Acute pancreatitis risk in type 2 diabetes patients treated with canagliflozin versus other antihyperglycemic agents: an observational claims database study

Yuan, Zuyi; DeFalco, Frank; Wang, Lu; Hester, Laura; Weaver, James; Swerdel, Joel N.; Freedman, Amy; Ryan, Patrick B.; Schuemie, Martijn J.; Qiu, Rose; Yee, Jacqueline; Meininger, Gary; Berlin, Jesse A.; Rosenthal, Norman

doi:10.1080/03007995.2020.1761312

Cited by 4 publications

(4 citation statements)

References 42 publications

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“…A further study of three US claims databases evaluated the risk of acute pancreatitis in new users of canagliflozin compared with new users of six other classes of glucose-lowering agents. 40 Compared with the present study, the PS matched analysis of the canagliflozin groups showed lower incidence rates for acute pancreatitis (1.5 to 2.2 per 1000 PY for canagliflozin in the on-treatment analysis versus 10.30 per 1000 PY with empagliflozin) in the present study, although this could partly reflect methodological differences between the studies and populations. Specifically, the definition of acute pancreatitis used in the present study was based on a validated algorithm selected to detect acute pancreatitis in all clinical settings rather than only at hospital discharge, resulting in more cases identified.…”

Section: Discussioncontrasting

confidence: 90%

“…The analysis showed no significant increase in the risk of acute pancreatitis associated with the use of SGLT2 inhibitors versus control groups (receiving oral anti‐diabetes therapies or insulin). A further study of three US claims databases evaluated the risk of acute pancreatitis in new users of canagliflozin compared with new users of six other classes of glucose‐lowering agents 40 . Compared with the present study, the PS matched analysis of the canagliflozin groups showed lower incidence rates for acute pancreatitis (1.5 to 2.2 per 1000 PY for canagliflozin in the on‐treatment analysis versus 10.30 per 1000 PY with empagliflozin) in the present study, although this could partly reflect methodological differences between the studies and populations.…”

Section: Discussionmentioning

confidence: 99%

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Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post‐authorization safety study

Fazeli Farsani,

Iglay,

Zhang

et al. 2024

Pharmacoepidemiology and Drug

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PurposeThis study was undertaken to evaluate the potential risk of acute pancreatitis with empagliflozin in patients with type 2 diabetes (T2D) newly initiating empagliflozin.MethodsData from two large US claims databases were analyzed in an observational study of patients with T2D receiving metformin who were newly prescribed empagliflozin versus sulfonylurea (SU). Because dipeptidyl peptidase‐4 inhibitors and glucagon‐like peptide‐1 receptor agonists have been associated with the risk of acute pancreatitis in some studies, patients on these agents were excluded. Using pooled analyses of data from the two databases (2014–2021), patients initiating empagliflozin were matched 1:1 within database to patients initiating SU using propensity scores (PS) that incorporated relevant demographic and clinical characteristics. Prespecified sensitivity analyses were performed for design parameters.ResultsThe analyses identified 72 661 new users of empagliflozin and 422 018 new users of SUs, with both patient groups on concurrent metformin therapy. Baseline characteristics within treatment groups appeared to be similar across the 72 621 matched pairs. After mean follow‐up of ~6 months, incidence rates of acute pancreatitis in the pooled matched cohort were 10.30 (95% confidence interval [CI] 9.29–11.39) events per 1000 patient‐years (PY) for empagliflozin and 11.65 (95% CI 10.59–12.77) events per 1000 PY for SUs. On a background of metformin, patients newly initiating empagliflozin did not have an increased risk of acute pancreatitis compared with those initiating an SU (pooled PS matched hazard ratio 0.88 [0.76–1.02]) across 75621.42 PY of follow‐up.ConclusionsThe results of this voluntary post‐approval safety study provide additional evidence that the use of empagliflozin for the treatment of T2D is not associated with an increased risk of acute pancreatitis.

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Section: Discussioncontrasting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post‐authorization safety study

Fazeli Farsani,

Iglay,

Zhang

et al. 2024

Pharmacoepidemiology and Drug

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“…Metformin, known for its potential to cause pancreatitis, 12 but also the 1st line treatment in T2D, so therefore expected to be used together with gliflozins, 1,33 was co‐suspect or interacting drug in 58 reports. The association between gliflozins and metformin was also found in all but one of the literature case reports of AP to gliflozins 22–24,26–28 . One possible mechanism proposed by other authors for AP cases associated with gliflozins and metformin could involve dehydration and lactic acidosis (due to metformin), leading to pancreatitis 19 …”

Section: Discussionmentioning

confidence: 72%

“…On the other hand, recent meta‐analyses of randomized clinical trials (RCTs) failed to identify a risk of pancreatitis associated with SGLT2i use 22,23 . Moreover, an observational study that looked at the association between canagliflozin and AP found no evidence to suggest that canagliflozin is associated with an increased risk of AP compared with other GLA 24 . Similar results were found in a nationwide register‐based cohort study from Sweden and Denmark 25 .…”

Section: Introductionmentioning

confidence: 75%

An investigation on the association between sodium glucose co‐transporter 2 inhibitors use and acute pancreatitis: A VigiBase study

Frent

Bucşa

Leucuţa

et al. 2021

Pharmacoepidemiology and Drug

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Purpose To characterize acute pancreatitis (AP) related to sodium glucose co‐transporter 2 inhibitors and to investigate this relationship through disproportionality analysis in an international pharmacovigilance database. Methods We analyzed all AP reports for canagliflozin, dapagliflozin and/or empagliflozin from the WHOs Global adverse drug reactions database VigiBase® up to July 2019. We characterized the patients, reporters, and reactions, and we present the proportional reporting ratio (PRR) and information component (IC) for each of the gliflozins. AP cases were reports containing at least one of 11 previously selected preferred terms. Gliflozin exposure was considered for all reports with at least one gliflozin as suspected/ interacting drug. Results Of the 19 834 180 individual case safety reports in VigiBase, in 600 reports containing 618 AP group reactions, gliflozins were suspected/ interacting drugs. Men were affected in 52.3% of the cases and 59.6% of the patients were in the 45–64 years age group. The reporters were in 417 cases healthcare professionals. Most of the reactions were reported for canagliflozin (59.7%), followed by empagliflozin (21%) and dapagliflozin (19.2%) and were serious (98.6%). Most of the reactions' outcomes (84% of the patients) were favorable. Ketoacidosis was frequently associated with the AP (21.3%). Significant PRR and IC were found for pancreatitis and pancreatitis acute for all three gliflozins, pancreatitis necrotizing for canagliflozin and empagliflozin and pancreatitis relapsing for empagliflozin. Conclusions Most of the AP cases were serious and with favorable outcome. We identified possible alternative causes for AP, like concomitant medication, hypertriglyceridemia, and cholelithiasis and a frequent association with ketoacidosis. We found a significant association between AP and the use of canagliflozin, dapagliflozin, and empagliflozin that would need further investigation.

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An Overview of Hypoglycemic Modern Drugs

Chen

2021

Structure and Health Effects of Natural Products on Diabetes Mellitus

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Acute pancreatitis risk in type 2 diabetes patients treated with canagliflozin versus other antihyperglycemic agents: an observational claims database study

Cited by 4 publications

References 42 publications

Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post‐authorization safety study

Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post‐authorization safety study

An investigation on the association between sodium glucose co‐transporter 2 inhibitors use and acute pancreatitis: A VigiBase study

An Overview of Hypoglycemic Modern Drugs

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