ABSTRACT
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.
Subject(s)
Benzhydryl Compounds/therapeutic use , Cardiovascular Diseases/therapy , Clinical Trials as Topic/methods , Diabetes Mellitus, Type 2/drug therapy , Evidence-Based Medicine , Glucosides/therapeutic use , Research Design , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Benzhydryl Compounds/adverse effects , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/mortality , Clinical Decision-Making , Diabetes Mellitus, Type 2/diagnosis , Diabetes Mellitus, Type 2/mortality , Glucosides/adverse effects , Hospitalization , Humans , Practice Guidelines as Topic , Practice Patterns, Physicians' , Protective Factors , Risk Assessment , Risk Factors , Sodium-Glucose Transporter 2 Inhibitors/adverse effects , Treatment OutcomeABSTRACT
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.
Subject(s)
Cardiovascular Diseases/epidemiology , Diabetes Mellitus, Type 2/drug therapy , Sodium-Glucose Transporter 2 Inhibitors/adverse effects , Cardiovascular Diseases/etiology , Comorbidity , Humans , Incidence , PrognosisABSTRACT
Apart from seeking target organ damage, the investigation of hypertension is primarily aimed at finding a treatable cause of the hypertension. The finding of one such cause is usually construed as being the sole culprit responsible for the patient's elevated blood pressure. The existence of multiple aetiologies of secondary hypertension in one patient is infrequent. In this report, we describe such a patient in whom secondary hypertension due to Cushing's disease, renovascular and finally baroreflex failure was successively documented.
