Statins and Cholesterol-lowering Drugs: Should You Take Them?

My colleague, a portly man nearing retirement, sits across the table from me in an upscale restaurant in Manhattan and orders an extra order of onion fries, patting his belly and chuckling about the extra Lipitor he will have to pop later to off-set his indulgence. He is not unfamiliar with drug safety issues as we both work for a large pharmaceuticals company in the drug safety group. Is dealing with cholesterol so easy that we can take the pills like candy when we think we need to? How safe are current cholesterol-lowering drugs and what is the latest research on new types of drugs?

Statins are the best selling drugs in the world and work by inhibiting an enzyme call HMG Co-A Reductase that stimulates LDL receptors to clear more LDL cholesterol, the “bad guy”, from the blood stream. Some of the new drugs are attempting to increase HDL, the “good guy” which is believed to off-set the negative effects of LDL on heart disease risk. Some companies are putting the two together to try for a double whammy-increasing the good HDL and decreasing the bad LDL- but these drugs have, so far, not shown the desirable effects that were hoped for.

The current level of information about statins and cholesterol can seem contradictory and confusing. Here are a few of the most common questions asked, with the latest answers from science.

Should adults who have not had a heart attack take statins?

There is no good evidence that cholesterol lowing agents prevent heart attacks in those who have not already had one. If your cholesterol level is over 200, and your bad cholesterol is high, your doctor may prescribe a drug to lower your cholesterol. There are pros and cons to taking any drug, and you must weigh the risks versus the benefits for your particular situation with your doctor. Cholesterol works in concert with many other elements to create risk for cardiovascular problems. Recent studies have show low-carb diets to be more effective at reducing cholesterol than low-fat diets so you might want to give that a try before taking a statin drug if you have not yet had heart problems.

What about adults who have had a heart attack?

If cholesterol remains high after a heart attack, then statins can reduce your chance of having another one according to many studies.

How low should I go with my cholesterol?

Current guidelines say 200 mg/dl and the trend is to recommend lower. However, low cholesterol has been shown to be associated with impaired memory and brain function so it is currently unclear how low is too low.

1. What about the new drugs that combine drugs to raise the good cholesterol and lower the bad?
   These drugs have not been shown to be effective at reducing plaques in neck vessels and there are some preliminary suggestions that one of these drugs, Vytorin may be linked to cancer. The cancer data are highly speculative at this point. The main reason to think twice about taking these drugs is that although they reduce cholesterol levels, they may not reduce cardiovascular risk because they don’t seem to prevent plaque build up in blood vessels. If you are taking one of these combination drugs, then talk to your doctor about whether you should stay on it or switch to a single statin drug. Popular statin drugs are Lipitor and Simvastatin and are the mainstay of cholesterol therapy worldwide.
2. Should kids take them?
   Only if high cholesterol is severe and resistant to other methods of lowering such as diet and exercise should statin therapy be considered for children. Cholesterol is used for growing bodies and brains and cholesterol-lowering drugs have not been tested for safety in children. A recent recommendation by the American Academy of Pediatrics (AAP) recommends statins for children aged 8 and over who have very high cholesterol and a family history of cardiovascular disease. These children should have tried and failed with other approaches before being given a statin. The AAP recommendations have caused uproar in public and health communities mainly because people fear more widespread use in kids than the AAP is actually recommending. As of July 2008, it is unclear whether the recommendations will remain in place and whether additional guidance on treating high-risk kids is warranted.
3. Are statins safe?
   All drugs are poisonous at some doses. Most drugs can be given safely when the correct dose is chosen. This is true of statins. Statins can be administered at doses that confer more benefit than risk given how much we currently understand about their actions. As with all drugs, how the balance of risks against benefits is perceived can depend on who is making the observation. It is interesting to note that 96% of scientific or medical authors with drug company ties say particular drugs are safe, while only 37% of authors with no drug company ties say the same thing. Very recent data suggest possible benefits in kidney transplant patients and there are several studies underway looking at the effectiveness of statins in cancer prevention. Statin drugs affect many systems within the body apart from cholesterol and scientists are learning more about the safety of statin use all the time. For the most common side effects see below.
4. What side effects are most common with cholesterol drugs?
   With statins the most common side effect is muscle pain. This can be mild or very severe. Severe forms of muscle pain can indicate a serious process called rhabdomyolysis (or muscle toxicity) A sign of severe muscle toxicity is coca-cola colored urine. Rhabdomyolysis is a medical emergency and is most likely to occur in situations where the muscle is stressed from something as well as the statin, such as a long run, or some kinds of infection. If you are a long-distance runner and you use statins you should be alert to unusually severe muscle pain after a strenuous run. Mild muscle pains are less of a concern and often disappear over time on the medicine.Some statins, such as Lipitor, are lipid-soluble and can therefore pass into the brain. These drugs have been implicated in memory loss. There is evidence to suggest statins may be related to dementia-like symptoms in some people. This is the subject of some controversy at the moment.
5. Can my doctor tell if I will get the muscle side effects?
   Usually no. However, there is a new gene (SLCO1B1) variant identified that seems to occur in people with statin-induced muscle toxicity. Identification of this gene offers the potential for a test that will tell patients whether they are at risk of serious muscle problems while taking a statin.

Disclaimer: This information is not meant to replace the advice of your doctor or healthcare professional. If you have any concerns about your cholesterol or any drug used to control it, you should talk to your doctor.