A Meta-Analysis of Amputation Risk in Empagliflozin Studies (1245.25, 1245.110, 1245.121)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 16,746
- Locations
- 1
- Primary Endpoint
- Incidence Rate of Lower Limb Amputation (LLA)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
EMPA-REG - Placebo
Participants of the EMP-REG OUTCOME study (1245.25) who received placebo.
Intervention: Placebo (Drug)
EMPA-REG - Empagliflozin low dose
Participants of the EMPA-REG OUTCOME study (1245.25) who received a low dose of empagliflozin once daily (QD).
Intervention: Empagliflozin (Drug)
EMPA-REG - Empagliflozin high dose
Participants of the EMP-REG OUTCOME study (1245.25) who received a high dose of empagliflozin once daily (QD).
Intervention: Empagliflozin (Drug)
EMPEROR-Preserved - Empagliflozin
Participants of the EMPEROR-Preserved study (1245.110) who received empagliflozin once daily (QD).
Intervention: Empagliflozin (Drug)
EMPEROR-Preserved - Placebo
Participants of the EMPEROR-Preserved study (1245.110) who received placebo once daily (QD).
Intervention: Placebo (Drug)
EMPEROR-Reduced - Empagliflozin
Participants of the EMPEROR-Reduced study (1245.121) who received empagliflozin once daily (QD).
Intervention: Empagliflozin (Drug)
EMPEROR-Reduced - Placebo
Participants of the EMPEROR-Reduced study (1245.121) who received placebo once daily (QD).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence Rate of Lower Limb Amputation (LLA)
Time Frame: 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 Outcomes
- 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.)