A cohort study of acute pancreatitis in relation to exenatide use

Dore, David D.; Bloomgren, Gary; Wenten, Madé; Hoffman, Clorinda; Clifford, C. Robin; Quinn, Sean M.; Braun, Daniel; Noel, Rebecca; Seeger, John D.

doi:10.1111/j.1463-1326.2011.01376.x

Cited by 132 publications

(99 citation statements)

References 28 publications

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“…These concerns have been corroborated by reports from adverse event databases (4,5), although such analyses have well-known limitations. In contrast, the observational studies conducted to date have been conflicting and inconclusive (6)(7)(8)(9)(10)(11)(12)(13)(14)(15).…”

Section: Dwilliam T Cefalu Editor In Chief Diabetes Carementioning

confidence: 89%

Incretin-Based Drugs and Adverse Pancreatic Events: Almost a Decade Later and Uncertainty Remains

Azoulay

2015

Diabetes Care

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Over the past few years, substantial clinical data have been presented showing that incretin-based therapies are effective glucose-lowering agents. Specifically, glucagon-like peptide 1 receptor agonists demonstrate an efficacy comparable to insulin treatment with minimal hypoglycemia and have favorable effects on body weight. Thus, many of the unmet clinical needs noted from prior therapies are addressed by these agents. However, even after many years of use, many continue to raise concerns about the long-term safety of these agents and, in particular, the concern with pancreatitis. This clearly remains a complicated topic. Thus, in this issue of Diabetes Care, we continue to update our readers on this very important issue by presenting two studies evaluating incretin-based medications and risk of pancreatitis. Both have undergone significant revisions based on peer review that provided significant clarification of the data. We applaud both author groups for being extremely responsive in providing the additional data and revisions requested by the editorial team. As such, because of the critical peer review, we feel both articles achieve the high level we require for Diabetes Care and are pleased to now present them to our readers. In keeping with our aim to comprehensively evaluate this topic, we asked for additional commentaries to be prepared. In the narrative outlined below, Dr. Laurent Azoulay provides a commentary about the remaining uncertainty in this area and also discusses the results from a nationwide population-based case-control study. In the narrative preceding Dr. Azoulay’s contribution, Prof. Edwin A.M. Gale provides a commentary on the report that focuses on clinical trials of liraglutide in the treatment of diabetes. From the journal’s perspective, both of the articles on pancreatitis and incretin-based therapies reported in this issue have been well vetted, and we feel both of the commentaries are insightful. —William T. Cefalu Editor in Chief, Diabetes Care

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Section: Dwilliam T Cefalu Editor In Chief Diabetes Carementioning

confidence: 89%

Incretin-Based Drugs and Adverse Pancreatic Events: Almost a Decade Later and Uncertainty Remains

Azoulay

2015

Diabetes Care

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“…Previously published retrospective studies suggested that the relationship between incretin-based therapy and pancreatitis was nonrandomized and therefore uncontrolled for baseline known and unknown risk factors for pancreatitis. Pancreatitis cases were not blindly adjudicated, which may have led to a bias of overreporting among the incretin-treated patients (4,5,27). The current study is the first in our knowledge to prospectively adjudicate pancreatitis, and therefore, it provides a more precise estimate of the actual rate.…”

Section: Discussionmentioning

confidence: 99%

Incidence of Pancreatitis and Pancreatic Cancer in a Randomized Controlled Multicenter Trial (SAVOR-TIMI 53) of the Dipeptidyl Peptidase-4 Inhibitor Saxagliptin

et al. 2014

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OBJECTIVETo determine the incidence of pancreatitis and pancreatic cancer in the SAVOR-TIMI 53 trial. RESEARCH DESIGN AND METHODSA total of 16,492 type 2 diabetic patients ‡40 years old with established cardiovascular (CV) disease or CV risk factors were randomized to saxagliptin or placebo and followed for 2.1 years. Outcome measures were investigator reported with blinded expert adjudication of total pancreatitis (acute and chronic) and reported cases of pancreatic cancer. No differences in time to event onset, concomitant risk factors for pancreatitis, investigatorreported causality from study medication or disease severity, and outcome were found between treatment arms. The investigators reported 5 and 12 cases of pancreatic cancer in the saxagliptin and placebo arms, respectively ], P = 0.09). RESULTS Trial investigators reported CONCLUSIONSIn the SAVOR-TIMI 53 trial, within 2.1 years of follow-up, risk for pancreatitis in type 2 diabetic patients treated with saxagliptin was low and apparently similar to placebo, with no sign of increased risk for pancreatic cancer. Further studies are needed to completely resolve the pancreatic safety issues with incretin-based therapy.

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“…Un risque accru de pancréatite a été évoqué, 31 mais ce point reste controversé. 32 C'est également le cas pour le cancer du pancréas pour les incrétinomimétiques, en général, et pour le cancer médullaire de la thyroïde pour le liraglutide, en particulier. 31 Quoi qu'il en soit, la sécurité à très long terme de ces médicaments doit encore être démontrée 33,34 et seul l'avenir nous dira la place réelle qu'ils vont se ménager dans l'arsenal thérapeutique, de plus en plus complexe, du DT2.…”

Section: Agonistes Des Recepteurs Du Glp-1unclassified

GLP-1 receptor agonists or DPP-4 inhibitors: How to guide the clinician?

Scheen

2013

Annales d'Endocrinologie

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RESUME :Le traitement pharmacologique du diabète de type 2 s'est enrichi, ces dernières années, de l'apport des médicaments à effet incrétine ciblant le glucagon-like peptide-1 (GLP-1). Ces médicaments comprennent soit des agonistes des récepteurs au GLP-1, à courte (injection 1 ou 2 x par jour : exénatide, liraglutide, lixisénatide) ou longue durée d'action (injection hebdomadaire : exénatide à libération prolongée, albiglutide, dulaglutide, taspoglutide) ; soit des agents inhibant l'enzyme inactivant le GLP-1, la dipeptidyl peptidase-4 (DPP-4), actifs par voie orale, les gliptines (sitagliptine, vildagliptine, saxagliptine, linagliptine, nombreuses, à quasi tous les stades du diabète de type 2. Le choix pourra s'orienter selon les caractéristiques cliniques, les objectifs fixés ou simplement les préférences du patient. Mots-clés :

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A cohort study of acute pancreatitis in relation to exenatide use

Abstract: Exenatide use was not associated with an increased risk of acute pancreatitis.

Cited by 132 publications

References 28 publications

Incretin-Based Drugs and Adverse Pancreatic Events: Almost a Decade Later and Uncertainty Remains

Incretin-Based Drugs and Adverse Pancreatic Events: Almost a Decade Later and Uncertainty Remains

Incidence of Pancreatitis and Pancreatic Cancer in a Randomized Controlled Multicenter Trial (SAVOR-TIMI 53) of the Dipeptidyl Peptidase-4 Inhibitor Saxagliptin

GLP-1 receptor agonists or DPP-4 inhibitors: How to guide the clinician?

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