Dataset Information

Adverse events associated with anticoagulation therapy in the periendoscopic period.

ABSTRACT: Chronic anticoagulation has been demonstrated to be a risk factor for GI bleeding (GIB) in patients undergoing endoscopic procedures.The aim of this study was to determine the incidence of GIB prospectively in a large cohort of patients enrolled in the Clinical Outcomes Research Initiative (CORI) database.Anticoagulated patients undergoing endoscopic procedures were interviewed by phone 30 to 45 days after the procedure to determine potential adverse events and management of warfarin therapy in the periendoscopic period.Participating CORI sites, Stanford University Hospital, Veterans Administration Palo Alto Health Care System.Postprocedural hemorrhagic or thrombotic events.Thirteen CORI sites agreed to participate, including 120,886 procedures in 95,807 patients. We contacted 929 patients on warfarin therapy and enrolled 483 patients (52%). The majority of the patients were men with atrial fibrillation undergoing colonoscopy. Warfarin was temporarily suspended in 437 (90%) of the patients before the procedure, and 114 (22%) received periprocedural heparin therapy. There were 10 major hemorrhagic events (2%), and the rate of hemorrhage was not higher in the patients receiving periprocedural heparin therapy (P = .1). However, polypectomy was a risk factor for postprocedural hemorrhage (P = .02). One fatal stroke (0.2%) occurred in a patient 2 weeks after endoscopy; however, information regarding warfarin management was not available.Small number of enrolled patients and lack of control group. Lack of information regarding prothrombin time before procedure, concurrent antiplatelet agents, and timing of bleeding in 50% of the cases. The study was underpowered to definitively conclude benefits of current guidelines regarding thrombosis or bleeding.Postprocedural hemorrhagic events were not increased in anticoagulated patients. Most patients receiving bridging therapy were managed according to current society guidelines.

SUBMITTER: Gerson LB

PROVIDER: S-EPMC3848307 | biostudies-literature | 2010 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Adverse events associated with anticoagulation therapy in the periendoscopic period.

Gerson Lauren B LB Michaels LeAnn L Ullah Nighat N Gage Brian B Williams Luke L

Gastrointestinal endoscopy 20100601 7

<h4>Background</h4>Chronic anticoagulation has been demonstrated to be a risk factor for GI bleeding (GIB) in patients undergoing endoscopic procedures.<h4>Objective</h4>The aim of this study was to determine the incidence of GIB prospectively in a large cohort of patients enrolled in the Clinical Outcomes Research Initiative (CORI) database.<h4>Design</h4>Anticoagulated patients undergoing endoscopic procedures were interviewed by phone 30 to 45 days after the procedure to determine potential a ...[more]

PMID: 20598248

Similar Datasets

Project description:BackgroundPivotal trials of chimeric antigen receptor T-cell (CAR-T) have identified common toxicities but may have been underpowered to detect cardiovascular and pulmonary adverse events (CPAEs).ObjectivesThis study sought to investigate CPAEs associated with commercial CD19-directed CAR-T therapy.MethodsIn this retrospective, pharmacovigilance study, the authors used the Food and Drug Administration adverse event reporting system to identify CPAEs associated with axicabtagene-ciloleucel and tisagenlecleucel. The authors evaluated disproportionate reporting by the reporting odds ratio (ROR) and the lower bound of the information component 95% credibility interval (IC025 >0 is deemed significant). Significant associations were further adjusted to age and sex (adj.ROR).ResultsThe authors identified CAR-T reports of 2,657 patients, including 546 CPAEs (20.5%). CPAEs overlapped with cytokine release syndrome in 68.3% (373 of 546) of the reports. Compared with the full database, CAR-T was associated with overreporting of tachyarrhythmias (n = 74 [2.8%], adj.ROR = 2.78 [95% CI: 2.21-3.51]), cardiomyopathy (n = 69 [2.6%], adj.ROR = 3.51 [2.42-5.09]), pleural disorders (n = 46 [1.7%], adj.ROR = 3.91 [2.92-5.23]), and pericardial diseases (n = 11 [0.4%], adj.ROR = 2.26 [1.25-4.09], all IC025 >0). Venous thromboembolic events (VTEs) were associated only with axicabtagene-ciloleucel therapy (n = 28 [1.6%], adj.ROR = 1.80 [1.24-2.62], IC025 >0). Atrial fibrillation (n = 55) was the leading tachyarrhythmia, followed by ventricular arrhythmias (n = 14). Tachyarrhythmias and VTEs were reported more often following axicabtagene-ciloleucel than tisagenlecleucel in an age- and sex-adjusted model (adj.ROR = 1.82 [1.04-3.18] and adj.ROR = 2.86 [1.18-6.93], respectively). Finally, the fatality rate of CPAEs was 30.9%.ConclusionsIn this largest post-marketing study to date, the authors identified an association between CAR-T and various CPAEs, including tachyarrhythmias, cardiomyopathy, pericardial and pleural disorders, and VTEs. These findings should be considered in the multidisciplinary assessment for and monitoring of CAR-T therapy recipients.

Project description:BackgroundTestosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.MethodsCommunity-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group.ResultsA total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load.ConclusionsIn this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy. (ClinicalTrials.gov number, NCT00240981.)

Project description:To assess the risk of new-onset or worsening hyperglycaemia, hypertension, weight gain and hyperlipidaemia with systemic corticosteroid therapy (CST) as reported in published randomised control trial (RCT) studies. Literature search using MEDLINE, EMBASE, Cochrane library, Web of Science and Scopus STUDY ELIGIBILITY CRITERIA: Published articles on results of RCT with a systemic CST arm with numerical data presented on adverse effect (AE). Reports of hyperglycaemia, hypertension, weight gain and hyperlipidaemia associated with systemic CST in patients or healthy volunteer's ≥17 years of age. Risk of bias tool, assessment at the level of AE and key study characteristics. A total of 5446 articles were screened to include 118 studies with 152 systemic CST arms (total participants=17 113 among which 8569 participants treated with CST). Pooled prevalence of hyperglycaemia in the CST arms within the studies was 10% (95% CI 7% to 14%), with the highest prevalence in respiratory illnesses at 22% (95% CI 9% to 35%). Pooled prevalence of severe hyperglycaemia, hypertension, weight gain and hyperlipidaemia within the corticosteroid arms was 5% (95% CI 2% to 9%), 6% (95% CI 4% to 8%), 13% (95% CI 8% to 18%), 8% (95% CI 4% to 17%), respectively. CST was significantly associated hyperglycaemia, hypertension and weight gain as noted in double-blinded placebo-controlled parallel-arms studies: OR of 2.13 (95% CI 1.66 to 2.72), 1.68 (95% CI 0.96 to 2.95) and 5.20 (95% CI 2.10 to 12.90), respectively. Intravenous therapy posed higher risk than oral therapy: OR of 2.39 (95% CI 1.16 to 4.91). There was significant heterogeneity in the AE definitions and quality of AE reporting in the primary studies and patient populations in the studies. The impact of cumulative dose effect on incidental AE could not be calculated. Systemic CST use is associated with increased risk of metabolic AEs, which differs for each disease group and route of administration. CRD42020161270.

Dataset Information

Adverse events associated with anticoagulation therapy in the periendoscopic period.

Publications

Adverse events associated with anticoagulation therapy in the periendoscopic period.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets