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胰腺炎:利拉鲁肽的潜在并发症?

Pancreatitis: a potential complication of liraglutide?

机构信息

University of Tennessee Health Science Center, College of Pharmacy, Department of Clinical Pharmacy, Knoxville, TN, USA.

出版信息

Ann Pharmacother. 2012 Nov;46(11):1547-53. doi: 10.1345/aph.1Q789. Epub 2012 Nov 7.

DOI:10.1345/aph.1Q789
PMID:23136352
Abstract

OBJECTIVE

To review the evidence surrounding a potential association between liraglutide and pancreatitis.

DATA SOURCES

A literature search was conducted in MEDLINE (1948-July 12, 2012) and EMBASE (1974-week 27, 2012) using the search terms pancreatitis, liraglutide, and glucagon-like peptide 1/adverse effects. Reference citations from identified publications were reviewed. The manufacturer was contacted and regulatory documents from the Food and Drug Administration website were reviewed for unpublished data related to cases of pancreatitis associated with liraglutide use.

STUDY SELECTION AND DATA EXTRACTION

All identified sources that were published in English were considered for inclusion.

DATA SYNTHESIS

Eleven cases of pancreatitis have been reported in patients taking liraglutide. Seven were from the LEAD (Liraglutide Effect and Action in Diabetes) studies, 1 was reported in the extension of a clinical trial, and 1 was in an unpublished obesity trial. Two were published postmarketing case reports. Nine of the cases reported were diagnosed as acute pancreatitis, while 2 were classified as chronic pancreatitis. The mean age of the patients was 57.5 years and mean body mass index was 33.92 kg/m(2). Six of the 11 cases occurred in male patients. Nine of the patients were white and 1 was African American. In 7 of the cases, onset occurred at liraglutide doses at or above 1.8 mg daily. Common comorbidities included history of pancreatitis, cholelithiasis, and diabetes. One case was fatal.

CONCLUSIONS

Pancreatitis is a potential complication with liraglutide therapy. Liraglutide should be used cautiously in patients at risk of pancreatitis (eg, alcohol abuse, history of pancreatitis, cholelithiasis).

摘要

目的

综述有关利拉鲁肽与胰腺炎之间潜在关联的证据。

资料来源

在 MEDLINE(1948 年-2012 年 7 月 12 日)和 EMBASE(1974 年-2012 年第 27 周)中使用胰腺炎、利拉鲁肽和胰高血糖素样肽 1/不良反应等检索词进行文献检索。还查阅了已确定出版物的参考文献。与利拉鲁肽使用相关的胰腺炎病例的未发表数据,向制造商咨询并查阅美国食品和药物管理局网站的监管文件。

研究选择和数据提取

所有以英文发表的已确定来源均被认为可纳入。

数据综合

有 11 例胰腺炎病例在使用利拉鲁肽的患者中报告。其中 7 例来自 LEAD(利拉鲁肽对糖尿病的作用和疗效)研究,1 例来自临床试验的扩展,1 例来自未发表的肥胖试验。2 例为上市后病例报告。报告的 9 例病例诊断为急性胰腺炎,而 2 例为慢性胰腺炎。患者的平均年龄为 57.5 岁,平均体重指数为 33.92kg/m²。11 例中的 6 例发生在男性患者中。9 例患者为白人,1 例为非裔美国人。在 7 例中,发病发生在利拉鲁肽剂量为 1.8mg/d 或更高时。常见的合并症包括胰腺炎、胆石症和糖尿病史。有 1 例病例为致命性。

结论

胰腺炎是利拉鲁肽治疗的潜在并发症。利拉鲁肽应谨慎用于有胰腺炎风险的患者(如,酗酒、胰腺炎史、胆石症)。

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