Internal Medicine Update 2008 Michael Adams, M.D., FACP Associate Professor of Medicine Georgetown University Hospital
Credits <ul><li>ACP Annual Session (permission received) </li></ul><ul><li>Robert Cato, M.D., FACP </li></ul><ul><li>Jack ...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
The Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly ( Horizon) trial
Background / Methods <ul><li>45% of women non compliant with oral bisphosphonates at one year </li></ul><ul><li>Zoledronic...
Horizon - results NNT (hip fx) = 91 NNT (vertebral fx via X-ray) = 13 NNT (clinical vertebral fx) = 48
Horizon <ul><li>Fracture outcomes independent of bisphosphonate use </li></ul><ul><li>BMD improved 5-8% (placebo: 1-2% dec...
Horizon – Conclusions <ul><li>Zoledronic acid increases BMD and reduces fx at similar rates to oral bisphosphonates </li><...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
Obesity surgery
Bariatric surgery <ul><li>2000 obese (BMI > 34 for men, >38 for women) who underwent surgery in Sweden 1987-2001 </li></ul...
Results – weight loss Controls: +1% Surgical: -18%
Results – mortality 5% 6% Mortality without baseline CVD 19% (p<0.05) 25% Mortality with baseline CVD 5% (P=0.02) 6.3% Mor...
Results – causes of mortality
Bariatric surgery trial – Conclusions <ul><li>Surgery patients had reduced weight, mortality from CV causes and cancer (Ca...
Bariatric surgery Bottom line:  Despite some study limitations, this is the first trial to show a mortality benefit from w...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
Cancer risk from CT scans JAMA 2007; 298(3):317-23.
Background / Methods <ul><li>Computer model to determine lifetime risk of cancer from a CT coronary angiogram </li></ul><u...
CTCA - results
CTCA results - LARs Highest organ LARs: lung / breast mod + aorta CTCA mod + aorta CTCA 1/1000 1/526 1/1338 1/2550 1/833 1...
CTCA - conclusion <ul><li>CT angiography carries a non-negligible risk of cancer </li></ul><ul><li>Worse in younger women ...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
Nephrogenic Systemic Fibrosis (Nephrogenic Fibrosing Dermopathy)
Background / Methods <ul><li>“ To determine if NSF is associated with gadolinium” </li></ul><ul><li>Case-control study con...
NSF - results N = 25
NSF - results NSF rate = 4.6 cases per 100 PD patients, 0.61 per 100 HD patients
Gadolinium and NSF - conclusion <ul><li>Patients with stage IV/V chronic kidney disease are at risk of NSF, especially PD ...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
Circulation . 2007;116:894-900.
Background / Methods <ul><li>Physicians’ Health Study component </li></ul><ul><li>51,000+ men (91% Caucasian) </li></ul><u...
Gout and CHD - results
Gout and CHD - results
Gout and CHD - conclusion <ul><li>Men with gout had an approximately 25% increase in cardiovascular disease and cardiac mo...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
Circulation . 2007;116:894-900. Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE)
Background / Methods <ul><li>“Optimal medical management” (OMM) recommended for stable CAD </li></ul><ul><li>In 2004, 85% ...
PCI for stable CAD - results <ul><li>Similar use of medications (ASA, beta blocker, statin, ACE): 71-95% </li></ul><ul><li...
PCI for stable CAD - results
PCI for stable CAD - conclusion <ul><li>“Elective PCI for patients with stable CAD has not been shown to reduce future cor...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
 
Background / Methods <ul><li>Aim: To determine if rosiglitazone has an effect on cardiovascular outcomes </li></ul><ul><li...
Rosiglitazone - results
Rosiglitazone - results
Rosiglitazone - results <ul><li>All cause mortality unchanged </li></ul><ul><li>Risk of MI higher with rosiglitazone use w...
Rosiglitazone – questions raised <ul><li>Is this a class effect? </li></ul><ul><ul><li>All TZDs are not alike (pioglitzaon...
Rosiglitazone - conclusion <ul><li>NEJM authors: “Our data suggest a cardiovascular risk associated with the use of rosigl...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
 
Background / Methods <ul><li>Aim: To determine if patients with mild persistent asthma could be controlled with simpler tr...
Background / Methods <ul><li>Baseline characteristics were not the same </li></ul><ul><ul><li>Fewer smokers in ICS group <...
Mild persistent asthma - results 30% failure 20% failure for both groups
Asthma - results <ul><li>% of symptom-free days similar for all groups </li></ul><ul><li>More patients in ICS group and IC...
Asthma treatment - conclusion <ul><li>NEJM authors: “Patients whose asthma is well controlled with the use of twice daily ...
 
Asthma treatment Bottom line:  Montelukast should be used for patients with a specific indication (allergies, asthma trigg...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
Beclomethasone plus Salbutamol Treatment (BEST)
Background / Methods <ul><li>Aim: To determine if symptom-driven therapy for mild persistent asthma is effective. </li></u...
 
 
 
BEST – results / conclusion <ul><li>All three arms better than as needed albuterol </li></ul><ul><li>Cumulative dose of IC...
Asthma – ACP reviewers’ comments <ul><li>Very specified population of asthma patients </li></ul><ul><ul><li>Mild, persiste...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
 
Background / Methods <ul><li>Aim: To determine if  alpha –blockers and calcium channel blockers hasten stone passage </li>...
Stone therapy - results Alpha-blocker forest plot NNT = 3.3
Stone therapy - results Calcium channel blocker forest plot NNT = 3.2
Stone therapy - results <ul><li>Side effects were low </li></ul><ul><ul><li>Alpha blocker: 4% had any side effect </li></u...
Stone therapy - conclusion <ul><li>Meta analysis; so firm conclusions limited </li></ul><ul><li>Consistent with other simi...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
 
Background / Methods <ul><li>Aim: To determine if Gardasil </li></ul><ul><ul><li>Reduces HPV infection </li></ul></ul><ul>...
Quadrivalent HPV vaccine - results <ul><li>Vaccine prevented 98% of HPV 16,18-related high-grade cervical lesions in per-p...
Quadrivalent HPV vaccine - results
Gardasil - results <ul><li>Nearly 100% effective in preventing new HPV 16 or 18 infections </li></ul><ul><li>Side effects ...
HPV vaccine - conclusion <ul><li>Vaccine very effective in preventing new infections and cervical abnormalities in suscept...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
 
Background / Methods <ul><li>Aim: To compare CT colography to optical colonoscopy for the detection of advanced colon neop...
CT colography - results
CT colography - results <ul><li>“ Fewer invasive procedures” </li></ul><ul><ul><li>Depends upon your idea of invasive </li...
CTC versus optical colonoscopy - conclusion <ul><li>“ CTC compares favorably to colonoscopy at finding asymptomatic colon ...
Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing ...
 
Background / Methods <ul><li>Some investigators have found little evidence to support the periodic health exam </li></ul><...
PHE - results
PHE - results <ul><li>Performing a periodic health exam did show improvement in the delivery of some routine / preventive ...
PHE - conclusion <ul><li>“ While more evidence is needed, particularly on long term clinical outcomes, the data assembled ...
 
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Update in Internal Medicine (Adams)

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  • A fib occurred &gt;30 days after infusion; no plausible biologic mechanism except altered Ca levels, but Zoledronic acid is undetectable at 30 days, and Ca is normal.
  • A fib occurred &gt;30 days after infusion; no plausible biologic mechanism except altered Ca levels, but Zoledronic acid is undetectable at 30 days, and Ca is normal.
  • Update in Internal Medicine (Adams)

    1. 1. Internal Medicine Update 2008 Michael Adams, M.D., FACP Associate Professor of Medicine Georgetown University Hospital
    2. 2. Credits <ul><li>ACP Annual Session (permission received) </li></ul><ul><li>Robert Cato, M.D., FACP </li></ul><ul><li>Jack Ende, M.D., FACP </li></ul><ul><li>Individual authors </li></ul>
    3. 3. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    4. 4. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    5. 5. The Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly ( Horizon) trial
    6. 6. Background / Methods <ul><li>45% of women non compliant with oral bisphosphonates at one year </li></ul><ul><li>Zoledronic acid is once-yearly, IV infusion </li></ul><ul><li>Decreases bone turnover and improves BMD </li></ul><ul><li>Fracture trial </li></ul><ul><li>7000 women with osteoporosis </li></ul><ul><li>Multi center RCT, 3 year follow up </li></ul><ul><li>Primary endpoints: spine / hip fractures </li></ul><ul><li>Secondary endpoints: BMD </li></ul>
    7. 7. Horizon - results NNT (hip fx) = 91 NNT (vertebral fx via X-ray) = 13 NNT (clinical vertebral fx) = 48
    8. 8. Horizon <ul><li>Fracture outcomes independent of bisphosphonate use </li></ul><ul><li>BMD improved 5-8% (placebo: 1-2% decrease) </li></ul><ul><li>Temporary side effects noted day of infusion </li></ul><ul><li>“ Serious” atrial fibrillation higher in Zoledronic acid patients (1.3% vs. 0.5%) </li></ul><ul><li>Increased creatinine (1.2% vs. 0.4%) - transient </li></ul><ul><li>No mortality differences </li></ul><ul><li>Jaw osteonecrosis: 1 per group </li></ul>
    9. 9. Horizon – Conclusions <ul><li>Zoledronic acid increases BMD and reduces fx at similar rates to oral bisphosphonates </li></ul><ul><li>Not a comparison trial </li></ul><ul><li>Hurdles: </li></ul><ul><ul><li>Infusion </li></ul></ul><ul><ul><li>Concern for a fib </li></ul></ul>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. 10. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    11. 11. Obesity surgery
    12. 12. Bariatric surgery <ul><li>2000 obese (BMI > 34 for men, >38 for women) who underwent surgery in Sweden 1987-2001 </li></ul><ul><li>Cohort analysis, non-randomized </li></ul><ul><li>No standardization of care, few exclusions </li></ul><ul><li>99.9% follow up (vital status) </li></ul>
    13. 13. Results – weight loss Controls: +1% Surgical: -18%
    14. 14. Results – mortality 5% 6% Mortality without baseline CVD 19% (p<0.05) 25% Mortality with baseline CVD 5% (P=0.02) 6.3% Mortality surgical control
    15. 15. Results – causes of mortality
    16. 16. Bariatric surgery trial – Conclusions <ul><li>Surgery patients had reduced weight, mortality from CV causes and cancer (Causal?) </li></ul><ul><li>Non-randomized </li></ul><ul><li>Most surgery was gastric banding (not bypass) </li></ul><ul><li>No specific follow up in control group (selection bias? More participation in health care in surgery group?) </li></ul><ul><li>BMIs used don’t correspond to definition of obesity </li></ul>
    17. 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. 18. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    19. 19. Cancer risk from CT scans JAMA 2007; 298(3):317-23.
    20. 20. Background / Methods <ul><li>Computer model to determine lifetime risk of cancer from a CT coronary angiogram </li></ul><ul><li>Lung / breast </li></ul><ul><li>Calculated age-specific LARs (lifetime attributable risk) </li></ul><ul><li>Delineated by sex </li></ul><ul><li>Estimated risk using dose reduction strategies </li></ul>
    21. 21. CTCA - results
    22. 22. CTCA results - LARs Highest organ LARs: lung / breast mod + aorta CTCA mod + aorta CTCA 1/1000 1/526 1/1338 1/2550 1/833 1/3261 Age 80 1/715 1/313 1/466 1/1911 1/556 1/1241 Age 60 1/377 1/220 1/284 1/1150 1/541 1/1007 Age 40 1/219 1/114 1/143 1/1000 1/435 1/686 Age 20 Women Men
    23. 23. CTCA - conclusion <ul><li>CT angiography carries a non-negligible risk of cancer </li></ul><ul><li>Worse in younger women </li></ul><ul><li>May be reduced by modifying radiation techniques </li></ul>Bottom line: CTCA for identifying patients with CAD should not be done indiscriminately.
    24. 24. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    25. 25. Nephrogenic Systemic Fibrosis (Nephrogenic Fibrosing Dermopathy)
    26. 26. Background / Methods <ul><li>“ To determine if NSF is associated with gadolinium” </li></ul><ul><li>Case-control study conducted by CDC after nephrologist reported a cluster of NSF cases </li></ul><ul><li>Controlled for other radiologic contrast agents and erythropoeitin </li></ul><ul><li>4-year data collection </li></ul>
    27. 27. NSF - results N = 25
    28. 28. NSF - results NSF rate = 4.6 cases per 100 PD patients, 0.61 per 100 HD patients
    29. 29. Gadolinium and NSF - conclusion <ul><li>Patients with stage IV/V chronic kidney disease are at risk of NSF, especially PD patients. </li></ul><ul><li>Time to onset ranges from days to years (median = 76 days) </li></ul>Bottom line: Gadolinium should be avoided if GFR < 30. If absolutely necessary, nongadolinium should be used, or HD should be done ASAP post gadolinium.
    30. 30. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    31. 31. Circulation . 2007;116:894-900.
    32. 32. Background / Methods <ul><li>Physicians’ Health Study component </li></ul><ul><li>51,000+ men (91% Caucasian) </li></ul><ul><li>Association between gout, death, CHD </li></ul><ul><li>Multivariate analysis to adjust for other risk factors </li></ul><ul><li>12 year follow up </li></ul>
    33. 33. Gout and CHD - results
    34. 34. Gout and CHD - results
    35. 35. Gout and CHD - conclusion <ul><li>Men with gout had an approximately 25% increase in cardiovascular disease and cardiac mortality </li></ul><ul><li>Association with uric acid and CVD: </li></ul><ul><ul><li>Renin-angiotensin system activation </li></ul></ul><ul><ul><li>Chronic inflammation </li></ul></ul><ul><ul><li>Direct effect of uric acid on endothelium </li></ul></ul><ul><ul><li>Associated risk factors for gout </li></ul></ul>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. 36. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    37. 37. Circulation . 2007;116:894-900. Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE)
    38. 38. Background / Methods <ul><li>“Optimal medical management” (OMM) recommended for stable CAD </li></ul><ul><li>In 2004, 85% of all PCI procedures were elective and in stable CAD patients </li></ul><ul><li>Aim: to determine if PCI reduces mortality and/or events in this population </li></ul><ul><li>2,000+ patients; PCI (+OMM) versus OMM alone </li></ul><ul><li>5 years </li></ul>
    39. 39. PCI for stable CAD - results <ul><li>Similar use of medications (ASA, beta blocker, statin, ACE): 71-95% </li></ul><ul><li>BP similar </li></ul><ul><li>LDL 71 </li></ul><ul><li>Short term improvements seen in angina in PCI group (similar to previous studies), but this disappeared by year 5 </li></ul>
    40. 40. PCI for stable CAD - results
    41. 41. PCI for stable CAD - conclusion <ul><li>“Elective PCI for patients with stable CAD has not been shown to reduce future coronary events or mortality.” </li></ul><ul><li>This group had better medical management than usual care </li></ul><ul><li>Study done prior to DES </li></ul>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. 42. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    43. 44. Background / Methods <ul><li>Aim: To determine if rosiglitazone has an effect on cardiovascular outcomes </li></ul><ul><li>Meta analysis </li></ul><ul><li>Excluded studies with zero events </li></ul><ul><li>40 studies which lasted 6 months or more </li></ul><ul><li>Outcomes reviewed: MI, cardiovascular death </li></ul>
    44. 45. Rosiglitazone - results
    45. 46. Rosiglitazone - results
    46. 47. Rosiglitazone - results <ul><li>All cause mortality unchanged </li></ul><ul><li>Risk of MI higher with rosiglitazone use when compared with other diabetic drugs combined (but not individually) </li></ul><ul><ul><li>Insulin </li></ul></ul><ul><ul><li>Metformin </li></ul></ul><ul><ul><li>Sulfonylurea </li></ul></ul><ul><li>Overall event rates were very low (0.5%) </li></ul>
    47. 48. Rosiglitazone – questions raised <ul><li>Is this a class effect? </li></ul><ul><ul><li>All TZDs are not alike (pioglitzaone better on lipid profile, rosiglitazone may increase LDL) </li></ul></ul><ul><li>Was the effect related to LDL levels alone? </li></ul><ul><li>CHF (TZDs may precipitate heart failure) </li></ul><ul><li>Is this a function of patients who have harder to control diabetes? </li></ul><ul><li>Typical CHD combined endpoints were not studied </li></ul><ul><li>Inherent limitations of meta analysis </li></ul>
    48. 49. Rosiglitazone - conclusion <ul><li>NEJM authors: “Our data suggest a cardiovascular risk associated with the use of rosiglitazone.” </li></ul><ul><li>ACP reviewers: </li></ul>Bottom line: Inconclusive. One ongoing study (RECORD) is not showing CV events with rosiglitzaone, and pioglitazone may reduce events (meta analysis). Use caution.
    49. 50. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    50. 52. Background / Methods <ul><li>Aim: To determine if patients with mild persistent asthma could be controlled with simpler treatment than twice daily inhaled corticosteroids </li></ul><ul><li>3 arms: </li></ul><ul><ul><li>Twice daily ICS </li></ul></ul><ul><ul><li>once daily ICS + LABA </li></ul></ul><ul><ul><li>Montelukast </li></ul></ul><ul><li>Outcomes: “treatment failure” = more intense management, symptom scores, physiologic deterioration </li></ul>
    51. 53. Background / Methods <ul><li>Baseline characteristics were not the same </li></ul><ul><ul><li>Fewer smokers in ICS group </li></ul></ul><ul><ul><li>More patients in montelukast group used daily ICS at baseline </li></ul></ul><ul><ul><li>Higher mini-AQLQ score in ICS group (less severe asthma) </li></ul></ul><ul><ul><li>Less GERD in ICS + LABA group </li></ul></ul><ul><ul><li>Fewer patients in montelukast group were triggered by allergens </li></ul></ul>
    52. 54. Mild persistent asthma - results 30% failure 20% failure for both groups
    53. 55. Asthma - results <ul><li>% of symptom-free days similar for all groups </li></ul><ul><li>More patients in ICS group and ICS + LABA group wanted to continue treatment </li></ul><ul><li>Funding: </li></ul><ul><ul><li>GSK </li></ul></ul><ul><ul><ul><li>Reviewed protocol </li></ul></ul></ul><ul><ul><ul><li>Reviewed final manuscript & offered comments for writing committee </li></ul></ul></ul><ul><ul><li>American Lung Association </li></ul></ul>
    54. 56. Asthma treatment - conclusion <ul><li>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.” </li></ul><ul><li>ACP reviewers: similar conclusions </li></ul><ul><li>Baseline differences in groups </li></ul><ul><ul><li>Esp. allergens and ICS use at baseline </li></ul></ul><ul><li>6 month study </li></ul>
    55. 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.
    56. 59. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    57. 60. Beclomethasone plus Salbutamol Treatment (BEST)
    58. 61. Background / Methods <ul><li>Aim: To determine if symptom-driven therapy for mild persistent asthma is effective. </li></ul><ul><li>4 arms: </li></ul><ul><ul><li>prn albuterol </li></ul></ul><ul><ul><li>prn combined ICS + albuterol </li></ul></ul><ul><ul><li>regular, twice daily ICS (+ prn albuterol) </li></ul></ul><ul><ul><li>regular, twice daily combined ICS + albuterol </li></ul></ul><ul><li>Outcomes: PEFs, symptom scores, severity of exacerbations </li></ul>
    59. 65. BEST – results / conclusion <ul><li>All three arms better than as needed albuterol </li></ul><ul><li>Cumulative dose of ICS lower in in as-needed combination group than other ICS groups </li></ul><ul><li>Target: mild, persistent asthmatics with infrequent exacerbations (compliance) </li></ul>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.
    60. 66. Asthma – ACP reviewers’ comments <ul><li>Very specified population of asthma patients </li></ul><ul><ul><li>Mild, persistent </li></ul></ul><ul><ul><li>Well-controlled </li></ul></ul><ul><ul><li>Did well in run-in period </li></ul></ul><ul><li>Motivation: less expensive / more convenient therapy </li></ul><ul><li>Concern: “adequate suppression of subclinical airway inflammation (some believe this is little more than theoretical).” </li></ul>
    61. 67. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    62. 69. Background / Methods <ul><li>Aim: To determine if alpha –blockers and calcium channel blockers hasten stone passage </li></ul><ul><li>Medical therapy may reduce need for surgery / ureteroscopy / lithotripsy and may reduce stricture and kidney damage </li></ul><ul><li>Meta analysis, 211 studies yielded 22 randomized trials </li></ul><ul><li>2000 patients </li></ul><ul><li>Tamsulosin, nifedipine </li></ul><ul><li>Outcome = likelihood of stone expulsion at 4 weeks </li></ul>
    63. 70. Stone therapy - results Alpha-blocker forest plot NNT = 3.3
    64. 71. Stone therapy - results Calcium channel blocker forest plot NNT = 3.2
    65. 72. Stone therapy - results <ul><li>Side effects were low </li></ul><ul><ul><li>Alpha blocker: 4% had any side effect </li></ul></ul><ul><ul><ul><li>0.2% discontinued use </li></ul></ul></ul><ul><ul><li>CCB: 15.2% had any side effect </li></ul></ul><ul><ul><ul><li>2.9% discontinued use </li></ul></ul></ul><ul><ul><li>Most were mild </li></ul></ul><ul><li>2 to 6 day average improvement in stone expulsion </li></ul><ul><li>Stone size was 3-18 mm (mean 5 mm) </li></ul>
    66. 73. Stone therapy - conclusion <ul><li>Meta analysis; so firm conclusions limited </li></ul><ul><li>Consistent with other similar analyses reviewing expulsion of stones 5-10 mm </li></ul>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.
    67. 74. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    68. 76. Background / Methods <ul><li>Aim: To determine if Gardasil </li></ul><ul><ul><li>Reduces HPV infection </li></ul></ul><ul><ul><li>Reduces infection with HPV 16 and 18 </li></ul></ul><ul><ul><li>Reduces CIN 2, CIN3 (and adenocarcinoma) </li></ul></ul><ul><ul><li>In </li></ul></ul><ul><ul><ul><li>All women, and </li></ul></ul></ul><ul><ul><ul><li>women without HPV infection or abnormal PAP smear </li></ul></ul></ul><ul><li>12000 patients, aged 15-26 </li></ul>
    69. 77. Quadrivalent HPV vaccine - results <ul><li>Vaccine prevented 98% of HPV 16,18-related high-grade cervical lesions in per-protocol population (no abnormality at baseline) </li></ul><ul><li>44% reduction in intention-to-treat analysis </li></ul><ul><li>No effect in patients with preexisting HPV 16 or 18 infections or abnormal PAPs </li></ul>
    70. 78. Quadrivalent HPV vaccine - results
    71. 79. Gardasil - results <ul><li>Nearly 100% effective in preventing new HPV 16 or 18 infections </li></ul><ul><li>Side effects were low </li></ul><ul><li>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.” </li></ul>
    72. 80. HPV vaccine - conclusion <ul><li>Vaccine very effective in preventing new infections and cervical abnormalities in susceptible patients </li></ul><ul><li>Studies women aged 15-26 (approved for 11-26) </li></ul>Bottom line: The HPV vaccine seems to be effective as prophylaxis and has limited side effects.
    73. 81. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    74. 83. Background / Methods <ul><li>Aim: To compare CT colography to optical colonoscopy for the detection of advanced colon neoplasms </li></ul><ul><li>Definition of advanced neoplasm: </li></ul><ul><ul><li>> 10mm </li></ul></ul><ul><ul><li>High grade dysplasia </li></ul></ul><ul><ul><li>Prominent villous component (> 75%) </li></ul></ul><ul><li>Retrospective analysis, 3000 patients </li></ul>
    75. 84. CT colography - results
    76. 85. CT colography - results <ul><li>“ Fewer invasive procedures” </li></ul><ul><ul><li>Depends upon your idea of invasive </li></ul></ul><ul><ul><li>Insufflation necessary </li></ul></ul><ul><li>7.7% of CTC patients had extracolonic findings </li></ul><ul><ul><li>Is this good or bad? </li></ul></ul>
    77. 86. CTC versus optical colonoscopy - conclusion <ul><li>“ CTC compares favorably to colonoscopy at finding asymptomatic colon polyps” </li></ul><ul><li><50% of eligible patients undergo colon cancer screening </li></ul><ul><li>Will this increase the # of patients willing to get screened? </li></ul>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
    78. 87. Topics <ul><li>Osteoporosis </li></ul><ul><li>Obesity / bariatric surgery </li></ul><ul><li>Hazards of Radiologic Testing </li></ul><ul><ul><li>Cancer risk associated with radiation exposure </li></ul></ul><ul><ul><li>Nephrogenic systemic fibrosis </li></ul></ul><ul><li>Cardiovascular </li></ul><ul><ul><li>Gout and CHD </li></ul></ul><ul><ul><li>PCI for stable CAD </li></ul></ul><ul><ul><li>DM / thiazolidinediones and CHD </li></ul></ul><ul><li>Asthma </li></ul><ul><ul><li>Treatment for mild persistent </li></ul></ul><ul><ul><li>Symptom-driven therapy </li></ul></ul><ul><li>Kidney stones </li></ul><ul><li>HPV vaccination </li></ul><ul><li>Colon cancer screening </li></ul><ul><li>The periodic health exam </li></ul>
    79. 89. Background / Methods <ul><li>Some investigators have found little evidence to support the periodic health exam </li></ul><ul><li>This review used a model of benefit (improved clinical outcomes) versus harms (loss time at work, inappropriate tests, cost) of the PHE </li></ul>
    80. 90. PHE - results
    81. 91. PHE - results <ul><li>Performing a periodic health exam did show improvement in the delivery of some routine / preventive / screening health interventions </li></ul><ul><li>Mixed results on costs, mortality </li></ul><ul><li>No harms were found </li></ul>
    82. 92. PHE - conclusion <ul><li>“ 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.” </li></ul>Bottom line: There is evidence to support what we all inherently know - the value of the periodic health exam.

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