Background:
@EN Hyperlipidemia is commonly associated with non-insulin dependent diabetes mellitus (NIDDM) and acts as a predisposing factor to the development of cardiovascular complications in NIDDM patients, Elevated plasma level of non-esterified free
fatty
acids is associated with hyperlipidemia and insulin resistance. Thus, inhibition of lipolysis is an important componet in the pharmacological management of hyperlipidemia in NIDDM patients. A long-acting nocotinic acid derivative, acipimox is
known
to
have advantage over nicotinic acid in decreased occurrence of adverse effects and improved glycemic control with preserving the effect of nicotinic acid on hyperlipidemia. However, there are still controversies on the effects of acipimox on
hyperlipidemia in NIDDM patients. In this placebo controlled, double-blind study, we investigatd the therapeutic effects of acipimox in management of hyperlipidemia and hyperglycemia in Korean NIDDM patients.
@ES Methods:
@EN Twenty-four NIDDM patients were randomized to treatment with either placebo or acipimox (250㎎ three times daily) for 12 weeks and 18 patients completed the study. We measured total cholesterol, triglyceride, HDL-cholesterol, apolipoprotein
A1,
apolipoprotein B, fasting plasma glucose, and HbA1c concentrations before study, at 4 weeks and at 12 weeks after treatment to assess the effect of acipimox. We also evaluated the development of adverse effects.
@ES Results:
@EN In acipimox-treated group, mean triglyceride concentrations after 12 weeks of treatment decreased significantly (4.11±0.47 mmol/L before treatment vs. 2.91±0.52mmol/L after 12 weeks of treatment of acipimox: p<0.005). In comparison, mean
triglyceride concentrations in placebo-treated group were not changed during the same period (3.33±0.50mmol/L vs. 3.50±0.55mmol/L). Total cholesterol, HDL-cholesterol, apolipoproten A1, apolipoprotein B, fasting plasma glucose and HbA1c
concentrations
were not significantly changed with administration of acipimox. Gastrointestinal distrubances occurred in 2 patients of placebo-treated group and in 2 patients of acipimox-treated group, and headache occurred in 1 patients of placebo-treated
group
and
in 2 patients of acipimox-treated group. Two patients with placebo treatment and 3 patients with acipimox treatment had to discontinue their medication because of these adverse effects. The type and the incidence of adverse effects and the
percentage of
the patients who had to discontinue their medication because of adverse effects were not significantly differences between placebo-treated group and acipimox-treated group.
@ES Conclusion:
@EN With 12 weeks' treatment of acipimox, triglyceride concentrations decreased significantly in NIDDM patients with hyperlipidemia and there were neither significant adverse effects nor aggravation of hyperglycemia.
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