Trial results support latest ADA/EASD guidelines on role of SGLT-2 inhibitors in managing type 2 diabetes
New trial results announced at the EASD’s recent Annual Meeting, provide fresh evidence in support of joint ADA/EASD guidelines on type 2 diabetes management – specifically, the emphasis on use of SGLT-2 inhibitors in patients at high risk of cardiovascular and kidney complications.
Patients with diabetes who have heart failure and reduced ejection fraction are at higher risk of heart failure and renal events – risk increases unseen in patients with pre-diabetes. EMPEROR-Reduced (a Phase III, randomised double-blind placebo-controlled trial) investigated the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction. Participants were people with and without type 2 diabetes, aged 18 years and over, who had chronic heart failure (left ventricular ejection fraction <40%). Those in the empagliflozin group were given 10 mg once daily, as well as standard of care (SOC). Placebo group participants received placebo plus SOC. Median follow up was 16 months. Composite primary endpoint was time to first event of adjudicated cardiovascular death or hospitalisation for heart failure (HHF). Secondary endpoints were first and recurrent HHF episodes and change in eGFR from baseline.
The results confirmed the cardiovascular benefits of SGLT-2 inhibition in type 2 diabetes across a diverse patient population, while demonstrating empagliflozin’s safety profile and tolerability. Treatment with the drug reduced risk of hospitalisation for heart failure and slowed progression of renal disease. Empagliflozin did not reduce HbA1c in those without diabetes and there was no increase in risk of hypoglycaemia.
Other results announced at the Annual Meeting provided further evidence of gliflozins’ beneficial effects on renal outcomes. The VERTIS CV trial, which investigated another SGLT-2 inhibitor – ertugliflozin - showed this drug to be safe, well tolerated and to have a side-effect profile similar to others in the gliflozin class. In particular, the study showed that ertugliflozin resulted in a 40% decline in kidney replacement therapy and renal death and preserved kidney function, especially in those at the greatest risk of worsening diabetic kidney disease.
The opinions expressed in this blog are those of the author, Dr Eleanor D Kennedy.