DALLAS, TEXAS. Patients with type 2 diabetes have a 2- to 4-fold excess risk of developing cardiovascular disease. The main reason for this is that their mechanism for suppressing fatty acid release from adipose (fat) tissue after food intake is impaired. This leads to high blood levels of triglycerides and low-density lipoprotein (LDL) cholesterol and low levels of beneficial high-density lipoprotein (HDL) cholesterol. All of these changes are highly detrimental and increase the risk of atherosclerosis. It has long been known that niacin (vitamin-B3) increases HDL cholesterol and decreases LDL cholesterol and triglycerides. However, taking crystalline niacin causes highly uncomfortable flushing and time-release formulations have been associated with liver toxicity. There has also been concern that niacin might increase fasting blood glucose levels.
Members of the Diabetes Multicenter Research Group have just released the results of a major clinical trial designed to test the efficacy and safety of a new extended-release (ER) niacin (Niaspan by Kos Pharmaceuticals, Miami, FL). The double-blind, placebo-controlled trial was carried out in 19 American hospitals and clinics and involved 148 patients with type 2 diabetes. The patients were randomized to receive a placebo, 1000 mg/day of Niaspan or 1500 mg/day of Niaspan for 16 weeks.
At the end of the 16 weeks the HDL cholesterol levels in the 1000 mg/day group had increased by about 16
per cent and the HDL level in the 1500 mg/day group had increased by 23 per cent. At the same time
triglyceride levels in the 1000 mg/day group and the 1500 mg/day group had decreased by about 17 per
cent (not statistically significant) and 32 per cent (statistically significant) respectively. The level of LDL
cholesterol increased slightly in both the placebo and 1000 mg/day groups, but decreased by 7 per cent in
the 1500 mg/day group. The niacin regimens were well tolerated, had no significant adverse effects, and did
not affect glucose control significantly. The researchers conclude that low doses (1000 – 1500 mg/day) of
ER niacin are effective and safe for the management of dyslipidemia (abnormally high fat levels in the blood
stream) associated with type 2 diabetes. NOTE: This study was partially funded by Kos