PMID- 32815436
OWN - NLM
STAT- MEDLINE
DCOM- 20201109
LR  - 20221207
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 132
IP  - sup2
DP  - 2020 Nov
TI  - Clinical review of the efficacy and safety of oral semaglutide in patients with 
      type 2 diabetes compared with other oral antihyperglycemic agents and placebo.
PG  - 15-25
LID - 10.1080/00325481.2020.1798638 [doi]
AB  - Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor 
      agonist (GLP-1RA), recently approved in the USA and other countries. This paper 
      reviews data from clinical trials (PIONEER 1, 2, 3, and 7) comparing oral 
      semaglutide (once-daily doses of 3, 7, or 14 mg) with either once-daily placebo, 
      empagliflozin 25 mg, or sitagliptin 100 mg. After 26 weeks in PIONEER 1, patients 
      randomized to 3, 7, or 14 mg doses of oral semaglutide monotherapy had 
      statistically significant reductions in glycated hemoglobin (HbA(1) (c)) of 0.9%, 
      1.2%, and 1.4%, respectively, versus 0.3% with placebo. In the active-comparator 
      studies, oral semaglutide 14 mg provided better glycemic control than 
      empagliflozin or sitagliptin after 26 weeks, with durable effects. Body weight 
      reductions were significantly greater with oral semaglutide than with placebo and 
      sitagliptin. However, body weight reductions with oral semaglutide 14 mg versus 
      empagliflozin 25 mg were not significantly different. Gastrointestinal adverse 
      events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early 
      in the course of treatment, and abated over time. Across these trials, 5-13% and 
      15-20% of patients experienced nausea with oral semaglutide 7 and 14 mg, 
      respectively, and 2.3-3.4% and 5.1-8.0%, respectively, discontinued treatment due 
      to gastrointestinal AEs. Severe or blood glucose-confirmed symptomatic 
      hypoglycemia occurred infrequently with oral semaglutide and was seen most often 
      in patients taking concomitant sulfonylureas. Findings from these trials indicate 
      that the addition of oral semaglutide reduces HbA(1) (c) and body weight and is 
      associated with a low risk of hypoglycemia. Oral semaglutide represents an 
      additional option for treating people with type 2 diabetes in primary care, with 
      the potential to expand the numbers of patients benefiting from GLP-1RAs beyond 
      that currently seen with injectable formulations.
FAU - Lavernia, Frank
AU  - Lavernia F
AD  - North Broward Diabetes Center , Pompano Beach, FL, USA.
FAU - Blonde, Lawrence
AU  - Blonde L
AUID- ORCID: 0000-0003-0492-6698
AD  - Department of Endocrinology, Ochsner Medical Center , New Orleans, LA, USA.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Video-Audio Media
DEP - 20200908
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 53AXN4NNHX (semaglutide)
RN  - 62340-29-8 (Glucagon-Like Peptides)
RN  - HDC1R2M35U (empagliflozin)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Administration, Oral
MH  - Benzhydryl Compounds/administration & dosage
MH  - Clinical Trials as Topic
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Glucagon-Like Peptides/*administration & dosage
MH  - Glucosides/administration & dosage
MH  - Glycated Hemoglobin/drug effects
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Primary Health Care
MH  - Sitagliptin Phosphate/administration & dosage
OTO - NOTNLM
OT  - Oral semaglutide
OT  - comparative studies
OT  - empagliflozin
OT  - sitagliptin
OT  - treatment intensification
OT  - type 2 diabetes
EDAT- 2020/08/21 06:00
MHDA- 2020/11/11 06:00
CRDT- 2020/08/21 06:00
PHST- 2020/08/21 06:00 [pubmed]
PHST- 2020/11/11 06:00 [medline]
PHST- 2020/08/21 06:00 [entrez]
AID - 10.1080/00325481.2020.1798638 [doi]
PST - ppublish
SO  - Postgrad Med. 2020 Nov;132(sup2):15-25. doi: 10.1080/00325481.2020.1798638. Epub 
      2020 Sep 8.