When Gertrude Stein famously wrote, "Rose is a rose is a rose is a rose," she seemed to reveal an ignorance of, if not contempt for, the flowers. After all, any gardener knows some roses look like flabby cabbages and others sport flesh-ripping thorns. Do physicians, MCOs, and PBMs who act as though "statin is a statin is a statin is a statin" display a similarly uncritical attitude toward the drugs — and unwittingly show a certain disregard for their patients? Or are statins (and roses) really rather more similar than not?
Back in the early days of statin therapy, circa 1990, the notion of reducing the risk of morbidity and mortality from heart disease by lowering levels of cholesterol was still greeted with some skepticism. Cholesterol, after all, is a component of every human cell. It was thought that overly aggressive cholesterol reduction might trigger cancer or some kind of central nervous disorder. But since then several large clinical trials (See "Major statin trials" on page 41) seem to have established the overall safety and clinical value of statins. Their best-known effect is reducing the amount of cholesterol carried by low-density lipoprotein (LDL), thereby preventing the accumulation of LDL cholesterol (LDL-c) in atherosclerotic plaque.
Today, LDL-c reduction is well accepted as a means of reducing cardiovascular risk, and the manufacturers of a half dozen statins vie for the attention of physicians, patients, and P&T committees — and a chunk of the $13.5 billion U.S. statin market. The entire market is supported by guidelines issued by the National Cholesterol Education Program (NCEP), which recommends statin therapy for patients at risk for coronary heart disease (CHD), and which physicians ignore at their legal peril. Armed with scientific studies — plus plenty of marketing savvy — each statin manufacturer seeks to demonstrate why its product should be preferred over the competition. If you haven't yet heard presentations about the effects of statins on high-density lipoprotein cholesterol (HDL-c) and inflammation, as measured by high-sensitivity C-reactive protein (hs-CRP), you soon will.
At the same time, all the statin manufacturers keep looking over their shoulder for the coming of the next blockbuster in cardiovascular drug therapy. It probably won't be yet another statin, but it might be one or more products that improve levels of HDL-c. HDL is best known for its ability to transport cholesterol away from peripheral tissues, thereby reducing the cholesterol burden in atherosclerotic plaque.