This Study Combines Data From 3 Other Studies Testing Empagliflozin in Patients With Diabetes or With Chronic Heart Failure. The Study Looks at the Numbers of Patients Who Had Lower Limb Amputations

Inclusion Criteria

• •Age ≥18 years, diagnosis of type 2 diabetes mellitus (T2DM)
• •Drug-naïve or pretreated with any background therapy
• •Glycated haemoglobin (HbA1c) criteria
• •* Patients who were drug-naïve: HbA1c of 7 to 10%
• •* Patients with background therapy: HbA1c of 7 to 9%
• •Body mass index (BMI) ≤45 kg/m2
• •With high cardiovascular risk, defined as ≥1 of the following criteria
• •* History of myocardial infarction (\>2 months prior to enrollment)
• •* Multi-vessel coronary artery disease: ≥2 major vessels or left main coronary artery
• •* Single-vessel coronary artery disease with no scheduled revascularization/previously unsuccessful revascularization
• •* Hospital discharge due to unstable angina pectoris (\>2 months prior to enrollment)
• •* History of stroke (\>2 months prior to enrollment)
• •* Peripheral occlusive arterial disease
• •Age ≥18 years (Japan, age ≥20 years)
• •Chronic heart failure (HF) new york hear association (NYHA) class II to IV
• •Ejection fraction (EF) and N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) criteria
• •* 1245.110: preserved EF (Left ventricular ejection fraction (LVEF) \>40%) and elevated NT-proBNP (\>300 pg/ml; \>900 pg/ml for patients with atrial fibrillation)
• •* 1245.121: reduced EF (LVEF ≤40%) and elevated NT-proBNP (≥2500 pg/ml if EF 36 to 40%, ≥1000 pg/ml if EF 31 to 35%, ≥600 pg/ml if EF ≤30% or if EF ≤40% with documented hospitalisation for HF within 12 months prior to screening; for patients with atrial fibrillation, double the level of NT-proBNP is applied for each EF category)
• •1245.110 only: structural heart disease within 6 months or documented hospitalisation for HF within 12 months prior to screening
• •1245.121 only: stable dose of medical therapy for HF consistent with local and international cardiology guidelines