학술논문

Once‐weekly semaglutide use in patients with type 2 diabetes: Real‐world data from the SURE Italy observational study.
Document Type
Article
Source
Diabetes, Obesity & Metabolism. Jun2023, Vol. 25 Issue 6, p1658-1667. 10p.
Subject
*WEIGHT loss
*TYPE 2 diabetes
*SEMAGLUTIDE
*SCIENTIFIC observation
*GLYCOSYLATED hemoglobin
*BODY weight
Language
ISSN
1462-8902
Abstract
Aims: SURE Italy, a multicentre, prospective, open‐label, observational, real‐world study, investigated once‐weekly semaglutide in patients with type 2 diabetes (T2D) in routine clinical practice. Materials and Methods: Adults with T2D and ≥1 documented glycated haemoglobin (HbA1c) level within 12 weeks of semaglutide initiation were enrolled. The primary endpoint was change in HbA1c from baseline to end of study (EOS; ~30 weeks). Other endpoints included changes in body weight, waist circumference and patient‐reported outcomes, and the proportion of patients achieving HbA1c <7.0% or <6.5%, weight loss ≥5% and a post‐hoc composite endpoint (HbA1c reduction of ≥1%‐point and weight loss ≥5%). These endpoints were reported for patients on semaglutide at EOS [effectiveness analysis set (EAS)]. Safety data were reported in the full analysis set. Results: Of 579 patients who initiated semaglutide (full analysis set), 491 completed the study on treatment (EAS). Mean baseline HbA1c was 8.0%, and 20.7% (120 of 579) of patients had HbA1c <7.0%. Mean semaglutide dose at EOS was 0.66 ± 0.28 mg. In the EAS, mean HbA1c and body weight decreased by 1.1%‐point (95% confidence interval 1.20, 1.05; P <.0001) and 4.2 kg (95% confidence interval 4.63, 3.67; P <.0001), respectively. At EOS, 61.7% and 40.8% of patients achieved HbA1c <7.0% and <6.5%, respectively, 40.5% achieved weight loss ≥5% and 25.3% achieved the post‐hoc composite endpoint. Patient‐reported outcomes improved from baseline to EOS. No new safety concerns were identified. Conclusions: In routine clinical practice in Italy, patients with T2D treated with once‐weekly semaglutide for 30 weeks achieved clinically significant improvements in HbA1c, body weight and other outcomes. [ABSTRACT FROM AUTHOR]