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Dec 22, 2003
Cheapest preparations of over-the-counter niacin most effective at lipid lowering
Seattle, WA - Many over-the-counter niacin preparations may have no free nicotinic acid (vitamin
B3)the lipid-lowering component for which the product is often marketedwhile others may have too
much, according to a new study. A survey of 29 over-the-counter products indicated that the
unregulated products contain variable doses of niacin; in some cases they contain no nicotinic acid,
and in others they have high concentrations of the agent, which could produce liver toxicity.
The paper appears in the December 16, 2003 issue of the Annals of Internal Medicine.[1]
As Dr C Daniel Meyers (Veterans Affairs Medical Center, Long Beach,
CA) and colleagues explain in their paper, niacin was one of the first agents found to lower LDL and
triglycerides while boosting HDL when given in daily doses of 1000 to 4000 mg. Large clinical
trials also showed it to reduce cardiovascular events. Nicotinic acid was never widely used,
however, because of side effects, primarily "niacin flushing": redness, itching, burning, and
paresthesias, which set in within 10 to 15 minutes of ingestion and last up to an hour. The
frequency and severity of these episodes decrease over time with repeated doses, and niacin is
thus available over the counter in the US as a dietary supplement, unregulated by the US FDA.
Meyers et al decided to take a closer look at over-the-counter preparations being marketed as niacin
after witnessing a series of hyperlipidemic patients reporting to the University of Washington
Medical Center Lipid Clinic in Seattle having failed to respond to over-the-counter niacin therapy.
When cheaper is better The researchers calculated the monthly cost for each of 29 preparations
bought from pharmacies, health-food stores, or over the internet. They then used high-performance
liquid chromatography to measure the free nicotinic acid content. Three types of preparations were
evaluated: immediate-release, sustained-release, and no-flush formulations. The researchers found
that the no-flush preparations were the most expensive, followed by the sustained-release
preparation, at less than half the cost, then the slightly cheaper immediate-release niacin
preparations. Ironically, the most expensive no-flush preparations were found to have no free
nicotinic acid, whereas the sustained-release and immediate-release preparations had comparable
nicotinic acid contentsthe cheap, immediate-release versions containing the most.
Cost and contents of niacin preparations
Measure No flush Sustained release Immediate release
Cost per month ($)
21.70
22.75
23.10
Average nicotinic acid content (mg)
24.6
25.4
"No-flush niacin is the most expensive of the niacin preparations yet contains no free nicotinic
acid and should not be used to treat dyslipidemia," Meyers et al conclude. "Sustained-release brands
are inexpensive and contain a full amount of free nicotinic acid, but several preparations have been
associated with increased hepatotoxicity."
Of note, the FDA has approved two prescription brands of niacin, one a sustained release (Niaspan®;
Kos Pharmaceuticals, Miami, FL) and the other an immediate release (Niacor®; Uspher-Smith,
Minneapolis, MN), but as the authors point out, these two drugs are considerably more expensive than
the over-the-counter alternatives.
For people wishing to try niacin for lipid lowering, the authors recommend immediate-release over-the-
counter niacin brands such as those made by Rugby Laboratories (Westbury, NY), since many of these
contain the full amount of nicotinic acid and immediate-release niacin is the only form of the agent
shown to prevent cardiovascular disease and death in clinical trials. As well, Meyers et al advocate
baseline laboratory tests for fasting glucose, liver aminotransferase levels, and uric acid in all
patients before niacin therapy begins, repeated six to eight weeks later and after any dose
increases.
Cheapest preparations of over-the-counter niacin most effective at lipid lowering
Seattle, WA - Many over-the-counter niacin preparations may have no free nicotinic acid (vitamin
B3)the lipid-lowering component for which the product is often marketedwhile others may have too
much, according to a new study. A survey of 29 over-the-counter products indicated that the
unregulated products contain variable doses of niacin; in some cases they contain no nicotinic acid,
and in others they have high concentrations of the agent, which could produce liver toxicity.
The paper appears in the December 16, 2003 issue of the Annals of Internal Medicine.[1]
As Dr C Daniel Meyers (Veterans Affairs Medical Center, Long Beach,
CA) and colleagues explain in their paper, niacin was one of the first agents found to lower LDL and
triglycerides while boosting HDL when given in daily doses of 1000 to 4000 mg. Large clinical
trials also showed it to reduce cardiovascular events. Nicotinic acid was never widely used,
however, because of side effects, primarily "niacin flushing": redness, itching, burning, and
paresthesias, which set in within 10 to 15 minutes of ingestion and last up to an hour. The
frequency and severity of these episodes decrease over time with repeated doses, and niacin is
thus available over the counter in the US as a dietary supplement, unregulated by the US FDA.
Meyers et al decided to take a closer look at over-the-counter preparations being marketed as niacin
after witnessing a series of hyperlipidemic patients reporting to the University of Washington
Medical Center Lipid Clinic in Seattle having failed to respond to over-the-counter niacin therapy.
When cheaper is better The researchers calculated the monthly cost for each of 29 preparations
bought from pharmacies, health-food stores, or over the internet. They then used high-performance
liquid chromatography to measure the free nicotinic acid content. Three types of preparations were
evaluated: immediate-release, sustained-release, and no-flush formulations. The researchers found
that the no-flush preparations were the most expensive, followed by the sustained-release
preparation, at less than half the cost, then the slightly cheaper immediate-release niacin
preparations. Ironically, the most expensive no-flush preparations were found to have no free
nicotinic acid, whereas the sustained-release and immediate-release preparations had comparable
nicotinic acid contentsthe cheap, immediate-release versions containing the most.
Cost and contents of niacin preparations
Measure No flush Sustained release Immediate release
Cost per month ($)
21.70
22.75
23.10
Average nicotinic acid content (mg)
24.6
25.4
"No-flush niacin is the most expensive of the niacin preparations yet contains no free nicotinic
acid and should not be used to treat dyslipidemia," Meyers et al conclude. "Sustained-release brands
are inexpensive and contain a full amount of free nicotinic acid, but several preparations have been
associated with increased hepatotoxicity."
Of note, the FDA has approved two prescription brands of niacin, one a sustained release (Niaspan®;
Kos Pharmaceuticals, Miami, FL) and the other an immediate release (Niacor®; Uspher-Smith,
Minneapolis, MN), but as the authors point out, these two drugs are considerably more expensive than
the over-the-counter alternatives.
For people wishing to try niacin for lipid lowering, the authors recommend immediate-release over-the-
counter niacin brands such as those made by Rugby Laboratories (Westbury, NY), since many of these
contain the full amount of nicotinic acid and immediate-release niacin is the only form of the agent
shown to prevent cardiovascular disease and death in clinical trials. As well, Meyers et al advocate
baseline laboratory tests for fasting glucose, liver aminotransferase levels, and uric acid in all
patients before niacin therapy begins, repeated six to eight weeks later and after any dose
increases.
