About 71 million American adults have elevated levels of LDL or “bad” cholesterol, according to the CDC. A high LDL cholesterol level increases your risk of heart disease, but it does not necessarily mean you should start on a statin, because LDL is just one risk factor out of several that determine your overall risk. Other factors that raise your risk of heart disease include older age, diabetes, having a family history of heart disease, high blood pressure, lack of exercise, whether you are obese, and whether you smoke. Your doctor should ask you about those risk factors and take them into consideration before deciding whether a statin is appropriate for you.
What drug dose is best?
There is one other important issue you should know about as you and your doctor choose a statin. For people who are at high risk of heart attack–for example, if you have diabetes, are a smoker and have elevated LDL levels–studies indicate that the lower your LDL, the lower the risk of heart attack and stroke.
Since higher doses and high intensity statins reduce LDL cholesterol more, the hypothesis has been that they are better and should be used more liberally. And the new ACC/AHA guidelines recommend high-intensity statins if a person does not have any conditions or problems that prohibit their use.
But higher doses and high-intensity statins come with more side effects. Higher doses of all statins have been linked to muscle aches, soreness, tenderness, or weakness. Studies indicate that between one in 20 to one in 10 people who take a statin—regardless of dose—experience these symptoms, and up to 10 percent in some studies have not been able to tolerate an 80 mg dose.
Higher doses have also been linked to an increased risk of a life-threatening form of muscle breakdown called rhabdomyolysis. This can lead to permanent kidney damage, coma, and death.
So even if you fall into a category that should receive a high-intensity statin, we advise caution and careful monitoring for the occurrence of side effects.
If you are already taking a low-intensity statin, such as simvastatin 10 mg, pravastatin 10 mg or 20 mg, lovastatin 20 mg, fluvastatin 20 mg or 40 mg, or pitavastatin 1 mg, the new guidelines do not mean that you should necessarily switch to a moderate- or high-intensity statin. This could be a good time to review your risk factors with your doctor to figure out your current risk level and determine whether or not it makes sense to change to a different statin. But if you and your doctor are satisfied that the low-intensity statin you are on is working for you, there’s no reason to switch.
Our recommendations about who should consider a statin drug are based in part on guidelines from the American College of Cardiology and the American Heart Association released in 2013. Those guidelines recommend that your doctor prescribe either a moderate- or high-intensity statin if you fall into one of four groups below. A moderate-intensity statin is expected to reduce LDL cholesterol by 30 percent to 50 percent, while a high-intensity statin would reduce LDL by 50 percent or more. (See table below).
Previous strategies focused on reducing elevated LDL cholesterol levels to very low levels. But the new guidelines look at your overall risk of a heart attack or stroke in the next 10 years as more important than LDL cholesterol levels alone. The guidelines determine your risk based on additional factors, including your age, blood pressure level, whether you smoke, are overweight, or have diabetes or other medical problems.
To calculate your risk of suffering a heart attack or stroke over the next 10 years, the new guidelines use a calculator, found here: http://tools.cardiosource.org/ASCVD-Risk-Estimator/. It uses your age, blood pressure, gender, levels of total and HDL cholesterol, race, and whether you smoke or have diabetes to generate a risk score.
This calculator generated controversy when it was released in November 2013. Some experts argued it might overestimate a person's risk, and could put people on a statin who don't actually need one.
It's good to know that this and other calculators are intended to help estimate you overall cardiovascular risk. The results are simply a guide for you and your doctor to use in deciding if you should take a statin.
The table below lists the four groups of people the new guidelines recommend should receive a statin.
If you have had a heart attack
People who have already suffered a heart attack are at very high risk of another (possibly fatal) heart attack and generally benefit from lowering their LDL cholesterol as much as possible.
People who have had a heart attack will probably be prescribed several different kinds of drugs, including a statin, and lifestyle changes will be strongly urged. In studies involving heart patients, atorvastatin has been shown to reduce the risk of second heart attacks and deaths, strokes, and major heart problems. In addition, atorvastatin may be a better option for people who have had a heart attack and need greater LDL reduction.
Several statins—atorvastatin, pravastatin, simvastatin, and rosuvastatin (Crestor)—have been proven to prevent strokes. The statins are also widely prescribed for people who have had a stroke or “ministroke,” which doctors call a transient ischemic attack, or TIA. An analysis by the Cochrane Collaboration found that the available evidence indicates overall that statins reduce the risk of fatal and nonfatal strokes by 22 percent.
For people who need a moderate-intensity statin:
Atorvastatin (generic of Lipitor)
Lovastatin (generic of Altoprev)
Pravastatin (generic of Pravachol)
Simvastatin (generic of Zocor)
For people who need a high-intensity statin:
Atorvastatin (generic of Lipitor)
All of our Best Buys—atorvastatin, lovastatin, pravastatin and simvastatin—have been shown to reduce the risk of heart attack and deaths from heart attacks, and they are all available as inexpensive generics. You could save more than $100 per month if you pay out-of-pocket and you choose a generic instead of a brand name statin.
If you currently take one of the high-intensity statins Crestor or Lipitor, but you don’t meet the ACC/AHA’s criteria for such a potent statin, a switch to one of our moderate-intensity Best Buy statins could save you thousands of dollars over the many years you may have to take a statin.
Combination statin drugs
Ezetimibe (Zetia) has racked up more than $1.1 billion in sales, but our medical advisers recommend skipping it and combination medications that contain it, such as Liptruzet and Vytorin (See box below).
Simcor, an extended-release combination of simvastatin and niacin, has been associated with an increase in adverse events that cause people to stop taking the drug compared with those who took simvastatin alone.
There is another combination tablet available that contains a statin and a drug used for treating high blood pressure for people who have both conditions.
The brand name of that drug, which we do not evaluate in this report, is Caduet. It is a combination of the calcium channel blocker amlodipine (Norvasc and generic) and atorvastatin (Lipitor and generic).
Skip Liptruzet, Vytorin, Zetia
Since the new guidelines focus on preventing heart attacks and strokes—not LDL lowering—there is no longer any reason to take Liptruzet, Vytorin, or Zetia.
Zetia (ezetimibe) is a different type of cholesterol-lowering medication than a statin. It decreases cholesterol absorption in the intestines. But it has not been shown to reduce heart attacks or strokes.
Vytorin combines simvastatin with ezetimibe in a single pill. Liptruzet is a combination of atorvastatin and ezetimibe. But there is no evidence that either Liptruzet or Vytorin works better than the statin alone to prevent heart attacks or strokes.
Two studies cast doubt on the benefits of Vytorin. The first was a two-year study that showed Vytorin was no better than simvastatin alone in reducing plaque buildup in arteries. The second was a five-year study that showed Vytorin did not reduce heart attacks or strokes compared to a placebo.
Merck, the manufacturer of Liptruzet, says the combo medication has not been proven to reduce the risk of heart attacks or strokes more than atorvastatin alone.
Statins reduce the risk of a first heart attack and repeat heart attacks, as well as the risk of death from heart attacks and other forms of heart disease. But some have been studied more extensively than others in terms of both their effectiveness and their safety. And ongoing research continues to define how the statins work and how they differ.
Reduction of heart attacks
Four statins—atorvastatin (Lipitor and generic), lovastatin (Altoprev, Mevacor, and generic), pravastatin (Pravachol and generic), and simvastatin (Zocor and generic)—have been proven to reduce the risk of heart attack over three to five years of use. And rosuvastatin (Crestor) has been shown to reduce the risk of heart attack over 1.9 years of use. But you should know that the longest studies have only looked at several years of use and no studies have looked at the impact of taking these drugs for 20 to 30 years or longer, the length of time that many people will wind up taking the medicines.
Fluvastatin (Lescol and Lescol XL) and pitavastatin (Livalo) have not been shown to prevent heart attacks and strokes. So we can’t recommend either one.
It’s important to note that although statins reduce the risk of a first or a repeat heart attack, they do not completely eliminate the possibility of these conditions.
In one three-year study that looked at preventing a first heart attack, 5 percent of people who took a placebo had a heart attack compared to 3 percent of those who took a statin. And another recent study found that while people who did not have cardiovascular disease, but did have one or more risk factors (and/or diabetes), benefitted from taking a statin, the reduction in risk was not dramatic. Of those taking statins, 6 percent had a heart attack, coronary event, or stroke versus 8 percent of those taking a placebo.
Reduction of deaths
Four statins—atorvastatin (Lipitor and generic); lovastatin (Altoprev, Mevacor, and generic); pravastatin (Pravachol and generic); and simvastatin (Zocor and generic)—have been found to reduce deaths from heart attacks among patients with a history of heart disease or risk factors for heart disease, such as diabetes and high blood pressure.
In addition, two of the statins–pravastatin and simvastatin–have been found to reduce the overall risk of dying among people considered to be at low risk of heart disease or heart attack. A major study of lovastatin has strongly suggested a similar benefit. Atorvastatin has only been tested—and found to be effective—in reducing deaths in high-risk patients. But here, too, the evidence strongly suggests that it would be effective in reducing deaths among low-risk people as well.
One trial, called JUPITER, showed that rosuvastatin (Crestor) reduced the risk of heart attacks and death in people considered to be at low risk of heart disease or heart attack. While a decrease in heart attack, stroke and death is good news, the actual reduction was quite small. The rate of these conditions dropped from about 2.8 percent in the placebo group to 1.6 percent in those who took Crestor. In addition, the JUPITER trial was stopped early after 1.9 years. Longer trials are needed to confirm the results.
For people who have had a heart attack
Starting a statin at the time of a heart attack or very soon after can reduce the risk of death substantially— treatment that is fast becoming routine. In an important head-to-head study of people who had a heart attack, a high dose of atorvastatin (Lipitor 80 mg) proved to be more effective in reducing the rate of premature death than a moderate dose of pravastatin (40 mg). In a second recent study, 80 mg of Lipitor reduced nonfatal heart attacks more than a 20 mg dose of simvastatin, but there was no significant difference in the number of deaths among people who took the two different drugs and doses.
Overall, statins appear to be quite safe. But they can have two important adverse effects: muscle tissue damage and liver damage. We discuss those safety concerns in more detail below.
Statins also pose a small risk of type 2 diabetes. The FDA added that risk to the labeling of all statins in 2012 after reviewing several studies that had found an increased risk of elevated blood sugar levels and diabetes in people who took the medications. For example, an analysis of 13 studies published in the journal Lancet in February 2010 found a 9 percent increased risk of diabetes in people who used statins. Or looked at another way, there would be one extra case of diabetes for every 255 people who took a statin for four years.
The FDA says statins can also cause memory loss, forgetfulness, and confusion. The FDA, which added this risk to the labeling of statins in February 2012, said studies and reports it has received indicate there have been rare cases of people who developed memory loss or impairment after taking the medications. Some people developed memory problems one day after taking a statin while others did not experience any problems until they had been taking a statin for years. The problems did not appear to be linked to higher doses of statins. The memory problems, which occurred in people over the age of 50, went away when the statin was stopped. In addition, as we previously noted, the long-term effects of taking statins for decades has not been assessed. So while these drugs appear to be relatively safe over several years of use, it’s uncertain if taking the medicines for 20 to 30 years or longer raises any unique concerns.
Because of the risk for birth defects, women who are pregnant or trying to become pregnant should not take any statin drug. Women who are breast feeding should not take a statin as well.
Muscle Tissue Damage
As we’ve previously noted, statins can cause muscle aches, soreness, tenderness, or weakness in up to 5 to 10 percent of people taking them. This includes people taking lower doses, although low doses (10 mg and 20 mg) are much less likely to cause problems.
The symptoms of muscle problems include unexplained muscle weakness or pain, feeling very tired even though you’ve slept well, nausea and vomiting, stomach pain, and brown- or dark-colored urine. Consult your doctor immediately if you begin to have any of those symptoms. These symptoms usually go away within days or weeks after you stop taking the drug. But they could be signs of a rare, life-threatening form of muscle breakdown called rhabdomyolysis. This can lead to permanent kidney damage and coma. One statin, cerivastatin (Baycol), was withdrawn from the U.S. market in 2001 because it caused several deaths due to rhabdomyolysis.
Taking a statin in combination with certain other drugs (gemfibrozil, niacin, and verapamil; check with your doctors for a list of others) can also significantly increase the risk of muscle damage and rhabdomyolysis. For the same reason, several additional drugs should not be taken with simvastatin, including:
Doses of simvastatin greater than 20 mg per day increase the risk of rhabdomyolysis when used in combination with amiodarone, a drug for treating an irregular heartbeat, amlodipine (used to treat high blood pressure), and ranolazine (used to treat angina).
The cholesterol-lowering drug ezetimibe (Zetia) has been associated with muscle aches and rhabdomyolysis when used on its own and in combination with statins.
Other factors that increase the risk of rhabdomyolysis include alcoholism, low phosphate levels, extreme exercise (such as running a marathon), and the use of illegal drugs, like cocaine, heroin, and PCP.
Liver problems while taking a statin are uncommon, and when it occurs it’s usually mild. Nevertheless, the FDA advises patients prescribed a statin to have liver function tests before starting treatment. Contact your doctor immediately if you develop signs of liver problems, which include unusual fatigue or weakness, loss of appetite, dark-colored urine, or your skin or whites of your eyes begin to turn yellow.
Differences among Statins
Overall, statins at low doses do not differ with respect to the risks of these adverse effects. Generally, people taking low doses of statins are at very low risk of muscle or liver problems. But studies in recent years have raised concerns about muscle damage associated with high doses of some of the statins. The largest study of the safety of a statin followed 8,245 people who took generic lovastatin in doses of 20 mg, 40 mg, or 80 mg for four years. The incidence of muscle and liver problems increased with increasing doses.
The available evidence indicates the highest dose of simvastatin—80 mg—poses an increased risk of muscle problems and rhabdomyolysis, so the FDA recommends that the 80 mg tablet not be used except in people who have already been taking it without problems for a year or longer.
Most experts think–and the evidence so far strongly suggests–that all the statins have the potential to cause muscle problems at high doses. But until definitive studies are done, it is not clear whether some statins now on the market may pose more of a risk than others.
Finally, studies have found that grapefruit juice can enhance the absorption of statin drugs. While no studies have found any ill effects from this, in theory it could increase the potential for muscle and liver problems, or other minor side effects. If you are taking a statin and enjoy grapefruit juice, talk with your doctor.
Age, Race, and Gender Differences
Women, people over age 65, and members of various ethnic groups have been under-represented in the major studies of statins. But one review of the studies suggests that the drugs are equally effective and safe in men, women, and people over age 65.
The benefits of statins are uncertain, however, in women who have very marginally elevated LDL and do not already have heart disease or other risk factors. We advise women who fall into this category to discuss this issue with their doctor. In addition to your LDL level, the discussion should also focus on your overall heart disease risk, based on whether you have other risk factors (age 55 or older, diabetes, family history of heart disease, high blood pressure, lack of exercise, overweight or obese, smoker). Bear in mind that at any particular age and LDL level, women generally have a much lower risk of heart disease than men. So if your risk is low and your doctor suggests a statin, you should ask whether it’s really necessary at this point in your life.
And as we have previously stated, women who are pregnant, trying to become pregnant, or breastfeeding should not take any statin drug.
If you are of Asian heritage (Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian), you should know that the labeling for rosuvastatin (Crestor) notes that studies have found levels of the drug that were twice as high in Asian people compared with Caucasians. The labeling advises that the dosage of the drug be adjusted accordingly for Asian people. Some advise that people of Asian heritage begin initially with a 5 mg dose.
Diet and lifestyle changes, such as quitting smoking, losing weight if you need to, and exercise, can help lower your risk of heart attack and stroke. Regardless of whether you take a statin or not, you should still follow them.
Consumer Reports. Are you taking the right treatment for your high cholesterol? Our analysis and new guidelines could change your choice. Published March 2014.