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DOI: 10.1055/a-2492-9440
Sind GLP-1-Rezeptor-Agonisten und SGLT2-Inhibitoren auch im höheren Lebensalter geeignet?
Are GLP-1 receptor agonists and SGLT2 inhibitors also suitable for older people?
Zusammenfassung
GLP-1-Rezeptor-Agonisten und SGLT2-Inhibitoren werden häufig verordnet, besonders bei älteren Patient*innen. Unsere Recherche untersuchte die Repräsentation dieser Gruppe in klinischen Prüfungen der Wirkstoffe Liraglutid, Dulaglutid, Semaglutid, Tirzepatid, Dapagliflozin und Empagliflozin. Wir analysierten Studien aus deutschen Fachinformationen, europäischen Assessment Reports und ClinicalTrials.gov. In 46% der 104 Studien fehlten Angaben zum Anteil älterer Menschen. Über 75-Jährige waren meist unterrepräsentiert, und Subgruppenanalysen nach Alter wurden selten publiziert. Kardiovaskuläre Endpunktstudien und Studien zu Herzinsuffizienz oder chronischer Nierenerkrankung zeigten eine stärkere Repräsentation älterer Patient*innen und verglichen häufiger primäre Endpunkte nach Altersgruppen. Verträglichkeitsdaten nach Altersgruppen finden sich hauptsächlich in den EMA Assessment Reports. Viele Studien zeigten eine Zunahme unerwünschter Ereignisse mit steigendem Alter, meist in allen Therapiearmen. Insgesamt ist die Datenlage bei älteren Patient*innen limitiert. Unsere Analyse fand keine signifikanten Unterschiede in Wirksamkeit und Sicherheit der Wirkstoffe zwischen den Altersgruppen.
Abstract
GLP-1 receptor agonists and SGLT2 inhibitors are widely prescribed, especially for older patients. Our research aimed to examine the representation of this population in clinical trials of these drugs, focusing on liraglutide, dulaglutide, semaglutide, tirzepatide, dapagliflozin, and empagliflozin. We included studies from German product summaries, European assessment reports, and ClinicalTrials.gov. In 46% of the 104 studies, there was no information on the proportion of older patients. Patients aged 75 or older were underrepresented in almost all studies, and subgroup analyses by age were rare. Cardiovascular outcome trials and those on chronic kidney disease or heart failure had better representation of older patients and more frequent age-group analyses. Safety data by age are mainly in European assessment reports. Many studies showed an increase in adverse events with age, typically across all study arms. Overall, data for older patients are limited. Our analysis found no significant differences in efficacy and safety of these drugs across age groups.
Schlüsselwörter
GLP-1-Rezeptor-Agonisten - SGLT2-Inhibitoren - Alter - Geriatrie - Adipositas - Typ-2-Diabetes mellitus - chronische Nierenerkrankung - HerzinsuffizienzKey Words
GLP-1 receptor agonists - SGLT2 inhibitors - old age - geriatrics - obesity - diabetes mellitus type 2 - chronic kidney disease - heart failurePublikationsverlauf
Artikel online veröffentlicht:
28. Februar 2025
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