Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level...
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![Page 1: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/1.jpg)
Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide
Type 2 Diabetes Clinical Trials
Featured Article:
Troels M. Jensen, Kishore Saha, and William M. Steinberg
Diabetes Care Volume 38: 1058-1066
June, 2015
![Page 2: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/2.jpg)
STUDY OBJECTIVE
• To report the incidence of pancreatitis in type 2 diabetes trials of liraglutide
• To report the details of pancreatitis cases
Jensen T. M. et al. Diabetes Care 2015;38:1058-1066
![Page 3: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/3.jpg)
STUDY DESIGN AND METHODS
• Data were pooled from Novo Nordisk–sponsored trials with liraglutide completed by 19 April 2013
• All pancreatitis cases were reviewed
Jensen T. M. et al. Diabetes Care 2015;38:1058-1066
![Page 4: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/4.jpg)
RESULTS
• Exposure to liraglutide and active comparators was 5,021 and 1,354 patient-years, respectively
• Eight cases were found of acute pancreatitis (AP) with liraglutide and one with any comparator (glimepiride)
• Incidence of AP:• 1.6 cases/1,000 patient-years exposure (PYE) for liraglutide• 0.7 cases/1,000 PYE for total active comparators
Jensen T. M. et al. Diabetes Care 2015;38:1058-1066
![Page 5: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/5.jpg)
RESULTS
• One of the eight AP cases reported with liraglutide did not meet diagnostic criteria for AP
• In six of eight cases, recognized risk factors for AP were present and/or the onset of AP occurred >6 months after liraglutide initiation
• Four cases of chronic pancreatitis (CP) with liraglutide and none with comparators were found
Jensen T. M. et al. Diabetes Care 2015;38:1058-1066
![Page 6: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/6.jpg)
Jensen T. M. et al. Diabetes Care 2015;38:1058-1066
![Page 7: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/7.jpg)
Jensen T. M. et al. Diabetes Care 2015;38:1058-1066
![Page 8: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/8.jpg)
CONCLUSIONS
• Incidences of reported AP and CP were numerically greater with liraglutide than with comparators
• Not all cases fulfilled diagnostic criteria
• Confounding variables were present in 75% of the AP cases with liraglutide therapy
Jensen T. M. et al. Diabetes Care 2015;38:1058-1066
![Page 9: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/9.jpg)
Jensen T. M. et al. Diabetes Care 2015;38:1058-1066
![Page 10: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/10.jpg)
Jensen T. M. et al. Diabetes Care 2015;38:1058-1066
![Page 11: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical.](https://reader036.fdocuments.in/reader036/viewer/2022062516/56649d755503460f94a55abd/html5/thumbnails/11.jpg)
Jensen T. M. et al. Diabetes Care 2015;38:1058-1066