Niacin Category Differences

In the management of dyslipidemia, extended-release prescription niacin and dietary niacin supplements should not be confused.


Differences between categories of niacin


Category Regulatory Approval Process Niacin Products Available
Prescription
  • Manufacturers need to submit new drug applications (NDAs) to the FDA prior to going to market
  • Face an extensive FDA review process to be legally marketed, including an examination of preclinical studies, manufacturing, clinical study data, and labeling1
  • FDA monitors products and can withdraw them from the market
  • Two prescription niacin products are available:
    • Extended-release (ER) NIASPAN® (Abbott)
    • Immediate-release (IR) NIACOR® (Upsher-Smith)2
OTC
  • Most products must comply with monographs that cover acceptable ingredients, doses, formulations, labeling, and testing3,4
  • Monographs are developed by an FDA committee, which reviews safety and efficacy3
  • Manufacturer must ensure that products conform to the applicable monograph4
  • FDA monitors products and can withdraw them from the market
  • None2
Dietary Supplement
  • Intended to address nutritional deficiencies
  • Labeling cannot claim that product is intended to treat, cure, or prevent disease5
  • Products are not required to undergo rigorous clinical studies evaluating and establishing efficacy to treat disease5,6
  • The manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed6
  • Generally, manufacturers do not need to register their products with the FDA or get FDA approval before producing or selling dietary supplements6
  • FDA monitors products and can witdraw them from the market
  • Many brands of dietary supplement niacin are available and are generally divided into 2 categories:
    • Immediate-release (IR), which is absorbed within 1 hour of ingestion
    • Sustained-release (SR), which is absorbed slowly over several hours
  • Some other formulations are called "no-flush"7

Experts agree that dietary niacin is not a substitute for prescription niacin.

"Dietary supplement niacin must not be used as a substitute for prescription naicin. It
should not be used for lowering cholesterol..." —American Heart Association6

"Niacin products that are available as dietary supplements are as such not approved for the treatment of dyslipidemia. Patients should also be warned not to self-medicate with niacin without consulting with a physician." —American Pharmacist Association7

Lipid effects

Effect of IR Niacin and SR Niacin on lipid levels.8

IR Niacin 2000 mg IR Niacin 3000 mg SR Niacin 2000 mg SR Niacin 3000 mg
LDL-C ↓ 16.1% ↓ 21.7% ↓ 32.5% ↓ 50%
TG ↓ 39% ↓ 41.8% ↓ 30.2% ↓ 41.1%
HDL-C ↑ 31.1% ↑ 35% ↑ 17.2% ↑ 9.4%

References

 

1. US Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry. The new drug development process: steps from test tube to new drug application review. http://www.fda.gov/cder/handbook/develop.htm. Accessed: October 23, 2007.

2. US Food and Drug Administration, Center for Drug Evaluation and Research. Electronic Orange Book: approved drug products with therapeutic equivalence evaluations. http://www.fda.gov/cder/ob/ Accessed: October 23, 2007.

3. US Food and Drug Administration, Center for Food Safety and Applied Nutrition. Dietary Supplement Health and Education Act of 1994. http://vm.cfsan.fda.gov/~dms/supplmnt.html Accessed: October 23, 2007.

4. US Food and Drug Administration, Center for Food Safety and Applied Nutrition. Dietary supplements overview. http://www.cfsan.fda.gov/~dms/supplmnt.html Accessed: October 23, 2007.

5. Meyers CD, Carr MC, Park S, Brunzell JD. Varying cost and free nicotinic acid content in over-the-counter niacin preparations for dyslipidemia. Ann Intern Med. 2003;139 (12):996-1002.

6. American Heart Association. Cholesterol-lowering drugs. Dallas: TX. Available online at: http://www.americanheart.org/presenter.jhtml?identifier=163

7. American Society of Health-System Pharmacists. ASHP therapeutic position statement on the safe use of niacin in the management of dyslipidemias. Am J Health Syst Pharm. 1997;54:2815-2819.

8. Mckenney JM, Proctor JD, Harris S, et al. A comparison of the efficacy and toxic effects of sustained release-vs immediate -release niacin in hypercholesterolemic patients. JAMA . 1994;271(9):672-677.

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