Dipeptidylpeptidase-4 inhibitors: risk of acute pancreatitis
»Ê¹ÚÌåÓýappre have been reports of acute pancreatitis associated with drugs in the dipeptidylpeptidase-4 (DPP-4) inhibitor class of antidiabetic agents (‘gliptinsâ€�).
Article date: September 2012
DPP-4 inhibitors are indicated for the improvement of glycaemic control in adults with type 2 diabetes mellitus. Drugs of this class include Onglyzaâ–� (saxagliptin), Trajentaâ–� (linagliptin), Galvusâ–� (vildagliptin) and Januvia (sitagliptin). A number of fixed-dose combination tablets containing a DDP-4 inhibitor with metformin are also available, including Eucreasâ–� (vildagliptin) and Janumet (sitagliptin).
Risk of pancreatitis
An increased risk of acute pancreatitis has been identified for all approved DPP-4 inhibitors. For most of the compounds this was detected in spontaneous post-marketing reports; for 1 of the newer compounds, linagliptin, a small increased number of cases compared with placebo was detected in clinical development.
Consequently, pancreatitis is now included in the for all DPP-4 inhibitors as a possible adverse reaction. »Ê¹ÚÌåÓýapp reporting rate of pancreatitis appears to be low (ranging between 1/1 000 and 1/100 patients receiving the drug) but the precise frequency is unknown as few cases have been reported in clinical trials. In most cases, pancreatitis resolved after discontinuation of treatment.
»Ê¹ÚÌåÓýapp possible mechanism leading to acute pancreatitis is not clear. Data from animal studies have been inconclusive or have not suggested a safety concern. In addition, patients with diabetes are known to have a higher incidence of pancreatitis compared with non-diabetic patients.
Advice for healthcare professionals:
- patients treated with DDP-4 inhibitors should be informed of the characteristic symptoms of acute pancreatitis � persistent, severe abdominal pain (sometimes radiating to the back) � and encouraged to tell their healthcare provider if they have such symptoms
- if pancreatitis is suspected, the DPP-4 inhibitor and other potentially suspect medicines should be discontinued
- report suspected adverse reactions through the Yellow Card scheme—see ; when reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, and treatment dates
Further information
BNF Treatment Summary.
Article citation: Drug Safety Update September 2012, vol 6, issue 2: A3
Post-publication note:
In March 2022, links were refreshed during routine review of older articles.