Steglatro (ingredient: ertugliflozin), the latecomer sodium-glucose co-transporter 2 (SGLT-2) inhibitor developed by MSD and Pfizer, fell short of experts’ anticipation for a significant cardiovascular benefit as a diabetes drug, the latest study showed.
According to the outcomes of the VERTIS-CV trial released during the American Diabetes Association’s online meeting on Tuesday, Steglatro demonstrated non-inferiority to placebo to meet the primary endpoint of major cardiovascular events (MACE), proving safety in patients with cardiovascular disease.
However, it failed to show a cardiovascular benefit, known as the established effect of SGLT-2 inhibitors.
|Steglatro (ingredient: ertugliflozin)|
Specifically, the incidence of MACE, a composite variable consisting of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, was 11.9 percent in the Steglatro group, which was the same as in the placebo group.
However, the Steglatro group did not show any significant improvement in the secondary endpoints set to demonstrate superiority over placebo.
The secondary endpoints of the VERTIS-CV study included time to cardiovascular death, hospitalization for heart failure, and time to the first occurrence of the composite of renal death, renal dialysis/transplant, or doubling serum creatinine.
Christopher Cannon, a cardiologist at Brigham and Women’s Hospital, said although the study did not achieve the secondary endpoints, the findings showed that Steglatro could reduce the risk of hospitalization for heart failure in patients with type-2 diabetes and cardiovascular disease.
The VERTIS-CV study’s weaker-than-expected data could have a considerable impact on the use of Steglatro, observers said.
Diabetes specialists had expected that Steglatro would show the most substantial cardiovascular benefit among SGLT-2 inhibitors.
With Steglatro being the late-comer, MSD and Pfizer were able to reflect in the VERTIS-CV study all the cardiovascular data of other first-comer SGLT-2 inhibitors such as Forxiga (dapagliflozin), Jardiance (empagliflozin), and Invokana (canagliflozin).
MSD and Pfizer recruited high-risk patients with cardiovascular disease for the VERTIS-CV study. They doubled the proportion of patients with heart failure compared to other studies to reflect Forxiga's benefit as heart failure treatment.
Experts raised concerns that failure to prove Steglatro’s cardiovascular benefit despite the favorable clinical design could raise a question over the SGLT-2 inhibitors' effect.
Before the announcement of the VERTIS-CV trial outcomes, Professor Kim Sung-rae at the Endocrinology and Metabolism Department of Bucheon St. Mary’s Hospital had said that falling short of the expected data would make the drug look like the ingredient itself was problematic.
Even if the outcomes turn out well, the clinical impact would not be significant because SGLT-2 inhibitors have already proved cardiovascular benefit, he had predicted.
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