An Evidence-based Approach to Dietary and Vitamin Supplements in Atherosclerotic Heart Disease

Transcription

1 An Evidence-based Approach to Dietary and Vitamin Supplements in Atherosclerotic Heart Disease Rhonda M. Cooper-DeHoff, Pharm D, MS, FACC University of Florida Associate Professor of Pharmacy and Medicine

2 Presenter Disclosure Statement No conflicts or commercial relationships to disclose

3 Learning Objectives After this lecture you will be able to: Understand evidence on current usage and expenditure patterns for dietary supplements Recall evidence on US regulations surrounding dietary supplements Recognize evidence regarding how dietary supplements may affect efficacy of and interact with prescription drugs Promote evidence based patient safety by counseling patients on issues pertaining to dietary supplement use

4 Definition and Cost of Complimentary and Alternative Medicine (CAM)

5 Definition Group of diverse medical and healthcare systems, practices and products that are not generally considered part of conventional medicine. Biologically Based Manipulative and Body- Based Approaches Mind-body Techniques Energy Medicine Alternative Medical Systems Vitamins & Minerals Natural Products Plants (gingko) Massage therapy Chiropract medicine Spiritual Meditative Biofield Magnetic field Acupunct. Chinese Medicine Diets Relaxation Reiki Ayurveda 1998

6 Out of Pocket Expense

7 DS and OTC drugs what s the difference?

8 DS vs OTC Drug Store Isles Look the Same Cost about the same Regulated in different ways

9 OTC Drugs Approved by FDA Proven safe, effective, pure, accurately labeled DS Dietary Supplement Health and Education Act (DSHEA) Statute of US federal legislation (Orin Hatch R-Utah 1993) Signed by Clinton in Oct 1994 Dietary Supplements are regulated on the food side of FDA (not drug side) Serving Size, not Dose No requirement to prove efficacy For safety, burden is on FDA to prove a product is harmful

10 United States Pharmacopia (USP) USP Nongovernmental, NFP organization USP Products sets standards for Rx and OTC drugs (required) 2001 USP launched verification program for DS (voluntary) Verifies what s on the label is in the bottle No harmful contaminants Product will break down and release ingredients in the body Product has been made under GMP

11 Purchases random products from store shelves Tests for purity, etc

12 Who is taking Dietary Supplements and Why

13 4 in 10 US adults (38%) used a DS in last 2 years Users tend to be Autonomy 1 in 3 US Adults (72 M) Female, Richer, more educated American Indian / Caucasian Ages Natural must be better Cheaper, less authoritative, less complicated Feel in control take both Rx and dietary supplements NIH-ODS, Kelly et al, 2005 Arch Int Med, AARP

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15 2011 Harvard School of Public Health Survey 41% 41% 36% 28% To feel better To improve overall energy levels To boost immune system To reduce risk of heart disease

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17 What are they taking and why do we care?

18 The 20 Top-Selling Herbal Supplements in the US for 2012 (Food, Drug, Mass Market Channel) St. John s wort (Hypericum perforatum)

19 1 in 3 US Adults (72 M) take both Rx and dietary supplements Herb-Drug Interactions Pharmacodynamic Augments or antagonizes the activity of the drug Pharmacokinetic Absorption, Distribution, Metabolism, or Elimination Warfarin + Garlic Bleeding Thiazide + Ginkgo BP Concentration Induction of metabolism Inhibition of metabolism Time

20 St. John s Wort Drug Interactions Cardiovascular Drugs Drug Effect Pathway Cyclosporin A 46% AUC CYP3A4, P-gp Digoxin 25% AUC P-gp Simvastatin 48% AUC CYP3A4 Tacrolimus 35% AUC CYP3A4 Warfarin 28% AUC CYP2C9 Verapamil 78% AUC CYP3A4 Nifedipine 53% AUC CYP3A4 Losartan efficacy CYP2C9 Drug Effect Pathway Irinotecan 24% ACU CYP3A4 Indinavir 57% AUC CYP3A4 Amitriptyline 22% AUC CYP3A4 Midazolam 20% AUC CYP3A4 Fexofendadine 10% AUC P-gp Alprazolam 53% AUC CYP3A4 Norethindrone 14% oral CL CYP3A4

21 Who is at the biggest risk? Surgical Patients Patients being treated for cancer Patients who take blood thinners

22 2006 AARP Survey Telling their Health Care Provider 35% in 2011 Harvard Survey CAM Complimentary and Alternative Medicines

23 Common Herbal Products That May Contribute to HTN Common Name Purported/ Common Uses Arnica Anti-inflammatory, analgesic Unclear Bitter Orange Weight Loss, Sore Throat, Gastritis, Gout Blue Cohash Amenorrhea, Dysmenorrhea Ephedra Energy, weight loss, decongestant Ginkgo Biloba Weight loss, Vertigo, tinnitus, dementia Ginseng Cachexia, diabetes, anxiety, impotence, neuralgia, insomnia Mechanism α 1 adrenergicreceptor agonist Alkaloid effect Stimulating adrenergic receptor Unclear (surprising b/c has vasodilatory properties) Unclear

24 Common Herbal Products That May Contribute to HTN Common Name Licorice (Glycyrrhizic Acid) Purported / Common Uses Gastritis, cough, bronchitis, constipation Mechanism Suppressesmetabolism of cortisol, increased stimulation of mineralocorticoid receptor, sodium & water retention, hypok + (15/9mmHg) Senna Constipation Hyperaldosteronism Southern Bayberry Antipyretic, circulatory stimulant, diarrhea St. John s Wort Anxiety, depression, insomnia Yohimbine Impotence, aphrodisiac, dietary supplement Mineralocorticoid receptor stimulant MAOI activity α 2 adrenergicreceptor antagonist (increased norepi/epi release)

25 Herbals Containing Stimulants INGREDIENT USE Adverse CV Effect Cola Nut (1-3.5% caff) Green Tea (2-4% caff) Guarana (2.5% caff) Khat, bath salts (amphetamine-like) Yerba mate (0.2-2% caff) Mental or physical fatigue Cognition, diuretic, cholesterol Weight loss, athletic perf, fatigue Depression, fatigue, obesity Appetite sup, mental stim. Arrhythmia, HR, palpit. Arrhythmia, HR, palpit. HR, CNS stimulant SOB, CNS stimulant Arrhythmia, HR, palpit. Ann Pharmacotherapy 2004;38:812-6

26 Dietary Supplement Adulteration

27 Red Yeast Rice -Content Becker D J et al. Ann Intern Med 2009;150: Halbert SC et al. Am J Cardiol 2010;105: Citrinin (byproduct of fermenting process) is a mycotoxin (nephrotoxic)

28 Doctor s Best Issues Voluntary Nationwide Recall of Red Yeast Rice due to Undeclared Lovastatin

29 Sexual Enhancement Products ViaXtreme Black Ant

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31 Advanced Slim 5 Weight Loss Products 6.6 mg Lorcaserin (Belviq) (10mg in standard tablet)

32 FDA Recalled Supplements

33 January 2016

34 Where s the evidence?

35 Information is beautiful

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37 Professional Societies The widespread, indiscriminate use of dietary supplements presents substantial risks to public health and pharmacists have an opportunity and a professional responsibility to reduce those risks State of complementary and alternative medicine in CV, lung and blood research fosters and encourages collaboration among scientists

38 Integrating complementary medicine into CV medicine puts emerging area of CAM into focus and enables physicians to provide better patient care

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40 Take Home Messages

41 Take Home Messages Talk to your patients about what they are taking Add dietary supplements to intake form Content DS may contain more than what is listed, USP verified provides some reassurance Avoid products that do not specify the exact amount of extract per serving

42 Take Home Messages Polypharmacy Meets Polyherbacy High potential for important drug-drugherb-herb interactions As long as people want to be THINNER, MORE ENERGETIC, MORE SEXUAL, MORE Without the work of dieting, exercise, sleeping.. These products will continue to be available

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