ENDUR-ACIN® lowers total and LDL-cholesterol in patients with hyperlipidemia, study shows
Highlights
- ENDUR-ACIN® treatment (1,500-2,000 mg/day) significantly reduces total and LDL-cholesterol in people with high blood cholesterol (>225 mg/dl).
- Low dropout rate or 4.5% (4/89), primarily due to skin flushing or gastrointestinal upset.
- ENDUR-ACIN® is a well tolerated treatment for high blood cholesterol with high patient compliance.
Summary
This randomized, double-blind, placebo controlled, crossover trial is a collaborative effort between researchers at the University of Minnesota, Minneapolis, and the National Research Centre for Preventive Medicine, Moscow, Russia.
For this study, researchers recruited participants from a volunteer sample of 135 patients, aged 20 to 70 years, with high blood cholesterol (>225 mg/dl), from an academic cardiology center in Moscow. The volunteers were asked to follow diet therapy alone (American Heart Association Step I Diet) for 8 weeks and those (89 men and women) who did not reduce total cholesterol below 225 mg/dl after 8 weeks were enrolled in the study.
Participants were given one of two treatments for 2 months in random order: ENDUR-ACIN® (1,500 mg/day) or a placebo, followed by an uncontrolled 2-month period during which all participants took higher dose ENDUR-ACIN® (2,000 mg/day). Participants continued to follow the Step 1 Diet for the duration of the study.
Results indicate that, compared to baseline, significant improvements in total cholesterol and LDL-cholesterol were reported after the initial diet intervention and after ENDUR-ACIN® treatment (see Table 1). Triglycerides, HDL-cholesterol, and lipoprotein(a) levels also improved. No significant changes in lipid variables occurred during the placebo period.
Table 1. Reduction in Total and LDL-Cholesterol after Treatment |
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Intervention |
TC |
LDL-C |
P-value |
After initial diet (8 wk) |
6% |
6% |
P<.001 |
After 1500 mg/d ENDUR-ACIN® (8 wk) |
14% |
18% |
P<.001 |
After 2000 mg/d ENDUR-ACIN® (8 wk) |
16% |
21% |
P<.001 |
TC indicates total serum cholesterol; LDL-C, low-density lipoprotein cholesterol. |
ENDUR-ACIN® treatment was well tolerated with no serious adverse effects were reported. Only 4.5% (4/89) of the participants withdrew from the study because of intolerance to ENDUR-ACIN®, primarily related to skin flushing or gastrointestinal upset. These findings indicate that ENDUR-ACIN® is an effective treatment for hypercholesterolemia that is well tolerated by patients.