Ontology highlight
ABSTRACT: Aims
To assess the cardiovascular (CV) safety of oral semaglutide, the first tablet formulation of a glucagon-like peptide-1 receptor agonist.Materials and methods
PIONEER 6 is a multinational, randomized, placebo-controlled, double-blind trial in patients with type 2 diabetes at high risk of CV events (defined as being aged ≥50 years and having established CV disease [CVD] or moderate [stage 3] chronic kidney disease [CKD], or being aged ≥60 years with ≥1 other CV risk factor). Patients were randomized to once-daily oral semaglutide (up to 14 mg) or placebo added to standard of care. The primary composite endpoint is time to first occurrence of CV death or non-fatal myocardial infarction or non-fatal stroke. The primary hypothesis was to exclude an excess in CV risk with oral semaglutide by assessing non-inferiority versus placebo for the primary endpoint (non-inferiority margin of 1.8 for the upper boundary of the 95% confidence interval of the hazard ratio). PIONEER 6 is event-driven, with follow-up continuing until accrual of at least 122 primary outcome events. There is no pre-defined minimal duration.Results
Overall, 3183 patients have been enrolled (mean age 66.1 years, 31.6% females) in 214 sites across 21 countries. At baseline, the mean duration of diabetes was 14.9 years, mean glycated haemoglobin concentration was 66 mmol/mol (8.2%), and 84.6% of patients had established CVD/moderate CKD.Conclusions
PIONEER 6 will provide evidence regarding the CV safety of oral semaglutide in patients with type 2 diabetes and high CV risk.
SUBMITTER: Bain SC
PROVIDER: S-EPMC6587508 | biostudies-literature | 2019 Mar
REPOSITORIES: biostudies-literature
Bain Stephen C SC Mosenzon Ofri O Arechavaleta Rosario R Bogdański Pawel P Comlekci Abdurrahman A Consoli Agostino A Deerochanawong Chaicharn C Dungan Kathleen K Faingold Maria C MC Farkouh Michael E ME Franco Denise R DR Gram Jeppe J Guja Cristian C Joshi Pankaj P Malek Rachid R Merino-Torres Juan F JF Nauck Michael A MA Pedersen Sue D SD Sheu Wayne H-H WH Silver Robert J RJ Tack Cees J CJ Tandon Nikhil N Jeppesen Ole K OK Strange Mette M Thomsen Mette M Husain Mansoor M
Diabetes, obesity & metabolism 20181111 3
<h4>Aims</h4>To assess the cardiovascular (CV) safety of oral semaglutide, the first tablet formulation of a glucagon-like peptide-1 receptor agonist.<h4>Materials and methods</h4>PIONEER 6 is a multinational, randomized, placebo-controlled, double-blind trial in patients with type 2 diabetes at high risk of CV events (defined as being aged ≥50 years and having established CV disease [CVD] or moderate [stage 3] chronic kidney disease [CKD], or being aged ≥60 years with ≥1 other CV risk factor). ...[more]