Some epidemiological data have suggested an elevated risk of acute pancreatitis and pancreatic cancer after exposure to glucagon‐like peptide (GLP)‐1 receptor agonists and dipeptidyl peptidase (DPP)‐4 inhibitors. Recently, such outcomes have been assessed and adjudicated as adverse events of special interest in cardiovascular outcomes studies. We performed a meta‐analysis of cases of acute pancreatitis and pancreatic cancer as well as any malignant neoplasm reported in cardiovascular outcomes trials (CVOTs) with GLP‐1 receptor agonists and DPP‐4 inhibitors. The numbers of cases observed with active drug or placebo (both on a background of standard care) were related to patient‐years of observation. Rate ratios and their confidence intervals were calculated for the individual agents as well as for the classes of GLP‐1 receptor agonists and DPP‐4 inhibitors. Neither data on individual CVOTs of GLP‐1 receptor agonists nor their meta‐analysis [rate ratio: 1.05 (0.78–1.41)] indicated a significantly elevated risk of acute pancreatitis. All individual DPP‐4 inhibitors displayed a non‐significant trend towards an increased risk of acute pancreatitis, which was significant in the meta‐analysis [1.75 (1.14–2.70); P = 0.01]. Neither GLP‐1 receptor agonists nor DPP‐4 inhibitors were associated with a significantly elevated or reduced risk of pancreatic cancer or for the totality of all malignant neoplasms. Based on a large database of randomized, placebo‐controlled, prospective cardiovascular outcomes studies with GLP‐1 receptor agonists and DPP‐4 inhibitors, no signal for pancreatic cancer or any malignant neoplasms were detected. However, a 75% risk increase for the development of an acute pancreatitis was seen in the meta‐analysis of DPP‐4 inhibitor CVOTs.
Removal of OTSCs with the prototype device was feasible and effective. The device may be valuable for OTSC removal in emergency as well as elective indications.
Background and study aims
TC-325 (Hemospray, Cook Medical) is a powder agent for endoscopic hemostasis in patients with upper gastrointestinal bleeding (UGIB). Although most publications are based on case-reports and retrospective studies, data on efficacy are promising. Here we report our experience with TC-325 for diffuse or refractory UGIB.
Patients and methods
Data on patients receiving TC-325 for endoscopic hemostasis from November 2013 to February 2017 at our center were analyzed retrospectively. Primary endpoints were technical success (successful immediate hemostasis) and clinical success (effective hemostasis and no recurrent bleeding). Secondary endpoints were recurrent bleeding within 3 and 7 days, hospital mortality and TC-325 associated complications. TC-325 was used for bleeding not amenable to standard endoscopic treatment (e. g. diffuse bleeding) or as salvage therapy after failure of conventional methods
Results
Fifty-two patients received TC-325 treatment. Most of the patients were treated for peptic ulcer bleeding (18/52 patients, 34.6 %) and post-interventional bleeding (13/52 patients, 25 %). Hemospray was used in 23/52 (44.2 %) patients as monotherapy and in 29/52 (55.8 %) patients as a salvage therapy. Application of the powder on the bleeding source was successful in all patients with no therapy-related adverse events (AEs). Immediate hemostasis was achieved in 51/52 (98.1 %) patients. Recurrent bleeding within 3 and 7 days was observed in 22/51 and 25/51 patients respectively (43.1 % and 49 %). The overall clinical success was 56.9 % on day 3 and 51 % on day 7. Total mortality was 15.4 % (8 patients), bleeding associated mortality was 3.8 % (2 patients). There were no therapy-related AEs.
Conclusions
TC-325 showed a high technical success rate as monotherapy for bleeding sources not amenable to standard methods or as an “add-on” therapy after unsuccessful hemostasis. However, rebleeding was frequent in this cohort and further studies are warranted to exactly define a treatment algorithm for TC-325 use.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.