Cargando…
Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme
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...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9321749/ https://www.ncbi.nlm.nih.gov/pubmed/35373893 http://dx.doi.org/10.1111/dom.14710 |
_version_ | 1784756124319219712 |
---|---|
author | Aroda, Vanita R. Bauer, Robert Christiansen, Erik Haluzík, Martin Kallenbach, Klaus Montanya, Eduard Rosenstock, Julio Meier, Juris J. |
author_facet | Aroda, Vanita R. Bauer, Robert Christiansen, Erik Haluzík, Martin Kallenbach, Klaus Montanya, Eduard Rosenstock, Julio Meier, Juris J. |
author_sort | Aroda, Vanita R. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9321749 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-93217492022-07-30 Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme Aroda, Vanita R. Bauer, Robert Christiansen, Erik Haluzík, Martin Kallenbach, Klaus Montanya, Eduard Rosenstock, Julio Meier, Juris J. Diabetes Obes Metab Original Articles 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. Blackwell Publishing Ltd 2022-05-09 2022-07 /pmc/articles/PMC9321749/ /pubmed/35373893 http://dx.doi.org/10.1111/dom.14710 Text en © 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Aroda, Vanita R. Bauer, Robert Christiansen, Erik Haluzík, Martin Kallenbach, Klaus Montanya, Eduard Rosenstock, Julio Meier, Juris J. Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme |
title | Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme |
title_full | Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme |
title_fullStr | Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme |
title_full_unstemmed | Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme |
title_short | Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme |
title_sort | efficacy and safety of oral semaglutide by subgroups of patient characteristics in the pioneer phase 3 programme |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9321749/ https://www.ncbi.nlm.nih.gov/pubmed/35373893 http://dx.doi.org/10.1111/dom.14710 |
work_keys_str_mv | AT arodavanitar efficacyandsafetyoforalsemaglutidebysubgroupsofpatientcharacteristicsinthepioneerphase3programme AT bauerrobert efficacyandsafetyoforalsemaglutidebysubgroupsofpatientcharacteristicsinthepioneerphase3programme AT christiansenerik efficacyandsafetyoforalsemaglutidebysubgroupsofpatientcharacteristicsinthepioneerphase3programme AT haluzikmartin efficacyandsafetyoforalsemaglutidebysubgroupsofpatientcharacteristicsinthepioneerphase3programme AT kallenbachklaus efficacyandsafetyoforalsemaglutidebysubgroupsofpatientcharacteristicsinthepioneerphase3programme AT montanyaeduard efficacyandsafetyoforalsemaglutidebysubgroupsofpatientcharacteristicsinthepioneerphase3programme AT rosenstockjulio efficacyandsafetyoforalsemaglutidebysubgroupsofpatientcharacteristicsinthepioneerphase3programme AT meierjurisj efficacyandsafetyoforalsemaglutidebysubgroupsofpatientcharacteristicsinthepioneerphase3programme |