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March 5, 2012
Essentialis reported results from a phase IIb trial of DCCR for the treatment of very high triglyceride (TG) levels. This double-blind, placebo-controlled study enrolled subjects into two sub-groups: Sub-group A received DCCR 290 mg or placebo in combination with atorvastatin (Lipitor) 20 mg for 18 weeks. Sub-group B received DCCR 290 mg or placebo for 12 weeks, followed by co-administration of fenofibrate (Trilipix) 135 mg for another six weeks. Results in sub-group A: when combined with statin, DCCR resulted in placebo-adjusted median reductions in TG of 28%, in VLDL-C of 51%, in non-HDL-C of 16%, and an increase in HDL-C of 11% after 18 weeks of treatment. In statin treated subjects, there was no change in mean LDL-C; however, all statin-treated subjects with LDL-C > 100 mg/dL at baseline who received DCCR showed improvements in LDL-C. Results in sub-group B: when combined with fenofibrate, DCCR resulted in median reductions in TG of 78%, in non-HDL-C of 34%, and an increase in HDL-C of 38%. DCCR was additive to fenofibrate for all lipid fractions except LDL-C. The increase in LDL-C was lower in fenofibrate + DCCR (42%) than in fenofibrate + placebo (57%).
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.