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Cardiology

Reliant submits data supporting use of Omacor with statin to lower high triglycerides

Published in Medical Letter on the CDC and FDA, January 28th, 2007

Reliant Pharmaceuticals announced a submission to the U.S. Food and Drug Administration (FDA) to seek approval for the expanded use of Omacor (omega-3-acid ethyl esters) as an adjunct to diet and statin therapy in adults whose triglyceride levels are high.

As part of this filing, Reliant submitted new data from the recently completed Combination of Omacor and Simvastatin (COMBOS) trial that evaluated the efficacy and safety of Omacor as an adjunct to diet and simvastatin therapy for the treatment of high triglycerides. COMBOS is a randomized, double-blind, placebo-controlled, parallel-group study including 254 patients.

Omacor is the first and only...

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