Status Report on the NHLBI-Sponsored CVD Prevention Guidelines

Transcription

1 Status Report on the NHLBI-Sponsored CVD Prevention Guidelines HIGH BLOOD PRESSURE Paul A. James, M.D. Roy J. and Lucille A. Carver College of Medicine The University of Iowa Iowa City IA

2 NHLBI Adult CVD Prevention Guidelines NHLBI-SPONSORED ADULT CVD PREVENTION GUIDELINES Joint National Committee on Prevention, Detection, Evaluation, & Treatment of High Blood Pressure (JNC) JNC 7: 2003 JNC 6: 1997 JNC 5: 1992 JNC 4: 1988 JNC 3: 1984 JNC 2: 1980 JNC 1: 1976 Detection, Evaluation, &Treatment of High Blood Cholesterol in Adults (ATP, Adult Treatment Panel) ATP III Update: 2004 ATP III: 2002 ATP II: 1993 ATP I: 1988 Clinical Guidelines on the Identification, Evaluation, & Treatment of Overweight and Obesity in Adults Obesity: 1998

3 Hypertension: A Moving Target JNC Classifications: Diastolic Blood Pressure Stage 4 DBP (mm Hg) Hypertensive Severe Severe Severe Moderate Moderate Moderate Stage 3 Stage 3 Stage 2 Stage 2 Stage Consider therapy Mild Mild Mild Stage 1 Stage 1 Stage Highnormal Highnormal Highnormal Highnormal Normal Normal Normal Normal Optimal Optimal Prehypertension Normal JNC I JNC II JNC III JNC IV JNC V JNC VI JNC 7 JNC I. JAMA. 1977;237: JNC II. Arch Intern Med. 1980;140: JNC III. Arch Intern Med. 1984;144: JNC IV. Arch Intern Med. 1988;148: JNC V. Arch Intern Med. 1993;153: JNC VI. Arch Intern Med. 1997;157: Chobanian AV et al. JAMA. 2003;289:

4 Hypertension: A Moving Target JNC Classifications: Systolic Blood Pressure 220 Stage Stage 3 Stage 3 SBP (mm Hg) No recommendations for SBP in JNC I or JNC II ISH Borderline ISH Borderline Normal Stage 2 Stage 2 Stage 1 Stage 1 Highnormal Highnormal Normal Normal Optimal Optimal Stage 2 Stage 1 Prehypertension Normal JNC I JNC II JNC III JNC IV JNC V JNC VI JNC 7 JNC I. JAMA. 1977;237: JNC II. Arch Intern Med. 1980;140: JNC III. Arch Intern Med. 1984;144: JNC IV. Arch Intern Med. 1988;148: JNC V. Arch Intern Med. 1993;153: JNC VI. Arch Intern Med. 1997;157: Chobanian AV et al. JAMA. 2003;289:

5 JNC 7 Emphasized Importance of Lower Blood Pressure JNC VI (1997) OPTIMAL < 120 and < 80 NORMAL < 130 and < 85 HIGH NORMAL or STAGE or STAGE or STAGE or 110 JNC VI. Arch Intern Med. 1997;157: JNC 7 (2003) NORMAL < 120 and < 80 PREHYPERTENSION or STAGE or STAGE or 100 JNC 7. JAMA. 2003;289(19):

6 Institute of Medicine Report: Quality Chasm In its current form, habits, and environment, American health care is incapable of providing the public with the quality health care it expects and deserves. Current: Decision making is based on training and experience. New: Decision making is based on evidence. Patients should receive care based on the best available scientific knowledge. Care should not vary illogically from clinician to clinician or from place to place. Evidence-based Clinical Practice Guidelines can help make this vision a reality Institute of Medicine, Crossing the Quality Chasm: New Health System for the Twenty-first Century. Washington: National Academy Press, 2001

7 Scientific Evidence Underlying ACC/AHA Guidelines (JAMA. 2009; 301: ) AHA LEVEL OF "A EVIDENCE IN CURRENT GUIDELINES* AF Heart failure 11.7% 26.4% PAD STEMI 15.3% 13.5% Perioperative Secondary prevention 12.0% 22.9% Stable angina SV arrhythmias UA/NSTEMI 6.4% 6.1% 23.6% Valvular disease VA/SCD 0.3% 9.7% PCI CABG Pacemaker Radionuclide imaging 4.9% 4.8% 11.0% 19.0% *in guidelines with level of evidence 0% 10% 20% 30%

8 Recent Evidence is changing practice New Evidence is causing us to question aggressive disease management strategies Important health outcomes rather than markers of disease are being examined. Examples: ACCORD (2010): Diabetics not improved with tighter control. JATOS (2008) and Valish (2010): Hypertension: no improvement in outcomes with Goal BP of <140 mm Hg in elderly compared to 150 mm Hg. Courage (2007): Stable angina: no benefit with PTCA over medical management

9 ACCORD Trial: A study that will change our practice. High risk patients for CVD with Type 2 DM: Average age = 62.2 years old. 1/3 had previous CV event. Studied intensive management of diabetes, blood pressure and lipids. Baseline: A1c = 8.3%, BP = 139/76, T.Chol = 193 mg/dl Documented the harms of intensive (overly exuberant?) therapy to manage risk factors for CVD.

10 ACCORD Trial Blood Pressure goal among high risk patients for CVD: Lower is not always better. Systolic BP<140 just as good as BP<120 for major CV events. Only stroke rate improved but overall mortality did not. Glycemic control with A1c of 6.5% compared to 7.5% did not reduce major CV events but mortality increased with more intensive treatment. Lipid control with fenofibrate added to simvastatin did not reduce major CV events, nonfatal MI or nonfatal stroke.

11 ACCORD Trial If we do not see benefit in high risk persons, we must question the goals of therapy in lower risk individuals. We need better RCT s and we should not rely on observational data. There are many incentives within our current health care system to prescribe and over treat. We must further assess the harms.

12 Adult CVD Guidelines: NHLBI approach Advice to NHLBI from advisory groups: Update risk factor guidelines (hypertension, cholesterol, obesity) Develop an integrated guideline Use an evidence-based approach including systematic reviews The NHLBI guideline development process Was established to assure rigor and to minimize bias Methods being used meet many of the new IOM standards Two recent IOM reports set new standards Finding What Works in Health Care standards for systematic reviews Clinical Practice Guidelines We can Trust standards for developing trustworthy CPGs

13 Expertise Represented Hypertension, primary care, cardiology, nephrology, clinical trials, research methodology, evidence-based medicine, epidemiology, guideline development and implementation, nutrition/lifestyle, nursing, pharmacology, systems of care, and informatics Panel also includes senior scientists from NHLBI and NIDDK with expertise in hypertension, clinical trials, translational research, nephrology, guideline development, and evidence-based methodology

14 Disclosures 4 panel members had relationships with industry to disclose 13 panel members had no relationships to disclose Panel members disclose their relationships and recuse themselves from voting on evidence statements and recommendations relevant to their relationships Guideline Executive Committee Policy on Disclosures:

15 How the Process Has Evolved Strictly evidence-based Focus only on randomized controlled trials assessing important health outcomes (no use of intermediate/surrogate measures) Every included study is rated for quality by two independent reviewers using standardized tools Evidence statements graded for quality using prespecified criteria Separate grading for recommendations Independent methodology team to ensure objectivity of the review Initial set of recommendations focused on 3 key questions

16 How Were Questions Selected? Panel Chairs and NHLBI staff developed questions based on their expertise, brief literature review, and speaking with colleagues These questions were sent to panel members to review, revise, and add or delete questions Resulted in 23 questions, which were sent to all panel members Panel members discussed these questions on conference calls, then independently ranked the 3-5 questions felt to be of highest priority The five highest ranked questions discussed further and prioritized

17 Rationale for the Questions Interest in assessing the evidence to support 140/90 mm Hg as a treatment threshold or goal Should the treatment threshold / goal be lower in populations with diabetes, chronic kidney disease, coronary artery disease, stroke, and other co-morbidities or characteristics? Should the treatment threshold / goal be different in older adults? Use of different treatment thresholds and goals is confusing Is there evidence that treatment to lower BP with a particular drug or drug class improves outcomes compared to another?

18 Question 1 Among adults with hypertension, does initiating antihypertensive pharmacological therapy at specific BP thresholds improve health outcomes? When to initiate drug treatment?

19 Question 2 Among adults, does treatment with antihypertensive pharmacological therapy to a specified BP goal lead to improvements in health outcomes? How low should you go?

20 Question 3 In adults with hypertension, do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific health outcomes? How do you get there?

21 Inclusion/Exclusion Criteria Randomized Controlled Trials RCTs are subject to less bias and represent the gold standard for determining efficacy and effectiveness 1 Search dates: 1966 to present Minimum one-year follow-up period Studies with sample sizes less than 100 excluded 1 Institute of Medicine Finding What Works In Health Care. Standards For Systematic Reviews. Washington, DC: The National Academies Press.

22 Populations Included Adults 18 years of age and older Prespecified subgroups including: Diabetes Chronic kidney disease Proteinuria Coronary artery disease Peripheral artery disease Previous stroke Heart Failure Older Adults Men and women Racial and ethnic groups Smoking

23 Outcomes Overall mortality, CVD-related mortality, CKD-related mortality, myocardial infarction, heart failure, hospitalization for heart failure, stroke Coronary revascularization (includes coronary artery bypass surgery, coronary angioplasty and coronary stent placement), peripheral revascularization (includes carotid, renal, and lower extremity revascularization) End stage renal disease (i.e., kidney failure resulting in dialysis or transplant), doubling of creatinine, halving of egfr

24 Question 1: Among adults with hypertension, does initiating antihypertensive pharmacological therapy at specific BP thresholds improve health outcomes? Articles Screened = 1496 Good = 8 Included = 44 Fair = 18 Poor = 18 Excluded = 1452 (Did not meet prespecified inclusion criteria) Total Abstracted = 26

25 Question 2: Among adults, does treatment with antihypertensive pharmacological therapy to a specified BP goal lead to improvements in health outcomes? Articles Screened = 1978 Good = 17 Included = 92 Fair = 39 Poor = 36 Excluded = 1886 (Did not meet prespecified inclusion criteria) Total Abstracted = 56

26 Question 3: In adults with hypertension, do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific health outcomes? Articles Screened = 2662 Good = 15 Included = 101 Fair = 51 Poor = 35 Excluded = 2561 (Did not meet prespecified inclusion criteria) Total Abstracted = 66

27 Data Abstraction and Evidence Tables Information from individual studies Key data abstracted into a database Evidence table for each study/paper: subjects, sample size, intervention, comparison, results Evidence summaries by Critical Question Tables and text of major elements relevant to the CQ Graded evidence statements Multiple ESs for each CQ Graded recommendations based on the evidence Multiple ESs could result in a single recommendation 27

28 NHLBI EVIDENCE QUALITY GRADING AND RECOMMENDATION STRENGTH High Evidence Quality Well-designed and conducted RCTs Moderate RCTs with minor limitations Well-conducted observational studies Low RCTs with major limitations Observational studies with major limitations Recommendation Strength A Strong B Moderate C Weak D Against E Expert Opinion N No Recommendation 28

29 Adult CV Guideline Report Content Methods description Critical Questions With study eligibility criteria and rationale Summary of evidence for each CQ Summary tables and text ( e.g. 24 studies, 10 RCTs ) Graded evidence statements (ES) Rationale for ES based on specific studies or previous systematic reviews Graded High, Medium, Low Graded recommendations Rationale for the recommendation based on the evidence Graded A, B, C, D, E, or N Reference citations 29

30 Conclusion The new NHLBI-sponsored adult CV guideline reports Are strictly evidence based Will not look like the previous guidelines Will have more depth and rigor; will have less breadth Will be released in 2012, one at a time as they are ready Will subsequently be integrated Will use evidence based strategies for Implementation 30

31 Next Steps Evidence statements and recommendations (in progress) Draft report (in progress) Review of the draft report by: Other federal agencies (CDC, CMS, AHRQ, HRSA, VA, etc.) Invited organizations and individuals Public Revisions based on comments received Final report

32 THANK YOU! For more information on the NHLBI guidelines, go to:

33 Committee Members Co-Chair: Suzanne Oparil, MD Professor of Medicine and Physiology & Biophysics, Director, Vascular Biology and Hypertension Program, Division of Cardiovascular Disease, Department of Medicine University of Alabama at Birmingham School of Medicine Jackson T. Wright, Jr., MD, PhD Director, Clinical Hypertension Program Director, William T. Dahms Clinical Research Unit, University Hospitals Case Medical Center Professor of Medicine Case Western Reserve University Sandra J. Taler, MD Associate Professor of Medicine Division of Nephrology and Hypertension Mayo Clinic College of Medicine Co-Chair: Paul A. James, MD Professor and Head, Department of Family Medicine in the Carver College of Medicine, Professor of Occupational and Environmental Health in the College of Public Health, Donald J. and Anna M. Ottilie Endowed Chair in Family Medicine University of Iowa Laura Svetkey, MD, MHS Director, Duke Hypertension Center Director of Clinical Research at the Sarah W. Stedman Nutrition and Metabolism Center Professor of Medicine Duke University Michael L. LeFevre, MD, MSPH Professor, Department of Family and Community Medicine, University of Missouri

34 Committee Members Joel Handler, MD Clinical Lead for Hypertension Care Management Institute Kaiser Permanente Southern California Permanente Medical Group, Department of Internal Medicine Barry L. Carter, PharmD Professor, Department of Pharmacy Practice and Science, College of Pharmacy Professor and Associate Head, Research Department of Family Medicine University of Iowa Daniel T. Lackland, DrPH Professor, Epidemiology and Medicine Department of Biostatistics, Bioinformatics, and Epidemiology Medical University of South Carolina Raymond R. Townsend, MD Director, Hypertension Section Professor of Medicine Department of Internal Medicine Renal University of Pennsylvania William C. Cushman, MD Chief, Preventive Medicine, Veterans Affairs Medical Center Lead Consultant in Hypertension to VA Medical Service Professor, Preventive Medicine and Medicine University of Tennessee Thomas D. MacKenzie, MD, MSPH Chief Quality Officer, Denver Health and Hospital Authority Associate Professor of Medicine University of Colorado School of Medicine

35 Committee Members Sidney C. Smith, Jr., MD, FACC, FAHA, FESC Director, Center for Cardiovascular Science and Medicine, Professor of Medicine University of North Carolina at Chapel Hill Olugbenga Ogedegbe, MD, MPH, MS, FAHA Associate Professor of Medicine Division of General Internal Medicine Department of Medicine New York University School of Medicine Cheryl Dennison Himmelfarb, RN, ANP, PhD, FAAN Associate Professor Department of Health Systems and Outcomes Johns Hopkins University School of Nursing Division of Health Sciences Informatics Johns Hopkins University School of Medicine Andrew S. Narva, MD (Ex-Officio) Director, National Kidney Disease Education Program Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Lawrence J. Fine, MD, DrPH (Ex-Officio) Chief, Clinical Applications and Prevention Branch Division of Prevention and Population Science National Heart, Lung, and Blood Institute Eduardo Ortiz, MD, MPH (NHLBI Lead, Ex-Officio, Non-Voting Member) Senior Medical Officer Division for the Application of Research Discoveries National Heart, Lung, and Blood Institute National Institutes of Health