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Monday, November 22, 2010 CALL-IN TELEPHONE NUMBER: (888)-632-5065 ACCESS CODE: 89036596 #

AHRQ’s Effective Health Care Program: Applying Existing Evidence to Guide Prescription Medication Use. Monday, November 22, 2010 CALL-IN TELEPHONE NUMBER: (888)-632-5065 ACCESS CODE: 89036596 #. Questions. To submit a question:

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Monday, November 22, 2010 CALL-IN TELEPHONE NUMBER: (888)-632-5065 ACCESS CODE: 89036596 #

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  1. AHRQ’s Effective Health Care Program: Applying Existing Evidence to Guide Prescription Medication Use Monday, November 22, 2010 CALL-IN TELEPHONE NUMBER: (888)-632-5065 ACCESS CODE: 89036596#

  2. Questions To submit a question: • Press the “Ask Question” button located at the bottom of the screen. • When you click on the button, a box will appear at the bottom of your screen requesting that you enter your question. • Once completed, press the “Submit” button. CALL-IN NUMBER: (888)-632-5065 ACCESS CODE: 89036596# 2

  3. Agenda • Brief Overview of AHRQ’s Effective Health Care Program- Amanda Brodt, facilitator • Comparative Effectiveness of ACE Inhibitors and/or ARBs Added to Standard Medical Therapy for Treating Patients With Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function-C. Michael White, Pharm.D., FCP, FCCP • Q&A from Audience 3

  4. Questions To submit a question: Press the “Ask Question” button located at the bottom of the screen. When you click on the button, a box will appear at the bottom of your screen requesting that you enter your question. Once completed, press the “Submit” button. 4

  5. Patient-Centered Outcomes Research and AHRQ’s Effective Health Care Program Amanda Brodt, M.P.H. AHRQ’s Office of Communications and Knowledge Transfer 5

  6. Patient-Centered Outcomes Research • Also known as comparative effectiveness research • Unbiased and practical, evidence-based information • Compares drugs, devices, tests and surgeries, and approaches to health care • benefits and harms • what is known and what isn’t • Descriptive, not prescriptive Harms Benefits 6

  7. A Framework for Patient-Centered Outcomes Research Evidence Generation Strategies Interventions Conditions Populations Improvements in Health Care Horizon Scanning Evidence Need Identification Dissemination Translation Evidence Synthesis Research Platform Infrastructure – Methods Development – Training 7

  8. Research Focus: 14 Priority Conditions Arthritis and nontraumatic joint disorders Cancer Cardiovascular disease, including stroke and hypertension Dementia, including Alzheimer’s disease Depression and other mental health disorders Developmental delays, ADHD and autism Diabetes mellitus Functional limitations and disability Infectious diseases, including HIV/AIDS Obesity Peptic ulcer disease and dyspepsia Pregnancy including preterm birth Pulmonary disease/asthma Substance abuse 8

  9. Effective Health Care Program Translation Products Patient Decision Aid (available soon) Executive Summary Web Site Systematic Review Report Clinician Guide Faculty Slides Consumer Guide Interactive Case Study Policymaker Summary 9 CE Modules

  10. Medication Resources 10

  11. Public Involvement Report Translation & Dissemination Topic Generation Topic Refinement Research Review Research Needs Development Topic Development During the Research Process Disseminating the Findings • Nominate topics using the online form • Participate in key question refinement • Comment via the web on draft key questions and reports Web links Newsletter blurbs Articles or commentaries Web conferences Continuing Education 11

  12. Comparative Effectiveness of ACE Inhibitors and/or ARBs Added to Standard Medical Therapy for Treating Patients With Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function C. Michael White, Pharm.D., FCP, FCCP Professor of Pharmacy, University of Connecticut Director, UCONN/HH Evidence-based Practice Center, Hartford, CT 12

  13. Background Questions addressed Results for each question Outline of Material 13

  14. An estimated 80 million American adults (1 in 3) have one or more forms of cardiovascular disease. 38.1 million are estimated to be age 60 or older. 16.8 million adults have ischemic heart disease, also known as coronary heart disease. Health Impact of Cardiovascular Disease in the United States Miniño AM, et al. Natl Vital Stat Rep 2006;54(19):1-49; Lloyd-Jones D, et al. Circulation 2009;119:e21-181. 14

  15. Standard therapy that can reduce cardiovascular events: Antiplatelet therapy Statins β-blockers Aggressive modification of risk factors ACEIs and ARBs have established benefit in patients with heart failure and myocardial infarctions with left ventricular (LV) dysfunction. Standard Therapy forStable Ischemic Heart Disease 15 Gibbons RJ, et al. J Am Coll Cardiol 2002;41:159-68; Fraker TD, Fihn SD. J Am Coll Cardiol 2007;50:2264-74.

  16. Despite standard medical therapy, these patients continue to experience considerable morbidity and mortality. ACEIs and ARBs have established benefit in patients with heart failure and left ventricular dysfunction. The evidence for prophylactic use of ACEIs and ARBs in patients without heart failure and with preserved left ventricular systolic function is less clear. Rationale for Additional Therapies for Patients With Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin II-receptor blocker. 16

  17. RAAS System Angiotensinogen Kininogen Kallikrein Renin Vasodilation Angiotensin I Bradykinin Angiotensin-converting enzyme inhibitor Angiotensin-converting enzyme Kininase II Angiotensin II Inactive Decreased peripheralvascular resistance Angiotensin II-receptor blocker Angiotensin II Type I Receptors LEGEND Stimulatory signal Reaction Aldosterone secretion Vasoconstriction Inhibitory pharmacologic effect Ceconi C, et al. Cardiovasc Res 2007;73:237-46; Faxon DP, et al. Circulation 2004;109:2617-2625; Schmidt-Ott KM, et al. RegulPept 2000; 93:65-77; Song JC, White CM. Pharmacotherapy 2000;20:130-9; Song JC, White CM. ClinPharmacokinet2002;41:207-24; Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009. Increased Na+ and H2O reabsorption Increased peripheral vascular resistance 17

  18. The topic was nominated in a public process. A specialized Technical Expert Panel guided selection of the clinical questions that the research would address. The research was based on a well-defined systematic literature review process. The methods used followed the Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews. The draft underwent public comment and peer review. The final report is available online at http://effectivehealthcare.ahrq.gov/ehc/products/57/335/bodyfinal.pdf. The Development Process 18

  19. The GRADE system of the Cochrane Collaboration was used to rate the strength of evidence resulting from the research but with a slight modification. The modified system uses four domains — risk of bias, consistency, directness, and precision — for assessment. For the purposes of the review, the strength of evidence pertaining to each key question was classified into three broad categories or grades: Rating the Strength of Evidence: Modified GRADE AHRQ. Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews, Version 1.0; Brozek J, et al. GRADEpro Version 3.2 for Windows. Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009. 19

  20. The comparative effectiveness of different combination treatments: ACEI or ARB + Standard Therapy Versus Standard Therapy Alone ACEI + ARB + Standard Therapy Versus ACEI + Standard Therapy ACEI or ARB + Standard Therapy Versus Standard Therapy Alone Close to a Revascularization Procedure The benefits and harms associated with each treatment modality. The differences in the benefits or harms between various subpopulations of patients. Clinical Questions Addressed 20 Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009.

  21. Outcomes of Interest End Points: Benefits Total mortality Cardiovascular (CV) death Nonfatal myocardial infarction (MI) Stroke Composite endpoint (CV death, nonfatal MI, stroke) Revascularization Quality-of-life measures End Points: Harms Hyperkalemia Cough Angioedema Hypotension Rash Blood dyscrasias Syncope Withdrawal from trial Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009. 21

  22. Trials Evaluating the Addition of an ACEI or ARB to Standard Medical Therapy for Stable IHD and Preserved LV Function Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009. 22

  23. Drugs and Target Doses 23 Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009.

  24. Benefits With HIGH Levels of Evidence From Adding an ACEI to Standard Medical Therapy for Stable IHD With Preserved LV Function *The difference between the two event rates, divided by the event rate for patients not treated with an ACEI. †The difference between the event rate in patients treated without an ACEI and with an ACEI × 100. ‡Event rate over 3.7 years. 24 Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009.

  25. Benefits With HIGH Levels of Evidence From Adding an ACEI to Standard Medical Therapy for Stable IHD With PreservedLV Function* * Only the data from the Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (TRANSCEND) trial were used in the analysis. †The difference between the two event rates, divided by the event rate for patients not treated with an ARB. ‡The difference between the event rate in patients treated without an ARB and with an ARB × 100. Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009. 25

  26. Evidence-Based Harms of Addingan ACEIor an ARB to Standard Medical Therapy for Stable IHD With Preserved LV Function The balance of benefits to harms is favorable. Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009. 26

  27. Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET) was the only trial that investigated the addition of an ACEI/ARB combination to standard medical therapy versus standard medical therapy plus an ACEI alone. There was no evidence of any greater clinical benefit with the addition of the ACEI/ARB combination as opposed to an ACEI alone. In third arm, ARB therapy provided similar benefits to ACE inhibitor. ACEI/ARB Combination vs. ACEI Alone for Stable IHD With Preserved LV Function 27 Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009.

  28. Balance of benefits to harms not favorable. No benefits, risks elevated (Moderate Level of Evidence). Harms of ACEI/ARB Combination vs. ACEI Alone for Stable IHD With Preserved LV Systolic Function 28 Modified from Yusuf S, et al. New Engl J Med 2008;358:1547-59.

  29. The Addition of ACEI or ARB to Standard Medical Therapy (SMT) Versus SMT Alone Close to a Revascularization Procedure in IHD with Preserved LV Function Seven trials conducted. CABG = coronary artery bypass grafting surgery; PTCA = percutaneous transluminal coronary angioplasty. Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009. 29

  30. The balance of benefits to harms was not favorable There were no clinical benefits from adding ACEIs or ARBs close to a revascularization procedure. There was an increased risk for these harms: ACEI or an ARB to Standard Medical Therapy (SMT) Versus SMT Alone Close to a Revascularization Procedure in Stable IHD and Preserved LV Function 30 Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009.

  31. Final Summary of Results Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009. 31

  32. Informed Decisionmaking Process Using These Project Results 32

  33. Additional data needed to address the benefits and harms in the following patient subpopulations: Patients who are receiving antiplatelet therapy Patients of different ethnicities (especially African Americans and Latinos) Patients who have genetic polymorphisms of the angiotensin-converting enzyme gene or the angiotensin II type I receptor gene Gaps in Knowledge 33 Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009.

  34. Questions To submit a question: Press the “Ask Question” button located at the bottom of the screen. When you click on the button, a box will appear at the bottom of your screen requesting that you enter your question. Once completed, press the “Submit” button. 34

  35. For more information about… • AHRQ’s Effective Health Care Program: www.effectivehealthcare.ahrq.gov. • Accessing these FREE resources through AHRQ’s Publications Clearinghouse: (800) 358-9295. • E-mail notices: http://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/. • If you have a question about utilizing AHRQ resources please e-mail us at: EHC_Clinicians@ahrq.hhs.gov. 35

  36. Thank you! • Thank you for joining us today! • Please take a moment to provide us feedback at the end of this event. • A recording and transcript for today’s event will be available on AHRQ’s Web site. 36

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