Drug-induced Adverse Events

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +25 new citations

Wed, 2020-11-11 10:02

25 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/11/11

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Categories: Literature Watch

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +25 new citations

Wed, 2020-11-11 06:00

25 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/11/11

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Categories: Literature Watch

[Systematic review and trial sequential analysis of randomized clinical trial of Hongjin Xiaojie Capsules for treatment of hyperplastic disease of breast].

Tue, 2020-11-10 12:37
Related Articles

[Systematic review and trial sequential analysis of randomized clinical trial of Hongjin Xiaojie Capsules for treatment of hyperplastic disease of breast].

Zhongguo Zhong Yao Za Zhi. 2020 Oct;45(19):4776-4783

Authors: Bao-Yong L, Li-Yan J, Yu-Fei L, Ai-Jing C, Qiong Z, Xiao-Hua P

Abstract
To systemically evaluate the clinical efficacy and safety of Hongjin Xiaojie Capsules for hyperplastic disease of breast(HDBA), so as to provide the evidence for its clinical application. The inclusion criteria are the RCT of single administration of Hongjin Xiaojie Capsules for treatment of HDBA. We retrieved following databases(CNKI, WanFang, VIP, SinoMed, Cochrane Library and PubMed) from their inception to October 1, 2019. Two researchers independently screened out literatures and extracted data, and assessed the methodological quality of eligible RCT according to the criteria in Cochrane Handbook for Systematic Reviews of Interventions. RevMan 5.3 was used for data analysis, binary data was summarized by risk ratio(RR) with confidence intervals(CI) of 95%, and continuous data were summarized by mean difference(MD) with CI of 95%. To estimate the sample size of systematic review, trial sequential analysis(TSA) was performed base on software TSA v0.9 version. Totally 14 RCTs were included, involving 3 057 patients. The results of Meta-analysis showed a significantly higher cure rate(RR=1.13, 95%CI[1.03, 1.25], P=0.01) and higher total effective rate(RR=1.09, 95%CI[1.05, 1.13], P<0.000 1) in Hongjin Xiaojie Capsules group than those in the Juyuansuan Tamoxifen group. The incidence of adverse events was significantly higher in Juyuansuan Tamoxifen group than that in Hongjin Xiaojie Capsules group(RR=0.28 95%CI[0.16, 0.49], P<0.001), and the adverse events included nausea, vomiting, abdominal pain, diarrhea, irregular menstruation, amenorrhea, unclear vision, dizziness and headache. The TSA for the cure rate demonstrated that the current available data reached the expected value. However, due to the low effect intensity of evidence, the pooled results might be affected by high risk bias of trials. The quality of evidence of included trials was generally low or very low. Inverted funnel diagram showed possible publication bias. This review suggested that Hongjin Xiaojie Capsules were potentially effective and safe in treatment of HDBA, especially, the incidences of drug-related adverse events from Hongjin Xiaojie Capsules were significantly lower than those from tamoxifen. However, because of lack of high-quality evidence for drawing a conclusion, more rigorously designed and high-quality trials are needed to confirm the efficacy and safety of Hongjin Xiaojie Capsules.

PMID: 33164445 [PubMed - in process]

Categories: Literature Watch

Safety and efficacy of aprepitant as mono and combination therapy for the prevention of emetogenic chemotherapy-induced nausea and vomiting: post-marketing surveillance in China.

Tue, 2020-11-10 12:37
Related Articles

Safety and efficacy of aprepitant as mono and combination therapy for the prevention of emetogenic chemotherapy-induced nausea and vomiting: post-marketing surveillance in China.

Chin Clin Oncol. 2020 Oct;9(5):68

Authors: Yang Y, Yang N, Wu L, Ouyang Q, Fang J, Li J, Liao W, Cai K, Huang J, Li J, Zhang Y, Wang X, Zhang H, Xu N, Zhao Q, Hu X, Li W, Zhong W, Zhong D, Cheng G, Ye S, Zhong M, Wang D, Liu H, Zheng J, Liu X, Xu H, Zhang L

Abstract
BACKGROUND: The goal of this study was to evaluate aprepitant usage in the context of routine clinical practice with dose/regimens at the discretion of prescribers for chemotherapy-induced nausea and vomiting (CINV) treatments.
METHODS: In this single arm, multicenter prospective study 1,000 patients with solid malignancies were enrolled across 21 centers in China. The primary endpoint was the rate of adverse events (AEs), including drug related AEs and serious AEs (SAEs). Secondary efficacy endpoints included the proportion of patients achieving complete response (CR; no vomiting, no nausea, and no use of rescue medication) within 120 h after highly emetogenic chemotherapy, the rates of no nausea and no vomiting, as well as quality of life (QoL). Multivariable logistic regression analysis was carried out to determine factors associated with the overall (0-120 h), acute (0-24 h) and delayed (25-120 h) CR.
RESULTS: Of the 1,000 highly emetogenic chemotherapy treated patients enrolled in the study ≥1 AE, ≥1 drug related AE, ≥1 SAE and drug related SAE rates in 998 patients were 45.9%, 2.5%, 4.0% and 0.1%, respectively. Approximately half of the patients (455/990, 46.0%) received aprepitant as part of a 3-drug anti-CINV regimen consistent with prescribing guidelines. The overall CR (0 to 120 h) for anti-emetic drug use was 41.0%, with an acute CR of 66.0% and a delayed CR of 46.5%. The rates of no vomiting and no nausea after solely aprepitant anti-emetic therapy from 0 to 120 h were 70.9% and 43.0%, for dual anti-emetic therapy 86.9% and 64.6%, and for triple therapy 86.4% and 69.5%, respectively. Multivariate regression analysis revealed that triple anti-emetic therapy (P=0.038), male gender (P<0.001) and a history of chemotherapy (P=0.016) were significantly associated with the overall acute CR.
CONCLUSIONS: Especially as a combination treatment, aprepitant is safe and efficient for preventing CINV in patients receiving highly emetogenic chemotherapy.

PMID: 33161724 [PubMed - in process]

Categories: Literature Watch

BIOLOGICAL TREATMENTS IN ALLERGY: PRESCRIBING PATTERNS AND MANAGEMENT OF HYPERSENSITIVITY REACTIONS.

Tue, 2020-11-10 12:37
Related Articles

BIOLOGICAL TREATMENTS IN ALLERGY: PRESCRIBING PATTERNS AND MANAGEMENT OF HYPERSENSITIVITY REACTIONS.

J Allergy Clin Immunol Pract. 2020 Nov 05;:

Authors: Barakat L, Torres MJ, Phillips EJ, Caminati M, Chang YS, Caimmi D, Sanchez-Borges M, Rosenwasser L, Didier A, de Blay F, Fontaine JF, Bosse I, Lefevre S, Bassani C, De Filippo M, Ansotegui I, Morais-Almeida M, Ebisawa M, Martin B, Yu-Hor Thong B, Demoly P, Tanno LK

PMID: 33161172 [PubMed - as supplied by publisher]

Categories: Literature Watch

A phase I trial of temsirolimus and erlotinib in patients with refractory solid tumors.

Tue, 2020-11-10 12:37
Related Articles

A phase I trial of temsirolimus and erlotinib in patients with refractory solid tumors.

Cancer Chemother Pharmacol. 2020 Nov 06;:

Authors: Park H, Williams K, Trikalinos NA, Larson S, Tan B, Waqar S, Suresh R, Morgensztern D, Van Tine BA, Govindan R, Luo J, Lockhart AC, Wang-Gillam A

Abstract
PURPOSE: Resistance to treatment with inhibitors of mammalian target of rapamycin (mTOR) is partially mediated by activation of epidermal growth factor receptor (EGFR). We conducted a phase I study to determine the recommended phase II dose (RP2D) and dose-limiting toxicities (DLT) of temsirolimus (mTOR inhibitor) combined with erlotinib (EGFR inhibitor) in patients with refractory solid tumors.
METHODS: Standard "3 + 3" design was used for dose escalation. An expansion cohort at RP2D included only patients with squamous histology or mutations relevant to PI3K or EGFR pathway activation. Patients started daily erlotinib 7 days prior to starting temsirolimus on cycle 1. Intravenous temsirolimus was then administered weekly. Starting dose levels were 15 mg for temsirolimus and 100 mg for erlotinib.
RESULTS: Forty-four patients received treatment on this study (28 in dose escalation and 16 in the expansion cohort). The RP2D was temsirolimus 25 mg IV weekly and erlotinib 100 mg orally daily. Two patients experienced DLTs (G3 dehydration and G4 renal failure). The most common drug-related adverse events (all grades) were rash, mucositis/stomatitis, diarrhea, nausea and fatigue. No complete or partial responses were observed. The median duration on this study was 69 days (range 3-770) for escalation and 88 days (range 25-243) for expansion cohorts. Among 11 response-evaluable patients in the expansion cohort, 9 (82%) had stable disease and 2 (18%) had progressive disease.
CONCLUSION: The combination of temsirolimus and erlotinib at the RP2D was well tolerated, and the regimen resulted in prolonged disease stabilization in selected patients (NCT00770263).

PMID: 33159216 [PubMed - as supplied by publisher]

Categories: Literature Watch

Letter to the editor: regarding a recent publication on the association between abuse and adverse effects of analgesic medications.

Tue, 2020-11-10 12:37
Related Articles

Letter to the editor: regarding a recent publication on the association between abuse and adverse effects of analgesic medications.

Reg Anesth Pain Med. 2020 Nov 06;:

Authors: Zheng Z, Curtis K, Bhatia A

PMID: 33159005 [PubMed - as supplied by publisher]

Categories: Literature Watch

What price Priadel?

Tue, 2020-11-10 12:37
Related Articles

What price Priadel?

Drug Ther Bull. 2020 Nov 06;:

Authors: Phizackerley D, Cave JA

PMID: 33158854 [PubMed - as supplied by publisher]

Categories: Literature Watch

Pharmaceutical management of elderly high-risk patients in perioperative settings (PHAROS): protocol of a pilot sequential intervention study.

Tue, 2020-11-10 12:37
Related Articles

Pharmaceutical management of elderly high-risk patients in perioperative settings (PHAROS): protocol of a pilot sequential intervention study.

BMJ Open. 2020 Nov 06;10(11):e039094

Authors: Richter J, Schönfeld MS, Langebrake C, Bergelt C, Kriston L, Olotu C, Kiefmann R

Abstract
INTRODUCTION: With increasing age, the risk of complications after surgery rises in elderly patients. Furthermore, the prevalence of multimorbidity and polypharmacy rises with age, making this elderly population especially vulnerable for drug-related problems and posing an additional risk for postoperative complications. Still, only few studies have concentrated on investigating how medication safety can be improved in these patients. The aim of this pilot study is to examine the impact of a comprehensive intervention (interprofessional systematic medication therapy management) on medication appropriateness in elderly polymedicated, multimorbid patients during hospital stay for elective surgery.
METHODS AND ANALYSIS: This pilot study will include a total number of 140 patients. Surgical high-risk patients ≥65 years taking more than five chronic systemic drugs will be recruited consecutively for 9 months in the control group capturing usual care regarding medication history and in-hospital medication therapy management without any study intervention. Recruitment of the intervention group will be conducted for another 9 months. The intervention consists of the following components: an additional medication history by a hospital pharmacist before admission, a subsequent medication review, optimisation of the long-term medication and recommendations to the patient's general practitioner. A follow-up will be performed 3 months after surgery. As the primary study outcome, medication appropriateness will be measured using the Medication Appropriateness Index.Secondary outcomes are postoperative complications, incidence and frequency of adverse drug reactions and potentially inappropriate medication in the elderly, satisfaction with inpatient and outpatient care, medication reconciliation and health-related quality of life. Multivariable analyses will be used to analyse all quantitative research questions.
ETHICS AND DISSEMINATION: Ethics approval was obtained by the medical ethics committee of the Medical Chamber of Hamburg (study ID: PV5754). Data will be published in peer-reviewed journals and presented at conferences.
TRIAL REGISTRATION NUMBER: The study is registered at www.drks.de: DRKS00014621.

PMID: 33158825 [PubMed - in process]

Categories: Literature Watch

Minimal risk of contrast-induced kidney injury in a randomly selected cohort with mildly reduced GFR.

Tue, 2020-11-10 12:37
Related Articles

Minimal risk of contrast-induced kidney injury in a randomly selected cohort with mildly reduced GFR.

Eur Radiol. 2020 Nov 06;:

Authors: Carlqvist J, Nyman U, Sterner G, Brandberg J, Fagman E, Hellström M

Abstract
OBJECTIVES: Previous large studies of contrast-induced or post-contrast acute kidney injury (CI-AKI/PC-AKI) have been observational, and mostly retrospective, often with patients undergoing non-enhanced CT as controls. This carries risk of inclusion bias that makes the true incidence of PC-AKI hard to interpret. Our aim was to determine the incidence of PC-AKI in a large, randomly selected cohort, comparing the serum creatinine (Scr) changes after contrast medium exposure with the normal intraindividual fluctuation in Scr.
METHODS: In this prospective study of 1009 participants (age 50-65 years, 48% females) in the Swedish CArdioPulmonary bioImage Study (SCAPIS), with estimated glomerular filtration rate (eGFR) ≥ 50 mL/min, all received standard dose intravenous iohexol at coronary CT angiography (CCTA). Two separate pre-CCTA Scr samples and a follow-up sample 2-4 days post-CCTA were obtained. Change in Scr was statistically analyzed and stratification was used in the search of possible risk factors.
RESULTS: Median increase of Scr post-CCTA was 0-2 μmol/L. PC-AKI was observed in 12/1009 individuals (1.2%) according to the old ESUR criteria (> 25% or > 44 μmol/L Scr increase) and 2 individuals (0.2%) when using the updated ESUR criteria (≥ 50% or ≥ 27 μmol/L Scr increase). Possible risk factors (e.g., diabetes, age, eGFR, NSAID use) did not show increased risk of developing PC-AKI. The mean effect of contrast media on Scr did not exceed the intraindividual Scr fluctuation.
CONCLUSIONS: Iohexol administration to a randomly selected cohort with mildly reduced eGFR is safe, and PC-AKI is very rare, occurring in only 0.2% when applying the updated ESUR criteria.
KEY POINTS: • Iohexol administration to a randomly selected cohort, 50-65 years old with mildly reduced eGFR, is safe and PC-AKI is very rare. • Applying the updated ESUR PC-AKI criteria resulted in fewer cases, 0.2% compared to 1.2% using the old ESUR criteria in this cohort with predominantly mild reduction of renal function. • The mean effect of CM on Scr did not exceed the intraindividual background fluctuation of Scr, regardless of potential risk factors, such as diabetes or NSAID use in our cohort of 1009 individuals.

PMID: 33155105 [PubMed - as supplied by publisher]

Categories: Literature Watch

Cardiac adverse events associated with chloroquine and hydroxychloroquine exposure in 20 years of drug safety surveillance reports.

Tue, 2020-11-10 12:37
Related Articles

Cardiac adverse events associated with chloroquine and hydroxychloroquine exposure in 20 years of drug safety surveillance reports.

Sci Rep. 2020 Nov 05;10(1):19199

Authors: Cohen IV, Makunts T, Moumedjian T, Issa MA, Abagyan R

Abstract
Chloroquine (CQ) and hydroxychloroquine (HCQ) are on the World Health Organization's List of Essential Medications for treating non-resistant malaria, rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). In addition, both drugs are currently used off-label in hospitals worldwide and in numerous clinical trials for the treatment of SARS-CoV-2 infection. However, CQ and HCQ use has been associated with cardiac side effects, which is of concern due to the higher risk of COVID-19 complications in patients with heart related disorders, and increased mortality associated with COVID-19 cardiac complications. In this study we analyzed over thirteen million adverse event reports form the United States Food and Drug Administration Adverse Event Reporting System to confirm and quantify the association of cardiac side effects of CQ and HCQ. Additionally, we identified several confounding factors, including male sex, NSAID coadministration, advanced age, and prior diagnoses contributing to drug related cardiotoxicity. These findings may help guide therapeutic decision making and ethical trial design for COVID-19 treatment.

PMID: 33154498 [PubMed - in process]

Categories: Literature Watch

A prospective, multicenter, noninterventional study in Taiwan to evaluate the safety and tolerability of lacosamide as adjunctive therapy for epilepsy in clinical practice.

Fri, 2020-11-06 07:27
Related Articles

A prospective, multicenter, noninterventional study in Taiwan to evaluate the safety and tolerability of lacosamide as adjunctive therapy for epilepsy in clinical practice.

Epilepsy Behav. 2020 Nov 02;113:107464

Authors: Wu T, Chuang YC, Huang HC, Lim SN, Hsieh PF, Lee WT, Cheng MY, Tsai MH, Jou SB, Chang CW, Hsieh HY, Du X, Hellot S, McClung C, Hung C

Abstract
RATIONALE: Lacosamide (LCM) was initially approved in Taiwan in March 2014 for use as adjunctive therapy for focal impaired awareness seizures and secondarily generalized seizures (SGS) in patients with epilepsy ≥16 years of age. The efficacy and tolerability of adjunctive LCM for the treatment of patients with focal seizures have been demonstrated in randomized, placebo-controlled trials. However, the trials do not reflect a flexible dose setting. This study (EP0063) was conducted to assess the safety and tolerability of LCM in real-world clinical practice in Taiwan. Effectiveness of LCM was also assessed as an exploratory objective.
METHODS: EP0063 was a multicenter, prospective, noninterventional study with an expected observation period of 12 months ± 60 days. Eligible patients were ≥16 years of age, had focal impaired awareness seizures and/or SGS (in line with approved indication in Taiwan at the time of the study), were taking at least one concomitant antiseizure medication (ASM), and had at least one seizure in the 3 months before baseline. Patients were prescribed LCM by their treating physician in the course of routine clinical practice. The primary safety variable was treatment-emergent adverse events (TEAEs) spontaneously reported to, or observed by, the treating physician. Based on safety data from previous studies of LCM and known side effects of other ASMs, certain TEAEs (including but not limited to cardiac and electrocardiogram, suicidality, and rash related terms) were analyzed separately. Effectiveness variables included Clinical Global Impression of Change (CGIC) and change in 28-day seizure frequency from baseline to 12 months (or final visit), and freedom from focal seizures.
RESULTS: A total of 171 patients were treated with LCM, of whom 139 (81.3%) completed the study. The Kaplan-Meier estimated 12-month retention was 82.9%. Patients had a mean (standard deviation [SD], range) age of 38.5 (14.0, 16-77) years, and 96 (56.1%) were male. Patients were taking a mean (SD, range) of 2.8 (1.1, 1-6) ASMs at baseline. Mean (SD, range) duration of LCM treatment was 288.7 (111.9, 2-414) days, and the mean (SD, range) daily dosage of LCM was 205.0 (82.7, 50.0-505.2) mg/day. Overall, 95 (55.6%) patients reported at least one TEAE, most commonly dizziness (33 [19.3%] patients). Drug-related TEAEs were reported in 74 (43.3%) patients, and drug-related TEAEs leading to discontinuation of LCM were reported in 14 (8.2%) patients. Two (1.2%) patients died during LCM treatment, which were considered not related to LCM. Two (1.2%) patients had suicidality-related TEAEs; these TEAEs were considered either not related to LCM or the relationship was not recorded. Rash-related TEAEs were reported in five (2.9%) patients (considered LCM-related in two patients). Based on the CGIC, at 12 months (or final visit), 109 (63.7%) patients were considered to have improved, 54 (31.6%) had no change, and the remaining eight (4.7%) were minimally worse. At 12 months (or final visit), the median percentage change in focal seizure frequency was -50.0. During the first 6 months of the study, 21 (12.3%) patients were free from focal seizures; 37 (21.6%) patients were free from focal seizures in the last 6 months of the study; and 14 (8.2%) were free from focal seizures for the full 12 months of the study.
CONCLUSIONS: Results of this prospective, noninterventional study suggest that adjunctive LCM was generally safe and well tolerated in this patient group in real-world practice in Taiwan. Effectiveness was also favorable, with more than 60% of patients considered to be improved by their physician at 12 months (or final visit).

PMID: 33152580 [PubMed - as supplied by publisher]

Categories: Literature Watch

The impact of PrEP: results from a multicenter Health Technology Assessment into the Italian setting.

Fri, 2020-11-06 07:27
Related Articles

The impact of PrEP: results from a multicenter Health Technology Assessment into the Italian setting.

J Prev Med Hyg. 2020 Sep;61(3):E451-E463

Authors: Ferrario L, Foglia E, Garagiola E, Pacelli V, Cenderello G, DI Biagio A, Rizzardini G, Errico M, Iardino R, Croce D

Abstract
Introduction: The use of oral tenofovir/emtricitabine (FTC/TDF) for pre-exposure prophylaxis (PrEP) among high-risk people without Human Immunodeficiency Virus (HIV), is emerging as an innovative strategy to decrease HIV epidemic. The study aims at evaluating the implications related to PrEP introduction, from a multidimensional point of view, as required by Health Technology Assessment (HTA) approach, with a particular attention on sustainability and social factors, influencing PrEP implementation.
Methods: An analysis was conducted involving 35 Italian Infectious Disease Departments. The introduction of PrEP (applied both as "add-on" and "substitute" prevention strategy) into the clinical practice was compared with a baseline scenario, consisting of condoms among men who have sex with men, and serodiscordant couples, and the use of Needle Syringe Programme among injection drugs users The above scenarios were analysed by means of a Health Technology Assessment (HTA) approach. The 9 EUnetHTA Core Model domains were assessed through comparative information, retrieved from literature evidence, and collection of qualitative and quantitative information, derived from real-world evidence, in particular from 35 Infectious Disease Departments and potential PrEP' users involved. A final multi-criteria decision analysis approach (MCDA) was implemented to simulate the appraisal phase and providing evidence-based information with regard to the preferable technology.
Results: Despite the improvement in patients' quality of life, PrEP would generate the development of other sexually transmitted and blood-borne diseases, with a consequent decrease of patients' safety in case of PrEP applied as a "substitute" prevention strategy. In addition, PrEP would generate an increase in staff workflow, with investment in medical supplies and training courses. PrEP would lead to significant economic investments both for the NHS (+40%), and for citizens (+2,377%) if used as an add-on strategy, assuming FTC/TDF patent cost. With the off-patent drug, the NHS would benefit from an advantage (37%), and a shrink of the patients' expenditure emerged (+682%). More economic resources are required if PrEP is applied as a substitute strategy, considering both the patent (NHS: 212%; citizens: 3,423%) and the off-patent drug (NHS: 73%; citizens: 1,077%). Conclusions. The most cost-containing strategy would be the use of PrEP, as an add-on strategy, with a consequent improvement in patients' safety, even if drug-related adverse events would be considered. The implementation of the off-patent drug would decrease the economic burden of the innovative prevention strategy. Hence, the organizational aspects related to its adoption would be deeply investigated, with the potential opportunity to create specific ambulatories devoted to PrEP users' especially for medium and big size hospitals.

PMID: 33150233 [PubMed - in process]

Categories: Literature Watch

American Society of Regional Anesthesia and Pain Medicine Local Anesthetic Systemic Toxicity checklist: 2020 version.

Fri, 2020-11-06 07:27
Related Articles

American Society of Regional Anesthesia and Pain Medicine Local Anesthetic Systemic Toxicity checklist: 2020 version.

Reg Anesth Pain Med. 2020 Nov 04;:

Authors: Neal JM, Neal EJ, Weinberg GL

Abstract
The American Society of Regional Anesthesia and Pain Medicine (ASRA) periodically updates its practice advisories and associated cognitive aids. The 2020 version of the ASRA Local Anesthetic Systemic Toxicity checklist was created in response to user feedback, simulation studies and advances in medical knowledge. This report presents the 2020 version and discusses the rationale for its update.

PMID: 33148630 [PubMed - as supplied by publisher]

Categories: Literature Watch

Simulation study comparing readability and effectiveness of the 2012 versus 2017 ASRA local anesthetic systemic toxicity checklists.

Fri, 2020-11-06 07:27
Related Articles

Simulation study comparing readability and effectiveness of the 2012 versus 2017 ASRA local anesthetic systemic toxicity checklists.

Reg Anesth Pain Med. 2020 Nov 04;:

Authors: Hsiung RL, Bean HA, Stafford CE, Mulroy MF, Weinberg G, Neal JM

PMID: 33148629 [PubMed - as supplied by publisher]

Categories: Literature Watch

Updates in the treatment of granulomatosis with polyangiitis and microscopic polyangiitis: At a crossroad.

Fri, 2020-11-06 07:27
Related Articles

Updates in the treatment of granulomatosis with polyangiitis and microscopic polyangiitis: At a crossroad.

Presse Med. 2020 Oct;49(3):104038

Authors: Garner S, Khalidi N

Abstract
There have been great advances in the management of ANCA associated vasculitis over the past decades. We have gone from an era where the disease was almost universally fatal to trying to prevent long-term side effects of treatment regimens. With the ability to use pulse cyclophosphamide or rituximab as alternates to oral cyclophosphamide for induction of remission, side effects of therapy have been greatly reduced. New approaches have drastically changed our approach to maintenance and we now favor much longer durations of maintenance therapy, as they are more successful in preventing relapse. Steroids have long been the bane of treatment as they are associated with a significant risk of infection and metabolic consequences. We are now in a steroid-sparing and looking ahead to a steroid-free era with new data being published showing lower doses of steroids being equally effective and several ongoing seminal trials looking at agents that could completely replace steroids very early on.

PMID: 32634467 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events.

Fri, 2020-11-06 07:27
Related Articles

Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events.

J Law Med Ethics. 2019 06;47(2):323-333

Authors: McManus L, Davis A, Forcier RL, Fisher JA

Abstract
While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of the adverse events (AEs) they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity.

PMID: 31298107 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

The effectiveness of preemptive analgesia for relieving postoperative pain after video-assisted thoracoscopic surgery (VATS): a prospective, non-randomized controlled trial.

Thu, 2020-11-05 09:57
Related Articles

The effectiveness of preemptive analgesia for relieving postoperative pain after video-assisted thoracoscopic surgery (VATS): a prospective, non-randomized controlled trial.

J Thorac Dis. 2020 Sep;12(9):4930-4940

Authors: Kong M, Li X, Shen J, Ye M, Xiang H, Ma D

Abstract
Background: The effectiveness of preemptive analgesia (PA) for relieving postoperative pain and reducing the side effects of analgesics following video-assisted thoracoscopic surgery (VATS) has not yet been determined. This study intends to test the clinical application value of PA in the perioperative period of VATS.
Methods: From January 2018 to August 2018, we divided patients who underwent VATS in our hospital into a trial group (PA group) and a control group (traditional analgesia group, TA group). The PA group received a PA program, and the TA group was administered a conventional postoperative analgesia scheme. We compared the two groups according to the intensity of postoperative pain using the numeric rating scale (NRS), the incidence rate of analgesic drug-related adverse reactions, and the severity of stress-induced inflammation.
Results: One hundred five cases from the PA group, and 80 cases from the TA group were included in the analysis. There were no significant differences between the two groups in baseline characteristics (P>0.05). The PA group had a lower incidence rate of side effects from the analgesics compared to the TA group, and there was a statistical difference at 48 and 72 hours after surgery (P<0.05). The PA group had a slightly lower score than the TA group for postoperative resting pain. However, this difference was not statistically significant (P>0.05). The motion pain NRS score of the PA group was lower than the TA group, and although there were no significant differences at 4, 24, and 48 hours (P>0.05), there was a statistically significant difference at 72 hours (P<0.05). In the subset of patients with motion pain NRS ≥3 points, the PA group was marginally higher than the TA group at 4 hours (P>0.05) but was lower than the TA group at 24, 48, and 72 hours, with a statistically significant difference at 24 and 72 hours (P<0.05). There were no statistically significant differences in perioperative stress indexes between the two groups (P>0.05).
Conclusions: PA can relieve postoperative pain following VATS and reduce the incidence rate of analgesic drug-related adverse effects.

PMID: 33145067 [PubMed]

Categories: Literature Watch

Lessons from a pandemic: Do not force your patients into the bed of Procrustes!

Thu, 2020-11-05 06:54
Related Articles

Lessons from a pandemic: Do not force your patients into the bed of Procrustes!

J Eval Clin Pract. 2020 Nov 04;:

Authors: Voiosu T, Voiosu A

PMID: 33146928 [PubMed - as supplied by publisher]

Categories: Literature Watch

Neuraxial and peripheral misconnection events leading to wrong-route medication errors: a comprehensive literature review.

Thu, 2020-11-05 06:54
Related Articles

Neuraxial and peripheral misconnection events leading to wrong-route medication errors: a comprehensive literature review.

Reg Anesth Pain Med. 2020 Nov 03;:

Authors: Viscusi ER, Hugo V, Hoerauf K, Southwick FS

Abstract
We conducted a search of the literature to identify case reports of neuraxial and peripheral nervous system misconnection events leading to wrong-route medication errors. This narrative review covers a 20-year period (1999-2019; English-language publications and abstracts) and included the published medical literature (PubMed and Embase) and public access documents. Seventy-two documents representing 133 case studies and 42 unique drugs were determined relevant. The most commonly reported event involved administering an epidural medication by an intravenous line (29.2% of events); a similar proportion of events (27.7%) involved administering an intravenous medication by an epidural line. Medication intended for intravenous administration, but delivered intrathecally, accounted for 25.4% of events. In the most serious cases, outcomes were directly related to the toxicity of the drug that was unintentionally administered. Patient deaths were reported due to the erroneous administration of chemotherapies (n=16), muscle relaxants (n=4), local anesthetics (n=4), opioids (n=1), and antifibrinolytics (n=1). Severe outcomes, including paraplegia, paraparesis, spinal cord injury, and seizures were reported with the following medications: vincristine, gadolinium, diatrizoate meglumine, doxorubicin, mercurochrome, paracetamol, and potassium chloride. These case reports confirm that misconnection events leading to wrong-route errors can occur and may cause serious injury. This comprehensive characterization of events was conducted to better inform clinicians and policymakers, and to describe an emergent strategy designed to mitigate patient risk.

PMID: 33144409 [PubMed - as supplied by publisher]

Categories: Literature Watch

Pages