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Ruth Campbell BSc (Pharm) Interior Health Authority Provincial Academic Detailing Service

Ruth Campbell BSc (Pharm) Interior Health Authority Provincial Academic Detailing Service. Statins and Cardiovascular Disease. It is a matter of perspective. R. AMADA INN. When we look with care:. Benefit is most apparent in the secondary population

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Ruth Campbell BSc (Pharm) Interior Health Authority Provincial Academic Detailing Service

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  1. Ruth Campbell BSc (Pharm) Interior Health Authority Provincial Academic Detailing Service Statins and Cardiovascular Disease

  2. It is a matter of perspective R AMADA INN

  3. When we look with care: Benefit is most apparent in the secondary population Primary population – in terms of MCE reduction • High risk men benefit • Women do not • Elderly do not We lack evidence to “treat to target”

  4. Why the confusion • Interpretation of relative risk reduction as being the most important thing • Composite Endpoints • Calculating risk and inferring statin benefit

  5. Our drug reduces your risk by 50% Drooping Ear Lobe disease disappears overnight in 50% of cases

  6. Primary Composite Outcome MI, Coronary Heart Disease Death, All Cause mortality Stroke Coronary revascularization and Hospitalization for unstable Angina Is the benefit illusion? Should we care?

  7. PRIMARY OUTCOME = combination of 5 different events CHD Death, MI, Stroke and Revascularization and Hospitilization Canon NEJM 2004:350:1495-504

  8. FATAL EVENTS Canon NEJM 2004:350:1495-504

  9. NON-FATAL EVENTS Canon NEJM 2004:350:1495-504

  10. CLINICIAN-DRIVEN ENDPOINTS (procedures, medical decisions) “Softer outcomes” Canon NEJM 2004:350:1495-504

  11. Statistical significance is reached only in coronary revascularization and hospitalization for unstable angina Canon NEJM 2004:350:1495-504

  12. FATAL EVENTS Canon NEJM 2004:350:1495-504

  13. Balance the risk with the benefit

  14. What is the risk? Run In Periods eliminate those at risk Those studied less likely to be at risk Harm reporting – illusions in statistics

  15. Serious Adverse Events aren’t consistently reported

  16. Risk Myopathies Incident diabetes Neuropathies Hemmorhagic stroke Cancer? Confusion?

  17. Who Benefits?

  18. Secondary prevention

  19. Secondary Prevention - What is the benefit? Treating 28 patients for 5 years prevents one Major Coronary Event

  20. A reduction in all cause mortality has not been documented in women

  21. And the Elderly?

  22. Amarenco N Engl J Med 2006;355:549-59

  23. Women – Primary prevention

  24. Lack of Evidence for benefit in women No Statistically significant benefit for: Non fatal MI Coronary Heart Disease death All Cause Mortality

  25. “ Conclusion—JUPITER demonstrated that in primary prevention rosuvastatin reduced CVD events in women with a relative risk reduction similar to that in men, a finding supported by meta-analysis of primary prevention statin trials.”

  26. Evidence for benefit in women? No Statistically significant benefit for: • Non fatal MI • Coronary Heart Disease death • All Cause Mortality Statistically Significant improvement in: • hospitalization for unstable angina • coronary revascularization

  27. Primary prevention elderly?

  28. Prosper? “Interpretation: Pravastatin given for 3 years reduced the risk of coronary disease in elderly individuals. PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle aged people”

  29. Mean age 75 52% women Prior CVD 44% SBP 155 DBP 84 TC 5.7 HDL-C 1.3 LDL-C 3.8 Smokers 27% Shepherd Lancet 2002;360:1623-30

  30. n = 26 K Cochrane Database of Systematic Reviews 2009, Issue 2, CD003160

  31. Calculate Risk – determining the benefit of statins for men at risk Use the right tool for the job

  32. www.framinghamheartstudy.org/risk/index.html

  33. FRS-CHD www.framinghamheartstudy.org/risk/index.html

  34. FRS-CVD www.framinghamheartstudy.org/risk/index.html

  35. www.bcguidelines.ca

  36. iPhone, BB, android apps • Qx Calculate • Framingham Risk Score (ATP-III) • Framingham General Cardiovascular Risk predictor – predicts cardiovascular risk

  37. Fatal or non-fatal MI Haffner NEJM 1998;339:229-34

  38. Fatal or non-fatal MI BulugahapitiyaDiabet Med 2009;26:142-8

  39. Non-diabetic, • primary prevention • 8% • Diabetic, • primary prevention • 12% • Non-diabetic, • secondary prevention • 24% CTT Lancet 2008;131:117-25

  40. Non-diabetic, • primary prevention • 8% • Diabetic, • primary prevention • 12% • Non-diabetic, • secondary prevention • 24% CTT Lancet 2008;131:117-25

  41. Non-diabetic, • primary prevention • 8% • Diabetic, • primary prevention • 12% • Non-diabetic, • secondary prevention • 24% CTT Lancet 2008;31:117-25

  42. www.dtu.ox.ac.uk/riskengine/index.php

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