Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes
N Engl J Med 2019;381:841–51 DOI 10.1056/NEJMoa1901118
GLP-1 receptor agonists are a well-established class of glucose-lowering therapies that are associated with a reduction in body weight and a low risk of hypoglycaemia. All approved GLP-1 receptor agonists at the time of this study were delivered via subcutaneous injection, which can cause concern amongst both patients and clinicians, and may also cause delays in GLP-1 initiation. Oral semaglutide was developed as a once-daily tablet. As CV disease is the primary cause of death in T2DM, new treatments must demonstrate no additional CV risk prior to approval. Therefore, PIONEER 6 was a pre-approval study to determine the CV risk of oral semaglutide versus placebo.
PIONEER 6 compared CV risks of 14 mg oral semaglutide with placebo in 3,183 patients with type 2 diabetes and found that oral semaglutide was noninferior to placebo in terms of CV risk profile.