April 2009 Netta Conyers-Haynes, Principal Consultant, Communications Kaiser Permanente's Aspirin, Lisinopril, Lovastatin (ALL) Program: From Consensus.

Slides:



Advertisements
Similar presentations
Should YOU Implement ALL? Or Use It As Step 1 of Titration to BP & Lipid Targets? Diabetes Lead Care Management Institute, Kaiser.
Advertisements

Statins in Renal Failure Andrea Fox Sunnybrook Health Science Center May 2010.
THE ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES STUDY (ACCORD)
Treat Everyone to an LDL-C of 70mg/dl? Daniel Edmundowicz, MS, MD, FACC Associate Professor Of Medicine Director, Preventive Cardiology UPMC Cardiovascular.
New concepts and guidelines in the management of LDL-c and CV Risk: Need for early intervention Prof. Ulf Landmesser University Hospital Zürich Switzerland.
Canadian Diabetes Association Clinical Practice Guidelines Acute Coronary Syndromes and Diabetes Chapter 26 Jean-Claude Tardif, Phillipe L. L’Allier, David.
Lipid Disorders and Management in Diabetes
Introduction to: 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults BLUF: -Shift from.
CVD prevention & management: a new approach for primary care Rod Jackson School of Population Health University of Auckland New Zealand.
Canadian Diabetes Association Clinical Practice Guidelines Dyslipidemia Chapter 24 G. B. John Mancini, Robert A. Hegele, Lawrence A. Leiter.
Benefits of intensive multiple risk factor intervention.
TNT: Study Design Treating to New Targets 2 5 years 10,001 Patients Clinically evident CHD LDL-C 130  250 mg/dL following up to 8-week washout and 8-week.
Study by: Granger et al. NEJM, September 2011,Vol No. 11 Presented by: Amelia Crawford PA-S2 Apixaban versus Warfarin in Patients with Atrial Fibrillation.
Cholesterol and Lipids TIPS Wokefield Park 15/5/2013.
Special Diabetes Program for Indians Competitive Grant Program SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Clinical Goals for the Healthy.
Facts and Fiction about Type 2 Diabetes Michael L. Parchman, MD Department of Family & Community Medicine September 2004.
LIPID LOWERING IN T2D (The Lower the Better?) CONS… TARGETING HARD CVD END POINTS Charles SAAB MD Consultant Endocrinologist DCRP Sacre-Coeur University.
DYSLIPIDEMIA IN ADULTS WITH DIABETES* 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada *Updated in Leiter.
ACCORD - Action to Control Cardiovascular Risk in Diabetes ADVANCE - Action in Diabetes to Prevent Vascular Disease VADT - Veterans Administration Diabetes.
Source: Site Name and Year IHS Diabetes Audit Diabetes Health Status Report ______Site Name_________ Health Outcomes and Care Given to Patients with Diabetes.
Role of Rosuvastatin in the Treatment of Dyslipidemia
HYPERLIPIDAEMIA. 4S 4444 patients –Hx angina or MI –Cholesterol Simvastatin 20mg (10-40) vs. placebo FU 5 years  total cholesterol 25%;  LDL.
Enhancing Care Management of the Chronically Ill Through Medication Management and Adherence Harry Leider, MD, MBA, FACPE Chief Medical Officer XLHealth.
... a KAISER PERMANENTE Innovation IndiGO: Tailoring Guidelines to Individuals David M Eddy MD PhD Founder and Chief Medical Officer Emeritus Archimedes.
Results of Monotherapy in ALLHAT: On-treatment Analyses ALLHAT Outcomes for participants who received no step-up drugs.
VBWG CHARISMA Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance trial.
A Coordinated Approach to Cardiovascular Care Sharon Levine MD Associate Executive Director The Permanente Medical Group Kaiser Permanente Bay Area Council.
Modern Management of Cholesterol in the High-Risk Patient.
STATINS AGAIN. Atorvastatin Off patent Atorvastatin 40 = £36 PA Simvastatin 40 = £14 PA Atorvastatin 80 = £72 PA Simvastatin 80 = £24 PA.
Slide 1 EZT 2002-W-6022-SS Ezetimibe Co-administered with Statins: Efficacy and Tolerability Copyright © 2003 MSP Singapore Company, LLC. All rights reserved.
The concept of Diabetes & CV risk: A lifetime risk challenge The Clinical Significance of LDL-Cholesterol: No Longer a Hypothesis? John J.P. Kastelein,
PPAR  activation Clinical evidence. Evolution of clinical evidence supporting PPAR  activation and beyond Surrogate outcomes studies Large.
Laura Mucci, Pharm.D. Candidate Mercer University 2012 Preceptor: Dr. Rahimi February 2012.
Innovations in Management of Cardiovascular Disease for Global Health
Collaborative Atorvastatin Diabetes Study CARDS Dr Sachin Kadoo.
Polypill x Aspirin Project Groups 3 and 4
BRIAN CLAYTON INTERNAL MEDICINE ADVISOR: ANNA MAE SMITH PRECEPTOR: DR. RAJESH PATEL Evidence Based Medicine Spring 2009.
Long-term Cardiovascular Effects of 4.9 Years of Intensive Blood Pressure Control in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk.
ACC/AHA Guidelines Not the Final or Only Word. Contemporary Guidelines
Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease (HOPE-3 trial) R4. 박은지 / PF. 정혜문 Salim Yusuf, M.B., B.S., D.Phil.,
DIABETES INSTITUTE JOURNAL CLUB CARINA SIGNORI, D.O., M.P.H. DECEMBER 15, 2011 Atherothrombosis intervention in metabolic syndrome with low HDL/High Triglycerides:
PUTTING PREVENTION FIRST Vascular Checks/ NHS Health Checks.
Journal Club Julie Shah, MD Milton S Hershey Medical Center Penn State University.
 In 2003, the USPSTF recommended that clinicians screen adults for obesity and offer intensive counseling and behavioral interventions to promote weight.
The Heart Outcomes Prevention Evaluation (HOPE) – 3 Trial
1 Effect of Ramipril on the Incidence of Diabetes The DREAM Trial Investigators N Engl J Med 2006;355 FM R1 윤나리.
Date of download: 9/18/2016 Copyright © The American College of Cardiology. All rights reserved. From: Next Steps in Primary Prevention of Coronary Heart.
Dr John Cox Diabetes in Primary Care Conference Cork
Blood Pressure and Lipid Trials: Rationale, Importance and Design
ACCORD Design and Baseline Characteristics
Reducing Adverse Outcomes after ACS in Patients with Diabetes Goals
Cholesterol practice questions
Triglycerides Cholesterol HDL-C or N NIDDM N or or N IDDM.
HDL cholesterol and cardiovascular risk Epidemiological evidence
First time a CETP inhibitor shows reduction of serious CV events
HDL cholesterol and cardiovascular risk
FATS- Familial Atherosclerosis Treatment Study
Introduction to: 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults BLUF: -Shift from.
Introduction to: 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults BLUF: -Shift from.
RAAS Blockade: Focus on ACEI
Jane Armitage on behalf of the HPS2-THRIVE Collaborative Group
Introduction to: 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults BLUF: -Shift from.
Section 7: Aggressive vs moderate approach to lipid lowering
RCHC’s Cardiovascular Health Initiative
Diabetes Journal Club March 17, 2011
Introduction to: 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults BLUF: -Shift from.
Introduction to: 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults BLUF: -Shift from.
Goals & Guidelines A summary of international guidelines for CHD
The following slides highlight a report on a presentation at the American College of Cardiology 2004, Scientific Sessions, in New Orleans, Louisiana on.
Many post-MI patients are not receiving optimal therapy
Presentation transcript:

April 2009 Netta Conyers-Haynes, Principal Consultant, Communications Kaiser Permanente's Aspirin, Lisinopril, Lovastatin (ALL) Program: From Consensus to Outcomes R. James Dudl, MD

Agenda  What is PHASE/ALL? How did it develop?  Is it More effective to treat pts with hi LDL/BP or Hi CVD risk?  Is a “bundle” of meds with ACEI’s more effective than just titrating a statin?  Treating for primary prevention: “How Low can you go” in treating risk before statins do more harm than good? Slide 2

What is ALL/PHASE?  video Slide 3

Slide 4 How Did It Develop: The Consensus Phase  By 1990’s Evidence emerged that lowering cholesterol decreased heart attacks & strokes  The 1995 program: Treat all eligible patients who came to clinic with niacin  Nurse Practitioners to make calls to do 6 titrations  Tested cholesterol every 3 months to address adherence

Why Not Just Keep Titrating up Statin Dose? ? Slide 5

Slide 6 Consensus Phase Results Evaluated by Archimedes medical-economic model  NO effect on Heart Attacks  Treating low risk patients (“worried well”), Avg 7% five yr CVD risk  Titrations didn’t work 1 per patient accomplished when 6 were needed  Benefit/Savings  No benefit therefore no savings  Cost of tests exceeded savings  Lessons:  Treating low risk patients is not effective  Titrating is very difficult in our system  Testing is expensive and didn’t lower heart attacks & strokes

Slide 7 Next step: Risk Stratification Phase  To find high-risk patients  Initiated population-based cholesterol screening Rapidly increased to ~80% tested in 2 years  To increase efficacy:  Added Lovastatin treatment (not yet generic)

Slide 8 Risk Stratification Phase Archimedes Results  Still no drop in heart attacks and strokes  MI’s /1000 DM members  MI’s /1000 DM members, Why? Many with high cholesterol tests & hi risk were not treated!  Lessons:  Testing still did not decrease events To start meds, the program needs to focus on starting meds  Treating cholesterol alone won’t decrease heart attacks and strokes in low to medium CVD risk pts  Program modeled: Statins were high cost and lower LDL but little drop in heart attacks and strokes

Does Increasing dose/ strength more matter? Slide 9

Figure 2. SCORE chart for use in high-risk European regions. Cooney M T et al. Circulation 2010;122: Copyright © American Heart Association

Slide 11 Sugar control Why Focus On Heart Attacks & Strokes in DM? It’s a CVD Risk Equivalent and…

Slide Back to Basics: What Causes a Heart Attack? Lipid Lowering Med Lisinopril [BP lowering] Aspirin “cracks”`

Slide 13

Slide 14 Model of the Outcomes Phase: A.L.L.  Systematic implementation in all pts with:  Diabetes (age ≥55yo) or  Cardiovascular disease (prior heart attack or stroke)  To insure they are offered daily dose of:  Aspirin mg  Lovastatin 40mg  Lisinopril 20 mg

Slide 15 Archimedes Modeling of A.L.L. & A1C in Diabetes : Effect on Morbidity & Mortality 71% Decrease

Slide 16 How We Increased Efficacy and Efficiency  Identify high-risk with minimal testing:  Diabetes (age ≥55yo) or history of heart attack or stroke  Simplify implementation and cut costs:  Eliminate titrations No change on effect of medications Less visits and testing

Slide 17 A.L.L. reduces cost in patients with diabetes Savings start at $300/m, average $600/m

Slide 18 Did we do it and did it work? *90,000 patients from No Cal (“PHASE” program), remainder of patients from So Cal. MPR=Mean Possession Ratio

Slide The effect per group was significant Even 1 day of 5 utilization was significant But taking it 2/3 of the time was much more beneficial >60% decrease

Slide 20 Archimedes Planned Outcomes Phase :  A.L.L. medications prescribed to a large number of patients  Heart attacks and strokes significantly decreased  Costs of meds were contained using A.L.L. Are there any other studies that show >60% benefit of bundled therapy?

CHAMP: Start BALL in Hosp New MI Slide 21 Am J Cardiol 2001 pg 819

Slide 22 Am J Cardiol 2001 pg % decrease

NHANES : to ,458 Periph Art Dis pts, ~70% Without CVD Slide 23 Circulation pg 17 Decreased MORTALITY

UK 13,029 Pts with 1 st MI decr death c/w matched controls not on Meds Slide 24 BMJ 2005;330;1059

Steno 2 T2DM w Proteinuria Showed ~60-80% Drop in MI’s & Strokes after 13.3 Yrs Slide 25 ACE/ARB 87% Statins 82% ASA 76% & A1C <8, bb & diuretics if bp high

But in treating CVD risk “How Low Can You GO! Slide 26 CVD risk 20% 10% 5% 2.5%

Why Treat Hi CVD Risk Pts, Not Hi Biomarker LDLc and BP?  Does therapy decrease with “normal” levels of biomarkers?  Are there many people at low levels of that may benefit?  Are we missing some that have high levels of BP & lipids, but don’t come to us? Slide 27

Anti HTN drugs Decreased CVD in Normotensive Pts with CVD Event… Slide 28 JAMA pg:913 23% 20%

ACEI’s Are Additive in Benefit to ASA & Statins… Slide 29

Lowering LDL-C reduces CVD events across the range of LDL-C levels CTT. Lancet 2010;

Statin adverse events  Excess risk of myopathy  0.5 per 1000 statin-treated persons over 5 years Higher with simvastatin 80 mg (lower doses in Asians)  5-year NNH = 2000  Excess risk of hemorrhagic stroke/1 mmol/L reduction in LDL-C  0.5 per 1000 statin-treated persons over 5 years Might be higher in populations at  risk hemorrhagic stroke (eg Asian)  5-year NNH = 2000 CTT Collaborators. Lancet 2012; 380:

Statin adverse events  Excess risk of new diabetes  5 per 1000 statin-treated persons over 5 years Meta-analysis of mostly moderate intensity statin therapy 5-year NNH = 200  15 per 1000 statin-treated persons over 5 years 54 per 8901 statin-treated persons over 2 years- Rosuvastatin 20 mg All cases occurred in those with baseline impaired fasting glucose 5-year NNH = 66 Sattar et al. Lancet 2010; 375: ; Ridker Lancet 2012; 380:

Slide 33

In Conclusion  Treating people with high risk for CVD is more effective that treating high BP or lipids  Treating with more than statins is more than twice as effective as increasing statin potency or dose  Combining treating people with over 5% CVD risk with a bundle of ACEI Statin and optionally ASA is so effective it should be impemented now Slide 34

 Questions, Comments or Concerns? Slide 35

Slide 36 For More Information: Jim Dudl, MD  National Clinical Lead, ALL Project, Kaiser Permanente Care Management Institute 

I thought Wt Loss & Ex did 75% of benefit, why are we jumping to meds?  Look Ahead ~5,000 T2DM pts f/u 11 yrs  “Look AHEAD found that people who are obese and have type 2 diabetes can lose weight and maintain their weight loss with a lifestyle intervention, although it…..  “did not reduce the number of cardiovascular events”. Slide 37 NIH News, October 19, 2012 Contact: Amy Reiter Amy Reiter