BACKGROUND: For patients with type 2 diabetes (T2D), cardiovascular disease (CVD) is the single most common cause of mortality. In 2008 and 2012, the Federal Drug Administration (FDA) and the European Medicines Agency (EMA) respectively mandated cardiovascular outcomes trials (CVOTs) on all new anti-diabetic agents, as prospective trials statistically powered to rule out excess cardiovascular risk in patients with T2D. Unexpectedly, some of these CVOTs have demonstrated not only cardiovascular safety, but also cardioprotective effects, as was first shown for the SGLT2 inhibitor empagliflozin in EMPA-REG OUTCOME. EXPERT OPINION: To debate newly available CVOT data and to put them into context, we convened as a group of medical experts from the Central and Eastern European Region. Here we describe our discussions, focusing on the conclusions we can draw from EMPA-REG OUTCOME and other SGLT2 inhibitor CVOTs, including when considered alongside real-world evidence. CONCLUSION: CVOTs investigating SGLT2 inhibitors have suggested benefits beyond glucose lowering that have been confirmed in real-world evidence studies.

1st Dept of Internal Medicine University of Szeged Szeged Hungary

Clinic for Endocrinology Diabetes and Metabolic Diseases Clinical Centre of Serbia Faculty of Medicine University of Belgrade Beograd Serbia

Clinical Centre of Endocrinology Medical University Sofia Sofia Bulgaria

Department of Diabetology and Internal Medicine Warsaw Medical University Warsaw Poland

Department of Endocrinology Diabetes and Metabolic Diseases University Medical Centre Ljubljana Slovenia

Department of Medicine 1 Rudolfstitung Hospital Vienna Austria

Diabetes Centre Charles University and General Faculty Hospital Prague Czech Republic

Division of Angiology Swiss Cardiovascular Center University Hospital of Berne Bern Switzerland

Division of Endocrinology and Diabetology Medical University of Graz Graz Austria

Division of Endocrinology Faculty of Internal Medicine University of Latvia Riga Latvia

Drexel University College of Medicine Philadelphia PA USA

Endocrinology Research Centre Moscow Russian Federation

Institute of Endocrinology Lithuanian University of Health Sciences Kaunas Lithuania

National Institute of Endocrinology and Diabetology Lubochna Slovakia

Private University of the Principality of Liechtenstein Triesen Liechtenstein

School of Medicine University of Zagreb Vuk Vrhovac University Clinic UH Merkur Zagreb Croatia

Unit of Endocrinology and Metabolism Sapir Medical Center Kfar Saba Israel

VIVIT Institute Academic Teaching Hospital Feldkirch Feldkirch Austria

Vorarlberg Institute for Vascular Investigation and Treatment Feldkirch Austria

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