Empagliflozin's CV Benefit Impresses At EASD, But What Will FDA Say?
This article was originally published in The Pink Sheet Daily
Boehringer/Lilly's Jardiance delivers impressive CV death benefit but no effect on myocardial infarction or stroke – prompting questions about relevance of MACE composite primary endpoint.
You may also be interested in...
ELIXA trial results show neither increased nor decreased risk of major adverse cardiovascular events; Sanofi's diabetes drug, still unapproved in the U.S., becomes the only GLP-1 receptor agonist with CV outcomes data.
FAERS reports identify cases of diabetic ketoacidosis, ordinarily rare in type 2 diabetes, which were not associated with high blood sugar levels.
If cardiovascular studies are required for non-cardiac drugs, they should be focused on specific signals of heart-related concern that may not include ischemic events, advisory committee cardiologists say during review of Novo Nordisk’s Saxenda for obesity.