EMPA-REG OUTCOME: cardiovascular outcome trials in diabetes come of age
Abstract
Without question, the highlight of the 2015 European Association for the Study of Diabetes conference in Stockholm was the presentation – to a capacity audience – of the results of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG) OUTCOME trial. This was a highly fitting event for the Association, which celebrated its 50th anniversary last year, the aims of which are innovation and clinical relevance. Moreover, the study is an exceptional example of the clinical relevance of metabolic and cardiovascular interactions in patients with diabetes. In brief, EMPA-REG OUTCOME was a multinational, randomized, double blind, placebo-controlled trial involving 7000 patients with type 2 diabetes at high risk for cardiovascular events by virtue of pre-existing macrovascular disease. The study was designed to assess the effect of the sodium-glucose cotransporter (SGLT-2) inhibitor empagliflozin (10 or 25 mg once daily), compared with placebo, in addition to standard care. The details, trailed in advance as positive in a press release from the sponsors Boehringer Ingelheim and Eli Lilly, were delivered during a clear and well-choreographed presentation by the investigators; the peer-reviewed paper was published simultaneously 1. The data exceeded the expectations of many attendees. There were 772 primary outcome events over a median observation period of 3.1 years. The primary major adverse cardiovascular event endpoint (cardiovascular…
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: 7,000 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.