scholarly journals Syncope Time Frames for Adverse Events after Emergency Department Presentation: An Individual Patient Data Meta-Analysis

Medicina ◽  
2021 ◽  
Vol 57 (11) ◽  
pp. 1235
Author(s):  
Ludovico Furlan ◽  
Lucia Trombetta ◽  
Giovanni Casazza ◽  
Franca Dipaola ◽  
Raffaello Furlan ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Meta Analysis ◽  
Management Strategies ◽  
Common Adverse Event ◽  
Ecg Monitoring ◽  
Risk Of Death ◽  
Life Threatening ◽  
The Mean ◽  
Time Frames

Background and Objectives: Knowledge of the incidence and time frames of the adverse events of patients presenting syncope at the ED is essential for developing effective management strategies. The aim of the present study was to perform a meta-analysis of the incidence and time frames of adverse events of syncope patients. Materials and Methods: We combined individual patients’ data from prospective observational studies including adult patients who presented syncope at the ED. We assessed the pooled rate of adverse events at 24 h, 72 h, 7–10 days, 1 month and 1 year after ED evaluation. Results: We included nine studies that enrolled 12,269 patients. The mean age varied between 53 and 73 years, with 42% to 57% females. The pooled rate of adverse events was 5.1% (95% CI 3.4% to 7.7%) at 24 h, 7.0% (95% CI 4.9% to 9.9%) at 72 h, 8.4% (95% CI 6.2% to 11.3%) at 7–10 days, 10.3% (95% CI 7.8% to 13.3%) at 1 month and 21.3% (95% CI 15.8% to 28.0%) at 1 year. The pooled death rate was 0.2% (95% CI 0.1% to 0.5%) at 24 h, 0.3% (95% CI 0.1% to 0.7%) at 72 h, 0.5% (95% CI 0.3% to 0.9%) at 7–10 days, 1% (95% CI 0.6% to 1.7%) at 1 month and 5.9% (95% CI 4.5% to 7.7%) at 1 year. The most common adverse event was arrhythmia, for which its rate was 3.1% (95% CI 2.0% to 4.9%) at 24 h, 4.8% (95% CI 3.5% to 6.7%) at 72 h, 5.8% (95% CI 4.2% to 7.9%) at 7–10 days, 6.9% (95% CI 5.3% to 9.1%) at 1 month and 9.9% (95% CI 5.5% to 17) at 1 year. Ventricular arrhythmia was rare. Conclusions: The risk of death or life-threatening adverse event is rare in patients presenting syncope at the ED. The most common adverse events are brady and supraventricular arrhythmias, which occur during the first 3 days. Prolonged ECG monitoring in the ED in a short stay unit with ECG monitoring facilities may, therefore, be beneficial.

scholarly journals Efficacy and Toxicity of Maintenance Pemetrexed Following Induction Treatment with Pemetrexed Plus Cisplatin for Advanced Non-small-cell Non-squamous Carcinoma of the Lung

2015 ◽  
Vol 6 (2) ◽  
pp. 14-18 ◽  
Author(s):  
D. H. Kim ◽  
A. Kinmond ◽  
S. Gilani ◽  
S. Giridharan ◽  
A. Jegannathen
Keyword(s):  
Adverse Event ◽  
Renal Function ◽  
Adverse Events ◽  
Disease Progression ◽  
Performance Status ◽  
Common Adverse Event ◽  
Small Cell ◽  
Induction Treatment ◽  
The Mean ◽  
Grade 3

AbstractINTRODUCTION: The aim of this study is to assess the efficacy and toxicity of maintenance pemetrexed following induction treatment with cisplatin and pemetrexed for patients with advanced non-small cell lung cancer.PATIENTS AND METHODS: Eligible patients following four cycles of intravenous pemetrexed (Alimpta©; 500 mg/m2) and intravenous cisplatin (75 mg/m2) were given 21-day cycles of maintenance pemetrexed (500 mg/m2) until disease progression, unacceptable adverse event or death. From a total 80 patients receiving palliative induction chemotherapy, 17 subsequently received maintenance pemetrexed.RESULTS: The mean number of maintenance cycles completed was 5.9 (range 1-20; median 3.0). The mean progression-free survival (PFS) was 5.2 months (range: 2-15; median: 2.0) and the 1-year PFS was 17%. Treatment was discontinued due to disease progression (71%), adverse event (21%) and death from study disease (7%). Grade 3-4 laboratory and non-laboratory adverse events were seen in 11.8 and 17.6% of patients, respectively. Anaemia was the most common adverse event (71% of all patients; 65% grade 1-2; 5.9% grade 3-4). The most common reason for withdrawal due to adverse event was declining renal function. There was a statistically significant correlation between worsening performance status and reducing number of maintenance cycles completed (Spearman’s rank; R = −0.511, p = 0.036).DISCUSSION: The median PFS was lower than in previous studies with a higher than previously reported frequency of adverse events. Clinicians must monitor renal function and full blood counts vigilantly, especially in patients with performance status greater than 0.

scholarly journals Adverse Events Following COVISHIELD Vaccination Among Adult Population in Bangladesh

2021 ◽  
Author(s):  
Md. Musab Khalil ◽  
Khandker Mahbub-Uz-Zaman ◽  
As-Saba Hossain ◽  
Farid Ahmed ◽  
Md. Fazlul Karim Chowdhury ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Adult Population ◽  
Cross Sectional Study ◽  
Common Adverse Event ◽  
Inclusion Criteria ◽  
Cross Sectional ◽  
Life Threatening ◽  
The Difference ◽  
Bangladeshi Population

AbstractThe study aimed to determine how frequently the adverse events of the COVISHIELD vaccine occur among the Bangladeshi population. This cross-sectional study was conducted at Sheikh Russel Gastroliver Institute and Hospital, Mohakhali, Dhaka, Bangladesh, in May 2021. The inclusion criteria were the adult populations who received the 2nd dose of the COVISHELD vaccine and had passed 28 days following the completion of the 2nd dose. Three hundred and five persons fulfilling the inclusion criteria were asked over the telephone—based on a predesigned questionnaire. The rates of adverse events were 54.1% and 41.3% after the 1st and 2nd dose of vaccine, respectively, and the difference was statistically significant (p < 0.001). Pain at the injection site was the most common adverse event (32.5% following the 1st dose and 27.9% following the 2nd dose). All of the symptoms were mild and lasted for about 2 days. Age and comorbidities were significantly associated with the adverse events (p < 0.001). Neither doses had any vaccine-related life-threatening adverse event nor had any symptoms related to vaccine-related blood clotting. Nineteen persons (6.2%) had been diagnosed with COVID-19 after the 1st dose of vaccination, and three (1%) persons had been diagnosed with COVID-19 after the 2nd dose of vaccination. As no significant life-threatening adverse event was observed, this study might help reduce the hesitancy for vaccination among the population and thus help reduce transmission of this highly contagious virus.

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

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

scholarly journals Peginesatide to Manage Anemia in Chronic Kidney Disease Patients on Peritoneal Dialysis

2015 ◽  
Vol 35 (4) ◽  
pp. 481-489 ◽  
Author(s):  
Raja Zabaneh ◽  
Simon D. Roger ◽  
Mohamed El-Shahawy ◽  
Michael Roppolo ◽  
Grant Runyan ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Adverse Event ◽  
Peritoneal Dialysis ◽  
Kidney Disease ◽  
Common Adverse Event ◽  
Erythropoietin Receptor ◽  
Open Label ◽  
Evaluation Period ◽  
Red Blood Cell Transfusions ◽  
The Mean

♦BackgroundPeginesatide is a novel, synthetic, peptide-based pegylated erythropoiesis-stimulating agent that is designed specifically to stimulate the erythropoietin receptor. The purpose of the present study was to assess, for the first time, the efficacy and safety of peginesatide in chronic kidney disease (CKD) patients receiving peritoneal dialysis (PD) and previously on epoetin treatment.♦MethodsIn this open-label multicenter study, 59 PD patients with CKD were converted from epoetin (alfa or beta) to once-monthly peginesatide. Doses were titrated to maintain hemoglobin levels between 10 g/dL and 12 g/dL during the 25 weeks of the study. The primary endpoint was change from baseline in mean hemoglobin values during the evaluation period (weeks 20 – 25).♦ResultsThe mean hemoglobin value during the evaluation period was 11.3 ± 1.07 g/dL, and the mean change from baseline was 0.10 ± 1.15 g/dL (95% confidence limits: –0.24, 0.44 g/dL). During the evaluation period, most patients maintained hemoglobin levels between 10 g/dL and 12 g/dL (63.0%) and within ±1.0 g/dL of baseline (60.9%). The median weekly epoetin dose at baseline was 96.0 U/kg, and the median starting peginesatide dose was 0.047 mg/kg. Forty-three patients (72.9%) completed the study. Six patients (10.2%) received red blood cell transfusions. The observed adverse event profile was consistent with underlying conditions in the PD patient population. The most common adverse event was peritonitis (20.3%), a complication commonly associated with PD. Four deaths occurred during the study (2 related to septic shock, and 1 each to myocardial ischemia and myasthenia gravis).♦ConclusionsIn this study, once-monthly peginesatide maintained hemoglobin levels in PD patients after conversion from epoetin.

scholarly journals A Bayesian meta-analytic approach for safety signal detection in randomized clinical trials

2017 ◽  
Vol 14 (2) ◽  
pp. 192-200 ◽  
Author(s):  
Motoi Odani ◽  
Satoru Fukimbara ◽  
Tosiya Sato
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Events ◽  
Hierarchical Structure ◽  
Meta Analysis ◽  
Event Data ◽  
Analysis Model ◽  
Exact Test ◽  
Adverse Event Data ◽  
Fisher’S Exact Test

Background/Aim: Meta-analyses are frequently performed on adverse event data and are primarily used for improving statistical power to detect safety signals. However, in the evaluation of drug safety for New Drug Applications, simple pooling of adverse event data from multiple clinical trials is still commonly used. We sought to propose a new Bayesian hierarchical meta-analytic approach based on consideration of a hierarchical structure of reported individual adverse event data from multiple randomized clinical trials. Methods: To develop our meta-analysis model, we extended an existing three-stage Bayesian hierarchical model by including an additional stage of the clinical trial level in the hierarchical model; this generated a four-stage Bayesian hierarchical model. We applied the proposed Bayesian meta-analysis models to published adverse event data from three premarketing randomized clinical trials of tadalafil and to a simulation study motivated by the case example to evaluate the characteristics of three alternative models. Results: Comparison of the results from the Bayesian meta-analysis model with those from Fisher’s exact test after simple pooling showed that 6 out of 10 adverse events were the same within a top 10 ranking of individual adverse events with regard to association with treatment. However, more individual adverse events were detected in the Bayesian meta-analysis model than in Fisher’s exact test under the body system “Musculoskeletal and connective tissue disorders.” Moreover, comparison of the overall trend of estimates between the Bayesian model and the standard approach (odds ratios after simple pooling methods) revealed that the posterior median odds ratios for the Bayesian model for most adverse events shrank toward values for no association. Based on the simulation results, the Bayesian meta-analysis model could balance the false detection rate and power to a better extent than Fisher’s exact test. For example, when the threshold value of the posterior probability for signal detection was set to 0.8, the false detection rate was 41% and power was 88% in the Bayesian meta-analysis model, whereas the false detection rate was 56% and power was 86% in Fisher’s exact test. Limitations: Adverse events under the same body system were not necessarily positively related when we used “system organ class” and “preferred term” in the Medical Dictionary for Regulatory Activities as a hierarchical structure of adverse events. For the Bayesian meta-analysis models to be effective, the validity of the hierarchical structure of adverse events and the grouping of adverse events are critical. Conclusion: Our proposed meta-analysis models considered trial effects to avoid confounding by trial and borrowed strength from both within and across body systems to obtain reasonable and stable estimates of an effect measure by considering a hierarchical structure of adverse events.

scholarly journals The correlation of respiratory system compliance and mortality in COVID-19 acute respiratory distress syndrome: do phenotypes really exist?

2021 ◽  
Vol 8 (2) ◽  
pp. 67-74
Author(s):  
Rachel L. Choron ◽  
Stephen A. Iacono ◽  
Alexander Cong ◽  
Christopher G. Bargoud ◽  
Amanda L. Teichman ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Respiratory System ◽  
Management Strategies ◽  
Respiratory System Compliance ◽  
Risk Of Death ◽  
Mortality Difference ◽  
Ventilator Management ◽  
Observational Cohort ◽  
Multivariable Regression ◽  
The Mean

Background: Recent literature suggests respiratory system compliance (Crs) based phenotypes exist among COVID-19 ARDS patients. We sought to determine whether these phenotypes exist and whether Crs predicts mortality. Methods: A retrospective observational cohort study of 111 COVID-19 ARDS patients admitted March 11-July 8, 2020. Crs was averaged for the first 72-hours of mechanical ventilation. Crs<30ml/cmH2O was defined as poor Crs(phenotype-H) whereas Crs≥30ml/cmH2O as preserved Crs(phenotype-L). Results: 111 COVID-19 ARDS patients were included, 40 phenotype-H and 71 phenotype-L. Both the mean PaO2/FiO2 ratio for the first 72-hours of mechanical ventilation and the PaO2/FiO2 ratio hospital nadir were lower in phenotype-H than L(115[IQR87] vs 165[87], p=0.016), (63[32] vs 75[59], p=0.026). There were no difference in characteristics, diagnostic studies, or complications between groups. Twenty-seven (67.5%) phenotype-H patients died vs 37(52.1%) phenotype-L(p=0.115). Multivariable regression did not reveal a mortality difference between phenotypes; however, a 2-fold mortality increase was noted in Crs<20 vs >50ml/cmH2O when analyzing ordinal Crs groups. Moving up one group level (ex. Crs30-39.9ml/cmH2O to 40-49.9ml/cmH2O), was marginally associated with 14% lower risk of death(RR=0.86, 95%CI 0.72, 1.01, p=0.065). This attenuated (RR=0.94, 95%CI 0.80, 1.11) when adjusting for pH nadir and PaO2/FiO2 ratio nadir. Conclusion: We identified a spectrum of Crs in COVID-19 ARDS similar to Crs distribution in non-COVID-19 ARDS. While we identified increasing mortality as Crs decreased, there was no specific threshold marking significantly different mortality based on phenotype. We therefore would not define COVID-19 ARDS patients by phenotypes-H or L and would not stray from traditional ARDS ventilator management strategies.

scholarly journals Effect of Patiromer in Hyperkalemic Patients Taking and Not Taking RAAS Inhibitors

2018 ◽  
Vol 23 (6) ◽  
pp. 524-531 ◽  
Author(s):  
Robert A. Kloner ◽  
Coleman Gross ◽  
Jinwei Yuan ◽  
Ansgar Conrad ◽  
Pablo E. Pergola
Keyword(s):  
Adverse Events ◽  
Serum Potassium ◽  
Common Adverse Event ◽  
Open Label ◽  
Serious Adverse Events ◽  
End Point ◽  
The Mean ◽  
Baseline Characteristics ◽  
Raas Inhibitors ◽  
Post Hoc

Introduction: Hyperkalemia (potassium >5.0 mEq/L) affects heart failure patients with renal disease regardless of the use of renin–angiotensin–aldosterone system inhibitors (RAASi). The open-label TOURMALINE study showed that patiromer, a sodium-free, nonabsorbed potassium binder, lowers serum potassium of hyperkalemic patients similarly when given with or without food; unlike prior studies, patients were not required to be taking RAASi. We conducted post hoc analyses to provide the first report of patiromer in patients not taking RAASi. Methods: Hyperkalemic patients received patiromer, 8.4 g/d to start, adjusted to achieve and maintain serum potassium of 3.8 to 5.0 mEq/L. If taking RAASi, stable doses were required. The primary end point was the proportion of patients with serum potassium 3.8 to 5.0 mEq/L at week 3 or 4. This analysis presents data by patients taking or not taking RAASi. Results: Demographics and baseline characteristics were similar in patients taking (n = 67) and not taking RAASi (n = 45). Baseline mean (SD) serum potassium was 5.37 (0.37) mEq/L and 5.42 (0.43) mEq/L in patients taking and not taking RAASi, respectively. Mean (SD) daily patiromer doses were similar (10.7 [3.2] and 11.5 [4.0] g, respectively). The primary end point was achieved in 85% (95% confidence interval [CI]: 74-93) of patients taking RAASi and in 84% (95% CI: 71-94) of patients not taking RAASi. From baseline to week 4, the mean (SE) change in serum potassium was −0.67 (0.08) mEq/L in patients taking RAASi and −0.56 (0.10) mEq/L in patients not taking RAASi (both P < .0001 vs baseline, P = nonsignificant between groups). Adverse events were reported in 26 (39%) patients taking RAASi and 25 (54%) not taking RAASi; the most common adverse event was diarrhea (2% and 11%, respectively; no cases were severe). Five patients (2 taking RAASi) reported 6 serious adverse events; none considered related to patiromer. Conclusions: Patiromer was effective and generally well-tolerated for hyperkalemia treatment, whether or not patients were taking RAAS inhibitors.

scholarly journals Perioperative outcomes and adverse events of minimally invasive versus open posterior lumbar fusion: meta-analysis and systematic review

2016 ◽  
Vol 24 (3) ◽  
pp. 416-427 ◽  
Author(s):  
Christina L. Goldstein ◽  
Kevin Macwan ◽  
Kala Sundararajan ◽  
Y. Raja Rampersaud
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Adverse Events ◽  
Minimally Invasive ◽  
Comparative Effectiveness ◽  
Meta Analysis ◽  
Perioperative Outcomes ◽  
Estimated Blood Loss ◽  
Significant Difference ◽  
Patient Reported

OBJECT The objective of this study was to determine the clinical comparative effectiveness and adverse event rates of posterior minimally invasive surgery (MIS) compared with open transforaminal or posterior lumbar interbody fusion (TLIF/PLIF). METHODS A systematic review of the Medline, EMBASE, PubMed, Web of Science, and Cochrane databases was performed. A hand search of reference lists was conducted. Studies were reviewed by 2 independent assessors to identify randomized controlled trials (RCTs) or comparative cohort studies including at least 10 patients undergoing MIS or open TLIF/PLIF for degenerative lumbar spinal disorders and reporting at least 1 of the following: clinical outcome measure, perioperative clinical or process measure, radiographic outcome, or adverse events. Study quality was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) protocol. When appropriate, a meta-analysis of outcomes data was conducted. RESULTS The systematic review and reference list search identified 3301 articles, with 26 meeting study inclusion criteria. All studies, including 1 RCT, were of low or very low quality. No significant difference regarding age, sex, surgical levels, or diagnosis was identified between the 2 cohorts (856 patients in the MIS cohort, 806 patients in the open cohort). The meta-analysis revealed changes in the perioperative outcomes of mean estimated blood loss, time to ambulation, and length of stay favoring an MIS approach by 260 ml (p < 0.00001), 3.5 days (p = 0.0006), and 2.9 days (p < 0.00001), respectively. Operative time was not significantly different between the surgical techniques (p = 0.78). There was no significant difference in surgical adverse events (p = 0.97), but MIS cases were significantly less likely to experience medical adverse events (risk ratio [MIS vs open] = 0.39, 95% confidence interval 0.23–0.69, p = 0.001). No difference in nonunion (p = 0.97) or reoperation rates (p = 0.97) was observed. Mean Oswestry Disability Index scores were slightly better in the patients undergoing MIS (n = 346) versus open TLIF/PLIF (n = 346) at a median follow-up time of 24 months (mean difference [MIS – open] = 3.32, p = 0.001). CONCLUSIONS The result of this quantitative systematic review of clinical comparative effectiveness research examining MIS versus open TLIF/PLIF for degenerative lumbar pathology suggests equipoise in patient-reported clinical outcomes. Furthermore, a meta-analysis of adverse event data suggests equivalent rates of surgical complications with lower rates of medical complications in patients undergoing minimally invasive TLIF/PLIF compared with open surgery. The quality of the current comparative evidence is low to very low, with significant inherent bias.

Comparing Demographic Characteristics and Adverse Event Rates at Two Dermatologic Surgery Practices

2014 ◽  
Vol 18 (5) ◽  
pp. 337-340 ◽  
Author(s):  
Jenna L. O'Neill ◽  
Brandon Shutty ◽  
Yun Sun Lee ◽  
James A. Solomon ◽  
Nikita Patel ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Geographic Location ◽  
Common Adverse Event ◽  
Adverse Event Rate ◽  
Dermatologic Surgery ◽  
Patient Demographics ◽  
Logistic Regression Procedure ◽  
Event Rates ◽  
Procedure Type

Background: Patient demographics and operative techniques may contribute to adverse events after surgeries. Objective: To identify differences in adverse event rates between different dermatologic surgery centers and potential contributing features affecting these rates. Methods: Data regarding demographics, procedure type, and adverse events were collected at two dermatologic surgery centers. Results: The most common adverse event at both sites was infection: 2.1% at site 1 versus 0.5% at site 2 ( p < .001). Using multivariate logistic regression, procedure type (Mohs surgery), geographic location (being at site 1), older age, and anatomic location of surgery were associated with a higher risk of infection. Conclusion: Adverse event rate appears to correlate with patient demographics, procedure type, and setting of surgery more than use of prophylactic antibiotics. Identification of differences in adverse event rates and potential contributing variables at different practices may allow for identification of opportunities to prevent adverse events.

scholarly journals Effectiveness and safety of non-steroidal anti-inflammatory drugs and opioid treatment for knee and hip osteoarthritis: network meta-analysis

BMJ ◽  
2021 ◽  
pp. n2321
Author(s):  
Bruno R da Costa ◽  
Tiago V Pereira ◽  
Pakeezah Saadat ◽  
Martina Rudnicki ◽  
Samir M Iskander ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Adverse Events ◽  
Meta Analysis ◽  
Hip Osteoarthritis ◽  
Randomised Trials ◽  
Increased Risk ◽  
Inflammatory Drugs ◽  
Topical Nsaids ◽  
Topical Diclofenac

Abstract Objective To assess the effectiveness and safety of different preparations and doses of non-steroidal anti-inflammatory drugs (NSAIDs), opioids, and paracetamol for knee and hip osteoarthritis pain and physical function to enable effective and safe use of these drugs at their lowest possible dose. Design Systematic review and network meta-analysis of randomised trials. Data sources Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, regulatory agency websites, and ClinicalTrials.gov from inception to 28 June 2021. Eligibility criteria for selecting studies Randomised trials published in English with ≥100 patients per group that evaluated NSAIDs, opioids, or paracetamol (acetaminophen) to treat osteoarthritis. Outcomes and measures The prespecified primary outcome was pain. Physical function and safety outcomes were also assessed. Review methods Two reviewers independently extracted outcomes data and evaluated the risk of bias of included trials. Bayesian random effects models were used for network meta-analysis of all analyses. Effect estimates are comparisons between active treatments and oral placebo. Results 192 trials comprising 102 829 participants examined 90 different active preparations or doses (68 for NSAIDs, 19 for opioids, and three for paracetamol). Five oral preparations (diclofenac 150 mg/day, etoricoxib 60 and 90 mg/day, and rofecoxib 25 and 50 mg/day) had ≥99% probability of more pronounced treatment effects than the minimal clinically relevant reduction in pain. Topical diclofenac (70-81 and 140-160 mg/day) had ≥92.3% probability, and all opioids had ≤53% probability of more pronounced treatment effects than the minimal clinically relevant reduction in pain. 18.5%, 0%, and 83.3% of the oral NSAIDs, topical NSAIDs, and opioids, respectively, had an increased risk of dropouts due to adverse events. 29.8%, 0%, and 89.5% of oral NSAIDs, topical NSAIDs, and opioids, respectively, had an increased risk of any adverse event. Oxymorphone 80 mg/day had the highest risk of dropouts due to adverse events (51%) and any adverse event (88%). Conclusions Etoricoxib 60 mg/day and diclofenac 150 mg/day seem to be the most effective oral NSAIDs for pain and function in patients with osteoarthritis. However, these treatments are probably not appropriate for patients with comorbidities or for long term use because of the slight increase in the risk of adverse events. Additionally, an increased risk of dropping out due to adverse events was found for diclofenac 150 mg/day. Topical diclofenac 70-81 mg/day seems to be effective and generally safer because of reduced systemic exposure and lower dose, and should be considered as first line pharmacological treatment for knee osteoarthritis. The clinical benefit of opioid treatment, regardless of preparation or dose, does not outweigh the harm it might cause in patients with osteoarthritis. Systematic review registration PROSPERO number CRD42020213656

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