Merck's Steglatro shows limited promise with heart failure hospitalization data

September 1,2020

Late to the party against its SGLT2 diabetes rivals, Merck & Co.'s Steglatro has also tracked way behind in the class' growing presence in heart failure. Now, the drugmaker has posted new data showing Steglatro could, in fact, show benefits in that indication—but it's a limited window into the future.

Steglatro cut heart failure patients' risk of total hospitalizations, total hospitalizations or death, and first hospitalizations regardless of a prior heart failure, according to new subdata presented Monday at the European Society of Cardiology virtual annual meeting. 

The newest findings stem from Merck's Vertis-CV trial, which was originally intended to test Steglatro's ability to match placebo in terms of diabetes patients' cardiovascular safety. 

The drugmaker later expanded the study—which was required by the FDA following Steglatro's approval in late 2017—to include a group of added heart failure endpoints after Eli Lilly and Boehringer Ingelheim released data showing SGLT2 med Jardiance bettered heart failure patients' CV outcomes.

Unlike that study and others from Johnson & Johnson and AstraZeneca that showed similar benefits, though, Steglatro's study wasn't set up to show superiority against placebo, a fact that limits the drug's positive data.

In terms of total heart failure hospitalizations, Steglatro cut patients' risk by 30% and the combined risk of total hospitalizations or cardiovascular death by 17%. Patients' rate of first hospitalizations were the same regardless of whether they had a prior heart failure, Merck said. 

Dr. Sam Engel, Merck’s associate vice president of clinical research for diabetes and endocrinology, said the newest findings add to "a growing body of evidence" around SGLT2 meds' effect on patients' cardiovascular outcomes, but he didn't go so far as to forecast Steglatro's own chances in the indication.

"What does seem to jump out, is there is a consistency of benefit that can be seen," Engel said, pointing to other drugmakers' findings. 

Engel said Merck was not conducting any superiority studies for Steglatro in heart failure but did not specify whether those trials could be on the horizon.