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ELIGIBILITY: MRC/BHF Heart Protection Study

ELIGIBILITY: MRC/BHF Heart Protection Study. Increased risk of CHD death due to prior disease: Myocardial infarction or other coronary heart disease; Occlusive disease of non-coronary arteries; or Diabetes mellitus or treated hypertension Age 40-80 years

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ELIGIBILITY: MRC/BHF Heart Protection Study

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  1. ELIGIBILITY: MRC/BHF Heart Protection Study • Increased risk of CHD death due to prior disease: • Myocardial infarction or other coronary heart disease; • Occlusive disease of non-coronary arteries; or • Diabetes mellitus or treated hypertension • Age 40-80 years • Total cholesterol >3.5 mmol/l (>135mg/dl) • Statin or vitamins not considered clearly indicated or contraindicated by patient’s own doctors

  2. PRIOR DISEASE at BASELINE

  3. AGE & SEX at BASELINE

  4. TOTAL & LDL CHOLESTEROL at BASELINE

  5. FACTORIAL TREATMENT COMPARISONS

  6. VITAMINS: Average blood VITAMIN levelsduring follow-up

  7. VITAMINS: CATARACT and FRACTURES

  8. VITAMINS: COGNITIVE IMPAIRMENT(TICS-m <22/39) at Final Follow-up

  9. VITAMINS: Summary of findings • This antioxidant vitamin regimen (600mg E, 250mg C & 20mg beta carotene daily) increased blood vitamin levels substantially • These vitamins appeared to be safe, but did not reduce the 5-year risks of any type of vascular disease, cancer or other major outcome • Given these results, continued recommendation of supplementation with such vitamins is difficult to justify

  10. FACTORIAL TREATMENT COMPARISONS

  11. STATIN USE: Compliance with study simvastatin or use of non-study statin

  12. HPS assesses 2/3 of the effect of actually using 40mg simvastatin daily • Average proportions using statin during HPS: 5/6 of active group vs 1/6 of control group • LDL difference in HPS (active vs control group) is ~2/3 of LDL difference from actually using statin • Risk reduction in HPS (active vs control group) is ~2/3 of risk reduction from actually using statin • ACTUAL EFFECT = 1.5 x APPARENT EFFECT

  13. SIMVASTATIN 40mg daily: Muscle symptoms

  14. SIMVASTATIN 40mg daily: Safety monitoring

  15. SIMVASTATIN: COGNITIVE IMPAIRMENT(TICS-m <22/39) at Final Follow-up

  16. SIMVASTATIN: Average LDL DIFFERENCE(mmol/l ± se) by BASELINE LDL cholesterol

  17. SIMVASTATIN: Average LDL DIFFERENCE (mg/dl ± se) by BASELINE LDL cholesterol

  18. Statin-allocated Placebo-allocated Upper LDL third Lower LDL third SIMVASTATIN: MAJOR VASCULAR EVENT in upper & lower thirds of baseline LDL 30 25 % with major vascular events 20 15 1.5 2.0 2.5 3.0 3.5 4.0 Average LDL cholesterol (mmol/l)

  19. SIMVASTATIN: Main conclusions • After allowance for non-compliance, 40mg daily simvastatin safely reducesthe risk of heart attack, of stroke, and of revascularisation by about one-third • 5 years of statin treatment typically prevents these “major vascular events” in about: • 100 of every 1000 people with previous MI • 80 " " " other CHD • 70 " " " cerebrovascular disease • 70 " " " other arterial disease • 70 " " " diabetes (age 40+) • irrespective of cholesterol level(or age, or sex, or other treatments)

  20. Millions of people with relevant conditions

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