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Latest & greatest articles for adverse events
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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
Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction: The ARTEMIS Randomized Clinical Trial. Despite guideline recommendations, many patients discontinue P2Y12 inhibitor therapy earlier than the recommended 1 year after myocardial infarction (MI), and higher-potency P2Y12 inhibitors are underutilized. Cost is frequently cited as an explanation for both of these observations.To determine whether removing (...) co-payment barriers increases P2Y12 inhibitor persistence and lowers risk of major adverse cardiovascular events (MACE).Cluster randomized clinical trial among 301 hospitals enrolling adult patients with acute MI (June 5, 2015, through September 30, 2016); patients were followed up for 1 year after discharge (final date of follow-up was October 23, 2017), with blinded adjudication of MACE; choice of P2Y12 inhibitor was per clinician discretion.Hospitals randomized to the intervention (n = 131
Sodium bicarb vs sodium chloride, and acetylcysteine vs placebo, did not differ for adverseevents after angiography. 29459959 2018 12 24 2018 12 24 1539-3704 168 4 2018 02 20 Annals of internal medicine Ann. Intern. Med. Sodium bicarb vs sodium chloride, and acetylcysteine vs placebo, did not differ for adverseevents after angiography. JC22 10.7326/ACPJC-2018-168-4-022 Carnicelli Anthony P AP Granger Christopher B CB eng Journal Article Comment United States Ann Intern Med 0372351 0003-4819 0
[Hydroxychloroquine to obtain pregnancy without adverse obstetrical events in primary antiphospholipid syndrome: French phase II multicenter randomized trial, HYDROSAPL]. Antiphospholipid syndrome is defined by the presence of thrombosis and/or obstetrical adverseevents (≥3 recurrent early miscarriage or fetal death or a prematurity<34 weeks of gestation) associated with persistent antiphospholipid antibodies. The pregnancy outcome has been improved by the conventional treatment (aspirin 100mg (...) /day with low molecular weight heparin [LMWH] from 30 to 75% of uncomplicated pregnancies. In PROMISSE study, 19% of pregnancies had at least one obstetrical adverseevent despite treatment (maternal, fetal or neonatal complications) in relation with APS. In the European registry of babies born from APS mothers, maternal and foetal adverseevents were observed in 13% of cases, with prematurity in 14% despite treatment. The presence of lupus erythematosus, a history of thrombosis, presence of lupus
In-hospital versus postdischarge major adverseevents within 30 days following lower extremity revascularization Studies using hospital discharge data likely underestimate postoperative morbidity and mortality after lower extremity revascularization because they fail to capture postdischarge events. However, the degree of underestimation and the timing of postdischarge complications are not well-characterized.We used the American College of Surgeons National Surgical Quality Improvement Program (...) procedure-targeted vascular databases from 2011 to 2015 to tabulate 30-day adverseevents (in hospital and after discharge) for lower extremity bypass (LEB) and percutaneous vascular interventions (PVIs) performed for claudication and chronic limb-threatening ischemia (CLTI).A total of 14,125 patients underwent lower extremity revascularization, 8909 patients (63%) with LEB and 5216 (37%) with PVI. For CLTI, total 30-day mortality was similar between PVI and LEB (2.3% vs 2.1%; P = .61), but in-hospital
Sodium glucose cotransporter 2 inhibitors and risk of serious adverseevents: nationwide register based cohort study. To assess the association between the use of sodium glucose cotransporter 2 (SGLT2) inhibitors and seven serious adverseevents of current concern.Register based cohort study.Sweden and Denmark from July 2013 to December 2016.A propensity score matched cohort of 17 213 new users of SGLT2 inhibitors (dapagliflozin, 61%; empagliflozin, 38%; canagliflozin, 1%) and 17 213 new users (...) of nationwide registers from two countries, use of SGLT2 inhibitors, as compared with GLP1 receptor agonists, was associated with an increased risk of lower limb amputation and diabetic ketoacidosis, but not with other serious adverseevents of current concern.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Combination of the CYP2C19 metabolizer and the GRACE risk score better predicts the long-term major adverse cardiac events in acute coronary syndrome undergoing percutaneous coronary intervention Both Global Registry of Acute Coronary Events (GRACE) risk score and CYP2C19 metabolizer status can independently predict major adverse cardiac events (MACEs) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). We investigated whether their combination
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 To read this article in full, please review your options for gaining access at the bottom (...) of the page. Article in Press 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 To view the full text, please login as a subscribed user or . Click to view the full text on ScienceDirect
New Oncologic Therapies Mean New Oncologic Emergencies: An Approach to Immunotherapy-Related AdverseEvents New Oncologic Therapies Mean New Oncologic Emergencies: An Approach to Immunotherapy-Related AdverseEvents - CanadiEM New Oncologic Therapies Mean New Oncologic Emergencies: An Approach to Immunotherapy-Related AdverseEvents In , by Arden Azim October 30, 2018 A 63-year-old man, Andrew, presents to the emergency department with a several-day history of worsening diarrhea. He has (...) pathways promotes anti-tumour immunity, it also removes some of the normal checks and balances on immune activity, and can lead to uncontrolled and aberrant immune activity. Therefore, complications of ICIs are due to auto-immune toxicity caused by over-activation of the immune system , and are referred to as immune-related adverseevents (irAEs) . 1,4 It is crucial to differentiate immune-related adverseevents from adverseevents seen with chemotherapy. Chemotherapy works by killing rapidly dividing
Prospective Validation of Clinical Criteria to Identify Emergency Department Patients at High Risk for Adverse Drug EventsAdverse drug events (ADEs) cause or contribute to one in nine emergency department (ED) presentations in North America and are often misdiagnosed. EDs have insufficient clinical pharmacists to complete medication reviews in all incoming patients, even though pharmacist-led medications reviews have been associated with improved health outcomes. Our objective was to validate (...) results. The primary outcome was a moderate or severe ADE, defined as an unintended and harmful event related to medication use or misuse, which required a change in medical therapy, diagnostic testing, consultation, or admission. An independent committee adjudicated uncertain and discordant cases. We calculated the diagnostic accuracy of both rules.Among 1,529 patients, 184 (12.0%) were diagnosed with an ADE. Rule 1 contained the variables 1) having a preexisting medical condition or having taken
Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious AdverseEvents in Patients with Staphylococcal Bacteremia: A Randomized Clinical Trial. The appropriate duration of antibiotics for staphylococcal bacteremia is unknown.To test whether an algorithm that defines treatment duration for staphylococcal bacteremia vs standard of care provides noninferior efficacy without increasing severe adverse events.A randomized trial involving adults with staphylococcal bacteremia (...) within a 15% margin; and (2) serious adverseevent rates in the intention-to-treat population, tested for superiority. The prespecified secondary outcome measure, tested for superiority, was antibiotic days among per-protocol patients with simple or uncomplicated bacteremia.Among the 509 patients randomized (mean age, 56.6 [SD, 16.8] years; 226 [44.4%] women), 480 (94.3%) completed the trial. Clinical success was documented in 209 of 255 patients assigned to algorithm-based therapy and 207 of 254
Pleural or pericardial metastasis: A significant factor affecting efficacy and adverseevents in lung cancer patients treated with PDâ€1/PDâ€L1 inhibitors Immunotherapy is a new paradigm for the treatment of non-small-cell lung cancer (NSCLC), and targeting the PD-1 or PD-L1 pathway is a promising therapeutic option. Although PD-1/PD-L1 inhibitors are more effective than standard chemotherapy in lung cancer, clinicians are afraid to actively use them because of hyperprogression (...) with pleural or pericardial metastasis than in patients without pleural or pericardial metastasis (4.3% vs. 35.7%; P = 0.007). Patients with pleural or pericardial metastasis had a significantly higher rate of adverseevents of any grade (91.3% vs. 50.0%; P = 0.002) and grade 3-5 adverseevents (52.2% vs. 25.0%; P = 0.046).Pleural or pericardial metastasis is a significant factor affecting the efficacy and rate of adverseevents in advanced NSCLC patients treated with PD-1/PD-L1 inhibitors. Clinicians
Individual and Joint Effects of Pulse Pressure and Blood Pressure Treatment Intensity on Serious AdverseEvents in the SPRINT Trial The objective of this study was to determine individual and joint effects of pulse pressure and blood pressure treatment intensity on serious adverseevents in the Systolic Blood Pressure Intervention Trial.Pulse pressure was calculated by subtracting diastolic blood pressure from systolic blood pressure. Blood pressure treatment intensity goal was ≤140mm Hg (...) 10mm Hg] 1.23; 95% confidence interval [CI], 1.18-1.28). The intensive treatment arm had a higher incidence rate of serious adverseevents than the control arm (34.2, 95% CI, 31.2-37.3, vs 26.0, 95% CI, 23.4-28.8, P = .0001; HR 1.32; 95% CI, 1.15-1.51). The combined effect was not significant in the relative risk scale (HR 0.97, Pinteraction = .48) but was significant in the risk difference scale (P = .027), contributing 2.5 additional serious adverseevents per 1000 person-years for every 10mm Hg
Adverseevents Top results for adverseevents - Trip Database or use your Google+ account Find evidence fast ALL of these words: Title only Anywhere in the document ANY of these words: Title only Anywhere in the document This EXACT phrase: Title only Anywhere in the document EXCLUDING words: Title only Anywhere in the document Timeframe: to: Combine searches by placing the search numbers in the top search box and pressing the search button. An example search might look like (#1 or #2) and (#3 (...) or #4) Loading history... Population: Intervention: Comparison: Outcome: Population: Intervention: Latest & greatest articles for adverseevents The Trip Database is a leading resource to help health professionals find trustworthy answers to their clinical questions. Users can access the latest research evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory guidance, clinical trials and many other forms of evidence
Exposure-adjusted adverseevents comparing blinatumomab with chemotherapy in advanced acute lymphoblastic leukemia In the phase 3 TOWER study, blinatumomab demonstrated an overall survival benefit over standard-of-care chemotherapy (SOC) in adults with relapsed or refractory (r/r) Philadelphia chromosome-negative (Ph-) B-precursor acute lymphoblastic leukemia (ALL). Nearly all patients in both treatment arms experienced an adverseevent (AE), and the incidence rate of serious AEs was higher (...) for blinatumomab. However, as treatment exposure differed between the 2 arms, we conducted an exploratory safety analysis comparing exposure-adjusted event rates (EAERs) of blinatumomab vs SOC. Analyses were conducted for all patients who received therapy (safety population). Patients received a median (range) of 2 cycles (1-9) of blinatumomab (N = 267) vs 1 cycle (1-4) of SOC (N = 109). Grade ≥3 AE rates were generally higher in cycle 1 of blinatumomab than in cycle 2 (76% vs 37%). After adjusting for time