https://orcid.org/0000-0002-5606-0139
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Abstract
Purpose
A surge in the use of semaglutide injection (Ozempic®) approved to treat type 2 diabetes (T2D) has led to a global supply shortage. We investigated contemporary user rates and clinical characteristics of semaglutide (Ozempic®) users in Denmark, and the extent of “off-label” prescribing for weight loss.
Patients and Methods
Nationwide population-based cross-sectional study based on linked health registries January 2018 through December 2023. All adults who received a first prescription of semaglutide once weekly (Ozempic®) were included. We examined quarterly rates of new users and total user prevalences, using other glucagon-like peptide-1 receptor agonists and weight loss medications as comparison. We also investigated user characteristics including T2D, glucose control, comedications, and cardiorenal disease.
Results
The new user rate of semaglutide (Ozempic®) remained stable at approximately 4 per 1000 adult person-years between 2019 and 2021 and then accelerated, peaking at 10 per 1000 in the first quarter of 2023 after which it declined sharply. User prevalence increased to 91,626 users in Denmark in 2023. The proportion of semaglutide (Ozempic®) new users who had a record of T2D declined from 99% in 2018 to only 67% in 2022, increasing again to 87% in 2023. Among people with T2D who initiated semaglutide (Ozempic®) in 2023, 52% received antidiabetic polytherapy before initiation, 39% monotherapy, and 8% no antidiabetic therapy. Most T2D initiators had suboptimal glucose control, with 83% having an HbA1c ≥48 mmol/mol and 68% ≥53 mmol/mol despite use of antidiabetic medication, and 29% had established atherosclerotic cardiovascular disease or kidney disease.
Conclusion
The use of semaglutide (Ozempic®) in Denmark has increased dramatically. Although not approved for weight loss without T2D, one-third of new users in 2022 did not have T2D. Conversely, most initiators with T2D had a clear medical indication for treatment intensification, and “off-label” use can only explain a minor part of the supply shortage.
Ethics Approval and Informed Consent
The study was approved by the Danish Data Protection Agency. According to Danish legislation, no approval from an ethics committee or informed consent from patients is required for studies based entirely on registry data.
Data Sharing Statement
Data are available as presented in the paper and in the Supporting Information files. Danish legislation does not allow us to distribute or make individual-level patient data directly available to other parties. Authorized researchers may apply for data access through the Research Service at the Danish Health Data Authority (e-mail: [email protected]). Up-to-date information on data access is available online (http://sundhedsdatastyrelsen.dk/da/forskerservice). Access to data from the Danish Health Data Authority requires approval from the Danish Data Protection Agency (https://www.datatilsynet.dk/english/the-danish-data-protection-agency/introduction-to-the-danish-data-protection-agency/).
Acknowledgments
The Department of Clinical Epidemiology, Aarhus University and Aarhus University Hospital is a member of The Danish Centre for Strategic Research in Type 2 Diabetes (DD2), supported by the Danish Agency for Science (grant nos. 09-067009 and 09-075724), the Danish Health and Medicines Authority, the Danish Diabetes Association, and The Novo Nordisk Foundation. Project partners are listed on the website http://www.DD2.dk. The Department of Clinical Epidemiology, Aarhus University and University Hospital, receives funding for other studies from EMA and companies in the form of research grants to (and administered by) Aarhus University. None of these studies have any relation to the present study.
Disclosure
Professor Anton Pottegård reports grants from Novo Nordisk, outside the submitted work. Professor Jens Søndergaard reports grants from Roche Diagnostics, AstraZeneca a/s; personal fees from Novo Nordisk a/s, Abbott Rapid Diagnostics a/s, outside the submitted work. The authors report no other conflicts of interest in this work.