Results from the PIONEER 6 trial suggest that oral semaglutide is safe for patients with type 2 diabetes at high cardiovascular (CV) risk, according to findings presented at the Scientific Sessions on Tuesday, June 11. PIONEER researchers reported that oral semaglutide, the first GLP-1 receptor agonist for oral administration, reduced CV death and all-cause mortality by nearly 50 percent versus placebo after a median follow-up of 15.9 months.
The PIONEER Program Trials enrolled more than 8,000 people with type 2 diabetes in 10 global clinical trials. PIONEER 6 was conducted across 21 countries and included 3,183 participants who were randomized to receive placebo or a 14 mg dose of oral semaglutide once daily. The study’s primary endpoint was time to first major adverse cardiac event (MACE), including cardiovascular death, nonfatal myocardial infarction, or non-fatal stroke.
“PIONEER 6 achieved its primary objective, confirming noninferiority for oral semaglutide versus placebo for cardiovascular safety in a high-risk population, with a non-significant 21 percent reduction in three-point MACE over a median follow-up period of just under 16 months,” said lead investigator Mansoor Husain, MD, Director of the Toronto General Hospital Research Institute, Executive Director of the Ted Rogers Centre for Heart Research, and Professor of Medicine at the University of Toronto. “In addition, although the numbers of events observed are low and the follow-up period relatively short, patients treated with oral semaglutide had a 50 percent reduction in both cardiovascular death and all-cause mortality compared to patients treated with placebo.”
Oral semaglutide is currently under review by the U.S. Food and Drug Administration, the European Medicines Agency, and Health Canada. It could be approved and available by the end of the year or early next year, said chief investigator John B. Buse, MD, PhD, Professor of Medicine, Director of the Diabetes Care Center, and Chief of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill.
“The GLP-1 receptor agonists are arguably the most powerful glucose-lowering and weight-lowering medications that we have,” Dr. Buse said. “However, there are some people who are reluctant to take the medication because it is currently only available as an injection, which is a barrier to using this otherwise good class of drugs. By eliminating the barrier of injection, oral semaglutide has the potential to be more frequently used early in the course of disease, and perhaps will become the preferred agent in the class.”
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