HDG thx for the detail re trial design
Re Jardiance ....I'll do one of your "Oh my God's"......you are apparently unaware that most ( but not all ) of the diabetics in R-IT would have access to Jardiance since it was approved in most ( but not all ) of the areas R-IT was recruiting in from mid 2014 onwards
eg
Type 2 diabetes: European Commission approves Jardiance® (empagliflozin) tablets for use in adults in Europe
European Commission approves third product from the Boehringer Ingelheim and Lilly Diabetes alliance
RIDGEFIELD, Conn. and INDIANAPOLIS, May 23, 2014 /PRNewswire/ -- The European Commission granted marketing authorization for Jardiance® (empagliflozin) tablets, a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes mellitus (T2D) to improve glycemic control in adults in Europe, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) announced.1
The European Commission approved JARDIANCE 10 and 25 mg once daily tablets for use when diet and exercise alone do not provide adequate glycemic control. JARDIANCE may be used alone when metformin is not considered appropriate due to intolerance, or alongside other glucose-lowering medicines including insulin, when glucose control is inadequate.
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Kiwi
PS ...belive the CV benefits were discovered / confirmed later in 2016 .......so those prescribing pre 2016 may not have been aware of CV risk reduction .......( doing this quickly so would need to confirm ) by FDA added CV risk reduction later to label
FDA Approves Jardiance to Treat Cardiovascular Disease in Diabetes Patients
Written by Kathleen Doheny
The diabetes drug empagliflozin (Jardiance) is now a ''double duty'' drug. It can be prescribed not only to help treat diabetes, but also to reduce the risk of cardiovascular death in adults diagnosed with both type 2 diabetes and cardiovascular disease.1
Jardiance
The FDA granted approval for this new indication in December, after reviewing a study of 7,000 patients with both conditions. 2 ............( believe this is Dec 2016 ...would need to chk ...drug approved for diabetics mid 2014 )
Doctors call this a major advance for these patients and say it has changed prescribing practices.
PPS
Here it is
FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes
Study links Jardiance to improved survival in patients with type 2 diabetes with cardiovascular disease
For Immediate Release
December 2, 2016
The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.
AI
