SCORED, SOLOIST Trials to Add to Proof for Treating Diabetes with SGLT2 Inhibitors

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SCORED, SOLOIST Studies Provide Evidence for Treatment of Diabetes with SGLT2 Inhibitors

Two large clinical studies conducted by researchers at Brigham and Women’s Hospital are shedding new light on the benefits for those with diabetes and chronic kidney disease, as well as those with diabetes or recent worsening heart failure. Previous studies have tried to show better blood sugar control, cardiovascular benefits, weight loss, and more in patients with diabetes taking sodium / glucose cotransporter-2 inhibitors (SGLT2).

The two paired studies evaluated sotagliflozin, a drug that inhibits SGLT2 and SGLT1, according to a study published in the New England Journal of Medicine.

“With the results of these two large studies added to other recent data on drugs in this class, it is now clear that most patients with type 2 diabetes and either kidney disease or heart failure should receive an SGLT2 inhibitor,” said Deepak L. Bhatt, MD, MPH, the executive director of Interventional Cardiovascular Programs at Brigham, in a press release.

Bhatt added that the “Sotagliflozin Cardiovascular and Renal Events in Patients with Type 2 Diabetes and Moderate Renal Impairment at Cardiovascular Risk” (SCORED) study provides additional randomized clinical trials demonstrating that SGLT2 inhibitors are part of the standard of care for patients should be with type 2 diabetes and kidney disease. The study “The Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes After Worsening Heart Failure” (SOLOIST-WHF) shows that early induction of SGLT2 inhibitors in the hospital is safe and effective and is standard of treatment should be used in patients with type 2 diabetes mellitus and heart failure.

Furthermore, sotagliflozin not only inhibits SGLT2 but also SGLT1. SGLT2 inhibition helps the body eliminate blood sugar through the urine, while SGLT1 inhibition leads to lowering blood sugar through the digestive tract.

In the SCORED study, researchers evaluated whether sotagliflozin could prevent cardiovascular events in patients with diabetes with chronic kidney disease. The study enrolled 10,584 patients who were followed for an average of 16 months but ended prematurely due to the loss of funding associated with Coronavirus Disease 2019 (COVID-19). The study authors changed the primary endpoint, but the initial endpoint reached statistical significance.

In contrast to previous studies, SCORED patients had the full range of albuminuria or urinary leakage of protein that can occur in diabetes. In addition, sotagliflozin significantly reduced the primary endpoint of overall incidence of cardiovascular death, hospitalizations for heart failure, or urgent visits for heart failure by approximately 26%, regardless of the patient’s degree of albuminuria.

In addition, sotagliflozin reduced the rate of cardiovascular death, myocardial infarction, or stroke, with an early benefit possibly mediated by the SGLT1 effect. The total number of fatal or non-fatal heart attacks and the total number of fatal or non-fatal strokes decreased by 32% and 34%, respectively.

“SCORED is the first study to show the benefits of SGLT2 inhibitors for the full spectrum of albuminuria,” said Bhatt in a press release. “It is also the first study with an SGLT2 inhibitor to show a positive effect on stroke.”

The study “The effect of sotagliflozin on cardiovascular events in patients with type 2 diabetes after worsening heart failure” (SOLOIST-WHF) enrolled 1,222 patients with type 2 diabetes mellitus and a recent worsening heart failure who had a Required hospitalization, included. Patients were randomly assigned to sotagliflozin or placebo and followed up for an average of 9 months. However, the study ended early due to the loss of funding from the COVID-19 pandemic.

Data from patients who participated in the study showed a significant 33% reduction in the primary endpoint of the study (defined as the total incidence of cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure) in patients with heart failure with reduced or conserved Ejection fraction. Taking the drug before leaving the hospital was safe and effective.

“SOLOIST is the first large, randomized trial to demonstrate the safety and efficacy of SGLT2 inhibitors when hospitalized in patients with acute heart failure,” said Bhatt in a press release. “So it really changes the field and supports the early adoption of this class of drugs.”

There were limitations to the SCORED and SOLOIST studies, including early retirement due to funding losses that resulted in failure to complete the intended duration of follow-up. However, both studies found statistically significant decreases in the rate of total cardiovascular events for their respective patient populations.

REFERENCE
SCORED and SOLOIST studies prove the treatment of diabetes with SGLT2 inhibitors. Brigham Health and Women’s Hospital. https://www.brighamandwomens.org/about-bwh/newsroom/press-releases-detail?id=3732. Published November 16, 2020. Accessed February 3, 2021.