Given the increase in median TG levels in the placebo group from baseline to Week 12, Dr.Iffat Chowdhury requested that the applicant submit information about the composition of the placebo capsule used in the clinical study. The placebo was composed of light mineral oil or paraffin light liquid. Data submitted by the applicant support the assertion that light mineral oil does not increase serum TG levels. Dr. Chowdhury notes in her review that similar increases in TG levels were observed in the placebo groups from the Lovaza clinical trials of hypertriglyceridemic patients.
In the secondary efficacy analyses, the median percent changes in VLDL-C levels were 13.7% in placebo, 0.0% in Vascepa 2 grams daily (p=0.1 versus pla cebo), and -19.5% in Vascepa 4 grams daily (p=0.0005 versus placebo). The median percent changes in Lp-PLA2 levels were - 2.4% in placebo, -5.1% in Vascepa 2 grams daily (p=0.2 versus placebo), and -17.1% in Vascepa 4 grams daily (p=0.0006 versus placeb o). The median percent changes in Apo B levels were 4.3% in placebo, 2.1% in Vas cepa 2 grams daily (p=0.2 versus placebo), and - 3.8% in Vascepa 4 grams daily (p=0.002 versus placebo). Similar results were observed when Dr. Japo Choudhury used parametric statistica l tests to analyze the secondary efficacy variables.
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