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在真实环境中比较口服和皮下注射司美格鲁肽的药物持续性。

Comparing medication persistence with oral and subcutaneous semaglutide in a real-world setting.

作者信息

Conti Matteo, Pontiggia Lorenzo, Vergani Michela, Muraca Emanuele, Cannistraci Rosa, Perra Silvia, Lattuada Guido, Perseghin Gianluca, Ciardullo Stefano

机构信息

Department of Medicine and Rehabilitation, Policlinico di Monza, Monza, Italy.

Department of Medicine and Surgery, University of Milano Bicocca, Milan, Italy.

出版信息

Acta Diabetol. 2024 Dec 16. doi: 10.1007/s00592-024-02424-9.

Abstract

AIMS

To compare medication persistence and efficacy of oral and subcutaneous semaglutide, in a real-world setting.

MATERIALS AND METHODS

This is a single-center, retrospective observational cohort study. Patients with type 2 diabetes mellitus (T2DM) starting treatment with either formulation of semaglutide between January 1 2019 and July 31 2023 and with at least one follow-up visit were included. The primary endpoint was the difference in the proportion of patients that continued treatment after 6, 12 and 18 months. Main secondary endpoints were change in HbA1c and body weight.

RESULTS

We included 242 patients on oral (n = 121) and subcutaneous (n = 121) semaglutide. At baseline, patients in the oral semaglutide group were significantly older (mean age: 67 ± 11 vs. 63 ± 11 years, p = 0.002) and had a lower body mass index (BMI: 30.5 ± 5.6 vs. 33.9 ± 7.1 kg/m, p < 0.001). The proportion of patients persistent to treatment was significantly lower in the oral group at 6 (85.3% vs. 94.8%; p < 0.001), 12 (72.3% vs. 92.4%, p < 0.001) and 18 (46.0% vs. 83.8%; p < 0.001) months. Most common reasons for discontinuation were gastro-intestinal side effects. When adjusted for age and BMI, body weight and HbA1c reduction were not significantly different between the two formulations, as the proportion of patients achieving the composite outcome of weight loss ≥ 5% and HbA1c < 7.0%.

CONCLUSIONS

The present real-world study suggests that persistence is significantly lower when semaglutide is administered as a once-daily tablet compared with a weekly injection, while there are no differences in efficacy between the two formulations.

摘要

目的

在真实世界环境中比较口服和皮下注射司美格鲁肽的药物持续性和疗效。

材料与方法

这是一项单中心回顾性观察队列研究。纳入了2019年1月1日至2023年7月31日期间开始使用任一种司美格鲁肽制剂治疗且至少有一次随访的2型糖尿病(T2DM)患者。主要终点是6、12和18个月后继续治疗的患者比例差异。主要次要终点是糖化血红蛋白(HbA1c)和体重的变化。

结果

我们纳入了242例接受口服(n = 121)和皮下注射(n = 121)司美格鲁肽的患者。基线时,口服司美格鲁肽组患者年龄显著更大(平均年龄:67±11岁 vs. 63±11岁,p = 0.002),体重指数更低(BMI:30.5±5.6 vs. 33.9±7.1 kg/m²,p < 0.001)。口服组在6个月(85.3% vs. 94.8%;p < 0.001)、12个月(72.3% vs. 92.4%,p < 0.001)和18个月(46.0% vs. 83.8%;p < 0.001)时持续治疗的患者比例显著更低。停药的最常见原因是胃肠道副作用。在对年龄和BMI进行调整后,两种制剂在体重和HbA1c降低方面无显著差异,达到体重减轻≥5%且HbA1c < 7.0%这一复合结局的患者比例也无差异。

结论

本项真实世界研究表明,与每周注射一次相比,司美格鲁肽每日一次口服给药时的持续性显著更低,而两种制剂在疗效上无差异。

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