Statins & primary prevention in women

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

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 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

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