Availability of age-stratified evidence for GLP1 receptor agonists and SGLT2 inhibitors: an analysis of European public assessment reports with a focus on older patients.

Background: GLP1 receptor agonists and SGLT2 inhibitors are widely prescribed and their use is increasingly frequent in older patient populations. We evaluated the extent to which older patients were represented in clinical trials of liraglutide, dulaglutide, semaglutide, tirzepatide, dapagliflozin and empagliflozin. Methods: To identify relevant trials, we screened the respective European Public Assessment Reports (n = 28) and the European Summaries of Product Characteristics (n = 9) for each of the six approved medicines. Further information was retrieved from the original publications of the identified trials and from the ClinicalTrials.gov database (n = 40). Overall, we analyzed n = 185 sources for 106 trial populations. Results: For 46% of the 106 analyzed trial populations, data for patients ≥65 years were identified. Where age distributions were reported, patients aged 75 years or older were markedly underrepresented in nearly all trials, and subgroup analyses of efficacy and safety by age were rarely published. Especially in cardiovascular outcome trials and trials including patients with chronic kidney disease or chronic heart failure, older patients were better represented and analyses of primary outcomes in different age groups were published more frequently. Safety data on different age groups were mainly identified in the European Public Assessment Reports. Whereas increasing numbers of adverse events with older age were observed in several trials, this increase typically affected all trial arms, independent of the drug treatment. Conclusion: Data availability for patients with older age is insufficient from pivotal trials to properly describe efficacy or safety of liraglutide, dulaglutide, semaglutide, tirzepatide, dapagliflozin, or empagliflozin.