In January of 2008 there was some unsettling news that came from the FDA about the risks of the cholesterol lowering medication Vytorin (a combination of Zetia (Ezetimibe) and the statin drug Zocor (simvastatin)). Data from the Enhance trial that was not previously revealed by the manufacturer, Merck/Schering-Plough, showed that the combination drug did not reduce atherosclerotic plaque any better than the generic statin drug, simvastatin, when given alone.
In fact, if anything Vytorin seemed to make atherosclerotic plaque worse, although it had a greater effect on lowering cholesterol. Vytorin has also been associated with an alarming increase in risk of liver damage. In addition, the Zetia that is in Vytorin has never been shown to reduce the risk of heart attacks or strokes. And Vytorin, at $2.84 a pop, as well as Zetia ($2.63) costs a heck-of-a-lot more than simvastatin, which is less than a dollar per pill.
Doctors use cholesterol lowering drugs to get cholesterol down to normal levels. However just because a drug lowers cholesterol levels doesn't mean it will do what patients care about most, that is save your life, or even reduce the risk of heart attacks and strokes.
The most commonly prescribed drugs to lower cholesterol, the statins, include Lipitor, Zocor, Crestor, Mevacor, and Pravachol. Statins lower LDL cholesterol by blocking an enzyme that churns out LDL cholesterol in the liver, called HMG CoEnzymeA reductase. Thirteen million prescriptions are written for statins every year. Ezetimibe (Zetia) is a drug that blocks absorption of LDL cholesterol by the small intestine, thus lowering LDL cholesterol levels in the blood. Zetia acts on cells lining the small intestine to interfere with their uptake of cholesterol. If we followed the recommendations of the experts, cholesterol lowering drugs would be given to every American with an LDL of greater than 130 mg/dL over age 45.
Since half of Americans over age 35 have an LDL greater than 130 that would mean that almost half of all Americans or 100 million people should, theoretically, be taking statins. Since a year of statins costs up to $3000, that would cost $300 billion a year. Comparing national guidelines for who should take a statin across different countries, the guidelines which called for the most liberal use of statins (you guessed it, the U.S.) which called for 25% of the population to be on statins, saved no more lives than the guidelines for one of the most restrictive countries, New Zealand, which would treat 13% of the population.
For healthy males without a history of heart disease and without risk factors for heart disease (smoking, hypertension, family history of heart disease, familial hypercholesterolemia, hypertension, obesity and diabetes), there isn't any evidence that cholesterol lowering drugs are helpful in terms of preventing heart attacks and strokes. For men with risk factors, the majority of the studies show that they may prevent heart attacks but don't decrease your risk of dying. Cholesterol lowering does not prevent heart attacks in women without heart disease or in men without heart disease who are over the age of 70.
And taking a statin won't prevent you from having a heart attack or dying if you have heart disease. It only slightly lowers your risk, by about 0.2% per year. The only study to show that statins reduce risk of death in patients without heart disease showed that although after 15 years men taking Pravachol had fewer deaths (106 versus 135 on placebo), there was a 51% increase in prostate cancer. Other studies have shown a slight increase in the risk of cancer, especially with the use of high dose statins to bring cholesterol down to very low levels. Statins can also cause liver damage, depression, memory problems, and joint pain. They can also cause damage to the muscle tissue which results in muscle pain. In rare cases this can lead to a breakdown of the muscle tissue which results in kidney failure. Zetia can headache, dizziness, diarrhea, muscle and joint pain, and more rarely jaundice, gall stones or inflammation of the pancreas.
Bottom line? The drugs you are taking to prevent heart disease may not be as useful as you think, and in some cases may be doing more harm than good. Let the buyer beware.
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