Why Are Statins So Important?The statin drugs are considered vitally important in cardiovascular medicine (and therefore, tend to be so controversial) because they are the only cholesterol-lowering drugs that have been convincingly shown to substantially and reliably reduce the risk of heart attacks, strokes, and death in high-risk patients.
In fact, it now seems clear that statins do far more than merely lower your cholesterol levels — they have an anti-inflammatory effect; they help to prevent abnormal blood clotting; they help to stabilize the arterial plaques whose rupture so often leads to heart attacks and strokes; and they have other beneficial effects as well.
The unique benefits of statin drugs in preventing cardiovascular problems, documented in several important clinical trials, makes most doctors very enthusiastic about using these drugs in their patients whose cardiovascular risk is elevated.
What's The Controversy About Statins in Women?The controversy arises because the evidence that statins are as effective in improving cardiovascular outcomes is less definitive in women than it is in men. Indeed, statistically the benefits of statins in women are unproven.
Here is what we know: Large randomized clinical trials enrolling both men and women with prior heart attacks or acute coronary syndrome, that is, in people who already have significant coronary artery disease (CAD), have shown statins to be effective in reducing subsequent cardiac events, including heart attacks and death. In people who don't yet have known CAD, but in whom the risk of CAD is high, randomized trials have also shown improved cardiovascular outcomes with statins.
But when you analyze the results obtained only among the women enrolled in these clinical trials, the benefits of statins have generally failed to reach statistical significance. That is, the benefits of statins in women remain unproven.
What Is the Explanation For This Lack of Proof?There are two possible explanations for why any benefit of statins in women remains unproven. The first, of course, is that perhaps statins just do not work as well in women as in men. This argument, which is indeed a plausible one, is invoked by anti-statin activists (and those who doubt the existence of such a thing should read my emails whenever I write an article that fails to utterly disparage these drugs) to demand that the use of this unproven treatment in women be stopped. While their arguments often appear to be clothed in emotion, they in fact have a good point. Using pure “evidence-based” standards, it can be legitimately argued that the use of statins should be reconsidered in women.
The second explanation, however, is at least equally as plausible. It is that statins are actually just as effective in women as in men, but not enough women have been enrolled in clinical trials to statistically prove this effectiveness. Evidence in favor of this explanation is that, in most of these trials, the magnitude of benefit seen with statins appears just the same in women as in men, but not enough women were enrolled to reach statistical significance at that level of benefit. So, the argument goes, if sufficient women had been enrolled in the statin trials, the statins would have been proven to be just as effective in women — and there would be no controversy at all.
It is indeed unfortunate that most statin trials - and in fact, most cardiovascular clinical trials - have enrolled a preponderance of men. This systemic problem, whatever the explanation, is thankfully being actively addressed and corrected in more recent and currently ongoing clinical trials. But regarding the published statin trials, the problem remains.
While the benefits of statins in women have not been proven, neither have they been disproved; and indeed, the studies seem quite suggestive of a benefit.
So Should Statins Be Used In Women?Today there is no definitive and universally-agreed upon answer to this question.
If you are a woman whose doctor is a strictly pure, by-the-book proponent of evidence-based medicine, he or she may recommend not using statins even if you have proven CAD. By strict evidence-based standards, statins in women have not passed muster.
But other equally reasonable doctors are looking at the question a bit differently. They note that the statin studies strongly suggest that the magnitude of benefit in women appears nearly equivalent to the benefit in men, and that if as many women as men had been enrolled in these studies, that benefit would very likely have been proven statistically. These doctors will tend to err on the side of the benefit of the doubt, and offer statins to their women patients, pending more definitive evidence.
If you are a woman with CAD, you and your doctor will need to weigh the known risks of statins against the potential benefits, and reach a decision that is compatible with your own thoughts and feelings on the matter. This process, it ought to be noted, is nothing unusual in medicine: where definitive proof is hard to come by, and where clinical judgment and the patient’s wishes - rather than some strict rule agreed upon by all the experts - are often the determining factors.
Finally, we ought to remind ourselves that if statins were not such a unique form of therapy, and if they did not work at so many levels (over and above mere cholesterol-lowering) to prevent cardiovascular events, there would not be any controversy here at all.
Davignon, J. Beneficial cardiovascular pleiotropic effects of statins. Circulation 2004; 109:III39.
Nissen, SE. High-dose statins in acute coronary syndromes. Not just lipid levels. JAMA 2004; 292:1365.
Gutierrez J, Ramirez G, Rundek T, Sacco RL. Statin therapy in the prevention of recurrent cardiovascular events. A sex-based meta-analysis. Arch Intern Med 2012; 172:909-919.