232. Safety and Effectiveness of Intravenous to Oral De-escalation Compared to Continued Vancomycin Therapy in Orthopedic Infections

Abstract Background The Oral versus Intravenous Antibiotics for Bone and Joint Infection (OVIVA) trial determined oral antibiotics administered during the first six weeks of therapy were non-inferior to parenteral antibiotics. There was no difference in the incidence of serious adverse effects. The objective of this study was to evaluate the safety and effectiveness of de-escalating to oral therapy compared to continuing parenteral vancomycin therapy in patients with orthopedic infections in a real-world setting. Methods We conducted a single-center, retrospective cohort study of patients discharged between April 1, 2018 and April 1, 2020 with an orthopedic infection, a prescription for at least four weeks of parenteral vancomycin, and documented follow-up. The primary outcome was incidence of adverse events defined as provider documentation of the event and changes to therapy. The secondary outcome was incidence of 6-month treatment failure defined as repeat surgical intervention or therapy escalation. Results One hundred fifty-seven patients were included. Twenty-nine (18.5%) patients were de-escalated to oral therapy. Three (10%) patients in the oral therapy group had an adverse event compared to 35 (27%) in the vancomycin group (p=0.058). Of the 35 patients with an adverse event in the vancomycin group, eight were due to parenteral access-related complications. Treatment failure occurred in three (10%) patients in the oral therapy group compared to 27 (21%) patients in the vancomycin group (p=0.29). Three (10%) patients in the oral therapy group had an unplanned readmission compared to 25 (20%) patients in the vancomycin group (p=0.24). Baseline Characteristics, Unplanned Readmission Rates, and Incidence of Adverse Events and 6-Month Treatment Failure Conclusion Patients de-escalated to oral therapy had fewer adverse events and similar incidences of treatment failure compared to patients maintained on parenteral vancomycin. Switching to oral therapy avoids some adverse events related to parenteral access. Our results in an uncontrolled, real-world setting are consistent with the OVIVA trial. Though limited by sample size, our data indicate switching to oral therapy in patients with an orthopedic infection improves safety outcomes without compromising effectiveness compared to continued parenteral vancomycin therapy. Disclosures Russell J. Benefield, PharmD, Paratek Pharmaceuticals (Grant/Research Support)

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Incidence of serious adverse events in bortezomib, lenalidomide and bortezomib plus lenalidomide maintenance for multiple myeloma: Interim analysis of MMRF-CoMMpass study.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e19516 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e19516-e19516

Author(s):

Venkata Vosuri ◽

Mark A Fiala ◽

Wenners Ballard ◽

Tanya Marya Wildes ◽

Mark A. Schroeder ◽

...

Keyword(s):

Multiple Myeloma ◽

Adverse Event ◽

Stem Cell ◽

Adverse Events ◽

Maintenance Therapy ◽

Incidence Rate ◽

Interim Analysis ◽

Therapy Group ◽

Cell Transplant ◽

Serious Adverse Events

e19516 Background: Autologous stem cell transplantation (ASCT) followed by maintenance therapy is the standard of care for transplant-eligible patients with newly diagnosed multiple myeloma. Maintenance typically consists of lenalidomide (LEN), however, bortezomib (BOR) and bortezomib-lenalidomide combination are other options. The respective toxicity of these regimens has not been well studied. We performed secondary data analysis to compare incidence of serious adverse events associated with each maintenance therapy group during post-ASCT maintenance treatment period. Methods: Data was extracted from the open-access MMRF Researcher Gateway corresponding with interim analysis from the CoMMpass study. We extracted data of first-time autologous stem cell transplant patients who completed maintenance therapy post-ASCT. We categorized patients into three sub groups bortezomib, lenalidomide or combination (bortezomib and lenalidomide) maintenance therapy. Incidence rate for serious adverse events (grade 3 or higher) was calculated by number of events per 100 person-months for each maintenance therapy. Results: 231 patients were eligible for our analysis. 169 patients received lenalidomide, 27 bortezomib and 35 combination. The most common adverse event was neutropenia and second most common is pneumonia. Neutropenia incidence was 1.1,0.7 and 0.9 per 100 person-months in lenalidomide, bortezomib and combination regimens respectively. Incidence of deep vein thrombosis, GI intolerance and peripheral neuropathy 0.1 per 100 person-months respectively was observed in lenalidomide group only. Combination maintenance had the highest total adverse event incidence rate of 5.4 per 100 person-months. Incidence of 1.7 and 3.8 per 100 person-months is observed in bortezomib and lenalidomide cohorts respectively. Conclusions: Lenalidomide and bortezomib maintenance had similar incidence of serious adverse events. A higher incidence of serious adverse events was noted in the combination lenalidomide/bortezomib regimens. Interestingly, we observed lower incidence of adverse events in all groups in CoMMpass study compared to respective clinical trials involving maintenance regimens. This may be due to under reporting of adverse events in CoMMpass study. The incidence of adverse events mentioned above should be interpreted in the context of drugs and other factors involved in the disease.

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267-OR: Reduction in Self-Reported Adverse Events Related to Severe Hypoglycemia in Individuals Using a Predictive Low Glucose System: Results from a Real-World Setting

Diabetes ◽

10.2337/db20-267-or ◽

2020 ◽

Vol 69 (Supplement 1) ◽

pp. 267-OR

Author(s):

HARSIMRAN SINGH ◽

MICHELLE L. MANNING ◽

MOLLY MCELWEE-MALLOY ◽

STEPHANIE HABIF

Keyword(s):

Adverse Events ◽

Real World ◽

Severe Hypoglycemia ◽

Real World Setting ◽

Glucose System ◽

Low Glucose

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Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Current Drug Safety ◽

10.2174/1574886313666181026100000 ◽

2019 ◽

Vol 14 (1) ◽

pp. 21-26 ◽

Cited By ~ 2

Author(s):

Viswam Subeesh ◽

Eswaran Maheswari ◽

Hemendra Singh ◽

Thomas Elsa Beulah ◽

Ann Mary Swaroop

Keyword(s):

Data Mining ◽

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Disproportionality Analysis ◽

Positive Signal ◽

Data Mining Algorithms ◽

Mining Algorithms

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.

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Adverse Effects of Natural Products: A Brief Pre-Systematic Review

Current Nutraceuticals ◽

10.2174/2665978601999200702163914 ◽

2020 ◽

Vol 01 ◽

Author(s):

Carla Pires ◽

Ana Fernandes

Keyword(s):

Systematic Review ◽

Adverse Event ◽

Natural Products ◽

Adverse Events ◽

In Vitro Study ◽

Google Scholar ◽

Inclusion Criteria ◽

Exclusion Criteria ◽

Meta Analyses

Background: Natural products are commonly used for treating health problems. These products may be associated with adverse events, which are defined as "noxious and unintended response to a medicinal product" by the European Medicine Agency. Objectives: To identify studies describing at least one adverse event (or with potential to promote an adverse event) related to the use of natural products, as well as to describe the involved product(s) and adverse event(s). Methods: A pre-systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Keywords: "natural product(s)" and ["adverse drug reaction(s)" or "adverse effect(s)"]. Screened databases: PubMed, SciELO, DOAJ and Google Scholar. Inclusion criteria: papers describing at least one adverse event associated with the use of natural products and published between 2017 and 2019. Exclusion criteria: Repeated studies, reviews and papers written in other languages than English, Portuguese, French or Spanish. Results: 104 studies were identified (20 PubMed; 0 SciELO; 2 DOAJ; 82 Google Scholar), but only 10 were selected (4 PubMed and 6 Google Scholar): 1 in-vitro study; 2 non-clinical studies, 1 study reporting in-vitro and clinical data and 5 studies were cases reports. Globally, 997 reports of adverse drug reactions with natural products were identified, mainly non-severe cases. Conclusion: Since a limited number of studies was found, we conclude that adverse events due to natural products may be underreported, or natural products may have a good safety profile. This review contributes for assuring the safety of natural products consumers, by evaluating the knowledge/information on the potential adverse events and interactions of these products.

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Adverse Events in Home-Care Nursing Agencies and Related Factors: A Nationwide Survey in Japan

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18052546 ◽

2021 ◽

Vol 18 (5) ◽

pp. 2546

Author(s):

Noriko Morioka ◽

Masayo Kashiwagi

Keyword(s):

Adverse Event ◽

Patient Safety ◽

Adverse Events ◽

Home Care ◽

Process Of Care ◽

Related Factors ◽

Cross Sectional ◽

Home Care Nursing ◽

Number Of Patients ◽

Care Nursing

Despite the importance of patient safety in home-care nursing provided by licensed nurses in patients’ homes, little is known about the nationwide incidence of adverse events in Japan. This article describes the incidence of adverse events among home-care nursing agencies in Japan and investigates the characteristics of agencies that were associated with adverse events. A cross-sectional nationwide self-administrative questionnaire survey was conducted in March 2020. The questionnaire included the number of adverse event occurrences in three months, the process of care for patient safety, and other agency characteristics. Of 9979 agencies, 580 questionnaires were returned and 400 were included in the analysis. The number of adverse events in each agency ranged from 0 to 47, and 26.5% of the agencies did not report any adverse event cases. The median occurrence of adverse events was three. In total, 1937 adverse events occurred over three months, of which pressure ulcers were the most frequent (80.5%). Adjusting for the number of patients in a month, the percentage of patients with care-need level 3 or higher was statistically significant. Adverse events occurring in home-care nursing agencies were rare and varied widely across agencies. The patients’ higher care-need levels affected the higher number of adverse events in home-care nursing agencies.

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The Association between Ranitidine Use and Gastrointestinal Cancers

Cancers ◽

10.3390/cancers13010024 ◽

2020 ◽

Vol 13 (1) ◽

pp. 24

Author(s):

Gerald McGwin

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Large Body ◽

Science Research ◽

Gastrointestinal System ◽

Gastrointestinal Cancers ◽

H2 Antagonists ◽

Study Results ◽

Risk Of Cancer

N-nitrosodimethylamine (NDMA) is a carcinogen in experimental animals. It has been classified a probable human carcinogen and has been found in ranitidine. This study sought to evaluate the association between ranitidine use and cancer of the gastrointestinal system. Events reported to the FDA Adverse Events Reporting System that were associated with the use of proton pump inhibitors (PPIs) and H2 antagonists were selected. Proportionate reporting ratios (PRRs) and associated 95% confidence intervals (CIs) were calculated to compare the proportion of all reported adverse events that were for gastrointestinal system cancers among adverse event reports for ranitidine to adverse event reports for other H2 antagonists. The proportion of adverse events for any gastrointestinal system cancer relative to all other events was elevated for ranitidine compared to PPIs and other H2 antagonists (PRR 3.66, 95% CI 3.19–4.20). Elevated and significant PRRs were observed for pharyngeal (PRR 9.24), esophageal (PRR 3.56), stomach (PRR 1.48), colorectal (PRR 16.31), liver (PRR 2.64), and pancreatic (PRR 2.18) cancers. The PRRs for anal (PRR 4.62) and gallbladder (PRR 4.62) cancer were also elevated though not statistically significant. In conjunction with a large body of epidemiologic and human and animal basic science research, the study results support the hypothesis that NDMA-contaminated ranitidine increases the risk of cancer and supports the withdrawal of these medications from the market.

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Characteristics of voluntary reporting of adverse drug events related to antipsychotics in Australia: 14-year analysis

Therapeutic Advances in Drug Safety ◽

10.1177/20420986211012854 ◽

2021 ◽

Vol 12 ◽

pp. 204209862110128

Author(s):

Hanan Khalil ◽

Dimi Hoppe ◽

Nabil Ameen

Keyword(s):

Adverse Event ◽

Adverse Effects ◽

Adverse Events ◽

Neuroleptic Malignant Syndrome ◽

Antipsychotic Drug ◽

Antipsychotic Drugs ◽

Common Adverse Event ◽

Drug Misuse ◽

Large Databases ◽

Chi Squared

Background: Retrospective analyses of large databases of treated patients can provide useful links to the presence of drug misuse or rare and infrequent adverse effects, such as agranulocytosis, diabetic ketoacidosis or neuroleptic malignant syndrome. The aim of this study is to describe the adverse effects to antipsychotics reported in the Australian Database of Adverse Event Notifications (DAEN). Methods: Data were collected from the DAEN – a spontaneous reporting database. The database, which covered the period from January 2004 to December 2017, was obtained from the Therapeutic Goods Administration (TGA) website ( www.TGA.gov ). The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. All data were analysed descriptively. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: A total of 7122 adverse events associated with the antipsychotics aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, pimozide, quetiapine and risperidone were reported to the TGA between January 2004 and December 2017. On average, there were 2.6 adverse events reported for each case. The most common adverse event reported for antipsychotics was neuroleptic malignant syndrome. There were no significant differences in the number of co-medications, formulations, indications, therapeutic dose, hospital admission and overdose among the antipsychotics between paediatric and adult populations. However, there were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years) ( p < 0.05, chi squared test). Conclusion: The antipsychotic drug associated with the highest adverse events in adults was clozapine, followed by olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. Plain language summary Adverse events reported of antipsychotics Background: Retrospective analyses of large databases of treated patients can provide useful clues to the presence of drug misuse or rare and infrequent adverse effects associated with antipsychotics. The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. Methods: All data were analysed descriptively and investigated for any associations between the variables collected. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: The antipsychotic drug associated with the highest adverse events was clozapine, followed by olanzapine. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. Conclusion: There were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years).Keywords: Antipsychotics, adverse effects, adverse events, safety

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AB0799 REAL-WORLD EXPERIENCE OF SECUKINUMAB FOR PSORIATIC ARTHRITIS WITH AXIAL INVOLVEMENT.

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.6564 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1699.3-1699

Author(s):

M. Martin Lopez ◽

B. Joven-Ibáñez ◽

J. L. Pablos

Keyword(s):

Psoriatic Arthritis ◽

Adverse Events ◽

Real World ◽

Spinal Pain ◽

Tender Joint Count ◽

P Value ◽

X Ray ◽

Activity Assessment ◽

Real World Setting ◽

Axial Involvement

Background:Evidence on the efficacy of biologics in the treatment of psoriatic arthritis (PsA) patients with axial manifestations affecting 30-70% of PsA patients is limited. Secukinumab (SEC) has provided significant and sustained improvement in the signs and symptoms of active PsA and ankylosing spondylitis.Objectives:This study aims to analyze the experience of using SEC for PsA patients with axial involvement in real-world setting.Methods:Multicentric observational, longitudinal, retrospective study conducted in a tertiary hospital between January 2016 and December 2019. Patients with PsA (CASPAR criteria) and clinical and/or image diagnosis of axial involvement receiving at least one dose of SEC were included. Patients with non-pathological sacroiliacs x-ray and MRI had to have spinal pain VAS ≥4/10 after failure to NSAIDs, prior to the onset of SEC, to be included. Medical records were reviewed to collect demographic and clinical data, features of PsA (manifestations, treatments and activity assessment). Descriptive statistics and then a comparative analysis with the Studentt-test to analyze the effectiveness of SEC were performed.Results:Of 98 PsA patients treated with SEC, 58 (59.2%) had axial involvement, of which 41 (71%) female. Mean age was 54 y.o (SD 10) and average duration of the disease was 10 years (SD 8). All 58 patients had peripheral disease (33% joint erosions), 55 (95%) had psoriasis, 20 (34%) showed dactilitis and 39 (67%) had enthesitis. Sacroiliacs x-ray was damaged in 38 (66%) patients (grade I-IV) and 23 (40%) pathological MRI, with HLAB27+ at 8 (14%) patients. Average BMI was 29 (SD 8), with an obesity rate of 33% (19 pt). Observed comorbidities were hypertension (27 pt, 47%), diabetes mellitus (6 pt, 10%), dyslipidemia (23 pt, 40%), active smoking (18 pt, 31%) and malignancy (6 pt, 10%). Regarding previous treatments, 90% had received cDMARDs, particularly methotrexate (86%) and 40 (69%) had been exposed to at least one bDMARD (15 pt to one, 9 to two, 6 to three and 10 to four or more). 7 patients were on 300 mg dose and 51 patients on 150 mg dose (dose escalation to 300 mg was performed in 16 patients and 44% respond and maintain SEC). Average drug survival time was 1.4 (SD 1) years. At 6 months of SEC therapy, tender and swollen joint count, spinal pain VAS, CRP, ASDAS-CRP and DAPSA had significantly decreased (Table 1). 29 (50%) patients suspended SEC during follow-up due to primary ineffectiveness (8), secondary ineffectiveness (16), adverse events (3), latex allergy (1) and remission (1). Adverse events do not differ from those reported in clinical trials.Table 1.Disease activity assessment at 6 months of secukinumab therapy.Baseline6 months after SECMean differenceP valueSJC4,8±5,41,9±3,1-2,8 (IC95% -3,9 a -1,7)p<0,0001TJC7,7±5,83,9±4,1-3,8 (IC95% -5,1 a -2,4)p<0,0001Spinal pVAS6,1±3,24,2±2,9-1,9 (IC95% -2,4 a -1,4)p<0,0001CRP (mg/L)7,7±9,94,9±5,9-2,9 (IC95% -4,5 a -1,2)p=0,0009ASDAS-CRP2,5±1,91,8±1,3-0,7 (IC95% -0,9 a -0,4)p<0,0001DAPSA27,7±12,116,7±10,4-11 (IC95% -15,3 a -6,8)p<0,0001SJC: swollen joint count, TJC: tender joint count, Spinal pVAS: spinal pain visual analog scale, CRP: C-reactive protein, SEC: secukinumab.Conclusion:Secukinumab in real-world setting provided improvements in the axial and peripheral manifestations of PsA, using both the 150 mg and 300 mg doses.Disclosure of Interests:MARIA MARTIN LOPEZ: None declared, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, José Luis Pablos: None declared

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The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends in adverse event rates in the Irish healthcare system

BMJ Quality & Safety ◽

10.1136/bmjqs-2020-011122 ◽

2021 ◽

pp. bmjqs-2020-011122 ◽

Cited By ~ 1

Author(s):

Warren Connolly ◽

Natasha Rafter ◽

Ronan M Conroy ◽

Cornelia Stuart ◽

Anne Hickey ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Positive Impact ◽

Retrospective Chart Review ◽

Published Data ◽

National Programmes ◽

Event Rates ◽

Hospital Associated Infections ◽

Design And Methods ◽

The Impact

ObjectivesTo quantify the prevalence and nature of adverse events in acute Irish hospitals in 2015 and to assess the impact of the National Clinical Programmes and the National Clinical Guidelines on the prevalence of adverse events by comparing these results with the previously published data from 2009.Design and methodsA retrospective chart review of 1605 admissions to eight Irish hospitals in 2015, using identical methods to those used in 2009.ResultsThe percentage of admissions associated with one or more adverse events was unchanged (p=0.48) at 14% (95% CI=10.4% to 18.4%) in 2015 compared with 12.2% (95% CI=9.5% to 15.5%) in 2009. Similarly, the prevalence of preventable adverse events was unchanged (p=0.3) at 7.4% (95% CI=5.3% to 10.5%) in 2015 compared with 9.1% (95% CI=6.9% to 11.9%) in 2009. The incidence densities of preventable adverse events were 5.6 adverse events per 100 admissions (95% CI=3.4 to 8.0) in 2015 and 7.7 adverse events per 100 admissions (95% CI=5.8 to 9.6) in 2009 (p=0.23). However, the percentage of preventable adverse events due to hospital-associated infections decreased to 22.2% (95% CI=15.2% to 31.1%) in 2015 from 33.1% (95% CI=25.6% to 41.6%) in 2009 (p=0.01).ConclusionAdverse event rates remained stable between 2009 and 2015. The percentage of preventable adverse events related to hospital-associated infection decreased, which may represent a positive impact of the related national programmes and guidelines.

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