Over the past few weeks, there have been some blockbuster articles about cholesterol medicine and its effectiveness at preventing heart disease.
John Carey has written an article in BusinessWeek (Jan. 28) "Do Cholesterol Drugs Do Any Good?" Additionally, Merck/Schering-Plough Pharmaceuticals recently announced the results of the ENHANCE trial, which was designed to study the effects on cholesterol plaques in the carotid artery between patients treated with a generic Simvastatin versus Vytorin. And, in the book "Good Calories, Bad Calories," Gary Taubes challenges the conventional wisdom of using cholesterol levels as a yardstick for cardiovascular risk.
Each of these works has stimulated confusion within patients and doctors alike.
As a member of the National Lipid Association, a practicing physician and author of this column, it is my privilege to help people make sense of what often seems conflicting information. During the time since these three news items have hit the press, I have had one of the highest rates of questions from patients regarding cholesterol management in my years of practice.
In the August 2006 High-Tech Health column, we explored cholesterol, lipoproteins and the relationship between the two. I encourage you to re-read our previous column in order to put the controversy suggested by the above mentioned press into better perspective.
I'd like to address the controversy surrounding the BusinessWeek article referenced above.
It examines an important method to determine the effectiveness of many medications. That method is described as "Number Needed to Treat" or NNT. This is a representation of how many people need to take a medicine to achieve a measurable outcome. The article focuses on the statin class of medicines and its effect on heart disease and examines the claims made by Pfizer surrounding its Lipitor cholesterol medication. While the context of this column would not allow an exhaustive analysis of the various research studies performed to determine the effectiveness of statins on the prevention of heart disease, it is enough to say that there is overwhelming evidence supporting their use.
The author primarily asks the question whether the expense and potential side effects of treating 100 patients is worth preventing one heart attack. He is accurate in asking the question whether simple lifestyle modification – good old diet and exercise – would deliver us to a more healthy population. I can tell you the simple answer to that question is: Absolutely yes! But I also can say that if you ask that 1-in-100 patient who avoids a heart attack in the disability or death it might cause, taking a statin medication might mean the difference between life and death.
Regarding the recent Merck/Schering-Plough Pharmaceuticals ENHANCE trial, let's first understand how the trial was designed and what it was designed to answer. Using a relatively small 720 patients with a rare condition that causes a very high level of cholesterol, half of the participants were given Simvastatin 80 mg, and half the patients received Vytorin 80/10 mg. Vytorin is a combination medicine containing both simvastatin and Zetia (ezetimibe). Zetia works to block cholesterol absorption in the GI tract and lowers total cholesterol an additional 14-17 percent when added to a statin like simvastatin.
The trial was designed to measure the carotid intimal medial thickness in these patients. Carotid intimal medial thickness measurement is the only American Heart Association-approved method for the earliest diagnosis of vascular disease. The trial was designed to determine change in intimal medial thickness. It was not designed around a specific clinical outcome, heart attack or stroke.
Patients taking simvastatin alone showed the same or better intimal medial thickness measurements than those patients taking the combination medicine Vytorin. This finding led to a great deal of press coverage asking the question whether lowering total cholesterol/LDL cholesterol results in less cholesterol clog in one's arteries. It must be understood that this was a small trial with a very specific population, and it is not possible to extrapolate this data to a larger population quite yet.
Coming in No. 1 on a recent bestsellers list is the book "Good Calories, Bad Calories: Challenging the Conventional Wisdom on Diet, Weight Control and Disease." This work examines the relationship between saturated fat, carbohydrates, cholesterol and amongst other things vascular disease. The author, Gary Taubes, accurately investigates the relationship of cholesterol on heart disease.
He raises the discussion surrounding how cholesterol was transported in our bodies. The particles that carried cholesterol are called lipoproteins. Bad cholesterol, or LDL, is carried in low-density lipoproteins, good cholesterol or HDL is carried in high-density lipoproteins. It is clearly recognized that the high-tech approach to prevention and treatment of heart attack and stroke revolves around managing both the total amount of cholesterol, number of lipoprotein particles that carry this cholesterol and the cellular receptors of those lipoprotein particles.
The author's advice to avoid carbohydrates and have a diet relatively rich in protein is reasonable in moderation. This advice needs to be tempered with a holistic approach to wellness that includes a diet plentiful in fresh fruits and vegetables, as they are the principal sources of antioxidants that can aid in the prevention of cancer and other metabolic diseases.
These three media news events highlight very narrow viewpoints on a challenging health topic.
Each issue taken separately does have specific scientific merit, but without an integrated approach to wellness, the information presented can cloud a more simple health truth. Without the proper lifestyle habits, coordination of diet, exercise and modern medical therapy, true wellness and disease prevention can be difficult to achieve. There is no substitute to an active physical lifestyle in combination with a diet that avoids high levels of simple carbohydrates when it comes to health. In 2008, we do not have a medicine as powerful as these simple measures when it comes to avoidance of heart disease and stroke.
J. Rand Baggesen, M.D. is the Director of Executive Healthcare for the Executive Health Evaluation Program at CJW's Levinson Heart Hospital, Central Virginia's premier program for early diagnosis and prevention of heart disease, stroke and cancer. Dr. Baggesen attended the Medical College of Virginia and completed his residency in family practice at Chesterfield Family Practice, a VCU/MCV/Chippenham affiliated program. He served as chief resident and is currently an associate professor of medicine at the Medical College of Virginia. www.Executive-MD.com. At the Executive Health Evaluation Program at CJW's Levinson Heart Hospital, they utilize an integrated approach to the early diagnosis of cancer. Utilizing the latest biochemical markers with the area's finest radiographic imaging, they strive to provide for clients the promise of high-tech health, early detection and better outcome.
w LAST TIME OUT: Consumer-directed choices.