Authors of a commentary in the January 20, 2007 issue of Lancet say that the use of statin drugs for primary prevention of cardiovascular disease (that is, in patients who do not yet have cardiovascular disease) in women and in people over the age of 69 cannot be supported by existing data from clinical trials. They call for a revision to the National Cholesterol Education Program (NCEP) guidelines to address this fact.
They base their opinion on a review of data from 8 randomized clinical trials, and conclude that total mortality was not reduced in these trials with the use of statins in women or older people who did not have pre-existing disease. They did find, however, that statins were associated with a significant 1.5% reduction in cardiovascular events, such as non-fatal heart attacks. Based on their analysis, the authors suggest that the NCEP guidelines be changed so as to not recommend the use of statins for primary prevention in women or in patients over 69.
Interestingly, a similar analysis published in the Archives of Internal Medicine in November, 2006 reached the opposite conclusion. This second analysis showed a significant reduction in heart attacks, strokes, and the need for coronary artery revascularization in primary prevention patients (including women and older patients) taking statins. Overall mortality was not significantly improved. These authors concluded that their results strongly support current NCEP guidelines.
Alert readers will notice right away that, while the conclusions the two groups reached were opposite (i.e., one group wants the recommendation for statin therapy in these patients to be dropped, the other wants it to continue), the actual results upon which these conclusions were reached are the same (i.e., a significant reduction in non-fatal heart attacks, strokes, and revascularization events, but not in overall mortality with statins).
Of note, neither group found that serious adverse events were greater in patients treated with statins than with placebo.
Should women and patients over the age of 69 with elevated cholesterol levels but no known cardiovascular disease take statins? Whichever answer you favor, you'll now find a prominent group of experts to support you.
I guess this means that individual patients who fall into these categories should discuss the pros and cons of statin therapy with their doctors. In these discussions, the following items ought to be considered:
Patients with multiple risk factors (diabetes, smoking, obesity, sedentary lifestyle, hypertension, etc.) stand to gain more from statins that those in whom cholesterol is the only risk factor. High risk patients should take statins. The present controversy is pretty much limited to patients at intermediate risk. ( To assess your risk level, look here.)
Non-fatal heart attacks, strokes, and revascularization procedures, while not as bad as dying, are still pretty bad. Significantly reducing the risk of having one or more of these events will, after deliberation, seem like a worthwhile endeavor to many.
While once again, doctors conducting clinical trials with statins are being accused of receiving funding (i.e., being reimbursed for the expense of conducting research) from drug companies, and therefore having conflicts of interest. But since the vast majority of medical studies are funded by industry, the vast majority of medical progress is made in this way. This is just the nature of the system, and is the price of medical progress. While it is appropriate to take the funding of the research into account, routinely and entirely discounting research conducted in this way seems personally counterproductive to one's own health. But, like the man said, it's a free country.