A latest research revealed within the journal Diabetes Remedy discusses the outcomes of the PIONEER REAL research performed within the Netherlands, which evaluated the efficacy of oral semaglutide in managing kind 2 diabetes and supporting weight reduction.
Examine: Actual-World Use of Oral Semaglutide in Adults with Sort 2 Diabetes within the PIONEER REAL Netherlands Multicentre, Potential, Observational Examine. Picture Credit score: Davor Geber / Shutterstock.com
Background
In 2021, about 500 million folks had been estimated to be residing with kind 2 diabetes all through the world. The prevalence of kind 2 diabetes is predicted to proceed to rise, with researchers estimating that roughly 700 million can be recognized with this situation by 2045.
Within the Netherlands, an estimated 1.1 million folks had been residing with diabetes in 2021, over 90% of whom had been recognized with kind 2 diabetes. With such a excessive prevalence, kind 2 diabetes is related to an annual price of €1.3 billion within the Netherlands.
The Netherlands Diabetes Federation recommends a stepwise introduction of diabetes remedies primarily based on glycated hemoglobin (HbA1c) ranges. Usually, therapy is initiated sequentially with metformin and sulphonylureas, adopted by the incorporation of insulin, glucagon-like peptide-1 receptor agonists (GLP-1RAs), or dipeptidyl peptidase-4 (DPP-4) inhibitors.
Semaglutide is a GLP-1 analog presently obtainable as every day subcutaneous and oral formulations. Along with weight-reduction plan and train, semaglutide has been proven to successfully handle blood glucose ranges in folks residing with kind 2 diabetes and cut back their danger of cardiovascular issues resembling hypertension and inflammatory responses.
The approval of semaglutide within the Netherlands was primarily based on the outcomes from the section three PIONEER medical trial. To supply further knowledge supporting the usage of once-daily oral semaglutide, the PIONEER REAL program was subsequently initiated in numerous nations all through Europe, North America, the Center East, and East Asia. Extra particularly, PIONEER REAL goals to check the efficacy of oral semaglutide with different injectable glucose-lowering medicines in adults with kind 2 diabetes.
Concerning the research
Between November 2020 and December 2022, the PIONEER REAL research was performed at 27 websites all through the Netherlands. All research individuals had been over 18 years of age, recognized with T2D, and had by no means been handled with an injectable glucose-lowering drug apart from short-term insulin.
The first research endpoint was to evaluate modifications in HbA1c ranges from baseline to the top of the research, whereas secondary endpoints included modifications in physique weight. The research individuals had been additionally supplied with a questionnaire-based evaluation of therapy satisfaction.
Examine participant traits
A complete of 187 sufferers had been included within the present research and obtained once-daily oral semaglutide for 34-44 weeks. The imply age of the research cohort was 58 years, 54% of whom had been male and 88% had been White. The imply length of residing with diabetes was 8.7 years.
The imply physique weight was 103.1 kilograms, whereas imply waist circumference and physique mass index (BMI) measurements had been 118.1 cm and 35.1 kg/m2, respectively.
A imply of 1.6 and a couple of.4 antidiabetic medicines had been utilized by research individuals at baseline and the top of the research, respectively. Oral semaglutide was not included amongst these medicines. About 10% of individuals reported not receiving any glucose-lowering medicines at baseline.
About 98% of individuals obtained three milligrams (mg) of oral semaglutide, whereas 2% obtained seven mg of oral semaglutide for a median length of 37.7 weeks.
Therapeutic efficacy of oral semaglutide
Oral semaglutide recipients skilled a major discount in HbA1c ranges from 8.6% at baseline to 7.3% on the finish of the research.
About 8% of the research cohort had HbA1c ranges lower than 7% at baseline. By the top of the research interval, 48% of individuals exhibited HbA1c ranges of lower than 7%.
A major discount in physique weight of 5.8 kg was noticed following semaglutide therapy. Notably, the HbA1c and physique weight results of oral semaglutide therapy didn’t differ considerably between sufferers handled by diabetes or non-diabetes specialists.
The individuals handled with semaglutide reported a major stage of therapy satisfaction, with 26.1% and 55.4% reporting that semaglutide was straightforward or very straightforward to eat, respectively.
By the top of the research, about 79% of individuals had been being handled with oral semaglutide, with a imply dose of 10.6 mg. Extra particularly, 53.7%, 42.2%, and 4.1% had been receiving 14 mg, seven mg, and three mg doses, respectively.
Security profile
A complete of 246 mild-to-moderate opposed results had been reported in 58% of oral semaglutide recipients. Ten extreme opposed occasions had been noticed in 4.8% of individuals, with one case of cholecystitis and one anal abscess possible associated to oral semaglutide therapy.
Gastrointestinal issues had been probably the most ceaselessly reported negative effects skilled by about 45% of research individuals, much like that noticed for different GLP-1RAs. Antagonistic results that led to semaglutide therapy termination included nausea, vomiting, and diarrhea.
One dying as a consequence of cardiac dysfunction occurred throughout the research interval; nonetheless, this occasion was possible unrelated to semaglutide therapy.
Journal reference:
- van Houtum, W., Schrombges, P., Amadid, H., et al. (2024). Actual-World Use of Oral Semaglutide in Adults with Sort 2 Diabetes within the PIONEER REAL Netherlands Multicentre, Potential, Observational Examine. Diabetes Remedy. doi:10.1007/s13300-024-01588-5, https://hyperlink.springer.com/article/10.1007/s13300-024-01588-5
