The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

October 28, 1999

Specific Treatments:

Treatment for increasing HDL cholesterol ("good cholesterol") in patients with dyslipidemia

Therapeutic Areas

General Information

Niaspan is one of only two products in the United States approved for increasing HDL levels. Low HDL cholesterol levels have been shown to be of the highest risk factors contributing to coronary heart disease(CHD) and other dangerous cardiac conditions.
Possible causes of low HDL cholesterol include:

  • Obesity
  • Low total, high polyunsaturated fat diet
  • Cigarette smoking
  • Thiazide diuretics
  • Some beta-blockers
  • Probucol
  • Anabolic steroids
  • Liver or kidney failure
  • Hyperthyroidism
  • Some forms of diabetes
  • Acute inflammation/injury/stress
  • Genetic defects in proteins which influence serum HDL concentrations.

    Most drugs for treating cholesterol problems are designed to reduce LDL ("bad cholesterol") levels. Niaspan's active ingredient, niacin, on the other hand, is most effective in elevating HDL ("good cholesterol") levels. This increase in HDL has been shown to significantly reduce chances of CHD.

    Niaspan's Once-At-Night dosing minimizes side effects, such as flushing and liver enzyme elevations, associated with older niacin preparations.
    In addition to increasing HDL cholesterol, Niaspan also lowers LDL cholesterol, triglycerides, and lipoprotein.

Clinical Results

In clinical studies, Niaspan increased HDL levels by 14% to 32%. (at doses of 1,000 mg to 2,000 mg per day). Furthermore, a seven-year study published in "The New England Journal of Medicine," indicated that a mere 6% increase in HDL cholesterol yielded greater than 20% reductions in cardiac events and stroke among 2,500 CHD patients whose only lipid abnormality at baseline was low HDL cholesterol.
Kos Pharmaceuticals reports that studies showed that changes in lipid concentrations (efficacy) are greater for women than for men.

Side Effects

The most common side effect of Niaspan is flushing, which is characterized by redness, tingling, or itching that typically occurs on the face, neck, chest, and back. In most cases, the flushing sensation lasts for one hour, approximately two to four hours after taking the dose. To minimize flushing, avoid drinking alcohol or hot drinks close to taking the dose, and avoid taking Niaspan with spicy foods.
Other less frequent side effects include upset stomach and rash.

Do NOT take Niaspan if:

  • You have active liver disease
  • You have peptic ulcer disease
  • You have arterial bleeding
  • You are allergic to any of the ingredients of the drug

Use with caution if you consume substantial amounts of alcohol, or if you have a past history of liver or kidney disease.

Mechanism of Action

Niacin, the main ingredient of Niaspan, raises the high-density lipoprotein (HDL) fraction of cholesterol. HDL carries cholesterol out of your circulation.

Literature References

Lipoprotein metabolism
Havel RJ and Kand JP (1989) "Structure and function of plasma lipoproteins" In: "The metabolic basis of inherited disease" (6th Edition). {Scriver CR, Beaudet Al, Sly WS, Valle D eds} New York: McGraw-Hilll pp 1129-38.
Structure and function HDL
Eisenberg S (1984) "High density lipoprotein metabolism". J Lipid Res 25:1017-58
Structure, function and metabolism of HDL
Carlson LA (ed). (1990) "Disorders of HDL" Smith-Gordon Publishers, London

Additional Information

To learn more about Niaspan, visit the Kos Pharmaceuticals web site:

For more information about HDL cholesterol, visit: