- Treatment with a newer class of drugs for type 2 diabetes substantially reduced the risk of death or hospitalization due to heart failure, compared to other medicines for the disease, according to a real-world study sponsored by the British pharma AstraZeneca.
- Results from the study, which were unveiled Sunday at the annual meeting of the American College of Cardiology, showed that SGLT-2 inhibitors such as AstraZeneca's Farxiga (dapagliflozin) lowered the risk of either outcome by 46%.
- AstraZeneca hopes the data could help support earlier use of SGLT-2s in treating type 2 diabetes and boost overall growth of the drug class, which is led by Johnson & Johnson's Invokana (canagliflozin) and also includes Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin).
People with type 2 diabetes have a significantly higher risk of heart failure and are more likely to suffer a heart attack or stroke. That's why a 2015 study demonstrating that Lilly and Boehringer's Jardiance significantly reduced the risk of cardiovascular deaths generated excitement around the prospects of the SGLT-2 drugs.
The results from that trial, known as EMPA-REG, led the Food and Drug Administration last year to update Jardiance's label with an expanded indication for reducing the risk of cardiovascular death in adult patients with type 2 diabetes and cardiovascular disease.
EMPA-REG also put pressure on other drugmakers to demonstrate the cardiovascular benefit of their drugs, raising the bar for diabetes drugs to prove both efficacy in lower glucose levels as well as protect against heart risks.
AstraZeneca has its own large cardiovascular outcomes trial, dubbed DECLARE, currently under way, aimed at showing a similar benefit to Farxiga. Results are expected in 2019 at the latest.
In the interim, however, the pharma sponsored the CVD-REAL study, which pulled data from health claims, registries and other medical records to assess the outcomes of over 300,000 patients across six countries, including the U.S. and the U.K.
Patients treated with Farxiga, Invokana or Jardiance were compared to those taking other medications for type 2 diabetes, such as insulins or DPP-4s.
Treatment with SGLT-2s cut the rate of hospitalization for heart failure by 39% and death from any cause by 51%, while reducing the rate of a composite endpoint of both outcomes by 46%, the study showed. Most of the patients on SGLT-2s received either Farxiga or Invokana, while fewer than 10% of patients took Jardiance.
Almost nine in ten patients included in CVD-REAL had no history of cardiovascular disease, a broader population than the higher-risk group studied in Lilly's trial.
"I’m hoping CVD-REAL helps support moving the class earlier on in the treatment paradigm," said Mike Crichton, head of AstraZeneca's U.S. Cardiovascular and Diabetes Business unit. "That’s not just my own hope. It is actually backed up by the [American College of Endocrinology's] guidelines as well that say SGLT-2s are a better choice over a DPP-4."
Worldwide sales of Farxiga grew rapidly last year, shooting up 70% to $835 million. But Farxiga still trails J&J's slower-growing Invokana by a wide margin. Last year, combined sales of Invokana and Invokamet (which adds metformin HCI to Invokana) totaled $1.41 billion.
And Jardiance's new label for cardiovascular benefit could prove a competitive edge until AstraZeneca's DECLARE study delivers positive results.
Still, AstraZeneca hopes CVD-REAL's data could start shifting perceptions of the SGLT-2 class, supporting broader use. "I think this is the start of us looking at diabetes a little bit differently," said Dr. Steve Zelenkofske, head of U.S. medical affairs in the AstraZeneca's Cardiovascular and Metabolic Disease division.