Epanova (Omthera Pharma) successes in EVOLVE and ESPIRIT trials for Dyslipidaemia
Omthera Pharmaceuticals, announced that Phase III results from its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) and ESPRIT (Epanova combined with a Statin in Patients with HypertrRglycerIdemia to Reduce Non-HDL CholesTerol) clinical trials for Epanova met all primary and secondary endpoints. Highlights: � Epanova significantly lowers triglycerides (TG) and reduces Non-HDL-C, widely believed to be the most accurate predictor of cardiovascular risk. � Epanova's 2 gram dosage is comparable in efficacy across the key lipid parameters to the 4 gram dose of other prescription Omega 3 products. � Upon approval, Epanova's 2 gram once-a-day dose will provide the lowest, most convenient dosing for patients and can be taken with or without meals, yielding better patient compliance. � Epanova was also studied at a 4 gram once-a-day dose, allowing patients to titrate to this higher dose for greater TG and Non-HDL-C lowering efficacy. In the ESPRIT trial in patients with TG between 200 � 500 mg/dL, the 4 gram dose of Epanova provided a 7% reduction in Non-HDL-C and a 21% reduction in TG, with a non-significant increase in LDLC of 1%. � Epanova's enhanced bioavailability produces substantially higher plasma levels of EPA and DHA, which may result in lower cardiovascular risk for patients. � Phase III results show that Epanova has a positive impact on other markers of cardiovascular risk, including ApoC-III and LpPLA2.