scholarly journals Cognitive dysfunction and adverse events during oral anticoagulant: a prospective cohort study

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
P Massoure ◽  
C Nguyen

Abstract Background Oral anticoagulants (AC), represent the leading cause of iatrogenic morbimortality in France. AC are widely prescribed among the elderly. The assessment of the cognitive dysfunction (CD) is not included within the common thrombotic and bleeding risk scores. Purpose The objective of this study was to examine an association between CD and adverse events (AE) in patients receiving oral AC. Methods A prospective monocentric cohort study was conducted in patients (≥60 years-old) on oral AC. Death, hemorrhages, falls, hospital readmission, thromboembolic events were collected over 6 months follow-up. Patients were included during an hospitalization for any medical or surgical condition and divided in three groups, according to their Mini Mental State Examination (MMSE): Group 1 (absence of CD) MMSE ≥27, Group 2 (mild CD) 24<mmse<26, >≤MMSE≤26, Group 3 (significant CD) MMSE ≤23. Results Among 120 patients (mean age: 82,2±8,8 years), the all-causes mortality (n=25) was significantly higher in the Group 3 (n=17, p=0,006); this also applies to the incidence of falls (n=34, p=0,009) or major hemorrhages (n=10, p=0,023). There was no thromboembolic event. Minor hemorrhages and hospital readmissions were not different in the 3 groups. Multivariate analysis shows a significant risk of mortality (OR 4.3, (p=0,025, IC [1,20–15,42]) in group 3. Conclusion After 6 months of follow up, the cognitive dysfunction was associated with mortality, major hemorrhages and falls among the elderly receiving oral AC. A systematic assessment of cognitive functions of these patients seems to be essential to analyze the global risk and the risks related to the AC treatment.</mmse<26,> FUNDunding Acknowledgement Type of funding sources: None.

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 561.2-562
Author(s):  
X. Liu ◽  
Z. Sun ◽  
W. Guo ◽  
F. Wang ◽  
L. Song ◽  
...  

Background:Experts emphasize early diagnosis and treatment in RA, but the widely used diagnostic criterias fail to meet the accurate judgment of early rheumatoid arthritis. In 2012, Professor Zhanguo Li took the lead in establishing ERA “Chinese standard”, and its sensitivity and accuracy have been recognized by peers. However, the optimal first-line treatment of patients (pts) with undifferentiated arthritis (UA), early rheumatoid arthritis (ERA), and rheumatoid arthritis (RA) are yet to be established.Objectives:To evaluate the efficacy and safety of Iguratimod-based (IGU-based) Strategy in the above three types of pts, and to explore the characteristics of the effects of IGU monotherapy and combined treatment.Methods:This prospective cohort study (ClinicalTrials.gov Identifier NCT01548001) was conducted in China. In this phase 4 study pts with RA (ACR 1987 criteria[1]), ERA (not match ACR 1987 criteria[1] but match ACR/EULAR 2010 criteria[2] or 2014 ERA criteria[3]), UA (not match classification criteria for ERA and RA but imaging suggests synovitis) were recruited. We applied different treatments according to the patient’s disease activity at baseline, including IGU monotherapy and combination therapies with methotrexate, hydroxychloroquine, and prednisone. Specifically, pts with LDA and fewer poor prognostic factors were entered the IGU monotherapy group (25 mg bid), and pts with high disease activity were assigned to combination groups. A Chi-square test was applied for comparison. The primary outcomes were the proportion of pts in remission (REM)or low disease activity (LDA) that is DAS28-ESR<2.6 or 3.2 at 24 weeks, as well as the proportion of pts, achieved ACR20, Boolean remission, and good or moderate EULAR response (G+M).Results:A total of 313 pts (26 pts with UA, 59 pts with ERA, and 228 pts with RA) were included in this study. Of these, 227/313 (72.5%) pts completed the 24-week follow-up. The results showed that 115/227 (50.7%), 174/227 (76.7%), 77/227 (33.9%), 179/227 (78.9%) pts achieved DAS28-ESR defined REM and LDA, ACR20, Boolean remission, G+M response, respectively. All parameters continued to decrease in all pts after treatment (Fig 1).Compared with baseline, the three highest decline indexes of disease activity at week 24 were SW28, CDAI, and T28, with an average decline rate of 73.8%, 61.4%, 58.7%, respectively. Results were similar in three cohorts.We performed a stratified analysis of which IGU treatment should be used in different cohorts. The study found that the proportion of pts with UA and ERA who used IGU monotherapy were significantly higher than those in the RA cohort. While the proportion of triple and quadruple combined use of IGU in RA pts was significantly higher than that of ERA and UA at baseline and whole-course (Fig 2).A total of 81/313 (25.8%) pts in this study had adverse events (AE) with no serious adverse events. The main adverse events were infection(25/313, 7.99%), gastrointestinal disorders(13/313, 4.15%), liver dysfunction(12/313, 3.83%) which were lower than 259/2666 (9.71%) in the previous Japanese phase IV study[4].The most common reasons of lost follow-up were: 1) discontinued after remission 25/86 (29.1%); 2) lost 22/86 (25.6%); 3) drug ineffective 19/86 (22.1%).Conclusion:Both IGU-based monotherapy and combined therapies are tolerant and effective for treating UA, ERA, and RA, while the decline in joint symptoms was most significant. Overall, IGU combination treatments were most used in RA pts, while monotherapy was predominant in ERA and UA pts.References:[1]Levin RW, et al. Scand J Rheumatol 1996, 25(5):277-281.[2]Kay J, et al. Rheumatology 2012, 51(Suppl 6):vi5-9.[3]Zhao J, et al. Clin Exp Rheumatol 2014, 32(5):667-673.[4]Mimori T, et al. Mod Rheumatol 2019, 29(2):314-323.Disclosure of Interests:None declared


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Yanfeng Ren ◽  
Maohua Miao ◽  
Wei Yuan ◽  
Jiangwei Sun

Abstract Background Although a U-shaped association between sleep duration and all-cause mortality has been found in general population, its association in the elderly adults, especially in the oldest-old, is rarely explored. Methods In present cohort study, we prospectively explore the association between sleep duration and all-cause mortality among 15,092 participants enrolled in the Chinese Longitudinal Healthy Longevity Survey (CLHLS) from 2005 to 2019. Sleep duration and death information was collected by using structured questionnaires. Cox regression model with sleep duration as a time-varying exposure was performed to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs). The dose-response association between them was explored via a restricted cubic spline function. Results During an average follow-up of 4.51 (standard deviation, SD: 3.62) years, 10,768 participants died during the follow-up period. The mean (SD) age of the participants was 89.26 (11.56) years old. Compared to individuals with moderate sleep duration (7–8 hours), individuals with long sleep duration (> 8 hours) had a significantly higher risk of all-cause mortality (HR: 1.13, 95%CI: 1.09–1.18), but not among individuals with short sleep duration (≤ 6 hours) (HR: 1.02, 95%CI: 0.96–1.09). Similar results were observed in subgroup analyses based on age and gender. In the dose-response analysis, a J-shaped association was observed. Conclusions Sleep duration was associated with all-cause mortality in a J-shaped pattern in the elderly population in China.


2020 ◽  
Author(s):  
Lili Dai ◽  
Sen Wang ◽  
Ying Shao ◽  
Yali Wang ◽  
Jiangzhu Ye ◽  
...  

Abstract Background: Efavirenz (EFV) is a widely used antiretroviral therapy (ART), but side effect risks of neuropsychiatric adverse events (NPAEs) have not been investigated in Chinese populations receiving rapid ART. Methods: This prospective cohort study assessed HIV-infected patients initiating antiretroviral treatment with EFV to determine prevalence of and factors associated with NPAEs over a 12-month follow-up period using the Hospital Anxiety and Depression Scale (HADS) and the Pittsburgh Sleep Quality Index (PSQI). Results: A total of 546 patients were enrolled. Prevalence of anxiety, depression, and sleep disturbances at baseline were 30.4%, 22.7%, and 68.1%, respectively. Six patients discontinued treatment due to drug related NPAEs. Treatment was associated with improvements in HADS-A, HADS-D, and PSQI scores over the 12-month follow-up, and the frequencies of patients with anxiety, depression, and sleep disturbances significantly decreased after 12 months. Abnormal baseline HADS-A, HADS-D, and PSQI scores and other factors, including high school education or lower, unemployment, divorce, and WHO III/IV stages, were associated with severe neuropsychiatric disorders over the 12 months. Conclusions: These findings suggested EFV-based first-line antiretroviral therapy was well-tolerated and associated with improvements in HADS-A, HADS-D, and PSQI scores. Certain risk factors associated with neuropsychiatric disorders may be useful in identifying HIV-infected patients at higher NPAE risk.


BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e033283 ◽  
Author(s):  
Frederik Dalgaard ◽  
Karen Pieper ◽  
Freek Verheugt ◽  
A John Camm ◽  
Keith AA Fox ◽  
...  

ObjectivesTo externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular AF in a population-based cohort.DesignRetrospective cohort study.SettingDanish nationwide registries.Participants90 693 patients with newly diagnosed non-valvular AF were included between 2010 and 2016, with follow-up censored at 1 year.Primary and secondary outcome measuresExternal validation was performed using discrimination and calibration plots. C-statistics were compared with CHA2DS2VASc score for ischaemic stroke/systemic embolism (SE) and HAS-BLED score for major bleeding/haemorrhagic stroke outcomes.ResultsOf the 90 693 included, 51 180 patients received oral anticoagulants (OAC). Overall median age (Q1, Q3) were 75 (66–83) years and 48 486 (53.5%) were male. At 1-year follow-up, a total of 2094 (2.3%) strokes/SE, 2642 (2.9%) major bleedings and 10 915 (12.0%) deaths occurred. The GARFIELD-AF model was well calibrated with the predicted risk for stroke/SE and major bleeding. The discriminatory value of GARFIELD-AF risk model was superior to CHA2DS2VASc for predicting stroke in the overall cohort (C-index: 0.71, 95% CI: 0.70 to 0.72 vs C-index: 0.67, 95% CI: 0.66 to 0.68, p<0.001) as well as in low-risk patients (C-index: 0.64, 95% CI: 0.59 to 0.69 vs C-index: 0.57, 95% CI: 0.53 to 0.61, p=0.007). The GARFIELD-AF model was comparable to HAS-BLED in predicting the risk of major bleeding in patients on OAC therapy (C-index: 0.64, 95% CI: 0.63 to 0.66 vs C-index: 0.64, 95% CI: 0.63 to 0.65, p=0.60).ConclusionIn a nationwide Danish cohort with non-valvular AF, the GARFIELD-AF model adequately predicted the risk of ischaemic stroke/SE and major bleeding. Our external validation confirms that the GARFIELD-AF model was superior to CHA2DS2VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.


Medicina ◽  
2020 ◽  
Vol 56 (8) ◽  
pp. 392
Author(s):  
Dalia Miltinienė ◽  
Giedrė Deresevičienė ◽  
Birutė Nakčerienė ◽  
Valerija Edita Davidavičienė ◽  
Edvardas Danila ◽  
...  

Background and objective: With an increase in survival rates among rheumatic patients, comorbidities and infections, in particular, have gained more importance, especially after the introduction of biologicals to the treatment algorithms. Tuberculosis (TB) infection has always been given a special attention in patients with rheumatic diseases (RD). Although Lithuanian population has one of the highest TB incidence rates among European countries, the incidence of TB in the rheumatic patients’ population is still unknown. The aim of this study was to assess the incidence rate of TB in an inflammatory RD retrospective cohort and to compare that rate with a rate in a general population. Material and Methods: Patients with the first-time diagnosis of inflammatory RD during the period between 1 January 2012 and 31 December 2017 were identified from the Lithuanian Compulsory Health Insurance Information System database SVEIDRA. All cases were cross-checked with Health Information center at the Institute of Hygiene, for the vital status of these patients and date of death if the fact of death was documented, and with Tuberculosis Register operated by Vilnius University Hospital Santaros Klinikos, for the confirmation of TB cases. Sex and age standardized incidence ratios (SIR) were calculated by dividing the observed numbers of TB among rheumatic patients by the expected number of cases, calculated using national rates from Lithuanian Department of Statistics Official Statistics website. Results: Overall, 8779 patients with newly diagnosed RD were identified during the 2013–2017 period, these included 458 patients who used biological disease modifying drugs (bDMARDs). The mean duration of the follow-up period was 2.71 years. The cohort consisted mainly of women (70%) and a half of the cohort were rheumatoid arthritis (RA) patients (53%). Mean age of patients at the time of RD diagnosis was 56 years (range = 18–97 years). There were 9 TB cases identified during 23,800 person years of follow-up: 2 cases among them were treated with bDMARDs. The mean calculated annual TB incidence in RD cohort was 37.81 per 100,000 person years, which is consistent with the incidence rate predicted by national estimates, with a resultant SIR of 0.90 (0.41–1.70). The unadjusted hazard ratio for bDMARD use versus no bDMARD use was 4.54 (0.94; 21.87) in a total cohort and very similar in rheumatoid arthritis cohort; in both cohorts, it was not a statistically significant risk. Conclusions: Here, we present the first nationwide cohort study to assess the incidence of TB in a broad spectrum of inflammatory RD. Although limited by short follow-up period, this study shows that TB incidence in RD cohort does not exceed TB incidence in the general Lithuanian population.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Weiss ◽  
R De Caterina ◽  
P Kelly ◽  
P Monteiro ◽  
J C Deharo ◽  
...  

Abstract Background Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), and available routine care data have so far broadly confirmed the safety of different NOACs in routine practice. However, such data for edoxaban are scarce, especially in extremely low and high body weight (BW). These extreme BWs may affect the bioavailability, distribution, and half-life of NOACs and, consequently, outcomes of treatment. Methods We analysed outcomes in normal-weight (BMI 18.5–25) vs overweight (BMI 25–30) and obese (BMI >30) patients enrolled into the ETNA-AF-Europe observational study (NCT02944019) collecting information on patients treated with edoxaban in 825 sites in 10 European countries. This snapshot analysis set includes data of 7,672 patients (56.3% of all enrolled patients) which have completed their 1-year follow-up visit (mean follow-up: 343.5 days). Results Median patient age was 74 years for all patients, 76 years for patients with a BMI 18.5–25 (group 1), 75 years for patients with BMI 25–30 (group 2), and 72 for patients with a BMI >30 (group 3). CrCl was 64 mL/min for patients with a BMI 18.5–25, 68 mL/min for patients with BMI 25–30, and 72 mL/min for patients with a BMI >30. The CHA2DS2-VASc (mean 3.1±1.38) and HAS-BLED (mean 2.5±1.10) score did not differ significantly between groups. As expected, diabetes and hypertension were significantly less prevalent in leaner patients and - accordingly - inversely correlated to age. There was no correlation between body weight and life-threatening bleeding (group 1: 0.28%; group 2: 0.40%; group 3: 0.14%). Also, stroke rates (group 1: 0.74%; group 2: 0.81%; group 3: 0.76%) did not differ between groups. Conclusion BMI, within the range here assessed, does not affect 1-year outcomes in European AF patients treated with edoxaban. Acknowledgement/Funding Daiichi Sankyo Europe GmbH, Munich, Germany


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Regula Monika Kronenberg ◽  
Shanthi Beglinger ◽  
Odile Stalder ◽  
Marie Méan ◽  
Andreas Limacher ◽  
...  

Abstract Previous studies reported lower rates of recurrent venous thromboembolism (rVTE) among statin users, but this association could be influenced by concurrent anticoagulation and confounding by statin indication. This study aimed to confirm the beneficial association between statins and rVTE, stratified according to periods with and without anticoagulation, and additionally employ propensity score weighted approach to reduce risk of confounding by indication. The setting was a prospective multicentre cohort study and the outcome was time to first rVTE in statin vs. non-statin users. 980 participants with acute VTE were enrolled (mean age 75.0 years, 47% women), with median follow-up of 2.5 years. Of 241 (24.3%) statin users, 21 (8.7%) suffered rVTE vs. 99 (13.4%) among 739 non-users. The overall adjusted sub-hazard ratio (aSHR) for rVTE comparing statin users to non-users was 0.72 (95%CI 0.44 to 1.19, p = 0.20). This association was only apparent during periods without anticoagulation (aSHR 0.50, 95%CI 0.27 to 0.92, p = 0.03; vs. with anticoagulation: aSHR 1.34, 95%CI 0.54 to 3.35, p = 0.53). Using propensity scores, the rVTE risk during periods without anticoagulation fell further (aSHR 0.20, 95%CI 0.08 to 0.49, p < 0.001). In conclusion, statin use is associated with a more pronounced risk reduction for rVTE than previously estimated, but only during periods without anticoagulation.


2018 ◽  
Vol 12 (1) ◽  
pp. 67-74
Author(s):  
Guillermo Sánchez ◽  
Diana Buitrago

Background: The clinical characteristics and physio-pathogenic mechanisms of asthma in patients older than 60 years appear to differ from the behavior described for other age groups. Therefore, the effectiveness of medications for elderly patients with asthma should not be extrapolated from studies conducted on teenagers or young adults. Objective: The study aimed to establish the clinical effect of montelukast 10 mg in elderly patients with mild and moderate asthma compared to its effect on young adults. Method: A prospective cohort study was conducted during 12 weeks of follow-up, which consecutively included the total population of adult patients attended by a group of 21 general practitioners, between July and December 2016. Young adults (18-59 years) and older adults were included (60 years or older) with mild or moderate asthma, which, according to the criteria of his treating physician, had been prescribed montelukast 10 mg/day. The variables of interest were: use of inhaled corticosteroids during the last month, use of inhaled beta-2 adrenergic agonists as a rescue in the last month, having attended the emergency service during the last month due to an asthma attack, presence of wheezing in the physical examination, the number of attacks in the last month and the number of days without symptoms in the last month. Results: A total of 126 patients entered the cohort and 104 completed the follow-up, of which 29% were older adults. On admission, 65.4% of patients (68/104) had used rescue inhaled beta2 in the last month and had been using schemes with corticosteroids. After 12 weeks of follow-up, 58.1% (43/74) of the young adults required treatment schedules with corticosteroids, while in the elderly, only 36.7% of the patients (11/30) required this treatment scheme (p-value: 0.047). Regarding the use of rescue inhaled beta-2 at 12 weeks, 55% of young adults reported using them, compared to 33.3% of older adults (p-value: 0.041). Conclusion: In this cohort of patients, treated with montelukast 10 mg/day for 12 weeks, there was a reduction of broncho-obstructive symptoms and exacerbations of the disease. In older adults compared to young adults, a greater reduction in the use of beta2 agonists rescue medications and in the concomitant use of inhaled corticosteroid schemes was documented.


2017 ◽  
Vol 7 (1) ◽  
Author(s):  
Yi-Chi Chen ◽  
Shuo-Chun Weng ◽  
Jia-Sin Liu ◽  
Han-Lin Chuang ◽  
Chih-Cheng Hsu ◽  
...  

Abstract Cognitive dysfunction is closely related to aging and chronic kidney disease (CKD). However, the association between renal function changes and the risk of developing cognitive impairment has not been elucidated. This longitudinal cohort study was to determine the influence of annual percentage change in estimated glomerular filtration rate (eGFR) on subsequent cognitive deterioration or death of the elderly within the community. A total of 33,654 elders with eGFR measurements were extracted from the Taipei City Elderly Health Examination Database. The Short Portable Mental Status Questionnaire was used to assess their cognitive progression at least twice during follow-up visits. Multivariable Cox regression models were used to estimate the hazard ratio (HR) for cognitive deterioration or all-cause mortality with the percentage change in eGFR. During a median follow-up of 5.4 years, the participants with severe decline in eGFR (>20% per year) had an increased risk of cognitive deterioration (HR, 1.33; 95% confidence interval [CI], 1.08–1.72) and the composite outcome (HR, 1.17; 95% CI, 1.03–1.35) when compared with those who had stable eGFR. Severe eGFR decline could be a possible predictor for cognitive deterioration or death among the elderly. Early detection of severe eGFR decline is a critical issue and needs clinical attentions.


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