医学
荟萃分析
血糖性
随机对照试验
安慰剂
胰岛素
曲线下面积
2型糖尿病
心理干预
1型糖尿病
胃肠病学
糖尿病
内科学
内分泌学
病理
替代医学
精神科
作者
A B Kamrul-Hasan,Sunetra Mondal,Lakshmi Nagendra,Anitha Yadav,Fatema Tuz Zahura Aalpona,Deep Dutta
标识
DOI:10.1016/j.eprac.2024.03.006
摘要
ABSTRACT
Background
Teplizumab has emerged as a potential disease-modifying drug in type 1 diabetes (T1D). This meta-analysis sought to summarize the therapeutic effect of teplizumab in newly diagnosed patients with T1D. Methods
Randomized controlled trials (RCTs) involving patients with T1D receiving teplizumab in the intervention arm and placebo (or no active intervention) in the control arm were searched throughout the electronic databases. The primary outcome was the change in area under the curve (AUC) of C-peptide levels from baseline. Results
Seven reports from six studies involving 834 subjects met the inclusion criteria. Compared to teplizumab, greater reductions in AUC of C-peptide from the baseline values were observed in the control group after six months (MD 0.07 nmol/L [0.01, 0.13], P=0.02), after 12 months (MD 0.07 nmol/L [0.04, 0.11], P=0.0001), after 18 months (MD 0.10 nmol/L [0.06, 0.14], P<0.00001), and after 24 months (MD 0.07 nmol/L [0.01, 0.14], P=0.03) of interventions. Moreover, fewer patients treated with teplizumab had a decreased C-peptide response after six months (OR 0.21), after 12 months (OR 0.17), after 18 months (OR 0.30) and after 24 months (OR 0.12) of treatment. The preservation of endogenous insulin production was supported by reduced use of exogenous insulin with maintenance of comparable glycemic control for up to 18 months post-treatment. Teplizumab imparted higher risks of grade 3 or higher adverse events (AEs), AEs leading to study medication discontinuation, nausea, rash, and lymphopenia. Conclusion
The results of the meta-analysis support teplizumab as a promising disease-modifying therapy for newly diagnosed T1D.
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