Obstructive sleep apnoe and cardiovascular, heart failure and mortality outcomes with empagliflozin versus placebo in the EMPA-REG OUTCOME trial
Abstract
Obstructive sleep apnoe (OSA) and type 2 diabetes (T2D) occurs more frequently in persons with obesity, and both OSA and T2D are associated with metabolic disturbances that increases the risk for cardiovascular disease (CVD). In EMPA-REG OUTCOME, a randomized placebo-controlled outcome trial involving 7020 patients with T2D and CVD, the sodium glucose co-transporter (SGLT)-2 inhibitor empagliflozin reduced HbA1c, systolic blood pressure, waist circumference, and weight, and also reduced the risk of 3-point major adverse CV events (3P- MACE) by 14%, CV death by 38% and hospitalization for heart failure (HHF) by 35%.
We investigated incidence rates of CV, HHF, and mortality outcomes in patients with or without OSA at baseline, and the treatment effect of empagliflozin, in EMPA-REG OUTCOME.
The trial included patients from 42 countries with T2D (with HbA1c 7.0–9.0% for drug-naïve patients and 7.0–10.0% for those on stable glucose-lowering therapy), established CVD, and estimated glomerular filtration rate >30 mL/min/1.73 m2. Patients were randomised (1:1:1) to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily in addition to standard of care. All CV outcomes were independently adjudicated and events were pooled for the 10 and 25mg doses. In this post-hoc analysis, OSA were assessed based on investigator reports using MedDRA 18.0 and incidence rates for outcomes were reported by adjusted event-rates per 100 patient-years. Analysis of effects on outcomes were…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. 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.