Advicor (
lovastatin and extended-release
niacin) is the first
cholesterol-lowering combination product to become available for the management of
hyperlipidemia.
Lovastatin significantly lowers
low-density lipoprotein cholesterol, whereas
niacin significantly lowers
triglycerides and
lipoprotein (a) and markedly increases
high-density lipoprotein cholesterol. These effects are ideal for managing a variety of
lipid disorders, including
metabolic syndrome.
Lovastatin and
niacin reduce
coronary heart disease mortality in primary and
secondary prevention patients, respectively. The extended-release
niacin component uses a unique technology to minimize adverse effects (e.g.,
flushing and hepatotoxicity) while retaining the same
lipid-altering effects as immediate-release
niacin. The combination product appears to be well tolerated, with discontinuation due to adverse effects other than
flushing occurring in a similar percent of patients as for
lovastatin in clinical trials. Approximately 9% of patients discontinued the combination product due to flush. No confined cases of
myopathy or hepatotoxicity have been reported with this product. Once-daily dosing provides ease of administration that should improve compliance and result in a greater proportion of patients meeting their
low-density lipoprotein cholesterol goals. The nomenclature surrounding
niacin products used to treat
dyslipidemias is confusing. While only two types of
niacin formulations exist (immediate-release formulations and formulations which dissolve more slowly than immediate-release formulations), government regulations allow for slowly dissolved
niacin formulations to be divided into two types of
niacin products; those that are available over-the-counter (OTC) and those that are available by prescription only. Over-the-counter slowly dissolved
niacin preparations are not classified as OTC per se, but are considered "nutritional supplements". For this reason, they fall under the jurisdiction of the Federal Trade Commission and do not fall under the umbrella of the FDA branch that controls dyslipidemic products (Endocrine and Metabolic Division of the Center for
Drug Evaluation and Research). The slowly dissolved
niacin nutritional supplements have not been reviewed by the FDA for safety nor efficacy in the treatment of
dyslipidemia nor are they required to meet
generic drug rules (even though various brands are available). These brands are described on their labels as "sustained-release", "timed-release", and "slow-release" for example. Only two slowly absorbed
niacin products have been approved by the FDA for the treatment of
dyslipidemia; they are Niaspan (Kos
Pharmaceuticals, Inc., Miami, FL) and
Advicor (Kos
Pharmaceuticals, Inc., Miami, FL). The term "extended-release" has been given to these two products to simplify the terminology and differentiate the products from immediate-release
niacin. In this review, we will use "extended-release" to refer to the FDA approved slowly dissolving
niacin preparation and "sustained-release" to refer to the nutritional supplements (not FDA approved).