Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study

TY - JOUR

T1 - Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study

AU - Sbraccia, Paolo

AU - Aberle, Jens

AU - Olsen, Anne Helene

AU - Rathor, Naveen

AU - Major-Pedersen, Atheline

N1 - © 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

PY - 2023/4

Y1 - 2023/4

N2 - 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.

AB - 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.

KW - Humans

KW - Liraglutide/therapeutic use

KW - Hypoglycemic Agents/therapeutic use

KW - Retrospective Studies

KW - Europe

KW - Italy

KW - Diabetes Mellitus, Type 2/drug therapy

U2 - 10.1111/dom.14945

DO - 10.1111/dom.14945

M3 - SCORING: Journal article

C2 - 36514273

VL - 25

SP - 985

EP - 991

JO - DIABETES OBES METAB

JF - DIABETES OBES METAB

SN - 1462-8902

IS - 4

ER -