Saxagliptin does not increase hypoglycaemia rate, nor incidence pancreatitisNews - Oct. 1, 2013
Presented at the EASD in Barcelona
Addition of saxagliptin to metformin does not give a higher rate of hypoglycaemia, in comparison to placebo when given in addition to metformin monotherapy (2.4 vs. 2.6 events per 100 patient years, HR: 0.92), as was shown in additional analyses of the SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) trial. There were only more hypoglycaemias seen in patients who were treated with saxagliptin and who also took sulfonylureas at baseline; agents that are known to cause hypglycaemia (9.7vs. 6.8 events per 100 patient years, HR: 1.42). More patients who took saxagliptin reached HbA1c targets without hypoglycaemia, vs. placebo (36.1% vs. 23.6%). Again, the group of patients who received sulfonylureas at baseline formed an exception (20.6% vs. 22.4% vs. placebo and sulfonylurea).
No difference was seen in the frequency of pancreatitis between saxagliptin and placebo-treated patients. In patients who experienced pancreatitis, no difference was seen in the duration of the event, the impact of the study drug, and the outcome of the adverse event between two treatments.
Concerns about the safety for the pancreas of incretin-based treatments for type 2 diabetes originate mainly from non-randomised studies with methodological limitations. SAVOR is the first large-scale, randomised, blinded study into a type 2 diabetes treatment that adjudicated pancreatitis events. This study shows that no increased general risk of pancreatitis or pancreas cancer is associated with use of saxagliptin.
We also reported on the primary results of the SAVOR study that were presented at the ESC congress earlier this month:
SAVOR-TIMI 53: Saxagliptin does not alter CV risk in type 2 diabetes mellitus The risk of CV mortality, MI or ischemic stroke was not altered after treatment of T2DM with saxagliptin, while glycaemic control was improved.