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Objectives To describe incidence, risk factors, and treatment of poststroke epilepsy (PSE) in Germany based on claims data. Methods Retrospective analysis of claims data from a German public sickness fund (AOK PLUS). Patients with acute stroke hospitalizations from January 01, 2011 and December 31, 2015 (index hospitalization) were followed for 12–72 months. Outcomes included incidence of PSE (patients with ≥2 seizure claims [during/after index hospitalization], or ≥1 seizure claim after index hospitalization), multivariate Cox‐regression analyses of time to seizure claim and death after index stroke hospitalization discharge, and antiepileptic drug (AED) treatment. Results Among 53 883 patients with stroke (mean follow‐up of 829.05 days [median 749]), 6054 (11.24%) had ≥1 seizure claim (mean age 73.95 years, 54.18% female). 2130 (35.18%) patients had a seizure claim during index hospitalization (indicative of acute symptomatic seizures). Estimated incidence of PSE (cases/1000 patient‐years) was 94.49 within 1 year. Risk of seizure claim following hospital discharge was higher in patients with hemorrhagic stroke (hazard ratio [HR] =1.13; p

Acute kidney injury is an expected adverse drug reaction listed in the European Union (EU) Summary of Product Characteristics (SmPC) for levetiracetam, one of the most widely used modern antiseizure medications (ASMs).We conducted a voluntary post-authorization safety study to characterize the rate of acute renal failure (ARF) in patients exposed to levetiracetam versus other ASMs.New users of ASMs without prior renal dysfunction were identified and followed for 30 days in the IBMOverall, 110,336 patients were eligible for the monotherapy cohort and 96,215 were eligible for the polytherapy cohort. The overall crude rate of ARF following a new ASM was 6.0 and 6.5 per 10,000 patients for the 'monotherapy' and 'polytherapy' cohorts, respectively, in the first 30 days after the index date. In the monotherapy cohort, the IRR for ARF was 1.37 (95% confidence interval [CI] 0.80-2.34) and the corresponding IRD was 2.0 (95% CI - 1.12 to 5.12) additional ARFs per 10,000 patient-months. In the polytherapy cohort, the adjusted IRR for ARF was 0.94 (95% CI 0.51-1.74) and the corresponding IRD was - 0.42 cases per 10,000 patient-months (95% CI - 4.01 to 3.17).The rate of ARFs in ASM new users was very low. In patients without prior ASMs, the estimated difference in risk of ARF associated with initiation of levetiracetam versus initiation of other ASMs was small, with 95% CIs compatible with small protective or harmful effects. In patients receiving polytherapy, the difference was compatible with the null and the 95% CI with small protective or harmful effects.

Rationale, aims, and objectives Several novel oral anticoagulants (NOACs) are licensed for atrial fibrillation (AF) treatment in the United Kingdom. We describe the incidence and mortality from ischaemic stroke and major bleeding in non-valvular atrial fibrillation (NVAF) patients in England, including treatment patterns before/following introduction of NOACs, healthcare resource utilization (HRU), and costs post-onset of these events. Method Data were extracted from the UK Clinical Practice Research Datalink linked to Hospital Episode Statistics secondary care and Office for National Statistics mortality data. Results Of 42 966 patients with a first AF record between 2011 and 2016, 9143 patients (21.3%) remained without AF (antiplatelets/antithrombotics) treatment post-index diagnosis. The proportion of patients receiving aspirin for ≥3 months post-index declined during the study (50.6%-5.5%), irrespective of CHA2 DS2 -VASc score, while the proportion prescribed NOACs increased (2.0%-70.1%). Rates of ischaemic stroke per 1000 patient-years (95% CI) were 9.4 (3.8-15.0) with NOACs, 10.4 (8.0-12.9) with warfarin, 20.1 (16.4-23.8) with aspirin, 21.3 (5.3-37.2) with other antiplatelets and 43.6 (39.3-47.8) in patients without AF prescription. Major bleeding occurred at a similar rate with different treatments. All-cause mortality rates were 42.8 (31.4-54.3) with NOACs, 46.3 (41.1-51.5) with warfarin, 56.5 (50.5-62.4) with aspirin, 102.2 (76.2-128.3) with other antiplatelets and 412.8 (399.6-426.0) with no AF prescription. Mean annual National Health Service healthcare costs up to 1 year post-index were lowest in patients receiving aspirin plus other antiplatelets without an event (£6152), and highest in patients with an event without AF prescriptions (£17 957). By extrapolation, national AF HRU in the United Kingdom in 2016 was estimated at £8-16 billion annually. Conclusions These data provide temporal insights into AF treatment patterns and outcomes for NVAF patients in England and highlight the need to review higher stroke risk AF patients not receiving antiplatelet/antithrombotic prescriptions.

Post-marketing surveillance for COVID-19 vaccines during the pandemic identified an extremely rare thrombosis with thrombocytopenia syndrome (TTS) reported post-vaccination, requiring further characterisation to improve diagnosis and management.We searched the AstraZeneca Global Safety Database (through April 26, 2021) for cases with co-reported thrombocytopenia and thrombosis (using standardised MedDRA queries/high-level terms) following AZD1222 (ChAdOx1 nCoV-19). Cases were adjudicated by experts as 'typical','possible', 'no' or 'unknown' according to available TTS criteria. Additional confirmatory datasets (May 20-June 20, October 1-December 28) were evaluated.We identified 573 reports, including 273 (47.6 %) 'typical' and 171 (29.8 %) 'possible' TTS cases. Of these 444 cases, 275 (61.9 %) were female, median age was 50.0 years (IQR: 38.0-60.0). Cerebral venous sinus thrombosis was reported in 196 (44.1 %) cases, splanchnic venous thrombosis in 65 (14.6 %) and thromboses at multiple sites in 119 (26.8 %). Median time to onset was 12.0 days (IQR: 9.0-15.0). Comparison with a pre-pandemic reference population indicated higher rates of autoimmune disorders (13.8 %, 4.4 %), previous heparin therapy (7.4 %, 1.2 %), history of thrombosis (5.5 %, 1.4 %), and immune thrombocytopenia (6.1 %, 0.2 %). Fatality rate was 22.2 % (127/573) overall and 23.6 % (105/444) in 'typical'/'possible' TTS, which decreased from 39.0 % (60/154) in February/March to 15.5 % (45/290) in April. Overall patterns were similar in confirmatory datasets.The reporting rate of 'typical'/'possible' TTS post first-dose vaccination in this dataset is 7.5 per million vaccinated persons; few cases were reported after subsequent doses, including booster doses. Peak reporting coincided with media-driven attention. Medical history differences versus a reference population indicate potentially unidentified risk factors. The decreasing fatality rate correlates with increasing awareness and publication of diagnostic/treatment guidelines. Adjudication was hindered by unreported parameters, and an algorithm was developed to classify potential TTS cases; comprehensive reporting could help further improve definition and management of this extremely rare syndrome.

INTRODUCTION: There is little evidence about gastrointestinal (GI) disorders in patients with schizophrenia. We examined association of schizophrenia with upper GI bleeding (UGIB) and nonbleeding ulcers and associated risk factors and mortality.METHODS: We used the data linked from population-based registries in Denmark. Among patients with incident schizophrenia in 1980-2011, we computed cumulative incidences and standardized incidence ratios of UGIB, bleeding ulcers, and nonbleeding ulcers compared with the general population; evaluated risk factors for the 3 GI endpoints, including somatic and psychiatric comorbidity; and examined subsequent all-cause mortality.RESULTS: Among 39,998 patients with schizophrenia, the standardized incidence ratios were 2.92 (95% confidence interval (CI), 2.76-3.08) for UGIB, 2.36 (95% CI, 2.15-2.58) for bleeding ulcers, and 2.00 (95% CI, 1.87-2.15) for nonbleeding ulcers. Risk factors for UGIB and nonbleeding ulcers included age, somatic comorbidity, and medication use. UGIB and nonbleeding ulcers were associated with the subsequent increase in mortality.CONCLUSIONS: Schizophrenia is associated with an increased risk of UGIB and nonbleeding ulcers, whose risk factors in patients with schizophrenia are similar to those in the general population.

Background Aim was to estimate the age and sex-stratified prevalence of Down's syndrome (DS) in the United Kingdom (UK) general population using a large primary care database. Method Data source was the Clinical Practice Research Datalink. We divided the number of individuals with a record of DS present on 01/07/2014 by the total number of individuals, and computed Wilson's confidence intervals. Prevalence by age and sex was represented using local linear smoothing plots. Results On July 1st 2014, 1159 females and 1317 males with DS were present in the data, corresponding to a prevalence of 5.9 per 10 000 (95% CI: 5.5; 6.2) in females and 6.8 (6.5; 7.2) per 10 000 in males. Prevalence of DS was increased in individuals aged 40 to 55 years compared to adjacent age groups. Conclusions A relative peak prevalence of DS at age 40–55 years may be attributed to the combined effects of a rise in life expectancy and the still limited availability of selective abortion.

Background: This study estimated the risk of infection-related hospitalizations and death in patients with and without multiple sclerosis (MS). Methods: We identified adults with MS in the US Department of Veterans Affairs (VA) system between 1999 and 2010. Each veteran with MS was matched, on age and sex, with up to four veterans without MS. Multivariable Cox proportional hazards regression models were performed to assess the influence of MS on the development of serious and fatal infections. Results: The cohort included 7743 veterans with MS and 30,972 veterans without MS. Mean (SD) age was 53.8 (13.3) years, and 80.8% were male. The incidence per 1000 person-years of overall serious infections was 19.2 (95% confidence interval [CI], 17.6–20.8) for those with MS and 10.3 (95% CI, 9.8–10.9) for those without MS. Fatal infection incidence rates were 1.2 (95% CI, 0.8–1.7) for patients with MS and 0.5 (95% CI, 0.3–0.6) for patients without MS. Regression models showed that veterans with MS were at greater risk for overall serious (hazard ratio [HR] = 1.52, P < .01) and fatal (HR = 1.85, P = .03) infections and serious respiratory (HR = 1.31, P = .01), urinary tract (HR = 4.44, P < .01), and sepsis-related infections (HR = 2.56, P < .01). Conclusions: This study provides evidence that VA patients with MS are more likely than those without MS to be hospitalized and die of infection.

INTRODUCTION: The European Medical Information Framework consortium has assembled electronic health record (EHR) databases for dementia research. We calculated dementia prevalence and incidence in 25 million persons from 2004 to 2012. METHODS: Six EHR databases (three primary care and three secondary care) from five countries were interrogated. Dementia was ascertained by consensus harmonization of clinical/diagnostic codes. Annual period prevalences and incidences by age and gender were calculated and meta-analyzed. RESULTS: The six databases contained 138,625 dementia cases. Age-specific prevalences were around 30% of published estimates from community samples and incidences were around 50%. Pooled prevalences had increased from 2004 to 2012 in all age groups but pooled incidences only after age 75 years. Associations with age and gender were stable over time. DISCUSSION: The European Medical Information Framework initiative supports EHR data on unprecedented number of people with dementia. Age-specific prevalences and incidences mirror estimates from community samples in pattern at levels that are lower but increasing over time. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under European Medical Informatics Framework (EMIF) grant agreement no. 115372, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and European Federation of Pharmaceutical Industries and Associations (EFPIA) companies’ in kind contribution. R.S. and G.P. are partly funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London.

Aim The aim of this study was to describe the incidence of morbidities and the prevalence of medical prescriptions in a large Down syndrome population. Method A retrospective cohort study was carried out using the UK Clinical Practice Research Datalink from 1 January 2004 to 31 December 2013. We matched individuals with Down syndrome to randomly selected control participants by practice site, sex, birth year, and recording period. Results A total of 6430 individuals with Down syndrome (3009 females, 3421 males) and 19 176 controls (8966 females, 10 210 males) were included in the study. The incidence of cardiovascular disorders, gastrointestinal diseases (incidence rate ratio [IRR] 7.9 at 3 to