Extended-release niacin (Niaspan), administered in relatively low doses—1,000 or 1,500 mg per day—for lipid therapy is a treatment option for type 2s who exhibit the typical diabetic lipid profile of high triglycerides, small dense LDL (“bad”) cholesterol, high free-fatty-acid levels and low HDL (“good”) cholesterol.
Kos Pharmaceuticals, the maker of Niaspan, sponsored a double-blinded, multicenter study in which 148 participants were randomly assigned to receive a placebo or Niaspan (1,000 or 1,500 mg per day) over 16 weeks.
The researchers found that HDL cholesterol was beneficially raised 19 percent at the 1,000 mg dose and 24 percent at the 1,500 mg dose in the Niaspan-treated groups. Triglyceride levels were reduced 13 and 28 percent at the 1,000 and 1,500 mg doses of Niaspan, respectively.
Four patients discontinued participation because of inadequate blood-glucose control, and four patients discontinued because of flushing side effects (including one who was receiving a placebo). The researchers noted in the article that the use of Niaspan in people with diabetes has been discouraged “because high doses can worsen glycemic control.”
—Archives of Internal Medicine, July 22, 2002
Clinical adviser’s note: Unlike the over-the-counter versions of niacin, which are not subjected to clinical trials for safety and efficacy for use as a cholesterol therapy, the Niaspan used in this study has been approved by the U.S. Food and Drug Administration for use in cholesterol therapy and is available by prescription only.
It is important to remember that when people with diabetes are treated with niacin for cholesterol disorders, they may need changes in their diabetes therapy to maintain control of blood-glucose levels. Because niacin is a powerful treatment for raising HDL levels that are too low, its use may be indicated despite challenges to glucose control.