At the FDA advisory panel empagliflozin enjoyed strong support from the cardiologists and statisticians but not from the endocrinologists. An FDA advisory panel last week turned out to be a much more contentious and divided than many had expected. Based on the FDA’s own analysis of last year’s Empa-Reg Outcome trial I had predicted that the…
Prominent Cardiologists Decry Tepid Support For Empagliflozin By Endocrinologists
July 5, 2016 by 1 Comment
Empagliflozin May Be Poised To Gain CV Indication
June 24, 2016 by Leave a Comment
–FDA reviewers have raised no major questions ahead of Tuesday’s advisory panel meeting. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will likely lend its support to an important new expanded indication for empagliflozin (Jardiance, Boehringer Ingelheim). The new indication is to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death,…
Time For Cardiologists To Start Prescribing Diabetes Drugs?
June 22, 2016 by 2 Comments
There’s an emerging consensus that now may be the time for cardiologists to start thinking seriously about prescribing diabetes drugs. Until now most cardiologists have not considered this to be part of their job description. But now new data from large cardiovascular outcome trials (CVOTs) shows that these drugs may one day become, like statins and…
Companies Plan To Study Diabetes Drug In Heart Failure Population
April 21, 2016 by 1 Comment
–New attention paid to the intersection of heart failure and diabetes Boehringer Ingelheim and Eli Lilly announced on Wednesday that they were planning two separate outcomes trials to test the effect of the diabetes drug empagliflozin (Jardiance) in patients with chronic heart failure. The trials herald a remarkable shift in emphasis, since there have been…
Wow! Maybe– Finally– A Positive Diabetes Drug Outcomes Trial
August 20, 2015 by 1 Comment
Until now the best thing anyone could say for sure about all the new diabetes drugs was that at least they didn’t kill people. That’s because although these drugs have been shown to be highly effective in reducing glucose levels, a series of large cardiovascular outcomes trials failed to provide any evidence of significant clinical…
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