Statin drugs have many uses, concerns

Dr. Conway McLean

In some fashion, heart disease has touched us all. Some of us because of the death of a loved one, while others simply take some medication because their doctor prescribed it, stating the drug could lower their susceptibility to heart problems. By lowering the levels of cholesterol, doctors believe they can help prevent heart attacks and stroke. Some studies have indeed shown that, in certain people, statins may reduce the risk of heart attack, stroke, or even death from heart disease.

About 800,000 people die of heart disease in the United States every year-that’s 1 in every 3 deaths. It is the leading cause of death for both men and women. How is our health care system combatting this tremendous problem? Has your physician prescribed nutritional counseling? Have any of your health care providers given more than token recommendations to improving your physical fitness? If the answer to any of these and many other pertinent questions is “Yes”, your provider is a rarity.

In our health care system, treatment for heart disease starts with a prescription, and, as we have come to expect, it is a prescription for a drug instead of one for exercise or dietary changes. The pharmaceutical industry has been busy, and there is now a plethora of drugs available for the treatment of various heart problems. A relatively recent addition to our pharmacologic armamentarium is that of the statin drugs. A report in the New England Journal of Medicine found that these cholesterol-lowering drugs have now become the most prescribed medication of any type, with more than 25 percent of Americans over 45 taking them.

This inflated number is set to increase following recommendations issued by a federal advisory board. They recommended statins for people between the ages of 40 and 75 with a 10 percent or greater risk of heart problems in the next 10 years based on published guidelines. And this, regardless of whether they have had a previous heart attack or stroke. Thus, it is becoming clear that these drugs are being more frequently prescribed and for a greater number of indications.

Statin cholesterol-lowering drugs are widely touted as the best way to lower your cholesterol and thereby prevent a heart attack. They’re recommended to people who have “high cholesterol,” those who have heart disease, and even for some healthy people as a form of preventive medicine. But are these drugs truly right for you? What do the studies show? Will the reduction of cholesterol levels result in a reduction of deaths due to heart disease? Another relevant question should be are the study results reliable? Although some of the statin trials have reported benefits in lowering the number of deaths due to heart disease, quite a few have not.

When a drug company is providing the funding for some study, the opportunities for bias are many. These include utilizing study designs that make their products look better. Pharmaceutical executives may select academics to perform these studies who generally are of similar thinking. Of course, statistics can be manipulated in ways that make their drugs look better than they are. The odds of reaching a favorable result from a privately sponsored study is significantly greater than research sponsored by government or nonprofit group. This according to a recently published analysis.

The cholesterol hypothesis states patients at highest risk should derive the greatest benefit from cholesterol lowering. However, statin trials in the elderly, in patients with heart failure, and in patients with renal failure have all failed to demonstrate benefits in reducing cardiac problems. An analysis of 18 cholesterol-lowering trials, some with statins and some with other drugs, in patients with peripheral arterial disease all failed to demonstrate a benefit to patient mortality. What about the benefits to those with diabetes? Diabetes mellitus is considered a risk factor for heart disease, but three randomized controlled trials specifically designed to assess the effect of statins in diabetes all failed to demonstrate a mortality benefit.

Statins work by inhibiting an enzyme that your liver needs to produce the so-called “bad cholesterol”. Statins also minimally increase the good cholesterol (HDL), which is responsible for moving bad cholesterol from your arteries back to the liver. Cholesterol is a waxy, fatty steroid that your body needs for things like the production of new cells as well as sex hormones. Cholesterol is part of our cell walls, is required for digestion, and for the conversion of sunlight to vitamin D.

Where does cholesterol come from? It comes from the food you eat and is also produced in your body (mainly by the liver). It travels via the bloodstream, which is where certain types of cholesterol can form plaques. Plaques are thick, hard deposits that cling to the walls of arteries and restrict blood flow. These plaques can break off, with the potential to form blood clots, which can lead to stroke and other serious health conditions.

The Mediterranean diet reduces mortality within months of starting it. This plan stresses the consumption of fresh vegetables, nuts and healthy oils (olive!), with significantly reduced consumption of sweets and red meat. The dramatic benefits of this diet are likely due to many differing mechanisms which do not directly involve cholesterol. The positive health consequences of this type of diet have been frequently demonstrated in a variety of medical trials with no significant complications. Can any of the statin drugs claim this? So what are the side effects and potential complications of the use of this ubiquitous class of pharmaceuticals?

Side effects with use of statin medication are not uncommon. They include muscle pain, increased risk of diabetes mellitus, altered mental states, and abnormalities in liver enzyme tests. Additionally, they carry the risk of some more severe adverse effects, particularly muscle damage, although this latter effect seems to occur rarely. Statins also appear to reduce levels of coenzyme Q10. This substance is used for energy production by every cell in your body, and is therefore vital to good health, high energy levels, longevity, and general quality of life. A recent discovery shows that statins inhibit the manufacture of vitamin K2, which protects your arteries from calcification. Without it, plaque levels worsen.

A recent decline in cardiovascular deaths in the United States has been touted as proof of the effectiveness of statin therapy, but this view fails to incorporate the impact of smoking cessation, lifestyle changes, and dramatic improvements in heart attack survival rates (due to timely reperfusion and the availability of defibrillators). Yet, heart disease has reached pandemic proportions globally, despite worldwide statin usage and cholesterol lowering campaigns. Heart disease is an extremely complex malady; previously-held expectations that it could be prevented or eliminated by simply reducing cholesterol appear unfounded. After twenty years we should concede the anomalies of the cholesterol hypothesis and refocus our efforts on the proven benefits of a healthy lifestyle incorporating a Mediterranean diet.

The research is clear: the road to good health is paved with ‘good’ food! Eat smart, specifically a Mediterranean-type diet. And exercise! An estimated one in three US adults do not meet current recommendations for physical activity. Also, be your own health advocate. When you are prescribed some medication, do some research. Ask questions. Chart any possible complications or side affects you may be experiencing or adverse reactions that coincided with the use of some new med. Hopefully your doctor is attuned to the possibility that some unexpected symptom is a drug-related event. Many patients state their physician is not. Do not depend on your doctor for good health; you are the only one who can make the fundamental changes in your life that lead to health and well-being.

Editor’s note: Dr. Conway McLean is a physician practicing foot and ankle medicine in the Upper Peninsula, with a move of his Marquette office to the downtown area. McLean has lectured internationally on wound care and surgery, being double board certified in surgery, and also in wound care. He has a sub-specialty in foot-ankle orthotics. Dr. McLean welcomes questions or comments