ENDUR-ACIN® is a safe and effective treatment for dyslipidemia, systematic review shows

Summary

This systematic review evaluated the safety and effectiveness of ENDUR-ACIN® wax matrix niacin in the treatment of dyslipidemia. For this review, the researchers performed an OVID-Medline literature search for prospective, placebo-controlled or cross-over studies or pharmacokinetic studies with ENDUR-ACIN® published in the English language literature.

Five published articles met the inclusion criteria, including two separate randomized clinical trials (Keenan, 1991; Aronov, 1996), one sequential extension study (Keenan, 1992a), one post-hoc analysis comparing younger versus older subjects (Keenan, 1992b), and one dissolution study (Poon, 2006).

Results indicate that ENDUR-ACIN® significantly improved blood lipids in a dose-dependent manner. At 1,500 mg/day, mean reductions were in the range of 10-13% for total cholesterol, 16%-20% for low-density lipoprotein (LDL) cholesterol, and 20% for the ratio of total to high-density lipoprotein (HDL) cholesterol. At a higher dosage of 2,000 mg/day, mean reductions were in the range of 16-19% for total cholesterol and 21-26% for LDL cholesterol. The average percent increase in HDL cholesterol was in the range of 6% and 7.2% at dosages of 1,500 mg/day and 2,000 mg/day, respectively. The average percent decrease in triglycerides was in the range of 9.3% and 17% at dosages of 1,500 mg/day and 2,000 mg/day, respectively.

Safety was evaluated based on liver function tests, uric acid and blood glucose levels. In the four clinical studies included in this review, no group mean serum levels for alkaline phosphatase (AP), aspartate aminotransferase (AST), or alanine aminotransferase (ALT) exceeded normal limits or had an increase greater than 1.6-fold. Abnormal laboratory results also did not occur more frequently in ENDUR-ACIN®-treated subjects than in controls in either of the two studies in which this was reported (Keenan, 1991; Keenan, 1992b). No significant change in uric acid from baseline was reported.

Fasting blood glucose rose in a dose-dependent manner with ENDUR-ACIN® treatment, with mean increases reaching statistical significance in two of the 2,000 mg/day groups and one of the 1,500 mg/day groups. In one study (Aronov, 1996), abnormal changes in fasting glucose levels were detected in 18 subjects after ENDUR-ACIN® treatment, which resolved 2 months after treatment cessation. Another study (Keenan, 1992a) reported a significant increase in fasting blood glucose after 6 weeks of ENDUR-ACIN® treatment, which self-resolved by the end of the 38-week trial.

These findings support the efficacy and safety of ENDUR-ACIN® (1,500-2,000 mg/day up to 38 weeks) for the treatment of dyslipidemia.