Supplements in Metabolic Disease Flashcards
Integrative health
Healing oriented practice that incorporates the relationship between the provider and whole person (mind, body, and spirit)
-emphasizes evidence and makes use of all therapeutic approaches
What percentage of patients didn’t report CAM use to health care provider?
72%
Dietary supplement and health education act (DSHEA 1994)
- regulate the evaluation of vitamins, herbals, aa, and other botanicals
- Regulated herbal supplements more like food than medication
- Products cannot be put on same shelf as OTC or meds
- Prior to 1994: all grandfathered in.
DSHEA: Do manufacturers need to register or get FDA approval?
no
- They are responsible to ensure product is safe
- ensure product label information is truthful and not misleading
DSHEA: FDA action?
- take action if product is unsafe once on market
- monitors safety (ADR MedWatch reporting)
- Monitors product information: labeling, claims, package inserts, accompanying literature
Adverse event reporting
FDA medwatch reporting system -voluntary -submit online or by mail What can be reported? Regulated drug Biologic Medical device Dietary supplement
Labeling requirements
Required disclaimer (“This statement has not been evaluated…”)
-May include a structure function claim (claim for its use), not required
-Label contains a supplement seal of approval (GMPs, CL, USP, NSF) if applicable
-Manufacturer follows Good Manufacture Practices:
More stringent practices
Record keeping
Quality control
Testing
Production
Verify quality of raw materials
Increase inspecting of facilities by FDA inspectors
483 inspection report
Fish Oil/Omega 3 Indications
hypertriglyceridemia
MOA Fish oil/omega3
- Decrease in hepatic secretion of VLDL-C, increase VLDL-C clearance, reduces TG transport
- omega 3 FA compete with arachidonic acid in COX and lipoxygenase pathways
Fish oil/omega 3 efficacy
Effects: decrease TG 20-50% Greater TG than 500? decrease by 45% combo with statin in lvls 200-499, decrease by 30% LDL-C neutral effects
Primary prevention (AHA rec): 500mg qd or 2 fishy meals/wk secondary prevention 1000 mg qd
Fish oil/omega 3 adverse reactions, drug interactions, herb rxns
adverse: fish taste, gi upset, heartburn, belching
drug interactions: anithypertensives, contraceptives, orlistat
Herb interactions: garlic, ginger, gingko, ginseng
dosage: 1-4 g qd of DHA and EPA
Tx option for pts who cannot take niacin due to gout and flushing rxn
- Limit to 12 oz per week in pregnancy
- GRAS (generally recognized as safe)
- **not effective in lowering TG or LDL-c
- increase risk of bleeding in combo with rx, OTCs or other supplements
Fiber
FDA permits health claims: 51% whole grain reduce risk of heart disease
Whole wheat, whole oats, barley, corn
Blond psyllium: 10-12 g/d (decreases TGs and LDL-c modestly), more effective with food
Oat bran:
beta glucan (soluble fiber)
Delay food absorption
Niacin
-decreases LDL-c and TGs
-increases HDL-c 15-35%
-Might have decreased risk of secondary MI, but not all cause mortality
-SE: HA, GI, flushing, increase blood glucose, and uric acid
-Monitor: LFT (hepatotoxicity)
Products: IM Niacin is greater than LA Niacin greater than ER Niacin
-Inositol nicotinate (“no flush niacin”)
Plant sterols MOA, efficacy, adverse rxns, dosage
MOA: inhibits about 50% intestinal absorption of chol
Efficacy: decreases TG, LDL-C, no effect on HDL
Adverse rxns: nausea, indigestion, diarrhea, constipation, gas
Dosage:
800mg-6g qd 30 min bf low fat meals
Plant Stanols: MOA, efficacy, adverse rxns, dosage
MOA: inhibits dietary and biliary cholesterol
Efficacy: decreases LDLc (10-15%), w/ statins: decreases TG and LDLC
Adverse rxns: diarrhea, steatorrhea
Dosage: 800 mg-4g qd
Plant sterols and stanols interactions and pearls
interactions
Herbs: beta carotene and Vit E
Drugs: Zetia
Clinical pearls:
2-3 weeks bf effective
-if dc, cholesterol levels rise to baseline in 2-3 weeks
-sterols and stanols equally effective
Ephedra MOA
Alkaloid constituents of the plant: ephedrine, pseudoephedrine, and small amount of phenylpropanolamine
Ephedrine and pseudoephedrine are non-selective alpha and beta receptors agonist which stimulate nervous system
Ephedra use/efficacy, adverse rxns
- weight loss
- 0.9 kg/mo up to 6 mo with
Bitter orange: MOA, adverse effects, caution in?
MOA:
contains 1-6% of synephrine which is related to ephedrine
-Adverse effects: same as ephedra
-Caution in: HTN, CV pts
Bitter orange clinical pearls
- manufacturers switch to this after ban on ephedra
- often contain caffeine
- GRAS
- no evidence that this supplement is safer than Ephedra!!
Calcium
- pts with low Ca intake often gain more weight and have a higher BMI
- Efficacy: 800-1200 mg qd Ca supplement have been shown to increase weight reduction and body fat loss
- 800-900 mg qd has shown wt loss of 8-9 kg
Adverse rxns: belching, flatulence
**supplement alone does not equal to a low fat dietary intake of calcium
Alli (Orlistat) MOA, efficacy, adverse rxns
- reversible inhibitor of pancreatic and gastric lipase
- efficacy: FDA approved for long term weight loss
- effects in BMI greater than 27
Adverse rxns:
HA, oily spotting, abdominal discomfort, gas, fecal urgency, steatorrhea & liver related events
Psyllium/Fibers 6g with dose or 12 qhs
Alli: dosing, drug interactions, clinical pearls
- 60mg tid with each meal that contains fat
- drug interactions: anticoagulants, amiodarone, levothyroxine, and vitamins
Clinical pearls:
- take a MVI qd 2hrs before or after dose
- due to risk of liver injury, inform pt signs/sx
Diabetes tx options
chromium
vanadium
Chromium MOA
Might reduce oxidative stress
Low levels are associated with impaired glucose & insulin
Chromium 0 has no activity
Chromium III found in food and supplements
Chromium VI used in welding industries & carcinogenic
Several salt forms: picolinate, nicotinate, polynicotinate, and chloride
- Chromium picolinate form most often used in studies
- caution in renal deficiency
- mixed data and effectiveness
- no reliable method to dx efficacy
Chromium adverse reactions and dosage
HA, insomnia, irritability, mood changes & sleep disturbance
Vomiting, diarrhea, and hemorrhage
Dosage: 200-1000 mcq divided doses
-0.4-2.5% absorbed and rapidly excreted in urine
interactions w/ chromium
Herbs: bilberry, brewer yeast, iron, Vit. C and zinc
Drugs: insulin, levothyroxine, NSAIDs & corticosteroid
Disease: diabetes, renal dysfunction
MOA Vanadium
Activates insulin receptor proteins, stimulates glucose oxidation and transport
Liver: stimulates glycogen synthesis
Adipose: inhibits lipolysis
Skeletal muscle: promotes glucose uptake
Efficacy of vanadium and adverse rxns
efficacy:
High dose of 100 mg qd may improve insulin sensitivity and possibly reduce blood glucose levels
Effective in Type 2 but not Type I diabetes
Adverse reactions:
GI upset, kidney toxicity, fatigue, lethargy & tongue discoloration
Vanadium interactions/pearls
Dosage: 50 mg bid of the sulfate form
Interactions:
Herbs: garlic, ginger, ginkgo & ginseng
Drugs: anticoagulants and antiplatelets
Disease: diabetes and renal dysfunction
Clinical pearls:
Average diet contains 6-18 mcq qd
Only 5% is absorbed
Garlic indications, MOA
indications: HTN, hyperlipidemia
MOA:
Allicin is the active ingredient
Inhibits hepatic cholesterol synthesis
Activates production of endothelium-derived relaxation factor to relax smooth muscle and vasodilation
Garlic adverse rxns
Halitosis, body odor, heartburn, GI upset
Garlic drug interactions
Anticoagulant
Antiplatelet
CYP3A4
CYP2E1
Herb interactions:
Ginger, ginkgo and vitamin E
Standardized % allicin and clinical pearls (garlic)
Standardized to 0.65 - 1.3 % allicin
Clinical pearls:
When using fresh product needs to sit for 10 minutes chopped up prior to use for best results
Generally recognized as safe (GRAS)
Discontinue 2 - 3 weeks prior to surgery
Products marketed as odorless, may not contain allicin
Coenzyme Q-10 indications, MOA
Indications:
Congestive heart failure
Preventing statin-induced myopathy
Mechanism of action:
Has antioxidant properties to stop damage and give energy to cells
Cofactor in metabolic pathways
Co Q10 efficacy, adverse rxns, drug interactions
No evidence when taken as monotherapy, possibly useful with prescription treatment for HF
No significant benefit for myopathy or statin tolerability
Adverse rxns:
GI upset, heartburn, and appetite loss
Drug interactions: anticoaguants
Lab interactions: increase T4/T8 ratio in normal pts
Disease interactions: may lower blood pressure, cigarette smoking may deplete body stores
Clinical Pears CoQ10
Some meds can lower CoQ10 levels: statins, beta blockers, and diuretics
-take it with a fatty meal
