Investigating the potential non‐authorized use of two different formulations of liraglutide in Europe: A real‐world drug utilization study
Authors' conclusion
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.
Study context
- Population
- Patients prescribed Saxenda (Italy) or Victoza (Italy/Germany) within 24 months of launch, 41 sites, December 2016 to May 2019440 prescreened
- Participants
- 225 patients
- Exposure
- Saxenda vs Victoza
- Saxendan = 75
- Outcome
- Use according to approved indications and posology
Methodological detailsnon-interventional, post-authorization safety study, medical record review, 41 sites, no formal statistical analysis
- Non-interventional
- Post-authorization safety study
- Medical record review
- 41 sites
- No formal statistical analysis
Main finding
As reported in the abstract
Prescriptions in accordance with approved indications
Observational data: associations, not effects.
Further findings
- Non-adherence to Saxenda stopping rule (treated ≥16 weeks, n=40)
- 5.0% · 2
- Non-adherence to Saxenda stopping rule (treated ≥16 weeks, n=40) — Adherence not assessable due to missing body weight
- 23 (57.5%)
Original publication
Investigating the potential non‐authorized use of two different formulations of liraglutide in Europe: A real‐world drug utilization study. Diabetes Obes Metab. Published 23 January 2023. doi:10. 1111/ dom. 14945
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