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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16746 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-07-13

Brief Summary

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The primary objective of this exploratory meta-analysis is to evaluate the frequencies, incidence rates, and hazard ratios of lower-limb amputation (LLA) events (primary outcome) and of adverse events related to amputation (secondary outcome) in patients treated with empagliflozin compared with placebo in the pooled population of the long-term studies 1245.25, 1245.110, and 1245.121 (SAF-M1), in the pooled population of studies 1245.110 and 1245.121 (SAFM2), and in each of the 3 studies separately.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Intervention Type DRUG

Empagliflozin

Empagliflozin once daily

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

* Uncontrolled hyperglycemia: fasting plasma glucose \>240 mg/dl
* Severe renal impairment defined as eGFR \<30 ml/min by Modification of diet in renal disease (MDRD) formula
* Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial, or participating in another trial (involving an investigational drug and/or follow-up)

* Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or transient ischaemic attack ≤90 days before screening
* Heart transplant recipient, or listed for heart transplant
* Acute decompensated HF
* Systolic blood pressure (SBP) ≥180 mmHg at randomisation
* Symptomatic hypotension and/or SBP \<100 mmHg at screening or randomisation
* Impaired renal function defined as Estimated glomerular filtration rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration Equation (based on serum creatinine value) \<20 ml/min/1.73 m2 or requiring dialysis at screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No