Incretin-based drugs and risk of acute pancreatitis: A nested-case control study within a healthcare database.
To assess the association between use of incretin-based drugs for diabetes mellitus and the occurrence of acute pancreatitis. A population-based, nested case-control study was performed within a cohort of 166,591 patients from the Lombardy region (Italy) aged 40 years or older who were newly treated with oral antihyperglycaemic agents between 2004 and 2007. Cases were 666 patients who experienced acute pancreatitis from April 1, 2008 until December 31, 2012. For each case patient, up to 20 controls were randomly selected from the cohort and matched on gender, age at cohort entry, and date of index prescription. Conditional logistic regression was used to model the risk of acute pancreatitis associated with use of incretin-based drugs within 30 days before hospitalization, after adjustment for several risk factors, including the use of other antihyperglycaemic agents. Sensitivity analyses were performed in order to account for possible sources of systematic uncertainty. Use of incretin-based drugs within 30 days was reported by 17 (2.6%) cases of acute pancreatitis versus 193 (1.5%) controls. The corresponding multivariate odds ratio was 1.75 (95% confidence interval, 1.02 to 2.99). Slightly lower and no significant excess risks were observed by shortening (15 days) and increasing (60 and 90 days) the time-window at risk. This study supports a possible increased risk of acute pancreatitis in relation to use of incretin-based drugs reported in a few previous studies. However, given the potential for bias and the inconsistency with other studies, additional investigations are needed to clarify the safety of incretin-based-drugs.
Dipartimento di Statistica e Metodi Quantitativi, Sezione di Biostatistica, Epidemiologia e Sanità Pubblica, Università Milano-Bicocca, Milan, Italy.
Davide
D
Soranna
Dipartimento di Epidemiologia, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy.
Cristina
C
Bosetti
Dipartimento di Scienze Farmacologiche e Biomolecolari, Università di Milano, Milan, Italy.
Manuela
M
Casula
Dipartimento di Scienze Farmacologiche e Biomolecolari, Università di Milano, Milan, Italy.
Elena
E
Tragni
Dipartimento di Scienze Farmacologiche e Biomolecolari, Università di Milano, Milan, Italy; IRCSS Multimedica, Milan, Italy.
Alberico L
AL
Catapano
Dipartimento di Scienze Cliniche e di Comunità, Università Milano, Milan, Italy.
Carlo L A
CL
Vecchia
Unità Organizzativa Governo dei dati, delle strategie e piani del sistema sanitario, Regione Lombardia, Milan, Italy.
Luca
L
Merlino
Dipartimento di Statistica e Metodi Quantitativi, Sezione di Biostatistica, Epidemiologia e Sanità Pubblica, Università Milano-Bicocca, Milan, Italy. Electronic address: giovanni.corrao@unimib.it.
Giovanni
G
Corrao
D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D016208:Databases, Factual / Q000706:statistics & numerical data; D003920:Diabetes Mellitus / Q000188:drug therapy*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D054795:Incretins / Q000009:adverse effects* / Q000627:therapeutic use*; D007558:Italy / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010195:Pancreatitis / Q000139:chemically induced* / Q000453:epidemiology*; D015995:Prevalence; D012307:Risk Factors
D007004:Hypoglycemic Agents; D054795:Incretins
Acute pancreatitis; Antihyperglycaemic agents; Drug safety; Healthcare databases; Incretin-based drugs; Nested case-control study