Saxagliptin for the treatment of diabetes - a focus on safety.

Abstract

INTRODUCTION:

The safety of agents used to treat type 2 diabetes (T2D), a chronic disease requiring life-long intervention, is of particular interest. Saxagliptin is a potent and selective DPP-4 inhibitor that has emerged as a therapeutic option for T2D.

AREAS COVERED:

Its safety was assessed in a development program of 20 phase 2/3 randomized clinical trials and in SAVOR-TIMI 53 trial that evaluated the cardiovascular outcomes. In order to capture any further safety signals, mainly in the long-term, a post-marketing safety surveillance is ongoing. This paper discusses the tolerability and safety profile of the agent, including cardiovascular, renal, pancreatic, hepatic and bone adverse events.

EXPERT OPINION:

Saxagliptin is a safe therapeutic option for patients with T2D, with low risk of hypoglycemia and good tolerability. It demonstrated cardiovascular safety (including in patients with pre-existing cardiovascular disease and/or HF) and safety with respect to all-cause mortality and adverse events of special interest. In SAVOR-TIMI53, saxagliptin was associated with an unexpected increased risk of HF hospitalization, mainly in the first 12 months; a mechanistic explanation for this has not been found. Further research needs to elucidate the effect of antidiabetic drugs on the heart, by including biomarkers and echocardiographic sub-studies within large outcome trials.

• Authors: Simona Cernea, Avivit Cahn, Itamar Raz
• Journal: Expert opinion on drug safety (Expert Opin Drug Saf) Vol. 15 Issue 5 Pg. 697-707 (May 2016) ISSN: 1744-764X [Electronic] England
• PMID: 26923222 (Publication Type: Journal Article, Review)

Chemical References

• Dipeptides
• Dipeptidyl-Peptidase IV Inhibitors
• Hypoglycemic Agents
• saxagliptin
• Adamantane

Topics

• Adamantane (adverse effects, analogs & derivatives, therapeutic use)
• Diabetes Mellitus, Type 2 (drug therapy)
• Dipeptides (adverse effects, therapeutic use)
• Dipeptidyl-Peptidase IV Inhibitors (adverse effects, therapeutic use)
• Hospitalization (statistics & numerical data)
• Humans
• Hypoglycemia (chemically induced)
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Randomized Controlled Trials as Topic