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Latest & greatest articles for adverse events
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Long-term Tolerability of Ticagrelor for the Secondary Prevention of Major Adverse Cardiovascular Events: A Secondary Analysis of the PEGASUS-TIMI 54 Trial. In the PEGASUS-TIMI 54 trial, treatment with ticagrelor reduced the incidence of cardiovascular death, myocardial infarction, or stroke by 15% to 16% among stable patients compared with placebo. However, more patients prematurely discontinued treatment with ticagrelor than with placebo.To investigate the reasons and timing (...) was evaluated by treatment arm, cause, and timing. This analysis was initiated in May 2015.Discontinuation of treatment.Over 33 months, 32%, 29%, and 21% of patients receiving 90 mg of ticagrelor, 60 mg of ticagrelor, and placebo, respectively, discontinued treatment (P < .001). Discontinuation of treatment due to an adverseevent occurred in 19%, 16%, and 9% of patients, respectively (P < .001). The most frequent adverseevents leading to discontinuation of treatment were bleeding (with Kaplan-Meier event
Seasonal and Geographic Variation in AdverseEvent Reporting Many illnesses demonstrate seasonal and geographic variations. Pharmacovigilance is unique among public health surveillance systems in terms of the clinical diversity of the events under surveillance. Since many pharmacovigilance signal detection methodologies are geared towards looking for increased frequency of spontaneous adverse drug event (ADE) reporting over variable time frames, seasonality of ADEs may have implications (...) for signal detection.The aim of this study was to investigate whether a set of illnesses that might be expected to display seasonality in general, did so when spontaneously reported as ADEs.We performed our analysis with the publically available US FDA AdverseEvent Reporting System (FAERS) data. We selected a convenience sample of events possibly triggered by seasonal factors (hypothermia, Raynaud's phenomenon, photosensitivity reaction, heat exhaustion, heat stroke, and sunburn) and events for which
Usefulness of the Myocardial Infarction and Cardiac Arrest Calculator as a Discriminator of Adverse Cardiac Events After Elective Hip and Knee Surgery The 2014 American College of Cardiology and American Heart Association guidelines on perioperative evaluation recommend differentiating patients at low risk (<1%) versus elevated risk (≥1%) for cardiac complications to guide appropriate preoperative testing. Among the tools recommended for estimating perioperative risk is the National Surgical (...) Quality Improvement Program (NSQIP) Myocardial Infarction and Cardiac Arrest (MICA) risk calculator. We investigated whether the NSQIP MICA risk calculator would accurately discriminate adverse cardiac events in a cohort of adult patients undergoing elective orthopedic surgery. We retrospectively reviewed 1,098 consecutive, elective orthopedic surgeries performed at Hershey Medical Center from January 1, 2013, to December 31, 2014. Adverse cardiac events were defined as myocardial infarction
Assessment and monitoring of biologic drug adverseevents in patients with psoriasis Current treatment guidelines for biologic therapies in psoriasis differ in their recommendation for the monitoring of adverse events.The aim of this paper was to draw together evidence from the currently available guidelines as a summary of how biologics licensed for the treatment of psoriasis should be monitored for adverse events.The MEDLINE database was searched to identity the current literature (...) in clinical practice are supported by minimal clinical evidence, highlighting the need for more studies to evaluate the role and value of the different modalities of screening and monitoring for adverseevents in those with psoriasis receiving treatment with biologic therapies.
Medicines Management, Medication Errors and Adverse Medication Events in Older People Referred to a Community Nursing Service: A Retrospective Observational Study Increasing numbers of older people are receiving support with medicines management from community nursing services (CNSs) to enable them to live in their own homes. Little is known about these people and the support they receive.To explore the characteristics of older people referred for medicines management support, type of support (...) provided, medication errors and adverse medication events (AMEs).A retrospective observational study of a random sample of 100 older people referred to a large non-profit CNS for medicines management support over a 3-month period was conducted. Measures were: demographics, referral source, current medical problems, medicines, medication aids, types of medication authorisations used by nurses, frequency of nurse visits and type of support provided, medication errors, AMEs and interdisciplinary teamwork
Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors: A Randomized Clinical Trial. Few cardiovascular outcomes trials have been conducted for obesity treatments. Withdrawal of 2 marketed drugs has resulted in controversy about the cardiovascular safety of obesity agents.To determine whether the combination of naltrexone and bupropion increases major adverse cardiovascular events (MACE, defined as cardiovascular (...) group and 90 patients (2.0%) in the naltrexone-bupropion group (HR, 0.88; adjusted 99.7% CI, 0.57-1.34). Adverse effects were more common in the naltrexone-bupropion group, including gastrointestinal events in 14.2% vs 1.9% (P < .001) and central nervous system symptoms in 5.1% vs 1.2% (P < .001).Among overweight or obese patients at increased cardiovascular risk, based on the interim analyses performed after 25% and 50% of planned events, the upper limit of the 95% CI of the HR for MACE
Comparison of the Global Registry of Acute Coronary Events Risk Score Versus the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse outcomes With Early Implementation of the ACC/AHA Guidelines Risk Score to Predict In-Hospital Mort Risk assessment plays a major role in the management of acute coronary syndrome. The aim was to compare the performance of the Global Registry of Acute Coronary Events (GRACE) and the Can Rapid risk stratification of Unstable angina patients (...) Suppress Adverse outcomes with Early implementation of the American College of Cardiology/American Heart Asociation guidelines (CRUSADE) risk scores to predict in-hospital mortality and major bleeding (MB) in 1,587 consecutive patients with acute coronary syndrome. In-hospital deaths and bleeding complications were prospectively collected. Bleeding complications were defined according to CRUSADE and Bleeding Academic Research Consortium (BARC) criteria. During the hospitalization, 71 patients (4.5
Predictive Validity of the Beers and Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) Criteria to Detect Adverse Drug Events, Hospitalizations, and Emergency Department Visits in the United States To compare the predictive validity of the 2003 Beers, 2012 American Geriatrics Society (AGS) Beers, and Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria.Retrospective cohort.Managed care administrative claims data from 2006 (...) to 2009.Commercially insured persons aged 65 and older in the United States (N=174,275).Association between adverse drug events (ADEs), emergency department (ED) visits, and hospitalization outcomes and inappropriate medication use using time-varying Cox proportional hazard models. Measures of model discrimination (c-index) and hazard ratios (HRs) were calculated to compare unadjusted and adjusted models for associations.The prevalence of inappropriate prescribing was 34.1% for the 2012 AGS Beers
Adverseevents in oncology patients with reduced platelet counts and oncurrent anemia Adverseevents in oncology patients with reduced platelet counts and oncurrent anemia Adverseevents in oncology patients with reduced platelet counts and oncurrent anemia Mitchell MD, Wagner J, Wong,TC, Mull N Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database (...) . Citation Mitchell MD, Wagner J, Wong,TC, Mull N. Adverseevents in oncology patients with reduced platelet counts and oncurrent anemia. Philadelphia: Center for Evidence-based Practice (CEP). 2016 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Anemia; Humans; Leukopenia; Medical Oncology; Platelet Count; Thrombocytopenia Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence
Disclosure and Discussion of AdverseEvents Disclosure and Discussion of AdverseEvents - ACOG Menu ▼ Disclosure and Discussion of AdverseEvents Page Navigation ▼ Number 681, December 2016 (Replaces Committee Opinion No. 520, March 2012) (Reaffirmed 2019) Committee on Patient Safety and Quality Improvement This Committee Opinion was developed by the American College of Obstetricians and Gynecologists’ Committee on Patient Safety and Quality Improvement in collaboration with committee member (...) Edward P. Denious, MD. This document reflects emerging concepts on patient safety and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Disclosure and Discussion of AdverseEvents ABSTRACT: Adverse outcomes, preventable or otherwise, are a reality of medical care. Most importantly, adverseevents affect patients, but they also affect health care practitioners. Disclosing information about adverseevents has
Prospective evaluation of sedation-related adverseevents in pediatric patients ventilated for acute respiratory failure PEDSCCM.org Criteria abstracted from series in Review Posted: founded 1995 Questions or comments?
Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations. The Advisory Committee on Immunization Practices (ACIP) recommends the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for pregnant women during each pregnancy, regardless of prior immunization status. However, safety data on repeated Tdap vaccination in pregnancy is lacking.To determine whether receipt of Tdap vaccine during pregnancy (...) administered in close intervals from prior tetanus-containing vaccinations is associated with acute adverseevents in mothers and adverse birth outcomes in neonates.A retrospective cohort study in 29,155 pregnant women aged 14 through 49 years from January 1, 2007, through November 15, 2013, using data from 7 Vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin.Women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years
Emergency Department Visits for AdverseEvents Related to Dietary Supplements. Dietary supplements, such as herbal or complementary nutritional products and micronutrients (vitamins and minerals), are commonly used in the United States, yet national data on adverse effects are limited.We used nationally representative surveillance data from 63 emergency departments obtained from 2004 through 2013 to describe visits to U.S. emergency departments because of adverseevents related to dietary (...) supplements.On the basis of 3667 cases, we estimated that 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year were attributed to adverseevents related to dietary supplements. These visits resulted in an estimated 2154 hospitalizations (95% CI, 1342 to 2967) annually. Such visits frequently involved young adults between the ages of 20 and 34 years (28.0% of visits; 95% CI, 25.1 to 30.8) and unsupervised children (21.2% of visits; 95% CI, 18.4 to 24.0). After
Adverseevents associated with single dose oral analgesics for acute postoperative pain in adults - an overview of Cochrane reviews. This is an update of a Cochrane overview published in Issue 9, 2011; that overview considered both efficacy and adverseevents. This overview considers adverseevents, with efficacy dealt with in a separate overview.Thirty-nine Cochrane reviews of randomised trials have examined the adverseevents associated with individual drug interventions in acute (...) postoperative pain. This overview brings together the results of those individual reviews.To provide an overview of adverseevent rates associated with single-dose oral analgesics, compared with placebo, for acute postoperative pain in adults.We identified systematic reviews in The Cochrane Database of Systematic Reviews on The Cochrane Library through a simple search strategy. All reviews were overseen by a single review group. We extracted information related to participants experiencing any adverseevent
The Incremental Risk of Coronary Stents on Postoperative AdverseEvents: A Matched Cohort Study To determine the incremental risk of coronary stents on adverseevents in surgical patients and whether it varies over time from stent placement.Postoperative adverse cardiac events decrease as the time from stent placement increases, but the risk attributable to the stent versus the underlying cardiac disease is uncertain, as prior studies lack a control surgical population.Data for patients (...) and nonstented populations were compared across time after stent placement.Adverse cardiac events followed surgery in 531 (5.7%) of the 9391 patients with stent and 680 (3.6%) of the 18,782 patients without stent (P < 0.001). In adjusted models, 30-day postoperative MI (odds ratio = 1.90; 95% confidence interval, 1.57-2.30) and revascularization (odds ratio = 2.03; 95% confidence interval, 1.65-2.50) but not mortality (odds ratio = 0.84; 95% confidence interval, 0.69-1.02) were higher in the stented cohort
The incremental risk of noncardiac surgery on adverse cardiac events following coronary stenting Recent coronary stent placement and noncardiac surgery contribute to the risk of adverse cardiac events, but the relative contributions of these two factors have not been quantified.This research was designed to determine the incremental risk of noncardiac surgery on myocardial infarction (MI) and coronary revascularization following coronary stenting.A U.S. retrospective cohort study of patients (...) it remained stable out to 24 months. Factors associated with a significant reduction in risk following surgery more than 6 months post-stent included elective inpatient procedures (ΔRD: 1.8%; p = 0.01), high-risk surgery (ΔRD: 3.7%; p = 0.01), and drug-eluting stent (DES) (ΔRD: 1.3%; p = 0.01).The incremental risk of noncardiac surgery on adverse cardiac events among post-stent patients is highest in the initial 6 months following stent implantation and stabilizes at 1.0% after 6 months. Elective, high
Global coronary flow reserve is associated with adverse cardiovascular events independently of luminal angiographic severity and modifies the effect of early revascularization Coronary flow reserve (CFR), an integrated measure of focal, diffuse, and small-vessel coronary artery disease (CAD), identifies patients at risk for cardiac death. We sought to determine the association between CFR, angiographic CAD, and cardiovascular outcomes.Consecutive patients (n=329) referred for invasive coronary (...) , global ischemia, and early revascularization, CFR and CAD prognostic index were independently associated with events (hazard ratio for unit decrease in CFR, 2.02; 95% confidence interval, 1.20-3.40; P=0.008; hazard ratio for 10-U increase in CAD prognostic index, 1.17; 95% confidence interval, 1.01-1.34; P=0.032). Subjects with low CFR experienced rates of events similar to those of subjects with high angiographic scores, and those with low CFR or high CAD prognostic index showed the highest risk
Cohort study: For patients who underwent elective non-cardiac surgery, a history of stroke is associated with an increased risk of major adverse cardiovascular events and death, particularly if time elapsed between stroke and surgery is less than 9?months For patients who underwent elective non-cardiac surgery, a history of stroke is associated with an increased risk of major adverse cardiovascular events and death, particularly if time elapsed between stroke and surgery is less than 9 months (...) accounts OR managers of institutional accounts Username * Password * your user name or password? You are here For patients who underwent elective non-cardiac surgery, a history of stroke is associated with an increased risk of major adverse cardiovascular events and death, particularly if time elapsed between stroke and surgery is less than 9 months Article Text Prognosis Cohort study For patients who underwent elective non-cardiac surgery, a history of stroke is associated with an increased risk