The fact that there is no statistically proven cardiovascular benefit from the use of statins for cholesterol reduction in women was first publicly disclosed by Uffe Ravnskov in his book, Cholesterol Myths and has been corroborated repeatedly by numerous longitudinal clinical studies.
The ASCOT study, the largest randomized clinical study of statin effectiveness in women, found that the women who took Lipitor, developed more heart attacks than women in the group given placebo.
While not statistically significant this finding hardly supports cardiovascular benefit. In this ASCOT study, 2,000 women were included among 10,000 patients having elevated blood pressure and at least three other cardiovascular risk factors.
Again and again, clinical studies have failed to show that the use of statins lowers cardiovascular risk in women who do not already have coronary heart disease or diabetes.
Throughout this period the FDA has stressed that the relationship between statins' cholesterol lowering effect and its effect on cardiovascular disease is not known. For women without heart disease or stroke there are no clinical trials showing that cholesterol lowering reduces women's risk of developing heart disease, heart attack, stroke, cardiovascular disease death, illness overall or even death from any cause. Again and again, clinical trials examining the prevention of acute coronary events by the use of statins have found no statistically significant benefit.
Research results in the past several years cast increasing doubt as to cholesterol's role in atherosclerosis, now pointing more and more convincingly to inflammation as the principle factor. Statin drugs appear to reduce cardiovascular risk not by cholesterol manipulation but by inflammation suppression and are now recognized for the powerful anti-inflammatory agents they really are.
The mechanism of action for this completely unexpected effect is suspected to be via the inhibition of nuclear factor kappa B, a transcription factor vital to our immunodefense system. In light of this new information it is not surprising that the use of any statin in the targeted group of women having neither cardiovascular disease nor diabetes and therefore insignificant vascular inflammation, would have little or no provable benefit.
Pfizer's promotion of Lipitor has thus created an artificial demand for Lipitor, which would not exist if full and fair disclosure had been made concerning benefit lack in the females free of diagnosed heart disease or diabetes.
The side effect profile of statin drugs is of major concern. The statin associated rhabdomyolysis deaths alone, the majority of which have been women, should give all physicians reason to ask themselves, "Is the expanding use of statins in primary prevention really justified?"
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor
