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在常规临床实践中早期使用口服司美格鲁肽的探索:IGNITE 研究。

Insights into the early use of oral semaglutide in routine clinical practice: The IGNITE study.

机构信息

Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

Novo Nordisk A/S, Søborg, Denmark.

出版信息

Diabetes Obes Metab. 2021 Sep;23(9):2177-2182. doi: 10.1111/dom.14453. Epub 2021 Jun 16.

Abstract

Oral semaglutide is the first oral glucagon-like peptide-1 receptor agonist for the treatment of type 2 diabetes, and showed significant benefits in glycaemic control and weight reduction versus active comparators in the PIONEER phase 3a randomized controlled trial programme. In this retrospective study, we present early data on the use of oral semaglutide in clinical practice, from the US IBM Explorys electronic health record database. In 782 patients prescribed oral semaglutide, 54.5% were women, and the mean age (SD) was 57.8 years (11.3); 66.0% of patients received their prescription from a primary care practitioner. Although prescribing information recommends increasing the dose to 7 mg after 30 days, 37.0% of patients received a prescription only for the initial 3 mg dose. Mean body mass index was 36.2 kg/m (7.6); mean HbA1c was 8.4% (1.8%). Mean HbA1c change from baseline to approximately 6 months after oral semaglutide initiation was -0.9% (95% CI: -1.1%; -0.6%), with greater reductions in patients with higher baseline HbA1c. These data indicate prevalent early adoption of oral semaglutide in primary care, show real-world improvements in glycaemic control, and identify potential treatment gaps.

摘要

口服司美格鲁肽是首个用于治疗 2 型糖尿病的口服胰高血糖素样肽-1 受体激动剂,在 PIONEER 3a 期随机对照试验项目中,与活性对照药物相比,它在血糖控制和体重减轻方面显示出显著益处。在这项回顾性研究中,我们从美国 IBM Explorys 电子健康记录数据库中展示了临床实践中使用口服司美格鲁肽的早期数据。在接受口服司美格鲁肽治疗的 782 名患者中,54.5%为女性,平均年龄(标准差)为 57.8 岁(11.3);66.0%的患者从初级保健医生那里获得了处方。尽管说明书建议在 30 天后将剂量增加到 7 毫克,但仍有 37.0%的患者仅接受了初始 3 毫克剂量的处方。平均体重指数为 36.2 kg/m(7.6);平均 HbA1c 为 8.4%(1.8%)。从基线到口服司美格鲁肽起始后大约 6 个月时的平均 HbA1c 变化为-0.9%(95%CI:-1.1%;-0.6%),基线 HbA1c 较高的患者降幅更大。这些数据表明口服司美格鲁肽在初级保健中得到了早期广泛采用,显示了血糖控制的实际改善,并确定了潜在的治疗差距。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f2d/8453868/3207de5b8f9b/DOM-23-2177-g001.jpg

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