A new study has demonstrated that Crestor, one of several “statin” drugs on the market, effects a 50% reduction in the risk of heart attack for people who exhibit signs of inflammation in their arteries.
The connection between inflammation and symptomatic coronary artery disease is not new. In the mid-1990’s, researchers discovered evidence of inflammation in cholesterol plaques in the arteries of patients who had suffered from heart attacks.
Interestingly, scientists have also demonstrated the presence of bacteria in inflamed cholesterol plaques. Indeed, at one time there was speculation that coronary artery disease was an infectious disease. (Quaschning T, Wanner C. The role of Chlamydia in coronary heart disease—fact or fiction? Nephrol Dial Transplant 1999;14: 2800-2803)
Unfortunately, enthusiasm for the “infectious disease” theory waned as statins became the mainstay for preventing cardiovascular events in this country. These drugs are widely prescribed for adults with hypercholesterolemia; recently, the American Academy of Pediatrics recommended statins for use in children with the same condition. Now we may see sweeping recommendations to employ statins in individuals who simply exhibit evidence of underlying arterial inflammation.
Potential Shortcomings of Crestor Study
Although the Crestor trial has generated a great deal of excitement, some medical experts are calling for caution at several levels:
- Dr. Paul Ridker, principal investigator for the trial, has financial ties to AstraZeneca, the company that funded the study. Dr. Ridker is also co-holder of a patent on the test that measures inflammation (high-sensitivity C-reactive protein, or CRP). So, despite Dr. Ridker’s claims that he has no conflicts of interest, he stands to profit from any comprehensive changes in practice recommendations that might stem from his research.
- Even though Crestor showed clear benefit in this trial, analysis of the data shows that 120 individuals would have to be treated with the drug for two years in order to prevent a single heart attack. (Hlatky M. Editorial NEJM)
- Though other statins may show the same benefit as Crestor, none of them have been similarly tested to date. At a cost of $1200 per year, using Crestor to treat everyone in the US whose CRP places them in a high-risk category could cost up to $9 billion annually (although thousands of heart attacks might be averted).
- Test subjects in the Crestor trial had normal cholesterols prior to enrollment; the long-term effects of lowering their cholesterol levels further are as yet unknown. Past research has raised concerns about this.
- Test subjects in the Crestor study showed a slightly higher tendency to develop diabetes. If this proved to be a trend, the costs of managing diabetes and its complications–not to mention its effects on quality of life– would have to be added to the equation.
Treatment Based on Whose Evidence?
Practitioners of Western medicine are wedded to the concept of “evidence-based medicine.” In short, their standard of care is based upon the results of well-designed studies. Unfortunately, most such studies in this country are funded by the very companies that stand to profit from preconceived results. Too often, physicians prescribe potent, expensive therapies on the basis of these trials, instead of relying on their own diagnostic skill and clinical acumen.
It would seem reasonable to step back a decade or so, to reexamine perfectly good clinical research that has already been done, and to ferret out the cause of the inflammation that damages coronary arteries and leads to heart attacks.
It’s just possible that there’s a short-term, inexpensive approach to this problem.