Abstract 14961: External Applicability of REDUCE-IT in a Large Diabetes Cardiovascular Outcomes Trial: A Post Hoc Analysis of EMPA-REG OUTCOME
Abstract
Introduction:
In the REDUCE-IT trial, icosapent ethyl (IPE) was shown to reduce major adverse cardiac events (MACE) including cardiovascular (CV) death in patients with elevated triglycerides (TG) and atherosclerotic CV disease (ASCVD) and/or diabetes. There are limited data evaluating the external applicability of REDUCE-IT inclusion criteria in contemporary diabetes trials. In EMPA-REG OUTCOME, empagliflozin (EMPA) reduced the risk of CV death and hospitalization for HF (HHF). We sought to evaluate the benefit of EMPA on CV outcomes across IPE eligibility in the EMPA-REG OUTCOME trial.
Methods:
In total, 7020 patients with type 2 diabetes and ASCVD were treated with EMPA 10mg, 25 mg, or placebo (PBO). We examined the proportion of patients that had baseline (BL) TG 135 to 499 mg/dl, LDL-C 41 to 100 mg/dl and using a statin (“REDUCE-IT-like patients”). We evaluated the effect of pooled EMPA vs. PBO on CV death, HHF, HHF or CV death (excluding fatal stroke), all-cause death, and 3-point-MACE across the subgroups of patients fulfilling vs not fulfilling the REDUCE-IT criteria at BL using Cox regression.
Results:
A total of 6935 patients had TG and 6932 had LDL-C available. 1810 patients (25.8%) were REDUCE-IT like with TG 206±69 vs. 158±140 mg/dl, and LDL-C 71±15 vs. 91±39 mg/dl in those who did not meet the criteria. At BL, the former had more often coronary artery disease (84 vs. 73%) and higher BMI (31.7±5.1 kg/m
2
vs. 30.3±5.3) vs. the latter group. CV event rates in PBO…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 7,020 participants or records.
Read the paper
Related studies
- Risk Factors for Coronavirus Disease 2019 (COVID-19) Death in a Population Cohort Study from the Western Cape Province, South Africa
- Global and regional estimates of genital human papillomavirus prevalence among men: a systematic review and meta-analysis
- A methodology for assessing deployment trauma and its consequences in OEF/OIF/OND veterans: The TRACTS longitudinal prospective cohort study
- Post‑COVID‑19 Syndrome in Outpatients: a Cohort Study
- Factors Influencing Primary and Secondary Implant Stability—A Retrospective Cohort Study with 582 Implants in 272 Patients
- Electroacupuncture for Painful Diabetic Peripheral Neuropathy: A Multicenter, Randomized, Assessor-Blinded, Controlled Trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.