Merck and Pfizer’s Steglatro, late the SGLT2 party, has been working to catch up to its in-class rivals, which already bear heart-helping approvals. But it’s cardiovascular outcomes data won’t help it get on their level.
Steglatro showed it could match placebo when it comes to the combined rate of heart attack, stroke and cardiovascular death among high-risk Type 2 diabetes patients, satisfying an FDA requirement to show that it’s not a threat to heart safety.
In each arm, 11.9% of patients suffered one of those cardiovascular events, the companies said Tuesday at the American Diabetes Association’s virtual annual meeting.
But while the results may show that Steglatro is safe, the drug is still lacking what competitors Jardiance from Eli Lilly and Boehringer Ingelheim Invokana from Johnson & Johnson and Farxiga from AstraZeneca already have: outcomes data showing they can ward off major CV events.
Jardiance was the first to produce that type of data, and followed up by scoring an FDA nod to decrease the risk of cardiovascular death among high-risk Type 2 diabetes patients. Invokana came next with clearance to reduce the risk of major CV events in that same population, and more recently, it also picked up a go-ahead to treat chronic kidney disease and reduce the risk of hospitalization for heart failure in patients with Type 2 diabetes and CKD.
Farxiga, meanwhile, bears approvals to reduce the risk of hospitalization for heart failure in high-risk Type 2 diabetes patients, as well as to cut the risk of cardiovascular death and hospitalization for heart failure in patients with a reduced ejection fraction, regardless of whether or not they have diabetes.
The trial, dubbed Vertis CV, “was expanded when it became evident that there were some other potential benefits that were seen with SGLT2 inhibitors,” Sam Engel, M.S., Merck’s associate VP of clinical research for diabetes and endocrinology, said.
Unfortunately for Merck and Pfizer, Steglatro also missed on all the secondary endpoints from the trial. The drug couldn’t prolong the time to cardiovascular death or hospitalization for heart failure, nor could it ward off a group of kidney problems, including death and dialysis.
That’s not to say the companies saw no positive signs. Researchers did spot a 30% reduction in the risk of hospitalization for heart failure, although that endpoint wasn’t part of the study’s hierarchical testing sequence.
“We’re obviously going to be looking at the data set from Vertis CV to understand more about this finding, and we look forward to sharing those analyses with the scientific community in the relatively near future,” Engel said.