VASCEPA Also Significantly Improved Multiple Lipid Parameters by Reducing VLDL-C, Non-HDL-C, APO B, and TC in Statin-Treated Patients as Compared to Placebo1
Median Percent Change in Other Lipid Biomarkers Compared to Placebo1
- VASCEPA significantly reduced TG, VLDL-C, non-HDL-C, Apo B, TC, and HDL-C levels from baseline relative to placebo
- The reduction in TG observed with VASCEPA was not associated with elevations in LDL-C relative to placebo
VASCEPA Was Studied In Patients With Persistent High TG Levels (200 mg/dL-499 mg/dL) Already on Statin Therapy1
ANCHOR Study Design1
Objectives and Methodology1
The ANCHOR Study was conducted to determine the efficacy and safety of VASCEPA therapy in lowering TG levels in statin-treated patients at high cardiovascular risk with well-controlled LDL-C and residually high TG levels.
ANCHOR was a randomized, placebo-controlled, double-blind, parallel-group, 12-week, phase 3 study. The study was conducted at 97 sites in the United States from December 2009 through February 2011.
Patients were eligible to enter the 12-week, double-blind period provided that they:
- Were older than 18 years
- Had qualifying TG levels
- Had been on ≥4 weeks of stable statin therapy at LDL-C goal for high-risk patients (LDL-C ≥40 and <100 mg/dL)
- Agreed to maintain a stable diet and exercise throughout the study
Patients were randomized to receive VASCEPA or placebo in addition to ongoing statin therapy.
ANCHOR Baseline Patient Characteristics1
|4 g/d (n=233)||(n=233)|
|≥65 y, %||39||37|
|Diabetes mellitus, %||73||73|
|Fasting plasma glucose, mg/dL*||133||130.1|
|Statin use, %|
|Statin efficacy regimens, %†|
†Lower-efficacy statin regimens: simvastatin 5 to 10 mg; medium-efficacy statin regimens: rosuvastatin 5 to 10 mg, atorvastatin 10 to 20 mg, simvastatin 20 to 40, simvastatin 10 to 20 mg plus ezetimibe 5 to 10 mg; higher-efficacy statin regimens: rosuvastatin 20 to 40 mg, atorvastatin 40 to 80 mg, simvastatin 80 mg, simvastatin 40 to 80 mg plus ezetimibe 5 to 10 mg.
The primary endpoint in the ANCHOR Study was the median percent change in TG levels from baseline to Week 12 (study end) in the active treatment group (receiving 4 g/d) compared to placebo.
Primary endpointMedian percent chance in TG levels from baseline to Week 12 as compared to placebo.
Secondary endpoints included:Median percent change in non-HDL-C, LDL-C, Apo B, and VLDL-C from baseline to Week 12 as compared to placebo.
Exploratory endpoints included:Median percent change in TC and HDL-C from baseline to Week 12 as compared to placebo.
- VASCEPA is not FDA-approved for the treatment of statin-treated patients with mixed dyslipidemia and high (≥200 mg/dL and <500 mg/dL) TG levels due to current uncertainty regarding the benefit, if any, of drug induced changes in lipid/lipoprotein parameters beyond statin lowered LDL-C on cardiovascular risk among statin-treated patients with residually high TG. No prospective study has been conducted to test and support what, if any, benefit exists.
- Recent cardiovascular outcomes trials (ACCORD Lipid, AIM-HIGH, and HPS2-THRIVE), while not designed to test the effect of lowering TG levels in patients with high TG levels after statin therapy, each failed to demonstrate incremental cardiovascular benefit of adding a second lipid-altering drug (fenofibrate or formulations of niacin), despite raising HDL-C and reducing TG levels, among statin-treated patients with well-controlled LDL-C.