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Statins: The Good, bad & ugly
Satish Madiraju, M.D., FACP, FACC,
FSVM
Interventional Cardiovascular Medicine
Saint Mary Mercy Hospital
Livonia, Michigan
A little history:
1976-Japanese scientists discover “Compactin” shown to block
cholesterol synthesis
1979-Merck investigators isolate the inhibitor “Lovastatin”
Rumors surface that Compactin might have caused cancers in dogs
Merck’s CEO Dr. Roy Vagelos decides to discontinue statin clinical
trials
July 1982-FDA helps Dr’s Illingsworth, Grundy & Bollheimer at OHSU
and Univ of Texas to treat familial hypercholesterolemia
JAMA Jan 20, 1984- results of LRCCPPT published-19% reduction in
heart disease, death or heart attack
March 23, 1984- Merck submits FDA application
First statin released by Merck in 1987
Cholesterol: Essential for life!
Good and bad cholesterol
Real Patient:
44 year old woman, single, overweight, works for
BCBS, smokes 1/2 pack per day and recently started
on Lipitor 20 mg.
No history of diabetes, hypertension, or family history
of coronary heart disease.
Recent blood test: Total cholesterol 210 mg/dl, LDL-C
137, HDL 43, Triglycerides 150
Should she be on a statin?
Absolute Risk versus
Relative Risk
Placebo compared to new drug in a clinical trial
Patients taking placebo have a heart attack risk of 2%
Patients taking new drug have heart attack risk of 1%
Absolute risk reduction with drug is 2% minus 1%=1%
Relative risk reduction: 1% is 50 percent less than 2%, hence
reported as a 50% reduction in heart attack risk
How much benefit do women
derive from statins?
Primary prevention trial
Seeks to show that in people without evidence of
cardiovascular disease, those treated with a statin will
be less likely to have a heart attack, or stroke or to die
of heart disease over the course of the trial than those
taking a placebo.
Secondary prevention trial
Seeks to show that in people with evidence of
cardiovascular disease, those treated with a statin will
suffer fewer subsequent events such as a heart
attack, stroke, or cardiac death over the course of the
trial than those taking a placebo.
Meta-analysis of statin trials and diabetes risk
13 percent increased risk of developing
diabetes
Statins & Diabetes
Elderly women at increased risk of developing
diabetes
Overweight and impaired glucose levels also
predispose
Patients should have glucose levels checked on
statins
No increased risk of cognitive
dysfunction
The Mediterranean diet
California Teacher’s Study
14 percent reduced risk of ischemic stroke
International Stroke Conference, February 12, 2015
Thank you

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Statins & primary prevention in women

  • 1. Statins: The Good, bad & ugly Satish Madiraju, M.D., FACP, FACC, FSVM Interventional Cardiovascular Medicine Saint Mary Mercy Hospital Livonia, Michigan
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  • 6. A little history: 1976-Japanese scientists discover “Compactin” shown to block cholesterol synthesis 1979-Merck investigators isolate the inhibitor “Lovastatin” Rumors surface that Compactin might have caused cancers in dogs Merck’s CEO Dr. Roy Vagelos decides to discontinue statin clinical trials July 1982-FDA helps Dr’s Illingsworth, Grundy & Bollheimer at OHSU and Univ of Texas to treat familial hypercholesterolemia JAMA Jan 20, 1984- results of LRCCPPT published-19% reduction in heart disease, death or heart attack March 23, 1984- Merck submits FDA application
  • 7. First statin released by Merck in 1987
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  • 11. Good and bad cholesterol
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  • 19. Real Patient: 44 year old woman, single, overweight, works for BCBS, smokes 1/2 pack per day and recently started on Lipitor 20 mg. No history of diabetes, hypertension, or family history of coronary heart disease. Recent blood test: Total cholesterol 210 mg/dl, LDL-C 137, HDL 43, Triglycerides 150 Should she be on a statin?
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  • 24. Absolute Risk versus Relative Risk Placebo compared to new drug in a clinical trial Patients taking placebo have a heart attack risk of 2% Patients taking new drug have heart attack risk of 1% Absolute risk reduction with drug is 2% minus 1%=1% Relative risk reduction: 1% is 50 percent less than 2%, hence reported as a 50% reduction in heart attack risk
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  • 26. How much benefit do women derive from statins?
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  • 28. Primary prevention trial Seeks to show that in people without evidence of cardiovascular disease, those treated with a statin will be less likely to have a heart attack, or stroke or to die of heart disease over the course of the trial than those taking a placebo.
  • 29. Secondary prevention trial Seeks to show that in people with evidence of cardiovascular disease, those treated with a statin will suffer fewer subsequent events such as a heart attack, stroke, or cardiac death over the course of the trial than those taking a placebo.
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  • 41. Meta-analysis of statin trials and diabetes risk 13 percent increased risk of developing diabetes
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  • 43. Statins & Diabetes Elderly women at increased risk of developing diabetes Overweight and impaired glucose levels also predispose Patients should have glucose levels checked on statins
  • 44. No increased risk of cognitive dysfunction
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  • 51. California Teacher’s Study 14 percent reduced risk of ischemic stroke International Stroke Conference, February 12, 2015