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Two Doses of AMR101 Significantly Reduce Trigylceride Levels

Tim Casey

January 2012

Orlando—A phase 3, randomized, double-blind, placebo-controlled trial found that patients with high triglyceride levels who took 4 or 2 g/day of AMR101 had a significant reduction in median placebo-adjusted triglyceride levels from baseline until the 12-week study ended. Low-density lipoprotein cholesterol (LDL-C) levels in the 4-g/day group were significantly reduced, while LDL-C levels in the 2-g/day group increased, but not significantly. Christie M. Ballantyne, MD, the study’s lead author and a professor at Baylor College of Medicine in Houston, Texas, presented the results in an oral abstract session at the AHA meeting. AMR101, an omega-3 agent that contains ≥96% pure icosapent ethyl, is in development to treat patients with high or very high tryglycerides. The ANCHOR (Evaluation of the Effect of Two Doses of AMR101 on Fasting Serum Triglyceride Levels in Patients with Persistent High Triglyceride Levels Despite Statin Therapy) study included 702 patients who enrolled at 97 sites in the United States. Dr. Ballantyne said that the increasing prevalence of obesity and diabetes has led to a growing number of people who have elevated triglyceride levels. US Food and Drug Administration–approved omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid) have been shown to decrease triglyceride levels, but they also may increase LDL-C levels in people who have high triglyceride levels, he noted. The study included patients >18 years of age who had coronary heart disease (CHD) or CHD-equivalent and were on optimized stable statin therapy (atorvastatin, rosuvastatin, or simvastatin) for ≥4 weeks. They had triglyceride levels between 200 and 500 mg/dL and LDL-C levels between 40 and 100 mg/dL. Exclusion criteria included a body mass index (BMI) >45 kg/m2, weight change >3 kg during the lead-in period, non–high-density lipoprotein cholesterol (non–HDL-C) levels <100 mg/dL, and hemoglobin A1c (HbA1c) >9.5%. Patients were prohibited from taking weight-loss agents, HIV protease inhibitors, isotretinoin, and systemic corticosteroids. After a 6- to 8-week screening period, patients were randomized to receive 4 g/day of AMR101 (n=233), 2 g/day of AMR101 (n=236), or placebo (n=233). The mean age of the patients was 61 years, approximately 96% were white, and approximately 61% were males. The mean BMI was approximately 33, and approximately 73% of the patients had diabetes. “This is reflective of a population that has emerged in the United States and has been copied throughout the world—very overweight individuals who have high triglycerides and either diabetes or insulin resistance and many who have CHD,” Dr. Ballantyne said. After 12 weeks, patients who took 4 g/day of AMR101 had a 21.5% median placebo-adjusted reduction in triglyceride levels (P<.0001); patients in the 2-g/day group had a 10.1% reduction (P=.005). There were also significant reductions in non–HDL-C levels in both groups. Dr. Ballantyne noted that there were larger reductions in certain subgroups, including those who had higher statin efficacy regimens and those who had higher triglyceride levels at baseline. He added that the reductions were similar regardless of the type of diabetes or the type of statin the patients used. Adverse events were similar between the groups, with most considered mild to moderate and unrelated to AMR101. Of the total study cohort, 25 discontinued the study because of adverse events, including 5 who took 4 g/day, 8 who took 2 g/day, and 12 who received the placebo. One patient in the placebo group died of a myocardial infarction. Dr. Ballantyne said patients who took either of the AMR101 doses did not have significant changes in fasting blood glucose, HbA1c, vital signs, electrocardiograms, or liver or kidney function. “In general, omega-3’s have been extremely well-tolerated agents and very safe in numerous studies for many, many years,” Dr. Ballantyne said.

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