On Feb. 28 the Food and Drug Administration (FDA) issued a label update for statins based on recent information about diabetes risk as well as some concerns about memory loss or confusion in some patients on statins.  Many RCA/HCM patients are taking statin drugs for the treatment of high cholesterol. Since elevated cholesterol levels are a known risk factor for heart disease as well as complications in patients already diagnosed with heart disease, patients may wonder what this new information means for their treatment.  Dr. Donald McElroy, cardiologist and chief medical officer of the OSF Cardiovascular Service line, has responded to this news update with some information for patients.

Q.  What are statin drugs?

A.  Statin drugs are a class of medications that are particularly effective in lowering cholesterol levels.  

The statins include:

• atorvastatin (brand name Lipitor)
• fluvastatin (brand name Lescol)
• lovastatin (brand name Mevacor)
• pravastatin (brand name Pravachol) 
• rosuvastatin calcium (brand name Crestor)
• simvastatin (brand name Zocor)

There are also some combination drugs that include one of the above mentioned drugs along with another drug that is used to treat another condition – for example high blood pressure, or high triglycerides.

Q.  What is the most important thing for patients to understand about this new information on statins?

A.  The most important thing to recognize is “The value of statins in preventing heart disease has been clearly established,” said Dr. Amy G. Egan, deputy director for safety in the F.D.A.’s division of metabolism and endocrinology products. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”  Our patients are taking statins to reduce the risk of life threatening events such as heart attacks – these drugs are considered vital to long term health and well-being.  The latest cautions do not really alter why these medications are needed.  Prescribing and taking these medications has been long established.  Not taking a prescribed statin drug is considered to be very risky.

Q.  What is the new information about Diabetes?

A. Diabetes risk in those treated with statins seems to be higher.  This came out earlier in the Jupiter Trial that looked at the use of Rosuvastatin (Crestor) and an alert was already on Crestor’s label.  The FDA decided to extend that alert to all drugs in the class with the exception of Pravastatin (Pravachol).  Dr. Egan with the FDA suggested that doctors check the blood sugar levels of patients after starting them on statin therapy since statins seem to increase blood sugar levels in some patients by small amounts.  When millions are treated, even small change leads to a diagnosis of diabetes for more people. Dr. Steven Nissen, chairman of Cardiovascular Medicine at the Cleveland Clinic, who has studied the medicines extensively was interviewed by the New York Times and shared these comments—“Diabetes patients and even those who develop diabetes while taking statins should continue taking the medicines. These are not major issues, and they really do not alter the decision-making process with regard to statins,”

Q.  What about memory loss?  Can statin use cause dementia?

A.  Reports about memory loss, forgetfulness and confusion span all statin drugs and all age groups of patients, the F.D.A. said. Dr. Egan admits that  dozens of well-controlled trials of statins have offered few hints that the drugs cause any kind of cognitive impairment.  However, the F.D.A. has received many reports over the years that some patients felt unfocused or “fuzzy” in their thinking after taking the medicines. “We are trying to be as transparent as possible with our alerts and labeling,” Dr. Egan said, even though the alert on the possibility of fuzzy thinking “is not overly helpful.”  As you can see this seems to be a somewhat “iffy” response on the part of the FDA and may lead to confusion on the part of our patients as well as providers. They [statins] have not been associated with dementia. There are intermittent reports of fuzziness seeming to improve when the patient stops the medicine.  In my experience this has not seemed to be the case. There does not appear to be a compelling case in the literature to support this association.

Q. If forgetfulness or memory loss is noted by a patient, should they stop the drug right away?

A.  Patient experiencing memory changes should certainly report this to the prescribing physician without stopping the medication.  It is important to discuss this with the provider to understand why the drug is recommended to them to treat their underlying risk – i.e. weigh the pros and cons.   The provider can make appropriate recommendations after a full understanding of the extent of the symptoms and review of the risks.  It is possible that such symptoms may not be related to the statin at all.  

Q. Are there also concerns about liver injury with statin use?

A.  Traditionally, physicians have been careful to monitor liver enzymes (a blood test) in patients taking statin drugs.  On the positive side the F.D.A. now states that routine monitoring of liver enzymes in the blood, once considered standard procedure for statin users, is no longer needed because the liver injury associated with statin therapy is so rare.  We can confirm in the practice setting that there is a low risk of liver injury in the majority of our patients. Most physicians will continue to monitor liver enzymes when a patient is first started on a statin and perhaps intermittently after.  If the results are stable, it is likely that no further testing may be required.  Obviously, the patient’s individual case must be considered – there may be other medications or conditions that would still warrant regular testing of liver enzymes.

Q.  So what is the Bottom Line Recommendation?

A. The decision to take a statin drug should be made on the patient’s risk of developing vascular disease.  These drugs are highly effective at preventing initial events such as heart attack and reducing the risk of surgery or stenting of vessels.  They are recommended in these patients as being the “standard of care.” 

These alerts are designed for health care providers.  No one recommends stopping these drugs because of potential risk. 

Ultimately, the decision to recommend a statin is based on the physician’s evaluation of the patient’s health and risk for cardiovascular disease or complications.