L3 CARDIOLOGY

Introduction to Dietary Supplements and Cardiovascular Health

  • Presented by: D. Gerber, PharmD, BCGP, FASCP

  • Course Communication:
      - Use Canvas Inbox for emails to Dr. Gerber.
      - Include a succinct subject line for efficient responses.
      - Example: "Why is true Red Yeast Rice an unapproved new drug?"
      - Expected response time: Within 48 hours.

Office Hours

  • Schedule:
      - Wednesdays, 12:00 PM - 12:30 PM
      - Format: Teams Meeting
      - Link available through Canvas Announcements.

Learning Objectives

After attending the lecture and studying this handout, pharmacy students should be able to:

  1. Identify a dietary supplement that is very similar to lovastatin (an HMG-CoA reductase inhibitor).

  2. Identify dietary supplements that increase the risk of bleeding.

  3. Describe appropriate actions prior to dental or surgical procedures for patients taking bleeding-risk-increasing supplements.

  4. Educate patients on the risks and benefits of red yeast rice compared to lovastatin.

  5. Identify dietary supplements that affect cholesterol levels.

  6. Identify American Heart Association (AHA) fish oil recommendations based on patient stratification.

  7. Identify dietary supplements affecting cardiovascular health.

  8. Describe the timing of psyllium administration in relation to medications.

  9. Discuss AHA's position on Vitamin E supplementation for cardiovascular prevention in females.

  10. Describe the USA legal status of true red yeast rice.

  11. Assess garlic supplements' effectiveness in lowering LDL cholesterol.

  12. Evaluate the AHA policy statement on CoQ10 for cardiovascular disease.

  13. Compare fish oil and Lovaza® regarding dose, risks, and benefits.

Additional Information References

  • Suggested readings for further understanding:
      - Liperoti, R., et al. (2017). Herbal Medications in Cardiovascular Medicine. Journal of the American College of Cardiology, 69(9), 1188-1199.
      - Hao, FJ. (2017). Traditional Chinese Medicine for Cardiovascular Disease: Evidence and Potential Mechanisms. J Am Coll Cardiol, 69(24), 2952–2966.
      - Leonard, SW., Joss, JD., Mustacich, DJ., et al. (2007). Effects of vitamin E on cholesterol levels of hypercholesterolemic patients receiving statins. Am J Health-Syst Pharm, 64, 2257-66.
      - Knox, J., Gaster, B. (2007). Dietary Supplements for the Prevention and Treatment of Coronary Artery Disease. J of Alt and Complementary Med, 13(1), 83-95.
      - Caron, MF., White, CM. (2001). Evaluation of Antihyperlipidemic Properties of Dietary Supplements. Pharmacotherapy, 21(4), 481-487.
      - Heck, AM., Dewitt, BA., Lukes, AL. (2000). Potential interactions between alternative therapies and warfarin. Am J Health-Syst Pharm, 57, 1221-1230.

Dietary Supplements Marketed For Cardiovascular Health

  • Cholesterol Lowering:
      - Red Yeast Rice
      - Policosanol
      - Fish Oil (Omega-3)
      - Plant sterols

  • Cardiovascular Health:
      - Vitamin E
      - Coenzyme Q10 (CoQ10)

Blood Pressure and Dietary Supplements

  • Research indicates some foods and dietary supplements may help reduce hypertension, including:
      - Cocoa
      - Garlic
      - Fish oil (omega-3 fatty acids)
      - Flaxseed
      - Green or black tea
      - Probiotics
      - Hibiscus (roselle)

  • Evidence for reducing blood pressure is limited, with small effects.

  • No supplement has proven to be comparable to antihypertensive drugs.

Dietary Supplements Evidence Overview

  • Evidence-Based Review of Herbal Medications:
      - Clear Evidence of Benefit:
        - (List specific herbs supported by strong clinical evidence)
      - Limited Evidence of Benefit:
      - No Evidence of Benefit:
      - Risks:
        - Potentially severe side effects

Vitamin E Overview

  • Other Names: Alpha-tocopherol

  • Safe upper intake level: ~1000 mg/day for healthy individuals.

  • Common dietary supplements contain 30-75 IU per tablet; higher doses (400 IU) are also available.

Vitamin E Benefits

  • Uses:
      - Treatment of rare vitamin E deficiency.
      - Symptoms of deficiency include hemolysis, neuromuscular disorders, ataxia, and peripheral neuropathy.
      - Conditions increasing deficiency risk include: pancreatic insufficiency, fat malabsorption, and protein-energy malnutrition.

Risks and Controversies of Vitamin E

  • Associated risks:
      - Increased all-cause mortality linked to daily doses of 400 IU or more over one year.
      - Antioxidant vitamin supplements (AHA standpoint): do not recommend use for primary prevention of cardiovascular disease.

  • Randomized controlled studies (Women's Health Study, Physician's Health Study II) found no protective benefits from high doses of vitamin E versus placebo for cardiovascular events.

Fish Oil Overview

  • Contains Omega-3 fatty acids, specifically EPA (Eicosapentaenoic acid) and DHA (Docosahexaenoic acid).

  • Huge consumption reported (~18.8 million U.S. adults taking omega-3 supplements).

AHA Recommendations for Fish Oil

  • For patients without heart disease:
      - Varied fish intake (twice weekly, omega-3 rich fish like salmon or trout).

  • For patients with heart disease:
      - Consume ~1 gram of EPA + DHA daily (preferably from fish).

  • For patients with high triglycerides:
      - 2 to 4 grams EPA + DHA daily under physician supervision.

Effectiveness of Fish Oil

  • Supplements may prevent death after heart attack but lack evidence for cardiovascular benefits in the general population.

  • As per AHA science advisory, the use of omega-3 for primary prevention is unsupported by scientific data.

2018 JAMA Research Insights

  • A meta-analysis reviewing omega-3 efficacy covered 10 trials involving 77,917 individuals.

  • Results showed that omega-3 supplementation was not associated with significant cardiovascular event reductions in high-risk individuals.

Red Yeast Rice Overview

  • Known as: Monascus purpureus; produced through the fermentation of rice.

  • Contains monacolins, statin-like compounds, including lovastatin (0.4% approximately).

  • Classified by the FDA as an unapproved new drug due to variability in active compound levels across products (0.4% to 1.9%).

Legal and Health Implications of Red Yeast Rice

  • Red yeast rice formulations with significant amounts of Monascus purpureus are illegal in the U.S.

  • Clinical studies have not consistently demonstrated cholesterol-lowering abilities of red yeast rice.

Coenzyme Q10 Overview

  • Alternate names: ubiquinone, Q10.

  • Naturally present in body tissues, especially in heart, liver, kidneys, and pancreas.

  • Levels decrease as people age.

CoQ10 Benefits & Risks

  • Evidence for heart disease prevention is inconclusive; does not significantly reduce muscle pain from statins.

  • American College of Cardiology does not support CoQ10 use in CVD, citing ineffective outcomes.

Risks of CoQ10

  • Drug interactions: anticoagulants (warfarin), insulin.

  • Mild side effects: insomnia, digestive upset, but serious side effects not reported.

Plant Sterols

  • FDA granted health claim labeling for foods with plant sterols for reducing coronary heart disease risk.

  • Doses: 800 mg to 6 grams per day, effective mainly in reducing total and LDL cholesterol without impacting HDL cholesterol.

Pharmacist's Role

  • Evaluate supplement names, key ingredient interactions, established benefits in high-quality studies, and assess patient decisions based on benefits vs risks.

Conclusion

  • The course encompasses the spectrum of dietary supplements concerning cardiovascular health and emphasizes evidence-based practices.

  • Consider all recommendations and guidelines from authoritative bodies like AHA or ACC to guide supplement use in clinical settings.