By Colin Kenny, Editor – Diabetes Distilled
An outcome study for oral semaglutide has evaluated the drug’s cardiovascular safety against placebo when added to standard care. Semaglutide is an injectable incretin that has recently become available; oral semaglutide has not yet been approved by the European Medicines Agency. Results showed no significant difference in three-point major adverse cardiac events, but there was a significant reduction in cardiovascular death and all-cause mortality with oral semaglutide.
In the Peptide Innovation for Early Diabetes Treatment study 6 (PIONEER 6), a total of 3,183 patients living with type 2 diabetes who had a mean age of 66 years were randomly assigned to receive oral semaglutide (n=1,591) or placebo (n=1,592). The majority of participants (84.7%) were aged 50 or older and had existing cardiovascular disease or chronic kidney disease.
Participants took their allocated agent 30 minutes before food in the morning and remained on the agent for an average of 15.9 months. The primary outcome was the first occurrence of a major adverse cardiovascular event (death from cardiovascular causes, non-fatal myocardial infarction or non-fatal stroke).
Major adverse cardiovascular events occurred in 61 patients (3.8%) receiving oral semaglutide and 76 (4.8%) patients taking placebo. Death from any cause occurred in 23 individuals (1.4%) in the oral semaglutide group versus 45 (2.8%) people in the placebo group. Gastrointestinal adverse events leading to the discontinuation of treatment were more common with oral semaglutide.
Patients with type 2 diabetes are currently being recruited for a further cardiovascular study of this oral agent.
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