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Special OTC Feature: Niacin ER: A viable alternative to Niaspan?

Jun 19, 2010
 
by Katy E. Wallis, University of Florida, 2010 Pharm D Candidate

With the economy at its lowest point in decades, prescription drug costs as high as ever, and the “donut hole” looming just around the corner for many senior citizens, the choices we make as healthcare workers have to be economically sound, in addition to being scientifically so. In question today, is whether prescription Niaspan is worth the extra cost in comparison to the over the counter niacin preparations. In an attempt to answer this question, information on the efficacy, tolerability, pill burden, and cost of each formulation is presented here.

Niacin is available over the counter in an immediate release, as well as an extended release formulation. It is available via prescription as a long acting tablet, Niaspan. Numerous studies have shown the beneficial effects of each niacin formulation including increased HDL, decreased LDL, VLDL, and TG, and decreased incidence of MI. Of all commercially available hypercholesterolemia products, those containing niacin have been shown to have the most favorable effects on HDL cholesterol.

 

In order to be efficacious however, the niacin must be taken, which brings us to tolerability. Flushing is a common side effect of niacin containing products and is the number one reason that patients discontinue niacin therapy, with an approximate rate of 25%-40%. This side effect generally begins within 20 minutes of dosing and lasts less than one hour. Tachyphylaxis to the flushing occurs within approximately one to two weeks of therapy; however the flushing is so unpleasant that patients often do not continue therapy long enough for the side effect to subside. The occurrence and severity of flushing is related to the rate of absorption and the peak concentration of nicotinic acid, therefore there is a wide degree of variability between niacin products in its incidence. Flushing occurs more frequently with the immediate release niacin products as they are absorbed more quickly and dosed more frequently. Flushing occurs less with extended release niacin, and least frequently with Niaspan. The severity and duration of flushing follow the same trend, with immediate release products causing the most severe, longest duration flushing and Niaspan causing the least severe, shortest duration flushing. Overall, Niaspan is associated with the best tolerability of the discussed products.

Also important in terms of compliance is pill burden. The more complex the regimen, the less likely the patient is to comply with it, the less efficacious the therapy will be. With niacin containing products, the immediate release formulations have the most cumbersome dosing regimens with recommended doses taken two to three times daily. Extended release niacin and Niaspan are both taken just once daily, increasing the likelihood for good compliance.

Finally, the cost of therapy varies greatly among the niacin containing products with the over the counter preparations being considerably less expensive than Niaspan. The average cost of 100 extended release niacin 500mg tablets is approximately $10. For 1000mg tablets, the cost for 100 tablets increases by only a couple dollars. The cost of immediate release niacin products is not significantly different than the extended release products. In contrast, the approximate cost of 100 Niaspan 500mg tablets is $230, and the cost of 100 Niaspan 1000mg tablets is $430.

Overall, Niaspan is better tolerated and is associated with better compliance than the over the counter niacin products. Because of the high cost of Niaspan, over the counter preparations may be necessary for patients without insurance, or for those who are in the Medicare coverage gap. For these patients, education regarding the occurrence of flushing and the likelihood that it will dissipate over time is essential. Also important is education regarding the ways that flushing can be minimized:

  • All niacin products should be taken with a low fat snack to slow absorption.
  • A regular strength aspirin (325mg) may be taken with the niacin dose, unless contraindicated.
  • Extended release and long acting formulations should be dosed at bedtime so that patients can sleep through any flushing that may occur.
  • Patients should avoid hot drinks or foods and hot showers or baths shortly after niacin dosing.

In summary, Niaspan offers efficacy and convenience, but at a large cost. For patients who cannot afford the high price of prescription Niaspan, over the counter extended release niacin should be recommended, as it offers efficacy at a significantly lower price. The immediate release niacin products should be avoided as the likelihood for adverse effects, poor compliance, and discontinuation of therapy is high, without any cost savings over extended release products. When recommending over the counter niacin, patient education regarding the incidence of flushing and its management is essential to the success of therapy.

References:

1. Davidson, Michael. Niacin Use and Cutaneous Flushing: Mechanisms and Strategies for Prevention. American Journal of Cardiology. 2008. 101:14b-19b.

2. Kamanna V, Vo A, Kashyap M. Nicotinic Acid: Recent Developments. Current Opinion in Cardiology. 2008. 23: 393-98.

3. Clinical Pharmacology. Online Database. Gold Standard, 2010. Accessed June 13, 2010. Available at http://www.clinicalpharmacology.com.

4. Drug costs obtained from: http://www.drugstore.com. Accessed June 14, 2010.