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. 2019 Jan 24;2(2):e00052.
doi: 10.1002/edm2.52. eCollection 2019 Apr.

Pancreatic safety of vildagliptin in patients with type 2 diabetes mellitus: A European, noninterventional, postauthorization safety study

Rachael Williams  1 , Wolfgang Kothny  2 , Carmen Serban  2 , Sandra Lopez-Leon  3 , Raymond Schlienger  2
Affiliations

Pancreatic safety of vildagliptin in patients with type 2 diabetes mellitus: A European, noninterventional, postauthorization safety study

Rachael Williams et al. Endocrinol Diabetes Metab. .

Abstract

This cohort study assessed the pancreatic safety of vildagliptin versus other noninsulin antidiabetic drugs (NIADs) based on data from five European electronic health care databases. Patients with type 2 diabetes aged ≥18 years on NIAD treatment were enrolled. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were estimated separately for acute pancreatitis and pancreatic cancer for vildagliptin (± other NIADs) compared with other NIADs using negative binomial regression. Approximately 2.8% of the enrolled patients (n = 738 054) used vildagliptin during the study, with an average follow-up time of 1.4 years. For acute pancreatitis, adjusted IRRs ranged between 0.89 andt 2.58 with all corresponding 95% CIs crossing 1. For pancreatic cancer adjusted IRRs ranged from 0.56 to 3.64, with the lower limit of 95% CIs >1 in some analyses. Post hoc sensitivity analyses taking latency time into account markedly lowered the risk estimates with corresponding 95% CIs crossing 1. Overall, the results do not suggest an increased pancreatitis risk with vildagliptin, while the observation for pancreatic cancer have to be interpreted carefully as this study was not designed to assess pancreatic cancer and rather be explained by certain underlying limitations including latency -time, chance findings and/or bias and confounding.

Keywords: dipeptidyl peptidase‐4 inhibitors; pancreatic cancer; pancreatitis; type 2 diabetes mellitus; vildagliptin.

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Conflict of interest statement

R. W. is an employee of CPRD, London, UK. W. K., C. S. and R. S. are employees and own shares of Novartis Pharma AG, Basel, Switzerland. S. L. is an employee and shareholder of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.

Figures

Figure 1
Figure 1
Adjusted incidence rate ratios of acute pancreatitis for the use of vildagliptin vs other NIADs. CI, confidence interval; CPRD GOLD, Clinical Practice Research Datalink General practice OnLine Database; IMS DA, Intercontinental Marketing Statistics Disease Analyzer; IR, incidence rate (per 1000 patient‐y); IRRs, incidence rate ratios; NE, not evaluated (due to zero cases in the vildagliptin group); NIAD, noninsulin antidiabetic drug; NR, National Registers; OPED, Odense Pharmacoepidemiological Database
Figure 2
Figure 2
Adjusted incidence rate ratios of pancreatic cancer for the use of vildagliptin versus other NIADs by databases and age subgroups. CI, confidence interval; CPRD GOLD, Clinical Practice Research Datalink General practice OnLine Database; IMS DA, Intercontinental Marketing Statistics Disease Analyzer; IR, incidence rate (per 1000 patient‐y); IRRs, incidence rate ratios; NE, not evaluated (due to zero cases in the vildagliptin group); NIAD, noninsulin antidiabetic drug; NR, National Registers; OPED, Odense Pharmacoepidemiological Database
Figure 3
Figure 3
Post hoc sensitivity analysis: Adjusted incidence rate ratios of pancreatic cancer for the use of vildagliptin vs other NIADs. CI, confidence interval; CPRD GOLD, Clinical Practice Research Datalink General practice OnLine Database; IMS DA, Intercontinental Marketing Statistics Disease Analyzer; IR, incidence rate (per 1000 patient‐y); IRRs, incidence rate ratios; NA, not available; NE, not evaluated (due to zero cases in the vildagliptin group); NIAD, noninsulin antidiabetic drug; NR, National Registers; OPED, Odense Pharmacoepidemiological Database
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