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

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
EMPEROR-Reduced - Placebo	Placebo	Participants of the EMPEROR-Reduced study (1245.121) who received placebo once daily (QD).
EMPEROR-Preserved - Placebo	Placebo	Participants of the EMPEROR-Preserved study (1245.110) who received placebo once daily (QD).
EMPA-REG - Placebo	Placebo	Participants of the EMP-REG OUTCOME study (1245.25) who received placebo.
EMPEROR-Reduced - Empagliflozin	Empagliflozin	Participants of the EMPEROR-Reduced study (1245.121) who received empagliflozin once daily (QD).
EMPA-REG - Empagliflozin high dose	Empagliflozin	Participants of the EMP-REG OUTCOME study (1245.25) who received a high dose of empagliflozin once daily (QD).
EMPA-REG - Empagliflozin low dose	Empagliflozin	Participants of the EMPA-REG OUTCOME study (1245.25) who received a low dose of empagliflozin once daily (QD).
EMPEROR-Preserved - Empagliflozin	Empagliflozin	Participants of the EMPEROR-Preserved study (1245.110) who received empagliflozin once daily (QD).

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Lower Limb Amputation (LLA)	From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days.	Incidence rate of lower limb amputation (LLA). Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. Abbreviation: pt-yrs = patient-years.

Secondary Outcome Measures

Name	Time	Method
Incidence Rate of Adverse Events Related to Amputation	From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days.	Incidence rate of adverse events (AEs) related to amputation. Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. A search with a pre-defined list of MedDRA preferred terms was performed to identify all AEs related to amputation. These AE included vascular disorders, diabetic-foot-related events, wound/infections, nervous system disorders and volume depletion events. Abbreviation: pt-yrs = patient-years.