Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme
Language English Country Great Britain, England Media print-electronic
Document type Journal Article, Research Support, Non-U.S. Gov't
PubMed
35373893
PubMed Central
PMC9321749
DOI
10.1111/dom.14710
Knihovny.cz E-resources
- Keywords
- GLP-1 analogue, antidiabetic drug, glycaemic control, incretin therapy, type 2 diabetes, weight control,
- MeSH
- Diabetes Mellitus, Type 2 * chemically induced drug therapy MeSH
- Glucagon-Like Peptides adverse effects MeSH
- Glycated Hemoglobin analysis MeSH
- Hypoglycemic Agents adverse effects MeSH
- Humans MeSH
- Body Weight MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Glucagon-Like Peptides MeSH
- Glycated Hemoglobin A MeSH
- Hypoglycemic Agents MeSH
- semaglutide MeSH Browser
AIMS: To evaluate the efficacy and safety of oral semaglutide versus comparators by patient characteristic subgroups in patients with type 2 diabetes. MATERIALS AND METHODS: Change from baseline in glycated haemoglobin (HbA1c) and body weight, and achievement of HbA1c <7.0% with oral semaglutide 7 mg, oral semaglutide 14 mg, flexibly dosed oral semaglutide (flex) and comparators were assessed across baseline subgroups (age, race, ethnicity, diabetes duration, body mass index and HbA1c) from the PIONEER programme. Treatment differences were analysed using a mixed model for repeated measurements for continuous variables and a logistic regression model for the binary endpoint. Pooled safety data were analysed descriptively. RESULTS: Changes from baseline in HbA1c and body weight, and the odds of achieving HbA1c <7.0%, were greater with oral semaglutide 14 mg/flex (n = 1934) and higher or similar with oral semaglutide 7 mg (n = 823) versus comparators (n = 2077) across most subgroups. Changes in HbA1c with oral semaglutide 14 mg/flex were greater for patients with higher baseline HbA1c (HbA1c >9.0%: -1.7% to -2.6%; HbA1c <8.0%: -0.7% to -1.2%). In some trials, Asian patients experienced greater HbA1c reductions with oral semaglutide 14 mg/flex (-1.5% to -1.8%) than other racial groups (-0.6% to -1.6%). The overall incidence of adverse events (AEs) with oral semaglutide was similar to that with comparators and was consistent across subgroups. More gastrointestinal AEs were observed with oral semaglutide, versus comparators, across subgroups. CONCLUSIONS: Oral semaglutide demonstrated consistently greater HbA1c and body weight reductions across a range of patient characteristics, with greater HbA1c reductions seen at higher baseline HbA1c levels.
Brigham and Women's Hospital Harvard Medical School Boston Massachusetts USA
Dallas Diabetes Research Center at Medical City Dallas Texas USA
Department of Internal Medicine Gastroenterology and Diabetology Augusta Clinic Bochum Germany
Diabetes Centre Institute for Clinical and Experimental Medicine Prague Czech Republic
Hospital Universitari Bellvitge IDIBELL CIBERDEM and University of Barcelona Barcelona Spain
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