0
Primary Prevention of  Cardiovascular Disease:  the role of aspirin and statins Michael Pignone, MD, MPH Professor of Medi...
Aspirin and statins <ul><li>Both effective for prevention of CVD events </li></ul><ul><ul><li>Some uncertainty about sub-g...
Challenges in  interpreting models <ul><li>Examining different modeling approaches can offer insights and highlight areas ...
Risk-based treatment preferred <ul><li>CVD prevention benefits increase with increasing CVD risk </li></ul><ul><li>Adverse...
Aspirin for CVD prevention Lancet  2009; 373: 1849–60 Overall Men Women Non-fatal MI 0.77 (0.67, 0.89) CHD death 0.95 (0.7...
Trial characteristics * 8831 women  ** 2583 women  ^ all women Year Duration (yrs) Subjects Dose (mg) BMD 1988 5-6 5,139 5...
Adverse effects of aspirin:  GI bleeding <ul><li>RR 1.54 (1.30, 1.82): Lancet meta-analysis </li></ul><ul><li>Excess risk ...
Summarizing aspirin  benefits and harms Men Women Non-fatal myocardial infarction Reduces risk No effect Fatal CHD events ...
Aspirin modeling studies Cost per QALY for 55 year old patients with 5% CVD risk Cost per QALY for 55 year old patient wit...
Comparison of inputs *ischemic strokes only Earnshaw 2007 (women) Greving 2008 Earnshaw 2011 (men) RR - MI 1.01 0.68 (men)...
Comparison of inputs *ischemic strokes only Earnshaw 2007 (women) Greving 2008 Earnshaw 2011 (men) Model type Markov Marko...
Aspirin - conclusions <ul><li>Aspirin appears cost-effective for men with increased risk (>10% risk) in all models </li></...
Statins
Effectiveness of statins for primary prevention Mills et al JACC 2008; 52: 1769-81 RR 95% CI Myocardial infarction 0.77 (0...
Trial characteristics Trial Duration (yrs) % female Drug and Dose (mg) ASCOT 3.3 81 Atorva 10 AFCAPS 5.2 15 Lova 20/40 ALL...
Statin adverse effects <ul><li>Muscle pain- common (10%) </li></ul><ul><li>Myopathy – rare (0.1%) </li></ul><ul><li>Rhabdo...
Statin modeling studies Cost /QALY for treatment of 55 year old patients with CVD risk of 5% Cost /QALY for treatment of 5...
Comparison of inputs * Based on LDL lowering and age; 22-28% in 45-55 age range  Lee 2010 Lazar 2011 Pletcher 2009 Greving...
Comparison of inputs * 17.5% stop within 6 months due to muscle symptoms Lee 2010 Lazar 2011 Pletcher 2009 Greving 2011 Mo...
Integrating aspirin and statin decision making
(Older) analysis: for men, start aspirin at 7.5% risk, add statin above 10% risk Statin cost assumed to be $710 per year P...
Sensitivity of Cost-effectiveness to  Cost of Statin Statin cost $710
Healthwarehouse.com <ul><li>Simvastatin 40mg Tablets </li></ul><ul><ul><li>30 Tablets $3.50 </li></ul></ul><ul><ul><li>90 ...
Does aspirin reduce cancer mortality? Rothwell et all Lancet 2011; 377:31-41
Updated modeling <ul><li>Examines joint decision making:  aspirin and statins </li></ul><ul><li>Updated model parameters <...
Stephanie Earnshaw to describe current model
Research Priorities <ul><li>Cost-effective adherence promotion </li></ul><ul><li>Disutility of daily medication use </li><...
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Primary Prevention of Cardiovascular Disease: The Role of Aspirin and Statins

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Presented by Michael Pignone, MD, MPH, at UCSF's symposium "The Role of Risk Stratification and Biomarkers in Prevention of Cardiovascular Disease" in Jan 2012.

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  • Hemorrhagic stroke RR = 1.32 (1.0, 1.75) Excess risk: 0.1 event per 1000 users per year = 1 per 10,000 per year
  • Transcript of "Primary Prevention of Cardiovascular Disease: The Role of Aspirin and Statins"

    1. 1. Primary Prevention of Cardiovascular Disease: the role of aspirin and statins Michael Pignone, MD, MPH Professor of Medicine UNC Division of General Internal Medicine UCSF CVD prevention symposium Jan 30, 2012
    2. 2. Aspirin and statins <ul><li>Both effective for prevention of CVD events </li></ul><ul><ul><li>Some uncertainty about sub-groups </li></ul></ul><ul><li>Different adverse effects </li></ul><ul><li>Costs converging </li></ul><ul><li>Challenge: which patients should receive either or both for primary CVD prevention? </li></ul><ul><li>Modeling may provide insight </li></ul>
    3. 3. Challenges in interpreting models <ul><li>Examining different modeling approaches can offer insights and highlight areas of uncertainty </li></ul><ul><ul><li>Framing of questions </li></ul></ul><ul><ul><li>Inputs </li></ul></ul><ul><ul><li>Model structure </li></ul></ul><ul><ul><li>Time horizon, discount rate </li></ul></ul><ul><ul><li>Expression of results </li></ul></ul>Pignone et al Ann Intern Med. 2005;142:1073-9
    4. 4. Risk-based treatment preferred <ul><li>CVD prevention benefits increase with increasing CVD risk </li></ul><ul><li>Adverse effects increase with age but otherwise relatively unrelated to risk </li></ul><ul><li>Thus, CVD risk can be used to guide cost-effective treatment </li></ul><ul><li>Global risk-based treatment strategies generally outperform risk factor-based strategies in modeling </li></ul>Lee et al Circulation 2010; 122:1478-
    5. 5. Aspirin for CVD prevention Lancet 2009; 373: 1849–60 Overall Men Women Non-fatal MI 0.77 (0.67, 0.89) CHD death 0.95 (0.78, 1.15) Major coronary event 0.82 (0.75, 0.90) 0.77 (0.67,0.89) 0.95 (0.77, 1.17) Stroke 0.95 (0.85, 1.06) Ischemic stroke 0.86 (0.74, 1.00) 1.01 (0.74, 1.39) 0.77 (0.59, 0.99)
    6. 6. Trial characteristics * 8831 women ** 2583 women ^ all women Year Duration (yrs) Subjects Dose (mg) BMD 1988 5-6 5,139 500 qd PHS 1989 5 22,071 325 qod TPT 1998 6.8 2,540 75 qd HOT 1998 3.8 18,790* 75 qd PPP 2001 3.6 4495** 100 qd WHS 2005 10.1 39,876^ 100 qod
    7. 7. Adverse effects of aspirin: GI bleeding <ul><li>RR 1.54 (1.30, 1.82): Lancet meta-analysis </li></ul><ul><li>Excess risk ≈ 1 per 1000 users / year </li></ul><ul><ul><li>Increases with age </li></ul></ul><ul><ul><li>RR higher in observational analyses (2.0) </li></ul></ul><ul><ul><li>No “safe” dosage </li></ul></ul><ul><ul><li>Enteric coating doesn’t prevent </li></ul></ul><ul><ul><li>PPI decreases risk, but routine use not economical* </li></ul></ul>*Earnshaw et al Arch Intern Med. 2011; 171(3):218-25
    8. 8. Summarizing aspirin benefits and harms Men Women Non-fatal myocardial infarction Reduces risk No effect Fatal CHD events Small or no reduction No effect Stroke No effect Reduces risk GI bleed Increased risk Increased risk
    9. 9. Aspirin modeling studies Cost per QALY for 55 year old patients with 5% CVD risk Cost per QALY for 55 year old patient with 10% CVD risk Earnshaw 2011 Dominant (men) Dominant (men) Greving 2008 111,949 € (men) ------------------------------- Dominated by no Tx (women) 20,298 € (men) ------------------------------ 114,356 € (women) Earnshaw 2007 Dominated by no Tx (women) Not assessed (women)
    10. 10. Comparison of inputs *ischemic strokes only Earnshaw 2007 (women) Greving 2008 Earnshaw 2011 (men) RR - MI 1.01 0.68 (men) 1.01 (women) 0.70 RR - stroke 0.76 1.00 (men) 0.76 (women)* 1.06 (total strokes) RR - GI bleed 7 per 10,000 absolute 1.72 (men) 1.68 (women) 2.0 Utility, MI 0.88 0.88 0.87 Utility stroke 0.5 (major) 0.75 (minor) 0.5 (major) 0.75(minor) 0.61 (initial) 0.83 (later) Utility, taking aspirin 1.0 0.999 1.0 Utility, GI bleed 0.94 0.94 0.94 Cost aspirin $5.75 97 € $14 Cost – GI bleed $7538 1625 € $13,342
    11. 11. Comparison of inputs *ischemic strokes only Earnshaw 2007 (women) Greving 2008 Earnshaw 2011 (men) Model type Markov Markov Markov Time horizon lifetime 10 years lifetime Year for costs 2005 2005 2009 Discount rate 3% ? (4%) 3% Secondary events modeled? Yes No Yes GI Bleed risk increase with age? No Yes Yes Risk of death from GI bleed? 1/100,000 3% 1/1000
    12. 12. Aspirin - conclusions <ul><li>Aspirin appears cost-effective for men with increased risk (>10% risk) in all models </li></ul><ul><li>For women, aspirin is not cost-effective for younger women and those with low CVD risk (under 5%) but appears cost-effective for higher risk older women </li></ul><ul><li>Cost-effectiveness for lower risk men (under 10%) unclear - depends on inputs and time horizon </li></ul>
    13. 13. Statins
    14. 14. Effectiveness of statins for primary prevention Mills et al JACC 2008; 52: 1769-81 RR 95% CI Myocardial infarction 0.77 (0.63, 0.95) Stroke 0.88 (0.78, 1.0) CVD mortality 0.89 (0.81, 0.98) All-cause mortality 0.93 (0.87, 0.99)
    15. 15. Trial characteristics Trial Duration (yrs) % female Drug and Dose (mg) ASCOT 3.3 81 Atorva 10 AFCAPS 5.2 15 Lova 20/40 ALLHAT 4.8 51 Prava 20/40 MEGA 5.3 68 Prava 10/20 PROSPER 3.2 58 Prava 40 WOSCOPS 4.9 0 Prava 40
    16. 16. Statin adverse effects <ul><li>Muscle pain- common (10%) </li></ul><ul><li>Myopathy – rare (0.1%) </li></ul><ul><li>Rhabdomyolysis – very rare (0.01%) </li></ul><ul><li>? Increased risk of diabetes </li></ul><ul><li>Change in liver enzymes without failure </li></ul><ul><li>Concerns about cancer risk and violence have not materialized </li></ul>Jacobson Mayo Clin Proc 2008;83:687-700
    17. 17. Statin modeling studies Cost /QALY for treatment of 55 year old patients with CVD risk of 5% Cost /QALY for treatment of 55 year old patients with CVD risk of 10% Lee 2010 < $50,000 (men) >$50,000 (women) < $50,000 (men) ≈ $50,000 (women) Lazar 2011 Pletcher 2009 Treating all with LDL > 130 dominates “treat none” Greving 2011 125,544 € (men) 167,080 € (women) 34,995 € (men) 41,544 € (women)
    18. 18. Comparison of inputs * Based on LDL lowering and age; 22-28% in 45-55 age range Lee 2010 Lazar 2011 Pletcher 2009 Greving 2011 RR MI 0.77 0.66 – 0.92* 0.71 (major coronary events) RR CHD death 0.83 --- RR stroke 0.83 --- 0.81 Statin cost $401 $48 9€ MI cost $17,000 --- 17,342€ Stroke cost $15,000 (acute) $48,000 (Year 1) --- 36K€ initial 21K€ subsequent Utility: taking statin No decrement No decrement 0.999
    19. 19. Comparison of inputs * 17.5% stop within 6 months due to muscle symptoms Lee 2010 Lazar 2011 Pletcher 2009 Greving 2011 Model type Markov Markov Markov Discount rate 3% 3% ? Time horizon lifetime 30 years 10 years Adherence 100%* 100% 60% Costing Year 2008 2008 2008
    20. 20. Integrating aspirin and statin decision making
    21. 21. (Older) analysis: for men, start aspirin at 7.5% risk, add statin above 10% risk Statin cost assumed to be $710 per year Pignone et al; Annals Int Med 2006; 144: 326-36 Low (5%) Moderate (7.5%) Moderate-High (10%) High (15%) ASA alone Aspirin less effective, more costly Aspirin more effective, less costly Aspirin more effective, less costly Aspirin more effective, less costly ASA + statin NA $56,200 $42,500 $33,600
    22. 22. Sensitivity of Cost-effectiveness to Cost of Statin Statin cost $710
    23. 23. Healthwarehouse.com <ul><li>Simvastatin 40mg Tablets </li></ul><ul><ul><li>30 Tablets $3.50 </li></ul></ul><ul><ul><li>90 Tablets $9.50 </li></ul></ul><ul><ul><li>360 Tablets $36.50 </li></ul></ul>
    24. 24. Does aspirin reduce cancer mortality? Rothwell et all Lancet 2011; 377:31-41
    25. 25. Updated modeling <ul><li>Examines joint decision making: aspirin and statins </li></ul><ul><li>Updated model parameters </li></ul><ul><ul><li>Statin costs </li></ul></ul><ul><ul><li>GI bleeding risk </li></ul></ul><ul><ul><li>Other health care costs </li></ul></ul><ul><li>Examines the potential effect of aspirin-related cancer mortality reduction </li></ul>
    26. 26. Stephanie Earnshaw to describe current model
    27. 27. Research Priorities <ul><li>Cost-effective adherence promotion </li></ul><ul><li>Disutility of daily medication use </li></ul><ul><li>Does aspirin affect cancer mortality? </li></ul><ul><li>Cost-effective methods for reducing adverse effects </li></ul><ul><li>Appropriate time horizons for primary prevention analyses </li></ul>
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