Women and Statins
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 10% 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 disease or diabetes.
Despite this, women have been a major target group by Pfizer for the promotion of their product, Lipitor. Print and television advertisements for Lipitor frequently show pictures of healthy and active appearing women with their cholesterol numbers attached with the text warning that high cholesterol is a risk factor for heart disease. Also adding that it is one of the major risk factors for stroke. The effect of such advertising is to provide women with the impression that Lipitor protects against cardiovascular disease.
Throughout this period FDA has stressed that the relationship between Lipitor’s cholesterol lowering effect and its effect on cardiovascular disease is not known. For women without heart disease of 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 significantly benefit.
Pfizer’s overall marketing campaign obfuscates and, indeed, fails to disclose the fact that while Lipitor lowers cholesterol there is no evidence that this reduction has any effect on the development of coronary heart disease or lowered mortality rates for women.
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 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 Lipitor or, indeed, use of any statin in Pfizer’s targeted group of women having neither cardiovascular disease or diabetes and therefore insignificant vascular inflammation, would have little or no provable benefit.
Clearly we are seeing statins as useful more for secondary than for primary prevention. In the presence of high cardiovascular risk such as a patient with history of heart attack or stroke documenting underlying atherosclerosis and inflammation, anti-inflammatory agents such as statins have obvious value.
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--