Statins: Need To Know

What you need to know about taking statins

Doctors prescribe statins to lower cholesterol and reduce the risk of heart disease. Here are pros and cons to consider when taking them.

Common Names

Lipitor (atorvastatin), Crestor (rosuvastatin), Zocor (simvastatin), Pravachol (pravastatin), Mevacor (lovastatin), Lescol (fluvastatin), Livalo (pitavastatin), Altoprev (lovastatin extended release)

Side Effects and What to Do About Them

Muscle Aches and Pains: As many as 30% of people taking statins report muscle aches and pains. Although rare, some people on statins have experienced myositis (inflammation of the muscles), or rhabdomyolysis (breakdown of muscle cells), which can result in potentially life-threatening kidney injury. People taking Zocor, Lipitor, or Mevacor appear to be most likely to experience muscle symptoms, according to a 2019 report in the journal Circulation Research. . They suggest trying a different statin or taking a lower dose of one you are on, though the latter could mean less cholesterol-lowering efficacy.

A study in the journal JAMA Internal Medicine suggests that older men taking statins appear to be slightly less active than those who do not take them, probably due to muscle pain. According to the study, statin users logged about 40 fewer minutes of moderate activity each week compared to nonusers. These findings confirm those of previous studies that found an association between a drop in activity and the use of statin medications, according to background information in the study. “Statins are extremely helpful for people who need them,” stressed study lead author David Lee, an assistant professor in the department of pharmacy practice at Oregon State University. Lee continued to say that, “the main hypothesis is that people who take a statin do experience an increase in muscle pain. It’s actually the most common side effect. Research also suggests that taking statins may increase the risk of developing back problems.

Researchers examined data on 14,000 adults more than 30 years old who were enrolled in TRICARE, the military’s health care program. Half had taken a statin drug an average of 3.7 years while the others had never taken one. Zocor was the most commonly taken statin in the study. Statin users had a higher likelihood of back disorders, such as spondylosis and intervertebral disc disorder, the researchers reported in JAMA Internal Medicine.

Researchers did caution that because the study subjects were TRICARE enrollees, they are not sure if the results would be applicable to those who lead a more sedentary lifestyle. “Our results provide additional motivation to further investigate the overall influence of statin therapy on musculoskeletal health, specifically if prescribed for primary prevention in physically active individuals,” the researchers concluded.

However, some research suggests that muscle pain and weakness that some people taking statins claim may be overblown and are the result of a “nocebo” effect shaping people’s negative opinion about a drug. This is the idea that if a person is told of the potential side effects of a medicine, they are more likely to experience them.

Researchers in the UK say a study they conducted shows that people are much more likely to say they experienced muscle-related symptoms with a statin when they know they are taking one. But when patients are unaware of whether they are taking a statin or a placebo, they reported similar levels of muscle problems.

When participants in the study were aware they were taking a statin — Lipitor was used — reports of muscle-related issues were 41% higher than those not on the drug, according to results published in the Lancet.

It is important to note that the study was funded in part by drugmaker Pfizer, Lipitor’s manufacturer. However, the researchers say that had no influence on the findings.

The study also found that statins were associated with fewer sleep quality issues, but did interrupt sleep with needing to go to the bathroom more frequently and at night. There was not enough evidence to determine whether statins were linked to any cognitive issues. “These results will help assure both physicians and patients that most [adverse events] associated with statins are not causally related to use of the drug and should help counter the adverse effect on public health of exaggerated claims about statin-related side-effects,” the researchers concluded.

However, if your urine suddenly turns dark, you should stop taking the statin immediately as this can be a sign of rhabdomyolysis. In a study in the journal Arteriosclerosis, Thrombosis, and Vascular Biology, the American Heart Association (AHA) said, based on a review of research, this was observed in less than 0.1% of people on a statin.

The AHA said based on their analysis of studies, “no more than 1% of patients develop muscle symptoms that are likely caused by statin drugs.” The group also said that muscle aches and pain can have many causes, such as low vitamin D levels, and are common in middle-aged and older adults.

The AHA agreed that some complaints of muscle pain while on a statin are a result of the so-called nocebo effect. The AHA argued that reports in the media of statins causing muscle pain, doctors warning about muscle aches and drug package inserts advising of the possibility support this idea. According to the AHA report, about 10% of Americans on a statin stop taking it because of side effects that they believe are caused by the drug, but may not be. If you think you are experiencing side effects from a statin, Mark Creager, MD, director of the Heart and Vascular Center at Dartmouth-Hitchcock Medical Center, said in a statement, talk to your doctor. Creager noted that stopping a statin can significantly increase the risk of a heart attack or stroke.

Patients who experience side effects while on statin medication are more likely to fail to meet cholesterol targets. A Norwegian study examined 1,095 patients hospitalized with a heart attack, coronary artery bypass graft or coronary stent. Researchers found that 57% of patients were failing to meet the cholesterol target of 1.8 mmol/l during follow-up. Patients with statin side effects were more than three times as likely to miss the cholesterol target (1.8 mmol/l) than those without side effects, according to the study published in the European Journal of Preventive Cardiology. Specific statin side effects (mainly muscle complaints), low adherence to taking the drug, and moderate- or low-intensity statin therapy were the main reasons for failing to meet the target.

For those who do experience muscle pain, there is some evidence as to why this happens. Researchers, from Radboud University Nijmegen Medical Center in the Netherlands, discovered patients taking statins had muscle weakness, pain and cramps, without any sign of damage to the tissue. Research suggests that muscle weakness and related side effects that can arise from statin use is likely due to the drug’s effect on the energy production centers, or mitochondria, of muscle cells.

If you experience muscle aches, talk to your doctor about trying a lower dose, a different statin, or discontinuing statin treatment and finding an alternative therapy. 

Diabetes: There is a risk of diabetes associated with statin use. In a 2017 report published in the journal Nutrition, Metabolism & Cardiovascular Diseases, researchers analyzed the results of 20 studies investigating the association between new-onset diabetes and statin use. Overall, they found that the risk of diabetes was 44% higher in people who took statins compared to those who did not take statins. The reasons for this are unclear, but research suggests that statins may  increase insulin resistance, and they also appear to inhibit the pancreas’ ability to secrete insulin.

In a study published in Diabetologia, scientists from Finland found that men who were prescribed statins to lower their cholesterol had a 46% greater chance of developing diabetes after six years compared to those who weren’t taking the drug. 

And in a study in BMJ Open Diabetes Research & Care, statin use was associated with a 36% increase in the risk of developing diabetes in people who were overweight and obese, and at high risk for the disease. The longer the patients were on statins, the greater their risk of getting diabetes. 

The AHA analysis found that statins may slightly raise the risk for diabetes, but in those who already have risk factors for it, such as obesity.

Cancer: A number of early studies pointed to potential association between statin use and increased cancer risk in certain people. Older people, those who take statins for a long time, and people with a history of breast cancer or prostate cancer, appear to be at higher risk. 

A study at the Fred Hutchinson Cancer Research Center in Seattle found that older women who took statins for 10 or more years have double the risk of being diagnosed with invasive ductal carcinoma and invasive lobular carcinoma, two common types of breast cancer. 

In a Taiwanese study published in Clinical Endocrinology, regular use of statins, particularly among women, was associated with an increased risk of thyroid cancer. Compared with controls, patients who routinely used statins had a 40% increased risk of having thyroid cancer. 

Conversely, the National Cancer Institute (NCI) has begun development of trials to determine potential beneficial effects of statins in preventing colorectal cancer and skin cancer. According to the NCI, the known benefits of statins in preventing cardiovascular disease, as well as years of strong evidence that statins are relatively safe, has led researchers to look into the possibility that statins have the potential to prevent cancer. 

A study in the journal Medicine found that previous use of any statin was associated with a reduction in the risk of brain cancer. For more on potential benefits of statins for brain cancer protection see MedShadow’s Statins May Lower Glioma Risk Over Time.

Elevated Liver Enzymes: According to a study in the journal Clinics in Liver Disease, it is common for people taking statins to have elevated liver enzymes, which could indicate liver damage. The increase in liver enzymes is dose-related, with higher doses of statins leading to a greater risk of increased enzyme levels.  However, in multiple studies, enzyme levels in people taking statins were not consistently different than in people taking a placebo, and irreversible liver damage was extremely rare. Research shows that the risk of liver injury caused by statin is estimated to be about 1%, similar to the risk in people taking a placebo.

After a review of post-marketing data and liver outcome studies from organizations submitting reports of drug-associated liver injury, the FDA revised statin labeling requirements to remove the recommendation for periodic liver enzyme monitoring. Healthcare professionals are advised to perform liver enzyme tests before starting a patient on statin treatment, with follow up tests only if clinically indicated. Patients are advised to notify their healthcare provider if they experience unusual fatigue, loss of appetite, yellowing of skin or eyes, upper belly pain, or dark colored urine. 

And as always, contact your doctor if you have any questions or concerns about potential liver problems. 

Cognitive Effects

A type of statin may increase the risk for memory loss and other cognitive issues, according to a study presented at the Alzheimer’s Association International Conference in 2018.

The drugs in question are known as lipophilic statins. Common ones are Lipitor, Zocor and Mevacor. Compared to other types of statins, these three medications tend to cross the blood-brain barrier more easily, which can lead to potential central nervous system complications.

Researchers at the University of Toronto looked at data from patients seen at a memory disorders clinic. Patients were divided into three groups. The first was a control group not taking a statin. The second group was taking Lipitor. And the final group was taking Crestor, which is known as a hydrophilic statin.

Data showed that those in the Lipitor group had lower cognitive and neurology assessment scores compared to those in the control or Crestor groups. Results also showed that there were no significant differences in test evaluations between the Crestor group and the control group. 

“Findings from this investigation suggest that lipophilic, blood-brain barrier penetrable statins may be associated with deficits in cognition and memory,” and the association is affected by the dose of the medication, lead author Alex Kai Chan of St. Michael’s Hospital in Toronto, concluded.

In contrast, in a 2018 study published in the American Journal of Epidemiology, researchers note that the authors of several review articles have concluded that there is no strong evidence that statins have adverse cognitive effects, and that short-term statin use does not adversely affect cognitive function, while long-term statin use may have a beneficial effect. 

In their own study, the researchers reviewed data on about 4,000 people over an 11-year period to investigate the relationship between blood levels of cholesterol, statin use, and cognitive function. Cognitive measures included attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, verbal fluency, abstraction, and judgment.  

Final examination of the study participants revealed a significant association between the use of statins and better global cognitive function and working memory. The researchers conclude that the study does not support a robust association between lipid concentrations and cognitive function or between the use of lipid-lowering medication, especially statins, and worse cognitive function.

Researchers have questioned whether the use of statins could lead to depression. Some research has shown the possibility that low cholesterol levels may trigger depression, but there is also contradictory evidence, and even the suggestion that statins could be protective against depression

Although there have been reports of cognitive issues associated with statins, as well as analyses finding no significant evidence that statins lead to dementia or mild cognitive impairment, the Food and Drug Administration (FDA) mandated that a warning of possible cognitive effects be added to the labeling of statins. If you experience memory loss or other negative cognitive effects after taking a statin, talk to your doctor immediately.

Drug Interactions

Doctors and patients need to be aware of drug-drug interactions between statins and medications used to treat heart disease, according to recommendations from the AHA.

Statins are prescribed to patients who have clogged arteries, a condition known as atherosclerosis, or those at risk for it, so in many cases, these people are also taking other heart meds.

The AHA published a list of drugs often given to heart patients that can interact with statins. These include:

  • Blood pressure-lowering medications known as calcium channel blockers. These include Norvasc (amlodipine), Cardizem (diltiazem) and Calan (verapamil).
  • Drugs to treat irregular heartbeat, such as Multaq (dronedarone), Cordarone (amiodarone) and Digox (digoxin).
  • Heart failure medications, including Entresto (sacubitril/valsartan) and Corlanor (ivabradine).
  • Drugs known as fibrates, which are used to lower triglycerides, another type of lipid (fat) in the blood, such as Lopid (gemfibrozil).
  • Blood thinners, such as Coumadin (warfarin) and Brilinta (ticagrelor).

The most common interaction when taking these drugs in combination with a statin is that it can increase the level of the statin in the blood, which can lead to muscle weakness or pain. However, the benefits of taking the medications outweigh the risks, which are relatively minor, the recommendations state. To minimize the risks, a doctor should adjust the dose of the statin.

But there are some drug combinations that should be avoided. For example, Lopid should never be taken with the statins Mevacor, Pravachol, or Zocor. 

The report notes that niacin, which is also used to lower lipids in the blood either as monotherapy or combination therapy with statins, does not provide benefits and is potentially harmful. The researchers conclude that “there are currently no clear indications for the routine use of niacin preparations in combination with statins.”

In 2016 the FDA  withdrew the approval of Niaspan (niacin extended-release) and the fibrate Trilipix (fenofibric acid) to be used in combination with a statin. Niaspan and Trilipix were supposed to be taken along with statins to reduce the risk of cardiovascular events, but studies showed that the combinations did not have any significant cardiovascular benefit.

“Based on the collective evidence from several large cardiovascular outcome trials, the agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol [better known as “good cholesterol”] levels in statin-treated patients results in a reduction in the risk of cardiovascular events,” the FDA states in the notice.

“Consistent with this conclusion, FDA has determined that the benefits of niacin ER tablets  and fenofibric acid [direct-release] capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn,” the document reads.

The FDA further says that that the manufacturers of the drugs must discontinue marketing the drugs for the reduction of cardiovascular risk indications. 

Trilipix, which was approved in 2008, is indicated to be taken with a statin and changes in diet to reduce triglycerides and increase HDL cholesterol levels in people with mixed dyslipidemia (high LDL, or “bad cholesterol,” and high triglyceride levels) in people with chronic heart disease or are at high risk for it.

Niaspan won approval in 1987 and is indicated for use in combination with lovastatin and simvastatin for hyperlipidemia and mixed dyslipidemia to increase HDL and lower LDL and triglyceride levels in patients for whom treatment with Niaspan or one of the statins alone is insufficient. In addition, it is approved for patients with a history of myocardial infarction and hyperlipidemia to reduce the risk of another heart attack.

However, Niaspan’s labeling had already been revised in a large trial known as AIM-HIGH, which showed that the drug did not reduce cardiovascular events or death in patients treated with simvastatin, prompting the inclusion of a limitation of use.

The FDA previously revoked approval for two combination drugs, Advicor (niacin ER and lovastatin) and Simcor (niacin ER and simvastatin), for the same reasons and were removed from the market.

In other instances, the AHA report recommends limiting the dose of a statin when taken together with another heart drug. People who take Norvasc should be limited to 20 mg a day or less of Mevacor or Zocor. Patients on Cordarone should take, at most, 20 mg a day of Zocor or 40 mg a day of Mevacor. Zocor should also be limited to 10 mg a day when given in combination with Multaq.

Taking a statin with certain antibiotics may not mix well. In a study in the Annals of Internal Medicine, researchers warn that if you are taking statins, avoid erythromycin and clarithromycin. Both can increase the concentration of statin in your blood stream, leading to muscle or kidney damage, possibly death. If you need an antibiotic, azithromycin is a better choice. 

And the FDA issued a warning about interactions between statins and protease inhibitors, drugs for human immunodeficiency virus (HIV) or hepatitis C virus (HCV). Again, the risk for muscle injury, and even rhabdomyolysis, may be increased due to a rise in the blood levels of statins when these drugs are taken at the same time. 

Another FDA report notes that eating grapefruit or drinking grapefruit juice can also impact how statins work. Eating a grapefruit or having a glass of grapefruit juice in the morning can be a healthy way to start your day – the fruit is high in vitamin C and potassium. But the FDA is reminding consumers that grapefruit can interact with many drugs and how they work in the body, especially if you have high blood pressure or an irregular heartbeat.

When grapefruit interacts with certain medications, the juice causes too much of the drug to enter the bloodstream, similar to what happens when statins are taken with some heart drugs. This can lead to more side effects. For example, drinking grapefruit juice while taking statins such as Zocor and Lipitor, can lead to too much of the drug remaining in your system, increasing your risk for liver and muscle damage that can lead to kidney failure.

For a further list of drugs that interact with grapefruit, click here.

You can also read the medication guide or patient information sheet that comes with your prescription drugs to see if there is a grapefruit juice warning. For OTC (over-the-counter) drugs, check out the Drug Facts label on the bottle.

If you have to avoid grapefruit and grapefruit juice, pay attention to the labels of other fruit juices as they may contain grapefruit juice. Seville oranges, pomelos and tangelos can have the same effect on drugs as grapefruit, so best to avoid them if you know your drug can interact with grapefruit.

Research also shows that the impact of grapefruit or grapefruit juice varies depending on the statin in use and the quantity and timing of ingestion of grapefruit or juice. So before giving up your grapefruit habit, talk to your doctor about how you might be able to safely keep grapefruit in your diet while taking a statin.   

Always discuss with your doctor or pharmacist all the medicines, herbal supplements and even vitamins you are taking to avoid drug interactions.

Effectiveness and Considerations

According to a 2019 study published in the journal Heart, about half of people prescribed statin medications fail to achieve an appropriate reduction in LDL cholesterol levels two years after taking the drug.

Researchers in the UK examined data on more than 165,000 people prescribed a statin between 1990 and 2016. They had not been treated for a heart attack or a stroke prior to receiving a prescription.

Guidelines in the UK say that statin therapy should lead to a 40% reduction in LDL levels. But this study, found that 51% of people didn’t achieve that goal.

Those who failed to achieve at least a 40% reduction in LDL were 22% more likely to develop cardiovascular disease compared to those who did achieve such a reduction. Those who responded well to statins had a 13% reduced risk of developing cardiovascular disease.

The study authors said that genetic factors and not taking a statin regularly may explain why some people respond better to statins than others. 

“Currently, there is no management strategy in clinical practice which takes into account patient variations in [low density cholesterol] response, and no guidelines for predictive screening before commencement of statin therapy,” the researchers wrote.

According to an analysis of studies appearing in The Lancet, the benefits of using statins greatly outweigh any risks associated with them, as side-effect rates have been greatly exaggerated.

The analysis does concede that serious side effects can be caused by long-term statin use. These include muscle pain or weakness, diabetes and hemorrhagic stroke. But the authors note that the number of people potentially impacted by these effects is quite small. For example, statin use may cause muscle pain or weakness in 50 to 100 patients per 10,000 treated for five years.

The researchers also noted that the bad rap statins have been getting in recent years may have led to avoidable deaths in people who stopped taking statins as a result of negative press.

“It is, therefore, of concern that exaggerated claims about side-effect rates with statin therapy may be responsible for its under-use among individuals at increased risk of cardiovascular events,” the article states. “For, whereas the rare cases of myopathy and any muscle-related symptoms that are attributed to statin therapy generally resolve rapidly when treatment is stopped, the heart attacks or strokes that may occur if statin therapy is stopped unnecessarily can be devastating.”

The researchers said they based their conclusions on results from a combination of randomized controlled trials (RCTs), meta-analyses and observational studies. But they added that observational studies tend to be less reliable since they examine outcomes of patients given the treatment with those who were not given the treatment. In many cases, the health of those given a drug is vastly different from those not on a particular drug. For example, they found evidence in RCTs that a two-point reduction in LDL cholesterol while taking 40mg of Lipitor daily is linked to a nearly 50% reduction in the risk for a major cardiovascular event.

There was also no indication in RCTs that statins cause side effects reported in some observational studies, such as aggression, kidney injury, liver disease, memory loss, and sleep problems.

A study published in the Annals of Internal Medicine found that people who continued with statins despite side effects had slightly better outcomes. People who stopped taking statins because of side effects were found to be slightly more likely to die or have a heart attack or stroke according to the study.

Many patients have reported that they stopped taking the drugs within six months to a year because of side effects. The research team analyzed whether people who continued taking statins ended up with better outcomes compared to those who abruptly stopped taking the drugs. Data was drawn from two Boston hospitals between 2000 and 2011.

Of the more than 200,000 adults whose data was studied, nearly 45,000 reported a side effect they thought might be related to the medication (usually muscle aches or stomach pain). Of those 45,000, researchers focused on 28,266 from that group. The majority — 19,989 individuals — kept taking statins anyway. Approximately four years after the side effects were reported, 3,677 patients had died or suffered a heart attack or stroke.

Among those who continued taking statins, 12.2% fell into that group, compared to 13.9% of those who stopped statins after a possible side effect.

Additionally, the researchers found that 26.5% of patients who switched to a different statin again experienced side effects, but 84.2% continued taking the medication anyway.

The study was based on data from electronic medical records, so there is no reporting on how many of those who stopped statins used other methods to lower their cholesterol levels, such as changing their diet and exercise regimens.

Statin therapy has been shown to reduce heart attacks, strokes, and other vascular events, as well as deaths from these events. But evidence of benefits in older people without vascular disease is lacking.

In fact, evidence indicates that doctors may want to think twice before prescribing a statin to seniors with no history of heart disease for prevention of heart attack. A study in JAMA Internal Medicine finds that statins do not appear to reduce that risk, and the mortality rate was higher in those taking a statin compared to those not on one.

Researchers analyzed data from 2,867 adults aged 65 and older with high blood pressure but without plaque build-up in the arteries that took part in the Lipid-Lowering Trial component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, which was conducted from 1994 to 2002. Of that total, 1,467 took Pravachol daily and the other 1,400 received usual care from their doctor to lower cholesterol.

There was no difference in cardiovascular events between the two groups, the researchers reported. Stroke, heart failure, and cancer rates were similar in the two groups. And there were more deaths in those taking pravastatin than those on usual care (141 vs. 130) among adults 65 to 74 and among adults 75 and older (92 vs. 65). However, the difference was not considered statistically significant.

Side effects such as muscle pain and fatigue may have a larger impact on seniors, according to lead author Benjamin Han, MD, of the New York University School of Medicine.

“Anything that can affect their physical function, anything that can affect their ability to do activities on a daily basis, puts them at a higher risk for further decline and a higher risk for mortality,” Han told HealthDay News in an interview.

In an accompanying editor’s note, Gregory Curfman, MD, editor-in-chief of Harvard Health Publications, noted that since statins have been associated with musculoskeletal disorders and cognitive dysfunction, which can boost the risk for falls and have a large impact on older adults, physicians should carefully consider the risk before prescribing or continuing statins in this population.

In another study, published in 2019 in the Annals of Internal Medicine, researchers argue that statins may be overprescribed since the risks outweigh the benefits in many people.

Current US guidelines recommend that statins be prescribed to those who have a 10% or greater risk of having a heart attack within the next 10 years and who have one or more risks for cardiovascular disease (CVD), such as high cholesterol, high blood pressure,  diabetes, or smoking. With those guidelines, as many as 40% of older Americans should take a statin to curtail their risk of developing heart disease or having a cardiovascular event.

Statins, however, are considered a must for those that have experienced a heart attack or stroke, as clinical evidence is strong that they can prevent another one from occurring.

Researchers looked at data from more than 40 studies on four commonly prescribed statins: Lipitor, Zocor, Pravachol and Crestor. They used a computer model to analyze the benefits and risks of statins. Possible side effects included muscle weakness, kidney or liver dysfunction, diabetes, cataracts, and headaches.

The researchers found that the harms of the drug outweigh the benefits until a patient’s risk is much higher than the 10% threshold cited in the US guidelines.

For example, a net benefit was not seen in men between 70 and 75 unless their 10-year CVD risk was at least 21%. Among men 40 to 44, the benefit was not greater than risk unless their risk was at least 14%.

Milo Puhan, MD, PhD, a senior author of the study with the University of Zurich, told NPR that as people age, the benefits of statins diminish compared to harm. He added that only 15% to 20% of older adults should be taking statins, much less than the 40% under the current guidelines.

In the AHA study, responding to the argument that statins are overprescribed, the researchers echoed observations that the benefits of statin medications outweigh their risks.

In addition to the finding that the slight increase in risk for diabetes occurs only in those who already have risk factors for it, such as obesity, the AHA analysis found no evidence of a relationship between statins and conditions such as cancer, cataracts, cognitive dysfunction, peripheral neuropathy, erectile dysfunction, and tendonitis.

For insight into how to interpret some of the contradictory and confusing headlines regarding statins’ potential benefits and harms, see MedShadow’s What to Believe. For more on potential problems with taking statins, and what to consider before deciding to take them, see MedShadow’s The Risks of Taking Statins. and Yes, Statins Work. But Who Should Take Them?

Alternatives to Statins

There is a large variety of alternatives for people who don’t want to take drugs (See MedShadow’s 5 Things to Know About Statin Alternatives). 

According to the National Heart, Lung, and Blood Institute (NHLBI) the most common cause of high cholesterol is an unhealthy lifestyle. In many cases, changes in diet and exercise can make a big difference in reducing cholesterol levels.The NHLBI offers a three-part program called TLC, or Therapeutic Lifestyle Changes, that uses diet, physical activity, and weight loss to lower high cholesterol. The program offers advice on how to make heart healthy lifestyle changes for everyone, no matter what your heart disease risk is. 

In fact, experts recommend that people who have high cholesterol and have not had a heart attack try changes in diet and getting lots of exercise before taking a statin. 

The National Institute on Complementary and Integrative Medicine offers the following guidelines on natural products that may be helpful in treating high cholesterol:

  • Stanols and sterols. Studies show that stanol or sterol supplements, taken with meals, can reduce cholesterol levels. The FDA permits some foods and dietary supplements that contain stanols or sterols to carry a health claim saying that they may reduce the risk of heart disease when consumed in appropriate amounts.
  • Soy. Some research shows that some soy products have a small cholesterol-lowering effect. Soy foods appear to be more effective in lowering cholesterol than soy protein supplements. 
  • Flaxseed. Studies suggest that some types of flaxseed supplements, including whole flaxseed and flaxseed lignans, have possible beneficial effects in lowering cholesterol. These potential benefits have not been shown for flaxseed oil.  
  • Garlic. An analysis of the research on garlic supplements concluded that they can lower cholesterol if taken for more than two months. 
  • Green tea. Evidence for green tea is limited, but there is some research that suggests it may have a modest cholesterol-lowering effect.
  • Oats and oat bran. Studies suggest that long-term intake of oats or oat bran can reduce the risk of cardiovascular disease by lowering total and LDL cholesterol.    

Other medications to lower cholesterol include Zetia (ezetimibe), which works by limiting the absorption of cholesterol. However, Zetia is usually taken in combination with a statin. Prevalite (cholestyramine), Welchol (colesevelam) and Colestid (colestipol) help to lower cholesterol by binding directly to bile acid, which is used in digestion. As a result, your liver uses cholesterol to make more bile acid, which reduces cholesterol levels in the blood.

A study published in JAMA indicates that some of these methods to lower cholesterol may be just as effective as statins in also reducing cardiovascular events. Researchers analyzed 49 trials involving more than 300,000 people that looked at different ways of lowering cholesterol. The trials were sorted into four groups: Those that examined statins; nonstatin treatments that work to lower LDL “bad” cholesterol levels such as diet and Zetia; fibrates and niacin; and the newest class of cholesterol-lowering drugs known as PCSK9 inhibitors. Statins and nonstatin interventions had similar reductions in the risk of a heart attack, stroke or need for a stent, according to the study. Fibrates and niacin also worked to mitigate the risk, though the reduction was not as great as with statins and nonstatin treatments. The PCSK9 inhibitors also showed some benefit, but there have been few studies conducted to determine their long-term benefit.

On the horizon is a drug that appears to lower  LDLcholesterol levels more than statins alone.

The new drug, bempedoic acid, works by targeting the enzyme ATP citrate lyase, which is involved in the production of LDL cholesterol. In a new study, adding bempedoic acid plus a statin led to a greater reduction in LDL cholesterol compared with just increasing the dosage of a statin.

Researchers conducted a one-year trial, enrolling 2,000 patients that had atherosclerotic cardiovascular disease, genetically inherited high cholesterol or both conditions. All patients continued to take the highest dose of a statin they could tolerate and were randomized to receive either bempedoic acid or a placebo.

Results, published in the New England Journal of Medicine, showed that adverse events occurred at similar rates in both groups. But those in the bempedoic arm saw their LDL decline by an average of 19.2 md/dL. An LDL level between 130 and 159 mg/DL is considered borderline high, 160-189 high and 190 and above very high.

The study was sponsored by Esperion Therapeutics, the developers of bempedoic acid.

Some of the adverse events seen in the trial were uric acid and gout, though researchers noted those can be managed and treated by health care providers. There were also more deaths in the bempedoic than the placebo group, though the authors said the deaths were likely unrelated to the drug and more likely the results of cancer and cardiac death due to cardiovascular disease.

It will likely be several years at the earliest that bempedoic acid could be approved. The FDA is requiring that Esperion conduct a cardiovascular outcome trial, which won’t be completed until 2022.

Be aware that many people who stop taking statins due to side effects have better luck with the drugs the second time around. Most patients who stop statin treatment are able to tolerate them when they go back on statin therapy. For more on this see MedShadow’s Statins Often Tolerated on the Second Try.

How They Work (Method of Action)

Most cholesterol found in the blood is manufactured inside the body, rather than through diet. Statins work by blocking the activity of an enzyme known as HMG-CoA reductase, which is involved in the body’s production of cholesterol. By doing so, statins help block the making of cholesterol in the liver. When the liver stops making cholesterol, its level in the blood falls.

What Worked for You? 

Share your experience with statins in the Disqus box below.

MedShadow Coverage on Statins

 

Further Reading

How Do Statins Work? (healthline)

Are You Taking the Right Treatment for Your High Cholesterol? (Consumer Reports)

How To Lower Your Cholesterol Without Drugs (Harvard Women’s Health Watch)

 


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Deirdre Wyeth

Deirdre Wyeth is the Digital Director of MedShadow.org. She has worked as a digital content strategist for almost 20 years. She specializes in web content, usability and SEO. You can learn more here.


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