i3 Drug Safety, Waltham, MA, USA.
Diabetes Obes Metab. 2011 Jun;13(6):559-66. doi: 10.1111/j.1463-1326.2011.01376.x.
Reports of acute pancreatitis associated with exenatide treatment prompted this study to estimate the association between acute pancreatitis and exenatide use relative to other antihyperglycaemic drugs.
This cohort study included patients without claims for prior pancreatic disease who initiated exenatide or other antihyperglycaemic drugs between June 2005 and December 2007. Acute pancreatitis was identified with diagnosis codes and confirmed through review of blinded medical records. Poisson regression models provided estimates of rate ratios (RRs) and 95% confidence intervals (CIs) comparing the rate of acute pancreatitis during periods of current (days supplied + 31 days), recent (current definition + 31 days) and past use (≥32 days beyond current definition) of exenatide relative to other antihyperglycaemic drugs, adjusted for propensity scores. A prespecified nested case-control analysis provided RR estimates adjusted for patient characteristics abstracted from medical records.
Initiators of exenatide (N = 25719) had more baseline claims for obesity and concomitant diabetes drugs than comparators (N = 234536). There were 40 confirmed cases of acute pancreatitis in the exenatide cohort and 254 among other antihyperglycaemic drug initiators. Compared to other antihyperglycaemic drugs, the propensity score-adjusted RR for exenatide was 0.5 (95% CI 0.2-0.9) for current use, 1.1 (95% CI 0.4-3.2) for recent use and 2.8 (95% CI 1.6-4.7) for past use. The case-control analysis resulted in a RR of 0.2 for current use (95% CI 0.0-1.4) and 0.1 for recent use (95% CI 0.0-1.3), but an attenuated RR in the past use association (RR 1.1; 95% CI 0.1-11.0).
Exenatide use was not associated with an increased risk of acute pancreatitis.
有报道称，接受 exenatide 治疗后会出现急性胰腺炎，因此本研究旨在评估与其他降糖药物相比，exenatide 与急性胰腺炎之间的关联性。
本队列研究纳入了 2005 年 6 月至 2007 年 12 月期间无既往胰腺疾病就诊记录且起始使用 exenatide 或其他降糖药物的患者。通过诊断代码识别出急性胰腺炎病例，并通过盲法病历审查予以确认。应用泊松回归模型比较了 exenatide 治疗的当前（用药天数+31 天）、近期（当前定义+31 天）和过去（当前定义后超过 32 天）时期与其他降糖药物相比，急性胰腺炎的发生率，并采用倾向评分进行调整。预先设定的巢式病例对照分析提供了调整病历中提取的患者特征后的 RR 估计值。
与对照相比，exenatide 起始使用者（N=25719）基线时的肥胖和伴随使用糖尿病药物的就诊记录更多。exenatide 队列中有 40 例经确认的急性胰腺炎病例，其他降糖药物起始使用者中有 254 例。与其他降糖药物相比，经倾向评分调整后，exenatide 的 RR 为当前治疗 0.5（95%CI 0.2-0.9），近期治疗 1.1（95%CI 0.4-3.2），过去治疗 2.8（95%CI 1.6-4.7）。病例对照分析得出当前治疗的 RR 为 0.2（95%CI 0.0-1.4），近期治疗的 RR 为 0.1（95%CI 0.0-1.3），但过去治疗关联性的 RR 减弱（RR 1.1；95%CI 0.1-11.0）。
exenatide 的使用与急性胰腺炎风险增加无关。
