OS10.8.A The effectiveness of antiepileptic drug duotherapies in glioma patients: a multicenter observational cohort study

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii14-ii14
Author(s):  
P B van der Meer ◽  
L Dirven ◽  
M Fiocco ◽  
M Vos ◽  
M C M Kouwenhoven ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Effects ◽  
Treatment Failure ◽  
Antiepileptic Drug ◽  
Observational Cohort Study ◽  
Proportional Hazard ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Models ◽  
Observational Cohort

Abstract BACKGROUND About 30% of glioma patients need an add-on antiepileptic drug (AED) due to uncontrolled seizures on AED monotherapy. This study aimed to determine whether levetiracetam combined with valproic acid (LEV+VPA), a commonly prescribed duotherapy, is more effective than other duotherapy combinations including either LEV or VPA in glioma patients. MATERIAL AND METHODS In this multicenter retrospective observational cohort study, treatment failure (i.e. replacement by or addition of a new AED, or withdrawal of an AED) for any reason was the primary outcome. Secondary outcomes included: 1) treatment failure due to uncontrolled seizures; and 2) treatment failure due to adverse effects. Time to treatment failure was defined as the time from the start of AED duotherapy until the time of treatment failure. Multivariable Cox proportional hazard models were estimated to study the association between risk factors and treatment failure. The maximum duration of follow-up was 36 months. RESULTS A total of 1435 patients were treated with first-line monotherapy LEV or VPA, of which 355 patients received AED duotherapy after they had treatment failure due to uncontrolled seizures on monotherapy. LEV+VPA was prescribed in 66% (236/355) and other AED duotherapy combinations including LEV or VPA in 34% (119/355) of patients. Patients using other duotherapy versus LEV+VPA had higher risk of treatment failure for any reason (cause-specific hazard ratio [csHR]=1.50 [95%CI=1.07–2.12], p=0.020), treatment failure due to uncontrolled seizures (csHR=1.73 [95%CI=1.10–2.73], p=0.018). There were no differences in failure due to adverse effects (csHR=0.88 [95%CI=0.47–1.67]), p=0.703) between the two groups. CONCLUSION This observational cohort study suggests that LEV+VPA has better efficacy than other AED combinations. Similar toxicities were experienced in the two groups.

NCOG-15. THE EFFECTIVENESS OF ANTIEPILEPTIC DRUG DUOTHERAPIES IN GLIOMA PATIENTS: A MULTICENTER OBSERVATIONAL COHORT STUDY

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi155-vi155
Author(s):  
Pim van der Meer ◽  
Linda Dirven ◽  
Marta Fiocco ◽  
Maaike Vos ◽  
Mathilde Kouwenhoven ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Effects ◽  
Treatment Failure ◽  
Antiepileptic Drug ◽  
Study Data ◽  
Observational Cohort Study ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Models ◽  
Observational Cohort

Abstract BACKGROUND Uncontrolled seizures on antiepileptic drug (AED) monotherapy are common in glioma patients and about a third of patients need an add-on AED. The aim of this study was to determine whether levetiracetam combined with valproic acid (LEV+VPA), a commonly prescribed duotherapy, was more effective than other duotherapy combinations, which included either LEV or VPA, in glioma patients. METHODS In this multicenter observational cohort study, data of patients with a diffuse grade 2-4 glioma and having uncontrolled seizures on their first-line monotherapy LEV or VPA, was retrospectively analyzed. Primary outcome was treatment failure (i.e. replacement by or addition of a new AED, or withdrawal of an AED) for any reason. Secondary outcomes included: 1) treatment failure due to uncontrolled seizures; and 2) treatment failure due to adverse effects. Time to treatment failure was estimated with multivariable Cox proportional hazard models, from moment of AED duotherapy treatment initiation. The maximum duration of follow-up was 36 months. RESULTS A total of 355 patients received AED duotherapy after they showed treatment failure due to uncontrolled seizures on monotherapy. LEV+VPA was prescribed in 66% (236/355) and other AED duotherapy combinations including LEV or VPA in 34% (119/355) of patients. Patients using other duotherapy versus LEV+VPA had higher risk of treatment failure for any reason (cause-specific hazard ratio [csHR]=1.50 [95%CI=1.07-2.12], p=0.020), due to uncontrolled seizures (csHR=1.73 [95%CI=1.10-2.73], p=0.018), but not due to adverse effects (csHR=0.88 [95%CI=0.47-1.67]), p=0.703). CONCLUSIONS This observational cohort study showed that LEV+VPA has better efficacy than other AED combinations with either LEV or VPA, but toxicity was similar in the two groups.

Dietary patterns generated by the Treelet Transform and risk of stroke: a Danish cohort study

2020 ◽  
Vol 24 (1) ◽  
pp. 84-94
Author(s):  
Signe B Frederiksen ◽  
Heidi H Themsen ◽  
Kim Overvad ◽  
Christina C Dahm
Keyword(s):  
Cohort Study ◽  
Dietary Patterns ◽  
Inverse Association ◽  
Proportional Hazard ◽  
Cox Proportional Hazard ◽  
National Patient ◽  
Cox Proportional Hazard Models ◽  
Record Review ◽  
Danish National Patient Register

AbstractObjective:To relate empirically derived dietary patterns identified using the Treelet Transform (TT) to risk of stroke.Design:A prospective cohort study using the Danish Diet, Cancer and Health cohort. Dietary information was obtained in 1993–1997 using a validated semi-quantitative FFQ. Incident stroke diagnoses, obtained from the Danish National Patient Register, were verified by record review. Dietary patterns were generated using TT, and participants were categorised into quintiles based on their adherence to each pattern. Sex-specific Cox proportional hazard models estimated associations between dietary patterns and stroke.Setting:Denmark.Participants:55 061 men and women aged 50–64 years at the time of enrolment.Results:Three dietary patterns explaining 15·4 % of the total variance were identified: a Prudent pattern, a Western pattern and a Wine & Snacks pattern. During a follow-up time of 10 years, 1513 cases occurred. Comparing the highest to lowest quintiles of intake, adherence to a Prudent pattern was inversely associated with stroke (HRmen 0·74, 95 % CI 0·60, 0·91; HRwomen 0·82, 95 % CI 0·62, 1·08), while adherence to a Western pattern was associated with greater risk (HRmen 1·61, 95 % CI 1·23, 2·10; HRwomen 2·01, 95 % CI 1·48, 2·72). No association was found for a Wine & Snacks pattern for women, but a weak inverse association was found for men (HR 0·81, 95 % CI 0·67, 0·99).Conclusions:The results of this study are broadly in line with current recommendations for a healthy diet to prevent stroke.

scholarly journals Treatment outcomes of initial differential antiretroviral regimens among HIV patients in Southwest China: comparison from an observational cohort study

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025666 ◽  
Author(s):  
Ruihua Kang ◽  
Liuhong Luo ◽  
Huanhuan Chen ◽  
Qiuying Zhu ◽  
Lingjie Liao ◽  
...  
Keyword(s):  
Cohort Study ◽  
Treatment Outcomes ◽  
Attrition Rate ◽  
Proportional Hazard ◽  
Hiv Patients ◽  
Cox Proportional Hazard ◽  
Real World Setting ◽  
Cox Proportional Hazard Models ◽  
Observational Cohort ◽  
Better Than

ObjectivesChina has continued to expand antiretroviral therapy (ART) services and optimise ART guidelines in an effort to significantly reduce and prevent mortality and transmission rates among HIV patients. However, no study to date has compared treatment outcomes of initial differential antiretroviral regimens among HIV patients in a real-world setting in China. This study aimed to compare the effects of different ART regimens on treatment outcomes among adults.DesignObservational retrospective cohort study.SettingData from 2011 to 2013 in Guangxi, China.ParticipantsPatients aged ≥18 years (n=25 732) were selected.ResultsA total of 25 732 patients were included in this study. The average mortality and attrition rate were 2.64 and 4.98, respectively, per 100 person-years. Using Cox proportional hazard models, zidovudine-based (AZT-based) regimen versus stavudine-based (D4T-based) regimen had an adjusted HR (AHR) for death of 0.65 (95% CI 0.58 to 0.73); the AHR of tenofovir-based (TDF-based) versus D4T-based regimens was 0.81 (95% CI 0.71 to 0.92), and of lopinavir–ritonavir-based (LPV/r-based) versus D4T-based regimens, 1.19 (95% CI 1.04 to 1.37). AZT-based versus D4T-based regimens had an AHR for dropout of 0.89 (95% CI 0.81 to 0.97); this ratio for TDF-based versus D4T-based regimens was 0.88 (95% CI 0.80 to 0.98), and for LPV/r-based versus D4T-based regimens, 1.42 (95% CI 1.27 to 1.58). AZT-based and TDF-based regimens had a lower risk compared with D4T-based regimens, while LPV/r-based regimens had a higher risk. High gastrointestinal reactions and poor adherence were observed among HIV patients whose initial ART regimen was LPV/r-based.ConclusionsOur study found that the treatment outcomes of initial ART regimens that were AZT-based or TDF-based were significantly better than D4T-based or LPV/r-based regimens. This finding could be related to the higher rates of gastrointestinal reactions and poorer adherence associated with the LPV/r-based regimens compared with other initial ART regimens.

Association of autoimmunity with survival in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) treated with immune checkpoint inhibitors (ICIs).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6537-6537
Author(s):  
Panagiota Economopoulou ◽  
Niki Gavrielatou ◽  
George Papaxoinis ◽  
Ioannis Kotsantis ◽  
Anastasios Pantazopoulos ◽  
...  
Keyword(s):  
T Cell Activation ◽  
Cell Activation ◽  
Recurrent Disease ◽  
Checkpoint Inhibitors ◽  
Strong Predictor ◽  
Proportional Hazard ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Models ◽  
Observational Cohort

6537 Background: ICIs are associated with immune-related adverse events (irAEs) that occur as a consequence of enhanced immune response due to T-cell activation. The objective of this observational cohort study was to investigate the association between irAEs and disease outcome in pts with R/M HNSCC. Methods: 110 pts treated with ICIs were reviewed. Overall survival (OS) was calculated from the date of initiation of ICI to the date of death. To overcome guarantee-time bias, we calculated post-irAEs survival from the date of first irAE presentation in patients who developed irAEs or from the date of ICI initiation in pts without irAEs. Results: Primary site was the oral cavity (N = 51), oropharynx (N = 20), larynx (N = 29), hypopharynx (N = 1), paranasal sinuses (N = 5) and nasopharynx (N = 4). 41 (37.3%) had metastatic and 69 (62.7%) recurrent disease. 32 pts (29.1%) developed irAEs, with more common thyroiditis (N = 15, 13.6%). Of 100 pts with evaluable disease, 14 (14%) responded. 6/31 (19.4%) with irAEs vs. 8/69 (11.6%) without irAEs responded to ICI (p = 0.354). After a median follow-up of 16.4 months, 69 pts died. Median OS was 10 mo (95%CI, 6.7-13.4), 10 mo (95%CI, 5.6-14.5) for pts with recurrent and 10 mo (95%CI, 7.7-12.3) for pts with metastatic HNSCC (p = 0.966). Median OS was 17.9 mo (95%CI, 7.9-27.9) for pts with irAEs and 6.6 mo (95%CI, 3.3-9.9) for pts without irAEs (p = 0.001). Median post-irAEs survival was 16.3 (95%CI, 7.1-25.5) for pts with irAEs vs. 6.6 mo (95%CI, 3.3-9.9) for pts without irAEs (p = 0.020). Responders to ICI did not differ in median post-irAEs survival irrespective of whether they developed irAEs (p = 0.561), while among non-responders, those who developed irAEs had significantly longer median post-irAEs survival compared to those who did not (10 vs. 6 mo, respectively, p = 0.044). Multiviariate Cox proportional hazard models showed that independent favorable prognostic factors for post-irAEs survival were the development of irAEs (HR 0.54, 95%CI 0.30-0.97, p = 0.039) and response to ICI (HR 0.16, 95%CI 0.05-0.50, p = 0.002). Conclusions: The development of irAEs is a strong predictor of improved survival in patients with advanced HNSCC treated with ICIs.

scholarly journals Prevalence and Course of IgA and IgG Antibodies against SARS-CoV-2 in Healthcare Workers during the First Wave of the COVID-19 Outbreak in Germany: Interim Results from an Ongoing Observational Cohort Study

Healthcare ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 498
Author(s):  
Mark Reinwald ◽  
Peter Markus Deckert ◽  
Oliver Ritter ◽  
Henrike Andresen ◽  
Andreas G. Schreyer ◽  
...  
Keyword(s):  
Cohort Study ◽  
Healthcare Workers ◽  
Significant Proportion ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Observational Cohort Study ◽  
Igg Antibodies ◽  
University Hospitals ◽  
Observational Cohort

(1) Background: Healthcare workers (HCWs) are prone to intensified exposure to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the ongoing pandemic. We prospectively analyzed the prevalence of antibodies against SARS-CoV-2 in HCWs at baseline and follow up with regard to clinical signs and symptoms in two university hospitals in Brandenburg, Germany. (2) Methods: Screening for anti-SARS-CoV-2 IgA and IgG antibodies was offered to HCWs at baseline and follow up two months thereafter in two hospitals of Brandenburg Medical School during the first wave of the COVID-19 pandemic in Germany in an ongoing observational cohort study. Medical history and signs and symptoms were recorded by questionnaires and analyzed. (3) Results: Baseline seroprevalence of anti-SARS-CoV-2 IgA was 11.7% and increased to 15% at follow up, whereas IgG seropositivity was 2.1% at baseline and 2.2% at follow up. The rate of asymptomatic seropositive cases was 39.5%. Symptoms were not associated with general seropositivity for anti-SARS-CoV-2; however, class switch from IgA to IgG was associated with increased symptom burden. (4) Conclusions: The seroprevalence of antibodies against SARS-CoV-2 was low in HCWs but higher compared to population data and increased over time. Screening for antibodies detected a significant proportion of seropositive participants cases without symptoms.

scholarly journals Antidepressant dose and the risk of deliberate self-harm

2014 ◽  
Vol 23 (4) ◽  
pp. 329-331 ◽  
Author(s):  
C. Barbui ◽  
S.B. Patten
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Propensity Score ◽  
Adverse Effects ◽  
Suicidal Behaviour ◽  
Research Question ◽  
Observational Cohort Study ◽  
Panic Attacks ◽  
Observational Cohort ◽  
Self Harm

Although the mechanism by which antidepressants (ADs) may increase the risk of suicide-related outcomes is unknown, it has been hypothesised that some adverse effects, including akathisia, insomnia and panic attacks, as well as an early energising effect that might allow patients with depression to act on suicidal impulses, may have a key role. Considering that these adverse effects are dose-related, it might be hypothesised that the risk of suicidal behaviour is similarly related to the AD dose. This research question has recently been addressed by a propensity score-matched observational cohort study that involved 162 625 patients aged 10–64 years with a depression diagnosis who initiated therapy with citalopram, sertraline or fluoxetine. In this commentary, we discuss the main findings of this study in view of its methodological strengths and limitations, and we suggest possible implications for day-to-day clinical practice.

scholarly journals Neonatal Severe Hyperbilirubinemia Online Registry in Jiangsu Province: protocol for a multicentre, prospective, open, observational cohort study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040797
Author(s):  
Qianqian Li ◽  
Xiaoyi Deng ◽  
Junmei Yan ◽  
Xiaofan Sun ◽  
Xiaoyue Dong ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Observational Cohort Study ◽  
Jiangsu Province ◽  
Survival Status ◽  
Bilirubin Encephalopathy ◽  
Brainstem Response ◽  
Observational Cohort ◽  
Severe Hyperbilirubinemia

IntroductionSevere hyperbilirubinaemia in newborns can be easily complicated by acute bilirubin encephalopathy or even kernicterus, which could lead to neurological sequelae or death. However, there is no systematic study of the management of severe hyperbilirubinaemia in China. The Neonatal Severe Hyperbilirubinemia Online Registry study aims to investigate the management of jaundice before admission, risk factors and outcomes of severe hyperbilirubinaemia in a real-world setting in China.Methods and analysisThis is a prospective, multicentre, open, observational cohort study. From May 2020 to April 2023, more than 2000 patients with neonatal severe hyperbilirubinaemia from 13 tertiary hospitals in Jiangsu Province will join the study. Demographic data and treatment information will be collected from their clinical data. Management measures for jaundice before admission will be collected by the WeChat applet (called ‘Follow-up of jaundice’) after being provided by the patient’s guardian using a mobile phone. Follow-up data will include cranial MRI examination results, brainstem auditory-evoked potential or automatic auditory brainstem response, physical examination results and Griffiths Development Scales-Chinese at the corrected ages of 3–6 months and 1 and 2 years. Results and conclusions will be recorded using ‘Follow-up of jaundice.’ In-hospital outcomes, including severity of hyperbilirubinaemia (severe, extreme, hazardous), acute bilirubin encephalopathy (mild, moderate, severe) and survival status (death or survival), will be collected at discharge. Follow-up outcomes will include loss to follow-up, survival status and kernicterus (yes or no) at 2 years. The research will enhance our comprehensive knowledge of jaundice management before admission, risk factors and outcomes of severe hyperbilirubinaemia in China, which will ultimately help to reduce the incidence of neonatal severe hyperbilirubinaemia.Ethics and disseminationOur protocol has been approved by the Medical Ethics Committee of Nanjing Maternity and Child Health Care Hospital. We will present our findings at national conferences and peer-reviewed paediatrics journals.Trial registration numberNCT04251286.

scholarly journals Treatment Duration for Uncomplicated Staphylococcus aureus Bacteremia To Prevent Relapse: Analysis of a Prospective Observational Cohort Study

2012 ◽  
Vol 57 (3) ◽  
pp. 1150-1156 ◽  
Author(s):  
Yong Pil Chong ◽  
Song Mi Moon ◽  
Kyung-Mi Bang ◽  
Hyun Jung Park ◽  
So-Youn Park ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Cohort Study ◽  
Antibiotic Therapy ◽  
Treatment Failure ◽  
Practice Guidelines ◽  
Observational Cohort Study ◽  
Care Hospital ◽  
Prospective Observational Cohort Study ◽  
Short Course ◽  
Observational Cohort

ABSTRACTPractice guidelines recommend at least 14 days of antibiotic therapy for uncomplicatedStaphylococcus aureusbacteremia (SAB). However, these recommendations have not been formally evaluated in clinical studies. To evaluate the duration of therapy for uncomplicated SAB, we analyzed data from our prospective cohort of patients with SAB. A prospective observational cohort study was performed in patients with SAB at a tertiary-care hospital in Korea between August 2008 and September 2010. All adult patients with SAB were prospectively enrolled and observed over a 12-week period. Uncomplicated SAB was defined as follows: negative results of follow-up blood cultures at 2 to 4 days, defervescence within 72 h of therapy, no evidence of metastatic infection, and catheter-related bloodstream infection or primary bacteremia without evidence of endocarditis on echocardiography. Of 483 patients with SAB, 111 met the study criteria for uncomplicated SAB. Fifty-three (47.7%) had methicillin-resistant SAB. When short-course therapy (<14 days) and intermediate-course therapy (≥14 days) were compared, the treatment failure rates (10/38 [26.3%] versus 16/73 [21.9%]) and crude mortality (7/38 [18.4%] versus 16/73 [21.9%]) did not differ significantly between the two groups. However, short-course therapy was significantly associated with relapse (3/38 [7.9%] versus 0/73;P= 0.036). In multivariate analysis, primary bacteremia was associated with a trend toward increased treatment failure (P= 0.06). Therefore, in the treatment of uncomplicated SAB, it seems reasonable to consider at least 14 days of antibiotic therapy to prevent relapse, as practice guidelines recommend. Because of its poor prognosis, primary bacteremia, even with a low risk of complication, should not be treated with short-course therapy.

scholarly journals Time to develop severe acute malnutrition and its predictors among children living with HIV in the era of test and treat strategies at South Gondar hospitals, northwest, Ethiopia, 2021: a multicentre retrospective cohort study

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Ermias Sisay Chanie ◽  
Getasew Legas ◽  
Shimeles Biru Zewude ◽  
Maru Mekie ◽  
Dagne Addisu Sewyew ◽  
...  
Keyword(s):  
Cohort Study ◽  
Treatment Failure ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Severe Acute Malnutrition ◽  
Acute Malnutrition ◽  
Proportional Hazard ◽  
Cox Proportional Hazard ◽  
Living With Hiv ◽  
South Gondar

Abstract Background Although severe acute malnutrition is a major public issue among HIV infected children, there is no prior evidence in Ethiopia. Hence, this study aims to assess the time to develop severe acute malnutrition and its predictors among children living with human immunodeficiency virus in Ethiopia, 2012. Methods An institution based retrospective cohort study was conducted in South Gondar hospitals among 363 HIV infected children from February 10, 2014, to January 7, 2021. Epi-data version 3.1 was used to enter data, which was then exported to STATA version 14 for analysis. Besides, WHO (World Health Organization) Anthro Plus software was used to assess the nutritional status of the children. A standardized data extraction tool was used to collect the data. The Kaplan Meier survival curve was used to estimate the median survival time. The Cox-proportional hazard model assumption was checked via the Schoenfeld residual ph test and a stph plot. Bivariable and multivariable Cox proportional hazard models were employed at 95% confidence intervals (CI). A variable having a p-value < 0.05 was considered a statistically significant predictor of severe acute malnutrition. Results A total of 363 children living with HIV, 97 (26.72%) developed severe acute malnutrition during the follow-up period. The overall incidence rate was 5.4 (95% CI: 4.7–5.9) person per year with a total of 21, 492 months or 1791 years of observation. Moreover, the median survival time was 126 months. Treatment failure [AHR =3.4 (95% CI: 2.05–5.75)], CD4 count below threshold [AHR =2.5 (95% CI: 1.64–3.95)], and WHO stage III & IV [AHR =2.9 (95% CI: 1.74–4.73)] were all significant predictors of severe acute malnutrition. Conclusion The time to develop severe acute malnutrition was found to be very low. Treatment failure, CD4 count below threshold, and WHO stage III were all significant predictors of severe acute malnutrition. Hence, emphasizing those predictor variables is essential for preventing and controlling the occurrence of severe acute malnutrition among HIV infected children.

Sign in / Sign up

Export Citation Format

Share Document