• Stephen C Bain, Ofri Mosenzon, Rosario Arechavaleta, Pawel Bogdański, Abdurrahman Comlekci, Agostino Consoli, Chaicharn Deerochanawong, Kathleen Dungan, Maria C Faingold, Michael E Farkouh, Denise R Franco, Jeppe Gram, Cristian Guja, Pankaj Joshi, Rachid Malek, Juan F Merino-Torres, Michael A Nauck, Sue D Pedersen, Wayne H-H Sheu, Robert J Silver, Cees J Tack, Nikhil Tandon, Ole K Jeppesen, Mette Strange, Mette Thomsen, and Mansoor Husain.
• Diabetes Research Unit Cymru, Swansea University Medical School, Swansea, UK.
• Diabetes Obes Metab. 2019 Mar 1; 21 (3): 499-508.

AimsTo assess the cardiovascular (CV) safety of oral semaglutide, the first tablet formulation of a glucagon-like peptide-1 receptor agonist.Materials And MethodsPIONEER 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.ResultsOverall, 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.ConclusionsPIONEER 6 will provide evidence regarding the CV safety of oral semaglutide in patients with type 2 diabetes and high CV risk.© 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

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