Statins and the Liver

Happy New Year!  We recently started a series in which we will be discussing the safety of all the different classes of medications used in Cholesterol Management. As I stated in the last post, all the information is current and evidence-based. It is provided by the National Lipid Association and was published in the American Journal of Cardiology.

I am asked on a daily basis if statins are safe.  I always respond that they are and also are one of the most studied medications. All medicines have both a generic and a brand name but I am sure most people only know the brand names so I will list them for you. The statins include Lipitor, Zocor, Vytorin, Mevacor, Crestor, Pravachol, and Lescol.

When The National Lipid Association Statin Safety Task Force wrote their report, each panel of experts wrote about a different area of the body in which any of these medications had been shown to affect in some way. We will begin with the Liver.

Concerned patients often ask if their statin will damage their liver? Let's start with the final conclusion of the Report of the Expert Liver Panel and then detail how they came to this conclusion.

"Outside of measuring liver biochemistries for the purpose of periodically updating a patient's medical history, we can find no scientific or medical basis for monitoring aminotransferase levels during long-term statin therapy as a measure to enhance patient safety. We acknowledge that the Panel's recommendations are at odds with current prescribing information for marketed statins: however, we are optimistic that the regulatory agencies and pharmaceutical industry will update their recommendations to be consistent with evidence-based data cited in this article."

What does this mean? Well, it simply means that all the liver function tests, which are commonly known as AST and ALT levels, that one's physician routinely draws to check for liver problems are unnecessary with the exception of updating labs during an annual physical exam or if the physician having some concrete reason to do so. The evidence-based data shows that routinely performing these tests do not make statins any safer.

The available data does not support doing so in the "asymptomatic" patient on a statin. Why do they say this? The reason the Panel says this is, believe it or not

"Very rare case reports of liver failure have occurred in patients receiving statin therapy."

Because the association between statin therapy and liver failure is so rare there is absolutely no way one can say with confidence that the liver failure was due to statin use. It is possible that this could be an "idiosyncratic reaction" to the statins. This means that a person could have an unexpected reaction or a type of allergy to the medicine and that is the reason for the liver failure. I like to think of it as the problem is with the way the patient's body responds to the drug rather than the class of drugs causing the problem.

The Liver Panel could find "no direct evidence of death due to liver failure caused by statin therapy." This does not mean that statins will not elevate the liver enzymes -- this is a known side effect. Generally a physician does nothing unless the level is more than 3 times the upper limit of normal but this does not mean that liver damage is occurring. This has been shown to happen less than 1% of the time across the dose range for marketed statins.

I asked a friend of mine who is a liver doctor at the largest hospital in the Western US his opinion on liver problems and statins. He said that he rarely performs liver biopsies any more when patients are on statins and have elevated liver enzymes because he has yet to see a case on statin-induced liver failure. There was always another explanation as to the cause of the liver failure.

My own feeling is that too many physicians stop this medication unnecessarily and forget the benefits of statins in reducing heart disease by at least 40% because they think a small rise in the liver function tests means that there is ongoing damage to the liver. Statins can be used safely in patients with chronic liver disease and well-treated cirrhosis but the physician may need to follow the patient a little more closely than would occur in a normal healthy patient on a statin.

Coming next: The effects of statin use on the kidneys.

Related Topics:

• Statins: Heart-Health Superstars
• Your Lower Cholesterol Toolbox

Technorati Tags: cholesterol, statins, liver, heart health

Alex Trebek

Cross-posted on the WebMD TV Checkup blog

I understand that Alex Trebek, the host of the television show Jeopardy, had a heart attack last night and that he apparently had no risk factors for Coronary Artery Disease.

Is it true that he did not have any of the 5 major risk factors for heart disease? The major risk factors for Coronary Heart Disease are Smoking, Diabetes, Hypertension(high blood pressure), Age, and High Cholesterol. I believe that he did not have the first three, but we all age so that is indeed a risk factor.

Most importantly, did he really have normal cholesterol levels? On his regular lipid panel done by his doctor, I am sure it was "normal" but there is so much more to the story. I will give you something to think about. Last year there were 125 million lipid panels done in the US but the number of patients with Coronary Heart Disease continues to rise.

Also, the CDC states that 50% of people who have heart attacks have "normal" cholesterol at the time of their heart attack. Was Alex Trebek one of the 50% ? My guess was that he was in that group.

Although I am a heart surgeon, I have dedicated my practice to preventing Cardiovascular Disease by opening up The Center for Cholesterol Management in Los Angeles where I perform advanced lipid testing on all my patients. There is more to lipid management than measuring "good" and "bad" cholesterol. Most of today's tests do NOT tell the whole story. In fact many times heart attacks can occur without any warning signs. I will try and describe advanced cholesterol testing in simple terms.

We all know that oil and water do not mix. Well, blood is like water and cholesterol is an oily substance. When too much cholesterol is deposited in one of the Coronary Arteries, a narrowing results which can lead to a heart attack.

Since blood and cholesterol do not mix, the cholesterol has to be transported through the body by particles and these particles include HDL(the good cholesterol) and LDL( the bad cholesterol). Think of these lipoprotein particles as cars on a highway and ask yourself, is it the number of cars that cause a traffic jam or the number of passengers in the cars? We all know that it is the number of cars.

Unfortunately, the cholesterol testing that is done by 99.9% of the physicians in the US measures the numbers of passengers in the cars when it has been show that it is the number of LDL particles(the cars) that cause Atherosclerosis. I perform LDL particle testing on all my patients and measure the number of LDL particles in the blood stream.

This type of testing misses no one with high cholesterol, which can lead to Atherosclerosis, heart attack, and death while conventional lipid testing can miss up to 50-60% of people with high cholesterol but their test shows it to be "normal".

Simply put, the more LDL particles one has, the greater the risk of Cardiovascular disease. An example would be this: Let's say on your cholesterol test at your doctor's office your LDL cholesterol is 120mg/dl. This is considered normal in a low-risk patient. How do I know if you have two big cars(LDL particles) carrying 60 people in each one or 120 small cars (LDL particles) with one person?

It is impossible to know without doing LDL particle testing. The first person has a LDL cholesterol level of 120mg/dl and this is transported through the blood in two big particles. This person is not going to get Atherosclerosis. The second person has exactly the same "normal" LDL cholesterol of 120mg/dl, but it is transported through the blood in 120 small LDL particles. There is no doubt that the second person has had untreated high cholesterol for years because the patient and the physician thought it was "normal".

Years of untreated high cholesterol (high LDL particle number) leads to Atherosclerosis and ultimately Cardiovascular Disease and maybe even death. For a more in depth discussion, you can go to my website at http://www.lipidcenter.com/ and click on the power point presentation titled Advanced Cholesterol Testing - A Basic Understanding.


Related Topics:

• WebMD Video: Tryglycerides and Heart Attack Risk
• Interactive Tool: Are You at Risk for a Heart Attack?

Technorati Tags: Alex Trebek, Jeopardy, heart attack, high cholesterol, health, wellness, heart disease

The Safety of Lipid Therapy: Statins

A question I am always asked is "Are statins safe?" In the next series of posts, I will cover this topic and also discuss the safety of all the different classes of drugs used in lipid management.

Many patients and physicians have questioned the safety of statins. These concerns have arisen from information in the news and print media, on the internet, and from direct-to-consumer advertising. Unfortunately, much of the factual evidence is either overlooked or unknown. Because of this 'misinformation', many patients refuse to initiate statin therapy and others stop long term treatment out of fear for their safety.

To address these concerns about the safety of lipid modulating drugs, The National Lipid Association appointed a Safety Assessment Task Force to evaluate statin safety and in a second report, the safety of nonstatin lipid altering drugs. The charge given to this task force was to conduct a "rigorous, scholarly, up-to-date, and unbiased assessment."

Four panels were assembled which focused on the muscle, liver, renal, and neurological effects of statins. To assure a rigorous comprehensive assessment of statin safety, the Task Force further commissioned reviews of special literature on adverse reactions and drug interactions. Reports of the work included an "up-to-the-minute" systematic review of published cohort and clinical trial data on statin safety, the most recent data from the FDA's AERS, an inspection of the data contained in the new drug applications, and the FDA's summary basis of approvals for marketed statins and associated adverse health events in a 22 million person managed health care data base.

The Task Force report on statin safety was published in April 2006 in The American Journal of Cardiology; the report on nonstatin safety was published in the same journal in March 2007. To me, this is the most comprehensive, evidence-based, unbiased assessment of all these drugs, and the guidelines should be followed by all physicians and their patients.

Now a little background. Cardiovascular disease continues to be an epidemic and is responsible for more than half of all deaths in the United States. Each day more than 2600 Americans die from cardiovascular disease. Approximately 80 million American are affected by CVD and more than 125 million lipid panels are performed annually. Despite the increase in cholesterol testing, the number of Americans affected with CVD continues to rise. Why is that? (In subsequent posts I will cover the reason why I believe this is happening.)

Abnormal lipids (Dyslipidemia) is well established as one of the strongest independent predictors of CV morbidity and mortality. There have been large outcome trials that have consistently shown that lowering LDL cholesterol reduces morbidity and mortality associated with coronary heart disease. As the data continues to accumulate, the notion that "lower is better" has uniformly been supported.

As a result of 5 large clinical trials, the National Cholesterol Education Panel (NCEP) Adult Treatment Panel (ATP) III has recognized this and new guidelines recommend further reducing the goal for the LDL cholesterol to less than 70mg/dl in the most high risk patients. You can read the NCEP guidelines on lipid management as well as the newer NCEP guidelines on treatment of the metabolic syndrome on my website.

But despite this new recommendation, the American Heart Association's 2007 statistical update shows that fewer than 20% of patients with CHD have achieved recommended goal levels of LDL cholesterol. In my next post, we will begin to look at the safety of each class of drugs starting with statins.

Related Topics:

• High-Risk Cholesterol: Myths vs Facts?
• High Cholesterol: Do You Know the Risks?

Technorati Tags: cholesterol, statins, heart disease, health and wellness