PMID- 38240875
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240318
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 15
IP  - 3
DP  - 2024 Mar
TI  - Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes: The PIONEER 
      REAL Switzerland Multicentre, Prospective, Observational Study.
PG  - 623-637
LID - 10.1007/s13300-023-01525-y [doi]
AB  - INTRODUCTION: Real-world data provide insight into how medications perform in 
      clinical practice. The PIONEER REAL Switzerland study aimed to understand 
      clinical outcomes with oral semaglutide in adults with type 2 diabetes (T2D). 
      METHODS: PIONEER REAL Switzerland was a 34-44-week, multicentre, prospective, 
      non-interventional, single-arm study of adults with T2D naive to injectable 
      glucose-lowering medication who were initiated on oral semaglutide in routine 
      clinical practice. The primary endpoint was change in glycated haemoglobin 
      (HbA(1c)) from baseline (BL) to end of study (EOS); secondary endpoints included 
      change in body weight (BW) from BL to EOS and the proportion of participants 
      achieving HbA(1c) < 7.0% and the composite endpoints HbA(1c) 
      reduction >/= 1%-points with BW reduction >/= 3% or >/= 5% at EOS. Safety was assessed 
      in participants who received >/= 1 dose of oral semaglutide. RESULTS: Of the 185 
      participants (female/male, n = 67/118) initiating oral semaglutide, 168 (90.8%) 
      completed the study and 143 (77.3%) remained on treatment with oral semaglutide 
      at EOS. At BL, participants had a mean age of 62 years, diabetes duration of 
      6.4 years, HbA(1c) of 7.7%, BW of 95.6 kg and body mass index of 33.2 kg/m(2); 
      56.2% of participants were receiving glucose-lowering medications. Significant 
      reductions were observed for HbA(1c) (estimated change - 0.91%; 95% confidence 
      interval [CI] - 1.10, - 0.71; p < 0.0001) and BW (estimated change - 4.85%; 95% 
      CI - 5.70, - 4.00; p < 0.0001). In total, 139 adverse events (AEs) were reported 
      in 65 (35.1%) participants; most were mild or moderate. The most frequent AEs 
      were gastrointestinal disorders (27.0%); 31 AEs in 20 (10.8%) participants led to 
      discontinuation of oral semaglutide. Six serious AEs were reported; all were 
      considered unlikely to be related to oral semaglutide. CONCLUSION: People living 
      with T2D treated with oral semaglutide in Switzerland achieved clinically 
      significant reductions in HbA(1c) and BW, with no new safety signals. CLINICAL 
      TRIAL REGISTRATION: ClinicalTrials.gov: NCT04537624. A graphical abstract is 
      available for this article.
CI  - (c) 2024. The Author(s).
FAU - Kick, Anastas
AU  - Kick A
AUID- ORCID: 0009-0001-8132-8299
AD  - Primary Care Group Practice Sanacare, Lugano, Switzerland.
FAU - M'Rabet-Bensalah, Khadija
AU  - M'Rabet-Bensalah K
AUID- ORCID: 0009-0001-5794-2184
AD  - Novo Nordisk Pharma AG, Zurich, Switzerland.
FAU - Acquistapace, Flavio
AU  - Acquistapace F
AD  - SCA: Primary Care Cardiological Practice, Lugano, Switzerland.
FAU - Amadid, Hanan
AU  - Amadid H
AUID- ORCID: 0000-0001-5759-4960
AD  - Novo Nordisk A/S, Soborg, Denmark.
FAU - Ambuhl, Robert A
AU  - Ambuhl RA
AD  - Primary Care Practice Schongrund, Rotkreuz, Switzerland.
FAU - Braae, Uffe Christian
AU  - Braae UC
AUID- ORCID: 0000-0002-2743-4584
AD  - Novo Nordisk A/S, Soborg, Denmark.
FAU - Item, Flurin
AU  - Item F
AUID- ORCID: 0009-0007-2412-2757
AD  - Novo Nordisk Pharma AG, Zurich, Switzerland.
FAU - Schultes, Bernd
AU  - Schultes B
AUID- ORCID: 0000-0002-5301-1163
AD  - Metabolic Center St. Gallen, friendlyDocs AG, St. Gallen, Switzerland.
FAU - Zuger, Thomas
AU  - Zuger T
AUID- ORCID: 0000-0001-6190-7405
AD  - Department of Endocrinology, Diabetes and Metabolic Diseases, Cantonal Hospital 
      of Olten, Olten, Switzerland.
FAU - Rudofsky, Gottfried
AU  - Rudofsky G
AUID- ORCID: 0000-0002-2576-7190
AD  - Department of Endocrinology, Diabetes and Metabolic Diseases, Cantonal Hospital 
      of Olten, Olten, Switzerland. gottfried.rudofsky@hin.ch.
AD  - Practice for Endocrinology, Diabetes and Obesity, Olten, Switzerland. 
      gottfried.rudofsky@hin.ch.
LA  - eng
SI  - ClinicalTrials.gov/NCT04537624
PT  - Journal Article
DEP - 20240119
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC10942937
OTO - NOTNLM
OT  - GLP-1 receptor agonist
OT  - Glucose-lowering medication
OT  - Glycaemic control
OT  - Incretin therapy
OT  - Real-world evidence
OT  - Semaglutide
OT  - Type 2 diabetes
COIS- Anastas Kick: no conflicts to disclose. Flavio Acquistapace: no conflicts to 
      disclose. Robert A. Ambuhl: no conflicts to disclose. Bernd Schultes: Bernd 
      Schultes has received presentation fees from and compensation as a member of a 
      scientific advisory board of Novo Nordisk and Eli Lilly, as well as for serving 
      as a study investigator for Novo Nordisk. Thomas Zuger: no conflicts to disclose. 
      Gottfried Rudofsky: no conflicts to disclose. Khadija M'Rabet-Bensalah, Hanan 
      Amadid, Flurin Item and Uffe Christian Braae are employees of and shareholders in 
      Novo Nordisk.
EDAT- 2024/01/19 12:43
MHDA- 2024/01/19 12:44
PMCR- 2024/01/19
CRDT- 2024/01/19 11:08
PHST- 2023/11/07 00:00 [received]
PHST- 2023/12/14 00:00 [accepted]
PHST- 2024/01/19 12:44 [medline]
PHST- 2024/01/19 12:43 [pubmed]
PHST- 2024/01/19 11:08 [entrez]
PHST- 2024/01/19 00:00 [pmc-release]
AID - 10.1007/s13300-023-01525-y [pii]
AID - 1525 [pii]
AID - 10.1007/s13300-023-01525-y [doi]
PST - ppublish
SO  - Diabetes Ther. 2024 Mar;15(3):623-637. doi: 10.1007/s13300-023-01525-y. Epub 2024 
      Jan 19.