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Update in General Internal Medicine 2009

Update in General Internal Medicine 2009. Diane Altkorn, M.D. Elizabeth Marlow, M.D. Scott Stern, M.D. Adam Cifu, M.D. Outline. Screening for prostate cancer Diabetes Cardiology Cardiac CT Screening for CAD Treatment of CAD COPD Colon cancer screening. Prostate Cancer Screening.

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Update in General Internal Medicine 2009

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  1. Update in General Internal Medicine2009 Diane Altkorn, M.D. Elizabeth Marlow, M.D. Scott Stern, M.D. Adam Cifu, M.D.

  2. Outline Screening for prostate cancer Diabetes Cardiology Cardiac CT Screening for CAD Treatment of CAD COPD Colon cancer screening

  3. Prostate Cancer Screening

  4. Prostate Cancer Screening Trial Prospective RCT of 76,693 men in U.S. Age 55-74 (87% < 70) 85% White, 4% Black, 2% Hispanic Intervention Screened group: Annual PSA & DRE Control group: Screening unregulated + test defined as PSA > 4.0 Andriole GL, et al. NEJM. 2009;360:1310-9

  5. Prostate Cancer Screening Trial Workup of patients with PSA > 4.0 or abnormal DRE not specified Therapy of patients with prostate cancer not specified Primary outcome: prostate cancer specific mortality Secondary outcome: prostate cancer incidence, staging

  6. Screening Rates

  7. Incidence of Prostate Cancer ● Screened: 7.4% ● Control: 6% ● RR of prostate ca in screened group = 1.22 (1.16-1.29)

  8. Prostate Cancer Specific Mortality ● Screened: 2 deaths/10,000 person years ● Control: 1.7 deaths/10,000 person years

  9. Limitations 1/3 of patients had PSA + DRE before study entry ≥ 50% control group screened Follow-up only 10 years; data complete for only 7 yrs Few black patients

  10. Impact ? A lot of screening does not reduce prostate cancer mortality when compared to a medium amount of screening

  11. European Trial Prospective RCT of 162,243 men 55-69; mean age = 61 Followed for mean of 8.8 yrs Race not specified Netherlands, Belgium, Sweden, Finland, Italy, Spain, Switzerland Intervention: Screened group: PSA every 4 yrs Control group: No screening specified Schroder FH, et al. NEJM. 2009;360:1320-8

  12. European Trial Criteria for + PSA varied Most centers: abnormal defined as > 3.0 Others: PSA > 4.0 Others used combination of PSA and DRE or free/total PSA, TRUS Prostate cancer treatment not specified Primary outcome: prostate cancer specific mortality

  13. Results PSA testing Screened group: 82% Control group: ? Prostate cancer incidence Screened group: 8.2% Control group: 4.8%

  14. Prostate Cancer Mortality RR = 0.8 (0.67-0.98) Absolute risk of death Screened group 214/72,890  0.29% Control group 326/89,353  0.36% Absolute risk reduction 0.07% NNS to save one life = 1410

  15. Limitations Unclear what percentage of control group screened Presumably few black patients Follow-up only 9 years Treatment of prostate cancer not specified May be identifying indolent cancers

  16. Adverse Effects of Treatment 2002 data open prostatectomy 80% erectile dysfunction 43% incontinence 36% absolute risk increase NNH = 3 for both U of C robotic surgery data 10-20% erectile dysfunction at one year 4% incontinence at one year Holmberg L, et al. NEJM. 2002;347:781

  17. If you screen 1400 men . . . 224 (16%) will have a + screen and need a biopsy 140 (10%) will have cancer and need treatment If treated with robotic prostatectomy 14 will have erectile dysfunction 6 will have incontinence 1 life will be saved

  18. Diabetes

  19. Diabetes Your next 2 patients both have diabetes: first, a 52 year old woman with HTN whose DM was diagnosed 1 month ago, and second, a 69 year old man with CAD, PAD, and HTN who has had diabetes for 10 years. What are your treatment goals for these patients?

  20. UKPDS UK Prospective Diabetes Study Group. Lancet 1998;352:837-853. UK Prospective Diabetes Study Group. Lancet 1998;352:854-865

  21. UKPDS 10 Year Follow Up • Intervention stopped in 1997 • 3277/4209 pts monitored for 10 more yrs • At beginning of observation, intensive groups had • Better A1c • More medications • Similar BP and LDL • Outcomes: any DM event, DM death, any death, MI, CVA, PAD, microvascular Holman RR et al. NEJM. 2008;359:1577-1589

  22. No difference in A1c over time

  23. Outcomes

  24. Limitations/Impact • Incomplete follow up of cohort • Reliance on questionnaires • Limited information on other risk factors, medication use • Legacy effect → early, tight control may have long term benefits

  25. VA Diabetes Trial

  26. Background: ADVANCE + ACCORD

  27. ADVANCE/ACCORD Results

  28. VADT RCT of 1791 veterans with type 2 DM Mean age 60; duration DM 11.5 yrs 97% men; 17% smokers 62% white, 17% black, 16% Hispanic A1c 9.4; BP 132/76; LDL 108 40% macrovascular disease; 62% microvascular; 52% on insulin Duckworth W, et al. NEJM. 2009;360:129-139

  29. Intervention Goal: intensive A1c 1.5% < standard therapy Stratified by macrovasc disease, insulin use BMI ≥ 27 → metformin + rosiglitazone BMI < 27 → SU + rosiglitazone Intensive group started at maximal doses; standard group at ½ maximal Insulin + other agents added per protocol + investigator discretion

  30. Outcomes Primary: composite of CV events MI, stroke, CV death, CHF, CV intervention, inoperable CV disease, amputation for PAD Secondary: angina, claudication, TIA, any death, microvascular, hypoglycemia Median follow up 5.6 yrs

  31. Effects of Treatment Aspirin, statins for all patients ADA treatment guidelines followed

  32. Results No difference in primary composite endpt RR = 0.88 (0.74-1.05) No difference in any individual CV endpt Trend ↑ sudden death in intensive group 1.2% vs. 0.5%, p = 0.07 No difference in any death or microvasc endpts More hypoglycemia in intensive group 8.5% vs. 3.1%; NNH = 18.5

  33. Limitations/Impact • Insufficient power • Use of rosiglitazone • Limited population • Intensive control does not reduce macrovascular endpoints

  34. Hypoglycemia + Dementia Cohort study of 16,667 Kaiser pts with type 2 DM, age ≥ 55, and no dementia Mean age 65 Prospectively identified dementia diagnoses from 1/1/03-2007 Retrospectively collected hypoglycemic episodes from 1980-2002 Whitmer RA, et al. JAMA. 2009;301:1565-1572

  35. Results 11% of pts diagnosed with dementia (2003-2007) 8.8% had hypoglycemia (HG) (1980-2002) Slightly older More African Americans More insulin therapy More HTN, stroke, ESRD 68.5% one episode, 18% 2 episodes, 13.5% ≥ 3 episodes

  36. Patients with HG had more dementia Excess risk = 2.39%/yr If ≥ 2 episodes, excess risk > 4%/yr Adjusted HR = 1.44 (1.25-1.66) 1 episode: 1.26 2 episodes: 1.80 ≥ 3 episodes: 1.94

  37. Did dementia cause HG? 2 yr lagged model HG 1980-2002; dementia 2005-2007 2 episodes HR = 1.65 ≥ 3 episodes HR = 2.06 Backward lag model HG 1980-1985; dementia 2003-2007 ≥ 1 episode HR = 1.32 (1.02-2.13)

  38. Limitations/Impact • Clinical diagnosis of dementia and CVA/TIA • Hypoglycemia a marker of more severe DM • Observational study • Possible association between hypoglycemia and development of dementia

  39. Summary • Intensive control at the time of diagnosis may lead to long term reduction in CV and microvascular events. (UKPDS) • Intensive control in older pts with multiple risk factors or established CV disease does not reduce future CV events. (ACCORD, ADVANCE, VADT)

  40. Summary • Intensive control does reduce microvascular events. • Intensive control may be harmful. • Risk of death may be increased • Risk of hypoglycemia definitely increased, with possible increased risk of developing dementia

  41. Cardiology: Cardiac CT

  42. Two patients Your first patient of the day is a 50 year old executive who has seen press releases showing amazing pictures of CT angiography of coronary arteries. He wonders if he can have this done to be sure his coronaries are ok. He has no CAD risk factors and is asymptomatic. Your second patient is a 65 year old woman, with multiple risk factors and typical angina. She too wonders if CT can be done instead of conventional coronary angiography.

  43. Electron beam CT image MDCTA http://www.amiradiology.com/images/photos/ctcardiac-2.jpg

  44. CORE Trial 64 slice MDCTA vs. conventional coronary angiography (CCA) 291 patients with suspected CAD Mean age 59, 74% men 67% White, 23% Asian 66% HTN, 23% DM, 60% hyperlipidemia 58% angina, 21% unstable angina Exclusion criteria: Calcium score > 600, Cr. > 1.5 mg/dl, intolerance to ß blockers or HR > 80 (post ß blockers), advanced CHF Miller JM, et al. NEJM. 2008;359:2324-2336.

  45. Intervention All patients received MDCTA + CCA ß blockers given for HR > 70 BPM Outcome: Diagnostic accuracy of MDCTA All evaluators blinded to results of other test

  46. Results 22% patients ineligible (CAC score > 600) 2.5% patients incomplete MDCTA CAD in 56% (≥ 50% stenosis) Single vessel 27%, 2 vessel 21%, 3 vessel 8% 111 patients (38%) revascularized Adverse events MDCTA: 2/291 minor allergic reactions CCA: 1 of each: death, TIA, hematoma, pseudoaneurysm, DVT

  47. MDCT Test Characteristics Sensitivity 85% Specificity 90% LR+ = 8.5 LR- = 0.17

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