1. Inicio
  2. Publicaciones
  3. Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: Rationale, design and patient baseline characteristics for the PIONEER 6 trial

Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: Rationale, design and patient baseline characteristics for the PIONEER 6 trial

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Bain, SC
  • Mosenzon, O
  • Arechavaleta, R
  • Bogdanski, P
  • Comlekci, A
  • Consoli, A
  • Deerochanawong, C
  • Dungan, K
  • Faingold, MC
  • Farkouh, ME
  • Franco, DR
  • Gram, J
  • Guja, C
  • Joshi, P
  • Malek, R
  • Nauck, MA
  • Pedersen, SD
  • Sheu, WHH
  • Silver, RJ
  • Tack, CJ
  • Tandon, N
  • Jeppesen, OK
  • Strange, M
  • Thomsen, M
  • Husain, M

Grupos

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.

Datos de la publicación

ISSN/ISSNe:
1462-8902, 1463-1326

DIABETES OBESITY & METABOLISM  WILEY

Tipo:
Article
Páginas:
499-508
PubMed:
30284349
Factor de Impacto:
2,497 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 80

Documentos

  • No hay documentos

Métricas

Filiaciones mostrar / ocultar

Keywords

  • cardiovascular disease; cardiovascular outcomes trial; GLP-1 receptor agonist; oral semaglutide; type 2 diabetes

Compartir