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Saxagliptin Products (Onglyza® and Kombiglyze™ XR) and Alogliptin Products (Nesina, Kazano, and Oseni) – Possible Heart Failure Risk – Updated

April 12, 2016

A safety investigation conducted by FDA revealed a possible increase in heart failure risk with medications containing saxagliptin or alogliptin. A new warning regarding this risk is being added to the labels of these medications. More patients who received alogliptin- or saxagliptin-containing medications were hospitalized for heart failure during two separate randomized, double-blind, placebo-controlled trials.

The SAVOR trial evaluated cardiovascular outcomes in patients with type 2 diabetes mellitus taking saxagliptin who are at an increased risk of cardiovascular events (N Engl J Med 2013; 369:1317-1326). There was no difference between saxagliptin and placebo in the composite outcome of cardiovascular death, myocardial infarction, or stroke. However, there were more patients hospitalized due to heart failure with saxagliptin (3.5%) compared with placebo (2.8%; hazard ratio 1.27; 95% CI, 1.07 to 1.51; P=0.007). There was not an increased risk of other cardiovascular outcomes or an increased risk of death due to any cause or cardiovascular causes.

The EXAMINE trial evaluated cardiovascular outcomes in patients with type 2 diabetes mellitus taking alogliptin (Lancet 2015; 385: 2067-76). Patients included in this trial had a recent history of a coronary event. There was no difference in hospital admissions due to heart failure with alogliptin (3.9%) and placebo (3.3%; hazard ratio 1.19; 95% CI, 0.9 to 1.58). There was no difference in the occurrence of cardiovascular death between the treatment groups. Additionally, there was no difference in the composite outcome of cardiovascular death and hospital admission for heart failure between the treatment groups. All of these results were determined during a post-hoc analysis of data from the EXAMINE trial.

Medications containing saxagliptin or alogliptin are used to lower blood sugar in combination with diet and exercise in adults with type 2 diabetes. Patients taking these medication are advised not to make any changes in therapy without first consulting a healthcare professional. Advise patients taking these medications to contact their provider if they experience signs and symptoms of heart failure (eg, abnormal breathing issues, weight gain plus swelling in ankles, fatigue). Consider discontinuing these medications in patients who develop heart failure.

Additional information is available at the following links:

Updated
April 12, 2016; February 14, 2014; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.