Evidence from routine clinical practice: EMPRISE provides a new perspective on CVOTs.

EMPA-REG OUTCOME is recognised by international guidelines as a landmark study that showed a significant cardioprotective benefit with empagliflozin in patients with type 2 diabetes (T2D) and cardiovascular disease. To assess the impact of empagliflozin in routine clinical practice, the ongoing EMPRISE study is collecting real-world evidence to compare effectiveness, safety and health economic outcomes between empagliflozin and DPP-4 inhibitors. A planned interim analysis of EMPRISE was recently published, confirming a substantial reduction in hospitalisation for heart failure with empagliflozin across a diverse patient population. In this commentary article, we discuss the new data in the context of current evidence and clinical guidelines, as clinicians experienced in managing cardiovascular risk in patients with T2D. We also look forward to what future insights EMPRISE may offer, as evidence is accumulated over the next years to complement the important findings of EMPA-REG OUTCOME.

Comparison of changes in blood glucose, insulin resistance indices, and adipokine levels in diabetic and nondiabetic subjects with morbid obesity after laparoscopic adjustable gastric banding.

OBJECTIVE: The aim of the study was to evaluate blood glucose, insulin resistance indices, and adipokine (leptin and adiponectin) levels in morbidly obese individuals with and without type 2 diabetes mellitus and to compare the changes in these parameters 1 year after laparoscopic adjustable gastric banding surgery. MATERIAL AND METHODS: In total, 103 patients (37 subjects with and 66 subjects without type 2 diabetes mellitus) were studied preoperatively and again 1 year after laparoscopic adjustable gastric banding. RESULTS: One year after laparoscopic adjustable gastric banding, the leptin concentrations decreased significantly in both treatment groups, while the adiponectin levels increased significantly in the nondiabetic patients (11.19 µg/mL [SD 7.20] vs. 15.58 µg/mL [SD 7.8], P=0.003) and tended to increase in the group of the patients with type 2 diabetes mellitus (8.98 µg/mL [SD 6.80] vs. 13.01 µg/mL [SD 12.14], P>0.05). A considerable decrease in the insulin resistance indices was noted in the patients with type 2 diabetes mellitus 1 year after the intervention, and it was followed by a partial or complete remission of type 2 diabetes mellitus in 23 (85.19%) of the 27 investigated diabetic patients. The postoperative insulin resistance indices in the patients with type 2 diabetes mellitus became similar to the values in the nondiabetic subjects. CONCLUSIONS: Weight loss after laparoscopic adjustable gastric banding is associated with a significant increase in adiponectin secretion in nondiabetic morbidly obese patients and with improvement in adiponectin secretion in type 2 diabetes individuals. In subjects with type 2 diabetes, this surgical intervention results in a significant reduction in blood glucose and insulin resistance.