Tuesday, September 3, 2013

SAVOR TIMI 53 and EXAMINE Study reveals long term outcome data on Saxagliptin and Alogliptin - No harm, but no benefits either

At the European society of cardiology, AstraZeneca / Bristol-Myers and Takeda presented detailed analysis of the CV outcome data from SAVOR-TIMI and EXAMINE trial conducted on saxagliptin and alogliptin respectively. EXAMINE trial evaluated T2DM patients with a recent acute coronary syndrome event, while SAVOR evaluated T2DM patients having CV risk factors.

Both the studies concluded that saxagliptin and alogliptin are CV safe and comparable to other oral anti diabetes medications. The growth of DPP-IV class  has plateaued in the last year and investor were hopeful, that if these drugs show superiority in terms of CV safety, the growth of the class can re-accelerate.  The study results though have failed to appease investors, but at the same time the overall safety data on the drugs is very much comforting and should eliminate any physician concerns with regard to pancreatitis and pancreatic cancer.

The detailed analysis of the data also did not show up if DPP-IV's could particularly be beneficial in specific patient subgroups. The CV events were balanced across all patient subgroups as defined by their baseline characteristics (duration of diabetes, use of concomitant medications, or renal impairment). 

Apart from CV safety, these DPP-IV's also failed to show any benefit on other endpoints like renal safety, hypoglycemia or weight gain

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