More incidences of acute and chronic pancreatitis occurred with the use of liraglutide compared with any of its comparators, according to a study published in Diabetes Care.
Researchers looked at data from Novo Nordisk-sponsored trials of liraglutide and reviewed all cases of pancreatitis. The total data included 5,021 patient-years of liraglutide exposure and 1,354 patient-years of comparator exposure. They found eight cases of acute pancreatitis with liraglutide (an incidence of 1.6 cases/1,000 patient-years exposure) and only one case with comparators (0.7 cases/1,000 patient-years exposure).
Of the acute pancreatitis cases reported with liraglutide, one did not meet diagnostic criteria for the condition. In six cases, risk factors for acute pancreatitis were present and/or the onset occurred more than 6 months after beginning liraglutide treatment.
The researchers also found that four cases of chronic pancreatitis were reported by patients taking liraglutide; no cases were reported with comparators. Only one of these cases met the diagnostic criteria for chronic pancreatitis; in the other three, the criteria were not met or information was missing.
Although the number of reported pancreatitis cases was small, incidences were still higher in patients taking liraglutide than comparators. Not all cases met diagnostic criteria, and confounding variables existed in 75% of the acute pancreatitis cases with liraglutide, so a definite conclusion cannot be reached.
OBJECTIVE To report the incidence of pancreatitis in type 2 diabetes trials of liraglutide and details of all pancreatitis cases.
RESEARCH DESIGN AND 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.
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.