Investigating the potential non‐authorized use of two different formulations of liraglutide in Europe: A real‐world drug utilization study
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Aim: To assess the in‐market use of Saxenda (liraglutide 3.0 mg) and Victoza (liraglutide 1.2 mg/1.8 mg) according to approved indications and posology. Materials and methods: This retrospective, non‐interventional study was conducted at 41 sites from December 2016 to May 2019. Via medical record review, physicians at each site identified patients who had been prescribed Saxenda (Italy) or Victoza (Italy/Germany) within the 24 months following launch in each country. Pseudonymized data were abstracted on patient and site characteristics, indication for the prescription, posology and duration of usage. Adherence to the approved indications and posology, and to the Saxenda stopping rule, were assessed. No formal statistical analysis was performed. Results: A total of 440 patients were prescreened and 225 (51.1%) were enrolled (Saxenda: N = 75, all in Italy; Victoza: N = 75 in Italy and N = 75 in Germany). In all, 96% (72/75) of Saxenda prescriptions, and 98.7% (148/150) of Victoza, were in accordance with the approved indications. Among the 40 patients treated with Saxenda for 16 weeks or longer, only two (5.0%) were confirmed as non‐adherent to the stopping rule. Adherence could not be assessed in 23 (57.5%) patients because of missing body weight measurements. Conclusions: This retrospective, real‐world post‐authorization safety study provides reassurance that Saxenda and Victoza are primarily used according to the approved European label, thus their real‐world utilization did not raise safety concerns.
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The majority of real-world studies conducted in patients initiating incretin-based anti-obesity medications were retrospective and included liraglutide users, while only a few studies investigated semaglutide titrated up to 2.4 mg.
“The majority of RWS conducted in patients initiating incretin-based AOM were retrospective51–71 and included liraglutide users, while only a few studies investigated semaglutide titrated up to 2.4 mg65,66,69–71 (Tables 1 and 2).”
From Incretin-based therapies for the treatment of obesity-related diseases (2024) · cites this paper as [60]
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A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management
Pi-Sunyer, X., Astrup, A., Fujioka, K., Greenway, F., Halpern, A., Krempf, M., Lau, D. C. W., le Roux, C. W., Violante Ortiz, R., Jensen, C. B., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1411892 · Cited by 2,724 · see citing works
Buse, J. B., Rosenstock, J., Sesti, G., Schmidt, W. E., Montanya, E., Brett, J. H., Zychma, M., & Blonde, L. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60659-0 · Cited by 1,503 · see citing works
Davies, M. J., Bergenstal, R., Bode, B., Kushner, R. F., Lewin, A., Skjøth, T. V., Andreasen, A. H., Jensen, C. B., DeFronzo, R. A., & for the NN8022-1922 Study Group (2015) · JAMA · doi:10.1001/jama.2015.9676 · Cited by 1,198 · see citing works
Astrup, A., Rössner, S., Van Gaal, L., Rissanen, A., Niskanen, L., Al Hakim, M., Madsen, J., Rasmussen, M. F., & Lean, M. E. (2009) · The Lancet · doi:10.1016/s0140-6736(09)61375-1 · Cited by 1,163 · see citing works
Nauck, M., Frid, A., Hermansen, K., Shah, N. S., Tankova, T., Mitha, I. H., Zdravkovic, M., Düring, M., Matthews, D. R., & for the LEAD-2 Study Group (2009) · Diabetes Care · doi:10.2337/dc08-1355 · Cited by 1,129 · see citing works
Incretin hormones: Their role in health and disease
Nauck, M. A., & Meier, J. J. (2018) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.13129 · Cited by 950 · see citing works
Zinman, B., Gerich, J., Buse, J. B., Lewin, A., Schwartz, S., Raskin, P., Hale, P. M., Zdravkovic, M., Blonde, L., & the LEAD-4 Study Investigators (2009) · Diabetes Care · doi:10.2337/dc08-2124 · Cited by 848 · see citing works
on behalf of the NN8022-1923 Investigators, Wadden, T. A., Hollander, P., Klein, S., Niswender, K., Woo, V, Hale, P. M., & Aronne, L. (2013) · International Journal of Obesity · doi:10.1038/ijo.2013.120 · Cited by 842 · see citing works
on behalf of the Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group, Russell-Jones, D., Vaag, A., Schmitz, O., Sethi, B. K., Lalic, N., Antic, S., Zdravkovic, M., Ravn, G. M., & Simó, R. (2009) · Diabetologia · doi:10.1007/s00125-009-1472-y · Cited by 835 · see citing works
on behalf of the NN8022-1807 Investigators, Astrup, A., Carraro, R., Finer, N., Harper, A., Kunesova, M., Lean, M. E. J., Niskanen, L., Rasmussen, M. F., Rissanen, A., et al. (2012) · International Journal of Obesity · doi:10.1038/ijo.2011.158 · Cited by 757 · see citing works
on behalf of the SCALE study group, Blackman, A., Foster, G. D., Zammit, G., Rosenberg, R., Aronne, L., Wadden, T., Claudius, B., Jensen, C. B., & Mignot, E. (2016) · International Journal of Obesity · doi:10.1038/ijo.2016.52 · Cited by 583 · see citing works
Liraglutide for weight management: a critical review of the evidence
Mehta, A., Marso, S. P., & Neeland, I. J. (2017) · Obesity Science & Practice · doi:10.1002/osp4.84 · Cited by 311 · see citing works
Blonde, L., & Russell-Jones, D. L. (2009) · Diabetes Obesity and Metabolism · doi:10.1111/j.1463-1326.2009.01075.x · Cited by 227 · see citing works
Iqbal, J., Wu, H., Hu, N., Zhou, Y., Li, L., Xiao, F., Wang, T., Jiang, H., Xu, S., Huang, B., et al. (2022) · Obesity Reviews · doi:10.1111/obr.13435 · Cited by 179 · see citing works
Diabetes and obesity: therapeutic targeting and risk reduction – a complex interplay
Niswender, K. D. (2009) · Diabetes Obesity and Metabolism · doi:10.1111/j.1463-1326.2009.01175.x · Cited by 85 · see citing works
Barnett, A. H. (2011) · Diabetes Obesity and Metabolism · doi:10.1111/j.1463-1326.2011.01523.x · Cited by 54 · see citing works
Vilsbøll, T., & Garber, A. J. (2012) · Diabetes Obesity and Metabolism · doi:10.1111/j.1463-1326.2012.01579.x · Cited by 30 · see citing works
Pilot study rectifies real-world study design to support regulatory decision makingPreprint
Major‐Pedersen, A., Aberle, J., Sbraccia, P., et al. (2022) · doi:10.22541/au.166999205.50183341/v1 · Cited by 1 · see citing works
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Incretin-based therapies for the treatment of obesity-related diseases
Caruso, I., Cignarelli, A., Sorice, G. P., Perrini, S., & Giorgino, F. (2024) · npj Metabolic Health and Disease · doi:10.1038/s44324-024-00030-5 · Cited by 48 · see citing works
- Authors
- Sbraccia, P., Aberle, J., Olsen, A. H., Rathor, N., & Major‐Pedersen, A.
- Affiliations
- University of Rome Tor Vergata (IT)
- Universitäres Adipositas Centrum Hamburg Germany
- Novo Nordisk (Denmark) (DK)
- Corresponding author
- Major‐Pedersen, Atheline
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2023-01-23
- Volume
- 25
- Issue
- 4
- Pages
- 985-991
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- OpenAlex
- W4311330084
- Cited by
- 3
- References
- 18
- Citations by year
- 2025: 2 · 2024: 1
- FWCI
- 0.45
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Obesity and Metabolism (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- liraglutide, Saxenda, medication use, off-label drug use, dosing adherence, stopping rules, obesity treatment, type 2 diabetes, real-world evidence
- MeSH terms
- Liraglutide, Diabetes Mellitus, Type 2, Europe, Humans, Hypoglycemic Agents, Italy, Retrospective Studies
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