BBD reports analyze effectiveness and safety of statin use

Consumer ReportsJun 29 2010

A series of new reports from Consumer Reports Best Buy Drugs (BBD) caution that the benefits of statin use by children and some women may not outweigh the risks. Drugs to lower cholesterol - including statins - are the most commonly prescribed drugs in the U.S. and garnered more than $14 billion in sales last year.

The BBD reports also analyze the effectiveness of statin drugs to lower cholesterol, reduce the risk of heart attack and death and to treat people who have cardiovascular disease. The report finds that a number of low-cost generic statins are as effective and safe as more expensive brand-name drugs in reducing these risks. The Consumer Reports BBD reports coincide with the introduction of Livalo, the so-called 7th statin, in an already crowded class of drugs.

The reports, available for free at www.ConsumerReportsenEspanol.org, note that there are no long-term studies of statin use in kids that establish whether or not these medications reduce the number of heart attacks or other cardiovascular events in adulthood. There is also concern over the long-term potential risk for children and adolescents who use these medications for years or decades, particularly the effects on the developing central nervous system, organs, immune function, and hormone levels.  For women who only have high LDL, the bad cholesterol, and no heart disease, the risks of statins might outweigh the benefits. Risks include headache, joint and muscle pain, and diarrhea. Other risks that are rarer include liver damage and rhabdomylosis, a breakdown of muscle tissue that can lead to coma and even death. There is also an association with an increased risk of type 2 diabetes.

"Contrary to what many consumers believe, we don't have solid medical evidence supporting the use of statins in children and there is no long-term safety data tracking kids who take statins for 10 or 20 years.  And when it comes to healthy women, statins limited benefits may not outweigh their risks," said John Santa, M.D., M.P.H., director of the Consumer Reports Health Ratings Center.

Since the first statin, lovastatin, came on the market in 1987, statins have been a boon to the pharmaceutical industry.  Cholesterol-lowering drugs were the most commonly prescribed drugs in the U.S. in 2009 and collectively earned more than $14 billion dollars last year alone, according to IMS Health.  When adults have high levels of low-density lipoprotein (LDL), known as the bad cholesterol, they are at increased risk of heart disease and heart attack.  Statins lower LDL cholesterol levels and can decrease blockages in the arteries that supply the heart, brain and leg muscles in people who have atherosclerosis.  

The Seventh Statin: What It Means for Consumers

The Consumer Reports BBBD reports coincide with the arrival of Livalo, the so called "7th Statin," which industry watchers expect to be promoted as a high potency drug, though it has not earned solid proof of preventing a cardiovascular event.  "With Livalo arriving on market, there's the potential for consumers to hear just one message - save your life, get the hot new statin.   Our concern is that consumers may not need such a high-potency statin, or they may not need one at all.  And if a statin is needed, much more is known about the safety profile and side affects of the older statins," said Santa.  According to a 2009 poll by the Consumer Reports National Research Center, one in five adults have asked a doctor for a drug they saw advertised and the majority of those requests were granted.

For people who do need to take a statin, Consumer Reports Best Buy Drugs recommends the best choices based on a systematic review of the medical evidence, noting that the use of a high potency statin such as Crestor, Lipitor, Livalo, or generic simvastatin, should be reserved for patients who need to reduce their LDL cholesterol by more than 30 percent. Evidence has mounted in recent years that the risk of life-threatening rhabdomyolysis from statins increases with the use of higher doses.

For people who need to lower their LDL by less than 30 percent, Consumer Reports Best Buy Drugs recommends starting with generic lovastatin or pravastatin.  These generics can be purchased for as little as $15 a month versus $125 for a branded drug like Crestor; the savings over a year can add up to as much as $1,300.  Since using a statin drug is considered a lifetime commitment, the savings over several years can amount to virtually thousands, even tens of thousands, of dollars.  Lipitor, the #1 highest selling branded drug in the U.S., costs up to $ 168 a month but is expected to become available as a lower-cost generic in 2011.

Guidance for Parents of Children with Elevated LDL

In a detailed report about kids and statins, Consumer Reports Best Buy Drugs speaks to a growing audience of parents whose children have about a one in five chance of becoming obese and, according to recent estimates by the Centers for Disease Control and Prevention (CDC), the same likelihood of lipid abnormalities.  Consumer Reports BBD suggests the following considerations for parents weighing long-term statin therapy for their children:

• First, identify whether your child has any of the traditional risk factors for cardiovascular disease: being overweight or obese; having diabetes; having a family history of premature heart disease; or being a smoker.
• If your child does have one of these risk factors, improve the child's diet and increase physical activity with a goal of weight loss if it is needed.  Lowering your child's cholesterol without a drug is preferable.  
• For children who have elevated cholesterol but do not have traditional risk factors for heart disease and are otherwise healthy, there is a substantial lack of evidence that treating high cholesterol in this group would reduce the number of heart attacks.  Consumer Reports BBD notes that to date, there are no long-term studies that show whether or not doing so reduces the number of heart attacks or other cardiovascular events as the child becomes an adult.  
• For children with traditional risk factors for heart disease, such as having diabetes or high blood pressure, smoking, those who are overweight or obese (high BMIs), or those with a family history of early-onset heart disease, cholesterol levels may be more important. But lifestyle changes are particularly crucial for this age group, and they include losing weight if needed, increasing exercise and improving a child's diet for at least two years before considering a drug therapy.
• A 2009 poll by the Consumer Reports National Research Center suggests that consumers think otherwise.  Only half of consumers are correctly informed about evidence supporting prescription medicines used to treat children.  One third (32%) of Americans are under the false impression that drugs to treat conditions in children have always been proven to be safe and effective in children.

Why Some Women Should Think Twice

Today, 22 percent of Americans 45 or older take statins. There are many women within this group and some may have a low risk for cardiovascular disease (CVD). That is an issue because understanding the benefit statins have for these women has not been clear-cut. Some research has been inconclusive due to the use of significantly fewer women than men in trials. And in some cases, trial results were not initially broken down according to gender. Other analyses have found that statin use did not appear to have a beneficial effect on total mortality for women with or without previous CVD. Consumer Reports BBD offers some considerations to help guide decision-making:  

• Women with elevated LDL cholesterol and no other heart disease risk factors can determine their 10-year risk of heart attack by using a free online tool provided by the National Cholesterol Education Panel: http://hp2010.nhlbihin.net/atpiii/calculator.asp
• For women with already low or very low risk, as determined by the calculator, there are other actions they can take to reduce the risk of heart attack or heart disease, including stopping smoking, losing weight if needed, increasing exercise, eating a "heart-healthy diet," and taking steps to curb stress.
• Women's cholesterol might naturally rise after menopause. High levels of HDL, or "good" cholesterol, are beneficial.

For women who require a statin:

• With all their benefits, statins have downsides that should be considered. Five to 10 percent of users experience mild to severe muscle pain and weakness.   An estimated one percent of people who take statins might develop abnormal liver-function tests.  As with many drugs, we know a lot more about the short-term side effects of statins, like diarrhea and nausea, than the longer-term effects.  That's why statin users should be checked regularly by their doctor.
• Ask your doctor for the lowest dose possible to achieve your goal of cholesterol reduction.   For most people, a generic statin will be as effective and safe as a branded medicine, and it will cost less.  If you begin to have significant muscle aches after taking a statin, review alternate options with your doctor.
• The majority of statins can be split in half without any loss of effectiveness.  Good candidates for splitting pills are those statins that cost the same at higher doses, such as Lipitor which costs up to $168 for a monthly supply of 20mg, 40 mg, or 80 mg.  When larger doses cost the same as the smaller dose, you can save money by getting the larger dose and splitting the pills in half.  Consumer Reports BBD recommends talking to your doctor before splitting your statin pills. For a guide to safe and effective pill splitting, go to www.CRBestBuyDrugs.org.