use caution.
50
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

51
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52
Background / Methods
  • Aim To determine if patients with mild
    persistent asthma could be controlled with
    simpler treatment than twice daily inhaled
    corticosteroids
  • 3 arms
  • Twice daily ICS
  • once daily ICS LABA
  • Montelukast
  • Outcomes treatment failure more intense
    management, symptom scores, physiologic
    deterioration

53
Background / Methods
  • Baseline characteristics were not the same
  • Fewer smokers in ICS group
  • More patients in montelukast group used daily ICS
    at baseline
  • Higher mini-AQLQ score in ICS group (less severe
    asthma)
  • Less GERD in ICS LABA group
  • Fewer patients in montelukast group were
    triggered by allergens

54
Mild persistent asthma - results
30 failure
20 failure for both groups
55
Asthma - results
  • of symptom-free days similar for all groups
  • More patients in ICS group and ICS LABA group
    wanted to continue treatment
  • Funding
  • GSK
  • Reviewed protocol
  • Reviewed final manuscript offered comments for
    writing committee
  • American Lung Association

56
Asthma treatment - conclusion
  • NEJM authors Patients whose asthma is well
    controlled with the use of twice daily
    fluticasone can be safely switched to once-daily
    fluticasone plus salmeterol. Oral montelukast is
    not as effective, although it provided good
    asthma control for most patients.
  • ACP reviewers similar conclusions
  • Baseline differences in groups
  • Esp. allergens and ICS use at baseline
  • 6 month study

57
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58
Asthma treatment
Bottom line Montelukast should be used for
patients with a specific indication (allergies,
asthma triggered by allergens, exercise-induced
asthma), but did not show benefit as stepdown
therapy for patients with mild persistent asthma
who were well controlled with ICS. Adding a
LABA to ICS may be helpful for these patients,
but studies of a longer duration are needed.
59
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

60
Beclomethasone plus Salbutamol Treatment (BEST)
61
Background / Methods
  • Aim To determine if symptom-driven therapy for
    mild persistent asthma is effective.
  • 4 arms
  • prn albuterol
  • prn combined ICS albuterol
  • regular, twice daily ICS ( prn albuterol)
  • regular, twice daily combined ICS albuterol
  • Outcomes PEFs, symptom scores, severity of
    exacerbations

62
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63
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64
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65
BEST results / conclusion
  • All three arms better than as needed albuterol
  • Cumulative dose of ICS lower in in as-needed
    combination group than other ICS groups
  • Target mild, persistent asthmatics with
    infrequent exacerbations (compliance)

Bottom line As needed (symptom-driven) therapy
with a combination inhaler for mild persistent
asthma is an effective option. Regular use of
short acting beta agonists not recommended.
66
Asthma ACP reviewers comments
  • Very specified population of asthma patients
  • Mild, persistent
  • Well-controlled
  • Did well in run-in period
  • Motivation less expensive / more convenient
    therapy
  • Concern adequate suppression of subclinical
    airway inflammation (some believe this is little
    more than theoretical).

67
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

68
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69
Background / Methods
  • Aim To determine if alphablockers and calcium
    channel blockers hasten stone passage
  • Medical therapy may reduce need for surgery /
    ureteroscopy / lithotripsy and may reduce
    stricture and kidney damage
  • Meta analysis, 211 studies yielded 22 randomized
    trials
  • 2000 patients
  • Tamsulosin, nifedipine
  • Outcome likelihood of stone expulsion at 4 weeks

70
Stone therapy - results
NNT 3.3
Alpha-blocker forest plot
71
Stone therapy - results
NNT 3.2
Calcium channel blocker forest plot
72
Stone therapy - results
  • Side effects were low
  • Alpha blocker 4 had any side effect
  • 0.2 discontinued use
  • CCB 15.2 had any side effect
  • 2.9 discontinued use
  • Most were mild
  • 2 to 6 day average improvement in stone expulsion
  • Stone size was 3-18 mm (mean 5 mm)

73
Stone therapy - conclusion
  • Meta analysis so firm conclusions limited
  • Consistent with other similar analyses reviewing
    expulsion of stones 5-10 mm

Bottom line Medical expulsive therapy with
tamsulosin (0.4 mg daily) or nifedipine (30 mg
daily) for 4 weeks is probably of benefit and may
reduce the need for other, more invasive
treatment of kidney stones.
74
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

75
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76
Background / Methods
  • Aim To determine if Gardasil
  • Reduces HPV infection
  • Reduces infection with HPV 16 and 18
  • Reduces CIN 2, CIN3 (and adenocarcinoma)
  • In
  • All women, and
  • women without HPV infection or abnormal PAP smear
  • 12000 patients, aged 15-26

77
Quadrivalent HPV vaccine - results
  • Vaccine prevented 98 of HPV 16,18-related
    high-grade cervical lesions in per-protocol
    population (no abnormality at baseline)
  • 44 reduction in intention-to-treat analysis
  • No effect in patients with preexisting HPV 16 or
    18 infections or abnormal PAPs

78
Quadrivalent HPV vaccine - results
79
Gardasil - results
  • Nearly 100 effective in preventing new HPV 16 or
    18 infections
  • Side effects were low
  • This study was designed, managed, and analyzed
    by Merck in conjunction with external academic
    investigators and members of the external data
    and safety monitoring board. The academic authors
    had full access to the data and the analyses and
    approved the final manuscript.

80
HPV vaccine - conclusion
  • Vaccine very effective in preventing new
    infections and cervical abnormalities in
    susceptible patients
  • Studies women aged 15-26 (approved for 11-26)

Bottom line The HPV vaccine seems to be
effective as prophylaxis and has limited side
effects.
81
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

82
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83
Background / Methods
  • Aim To compare CT colography to optical
    colonoscopy for the detection of advanced colon
    neoplasms
  • Definition of advanced neoplasm
  • 10mm
  • High grade dysplasia
  • Prominent villous component ( 75)
  • Retrospective analysis, 3000 patients

84
CT colography - results
85
CT colography - results
  • Fewer invasive procedures
  • Depends upon your idea of invasive
  • Insufflation necessary
  • 7.7 of CTC patients had extracolonic findings
  • Is this good or bad?

86
CTC versus optical colonoscopy - conclusion
  • CTC compares favorably to colonoscopy at finding
    asymptomatic colon polyps
  • screening
  • Will this increase the of patients willing to
    get screened?

Bottom line CTC may be a reasonable alternative
to colonoscopy in patients who are otherwise
unwilling to undergo optical colonoscopy,
BUT…patients need to be informed as to the
details of the procedure (insufflation), and the
fact that they may need an optical colonoscopy
with biopsy if a polyp is found
87
Topics
  • Cardiovascular
  • Gout and CHD
  • PCI for stable CAD
  • DM / thiazolidinediones and CHD
  • Asthma
  • Treatment for mild persistent
  • Symptom-driven therapy
  • Kidney stones
  • HPV vaccination
  • Colon cancer screening
  • The periodic health exam
  • Osteoporosis
  • Obesity / bariatric surgery
  • Hazards of Radiologic Testing
  • Cancer risk associated with radiation exposure
  • Nephrogenic systemic fibrosis

88
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89
Background / Methods
  • Some investigators have found little evidence to
    support the periodic health exam
  • This review used a model of benefit (improved
    clinical outcomes) versus harms (loss time at
    work, inappropriate tests, cost) of the PHE

90
PHE - results
91
PHE - results
  • Performing a periodic health exam did show
    improvement in the delivery of some routine /
    preventive / screening health interventions
  • Mixed results on costs, mortality
  • No harms were found

92
PHE - conclusion
  • While more evidence is needed, particularly on
    long term clinical outcomes, the data assembled
    in this systematic review support PHEs. We hope
    that third party payers will as well.

Bottom line There is evidence to support what
we all inherently know - the value of the
periodic health exam.
93
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