Antiepileptic drugs in migraine and epilepsy: Who is at increased risk of adverse events?

Cephalalgia ◽  
2016 ◽  
Vol 38 (2) ◽  
pp. 274-282 ◽  
Author(s):  
Michele Romoli ◽  
Cinzia Costa ◽  
Sabrina Siliquini ◽  
Ilenia Corbelli ◽  
Paolo Eusebi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Antiepileptic Drugs ◽  
Occurrence Rate ◽  
Tolerability Profile ◽  
Treatment Dropout ◽  
Specific Drug ◽  
Increased Risk ◽  
The Impact

Background The impact of adverse events (AEs) of antiepileptic drugs (AEDs) have an impact on compliance and dropouts. We compared tolerability of AEs of AEDs among patients with migraine, epilepsy, or both. Methods Overall, 335 patients (epilepsy (n = 142), migraine (n = 131), and both (n = 62)), were evaluated with the Liverpool Adverse Events Profile (LAEP) to assess the magnitude, profile and occurrence rate of the AEs of valproate, topiramate, and lamotrigine. Results AEs were significantly more common with topiramate treatment (71.0%) and among migraineurs (69.5%), the latter being more prone to discontinue AEDs (46.6%). The profile of AEs with topiramate and valproate differed among groups. Moreover, treatment with both topiramate and valproate was associated, for all groups, with a worse tolerability profile compared to lamotrigine. Conclusion Our data suggest a specific drug and disease AE profile of AEDs. Specifically, migraineurs are the most affected by AEs, even though they receive very low dosages of AEDs. This finding might be considered a clinical implication of central sensitization mechanisms. Both the profile and tolerability of AEs, highly influencing quality of life, depended on the underlying conditions, and deeply impacted on treatment dropout. Therefore, before starting, switching or stopping AED treatment, all options need to be considered.

scholarly journals 008 Associations between comorbidities and adverse events of antiepileptic drugs and quality of life: a survey of epilepsy patients in australia

2019 ◽  
Vol 90 (e7) ◽  
pp. A3.2-A3
Author(s):  
Jeremy M Welton ◽  
Christine Walker ◽  
Kate Riney ◽  
Alvin Ng ◽  
Lisa M Todd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Antiepileptic Drugs ◽  
List Type ◽  
Linear Regression Models ◽  
Cross Sectional ◽  
Stepwise Selection ◽  
Memory Problems ◽  
The Impact

IntroductionThis study explored the impact of specific types of comorbidities and adverse events (AEs) from antiepileptic drugs (AEDs) on quality of life (QoL) among adult patients with epilepsy (PwE) in Australia.MethodsCross-sectional surveys were completed by PwE, or caregiver proxies, recruited via the online pharmacy application MedAdvisor and Australian PwE Facebook groups from May–August 2018 Data were collected on demographics, epilepsy severity and management, AEs, comorbidities, and QoL (using QOLIE-10-P total score).1 Multiple linear regression models were constructed to explore associations between AEs or comorbidities and QOLIE-10-P, with possible confounders determined using stepwise selection.Results978 responses were included (mean age 44.5 years, 64% female, 52% employed). 97% reported recent AED use, 47% on AED monotherapy, 35% exposed to ≤2 lifetime AEDs, and 55% seizure-free for >1 year. After stepwise selection, control variables included in both models were: time since diagnosis, employment status, seizure frequency, number of currently prescribed AEDs, and number of general practitioner visits per year. In the model for comorbidities, ‘psychiatric disorders’ was associated with the largest QOLIE-10-P decrease (-23.30, p<0.001). In the model for AEs, which additionally controlled for depression and anxiety disorder, ‘memory problems’ was associated with the largest decrease in QOLIE-10-P (-14.27, p<0.001).ConclusionsIn this survey of Australian PwE, of which many had relatively well-controlled epilepsy, psychiatric and memory problems were common and associated with the greatest detrimental impact on QoL. Further research is needed to understand causality, relationships between possibly interrelated or overlapping symptoms, and management strategies. UCB Pharma-sponsored.ReferenceCramer JA, Perrine K, Devinsky O, Meador K. A brief questionnaire to screen for quality of life in epilepsy: The QOLIE-10. Epilepsia 1996;37:577–582.

scholarly journals The Impact of Older Age on Functional Recovery and Quality of Life Outcomes after Surgical Decompression for Degenerative Cervical Myelopathy: Results from an Ambispective, Propensity-Matched Analysis from the CSM-NA and CSM-I International, Multi-Center Studies

2019 ◽  
Vol 8 (10) ◽  
pp. 1708 ◽  
Author(s):  
Jamie R. F. Wilson ◽  
Jetan H. Badhiwala ◽  
Fan Jiang ◽  
Jefferson R. Wilson ◽  
Branko Kopjar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Cervical Myelopathy ◽  
Neck Disability Index ◽  
Older Age ◽  
Functional Improvement ◽  
Increased Risk ◽  
Degenerative Cervical Myelopathy ◽  
The Impact

Background: The effect on functional and quality of life (QOL) outcomes of surgery in elderly degenerative cervical myelopathy (DCM) patients has not been definitively established. Objective: To evaluate the effect of older age on the functional and QOL outcomes after surgery in an international, multi-center cohort of patients with DCM. Methods: 107 patients aged over 70 years old (mean 75.6 ± 4.4 years) were enrolled in the AOSpine CSM-North America and International studies. A propensity-matched cohort of 107 patients was generated from the remaining 650 adults aged <70 years old (mean 56.3 ± 9.6 years), matched to gender, complexity of surgery, co-morbidities, and baseline functional impairment (modified Japanese Orthopedic Association scale (mJOA). Functional, disability, and QOL outcomes were compared at baseline and at two years post-operatively, along with peri-operative adverse events. Results: Both cohorts were equivalently matched. At two years, both cohorts showed significant functional improvement from the baseline but the magnitude was greater in the younger cohort (mJOA 3.8 (3.2–4.4) vs. 2.6 (2.0–3.3); p = 0.007). This difference between groups was also observed in the SF-36 physical component summary (PCS) and mental component summary (MCS) outcomes (p = <0.001, p = 0.007), but not present in the neck disability index (NDI) scores (p = 0.094). Adverse events were non-significantly higher in the elderly cohort (22.4% vs. 15%; p = 0.161). Conclusions: Elderly patients showed an improvement in functional and QOL outcomes after surgery for DCM, but the magnitude of improvement was less when compared to the matched younger adult cohort. An age over 70 was not associated with an increased risk of adverse events.

The Impact of Adverse Events on Functional Capacity and Quality of Life After HeartWare Ventricular Assist Device Implantation

ASAIO Journal ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Marc D. Samsky ◽  
Carmelo A. Milano ◽  
Salpy Pamboukian ◽  
Mark S. Slaughter ◽  
Emma Birks ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Functional Capacity ◽  
Ventricular Assist Device ◽  
Assist Device ◽  
Ventricular Assist ◽  
Device Implantation ◽  
The Impact

Management of Oral Anti-Coagulation in Patients with Heart Failure—Insights from the ThrombEVAL Study

2018 ◽  
Vol 118 (11) ◽  
pp. 1930-1939
Author(s):  
Sebastian Göbel ◽  
Jürgen Prochaska ◽  
Lisa Eggebrecht ◽  
Ronja Schmitz ◽  
Claus Jünger ◽  
...  
Keyword(s):  
Heart Failure ◽  
Adverse Events ◽  
Vitamin K Antagonists ◽  
Plasma Concentrations ◽  
Regular Care ◽  
Increased Risk ◽  
Patients With Heart Failure ◽  
Specialized Care ◽  
The Impact

AbstractPatients with heart failure (HF) are frequently anti-coagulated with vitamin K-antagonists (VKAs). The use of long-acting VKA may be preferable for HF patients due to higher stability of plasma concentrations. However, evidence on phenprocoumon-based oral anti-coagulation (OAC) therapy in HF is scarce. The aim of this study was to assess the impact of the presence of HF on quality of phenprocoumon-based OAC and the subsequent clinical outcome. Quality of OAC therapy and the incidence of adverse events were analysed in a cohort of regular care (n = 2,011) from the multi-centre thrombEVAL study program (NCT01809015) stratified by the presence of HF. To assess the modifiability of outcome, results were compared with data from individuals receiving specialized care for anti-coagulation (n = 760). Overall, the sample comprised of 813 individuals with HF and 1,160 subjects without HF in the regular care cohort. Quality of OAC assessed by time in therapeutic range (TTR) was 66.1% (47.8%/82.8%) for patients with HF and 70.6% (52.1%/85.9%) for those without HF (p = 0.0046). Stratification for New York Heart Classification (NYHA)-class demonstrated a lower TTR with higher NYHA classes: TTRNYHA-I 69.6% (49.4%/85.6%), TTRNYHA-II 66.5% (50.1%/82.9%) and TTRNYHA-≥III 61.8% (43.1%/79.9%). This translated into a worse net clinical benefit outcome for HF (hazard ratio [HR] 1.63 [1.31/2.02]; p < 0.0001) and an increased risk of bleeding (HR 1.40 [1.04/1.89]; p = 0.028). Management in a specialized coagulation service resulted in an improvement of all, TTR (∆+12.5% points), anti-coagulation-specific and non-specific outcome of HF individuals. In conclusion, HF is an independent risk factor for low quality of OAC therapy translating into an increased risk for adverse events, which can be mitigated by specialized care.

Retrospective Chart Review of Cryopreserved Amniotic Membrane for Knee Pain

2020 ◽  
Author(s):  
Ruben Berrocal Timmons
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Amniotic Membrane ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Final Analysis ◽  
Mean Values ◽  
Number Of Patients ◽  
The Impact

Objective: Treatment of joint pain with an injection of the amniotic membrane has not been adequately studied. This study retrospectively reviewed Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analgesic usage data from patients treated with the injection of cryopreserved amniotic membrane (CAM) in their knees to determine the impact of treatment on patients’ pain, quality of life, and analgesic usage. Methods: Chart review was conducted on 40 patients. Institutional Review Board (IRB) approval was obtained prior to initiation of the project. The membrane was utilized as per the FDA guidance of 21CFR1271. Retrospective data, including demographics, medical history, pain score, quality of life score, analgesic usage and adverse events, were collected from their medical records for each consenting patient through 6 months after CAM injection. Results: A total of 40 patients were considered in the final analysis. Mean VAS for pain level improved from 7.0 to 2.6 (p<0.001). WOMAC daily activity function score improved from a mean score of 52 to 28 (p<0.001). Opioid and non-steroidal anti-inflammatory drug (NSAID) usage decreased from 97% to 25% (p<0.001). No adverse events were reported. Conclusion: Mean values for VAS and WOMAC scores significantly improved at all time points and the number of patients who used analgesics decreased as compared to baseline. CAM injection into painful knee joints decreases pain, improves physical function, and decreases the use of analgesics in the absence of adverse events.

scholarly journals O26 Non-serious infections in patients with RA: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Katie Bechman ◽  
Kapil Halai ◽  
Sam Norton ◽  
Andrew P Cope ◽  
Kimme L Hyrich ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
British Society ◽  
Tnf Inhibitor ◽  
Drug Survival ◽  
Increased Risk ◽  
Serious Infections ◽  
The Impact ◽  
Biologics Register

Abstract Background Patients with rheumatoid arthritis (RA) are at an increased risk of infection. Most attention has been given to serious infections, but these are the tip of the iceberg. Non-serious infections (NSI) are far more frequent, and although not life-threatening, have potential to impact treatment outcomes (drug survival) and quality of life. Our objective was to describe frequency of NSI and compare incidence of NSI by biologic drug within the British Society for Rheumatology Biologics Register (BSRBR-RA). Methods The BSRBR-RA is a prospective observational cohort study. NSI was identified as not requiring hospitalisation, intravenous therapy or leading to disability or death. Infections were captured from clinician questionnaires and patient diaries. Individuals were considered ‘at risk’ from the date of commencing biologic treatment for 3 years. Drug exposure was defined by agent; TNF inhibitor, IL-6 inhibitor, anti-CD20 or csDMARD only. To account for a high frequency of events, a multiple-failure Cox model was used. Multivariable adjustment included age, gender, DAS28-ESR, HAQ-DI, disease duration, smoking, steroid usage, year recruited to BSRBR-RA, line of biologic therapy and cumulative infection number. Results There were 17,304 NSI in 10,099 patients, with an event rate of 27.0 per year (95% CI 26.6 to 27.4). Increasing age, female gender, comorbidity burden, corticosteroid therapy, DAS28 and HAQ-DI were associated with an increased risk of NSI. The rate of NSI was numerically lowest with csDMARDs. Compared to TNFi, IL-6 inhibitor had a higher risk of NSI, whilst the csDMARD cohort had a lower risk. Between the TNFi agents, adalimumab had a higher risk than etanercept (Table 1). Conclusion These results confirm that NSI is a frequent occurrence for patients, which historically has received little attention in research literature. The data suggest biologics increase the risk of NSI, especially IL-6 inhibition. Whilst unmeasured confounding must be considered, the magnitude of effects are large and it seems likely that a causal link between targeted immunosuppression and NSI risk exists. Further research is needed to understand the impact of NSI on clinical outcomes including drug survival and quality of life. Disclosures K. Bechman: None. K. Halai: None. S. Norton: None. A.P. Cope: None. K.L. Hyrich: Honoraria; AbbVie paid to the institution and grant income from Pfizer and Bristol-Myers Squibb for activities outside of this work. J.B. Galloway: Honoraria; for speaking or attending conferences from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Pfizer and Union Chimique Belge.

scholarly journals Lack of application of the European Work Time Directive: effects on workload, work satisfaction and burnout among Italian physicians

2017 ◽  
Vol 11 (2) ◽  
pp. 159
Author(s):  
Paola Gnerre ◽  
Domenico Montemurro ◽  
Andrea P. Rossi ◽  
Costantino Troise ◽  
Carlo Palermo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Work Conditions ◽  
Public Hospitals ◽  
Burnout Syndrome ◽  
Negative Consequences ◽  
Work Time ◽  
Increased Risk ◽  
Wide Range ◽  
The Impact

The Italian Parliament has excluded hospital physicians from the application of the European Work Time Directive (EWTD), which imposes a maximum workweek of 48 h and compulsory resting periods. This resulted in extended and excessive work time for the category. This paper is aimed at evaluating the impact of this legislation gap, by assessing the presence of excessive work-related stress and risk for burnout syndrome among Italian physicians working in public hospitals. This observational study is based on an on-line survey conducted on a sample of 1925 Italian doctors (covering a wide range of age, work experience and contractual positions) from October 2014 to February 2015. The questionnaire included 30 questions concerning their personal and professional life (<em>e.g</em>., assessment of workloads, number of uncomfortable or extra shifts, unused days-off, <em>etc</em>.). On the basis of the results, it can be inferred that the average Italian doctor working in public hospitals is under considerable stress at work with negative consequences on his health. He is exposed to high risk of suffering from sleep disorders and cardiovascular diseases (due to the lack of time for private practice and eating regular meals). Overall, his perception is that his job worsens his quality of life. This study shows the relevance of the risk of burnout among Italian physicians employed in public hospitals due to severe workload and work conditions. The resulting impact on the quality of care and the significant cost involved - both in human and economic terms - calls for significant emergency measures by the Italian health work organization. An important increase and prolonged working time is associated with a worsening of the objective cognitive performance and an increase of clinical risk, but also to an increased risk of diseases for operators and of the burnout syndrome. Our survey shows that lack of application of the EWTD has adverse effects on the quality of life and performance of Italian doctors. Failure to respond by all Italian doctors is the greatest limitation of our survey.

scholarly journals Atrial fibrillation and clinical outcomes 1 to 3 years after myocardial infarction

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001726
Author(s):  
Anthony P Carnicelli ◽  
Ruth Owen ◽  
Stuart J Pocock ◽  
David B Brieger ◽  
Satoshi Yasuda ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Adverse Outcomes ◽  
Increased Risk ◽  
History Of ◽  
The Impact

ObjectiveAtrial fibrillation (AF) and myocardial infarction (MI) are commonly comorbid and associated with adverse outcomes. Little is known about the impact of AF on quality of life and outcomes post-MI. We compared characteristics, quality of life and clinical outcomes in stable patients post-MI with/without AF.Methods/resultsThe prospective, international, observational TIGRIS (long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease) registry included 8406 patients aged ≥50 years with ≥1 atherothrombotic risk factor who were 1–3 years post-MI. Patient characteristics were summarised by history of AF. Quality of life was assessed at baseline using EQ-5D. Clinical outcomes over 2 years of follow-up were compared. History of AF was present in 702/8277 (8.5%) registry patients and incident AF was diagnosed in 244/7575 (3.2%) over 2 years. Those with AF were older and had more comorbidities than those without AF. After multivariable adjustment, patients with AF had lower self-reported quality-of-life scores (EQ-5D UK-weighted index, visual analogue scale, usual activities and pain/discomfort) than those without AF. CHA2DS2-VASc score ≥2 was present in 686/702 (97.7%) patients with AF, although only 348/702 (49.6%) were on oral anticoagulants at enrolment. Patients with AF had higher rates of all-cause hospitalisation (adjusted rate ratio 1.25 [1.06–1.46], p=0.008) over 2 years than those without AF, but similar rates of mortality.ConclusionsIn stable patients post-MI, those with AF were commonly undertreated with oral anticoagulants, had poorer quality of life and had increased risk of clinical outcomes than those without AF.Trial registration numberClinicalTrials: NCT01866904.

scholarly journals Digitalization of adverse event management in oncology to improve treatment outcome—A prospective study protocol

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0252493
Author(s):  
Angelika M. R. Kestler ◽  
Silke D. Kühlwein ◽  
Johann M. Kraus ◽  
Julian D. Schwab ◽  
Robin Szekely ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Treatment Outcome ◽  
Side Effects ◽  
Adverse Events ◽  
Study Protocol ◽  
Reporting System ◽  
Smartphone Application ◽  
Patient Reporting ◽  
The Impact

The occurrence of adverse events frequently accompanies tumor treatments. Side effects should be detected and treated as soon as possible to maintain the best possible treatment outcome. Besides the standard reporting system Common Terminology Criteria for Adverse Events (CTCAE), physicians have recognized the potential of patient-reporting systems. These are based on a more subjective description of current patient reporting symptoms. Patient-reported symptoms are essential to define the impact of a given treatment on the quality of life and the patient’s wellbeing. They also act against an underreporting of side effects which are paramount to define the actual value of a treatment for the individual patient. Here, we present a study protocol for a clinical trial that assesses the potential of a smartphone application for CTCAE conform symptom reporting and tracking that is adjusted to the standard clinical reporting system rather than symptom oriented descriptive trial tools. The presented study will be implemented in two parts, both lasting over six months. The first part will assess the feasibility of the application with 30 patients non-randomly divided into three equally-sized age groups (<55years, 55-75years, >75years). In the second part 36 other patients will be randomly assigned to two groups, one reporting using the smartphone and one not. This prospective second part will compare the impact of smartphone reported adverse events regarding applied therapy doses and quality of life to those of patients receiving standard care. We aim for early detection and treatment of adverse events in oncological treatment to improve patients’ safety and outcomes. For this purpose, we will capture frequent adverse events of chemotherapies, immunotherapies, or other targeted therapies with our smartphone application. The presented trial is registered at the U.S. National Library of Medicine ClinicalTrials.gov (NCT04493450) on July 30, 2020.

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