Trilipix CV Outcomes Study To Focus On Patients With High Triglycerides, Low HDL-Cholesterol

FDA follows its advisory committee’s recommendation and requires a post-marketing study of Abbott’s fibrate to determine whether combination use with a statin provides a cardiovascular benefit over statin monotherapy in high-risk patients.

FDA’s requirement for a new cardiovascular outcomes study of Abbott Laboratories Inc.’s Trilipix (fenofibric acid) provides an opportunity to confirm benefit in one patient subgroup in the ACCORD-Lipid trial that showed positive results.

Abbott will conduct a randomized, double-blind, placebo-controlled trial evaluating the effect of Trilipix on the incidence of major CV events...

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