The ANCHOR trial ran at 97 U.S. sites, and enrolled patients who were, on average, 61 years old, 61% of whom were men. Their average body mass index was 33 kg/m2 and 73% had diabetes. Some 63% were on a "medium" efficacy statin regimen, 30% were on a "high" efficacy regimen, and 7% were on a "low" efficacy statin regimen. The study’s primary end point was the change in triglyceride level, compared with placebo treatment, and the secondary end points included the change in LDL cholesterol, compared with placebo.
The 4-g/day dosage produced an average placebo-corrected 21.5% reduction in triglyceride level, an average 6.2% cut in LDL cholesterol, an average 13.6% decrease in non-HDL cholesterol, and an average 4.9% reduction in HDL cholesterol, all statistically significant changes. The 2-g/day dosage produced smaller placebo-corrected reductions, including a 10.1% cut in triglycerides that was statistically significant, and a nonsignificant 3.6% decrease in LDL cholesterol. The results also showed that triglyceride reductions were larger in patients who started with higher triglyceride levels at baseline, and in patients on higher-efficacy statin regimens, Dr. Ballantyne reported.
Both EPA dosages tested were well tolerated, with adverse effects that were mild to moderate and most appearing to be unrelated to the study medication. "In general, omega-3 fatty acids have been very well tolerated and very safe in numerous studies over many years," Dr. Ballantyne said. "GI tolerability was quite good, but the taste issue remains," he said.
Dr. Ballantyne said that he currently prescribes EPA to some of his patients. He prefers to prescribe Lovaza (a brand-name, prescription-only formulation of omega-3 fatty acid ethyl esters that contains both EPA and docosahexaenoic acid) because it is a "high quality agent," he said in an interview. "If a patient cannot afford that, we give them tips on how to purchase high-quality supplement" formulations of omega-3 fatty acids, he added.
ANCHOR was sponsored by Amarin, the company developing AMR101. Dr. Ballantyne said that he has been a consultant for Amarin and has consulted for, received honoraria from, and/or been a speaker for numerous other pharmaceutical companies. Dr. Brinton said that he has been a consultant to Amarin and has also consulted for and/or been a speaker for several other firms.