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Careful monitoring of statin patients essential

We estimate more than 100 million Americans have total blood cholesterol levels of 200 milligrams per deciliter (mg/dl) or higher, and study after study has demonstrated that statin drugs are the most effective medications we have to lower these numbers.

Lovastatin (Mevacor), which was the first statin drug approved by the FDA in 1987, reduced cholesterol levels by 25 percent in clinical trials. Since then, several major studies have corroborated the statins' effectiveness in lowering cholesterol and along with it the risk of dying from heart disease and/or having recurrent heart attacks.

Push for stronger statins
It's not surprising then there has been an insistent push to develop stronger statins, and so it has gone. From the introduction of lovastatin to cerivastatin (Baycol^®), the potency of these drugs has increased, and their effectiveness has increased as well with some trials reporting LDL cholesterol reductions of as much as 40 percent and more. But as we have pushed for the development of stronger statins, it may be possible we're also pushing the risk-benefit envelope.

Millions take statins
In addition to developing more potent drugs, we've also been prescribing statins to rapidly escalating numbers of patients because they are so effective and have few side effects. Clinical trials and published studies have involved thousands of patients, but millions now take statins. As the number of users rises, some of whom are dissimilar from patients participating in the clinical trials, the possibility of finding serious or lethal side effects does as well. This is the mathematics of pharmaceuticals and explains why the FDA maintains post-market surveillance.

About 700,000 Americans were taking cerivastatin before the recall, so it had a relatively low percentage of the statin drug market share. That's the good news since it is now linked to a higher risk of dangerous side effects. It was initially approved in the U.S. in 1997, and it works as all the statins do by blocking a specific enzyme that's involved in the synthesis of cholesterol.

While all the statins have been associated with a very small risk of dangerous muscle-destroying side effects, cerivastatin, particularly when used in combination with other drugs such as gemfibrozil to lower trigycerides, has a slightly higher risk.

Few side effects
In general, statins have very few side effects. Some patients experience some gastrointestinal upsets, and in a few cases there may be some liver abnormalities along with muscle tenderness and weakness. This can be confusing to patients since newly diagnosed heart patients often begin new exercise and diet programs and some of the muscle soreness and weakness can be attributed to exercise rather than side effects of a statin.

Physician monitoring important
That's why it's so important for physicians to monitor everyone who begins statin treatment. The incidence of serious muscle injury and progression to life-threatening rhabdomyolysis is very rare, but it's essential to report any of the following symptoms to your doctor immediately:

• Muscle pain, weakness and/or tenderness
• Fever
• Dark urine
• Nausea and/or vomiting
• Malaise (a general feeling of illness or discomfort)

New statin patients should have an initial blood test to evaluate their blood lipids, liver enzymes and the muscle enzyme CK. They should then be checked every six to 12 weeks for the first 15 months or so to evaluate the effectiveness of the treatment and to detect potential liver and muscle problems. If liver enzymes or CK are elevated, they return to normal within a few weeks of stopping the drug.

In general, the elderly are more at risk for these side effects, and they may tolerate smaller doses and less potent statins better. Also patients who are taking other medications such as gemfibrozil or cyclosporin need to be particularly carefully monitored.

Lessons learned
What have we learned from our experience with Baycol? In general, the statins are very safe drugs with a substantial benefit to heart patients and those at risk for heart disease. Physicians, however, need to be very careful about who gets them and at what doses. As the dose increases, so do the side effects. We need to monitor new patients carefully with lab tests, and we need to check with patients to ensure they don't begin taking other medications or supplements that may interact with statins.

Anyone taking statins needs to watch for side effects such as those we've described. If you experience any of them, call your doctor right away. Often a change in the kind of statin or dosage can eliminate the problem quickly. And if you begin taking another medication, including herbal and other so-called natural supplements, call your doctor. They can have an effect on your body and how it reacts to other drugs.

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Dr. Foody is a cardiologist at Yale-New Haven Heart Center and Yale-New Haven Hospital, as well as an assistant professor of cardiology at the Yale School of Medicine.