Bristol-Myers Squibb Company
(NYSE:BMY) today announced additional results from the SAVOR cardiovascular outcomes trial, which found no increased rate of hypoglycemia among patients treated with
(saxagliptin) compared to placebo when added to metformin monotherapy and higher rates of hypoglycemia only in the
group compared to the placebo group among patients taking sulfonylureas, agents known to cause hypoglycemia, at baseline. Additionally, a greater percentage of patients taking
reached their target HbA1c without hypoglycemia, except patients who were treated with sulfonylureas alone at baseline. These findings are consistent with previous studies of
Results were presented today at the 49
Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain.
“Treating diabetes often requires the use of multiple therapies to help lower blood glucose levels without increasing the risk of hypoglycemia,” said Itamar Raz, MD, Co-Primary Study Investigator and Head of the Diabetes Unit, Department of Medicine, Hadassah University Hospital, Jerusalem, Israel. “In a post-hoc analysis from SAVOR, the data reflected that when saxagliptin was used in combination with metformin, there was a lowering of blood sugar and no increase in the risk of hypoglycemia.”
Additionally, results from SAVOR found rates of any events of adjudication-confirmed pancreatitis were balanced between the
and placebo treatment groups (24 patients in the
arm versus 21 patients in the placebo arm). Moreover, in patients who experienced pancreatitis, the duration of the event, study drug actions and outcome of the adverse event were balanced across the two treatment arms. Observed rates of pancreatic cancer were also low (five patients in the
arm versus 12 patients in the placebo arm).
“Recent discussions regarding the pancreatic safety of some type 2 diabetes medicines, including incretin-based therapies such as DPP-4 inhibitors, have been largely based on non-randomized studies with significant limitations,” said Prof. Raz. “SAVOR is the first large-scale, randomized, blinded study of a type 2 diabetes treatment to report an adjudicated review of pancreatitis events, and results from this trial showed no overall increased risk of pancreatitis or pancreatic cancer in patients taking saxagliptin.”