Funding to Oxford University for MRC/BHF Heart Protection Study

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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 gt3.5 mmol/l (gt135mg/dl)
• Statin or vitamins not considered clearly
  indicated or contraindicated by patients own
  doctors

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PRIOR DISEASE at BASELINE
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AGE SEX at BASELINE
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TOTAL LDL CHOLESTEROL at BASELINE
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FACTORIAL TREATMENT COMPARISONS
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VITAMINS Average blood VITAMIN levelsduring
follow-up
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VITAMINS CATARACT and FRACTURES
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VITAMINS COGNITIVE IMPAIRMENT(TICS-m lt22/39) at
Final Follow-up
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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

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FACTORIAL TREATMENT COMPARISONS
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STATIN USE Compliance with study simvastatin or
use of non-study statin
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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

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SIMVASTATIN 40mg daily Muscle symptoms
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SIMVASTATIN 40mg daily Safety monitoring
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SIMVASTATIN COGNITIVE IMPAIRMENT(TICS-m lt22/39)
at Final Follow-up
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SIMVASTATIN Average LDL DIFFERENCE(mmol/l se)
by BASELINE LDL cholesterol
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SIMVASTATIN Average LDL DIFFERENCE (mg/dl se)
by BASELINE LDL cholesterol
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SIMVASTATIN MAJOR VASCULAR EVENT in upper
lower thirds of baseline LDL
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with major vascular events
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1.5
2.0
2.5
3.0
3.5
4.0
Average LDL cholesterol (mmol/l)
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SIMVASTATIN Main conclusions

• After allowance for non-compliance, 40mg daily
  simvastatin safely reduces the 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)

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Millions of people with relevant conditions
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