Re: Farmas USA
Amarin Announces Publication of Case Study Results Describing Reductions in Multiple Lipid Parameters for Individual Hyperlipidemic Patients Switched to Vascepa(R)
The publication, titled, "A Retrospective Case Series of the Lipid Effects of Switching from Omega-3 Fatty Acid Ethyl Esters to Icosapent Ethyl in Hyperlipidemic Patients," was authored by Richard S. Castaldo, MD, is now available electronically through Postgraduate Medicine (available at: https://postgradmed.org/doi/10.3810/pgm.2014.05.2775) and is scheduled for print publication in the May 2014 issue. Dr. Castaldo conducted a retrospective chart review at 4 medical practice locations in Western New York of 14 treated patients who were initially diagnosed with high TG levels, or hyperlipidemia, and whose lipid parameters were measured two or more months after being switched to 4 g/day EPA-only Vascepa from 4 g/day Lovaza. The patients ranged from 45 to 79 years of age and were on their same prescription lipid-lowering background medication at the same dose throughout the studied period, with 10 patients on a statin, and 4 patients on a cholesterol absorption inhibitor. After being switched from Lovaza to Vascepa, 12 patients experienced a decrease in TG and LDL-C levels and 13 patients experienced a decrease in TC and non-HDL-C levels. Changes in high-density lipoprotein cholesterol (HDL-C) levels were also assessed, but the results were mixed, with no change in 1 patient, decreases in 9 patients, and increases in 4 patients. Dr. Castaldo's chart review also found Vascepa to be well tolerated with a safety profile consistent with that referenced in the U.S. Food and Drug Administration (FDA) approved label for Vascepa.
"We have heard many anecdotal reports of the success physicians have had with Vascepa since its launch last year," said Steven B. Ketchum, Ph.D., President of Research and Development of Amarin. "The results published by Dr. Castaldo provide important hypothesis generating evidence of the potential benefit of treating patients with EPA-only Vascepa that requires additional study for substantiation. These real-world results are exciting and encouraging when considered alongside the findings of the pivotal Phase 3 studies conducted with Vascepa, which demonstrated that EPA-only Vascepa reduced TG levels without increasing levels of bad cholesterol, LDL-C, in patients with high and very high triglyceride levels."
AMRN
