Extended-release niacin, alone o r combined with a statin
agent, significantly improved dyslipidemia in patients with type II
diabetes with only minimal impact on blood glucose control, according
to an article in the July 21st issue of the Archives of Internal Medicine.
The study, the largest of its kind conducted with niacin, highlights
the therapeutic utility of extended-release preparations in managing
lipid abnormalities in this patient population with an extremely high
cardiovascular risk.
The Assessment of Diabetes Control and Evaluation of the Efficacy
of Niaspan Trial (ADVENT), involved 146 patients: During the 16-week
trial, 49 patients were randomized to placebo, whereas 45 received
1000 mg niacin daily and 52 received 1,500 mg niacin daily. Of the
total, 69 patients (47 percent) were also receiving a statin agent,
usually atorvastatin.
In dose-dependent manner, niacin increased high-density lipoprotein
cholesterol by as much as 24 percent and reduced levels of triglycerides
by as much as 36 percent compared with placebo.
These improvements were achieved with minimal impact on glucose
control as measured by fasting blood glucose and hemoglobin A1c:
There was no significant difference in fasting glucose among the
three patient groups. There was no significant difference between
the lower-dose niacin group and the placebo group in levels of hemoglobin
A1c, and the increase in hemoglobin A1c level for the higher-dose
niacin group was only 0.03 percent at 16 weeks, which just reach
statistical significance.
Rates of adverse effects were the same among all groups except
for flushing, which was more common in niacin patients. No patient
experienced elevated liver enzymes greater than three times the
upper limit of the reference range. There were no reports of drug-induced
myopathy, even among patients also taking a statin drug.
"Approximately 97% of people with diabetes have at least one
lipid abnormality, therefore effective dyslipidemia treatment is
an important consideration for diabetic patients, who are at great
risk of heart disease," said Scott M. Grundy, M.D., Ph.D.,
principal investigator of the study. "The ADVENT study is significant
for people with diabetic dyslipidemia because we now know that low
doses of niacin can effectively
treat lipid abnormalities in these patients."