VERTIS CV: Ertugliflozin reduces HF events in diabetes, ASCVD
Click Here to Manage Email Alerts
Among patients with type 2 diabetes and atherosclerotic CVD, the SGLT2 inhibitor ertugliflozin reduced risk for first and total HF events compared with placebo, according to new data from the VERTIS CV study.
As Healio previously reported, in the main results of VERTIS CV, patients with type 2 diabetes and established ASCVD had similar risk for CV events at 3.5 years whether assigned ertugliflozin (Steglatro, Merck/Pfizer) or placebo, but those assigned ertugliflozin had reduced risk for HF hospitalization. Francesco Cosentino, MD, PhD, from the cardiology unit at Karolinksa Institute and Karolinska University Hospital, Stockholm, presented more data on HF outcomes at the virtual European Society of Cardiology Congress.
“Patients with diabetes are at substantial risk of heart failure and represent a substantial proportion of patients hospitalized for heart failure,” Cosentino said during a presentation.
For these analyses, patients assigned ertugliflozin 5 mg per day and those assigned ertugliflozin 15 mg per day were pooled and compared with those assigned placebo.
The prespecified secondary endpoint of time to first HF hospitalization favored those assigned ertugliflozin (HR = 0.7; 95% CI, 0.54-0.9), Cosentino said during a presentation, noting the treatment effect compared with placebo was consistent in those taking the 5 mg dose of ertugliflozin (HR = 0.71; 95% CI, 0.52-0.97) and in those taking the 15 mg dose (HR = 0.68; 95% CI, 0.5-0.93).
The prespecified secondary endpoint also favored ertugliflozin regardless of whether patients had a history of HF (P for interaction = .4) and whether patients had reduced (45% or less), preserved (more than 45%) or unknown ejection fraction (P for interaction = .15), Cosentino said. He added there was a trend toward greater effect of ertugliflozin in patients with reduced EF compared with patients with preserved or unknown EF (P for interaction = .06).
However, he said, the treatment effect of ertugliflozin for the prespecified secondary outcome was more favorable in the following categories:
- patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 vs. those with eGFR 60 mL/min/1.73 m2 (P for interaction = .04);
- patients with micro- or macroalbuminuria vs. those with normal albumin levels (P for interaction = .04);
- patients taking diuretics vs. those not taking them (P for interaction = .02); and
- patients taking loop diuretics vs. those not taking them (P for interaction = .01).
When the researchers analyzed total events over 3.5 years, counting first and subsequent events, they found ertugliflozin reduced risk for total HF hospitalizations (RR = 0.7; 95% CI, 0.56-0.87) and total HF hospitalizations or CV death (RR = 0.83; 95% CI, 0.72-0.96) compared with placebo.
“Ertugliflozin reduced HF hospitalization events in patients with diabetes and atherosclerotic cardiovascular disease, with or without a history of heart failure, consistent with the results for other SGLT2 inhibitors,” Cosentino said during the presentation. “Ertugliflozin reduced total HF hospitalization events and total HF hospitalization/CV death events. These results support current guidelines from cardiology and diabetes societies that recommend use of SGLT2 inhibitors in patients with diabetes to reduce the risk of hospitalization for heart failure.”
Collapse
Cosentino F, et al. Efficacy of ertugliflozin on heart failure-related events in patients with type 2 diabetes mellitus and established atherosclerotic cardiovascular disease: Results of the VERTIS CV trial. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 1, 2020 (virtual meeting).
Click Here to Manage Email Alerts