Diabetes Trial Files: Empa on Ventricular Arrhythmias in T2DM, Semaglutide for CKD in T2DM, and Tirzepatide vs. Insulin Glargine
Effect of empagliflozin on ventricular arrhythmias in patients with type 2 diabetes treated with an implantable cardioverter-defibrillator (EMPA-ICD)
Fujiki S et al. Cardiovascular Diabetology (June 2024)
Bottom Line: This randomized controlled trial investigated the effects of once-daily empagliflozin on ventricular arrhythmias in 150 patients with type 2 diabetes treated with an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator (ICD/CRT-D). The primary outcome was the change in the number of ventricular arrhythmias from the 24 weeks before to the 24 weeks during treatment. The results showed a statistically significant decrease in ventricular arrhythmias with empagliflozin compared to placebo. Secondary outcomes included changes in appropriate device discharges, blood ketones, hematocrit, blood brain natriuretic peptide, and body weight. No significant difference was found between the groups for appropriate device discharges. Empagliflozin was associated with an increase in blood ketones and hematocrit and a decrease in blood brain natriuretic peptide and body weight. In conclusion, empagliflozin reduces the number of ventricular arrhythmias in patients with type 2 diabetes treated with ICD/CRT-D.
Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes (FLOW)
Perkovic V et al. NEJM (May 2024)
Bottom Line: This randomized controlled trial, conducted by Novo Nordisk, aimed to determine the efficacy of semaglutide in reducing the risk of kidney failure, cardiovascular events, and death in patients with type 2 diabetes and chronic kidney disease. A total of 3533 participants were randomly assigned to receive either subcutaneous semaglutide at a dose of 1.0 mg weekly or placebo. The primary outcome, major kidney disease events, was 24% lower in the semaglutide group compared to the placebo group. Additionally, the results for all confirmatory secondary outcomes favored semaglutide, including a slower decrease in eGFR, lower risk of major cardiovascular events, and lower risk of death from any cause. Serious adverse events were also reported in a lower percentage of participants in the semaglutide group. In conclusion, semaglutide was found to be effective in reducing the risk of kidney disease and death from cardiovascular causes in this patient population.
Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4)
Del Prato S et al. The Lancet (October 2021)
Bottom Line: This phase 3, open-label, parallel-group study included 2002 participants with type 2 diabetes and high cardiovascular risk. They were randomly assigned to receive subcutaneous injections of tirzepatide (5 mg, 10 mg, or 15 mg) or insulin glargine (100 U/mL) for 52 weeks. The primary outcome was non-inferiority of tirzepatide in reducing HbA1c compared to glargine. Tirzepatide showed a statistically significant reduction in HbA1c compared to glargine, with a lower incidence of hypoglycemia. Adverse events such as nausea, diarrhea, decreased appetite, and vomiting were more common with tirzepatide, but were mostly mild to moderate. There was no significant difference in cardiovascular events between the two groups. In conclusion, tirzepatide showed greater and clinically meaningful reduction in HbA1c with a lower incidence of hypoglycemia compared to insulin glargine in adults with type 2 diabetes and high cardiovascular risk.
Diabetes Trial Files Issue #DIA-2024-01
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