US Pharm. 2022;47(9):35-40.
Cardiovascular disease (CVD) remains the leading cause of mortality and morbidity in the United States, with coronary heart disease (CHD) being the most common type of heart disease.1 Dyslipidemia is a major contributor to the development of CHD and other forms of atherosclerosis; individuals with high total cholesterol levels have about twice the risk for heart disease. This is not to say that all cholesterol is bad. Cholesterol is an important substance that the body requires to synthesize hormones and provide stability in the lipid bilayer of cell membranes.2 However, when there is an excess amount of cholesterol in the body, it can deposit in the blood vessels and lead to reduced perfusion of the blood through the arteries. Low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) are important modifiable risk factors for the prevention of atherosclerotic disease. Adults with extremely high levels of LDL-C (>190 mg/dL) are at a much greater risk for cardiovascular events compared with those with LDL-C levels of <130 mg/dL.3 Conversely, HDL-C levels are inversely correlated with the risk of cardiovascular events, with levels <40 mg/dL considered a negative risk.4 Almost 29% of adults have LDL-C levels above 130 mg/dL, and more than 18% have HDL-C levels below 40 mg/dL.5,6
There are certain health conditions, lifestyle habits, and nonmodifiable factors that are associated with an increased risk of developing high cholesterol. Health conditions such as type 2 diabetes, hypothyroidism, and chronic kidney disease can affect blood cholesterol to undesirable levels. A family history of high cholesterol may also increase risk of developing high cholesterol. At a BMI of 30 or greater, obesity is also capable of increasing LDL and triglyceride levels and lowering HDL levels. Accordingly, consuming a diet that is high in saturated fats and trans fats—which are found in most meat, poultry, and dairy products—will increase cholesterol production in the body. Lack of physical activity will promote weight gain and lead to higher levels of cholesterol. Increased levels of cholesterol can happen at any age in life but there is a higher risk in older ages. Men will generally have a higher risk compared with women, but women will have an increased risk especially after 55 years of age or after menopause. There are also certain drug classes that may promote high cholesterol, such as antiarrhythmic medications, beta-blockers, steroids, and high doses of diuretic medications. This is why it is important for everyone over the age of 20 years to have their cholesterol measured at least once every 5 years.7,8
In 2013, the American College of Cardiology (ACC) and the American Heart Association (AHA) released guidelines for the treatment of blood cholesterol: ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults.9 Rather than providing specific cholesterol targets, the current guideline focuses on intensity of statin treatment in four different groups. In 2018, these guidelines were updated, providing specific recommendations for specific reductions in LDL-C.10 Recommendations for pharmacotherapy should be a shared decision between the provider and patient, including an interpretation of the patient’s 10-year risk of atherosclerotic disease.
Pharmacists are in an ideal position to provide and educate patients regarding the use of OTC products for the management of high cholesterol. They can help patients make informed decisions based on the available data. The following is a discussion of popular OTC agents and lifestyle changes utilized in the management of dyslipidemia.
Conventional Treatment of Dyslipidemia
HMG-CoA reductase inhibitors, also known as statins, are the drugs of choice in the management of dyslipidemia. Statin drugs are divided into three categories based on intensity of statin therapy and will reduce LDL levels by as much as 50% to as low as 30%, depending on the intensity (see TABLE 1). In patients with established clinical atherosclerotic cardiovascular disease (ASCVD), including a history of myocardial infarction, ischemic stroke, peripheral arterial disease, or coronary artery disease, a high-intensity statin is recommended. Moderate-intensity statin therapy should be considered only in adults aged older than 75 years who are unable to tolerate high-intensity statin therapy. Primary prevention considers multiple factors, such as presence of diabetes, age, and estimated ASCVD risk (see TABLE 2).
Nearly one-half of treatment-eligible adults are not taking cholesterol-lowering medications.11 This can be attributed to many reasons, including cost, perceived susceptibility to cardiovascular risks, and most commonly, fear and concerns regarding safety and adverse effects.12,13 Some of these patients may be looking for alternative ways to lower their cholesterol and reduce their risk for CVD.
Complementary and Alternative Medicine
Approximately 34% of adults in the U.S. are using some form of complementary and alternative medicine (CAM).14 Cholesterol is included as one of the top-10 conditions for which adults are using CAM.15 Fish oil and garlic—two supplements commonly used for the reduction of high cholesterol—were among the top 10 most frequently used natural products.14
Omega-3 Fatty Acids
Omega-3 fatty acids, better known as fish oil, are the most frequently used natural product among adults, with consumption increasing almost 10-fold in the past decade.14,16 They contain two long-chain fatty acids, docosahexaenoic acid (DHA) and eicosatetraenoic acid (EPA), and a short-chain fatty acid known as alpha-linolenic acid. They have shown to be effective in lowering serum triglycerides up to 50%; however, DHA can raise LDL-C and HDL-C.17 In 2002, the AHA recommended omega-3 fatty acids (EPA and DHA) for the reduction of triglyceride levels in patients with hypertriglyceridemia, a condition in which triglyceride levels are 200 to 499 mg/dL.18 A daily dosage of 2 g to 4 g of EPA and DHA is recommended to achieve this effect, particularly with FDA-approved prescription products. Prescription omega-3 fatty acids are indicated as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglycerides ≥500 mg/dL). In patients taking 4 g/day of prescription omega-3 fatty acids, triglyceride levels were lowered up to 30% with no increase of LDL-C. In patients with severe hypertriglyceridemia, there was a greater reduction of triglycerides but also an increase in LDL-C with products containing DHA.18
There are over 400 OTC products currently marketed as omega-3 fish oil dietary supplements.19 These products not only contain EPA and DHA, but may also include saturated fats, fat-soluble vitamins, and cholesterol.20 Fish oil supplements vary in their EPA and DHA concentrations, ranging from 20% to more than 80%, leading to reduced efficacy. Some dietary supplements may contain saturated fats and oxidized lipids, which can impact and increase the risk of CVD.21 The FDA recommends 3 g as the maximum daily dose for dietary omega-3 fatty acid supplements for safe use. If patients require more than 3 g, they should be under a physician’s supervision.22 On average, patients will need to take 11.2 servings per day (one to three capsules per serving) to achieve this higher recommended dose.17 Many patients will have difficulty with this high pill burden.
Overall, these products are generally well tolerated. The most common adverse effects include stomach upset, diarrhea, and reflux. Many patients will complain about a “fishy” taste, especially if they are taking higher doses. Advising them to take enteric-coated formulations or freezing the capsules may help reduce this. Another effect associated with its use is excessive bleeding. Patients on anticoagulants or antiplatelet agents should use omega-3 fatty acids cautiously.
Garlic is a bulbous perennial plant that belongs to the Amaryllis family. It has shown to produce a wide range of health effects and has been used as a supplement to treat and prevent different diseases, including CVD, by lowering blood pressure and preventing atherosclerosis.23 Garlic has been suggested to modestly reduce total cholesterol and LDL levels.24 A comprehensive meta-analysis on the effect of garlic on blood lipids discovered that garlic could reduce total cholesterol by approximately 17 mg/dL and LDL by 9 mg/dL.25 These results were particularly evident in those who took garlic for more than 2 months and in those who had elevated cholesterol and triglyceride levels prior to treatment. The possible mechanism of these actions results from reduced absorption of cholesterol and reduced synthesis of cholesterol and fatty acid.26 However, garlic has no effect on HDL or triglyceride levels.24
Garlic comes in several different oral formulations such as garlic powder (which is used to make tablets), garlic oil (which can also present as capsules), and aged extract. These different preparations may also play a role in how effectively they can treat dyslipidemia. Products that contain aged-garlic extract appear to be more effective at lowering total cholesterol levels compared with garlic powder products, although, among the garlic powder products, enteric-coated garlic powder products reduced total cholesterol levels to a significant degree.25
Study results have shown that garlic is highly tolerable and poses minimal side effects, in comparison to conventional therapies.27 Common adverse effects include bad breath and body odor, stomach pain, and gas. Garlic has antiplatelet effects and can increase a patient’s risk for bleeding. Patients who are on anticoagulants and antiplatelet agents should be warned about this potential risk.28
Niacin, also known as nicotinic acid, is a form of vitamin B3 and is one of the most effective agents to raise HDL-C levels; it can raise HDL-C by almost 35%.29 Niacin also reduces LDL-C levels up to 25% and triglycerides 20% to 50%.29,30 This effect is dose related, requiring 1 g to 4 g per day. Despite this, cholesterol management guidelines do not recommend niacin as add-on therapy to statins because of the lack of cardiovascular benefit.10,31
Niacin is available in three formulations. Two formulations are available without a prescription: immediate-release and controlled-release or sustained-release. An extended-release product known as Niaspan is available only with a prescription and is FDA approved for its lipid-lowering properties. Niaspan is considered more tolerable compared with niacin supplements.32 Flushing of the skin is a very common side effect of niacin, especially with immediate-release products. Flushing presents as itchy and red skin that is warm to the touch and generally lasts for about an hour. A formulation was made specifically to target this side effect and is labeled on the shelves as “flush-free” niacin. However, it is important to note that these products do not contain niacin; rather, they contain inositol hexanicotinate, which has shown to be ineffective as a lipid-lowering agent.33 Niacin-induced flushing can be prevented by pretreatment of aspirin or a nonsteroidal anti-inflammatory drug 30 minutes prior to niacin with meals and avoiding spicy foods or hot beverages after taking niacin. Additionally, increasing the dose slowly over time will help to reduce incidences of flushing.34 Other adverse effects of niacin include pruritus, hyperglycemia, and hepatotoxicity. Hepatotoxicity is mostly seen with sustained-release niacin, and therefore this formulation is contraindicated in those with liver failure.
Red Yeast Rice
Red yeast rice (RYR) is white rice that has been cultivated with various strains of a yeast known as Monascus purpureus. RYR supplements have shown to lower cholesterol and related lipid levels. This activity may be due to the effect of monacolin K present in RYR products.35 Monacolin K is a molecule that inhibits the production of cholesterol and is chemically identical to lovastatin. Average daily doses of 1,200 mg to 2,400 mg of RYR resulted in reductions of up to 27% of LDL and 24% of non-HDL levels when taken for 12 weeks.36 Additionally, RYR has helped to reduce total cholesterol by approximately 17% and triglyceride levels by 8%. Clinical trials have shown that RYR reduces LDL on an average of 1.02 mmol/L, which was proportional to the reduction seen with low-intensity and low-dose statin medications.37
It is important to note that due to the lack of regulation, there is varying information about the content of monacolin in red yeast dietary supplements. Products can vary from having little to no monacolin content or having several different types at differing concentrations.38 In 2007, the FDA issued a warning against the use of red yeast products, determining that any product containing more than a trace amount of monacolin K cannot be sold legally as a dietary supplement.39 Another issue that arises from the lack of standardization of the production of red yeast products is the formation of toxic byproducts known as citrinin, which can be harmful to the kidneys.40 The adverse effect profile is like that of statin drugs, including hepatotoxicity and myopathy.
According to the American Diabetic Association, it is recommended for adults to consume 14 g of dietary fiber per 1,000 kcal, which would equate to 25 g for women and 38 g for men.41 While soluble fiber can be obtained from fiber-rich foods, it is also available as a supplement. This includes oat beta-glucan, pectin, various gums, and psyllium. When ingested and allowed to ferment in the gut, soluble fiber produces short-chain fatty acids that decrease cholesterol synthesis in the liver. This promotes the reduction of blood cholesterol and increased excretion of cholesterol and bile acids.42
Clinical studies have shown that supplemental fiber can reduce LDL by 5% to 15%.43 Highly viscous fiber blends showed to be proportional with total cholesterol and LDL reduction.44 Notably, psyllium husk fiber has been the most studied among the others and revealed that an average of 10.2 g per day significantly reduced LDL by 5.94 mg/dL and non-HDL by 7.02 mg/dL.45 Adverse effects of fiber include flatulence, abdominal bloating, and diarrhea. When first starting fiber supplements, it is important to gradually increase dietary intake over time to reduce the occurrence of these side effects. Additionally, fiber supplements, especially those with high viscosity, may reduce the absorption of other medications, so it is recommended to take supplements 1 hour before or 2 hours after to avoid potential drug interactions.
Introducing and maintaining certain lifestyle modifications are crucial in lowering cholesterol and reducing cardiovascular risk. Following a healthy lifestyle is the foundation for maintaining healthy serum levels. One of the key messages from the 2018 ACC/AHA guidelines is the importance of a heart-healthy lifestyle to reduce ASCVD risk. There are many healthy diet patterns such as DASH (Dietary Approaches to Stop Hypertension), AHA (American Heart Association diet), or MED (Mediterranean diet) that can be incorporated into the diet to promote lowering cholesterol and LDL levels. These diet plans generally follow a similar format that encourages eating vegetables, fruits, and whole grains. It also includes fat-free or low-fat dairy products, lean protein sources such as fish and poultry, beans, and nuts. It limits foods that are high in saturated fats and drinks or sweets containing sugar. It is recommended to achieve 5% to 6% of calorie intake from saturated fat to help reduce dietary cholesterol and LDL levels. Weight is also an important modifiable factor. An average of 40 minutes of moderate-to-vigorous physical activity is recommended three to four times per week. Moderation and calorie restriction may also help with weight loss. Additionally, it will also be beneficial to avoid smoking and limit alcohol consumption.10,46
Role of the Pharmacist
Incorporating practices to help control cholesterol levels is an essential step towards living a heart-healthy lifestyle. During this process, pharmacists can promote appropriate lifestyle modifications. Pharmacists may also assess patient-specific risk factors to help guide treatment. It is also important to acknowledge and address challenges and barriers expressed by the patient including medication adherence or difficulties maintaining proper healthy practices or quitting poor habits that are damaging to one’s health.
Dyslipidemia is a prevalent condition affecting over 100 million people and can more than double a person’s risk for the development of CVD. Because of this, many individuals are seeking alternative ways to lower their cholesterol. Pharmacists can play a vital role in this process by educating patients and helping them make informed decisions regarding the use of the various available supplements.
Supplements that are supported by clinical evidence and guidelines include omega-3 fatty acids and soluble fiber. Pharmacists should keep in mind, however, that these supplements are not regulated by the FDA and there may be inconsistencies between different manufacturers and batches. Pharmacists should avoid recommending garlic, RYR, sustained-release niacin, no-flush niacin, and niacinamide due to lack of efficacy or documented adverse effects. Overall, OTC supplements should rarely be used for primary prevention of CVD because they have not been shown to improve outcomes or mortality. Pharmacists should place a strong emphasis on the importance of and benefits associated with therapeutic lifestyle changes, such as maintaining a healthy weight, eating a low-fat, low-cholesterol, high-fiber diet, and physical activity. Patients should also be reminded to inform their healthcare providers of any supplements that they be using.
What Is Cholesterol?
Cholesterol is a substance that your body needs to keep you healthy. It comes from two sources: your body and the food you eat, such as meat, poultry, and dairy products. Too much cholesterol can increase your risk for heart disease.
What Is the Difference Between “Good” and “Bad” Cholesterol?
“Bad” cholesterol, also known as LDL, will build up in the inner walls of your arteries, making them narrow. This slows down flow. If this buildup of plaque breaks off, a clot forms that can completely block flow, causing a heart attack.
“Good” cholesterol, also known as HDL, helps protect you from heart attacks and strokes. This type of cholesterol carries the bad cholesterol away from the arteries.
How Can I Improve My Cholesterol?
Eating healthy foods, maintaining a healthy weight, and staying physically active are all ways to help improve your cholesterol.
Can Supplements Help?
There are a few things you can take to help you lower your cholesterol, but you should speak with a healthcare provider before starting. Supplements that may have some benefit include omega-3 fatty acids/fish oil and soluble fibers (psyllium).
Supplements that should be avoided include red yeast rice, garlic, sustained-release niacin, “no-flush” niacin and niacinamide. These supplements have no data to support their use in lowering cholesterol levels or they have been associated with liver damage.
What Are “Normal” Cholesterol Numbers?
All individuals aged 20 years and older should have their cholesterol levels checked at least once every 5 years. The blood test should be taken after fasting for 9 to 12 hours.
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