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September 2, 2013
Acasti Pharma reported results of a phase II, randomized, open-label, dose-ranging, multicenter trial of CaPre in 230 subjects for the treatment of mild to severe hypertriglyceridemia, 88% with mild to moderate baseline triglycerides between 200mg/dL and 500mg/dL (2.28mmol/L to 5.7mmol/L). Patients treated with 4g of CaPre for four weeks reached a mean triglyceride decrease of 15.5% from baseline and an absolute mean improvement of 18.1% as compared to Standard of Care (SoC). Results also showed increased benefits after eight weeks of treatment, with patients on a daily dose of 4g of CaPre registering a mean triglyceride decrease of 21.6% and an absolute mean improvement of 14.3% as compared to SoC. After eight weeks of treatment, patients under a daily dose of 4g of CaPre had a mean LDL decrease of 8.3% and non-HDL decrease of 14.3%, while lower doses did not show deleterious effect on LDL or non-HDL. Moreover there was, after a fourweek treatment, a statistically significant HDL increase of 11.1% between the SoC and the 4.0g CaPre treatment groups.
December 6, 2010
Amarin released positive results from a phase III trial of AMR101 for the treatment of very high triglycerides This international, placebo-controlled, randomized, double-blind, study, dubbed MARINE, enrolled 229 subjects with fasting triglyceride levels of greater than 500 mg/dL. Following a six-to-eight week washout period, the subjects were randomized to AMR101 (2 or 4 grams) or placebo for 12 weeks. The primary endpoint was the percentage change in triglyceride (TG) level from baseline to week 12. Statistical significance was reached in both AMR101 treatment arms. The arm treated with 4 grams of AMR101 showed a significant median TG decrease of 33% (P<0.0001) compared to placebo, and the arm treated with 2 grams showed a significant median TG decrease of 20% (P≡0.0051) compared to placebo. AMR101 did not result in an increase in median LDL-C compared to placebo at either dose. In addition, there were statistically significant reductions in several lipid markers, including Apo B, Lp-PLA2, VLDL-C and Total Cholesterol. AMR101 appeared to be well tolerated.