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A critical analysis of the clinical use of incretin-based therapies: Are the GLP-1 therapies safe?基于肠促胰岛素的治疗方法的临床应用的批判性分析:GLP-1 治疗方法安全吗?
Diabetes Care. 2013 Jul;36(7):2118-25. doi: 10.2337/dc12-2713. Epub 2013 May 3.
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Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors.外分泌和内分泌胰腺在具有外分泌胰腺发育不良增加的人类中随着肠促胰岛素治疗而显著扩张,并且具有产生胰高血糖素的神经内分泌肿瘤的潜力。
Diabetes. 2013 Jul;62(7):2595-604. doi: 10.2337/db12-1686. Epub 2013 Mar 22.
3
Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study.基于胰高血糖素样肽 1 的治疗与 2 型糖尿病患者急性胰腺炎住院风险的相关性:一项基于人群的匹配病例对照研究。
JAMA Intern Med. 2013 Apr 8;173(7):534-9. doi: 10.1001/jamainternmed.2013.2720.
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Exenatide therapy and the risk of pancreatitis and pancreatic cancer in a privately insured population.依西那肽治疗与私人保险人群中胰腺炎和胰腺癌风险。
Diabetes Technol Ther. 2012 Oct;14(10):904-11. doi: 10.1089/dia.2012.0075. Epub 2012 Jul 30.
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Chronic GLP-1 receptor activation by exendin-4 induces expansion of pancreatic duct glands in rats and accelerates formation of dysplastic lesions and chronic pancreatitis in the Kras(G12D) mouse model.外源性 GLP-1 受体激动剂 exendin-4 持续激活可诱导大鼠胰管腺扩张,并加速 Kras(G12D) 小鼠模型中发育不良病变和慢性胰腺炎的形成。
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The association of pancreatitis with antidiabetic drug use: gaining insight through the FDA pharmacovigilance database.糖尿病药物使用与胰腺炎相关性的研究:通过 FDA 药物警戒数据库深入了解。
Acta Diabetol. 2013 Aug;50(4):569-77. doi: 10.1007/s00592-011-0340-7. Epub 2011 Oct 19.
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Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies.胰脏炎、胰脏癌与甲状腺癌与 GLP-1 类药物治疗
Gastroenterology. 2011 Jul;141(1):150-6. doi: 10.1053/j.gastro.2011.02.018. Epub 2011 Feb 18.
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A cohort study of acute pancreatitis in relation to exenatide use.一项关于急性胰腺炎与 exenatide 使用相关的队列研究。
Diabetes Obes Metab. 2011 Jun;13(6):559-66. doi: 10.1111/j.1463-1326.2011.01376.x.
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Stratum-specific positive predictive values of claims for acute pancreatitis among commercial health insurance plan enrollees with diabetes mellitus.糖尿病商业健康保险计划参保者中急性胰腺炎理赔的分层特异性阳性预测值。
Pharmacoepidemiol Drug Saf. 2011 Feb;20(2):209-13. doi: 10.1002/pds.2077. Epub 2010 Dec 23.
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Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis.2 型糖尿病患者使用 exenatide 或 sitagliptin 治疗急性胰腺炎:一项回顾性观察性药物索赔分析。
Diabetes Care. 2010 Nov;33(11):2349-54. doi: 10.2337/dc10-0482. Epub 2010 Aug 3.

一项基于索赔数据的前瞻性评估,比较利拉鲁肽与其他抗糖尿病药物引发胰腺炎和胰腺癌的风险。

A prospective, claims-based assessment of the risk of pancreatitis and pancreatic cancer with liraglutide compared to other antidiabetic drugs.

作者信息

Funch D, Gydesen H, Tornøe K, Major-Pedersen A, Chan K A

机构信息

Optum, Epidemiology, Waltham, MA, USA.

出版信息

Diabetes Obes Metab. 2014 Mar;16(3):273-5. doi: 10.1111/dom.12230. Epub 2013 Nov 26.

DOI:10.1111/dom.12230
PMID:24199745
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4237552/
Abstract

AIM

We evaluated the relationship between liraglutide and acute pancreatitis or pancreatic cancer in an ongoing post-marketing safety assessment programme.

METHODS

Initiators of liraglutide, exenatide, metformin, pioglitazone or groups containing initiators of dipeptidyl peptidase-4 inhibitors or sulfonylureas were identified in a US commercial health insurance claims database (1 February 2010 to 31 March 2013) and followed for a median of 15 months. We estimated incidence rates (IR/100 000 person-years), rate ratio (RR) and 95% confidence intervals (CI) of new insurance claims with diagnoses of primary inpatient acute pancreatitis or pancreatic cancer from Poisson regression models.

RESULTS

The IR for acute pancreatitis for liraglutide was 187.5 compared with 154.4 for all non-glucagon-like peptide-1 (GLP-1)-based therapies (adjusted RR 1.10; CI 0.81-1.49). The IR for pancreatic cancer was 19.9 for liraglutide compared with 33.0 for all non-GLP-1-based therapies (adjusted RR 0.65; 95% CI 0.26-1.60).

CONCLUSION

We did not observe excess risk of either outcome associated with liraglutide relative to individual or pooled comparator drugs.

摘要

目的

在一项正在进行的上市后安全性评估项目中,我们评估了利拉鲁肽与急性胰腺炎或胰腺癌之间的关系。

方法

在美国商业健康保险理赔数据库(2010年2月1日至2013年3月31日)中识别出使用利拉鲁肽、艾塞那肽、二甲双胍、吡格列酮的患者或包含二肽基肽酶-4抑制剂或磺脲类药物起始使用者的群组,并对其进行了为期15个月的随访。我们通过泊松回归模型估计了诊断为原发性住院急性胰腺炎或胰腺癌的新保险理赔的发病率(每100,000人年的发病率)、率比(RR)和95%置信区间(CI)。

结果

利拉鲁肽治疗急性胰腺炎的发病率为187.5,而所有非基于胰高血糖素样肽-1(GLP-1)的治疗方法的发病率为154.4(调整后的RR为1.10;CI为0.81-1.49)。利拉鲁肽治疗胰腺癌的发病率为19.9,而所有非基于GLP-1的治疗方法的发病率为33.0(调整后的RR为0.65;95%CI为0.26-1.60)。

结论

相对于个体或汇总的对照药物,我们未观察到利拉鲁肽与这两种结局中的任何一种存在额外风险。