ENDUR-ACIN® treatment is especially beneficial in older patients with dyslipidemia, study shows

Summary

This randomized, double-blind, placebo-controlled trial was designed to investigate the efficacy and tolerance of several dosages of ENDUR-ACIN® wax matrix niacin and differences in younger versus older patients with dyslipidemia.

For this study, researchers recruited patients between the ages of 20 and 70 years who had documented high blood cholesterol (75^th and 95^th percentile for age and sex by Lipid Clinics Research Clinics Standards). The intention was to recruit subjects with polygenic rather than familial hypercholesterolemia. Exclusion criteria included fasting triglyceride level above 400 mg/dl, fasting blood glucose above 140 mg/dl, hyperuricemia, history of gout, liver disease or peptic ulcer, drug or alcohol abuse, or concurrent use of drugs known to affect lipid levels.

A total of 201 participants were enrolled in the study with 158 (79%) completers. Of the 43 dropouts, most cited scheduling or other issues unrelated to treatment. Only 3.4% (4/117) of participants in the niacin-treatment groups dropped out.

After a minimum of 6 weeks of diet therapy (American Heart Association Step 1 Diet), participants were randomly assigned to one of seven treatment groups (stratified by age, sex and LDL cholesterol) for 8 weeks: diet alone, placebo (2 groups) and ENDUR-ACIN® (4 groups). Diet therapy continued for the duration of the study. For this post-hoc analysis, the placebo groups were combined and the ENDUR-ACIN® treatment groups were consolidated into one high-dose (up to 1,500-2,000 mg/day) and one low-dose (up to 1,000-1,250 mg/day) groups.

Older participants (50-70 years) achieved significant (P<.01) improvements in total cholesterol (-22%), LDL cholesterol (-29%), HDL cholesterol (+8%), and triglyceride levels (-21%), and total-to-HDL cholesterol ratio (-25%) after the 8-week therapy compared to placebo, diet alone or low-dose ENDUR-ACIN®.

Younger participants (less than 50 years) achieved significant (P<.05) improvements in total cholesterol (-11%), LDL cholesterol (-16%), HDL cholesterol (+7%), and total-to-HDL cholesterol ratio (-14%) after the 8-week therapy compared to placebo, diet alone or low-dose ENDUR-ACIN®.

In the high-dose ENDUR-ACIN® groups, older participants had significantly greater improvements in total and LDL cholesterol, and triglyceride levels and total-to-HDL cholesterol ratio compared to younger participants. HDL cholesterol increases were not significantly different between age groups.

These finding indicate that ENDUR-ACIN® treatment (up to 1,500-2,000 mg/day) for 8 weeks is well tolerated and especially effective for the treatment of dyslipidemia in older patients.