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Epanova (Omthera Pharma) successes in EVOLVE and ESPIRIT trials for Dyslipidaemia

Read time: 1 mins
Last updated: 6th Nov 2012
Published: 6th Nov 2012
Source: Pharmawand

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.

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