Gradual Titration of Semaglutide Results in Better Treatment Adherence and Fewer Adverse Events: A Randomized Controlled Open-Label Pilot Study Examining a 16-Week Flexible Titration Regimen Versus Label-Recommended 8-Week Semaglutide Titration Regimen.

IF 16.6

Diabetes care Pub Date : 2025-09-01 DOI:10.2337/dc25-0690

Roy Eldor, Noa Avraham, Orit Rosenberg, Miriam Shpigelman, Avivit Golan-Cohen, Tali Cukierman-Yaffe, Eugene Merzon, Assaf Buch

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Abstract

Objective: To determine whether a slower, flexible titration regimen of semaglutide would improve adherence and reduce gastrointestinal adverse events (GI-AEs) compared with the label-recommended regimen in patients with type 2 diabetes (T2D).

Research design and methods: A total of 104 patients with T2D were randomized to label-recommended titration (0.25 mg, 0.5 mg, 1 mg at 4-week intervals) or flexible titration (starting at 0.0675 mg [measured as five clicks made by the dose selector dial], with gradual increases by 0.0675 mg/week and delays for GI-AEs) for 26 weeks.

Results: While final doses were similar between groups, only 2% of patients in the flexible arm withdrew due to GI-AEs vs. 19% in the label arm (P = 0.005). The flexible arm reported less nausea (45.1% vs. 64.2%; P = 0.051) and asthenia (9.8% vs. 24.5%; P = 0.047), with fewer days experiencing nausea (2.88 vs. 6.3 days; P = 0.017). HbA1c and BMI changes were similar between groups.

Conclusions: Slower, flexible titration improved adherence and reduced adverse events without compromising efficacy.

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渐进式西马鲁肽滴定治疗依从性更好，不良事件更少：一项随机对照开放标签试点研究，比较了16周灵活滴定方案和标签推荐的8周西马鲁肽滴定方案。

目的：与标签推荐的2型糖尿病（T2D）患者方案相比，确定较慢、灵活的西马鲁肽滴定方案是否能改善依从性并减少胃肠道不良事件（gi - ae）。研究设计和方法：共有104例T2D患者被随机分为标签推荐滴定组（0.25 mg, 0.5 mg, 1 mg，每4周一次）或灵活滴定组（从0.0675 mg开始[通过剂量选择表盘按5次点击测量]，逐渐增加0.0675 mg/周，gi - ae延迟），持续26周。结果：虽然两组之间的最终剂量相似，但柔性组中只有2%的患者因gi - ae退出，而标签组中有19% （P = 0.005）。柔性臂组恶心程度较低(45.1% vs. 64.2%；P = 0.051)和虚弱(9.8% vs. 24.5%；P = 0.047)，恶心天数较少(2.88天vs. 6.3天；P = 0.017)。各组间HbA1c和BMI变化相似。结论：缓慢、灵活的滴定提高了依从性，减少了不良事件，同时不影响疗效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes care

CiteScore

29.50

自引率

0.00%

发文量