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The safety of statins is of great interest to the public, as well as to clinicians and policy makers, because of the problems with the safety of cerivastatin (Baycol, Bayer), which ultimately, leads to its withdrawal from the market. With the recent advent of a new statin, rosuvastatin (Crestor, AstraZeneca), these concerns have resurfaced.
Medication safety is always an issue, but especially so with the statins for several reasons. First, they are prescribed frequently. Statins are the single most prescribed category of agents in the United States today. Second, they are prescribed for long periods of time. Over the many years that a typical patient takes a statin, there are many chances for adverse events, including unforeseen changes in the patients’ health status. A third is that statins are most commonly used in middle-aged or elderly patients who tend to be taking many other medications for other problems. This heightens safety concerns, both because the poly-p******y, typical of these age groups, greatly increases the overall risk of drug-drug interactions and, because many of the diseases common in older patients, contribute to drug safety concerns; and finally, because advanced age itself, even with excellent health, probably increases the risk of drug toxicity.
Statins are drugs that can lower cholesterol. They work by blocking a substance in the body that makes cholesterol. Statins may also help the body reabsorb cholesterol that has built up in plaques on the artery walls, preventing further blockage in the blood vessels and heart attacks. Still, lifestyle changes are essential for reducing the risk of heart disease, whether you take a statin or not.
Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known.
Recently, researchers conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin–ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization (≥30 days after randomization), or nonfatal stroke. The median follow-up was 6 years.
The study concluded that when added to statin therapy, the addition of ezetimibe resulted to an incremental dropping of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit.
The study was published online in the New England Journal of Medicine.