Pia S. Pollack

TL;DR: In the context of balanced primary and secondary end points, saxagliptin treatment was associated with an increased risk or hospitalization for heart failure, and this increase in risk was highest among patients with elevated levels of natriuretic peptides, previousheart failure, or chronic kidney disease.

TL;DR: Elevated levels of each biomarker were associated significantly with increased risk for all cardiovascular end points and when added to clinical variables, biomarkers significantly improved the discrimination and appropriate reclassification of risk.

TL;DR: Despite elegant physiological studies suggesting a potential hemodynamic interaction between dipeptidyl peptidase 4 inhibitors and ACE inhibitors, there were no differences in heart or blood pressure changes after randomization according to baseline ACE inhibitor use in patients treated with saxagliptin or placebo.

TL;DR: To initiate a dialogue about the compelling need for and the challenges in developing such alternative endpoints for patients with HFpEF, the US Food and Drug Administration on November 12, 2015, facilitated a meeting represented by clinicians, academia, industry, and regulatory agencies.

TL;DR: Saxagliptin versus control was associated with a reduction in glucagon area under the curve (AUC) from baseline and increases in insulin AUC, C-peptide A UC, and the homeostasis model assessment of β-cell function.