Final answer:
The EMPA-REG Outcomes Trial studied 7020 patients with type 2 diabetes and established cardiovascular disease. The median observation time is unspecified. Understanding clinical trials is essential for medical professionals evaluating new treatments.
Step-by-step explanation:
In the EMPA-REG Outcomes Trial, 7020 patients with type 2 diabetes and established cardiovascular disease were treated in a multi-center, double-blind, placebo-controlled trial. The median observation time was not provided in the material presented, so we cannot give a direct answer for that part of the question.
A thorough understanding of this type of trial is critical for anyone studying in the field of medicine, as such trials are fundamental to the development and approval of new pharmaceutical treatments. Clinical trials, such as the EMPA-REG outcomes trial, are designed to evaluate the safety and efficacy of medications or treatment strategies. This trial methodology, which often includes a placebo group and rigorous observation protocols, is the gold standard for determining whether a new treatment should be approved for widespread use.
The EMPA-REG Outcomes Trial is particularly significant because it deals with a medication intended for a common condition—type 2 diabetes—which also carries a significant risk of cardiovascular disease. By focusing on patients with both type 2 diabetes and established cardiovascular disease, the trial aimed to determine not just the medication's effectiveness in controlling blood sugar levels, but also its impact on cardiovascular outcomes, which are a leading cause of mortality in this patient population.