title: 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.
abstract: OBJECTIVE
  To report the incidence of pancreatitis in type 2 diabetes trials of liraglutide and details of all pancreatitis cases.
  
  
  METHODS
  Data from Novo Nordisk-sponsored trials with liraglutide (phase 2 and 3; NN2211 identifiers) completed by 19 April 2013 were pooled. All pancreatitis cases were reviewed.
  
  
  RESULTS
  Total exposure to liraglutide and active comparators was 5,021 and 1,354 patient-years, respectively (n = 6,345 and 1,846, respectively). Eight cases of acute pancreatitis (AP) with liraglutide and one with any comparator (glimepiride) were found. The incidence of AP was 1.6 cases/1,000 patient-years exposure (PYE) for liraglutide vs. 0.7 cases/1,000 PYE for total active comparators. One of the eight AP cases reported with liraglutide did not meet diagnostic criteria for AP. In six of these eight cases, recognized risk factors for AP were present and/or the onset of AP occurred >6 months after liraglutide initiation. All patients were receiving multiple medications. Four cases of chronic pancreatitis (CP) with liraglutide and none with comparators were found. One of these four cases fulfilled diagnostic criteria for CP; these criteria were not met or information was missing in the remaining three.
  
  
  CONCLUSIONS
  Based on the small number of cases observed, the incidences of reported AP and CP were numerically greater with liraglutide than with comparators. Not all cases fulfilled diagnostic criteria, and confounding variables were present in 75% of the AP cases with liraglutide therapy, precluding firm conclusions.
authors.affiliation: UK Medical Affairs, Novo Nordisk Ltd., Gatwick, U.K. toej@novonordisk.com.
authors.forename: Troels M
authors.initials: TM
authors.lastname: Jensen
authors.affiliation: Global Safety, Novo Nordisk A/S, Bagsværd, Copenhagen, Denmark.
authors.forename: Kishore
authors.initials: K
authors.lastname: Saha
authors.affiliation: Rockville Internal Medicine Group and the Department of Medicine, George Washington University, Washington, DC.
authors.forename: William M
authors.initials: WM
authors.lastname: Steinberg
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D000069450:Liraglutide / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000139:chemically induced*; D050500:Pancreatitis, Chronic / Q000139:chemically induced; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D013453:Sulfonylurea Compounds / Q000009:adverse effects
chemical_list: D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; C057619:glimepiride; D000069450:Liraglutide