Recently, we were struck by the increase in public media hype about the benefits of statin drugs (see, e.g. Newsweek, July 14, 2003, "You Want Statins With That?"), which are sometimes described as "the new aspirin" in terms of their benefits and safety. Even our public health institutions have become advocates of these drugs.
We are mindful that for decades many women took hormone replacement therapy (HRT), convinced by claims of the wonders of hormone replacement therapy. HRT was variously touted as a safe and effective cure for menopausal symptoms, aging, osteoporosis, and even Alzheimer’s disease. We watched with dismay as medical research proved many of the alleged benefits of HRT wrong and, more important, showed that HRT is unsafe and even dangerous. (See, e.g. HRT Can Increase Risk of Alzheimer's Disease and Dementia and the reports cited at the end of that report.)
According to ( Newsweek, 12-15 million Americans are currently prescribed a statin drug to reduce their high cholesterol. This number is predicted to surge as the U.S. population ages. Given the large numbers of Americans taking statin drugs and the growing hype about statins, we decided to do a little research of our own. CHS is committed to patient education; and, in that spirit, we present our findings here.
Our concerns about the misleading and/ or false claims that are circulated about cholesterol, the need for pharmaceutical interventions, and the safety of cholesterol-lowering drugs such as statins are listed below:
Media messages and advertisements often present statistics about the dangers of high cholesterol, giving one number - total cholesterol - to identify cholesterol high enough to warrant medical and pharmaceutical intervention. The high total cholesterol number is not broken down into its component parts, LDL, HDL, and triglycerides. (For the importance of considering the component parts, see Heart Disease Center: CHS Report - Cholesterol Measures. ) Yet, in some cases, a high total cholesterol is not cause for concern. Presenting the one number identified as high total cholesterol requiring intervention with drugs is misleading and could lead patients to overlook more relevant information. Moreover, statistics showing reductions in total cholesterol that result from the use of a statin drug don't tell us whether it is only LDL cholesterol that is reduced or whether HDL or good cholesterol is also reduced, a result that is not beneficial.
Media messages and advertisements often urge patients to use drugs to reduce their LDL cholesterol below 130 and even below 100 in order to lower their risk of heart attack. The messages typically fail to warn patients that LDL cholesterol levels below 130 may actually increase the risk of coronary heart disease. For example, the FDA has recently approved a new laboratory blood test that can increase the ability of doctors to predict the risk of coronary heart disease (CHD). The test, called PLAC, works by measuring an enzyme called lipoprotein-associated phospholipase A2. FDA cleared the test based on results of a 9 year study of more than 1,348 patients. The study was a part of a large multi-center epidemiologic study sponsored by the National Heart, Lung, and Blood Institute. Patients were free from CHD at the start of the study and were followed for the development of disease for nine years. The greatest increased risk for CHD was found in subjects with the highest PLAC test results, and LDL cholesterol levels lower than 130mg/dL.
Giving a statin drug to a person with LDL cholesterol of 140 or below, as is frequently done today, would result in a 30 to 60% reduction in his or her LDL cholesterol, potentially placing him or her at increased risk for heart attack if his or her lipoprotein-associated phospholipase A2 is high.
Media and advertising messages focus on lowering total cholesterol to reduce our risk of heart attack, yet, recent evidence documents the key relationship between the Metabolic Syndrome and Heart Disease. A new study has found that men with at least 3 of the 5 factors that define the metabolic syndrome had a 76% greater risk of heart attack than men without the syndrome. This risk was independent of LDL cholesterol levels. In fact, LDL cholesterol levels are not even a factor in the definition of the metabolic syndrome. Those factors are:
Focus on the metabolic syndrome rather than LDL cholesterol as the key to our heart health would have several extra beneficial effects, including reduction in the risk of diabetes and obesity, two major public health issues.
Claims that changes in diet cannot lower our cholesterol more than a few percentage points or that most people will not follow a cholesterol-lowering diet can lead us to seek a drug to do the job. Yet, a recent study that Compares a Statin Drug with a New Diet to Reduce Cholesterol and C-reactive Protein Levels found that both the statin drug and the new diet resulted in the same reductions in cholesterol and CRP levels, as well as the risk of heart attack. Moreover, most of the participants found the diet workable.
Media and advertising messages tell us that a simple creatine kinase or CK test can monitor our liver function to detect any serious problems. Yet, medical research has documented Statin-Related Muscle Problems, and the Risk of Polyneuropathy due to statins. Medical research has also documented the Inadequacy of the CK Blood Test to Diagnose Statin-Associated Myopathy. The adverse effects of statin drugs increase as the dosage increases.
We see claims for other benefits of statins that are unrelated to heart disease and that are unproven or false. For example, recent claims have been made that statins can prevent and/or treat Alzheimer's Disease and osteoporosis. The former claim is unproven, and the latter claim is false according to a recent study of over 93,000 women. The new study, published in the Annals of Internal Medicine (July 15, 2003) concluded that "statin use did not improve fracture risk or bone density...." The authors concluded that "the cumulative evidence does not warrant use of statins to prevent or treat osteoporosis." CHS will review this study in full for the August 15, 2003 newsletter.
Given the many misleading and/or false claims about the role of total cholesterol in heart disease and about the safety and efficacy of statin drugs, what are we, as patients, to do? The answer is the same one that you will find throughout CHS. Make a list of your questions based on your reading of this editorial and ask your doctor to make sure you have all the appropriate lab and office tests to enable you and him or her to find the best treatment for you.
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