Posts Tagged ‘ACCORD’

August 12th, 2014

What Can We Really Deduce from ACCORD?

For Kasia Lipska, post hoc analyses of intensive glucose lowering in the ACCORD trial require greater scrutiny.

March 10th, 2014

Selections from Richard Lehman’s Literature Review: March 10th

This week’s topics include cognitive function and brain structure in type 2 diabetics after intensive lowering of BP and lipid levels, the association of β-blocker therapy with risks of adverse CV events and deaths in those with ischemic heart disease undergoing noncardiac surgery, and more.

August 10th, 2011

Rethinking Trilipix — And the Process for Approving Lipid-Modifying Drugs

Editor’s Note: In an article published in the New England Journal of Medicine, three members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (Allison Goldfine, Sanjay Kaul, and William Hiatt) offer their perspective on the May 19 committee meeting to review the controversial ACCORD-Lipid Study. Here, one of those authors, Sanjay Kaul, provides his […]

May 19th, 2011

FDA Panel Delivers Mixed Verdict on Trilipix (Fenofibrate)

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee delivered a mixed verdict on fenofibrate (Trilipix, Abbott). On the one hand, the panel agreed unanimously that the FDA should require Abbott to perform a large clinical trial in high-risk patients with elevated triglyceride levels and low HDL levels who nevertheless have achieved target LDL cholesterol levels […]

May 17th, 2011

FDA Reviewers Scrutinize ACCORD and Trilipix

The FDA has released the agenda, questions, roster, and briefing materials for Thursday’s meeting of the Endocrinologic and Metabolic Drugs Advisory Committee in which the ACCORD trial and the fate of Abbott’s Trilipix (fenofibric acid) will be discussed. The key questions on which the advisory committee members will be asked to vote are: Should the FDA require […]

March 3rd, 2011

5-Year Followup of ACCORD: Still No Support For Intensive Glucose Lowering

Long-term followup of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial has once again failed to support routine intensive glucose lowering in high-risk type 2 diabetics. In 2008, as reported in the New England Journal of Medicine, the intensive glucose-lowering regimen (target glycated hemoglobin level of <6%) was terminated early after an increase in mortality was […]