WASHINGTON, D.C.—A massive data analysis showed that SGLT2 diabetes drugs significantly cut heart failure hospitalizations and deaths, results that stand to have a “substantial impact” on prescribing habits, if AstraZeneca’s U.S. president sees his predictions come true.
In a real-world study dubbed CVD-Real, researchers sifted records on more than 300,000 patients in six countries to find that SGLT2 meds cut heart failure hospitalization rates by 39% compared with other types of diabetes treatments.
The drug class—which includes AZ's own Farxiga as well as Johnson & Johnson's Invokana and Eli Lilly and Boehringer Ingelheim’s Jardiance—also reduced deaths from any cause by 51%, according to the study, presented Sunday at the American College of Cardiology conference.
The analysis echoes the results of a landmark Jardiance outcomes study, Empa-Reg Outcome, in which patients taking the SGLT2 drug saw a 35% reduction in risk for heart failure hospitalizations. Though CVD-Real wasn't designed to prospectively test the class' ability to prevent heart failure complications and death, the analysis suggests Jardiance isn't the only SGLT2 med to deliver those benefits. More than 90% of patients in the analysis were on Farxiga or Invokana.
And that, in turn, means the new study offers "an opportunity for diabetologists and cardiologists to think different” about how they treat patients, AstraZeneca’s president in the U.S., Ruud Dobber, said in an interview.
AstraZeneca wondered whether there could be a class effect after Lilly and BI unveiled Jardiance outcomes data in 2015, said Jim McDermott, AZ’s VP of medical affairs for diabetes. It started the CVD-Real analysis in an attempt to answer that question.
Importantly, the analysis included patients at varying levels of risk for heart failure, McDermott said. The results show a classwide effect on heart failure and mortality, not only in patients at high risk for heart failure, but in a broad patient population, he said.
CVD-Real “will add to the growing evidence that antidiabetic drugs are not only good only to treat blood glucose, but also to prevent other nasty comorbidities like heart failure and even preventing death,” Dobber added.
McDermott said the CVD-REAL results leave him “cautiously optimistic” for Declare, a Farxiga cardiovascular outcomes trial set to read out by 2019.
On that front, AstraZeneca trails Eli Lilly and BI, which last year notched an FDA indication for Jardiance as tool to cut the risk of CV death in patient with diabetes and heart disease. The Empa-Reg outcomes trial showed a 38% reduction in cardiovascular deaths and a 32% reduction in all-cause mortality in addition to the 35% reduction in hospitalizations for heart failure.
Invokana’s cardiovascular outcomes trial is set to provide data this year. A J&J spokesperson said the new study results represent "good news" for the drug class and for patients.
On Friday, BI and Lilly announced they're starting two trials to test Jardiance in type 2 diabetes patients who have chronic heart failure, and in heart failure patients who don't have diabetes.
Merck and Pfizer are also working to bring an SGLT2 competitor to the market, and recently filed with U.S. and European regulators for the drug, ertugliflozin, plus two combos containing the med.
Farxiga sales grew 70% to $835 million last year; the product now sits atop the company’s sales charts in diabetes. AZ has also kicked off outcomes trials for its drug in chronic heart failure and chronic kidney disease.