Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F22%3A00082914" target="_blank" >RIV/00023001:_____/22:00082914 - isvavai.cz</a>

Výsledek na webu

<a href="https://dom-pubs.onlinelibrary.wiley.com/doi/epdf/10.1111/dom.14710" target="_blank" >https://dom-pubs.onlinelibrary.wiley.com/doi/epdf/10.1111/dom.14710</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/dom.14710" target="_blank" >10.1111/dom.14710</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme

Popis výsledku v původním jazyce

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 &lt;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 &lt;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 &gt;9.0%: -1.7% to -2.6%; HbA1c &lt;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.

Název v anglickém jazyce

Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme

Popis výsledku anglicky

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 &lt;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 &lt;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 &gt;9.0%: -1.7% to -2.6%; HbA1c &lt;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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30202 - Endocrinology and metabolism (including diabetes, hormones)

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Diabetes, obesity and metabolism

ISSN

1462-8902

e-ISSN

1463-1326

Svazek periodika

24

Číslo periodika v rámci svazku

7

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

13

Strana od-do

1338-1350

Kód UT WoS článku

000792511300001

EID výsledku v databázi Scopus

2-s2.0-85129593478