(070) Semaglutide injection with type 2 diabetes indication – User trends and Off-label Prescribing for Weight Loss from 2018 through 2023 in Denmark

Background: Semaglutide injection approved to treat hyperglycemia in adults with type 2 diabetes at doses of 0.5 to 2.0 mg (SEM-T2D) has seen a surge in use and a global supply shortage.

Objectives: To examine contemporary trends in Denmark in the use of SEM-T2D and to examine characteristics of users, including “off-label” prescribing of SEM-T2D for weight loss.

Methods: We conducted a population-based drug utilization study using the nationwide Danish registries from 2018 through 2023. Participants were all adults who received a first prescription of SEM-T2D. New user rates per quarter were estimated by dividing the number of new users in each quarter by the estimated person-time at risk in that quarter (presented in person-years), using the size of the Danish population on January 1st of the same year. Prevalence proportions of users were estimated as the number of people who had at least one prescription filled within the period of interest. Main outcomes included rates per quarter of new medication users per 1000 adult person-years, total prevalence of users, proportions with T2D, and T2D characteristics.

Results: After the approval of SEM-T2D in 2018, the new user rate increased, reaching approximately four per 1000 adult person-years between 2019 and 2021. Starting in 2021, the incidence accelerated and reached 10 new users per 1000 adult person-years in the first quarter of 2023, after which it declined sharply. User prevalence increased to 91,626 users in 2023 (Danish population 6.0 million, ~320.000 with type 2 diabetes). The proportion of new users of SEM-T2D who had a record of T2D was 99% in 2018, which decreased to 67% in 2022, increasing again to 87% in 2023. Among new users with T2D in 2023, 52% received antidiabetic polytherapy before starting SEM-T2D, 39% received prior monotherapy, and 8% received no antidiabetic therapy. Most T2D initiators (68% to 83%) had suboptimal glucose control before SEM-T2D initiation, and a history of established atherosclerotic cardiovascular disease or kidney disease was observed in 29%.

Conclusions: The use of SEM-T2D injection in Denmark has increased substantially. Although the medication is not approved for weight loss alone, one-third of new users in 2022 did not have T2D. However, most initiators with T2D had a clear medical indication for glucose-lowering medication intensification, and “off-label” use can only explain a minor part of the supply shortage.