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September 23, 2013
Isis Pharmaceuticals reported results of a phase II trial of ISIS-APOCIIIRx as a monotherapy in patients with very high to severely high triglycerides. The double-blind, randomized, placebo-controlled, 13-week study enrolled 28 patients with triglyceride levels between 440mg/dL and 2,000mg/dL who received 100mg, 200mg or 300mg dose of ISIS-APOCIIIRx, or placebo via weekly subcutaneous injections. Patients had an average fasting triglyceride level of 602mg/dL with incoming triglyceride levels up to 1,822mg/dL. Patients treated with ISIS-APOCIIIRx achieved statistically significant mean reductions of up to 79% in apolipoprotein C-III (apoC-III) and up to 75% in triglycerides. In addition, patients treated with ISIS-APOCIIIRx achieved statistically significant mean increases of up to 57% in high-density lipoprotein cholesterol (HDL-C), the “good” cholesterol. Patients also achieved up to 89% mean reduction in apoCIII-associated very low-density lipoprotein (VLDL) particles. A phase III program is anticipated within the next year.
July 29, 2013
Isis Pharmaceuticals reported results from a phase II trial of ISIS-APOCIII for the treatment of patients with high to severely high triglycerides on stable doses of fibrates. The double-blind, randomized, placebo-controlled, 13-week study enrolled 26 patients who received either a 200mg or 300mg dose of ISIS-APOCIII, or placebo, via weekly subcutaneous injections. All patients were on stable doses of fibrates with average baseline levels of fasting triglycerides between 282mg/dL and 457mg/dL. Patients treated with ISISAPOCIII experienced reductions of up to 70% in apolipoprotein C-III (apoC-III) and up to 64% in triglycerides. In addition, patients treated with ISIS-APOCIII experienced an up to 52% increase in high-density lipoprotein cholesterol (HDL-C), the "good" cholesterol, and an up to 77% reduction in apoC-III-associated very low-density lipoprotein (VLDL) particles. Isis also is evaluating ISIS-APOCIII in this phase II study as a monotherapy in patients with severely high triglycerides.
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.