AZ unveils new data on Farxiga backing earlier use

AstraZeneca has presented findings from a real-world analysis potentially supporting earlier and wider use of the SGLT-2 inhibitor class of drugs in the diabetes treatment pathway.

A two-country analysis of more than 30,000 patients with type II diabetes presented at the American Diabetes Association’s 77th Scientific Sessions showed a significant reduction in the rates of hospitalisation for kidney disease by 62 percent, hospitalisation for heart failure (HF) by 37 percent and death from any cause by 27 percent for patients using Farxiga (dapagliflozin) versus DPP-4 inhibitors.

Also, a three-country analysis of nearly 100,000 patients with type II diabetes showed a significant reduction in rates of CV death by 47 percent and hospitalisation for HF by 30 percent for patients new to SGLT-2s versus other diabetes medicines.

"SGLT-2 inhibitors are being prescribed with greater frequency for patients with type-2 diabetes, so it is vital that we have a clear understanding of the safety profile of these medicines and examine their effectiveness in a real-world setting," said Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development.

"The data we are presenting at ADA underpins the safety of Farxiga and highlights the potential for earlier use of the SGLT-2 inhibitor class, and in broader patient populations than originally understood."

The drug giant also unveiled findings of an updated safety analysis of data pooled from 30 Phase IIb/III clinical trials for Farxiga, which showed no new safety signals and the incidence of adverse events was generally similar to that in the control groups. Importantly, there was no imbalance in lower-limb amputations, with eight (0.1 percent) patients and seven (0.2 percent) patients identified in the Farxiga and control groups, respectively, the firm noted.

Farxiga is currently approved as an adjunct to diet and exercise to improve glycaemic control in adults with type II diabetes, but is not indicated to reduce the risk of CV events, death or hospitalisation for heart failure.

The cardiovascular outcomes trial of the drug, DECLARE, is ongoing and expected to provide data in 2019 at the latest.