Funch D, Gydesen H, Tornøe K, Major-Pedersen A, Chan K A
Optum, Epidemiology, Waltham, MA, USA.
Diabetes Obes Metab. 2014 Mar;16(3):273-5. doi: 10.1111/dom.12230. Epub 2013 Nov 26.
We evaluated the relationship between liraglutide and acute pancreatitis or pancreatic cancer in an ongoing post-marketing safety assessment programme.
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.
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).
We did not observe excess risk of either outcome associated with liraglutide relative to individual or pooled comparator drugs.
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。
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)。
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)。
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。