statins & primary prevention in women
TRANSCRIPT
Statins: The Good, bad & ugly
Satish Madiraju, M.D., FACP, FACC, FSVMInterventional Cardiovascular MedicineSaint Mary Mercy HospitalLivonia, 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
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 RiskPlacebo 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
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.
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
California Teacher’s Study
14 percent reduced risk of ischemic stroke
International Stroke Conference, February 12, 2015