Trilipix Advisory Committee Call For Outcomes Trial Could Be Damaged By Niaspan Failure
Abbott Laboratories is facing a difficult proposition with its cholesterol franchise. At the May 19 review of the ACCORD-Lipid data on use of Trilipix with a statin, FDA's Endocrinologic and Metabolic Drugs Advisory Committee called for outcomes trials to determine whether the combination has value in a particular subpopulation.
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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.
More Disheartening News For Abbott Cholesterol Franchise: Niaspan/Statin Study Halted Due To Lack Of Added Benefit
NIH's early termination of the AIM-HIGH trial does further damage to combination therapy for increasing HDL cholesterol and lowering triglycerides in patients with well-controlled LDL cholesterol.
Advisory committee says data inconclusive with subgroups and recommended another study to determine if there is increased risk in women and/or benefit for high TG, low HDL-C patients.