01.08.2019 |
Mansoor Husain, M.D., Andreas L. Birkenfeld, M.D., Morten Donsmark, Ph.D., Kathleen Dungan, M.D., M.P.H., Freddy G. Eliaschewitz, M.D., Denise R. Franco, M.D., Ole K. Jeppesen, M.Sc., Ildiko Lingvay, M.D., M.P.H., M.S.C.S., Ofri Mosenzon, M.D., Sue D. Pedersen, M.D., Cees J. Tack, M.D., Mette Thomsen, M.D., D.M.Sc., Tina Vilsbøll, M.D., D.M.Sc., Mark L. Warren, M.D., and Stephen C. Bain, M.D., for the PIONEER Investigators
בשל "הגנת זכויות יוצרים", מובא להלן קישור למאמר בלבד. לקריאתו בטקסט מלא, אנא פנה לספרייה הרפואית הזמינה לך.
Establishing cardiovascular safety of new therapies for type 2 diabetes is important.
Safety data are available for the subcutaneous form of the glucagon-like peptide-1 receptor agonist semaglutide but are needed for oral semaglutide.
We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (age of ≥50 years with established cardiovascular or chronic kidney disease, or age of ≥60 years with cardiovascular risk factors only).
The primary outcome in a time-to-event analysis was the first occurrence of a major adverse cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke).
The trial was designed to rule out 80% excess cardiovascular risk as compared with placebo (noninferiority margin of 1.8 for the upper boundary of the 95% confidence interval for the hazard ratio for the primary outcome).
The New England Journal of Medicine, VOL. 381 NO. 9