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Latest & greatest articles for adverse events
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Effect of Apabetalone Added to Standard Therapy on Major Adverse Cardiovascular Events in Patients With Recent Acute Coronary Syndrome and Type 2 Diabetes: A Randomized Clinical Trial. Bromodomain and extraterminal proteins are epigenetic regulators of gene transcription. Apabetalone is a selective bromodomain and extraterminal protein inhibitor targeting bromodomain 2 and is hypothesized to have potentially favorable effects on pathways related to atherothrombosis. Pooled phase 2 data suggest (...) favorable effects on clinical outcomes.To test whether apabetalone significantly reduces major adverse cardiovascular events.A randomized, double-blind, placebo-controlled trial, conducted at 190 sites in 13 countries. Patients with an acute coronary syndrome in the preceding 7 to 90 days, type 2 diabetes, and low high-density lipoprotein cholesterol levels were eligible for enrollment, which started November 11, 2015, and ended July 4, 2018, with end of follow-up on July 3, 2019.Patients were
Impact of Timing of Preprocedural Opioids on AdverseEvents in Procedural Sedation The risk of respiratory depression is increased when opioids are added to sedative agents. In our recent multicenter emergency department (ED) procedural sedation cohort, we reported a strong association between preprocedural opioids and sedation-related adverseevents. We sought to examine the association between timing of opioids and the incidence of adverse sedation outcomes.We conducted a secondary analysis
ASGE review of adverseevents in colonoscopy ASGE STANDARDS OF PRACTICE COMMITTEE REVIEW ASGE review of adverseevents in colonoscopy Shivangi T. Kothari, MD, FASGE, 1, * Robert J. Huang, MD, 2, * Aasma Shaukat, MD, MPH, FASGE, 3 Deepak Agrawal, MD, FASGE, 4 James L. Buxbaum, MD, FASGE, 5 Syed M. Abbas Fehmi, MD, MSc, FASGE, 6 Douglas S. Fishman, MD, FASGE, 7 Suryakanth R. Gurudu, MD, FASGE, 8 Mouen A. Khashab, MD, 9 Laith H. Jamil, MD, FASGE, 10 Terry L. Jue, MD, FASGE, 11 Joanna K. Law, MD (...) - cedure. However, adverseevents (AEs) related to this routinely performed procedure for screening, diagnostic, ortherapeuticpurposesareanimportantclinicalconsideration.ThepurposeofthisdocumentfromtheAmerican Society for Gastrointestinal Endoscopy’s Standards of Practice Committee is to provide an update on estimates of AEs related to colonoscopy in an evidence-based fashion. A systematic review and meta-analysis of population- based studies was conducted for the 3 most common and important serious
ERCP-related adverseevents ERCP-relatedadverseevents:EuropeanSocietyofGastrointestinal Endoscopy (ESGE) Guideline Authors Jean-MarcDumonceau 1 ,ChristineKapral 2 ,Lars Aabakken 3 ,IoannisS.Papanikolaou 4 ,Andrea Tringali 5,6 ,Geoffroy Vanbiervliet 7 ,Torsten Beyna 8 ,MarioDinis-Ribeiro 9,10 ,IstvanHritz 11 ,AlbertoMariani 12 ,Gregorios Paspatis 13 ,Franco Radaelli 14 , SundeepLakhtakia 15 ,AndrewM.Veitch 16 ,JeaninE.vanHooft 17 Institutions ?1 Gastroenterology Service, Hôpital Civil Marie (...) viewableat: https://doi.org/10.1055/a-1075-4080 Dumonceau Jean-Marc et al. ERCP-related adverseevents: ESGEClinical Guideline… Endoscopy1Introduction The range and incidence of adverseevents (AEs) related to endoscopic retrograde cholangiopancreatography (ERCP) dif- fer substantially from those related to other endoscopic proce- dures. Familiarity with these AEs is critical for providing patient information during the consent phaseas well as for prophylaxis and management. Adverseevents related
During Conscious Sedation the Risk of AdverseEvents Is Likely Increased in Obese Children Compared to Those of Healthy Weight UTCAT3394, Found CAT view, CRITICALLY APPRAISED TOPICs University: | | ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM View the CAT / Title During Conscious Sedation the Risk of AdverseEvents Is Likely Increased in Obese Children Compared to Those of Healthy Weight Clinical Question Are obese children undergoing conscious sedation at increased risk for adverseevents (...) compared to children who are at healthy weight? Clinical Bottom Line For children with childhood obesity, conscious sedation may lead to more adverseevents including oxyhemoglobin desaturation, nausea and true apnea. However, additional evidence is needed to know if there is any clinical and statistical difference between obese children and healthy weight children during conscious sedation. This is supported by both a cross-sectional retrospective study and a review of literature on the relationship
Performance of cardiac troponins within the HEART score in predicting major adverse cardiac events at the emergency department This study compared the performance of a single blood draw of high-sensitivity troponin T (hsTnT), high-sensitivity troponin I (hsTnI) and conventional troponin I (cTnI) within a modified HEART score for predicting 30-day MACE at Emergency Department (ED) presentation, and established local reference norms for all three assays by determining the cut-off point which
Predicting Major AdverseEvents in Patients With Acute Myocardial Infarction Early and accurate detection of short-term major adverse cardiac events (MACE) in patients with suspected acute myocardial infarction (AMI) is an unmet clinical need.The goal of this study was to test the hypothesis that adding clinical judgment and electrocardiogram findings to the European Society of Cardiology (ESC) high-sensitivity cardiac troponin (hs-cTn) measurement at presentation and after 1 h (ESC hs-cTn 0/1 (...) h algorithm) would further improve its performance to predict MACE.Patients presenting to an emergency department with suspected AMI were enrolled in a prospective, multicenter diagnostic study. The primary endpoint was MACE, including all-cause death, cardiac arrest, AMI, cardiogenic shock, sustained ventricular arrhythmia, and high-grade atrioventricular block within 30 days including index events. The secondary endpoint was MACE + unstable angina (UA) receiving early (≤24 h
Inhaled steroids with and without regular formoterol for asthma: serious adverseevents. Epidemiological evidence has suggested a link between beta2-agonists and increases in asthma mortality. There has been much debate about whether regular (daily) long-acting beta2-agonists (LABA) are safe when used in combination with inhaled corticosteroids (ICS). This updated Cochrane Review includes results from two large trials that recruited 23,422 adolescents and adults mandated by the US Food and Drug (...) Administration (FDA).To assess the risk of mortality and non-fatal serious adverseevents (SAEs) in trials that randomly assign participants with chronic asthma to regular formoterol and inhaled corticosteroids versus the same dose of inhaled corticosteroid alone.We identified randomised trials using the Cochrane Airways Group Specialised Register of trials. We checked websites of clinical trial registers for unpublished trial data as well as FDA submissions in relation to formoterol. The date of the most
Association of Treatment With Metformin vs Sulfonylurea With Major Adverse Cardiovascular Events Among Patients With Diabetes and Reduced Kidney Function. Before 2016, safety concerns limited metformin use in patients with kidney disease; however, the effectiveness of metformin on clinical outcomes in patients with reduced kidney function remains unknown.To compare major adverse cardiovascular events (MACE) among patients with diabetes and reduced kidney function who continued treatment (...) of 6.6% [IQR, 6.1%-7.2%] at cohort entry). During follow-up (median, 1.0 year for metformin vs 1.2 years for sulfonylurea), there were 1048 MACE outcomes (23.0 per 1000 person-years) among metformin users and 1394 events (29.2 per 1000 person-years) among sulfonylurea users. The cause-specific adjusted hazard ratio of MACE for metformin was 0.80 (95% CI, 0.75-0.86) compared with sulfonylureas, yielding an adjusted rate difference of 5.8 (95% CI, 4.1-7.3) fewer events per 1000 person-years
Planning to reduce 30-day adverseevents after discharge of frail elderly patients with acute heart failure: design and rationale for the DEED FRAIL-AHF trial. To demonstrate the efficacy of a system for comprehensive care transfer (Multilevel Guided Discharge Plan [MGDP]) for frail older patients diagnosed with acute heart failure (AHF) and to validate the results of MGDP implementation under real clinical conditions. The MGDP seeks to reduce the number of adverse outcomes within 30 days
Excess Antibiotic Treatment Duration and AdverseEvents in Patients Hospitalized With Pneumonia: A Multihospital Cohort Study. Randomized trials demonstrate no benefit from antibiotic treatment exceeding the shortest effective duration.To examine predictors and outcomes associated with excess duration of antibiotic treatment.Retrospective cohort study.43 hospitals in the Michigan Hospital Medicine Safety Consortium.6481 general care medical patients with pneumonia.The primary outcome (...) , or did not have a total antibiotic treatment duration documented at discharge were more likely to receive excess treatment. Excess treatment was not associated with lower rates of any adverse outcomes, including death, readmission, emergency department visit, or Clostridioides difficile infection. Each excess day of treatment was associated with a 5% increase in the odds of antibiotic-associated adverseevents reported by patients after discharge.Retrospective design; not all patients could
Effect of Albuterol Premedication vs Placebo on the Occurrence of Respiratory AdverseEvents in Children Undergoing Tonsillectomies: The REACT Randomized Clinical Trial Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered breathing and chronic tonsillitis. Up to half of children having this procedure experience a perioperative respiratory adverse event.To determine whether inhaled albuterol sulfate (salbutamol sulfate) premedication decreases the risk (...) of perioperative respiratory adverseevents in children undergoing anesthesia for tonsillectomy.A randomized, triple-blind, placebo-controlled trial (the Reducing Anesthetic Complications in Children Undergoing Tonsillectomies [REACT] trial) was conducted at Perth Children's Hospital (formerly Princess Margaret Hospital for Children), the only tertiary pediatric hospital in Western Australia. Participants included 484 children aged 0 to 8 years who were undergoing anesthesia for tonsillectomy. The study
What Is the Diagnostic Accuracy of Cardiac Biomarkers for the Prediction of Adverse Cardiac Events in Patients Presenting With Acute Syncope? What Is the Diagnostic Accuracy of Cardiac Biomarkers for the Prediction of Adverse Cardiac Events in Patients Presenting With Acute Syncope? - Annals of Emergency Medicine Email/Username: Password: Remember me Search Terms Search within Search Share this page Access provided by Volume 73, Issue 5, Pages 511–513 What Is the Diagnostic Accuracy of Cardiac (...) Biomarkers for the Prediction of Adverse Cardiac Events in Patients Presenting With Acute Syncope? x Jason R. West , MD (EBEM Commentator) , x James Russell , MD (EBEM Commentator) Department of Emergency Medicine, Lincoln Medical and Mental Health Center, Bronx, NY DOI: | Publication History Published online: August 27, 2018 Expand all Collapse all Article Outline Take-Home Message The sensitivity of brain-type natriuretic peptides and troponin for identifying syncopal patients at risk for major cardiac
Serious adverseevents and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England. To provide accurate risk estimates of serious adverseevents after elective shoulder replacement surgery for arthritis, including age and sex specific estimates of the lifetime risk of revision surgery.Population based cohort study.Hospital episode statistics for NHS England, including civil registration mortality data.58 054 (...) elective shoulder replacements in 51 895 adults (aged ≥50 years) between April 1998 and April 2017.The lifetime risk of revision surgery, calculated using an actuarial life table approach and the cumulative probability method. Rates of serious adverseevents at 30 and 90 days post-surgery: pulmonary embolism, myocardial infarction, lower respiratory tract infection, acute kidney injury, urinary tract infection, cerebrovascular events, and all cause death. Secondary outcome measures were the number
Association of Initial and Serial C-Reactive Protein Levels With Adverse Cardiovascular Events and Death After Acute Coronary Syndrome: A Secondary Analysis of the VISTA-16 Trial. Higher baseline high-sensitivity C-reactive protein (hsCRP) levels after an acute coronary syndrome (ACS) are associated with adverse cardiovascular outcomes. The usefulness of serial hsCRP measurements for risk stratifying patients after ACS is not well characterized.To assess whether longitudinal increases in hsCRP (...) measurements during the 16 weeks after ACS are independently associated with a greater risk of a major adverse cardiac event (MACE), all-cause death, and cardiovascular death.Secondary analysis of the double-blind, multicenter, randomized clinical Vascular Inflammation Suppression to Treat Acute Coronary Syndromes for 16 Weeks (VISTA-16) trial conducted between June 1, 2010, and March 7, 2012 (study termination on March 9, 2012), which included 5145 patients from 362 academic and community hospitals
Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial. Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been (...) if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015.According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred.The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal
Management of anlotinib-related adverseevents in patients with advanced non-small cell lung cancer: Experiences in ALTER-0303. Anlotinib is an oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor, fibroblast growth factor receptor, platelet-derived growth factor receptor, and stem cell factor receptor (c-Kit). In the phase III ALTER-0303 trial (Clinical Trial Registry ID: NCT 02388919), anlotinib significantly improved overall survival versus placebo in advanced (...) non-small cell lung cancer patients who had received at least two previous chemotherapy and epidermal growth factor receptor/anaplastic lymphoma kinase targeted therapy regimens. This study summarized adverseevent management in this trial.Patients were randomized (2:1) to anlotinib or placebo up to progression or intolerable toxicity. Adverseevents were graded according to the National Cancer Institute Common Terminology Criteria for AdverseEvents Version 4.0 and managed by investigators. Key