A trial that started back in 1990 continues to demonstrate a significant mortality advantage for intensive insulin therapy in heart attack (MI) patients. But experts say the trial design is so outdated that the findings should have no influence on clinical practice today. During the years 1990 through 1993 the Swedish DIGAMI I (Diabetes Mellitus…
Seeking Cardiovascular Safety Data, FDA Blocks Approval Of Novo Nordisk’s Long-Acting Insulin
February 11, 2013 by Leave a Comment
The FDA informed Novo Nordisk on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But…
Guest Post– Reality Check: The ORIGIN of Spin in a Randomized Trial
June 20, 2012 by 2 Comments
Editor’s Note: The following guest post is reprinted with permission from CardioExchange, the cardiology social media website published by the New England Journal of Medicine. Steven Coca is a nephrologist at the Yale School of Medicine. Reality Check: The ORIGIN of Spin in a Randomized Trial by Steven Coca, DO, MS In the ORIGIN randomized trial, involving about 12,500 people…
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