As AstraZeneca looks ahead to results for its Farxiga outcomes study, the company this week rolled out a head-to-head analysis showing the SGLT2 drug beat Merck's Januvia and its ilk on cardio risks—and that has one of AZ's diabetes leaders "very optimistic" for the Declare readout.
A new analysis of CVD-Real data compared the risk of death, hospitalization for heart failure, heart attack and stroke in new patients on Farxiga versus any DPP-4 inhibitor, a class that includes Merck's Januvia and AstraZeneca's own Onglyza.
The analysis used national registries, claims and medical records from South Korea, Japan, Israel and Canada. Investigators found a "significantly" lower risk of all cardio events for Farxiga patients compared with those on the DPP4 class.
AstraZeneca VP of medical affairs for diabetes Jim McDermott said the new data adds to his confidence about the company's big Declare study, expected to read out later this year. Declare is examining cardiovascular efficacy and safety for Farxiga in a broad range of Type 2 diabetes patients, including those with CV risk factors and those with established cardiovascular disease.
One of Farxiga's competitors, however, already has impressive CV outcomes data in hand—and even an FDA approval to lower cardiovasular risks. That's Eli Lilly and Boehringer Ingelheim's Jardiance, which also put up new studies at ADA. In one case, an analysis showed Jardiance cut the risk of kidney disease progression in Type 2 patients regardless of whether they had their CV risk factors—such as high blood pressure—under control.
AZ has its own kidney studies ongoing, and J&J recently reported that Invokana improved renal outcomes in its large cardio and kidney outcomes study.
CVD-Real was an observational study that assessed cardiovascular benefits for SGLT2 drugs. It wasn't designed to prospectively test whether the drugs can prevent heart failure complications and death.
At the American College of Cardiology meeting last year, AstraZeneca presented data from the study showing SGLT2 drugs cut heart failure hospitalization rates by 39% and reduced deaths from any cause by 51% compared with other types of diabetes treatments. The company followed that up with more data from the study in March.
All of the findings are leading up to the Declare data readout, McDermott and Rod Wooten, VP of cardiovascular and metabolic disease at AZ, said in an interview Sunday at ADA.
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The new analysis was one of 45 abstracts AstraZeneca presented at ADA this year. The drugmaker also presented data on a combo of Farxiga and Onglyza, plus 2-year data on a combo of Farxiga and Bydureon, among other presentations.
Overall, the data AZ presented at ADA should "impact prescribing, especially when it comes to primary care," Wooten said. He said specialists have followed developments in the disease area, but primary care physicians are still prescribing "agents that really haven't demonstrated the breadth of benefit to the patient beyond A1C."
"Every single trial of our currently marketed agents enhances the evidence of why it's so important to treat early and aggressive," he said.