Recent news has caused millions of Americans to question whether they should be taking statin drugs, used for lowering cholesterol and preventing heart disease. TheFood and Drug Administration (FDA)recently announced safety labeling changes for statins and a prominent cardiologist warned in the New York Times that too many people are taking statin drugs.
The concerns affect many people since these blockbuster drugs are practically ubiquitous. Government studies indicate that there is a one in four chance that you are taking these medications if you are 45 years and older. About half of American men and a third of American women in the 65 to 74 years age range are taking statins.
Available products include single ingredient products ((atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin) and combination products (Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe)). Together they account for $14 billion in U.S. sales.
If you are taking statins, what should you do about this new information? Here are five key things to consider.
1. It is your decision.
First and foremost, this is your decision. Medicine is often defined by decisions with trade-offs and uncertainty. Choices about medications can be particularly challenging when they concern prevention. When you choose to take a drug for prevention, you have decided that the risks of the drug are more than offset by its future benefit.
Your doctors and health care professionals can guide you, but you deserve to be informed about the decision and make the choice that feels most comfortable to you. You do not know if you will be the person who avoids a heart attack or will suffer a side effect. You should have the information about what you are likely to gain by taking the medication – and what risks you are incurring. The decision to take the drug should mean that you believe that you are more likely to benefit from the drug than to be harmed by it. And even if a drug has a benefit for you, you have a right to decide whether it is right for you.
Moreover, in decisions about drugs for prevention, it is important to remember that lifestyle choices (e.g., not smoking, being active, eating healthy, and keeping your weight under control) should be a part of any strategy to lower risk of heart disease.
2. Statins reduce risk.
Among all prevention drugs, statins are among the most effective in lowering risk. These drugs have been shown, with quite a lot of evidence, to reduce the risk of heart attacks and deaths in a wide range of patients. Those taking statins have about a 20% lower risk of a heart attack and 10% lower risk of death. Higher dose and higher potency statins tend to reduce risk of heart disease a bit more.
The drugs with the strongest evidence of benefit are atorvastatin, lovastatin, pravastatin, simvastatin, and rosuvastatin.
This benefit is important because not all drugs that lower cholesterol or improve risk factors actually reduce the risk of heart disease. And some drugs even paradoxically increase risk. Questions remain about the effects on risk of many other lipid lowering drugs, such as niacin, fibrates, and ezetimibe.
3. Statins have risks.
Statins, like all drugs, have potential side effects. That is, although they are generally safe, they can cause harm in some people. Some of these side effects are well documented. In some people statins can cause muscle aches, soreness and weakness. This side effect is not uncommon and may occur in as many as one in ten people taking these medications. These symptoms usually resolve after discontinuing the drug – and they may not occur with another type of statin.
The new FDA announcement stated that there are rare reports of reversible memory loss and confusion, side effects that were considered not serious and went away when the drug was stopped. The reports about these side effects were submitted to the FDA by doctors and their relationship to statins is not certain.
The FDA also reported that blood sugar levels sometimes rise with statin therapy, but the importance of the finding is not known. For perspective, a recent study found that increases in blood sugar by a blood pressure drug, chlorthalidone, did not increase risk as much as would have been expected. Statins can very rarely also have more dramatic side effects such as life-threatening muscle damage or liver disease.
Finally, statins are generally drugs that are prescribed for a lifetime. Their effect over decades of use has yet to be determined.
Despite these risks, the trials showed a substantial benefit to these drugs – which is what has led them to be widely prescribed. But the drugs do cause harm for some even as they confer benefit for others.
4. Your risk matters.
Although the guidelines tend to focus on cholesterol levels in the decision to take statins, your overall risk of heart disease may be a more important factor in your decision. Since statins lower risk for people regardless of their cholesterol level, your benefit from the drug will depend on your risk of heart disease. If you have a low risk of heart disease, then you will have little to gain from treatment. A 20% reduction in a low risk of a heart attack may not mean much. The higher your risk, the more you have to gain.
Colleagues and I did a study and found that prescribing statins based on risk rather than cholesterol levels would lead to more lives being saved by treating fewer people. You can calculate your risk of heart disease from some online resources (http://www.reynoldsriskscore.org/ or http://www.framinghamheartstudy.org/risk/coronary.html). For many people a risk of less than 1% a year is considered low.
If you have heart disease, your risk of future events is higher and the benefit from statin therapy is generally considered substantial. In that case you do not even need to calculate your risk.
5. Minimize the statin risk.
If you do take statins, you have some choices that can minimize your risk.
First, you should be alert to symptoms that may signal a side effect. Talk to your doctor if you develop muscle aches, weakness or any new symptoms that concern you.
Second, lower doses are better. People with a higher risk of heart disease or with heart disease may benefit more from higher dose or higher potency statins (such as atorvastatin) but others may do better with a lower dose or less potent statin. These drugs tend to have fewer side effects.
Third, be aware that some other drugs you are taking may increase the risk of statins. Some drugs can markedly raise the risk of side effects of statins and you should ask your doctor about possible interactions if you are taking other medications. Also, for some statins, grapefruit juice can make the statin drugs more potent – though it is not clear if this raises the risk of side effects.
Finally, pravastatin appears not to increase blood sugar levels – so if this is a concern of yours, then you might want to try this medication. This statin is also less affected by other medications.
Bottom line: Statins are capable of remarkable reductions in the risk of heart disease and death. During the increase in their use there has been a marked decline in heart attacks and deaths from heart disease. The people with the most to gain are those with an increased risk of heart disease. If you are one such individual, and if your risk cannot be lowered by lifestyle changes, then statins are an excellent option. But it is your choice – and if you do take them, then be alert for side effects and minimize your risk.
The new information from the FDA or the admonitions from some experts does not fundamentally change the decision you have to make. Side effects are rare – but you should only take any drug if you are convinced that the benefits substantially outweigh the potential harms.