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Update in Outpatient Internal Medicine

Update in Outpatient Internal Medicine. Robert A. Gluckman, MD, FACP Chief Medical Officer- Providence Health Plans March 6, 2012. Goals. PCI in stable CAD Using evidence to promote accountable care Practice variation in cardiac care Expanded use of aldosterone antagonists in CHF

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Update in Outpatient Internal Medicine

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  1. Update in Outpatient Internal Medicine Robert A. Gluckman, MD, FACP Chief Medical Officer- Providence Health Plans March 6, 2012

  2. Goals • PCI in stable CAD • Using evidence to promote accountable care • Practice variation in cardiac care • Expanded use of aldosterone antagonists in CHF • Niacin in patients with CAD and controlled LDL • New agents for stroke prophylaxis in atrial fibrillation • Anti-depressant use in the elderly • CT screening for lung cancer • USPTF Recommendations for PSA screening • Systems of Care • Hospital Discharge • Hypertension

  3. Does PCI added to OMT benefit patients with stable CAD?

  4. Initial Coronary Stent Implantation Plus Medical Therapy Alone as Initial Strategy in Stable CAD • Meta analysis 8 trials enrolled 7229 patients with one of: • Stable after MI • Inducible ischemia • Diabetes • Stable angina • Mean follow up 4.3 years • Drug eluting stents performed in a minority of patients Arch Int Med 2012:172:312-319

  5. Initial Coronary Stent Implantation Plus Medical Therapy Alone as Initial Strategy in Stable CAD

  6. Appropriate Use of PCI • Multicenter prospective study of patients within the National Cardiovascular Data Registry from 7/1/09- 9/30/10 • 500,154 PCI’s • 71.1% acute indications • STEMI, NSSTEMI, unstable angina with high risk features • 28.9% non-acute indication • 17 member expert panel developed appropriateness criteria • Classified as appropriate, uncertain, inappropriate • Acute interventions 98.6% appropriate • Inappropriate procedures largely stable patients, > 12 hours from symptom onset JAMA 2011; 306:53-61

  7. Appropriate Use of PCI • Non-acute PCI • 50.4% appropriate • 38% uncertain • 13.4%% had CCS Class III-IV angina • 5.1% documented high risk ischemia on non-invasive testing • 2.7% > 2 meds (83.5% on 0-1 med) • 11.6% inappropriate • 53.8% no symptoms • 68.7% documented low risk ischemia on non-invasive testing • 42.3% no meds, 53.5% 1 med

  8. Appropriateness of Diagnostic Angiography • Retrospective analysis of 565,504 patients without previous MI or revascularization from 2005-2008 undergoing elective coronary angiography JACC 2011;58:801-809

  9. Benefit and Practice Variation in the Use of PCI- Summary • OMT is preferred as initial strategy for stable CAD • The ACC is leading the way for specialty society efforts to reduce inappropriate procedures • General internists should be active collaborators rather than passive observers in engaging with specialty colleagues in reducing practice variation • Document anginal class and OMT prior to cardiology referral for CAD • Increased transparency of local and regional utilization patterns is coming and can potentially reduce ineffective or marginally effective utilization

  10. Should Niacin be added to a statin in patients with controlled LDL and low HDL?

  11. Niacin in Patients with Low HDL and CVD AIM-HIGH Investigators • 3414 patients with established CVD • HDL <40 mg/dl for men, < 50 mg/dl for women • Triglyceride 150-400 mg/dl • Simvastatin 40-80 mg to achieve LDL 40-80 mg/dl • Ezetimibe added to achieve target LDL if needed • Randomized to 1500-2000 mg extended release niacin (Niaspan) • Primary endpoint- CHD death, MI, CVA, symptom driven revascularization, hospitalization for ACS NEJM 2011;365:2255-67

  12. Niacin in Patients with Low HDL and CVDAIM-HIGH Investigators • Niacin to raise HDL in patients with CAD and controlled LDL of no benefit • Results of AIM-HIGH should not be extrapolated to CAD patients with uncontrolled LDL despite maximally tolerated statin therapy or statin intolerant patients • AIM-HIGH does not address raising HDL for primary prevention- no current evidence and costly

  13. Eplerenone in Patients with CHF and Mild Symptoms • 2737 patients with NYHA Class II CHF and EF ≤ 35% • Hospitalized within the last 6 months or increased BNP • Randomized to eplerenone titrated to 50 mg qd vs. placebo • Started 25 mg qd and increased to 50 mg qd at 4 weeks • If CrCl 30-49 ml/min started 25 mg qod and titrated to qd if K+ ≤ 5.0 • Dose decreased if K+ 5.5-5.9 • Drug stopped for K+ ≥ 6.0, remeasured after 72 hours and restarted if K+ < 5.0 NEJM 2011 ;364:11-21

  14. Eplerenone in Mild CHF

  15. Aldosterone Antagonists in CHF • Observational analysis of 43,625 patients admitted with CHF and discharged home • 242 hospitals participating in the Get With The Guidelines-HF Program • 12,565 patient eligible for aldosterone antagonist therapy • EF ≤ 35% • Serum potassium ≤ 5.0 mEq/L • Serum creatinine ≤ 2.5 mg/dl in men • Serum creatinine ≤ 2.0 mg/dl in women • 34.5% eligible patients received aldosterone antagonist • 10.55% inappropriate or potentially inappropriate use JAMA 2009 302;1658-1665

  16. Aldosterone Antagonists in CHF • Patients admitted for CHF may have multiple medication changes • Clinician concern about initiating multiple interventions may be a barrier to initiating treatment • Dose intensification of multiple medications is generally needed in CHF patients • Clinical inertia may be a barrier to optimal care in CHF • Need for specialty/PCP role clarification

  17. Rivaroxaban vs. Warfarin in non-valvular atrial fibrillation • 14,624 patients with non-valvular atrial fibrillation randomized to rivaroxaban 20 mg (factor Xa inhibitor) once daily vs. dose adjusted warfarin • Dose adjusted to 15 mg for CrCl 30-49 ml/min • Patients had CHADS2 score ≥ 2 • 87% had CHADS2 score ≥ 3 • 55% had previous embolic event • Time in therapeutic range 55% in warfarin group • Median follow up 2.1 years • Primary endpoint reported on per protocol analysis rather than intention to treat analysis NEJM 2011;365:883-91

  18. Rivaroxaban vs. Warfarin in non-valvular atrial fibrillation

  19. Apixiban for Atrial Fibrillation-ARISTOTLE Trial • 18,201 patients with atrial fibrillation and one additional risk factor for stroke • Randomized to a apixiban (Direct Factor Xa inhibitor) 5 mg po bid vs. warfarin • Dose reduced to 2.5 mg if 2 of the following • Age ≥ 80 • Weight ≤ 60 kg • Creatinine ≥ 1.5 mg/dl • INR median time in therapeutic range 66% • Median duration of follow-up 1.8 years • Primary outcome ischemic/hemorrhagic stroke or systemic embolism • Secondary outcome major bleeding, death NEJM 2011;365:981-92

  20. Apixiban for Atrial Fibrillation-ARISTOTLE Trial

  21. New Anticoagulants in Atrial Fibrillation- Summary • Apixiban, dabigitran, and rivoroxaban all reduce hemorrhagic stroke, major bleeding • Dabigitran only drug to reduce ischemic stroke • Apixibanredues rate of major bleeding and total mortality • Cost an issue, especially for Medicare patients or other coverage with greater cost share for drugs • Patients well controlled on warfarin may not require med change • Beneficial when difficult to control or monitor in adherent patients. • Cannot extrapolate to non-adherent patients due to shorter half life

  22. Anti-depressant Use and Risk in the Elderly • Cohort analysis of 60,746 patients in 570 practices in the UK • Mean age 75, 1/3 men, 2/3 women • Restricted analysis to patients with depression • Median duration of treatment 1 year • Mean follow up 5 years per patient • 89% patients received a prescription for antidepressant • 10.7% single prescription • 10.9% ≥ sixty prescriptions • 54.7% prescriptions SSRI • 31.6% prescriptions TCA • 70% low dose BMJ 2011;343:d4551

  23. Rates of outcomes highest with 28 days of starting or stopping drug

  24. Anti-depressant Use and Risk in the Elderly • Study limited due to observational design • Adjusted for age, sex, severity of depression, co-morbidities and other drugs • Possible explanations • Frail elderly may be given SSRI over TCA (channeling bias) • TCA frequently given at below defined daily doses (reflecting primary care practice)

  25. Sertraline or Mirtazipine for Depression in Dementia (HTA-SADD) • 326 patients with probable or possible dementia and depression ≥ 4 weeks, Cornell scale for depression in dementia >8 • Patients recruited from geriatric psychiatry services • Randomized to sertraline, mirtazipine, or placebo • Sertraline target dose 150 mg (mean 95 mg in patients on med) • Mirtazipine target dose 45 mg (mean 30 mg in patients on med) • Primary outcome- reduction in CSDD at 13 weeks • 39 week outcomes also assessed Lancet 2011;378:403-11

  26. Placebo Sertraline Mirtazipine Adverse events greater in drug groups Caregivers whose relatives given placebo had higher SF-12 and GHQ-12 scores at 13 weeks

  27. Conclusions- Anti-depressant treatment in the elderly • Caution warranted when prescribing antidepressants • Should not be prescribed without clear indication • SSRI’s may not be safer than other classes • Close follow-up warranted • Sertraline and mirtazipine do not appear effective in treating depression in patients with probable dementia • Trial of watchful waiting and care giver behavioral strategies should be first line in patients with dementia • Results not applicable to treatment of hallucinations, delusions or agitation in dementia but close follow up and assessment warranted

  28. Randomized Trial of DepressionFollow-Up Care by On Line Messaging • 208 patients with newly prescribed antidepressant depression in 9 primary clinics in Group Health Cooperative • Patients already enrolled in on line messaging • Excluded patients with anti-depressant within 270 days, with bi-polar disorder or any previous mood stabilizer, anti-psychotic • Randomized to usual care in primary care setting (including psychotherapy, medication, online messaging) vs. usual care plus nurse based outreach via online messaging • Outreach included PHQ-9, medication adherence, side effects, facilitated visits, referral as needed • 3 contacts plus additional patient initiated contact • Scripted response and algorithm based on questionnaire, tight coordination with PCP • Review with supervising psychiatrist, did not provide direct care JGIM 2011 26(7):698-704

  29. Randomized Trial of DepressionFollow-Up Care by On Line Messaging

  30. The National Lung Screening Trial • 53,454 patients age 55-74 with ≥ 30 pack year smoking history, current smoker or quit within 15 years • 8% age 70-74 • Randomized to yearly low dose chest CT vs. CXR for 3 years • Median follow-up 6.5 years • 18,146 positive tests in CT group • 96.4% false positive • 5,043 positive tests in CXR group • 94.5% false positive • Most diagnostic evaluations were f/u imaging • 4% CT group underwent a surgical procedure • 16 deaths, 6 in patients without lung cancer NEJM 2011;365:395-409

  31. 247/100,000 Patient-years 309/100,000 Patient-years 6.7% reduction in total mortality

  32. Conclusions- CT screening for lung cancer • In this trial, CT screening resulted in a 20% reduction in lung cancer death and 6.7% reduction in overall mortality • Complications uncommon but higher in screened group • Areas of uncertainty • Potential for higher rates of of biopsy in the community • Can low treatment complications be replicated • Overdiagnosis rate • Cost-effectiveness • Duration and interval of screening • Target patient population • Authors recommended policy makers wait for additional data • NCCN recommends screening in high risk smokers

  33. Screening for Prostate CancerUSPTF Review • Addressed 4 questions • Does PSA screening reduce all cause or prostate cancer specific mortality? • What are the harms of PSA screening? • What are the benefits of treatment of early stage or screening detected prostate cancer? • What are the harms of treatment of early stage or screening detected prostate cancer? • Grade D recommendation- population based screening provides net harm Annals of Int Med 2011; 155:762-771

  34. Screening for Prostate CancerUSPTF Review Does PSA screening reduce all cause or prostate cancer specific mortality? • 2 fair quality and 3 poor quality RCT’s included • PLCO no benefit after 7 years, limited due to severe contamination • ERSPC- 9 year follow up, benefit limited to pre-specified subgroup aged 55-69; 1410 NNS, 48 NNT • Göteberg participating center in ERPSC reported results separately 14 year follow up; NNS 294, NNT 12

  35. Screening for Prostate CancerUSPTF Review • What are the harms of PSA screening? • 12-13% false positive risk, 5.5% risk of negative biopsy • 3.5% biopsies result in fever, 0.5% hospitalization, 0.4% urinary retention • Adverse psychological effects not reported

  36. Screening for Prostate CancerUSPTF Review • What are the benefits of treatment of early stage or screening detected prostate cancer? • Prostatectomy compared with WW in 1 good quality RCT, 75% T2 tumors, not screen detected NNT 16, benefit limited to men ≤ 65x • Rad Rx 5 cohort studies 19-38% reduction in all cause mortality • RP cohort studies reveal 50-60% reduction in all cause mortality • PIVOT Trial awaiting publication; 12 year follow up; active surveillance in low risk prostate cancer equivalent to treatment

  37. Screening for Prostate CancerUSPTF Review • What are the harms of treatment of early stage or screening detected prostate cancer? • Prostatecomy assessed in 1 RCT, 4 cohort studies • Urinary incontinence absolute increased 24-28% • Erectile dysfunction increased 26-36% • Similar SF 36 to WW • 0.6%- 3% rate serious CV complication, 1-2% vascular event (i.e. DVT, PE) • Radiation Therapy • 14% ARI erectile dysfunction, 2.7%-7% rate of UI, small rate bowel urgency

  38. Screening for Prostate CancerUSPTF Review-Conclusions • Small mortality benefit in men < 70 • Harm and overdiagnosis serious public health hazard • Limited data on impact of a chronic illness that effects life expectancy (i.e. DM, HTN, CAD) • PHS multi-disciplinary team to develop a single recommendation • Reconsider continuation of screening in patients as they age or if patient has an illness that impacts life expectancy • If providers choose to perform PSA screening, strategies to promote active surveillance for low risk disease should be aggressively developed

  39. Care Transitions Intervention (CTI) • Quasi-experimental prospective cohort study of FFS Medicare patients in 6 Rhode Island hospitals • Assess generalizability of previous RCT • Intervention consisted of health coaching • Visit in hospital before discharge • Home visit within 3 days • Telephone call within 7-10 days • Final telephone call by day 30 • Coaches worked 18-24 hours per week and carried case loads of 12-15 patients Arch Int Medicine 2011;171:1232-37

  40. Intervention • Ensure medications taken match those prescribed and patients can describe which meds to take and how often • Identify health conditions and maintain a personal health record • Discuss/practice how to schedule a follow-up appointment • Patients make their own appointments • Help the patient recognize “red flags” that should prompt a telephone call or urgent appointment with provider • Enrolled patients in state-wide HIE • Discussed and encouraged completion of advanced directive

  41. Home BP Measurement and BP Control • 593 patients with 12 month average BP >140/90 despite medication randomized to • Usual care • Nurse administered behavioral therapy • Nurse/MD algorithm generated medication management • Combined behavioral/medication management • 59% of patients had controlled BP at protocol visit • BP taken by trained assistant after sitting 5 minutes in quiet room • Patients instructed to take BP every other day • Results automatically transmitted telephonically • Patients contacted if < BP’s transmitted over 2 weeks Arch of Int Medicine 2011;171:1173-80

  42. Hypertension • Remeasurement of BP using strict protocol may more accurately define patient population with uncontrolled hyperension • Patients with uncontrolled hypertension require therapeutic intensification and efforts to improve adherence • Team based care and frequent patient/provider contact increases BP control

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