Abstract
Aim:- To describe baseline characteristics and safety data of real-world use of semaglutide 2.4 mg. Methods:- Patients with a body mass index (BMI) >= 40 kg/m2 and at least one of the following treated weight- related comorbidities (WRC: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease) were eligible to receive treatment through Temporary Utilization Authorization (TUA: March to June 2022) or Early Access Program (EAP: July 2022 to October 2023). Data were collected according to Health Authorities' requirements. Only descriptive statistics were used. Results:- Overall, 5,797 (62.8%) treatment requests were sent by sites specialized in obesity management. In total, 478 and 8,568 patients were treated within TUA and EAP cohorts respectively, with mean follow-up durations of 1.2 and 4.5 months, respectively. Mean (SD) BMI was 48.9 (9.7) and 47.0 (7.4) kg/m2, respectively. Age ranged from 18 to 81 years. In the EAP, 57.4%, 26.5%, 12.3% and 3.7% of patients had 1, 2, 3 and 4 WRC. In addition, 15.5% had type 2 diabetes, 18.1% reported depression and 15.4% had osteoarthritis. In the EAP, 247 (2.9%) patients discontinued treatment after a median time of 2.8 months (IQR: 1.2-5.1), mainly due to adverse events (AEs) (47.0%). During TUA, 3 patients discontinued due to AEs. Pancreatitis was reported in 7 cases overall. Conclusion:- The high number of treatment prescriptions in a short period highlights the high unmet medical need. No new safety concerns were identified in this population with severe obesity treated in a real-world setting.