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- Borisov, S, et al.
(författare)
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Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
- 2019
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Ingår i: The European respiratory journal. - : European Respiratory Society (ERS). - 1399-3003 .- 0903-1936. ; 54:6
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Tidskriftsartikel (refereegranskat)abstract
- The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1–2) and 57 (11.3%) as serious (grade 3–5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.
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| 3. |
- Ntaios, G., et al.
(författare)
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Age- and sex-specific analysis of patients with embolic stroke of undetermined source
- 2017
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Ingår i: Neurology. - : Ovid Technologies (Wolters Kluwer Health). - 0028-3878 .- 1526-632X. ; 89:6, s. 532-539
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To investigate whether the correlation of age and sex with the risk of recurrence and death seen in patients with previous ischemic stroke is also evident in patients with embolic stroke of undetermined source (ESUS). Methods: We pooled datasets of 11 stroke registries from Europe and America. ESUS was defined according to the Cryptogenic Stroke/ESUS InternationalWorking Group. We performed Cox regression and Kaplan-Meier product limit analyses to investigate whether age (<60, 60-80, >80 years) and sex were independently associated with the risk for ischemic stroke/TIA recurrence or death. Results: Ischemic stroke/TIA recurrences and deaths per 100 patient-years were 2.46 and 1.01 in patients <60 years old, 5.76 and 5.23 in patients 60 to 80 years old, 7.88 and 11.58 in those.80 years old, 3.53 and 3.48 in women, and 4.49 and 3.98 in men, respectively. Female sex was not associated with increased risk for recurrent ischemic stroke/TIA (hazard ratio [HR] 1.15, 95% confidence interval [CI] 0.84-1.58) or death (HR 1.35, 95% CI 0.97-1.86). Compared with the group <60 years old, the 60-to 80-and >80-year groups had higher 10-year cumulative probability of recurrent ischemic stroke/TIA (14.0%, 47.9%, and 37.0%, respectively, p, 0.001) and death (6.4%, 40.6%, and 100%, respectively, p, 0.001) and higher risk for recurrent ischemic stroke/TIA (HR 1.90, 95% CI 1.21-2.98 and HR 2.71, 95% CI 1.57-4.70, respectively) and death (HR 4.43, 95% CI 2.32-8.44 and HR 8.01, 95% CI 3.98-16.10, respectively). Conclusions: Age, but not sex, is a strong predictor of stroke recurrence and death in ESUS. The risk is approximate to 3-and 8-fold higher in patients >80 years compared with those <[60 years of age, respectively. The age distribution in the ongoing ESUS trials may potentially influence their power to detect a significant treatment association.
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| 4. |
- Ntaios, G., et al.
(författare)
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Renal Function and Risk Stratification of Patients With Embolic Stroke of Undetermined Source
- 2018
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Ingår i: Stroke. - : Ovid Technologies (Wolters Kluwer Health). - 0039-2499 .- 1524-4628. ; 49:12, s. 2904-2909
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Tidskriftsartikel (refereegranskat)abstract
- Background and Purpose-We aimed to assess if renal function can aid in risk stratification for ischemic stroke or transient ischemic attack (TIA) recurrence and death in patients with embolic stroke of undetermined source (ESUS). Methods-We pooled 12 ESUS datasets from Europe and America. Renal function was evaluated using the estimated glomerular filtration rate (eGFR) and analyzed in continuous, binary, and categorical way. Cox-regression analyses assessed if renal function was independently associated with the risk for ischemic stroke/TIA recurrence and death. The Kaplan-Meier product limit method estimated the cumulative probability of ischemic stroke/TIA recurrence and death. Results-In 1530 patients with ESUS followed for 3260 patient-years, there were 237 recurrences (15.9%) and 201 deaths (13.4%), corresponding to 7.3 ischemic stroke/TIA recurrences and 5.6 deaths per 100 patient-years, respectively. Renal function was not associated with the risk for ischemic stroke/TIA recurrence when forced into the final multivariate model, regardless if it was analyzed as continuous (hazard ratio, 1.00; 95% CI, 0.99-1.00 for every 1 mL/min), binary (hazard ratio, 1.27; 95% CI, 0.87-1.73) or categorical covariate (likelihood-ratio test 2.59, P=0.63 for stroke recurrence). The probability of ischemic stroke/TIA recurrence across stages of renal function was 11.9% for eGFR >= 90, 16.6% for eGFR 60-89, 21.7% for eGFR 45-59, 19.2% for eGFR 30-44, and 24.9% for eGFR <30 (likelihood-ratio test 2.59, P=0.63). The results were similar for the outcome of death. Conclusions-The present study is the largest pooled individual patient-level ESUS dataset, and does not provide evidence that renal function can be used to stratify the risk of ischemic stroke/TIA recurrence or death in patients with ESUS.
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| 5. |
- Ntaios, G., et al.
(författare)
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Risk Stratification for Recurrence and Mortality in Embolic Stroke of Undetermined Source
- 2016
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Ingår i: Stroke. - 0039-2499. ; 47:9, s. 2278-2285
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Tidskriftsartikel (refereegranskat)abstract
- Background and Purpose - The risk of stroke recurrence in patients with Embolic Stroke of Undetermined Source (ESUS) is high, and the optimal antithrombotic strategy for secondary prevention is unclear. We investigated whether congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and stroke or transient ischemic attack (TIA; CHADS 2) and CHA 2 DS 2 -VASc scores can stratify the long-term risk of ischemic stroke/TIA recurrence and death in ESUS. Methods - We pooled data sets of 11 stroke registries from Europe and America. ESUS was defined according to the Cryptogenic Stroke/ESUS International Working Group. Cox regression analyses were performed to investigate if prestroke CHADS 2 and congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or TIA, vascular disease, age 65-74 years, sex category (CHA 2 DS 2 -VASc) scores were independently associated with the risk of ischemic stroke/TIA recurrence or death. The Kaplan-Meier product limit method was used to estimate the cumulative probability of ischemic stroke/TIA recurrence and death in different strata of the CHADS 2 and CHA 2 DS 2 -VASc scores. Results - One hundred fifty-nine (5.6% per year) ischemic stroke/TIA recurrences and 148 (5.2% per year) deaths occurred in 1095 patients (median age, 68 years) followed-up for a median of 31 months. Compared with CHADS 2 score 0, patients with CHADS 2 score 1 and CHADS 2 score >1 had higher risk of ischemic stroke/TIA recurrence (hazard ratio [HR], 2.38; 95% confidence interval [CI], 1.41-4.00 and HR, 2.72; 95% CI, 1.68-4.40, respectively) and death (HR, 3.58; 95% CI, 1.80-7.12, and HR, 5.45; 95% CI, 2.86-10.40, respectively). Compared with low-risk CHA 2 DS 2 -VASc score, patients with high-risk CHA 2 DS 2 -VASc score had higher risk of ischemic stroke/TIA recurrence (HR, 3.35; 95% CI, 1.94-5.80) and death (HR, 13.0; 95% CI, 4.7-35.4). Conclusions - The risk of recurrent ischemic stroke/TIA and death in ESUS is reliably stratified by CHADS 2 and CHA 2 DS 2 -VASc scores. Compared with the low-risk group, patients in the high-risk CHA 2 DS 2 -VASc group have much higher risk of ischemic stroke recurrence/TIA and death, approximately 3-fold and 13-fold, respectively. © 2016 American Heart Association, Inc.
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| 8. |
- Ntaios, G, et al.
(författare)
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Small-vessel occlusion versus large-artery atherosclerotic strokes in diabetics: Patient characteristics, outcomes, and predictors of stroke mechanism
- 2016
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Ingår i: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881. ; 1:2, s. 108-113
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Tidskriftsartikel (refereegranskat)abstract
- Abstract Introduction: Diabetes mellitus exerts a detrimental effect on cerebral vasculature affecting both macrovasculature and microvasculature. However, although ischaemic stroke is typically included among macrovascular diabetic complications, it is frequently omitted from microvascular diabetic complications. We aimed to compare the proportion of large-artery atherosclerotic and small-vessel occlusion strokes among diabetic stroke patients, explore their differences and outcomes, and assess potential mechanisms which may determine why some diabetic patients suffer large-artery atherosclerotic stroke whereas others suffer small-vessel occlusion stroke. Methods: We pooled data of diabetic patients from four prospective ischaemic stroke registries (Acute Stroke Registry and Analysis of Lausanne (ASTRAL), Athens, Austrian, and Helsinki Stroke Thrombolysis Registries). Stroke severity and prognosis were assessed with National Institutes of Health Stroke Scale (NIHSS) and ASTRAL scores, respectively; functional outcome with three-month modified Rankin score (0–2 considered as favourable outcome). Logistic- regression analysis identified independent predictors of large-artery atherosclerotic stroke. Results: Among 5412 patients, 1069 (19.8%) were diabetics; of them, 232 (21.7%) had large-artery atherosclerotic and 205 (19.2%) small-vessel occlusion strokes. Large-artery atherosclerotic stroke had higher severity than small-vessel occlusion stroke (median NIHSS: 6 vs. 3, p < 0.001), worse prognosis (median ASTRAL score: 23 vs. 19, p < 0.001), and worse three-month outcome (60.3% vs. 83.4% with favourable outcome, p < 0.001). In logistic-regression analysis, peripheral artery disease (odds ratio: 4.013, 95% confidence interval: 1.667–9.665, p < 0.01) and smoking (odds ratio: 1.706, 95% confidence interval: 1.087–2.675, p < 0.05) were independently associated with large-artery atherosclerotic strokes. Conclusion: In the diabetic stroke population, small-vessel occlusion and large-artery atherosclerotic strokes occur with similar frequency. Large-artery atherosclerotic strokes are more severe and have worse outcome than small-vessel occlusion strokes. The presence of peripheral artery disease and smoking independently predicted large-artery athero- sclerotic stroke.
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