ENDUR-ACIN® improves total and HDL-cholesterol in patients with coronary artery disease, study shows
Highlights
- ENDUR-ACIN® improves blood cholesterol in hyperlipidemic patients with coronary artery disease
- 13% reduction in total cholesterol, on average
- 31% increase in HDL cholesterol, on average
- Well tolerated with only 4% dropout rate (4/101)
Summary
This open label study was designed to assess the effect of nicotinic acid in either immediate-release (IR) or extended-release (ENDUR-ACIN®) forms on total and HDL-cholesterol levels in patients with heart disease.
For this study, researchers followed 101 patients (86 men and 15 women), ranging in age from 36 to 73 years, with coronary artery disease and a total:HDL-cholesterol ratio greater than 4.0. Only patients with liver disease, peptic ulcer disease or poorly controlled diabetes were excluded.
Depending on the time of study entry, patients received either immediate-release niacin (100 mg/day) or ENDUR-ACIN® (250 mg/day, twice daily) with a gradual increase as tolerated over 4 to 8 weeks to 1 g, twice daily. Four patients received higher dosages (no more than 2 g, twice daily). Blood cholesterol measured at 6 weeks and every 3 to 6 months thereafter; blood chemistry (including liver enzymes) was measured at baseline and periodically thereafter. The mean dosage was 1,415+698 mg/day. The mean follow-up duration was 11+7 months.
Results indicate that niacin treatment resulted in significant (P<.05) improvement in total cholesterol, HDL-cholesterol and total:HDL-cholesterol ratio (see Table).
|
Effect of Niacin Treatment on Total and HDL-Cholesterol |
|||
|
Parameter |
Total Group (n=101) |
>1000mg/d (n=39) |
>1000mg/d (n=62) |
|
Total Cholesterol |
13% decrease |
5% decrease |
18% decrease |
|
HDL-cholesterol |
31% increase |
29% increase |
32% increase |
|
Total:HDL-cholesterol Ratio |
32% decrease |
24% decrease |
36% decrease |
Only 4% (4/102) of patients required discontinuation of niacin due to side effects. A total of 38% (38/101) reported side effects from niacin therapy, primarily flushing and related symptoms (i.e., itching, tingling, rash, and headache). Minor digestive upset was reported less frequently. Adding aspirin, switching to extended-release ENDUR-ACIN® or reducing dosage helped resolve or reduce these symptoms. Mild glucose intolerance or slight worsening of preexisting diabetes was reported in 25 patients (25%). Abnormal liver function tests were reported in 19 patients (19%), but responded to either dosage reduction or temporary suspension of niacin therapy with subsequent reinstitution.
These findings indicate that ENDUR-ACIN® is a well-tolerated, effective therapy for managing blood cholesterol in patients with coronary artery disease.
