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