AstraZeneca’s data analysis reveals no increased risk with saxagliptin for hHF patients

11th June 2015 (Last Updated June 11th, 2015 18:30)

AstraZeneca has presented the results of an observational and retrospective study, which demonstrated that no evidence of increased risk of hospitalisation for heart failure (hHF) with saxagliptin compared against sitagliptin.

AstraZeneca has presented the results of an observational and retrospective study, which demonstrated that no evidence of increased risk of hospitalisation for heart failure (hHF) with saxagliptin compared against sitagliptin.

Both are dipeptidyl peptidase-4 (DPP-4) inhibitors in patients with type 2 diabetes.

Washington Georgetown University Medical Centre associate professor and study principal investigator Dr Alex Fu said: "These new data provide valuable real-world information regarding the cardiovascular safety of the DPP-4 inhibitor class in patients with type 2 diabetes."

The real-world evidence study used a retrospective, observational, new-user cohort design, which included US inpatient medical, outpatient medical, and outpatient pharmacy insurance claims data for patients with type 2 diabetes from August 2010 to 2013.

Around 100,000 patients have been included for the comparison of saxagliptin versus sitagliptin and more than 200,000 patients were included for the comparison of DPP-4 inhibitors versus sulfonylureas.

The real-world evidence analysis is said to follow findings of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR), which was a large, randomised, double-blind, placebo-controlled Phase IV clinical trial in patients with type 2 diabetes at high risk of CVD.

According to the firm, SAVOR reached the primary safety objective, showing that saxagliptin did not increase the risk for cardiovascular death, nonfatal myocardial infarction (MI) and nonfatal ischaemic stroke when added to a patient's current standard of care, with or without other antidiabetic therapies.

In the study, no treatment differences were observed between saxagliptin and placebo for the secondary endpoint of nonfatal MI, nonfatal stroke, cardiovascular death, hospitalisation for heart failure, hospitalisation for unstable angina, or hospitalisation for coronary revascularisation.