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Plant Sterol Information for Health Care Professionals

Summary: Plant Sterols
(From the 2016 American College of Cardiology Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering1)

  • Mechanism of action: Not fully elucidated, but in part related to displacement of cholesterol from the micellar phase. Phytosterols ↓ cholesterol content of micelles and hence ↓ its transport towards the intestinal brush border membrane. May also interfere with transporter-mediated processes of cholesterol uptake via NPC1L1 protein and ABCG5 and ABCG8 transporters1
  • FDA-approved claims:  Foods containing at least 0.65 g per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease1,2
  • Dose and route of administration: 1-3 g PO per day consumed with meals either once daily or in divided doses1
  • Mean % LDL-C reduction: Consumption of 2 g/day of phytosterols ↓ LDL-C by 5%–15%. LDL-C ↓ plateaus at doses above 3 g/day1
  • Adverse effects: Phytosterol esters have “generally recognized as safe” (GRAS) status in the US. Potential safety concern regarding phytosterol consumption in patients with phytosterolemia. Side effects may include mild bloating, diarrhea, or constipation1
  • Drug–drug interactions: Bile acid sequestrant administration should be separated from phytosterol use by 2-4 hours to avoid binding of the latter in the gut1
  • CV outcomes trialsThe effect of phytosterols on cardiovascular morbidity and mortality has not been determined1

 

Summary: Piper Biosciences Cholesterol Wellness Chewables

  • Recommended patient selection: 1) Patients with elevated cholesterol in whom statins are not indicated, 2) patients taking statins, as an adjunct to achieve LDL-C targets or 3) patients who are statin intolerant
  • Medical guidelines: Plants sterols have been recommended by the American College of Cardiology1, National Lipid Association3, American Diabetes Association4, European Society of Cardiology5, European Atherosclerosis Society5,6, and the National Institutes of Health (National Cholesterol Education Program ATP III)7. Plant sterols are also in the treatment guidelines for familial hypercholesterolemia
  • Dosing: 3 chewable gummies twice a day around meal time. Each daily pack provides 6 gummies for a daily dose of 1.4 grams of plant sterols
  • Manufacturer: Piper Biosciences was founded by a Stanford School of Medicine professor and is advised by leading preventive cardiologists. Each product is third party tested, with quality testing data available on the website. The product is recommended at top academic lipid centers

 

What are plant sterols?

Plant sterol supplementation is commonly recommended by physicians to lower cholesterol* and is part of the treatment guidelines of American College of Cardiology1, National Lipid Association3, American Diabetes Association4, European Society of Cardiology5, European Atherosclerosis Society5,6, and the National Institutes of Health (National Cholesterol Education Program ATP III)7. Plant sterols are present in small amounts in vegetable oils, nuts, fruits and vegetables. According to the US National Institutes of Health, consuming ~2 g/day of plant sterols, as part of a healthy diet, can lower LDL- C levels by 5-15%, within several weeks8.

Plant sterols are ubiquitous in plant-based foods. In a normal Western diet, the average daily intake of plant sterols is about 300 mg, but can be as high as 600 mg in vegetarians6. Since it is unlikely that patients can ingest the recommended 2 grams of plant sterols solely through food, medical societies recommend plant sterol supplements. According to the U.S. Food and Drug Administration (FDA): Products containing at least 400mg of plant sterols per serving, eaten twice a day with meals for a daily intake of at least 800mg as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease2.

 

How do plant sterols reduce cholesterol?

Similar to soluble fiber, plant sterols help block the re-absorption of cholesterol in the small intestine. This can reduce LDL (bad) cholesterol by 5-15% while not affecting HDL (good) cholesterol or triglyceride levels8.

According to the National Lipid Association3:

“One mechanism by which [plant sterols] lowers LDL-C is reducing intestinal cholesterol absorption by competing with cholesterol for limited space in mixed micelles. This makes less cholesterol available to the enterocytes for transport via Niemann-Pick C1-Like 1 transporters. A second mechanism is that an increase in the intracellular level of [plant sterols] in the enterocytes triggers an up-regulation of adenosine triphosphate-binding cassette transporter (ABC) G5 and ABCG8 that move sterols (including cholesterol) out of the enterocytes and into the intestinal lumen. The net result of these actions is to reduce hepatic cholesterol content, which then results in an up-regulation of hepatic LDL receptors that remove apo B-containing lipoproteins from the blood, thus lowering the blood cholesterol concentration, particularly LDL-C.”

 

Are plant sterols a drug? Are they regulated by FDA?

Plant sterols are not a drug. They are classified as a dietary supplement by the FDA when they are marketed with an FDA-authorized claim about the link between plant sterols and the risk of heart disease. Plant sterols have been used clinically for over 60 years. From the 1950’s to 1980’s, drug maker Lilly marketed Cytellin, a plant sterol formulation to treat hypercholesterolemia. More recently, plant sterols have been made available as a dietary supplement in the United States and FDA mandates manufacturers produce these supplements in accordance with current Good Manufacturing Practices. Plant sterols and stanols are one of the rare categories of supplements in which FDA allows disease-related efficacy claims. According to FDA: “Products containing at least 400mg of plant sterols per serving, eaten twice a day with meals for a daily intake of at least 800mg as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease2.”

 

Which medical societies recommend plant sterols?

American College of Cardiology, 2016
2016 ACC Expert consensus decision pathway on the role of non-statin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk. Journal of the American College of Cardiology 2016; 68.

American Diabetes Association, 2016 
Standards of Medical Care in Diabetes. Cardiovascular Disease and Risk Management. Diabetes Care 2016; 39.

National Lipid Association (USA), 2015
National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 2. Journal of Clinical Lipidology 2015;9.

European Atherosclerosis Society, 2014
Plant sterols and plant stanols in the management of dyslipidaemia and prevention of cardiovascular disease. Consensus statement of the European Atherosclerosis Society. Atherosclerosis 2014; 232.

National Cholesterol Education Program ATP III, (National Institutes of Health), 2001
Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)

 

How well do plant sterols work? How many studies have been published?

According to the United States NIH8:

“As with soluble fiber, plant stanols and sterols help block the absorption of cholesterol from the digestive tract, which helps to lower LDL—without affecting HDL or triglycerides. Studies show that a daily intake of about 2 grams of either stanols or sterols reduces LDL cholesterol by about 5–15 percent—often within weeks.”

According to the National Lipid Association3:

“There is a large evidence base supporting the LDL-C-lowering effect of [plant sterols], which has been summarized in multiple meta-analyses. The meta-analyses conducted by Law et al. and Katan et al. were the first to examine the effects of [plant sterols] on cholesterol levels…More recently Musa-Veloso et al. conducted the largest meta-analysis on [plant sterol] consumption, which included 114 trials representing 182 trial arms and evaluating LDL-C lowering dose-response effects separately for plant sterols and plant stanols.”

 

Which patients are candidates for plant sterols?

According to the National Lipid Association3, plant sterols can be integrated into the lifestyle therapies recommended to patients with low or moderate cardiovascular risk. Other lifestyle therapies include reducing saturated fat intake, increasing intake of soluble fiber, etc.

According to the European Atherosclerosis Society6: “Plant sterols/stanols may be considered 1) in individuals with high cholesterol levels at intermediate or low global cardiovascular risk who do not qualify for pharmaco-therapy, 2) as an adjunct to pharmacologic therapy in high and very high risk patients who fail to achieve LDL-C targets on statins or are statin-intolerant.”

 

How much plant sterols does this product contain?

One pouch of this product provides 6 gummies which supplies a total of 1.4 grams/day of plant sterols. The patient should be encouraged to eat a heart healthy, plant-based diet which will provide additional plant sterols to achieve the 2.0 grams per day target.

 

What are the ingredients?

Active Ingredient: Plant Sterols (from soy) 700mg per serving

Other Ingredients: Tapioca Syrup, Organic Sugar, Maltodextrin, Pectin, Citric Acid, Natural Flavors, Colors Added (Organic Black Carrot Juice Concentrate, Organic Annatto), Fractionated Coconut Oil (Containing one or more of the following: Carnauba Wax, Beeswax).

      

 

Who is Piper Biosciences?

Piper Biosciences is a California based company that developed this first-of-its-kind clinical strength plant sterol chewable and lifestyle modification program. The company has strong academic ties through its founder and through its advisory group of world-renowned preventive cardiologists.

Piper Biosciences was founded by Rajiv Doshi, MD, an Adjunct Professor at Stanford University School of Medicine and inventor of Provent Sleep Apnea Therapy and Theravent Snoring Strips. Dr. Doshi had serious concerns about the dietary supplement industry, including poor quality, adulterated products and questionable product claims. Piper Biosciences is developing a first-of-its-kind, transparent brand to provide the highest quality products based on the medical guidelines. Piper’s advisors are world renowned preventive cardiologists and population health managers seeking to reduce the global burden of heart disease.

 

What are the educational messages on the packages and in digital content?

Each daily pouch has a behavior change message based on the medical guidelines—reinforcing the messages that physicians provide to their patients. Messages include how to reduce saturated fat intake, increase dietary fiber intake and increase physical activity. We also provide patients digital content focused on improving nutrition. The NIH has recommended the use these healthy lifestyle changes along with usage of plant sterols, to reduce LDL by up to 30%.  

 

How do I prescribe?

Patients should be directed to purchase the product on piperbio.com or via Amazon.com. Repeat lipid testing is recommended between 2-6 months to confirm efficacy.

 

How do I get samples for my patients?

If you are a healthcare provider, please fill out our samples request form. We may be able to provide samples for your patients.

 

Other questions?

Please email us as hello@piperbio.com. 

 

References

  1. American College of Cardiology, 2016
    2016 ACC Expert consensus decision pathway on the role of non-statin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk. Journal of the American College of Cardiology 2016; 68.
  1. US FDA Code of Federal Regulations 101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD).
  1. National Lipid Association (USA), 2015
    National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 2. Journal of Clinical Lipidology 2015;9.
  1. American Diabetes Association, 2016 
    Standards of Medical Care in Diabetes. Cardiovascular Disease and Risk Management. Diabetes Care 2016; 39.
  1. European Society of Cardiology & European Atherosclerosis Society, 2016
    The Task Force for the management of dyslipidemias of  the European Society of cardiology (ESC) and the European Atherosclerosis Society (EAS). 2016 ESC/EAS Guidelines for the management of dyslipidemias. Atherosclerosis 2016; 253.
  1. European Atherosclerosis Society, 2014
    Plant sterols and plant stanols in the management of dyslipidaemia and prevention of cardiovascular disease. Consensus statement of the European Atherosclerosis Society. Atherosclerosis 2014; 232.
  1. National Cholesterol Education Program ATP III, (National Institutes of Health), 2001
    Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)
  1. National Institutes of Health, National Heart, Lung and Blood Institute, 2005
    Your Guide to Lowering Your Cholesterol with TLC
*According to the U.S. Food and Drug Administration (FDA): Products containing at least 400mg of plant sterols per serving, eaten twice a day with meals for a daily intake of at least 800mg as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. One serving of our Clinical Strength product supplies 700mg of plant sterols for a daily intake of 1400mg.

Individual results may vary. Supplementation with plant sterols typically reduces cholesterol by 5-15% within several weeks. Adding other lifestyle changes, including a heart healthy diet, can reduce cholesterol by up to 30%. Repeat lipid testing is recommended. Speak with your physician if you have questions.