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英国利拉鲁肽根据标签用于体重管理的真实世界使用情况:一项使用临床实践研究数据链初级保健数据库的队列研究。

Real-world use of liraglutide for weight management according to label in the United Kingdom: A cohort study using the Clinical Practice Research Datalink primary care databases.

作者信息

Murray-Thomas Tarita, Dcruz John M, Harder-Lauridsen Nina M, Olsen Anne H, Williams Rachael, Major-Pedersen Atheline

机构信息

Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London.

Novo Nordisk A/S, Søborg, Denmark.

出版信息

Diabetes Obes Metab. 2025 Jul;27(7):3705-3713. doi: 10.1111/dom.16393. Epub 2025 Apr 28.

Abstract

AIMS

To assess real-world use of Saxenda® (liraglutide 3.0 mg) and off-label use of Victoza® (liraglutide 1.2 mg/1.8 mg) for weight management and Saxenda® posology in the United Kingdom. Their similar doses and formulation pose a risk of inadvertent use due to their use for different indications.

MATERIALS AND METHODS

This retrospective, non-interventional drug utilization cohort study (DUS), based on anonymized patient data from the Clinical Practice Research Datalink databases (CPRD Aurum, GOLD), included adult liraglutide initiators without prior prescription 12 months before the index date. Descriptive statistics were used to characterize Saxenda® and Victoza® user demographics and drug utilization.

RESULTS

Totally 604 Saxenda® and 4853 Victoza® patients were included. Approximately half of the Saxenda® initiators (Si's) (N = 306) had available body weight, of which 96.4% initiated treatment according to the weight loss indication. Si's were more likely female than Victoza® initiators (Vi's) (86.4% vs. 52.1%), younger (mean age ± SD: 46.5 ± 11.7 years) versus (57.5 ± 12.0 years) and with shorter duration of follow-up observation (18.8 ± 13.9 months) versus (32.9 ± 15.9 months). N < 5 of 16 patients with 24-weeks body mass index (BMI) data did not adhere to the Saxenda® stopping rule. N < 5 of 92 patients with valid dose used Victoza® outside the diabetes indication.

CONCLUSIONS

This DUS provides descriptive data for initiators of liraglutide in the initial 5-year period following the launch of Saxenda® in the United Kingdom. Real-world use of Saxenda® and Victoza® raised no new safety concerns. Where assessment was possible, Saxenda® and Victoza® were mostly prescribed by physicians according to their approved indications.

摘要

目的

评估司美格鲁肽(3.0毫克利拉鲁肽)在英国用于体重管理的实际应用情况以及维达列汀(1.2毫克/1.8毫克利拉鲁肽)的超适应症使用情况,同时评估司美格鲁肽在英国的用药剂量。由于它们用于不同适应症,其相似的剂量和剂型存在误用风险。

材料与方法

这项回顾性、非干预性药物利用队列研究(DUS)基于临床实践研究数据链数据库(CPRD Aurum、GOLD)中的匿名患者数据,纳入了在索引日期前12个月无先前处方的成年利拉鲁肽起始使用者。描述性统计用于描述司美格鲁肽和维达列汀使用者的人口统计学特征和药物使用情况。

结果

共纳入604名司美格鲁肽患者和4853名维达列汀患者。约一半的司美格鲁肽起始使用者(Si's)(N = 306)有可用体重数据,其中96.4%根据减肥适应症开始治疗。Si's女性比例高于维达列汀起始使用者(Vi's)(86.4%对52.1%),年龄更小(平均年龄±标准差:46.5±11.7岁)对比(57.5±12.0岁),随访观察时间更短(18.8±13.9个月)对比(32.9±15.9个月)。16名有24周体重指数(BMI)数据的患者中,不到5名未遵守司美格鲁肽停药规则。92名使用有效剂量的患者中,不到5名在糖尿病适应症之外使用维达列汀。

结论

这项DUS为司美格鲁肽在英国上市后的最初5年里利拉鲁肽起始使用者提供了描述性数据。司美格鲁肽和维达列汀的实际应用未引发新的安全问题。在可能进行评估的情况下,司美格鲁肽和维达列汀大多由医生根据其获批适应症开具处方。

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