Epidemiology, real-world treatment and mortality of patients with status epilepticus in Germany: insights from a large healthcare database.

Status epilepticus is a life-threatening emergency, and to date, few studies have reported on its long-term treatment and outcomes. This study aimed to estimate the incidence, the treatment and outcomes, the healthcare resource utilization and the costs of status epilepticus in Germany. Data from 2015 to 2019 were obtained from German claims (AOK PLUS). Patients with ≥1 status epilepticus event and no event in the preceding 12 months (baseline) were included. A subgroup of patients with an epilepsy diagnosis during baseline was also analysed. Of the 2782 status epilepticus patients (mean age = 64.3 years; 52.3% female), 1585 (57.0%) were previously diagnosed with epilepsy. The age- and sex-standardized incidence was 25.5 cases/100 000 persons in 2019. The mortality rate after 12 months was 39.8% overall (19.4% and 28.2% after 30 and 90 days, respectively) and 30.4% in the epilepsy patient subgroup. Factors associated with higher mortality were age, comorbidity status, presence of brain tumours and an acute stroke. An epilepsy-related hospitalization at onset of or 7 days prior to the status epilepticus event as well as prescription of antiseizure medication during baseline was associated with a better survival rate. Overall, 71.6% of patients (85.6% in the epilepsy subgroup) were prescribed with out-patient antiseizure medication and/or rescue medication within 12 months. All patients sustained on average 1.3 status epilepticus-related hospitalizations (20.5% had more than one) during a mean follow-up period of 545.2 days (median 514 days); total direct costs including in-patient and out-patient status epilepticus treatments were 10 826€ and 7701€ per patient-year overall and for the epilepsy patient subgroup, respectively. The majority of status epilepticus patients received an out-patient treatment in line with epilepsy guidelines, and patients previously diagnosed with epilepsy have a higher likelihood to receive it. The mortality in the affected patient population is high; risk factors were older age, higher comorbidity burden, the presence of brain tumours or an acute stroke.

Osteoporotic fractures and subsequent fractures: imminent fracture risk from an analysis of German real-world claims data.

PURPOSE: In osteoporosis, prior fracture is a strong predictor of subsequent fracture. This study aimed to assess the imminent risk of subsequent fracture following an initial fracture in osteoporosis patients in Germany, and to identify clinical and demographic characteristics that are independently associated with subsequent fracture risk. METHODS: In this retrospective, observational cohort study using German real-world claims data, male and female patients aged ≥ 50 years with osteoporosis who experienced an initial ("index") hip/femur, vertebral, forearm/wrist/hand or shoulder/upper arm fracture between 2010 and 2014 were included. The incidence and timing of subsequent fractures during a 1-year follow-up period were analyzed. Independent risk factors for subsequent fracture were identified by multivariate regression analysis. RESULTS: A total of 18,354 patients (mean age: 77 years; standard deviation: 9.8) were included. Of these, 2918 (15.9%) suffered a subsequent fracture during the 1-year follow-up period. The incidence of subsequent fracture was higher following an index vertebral fracture (18.0%) than after an index forearm/wrist/hand fracture (14.1%) or index hip/femur fracture (12.1%). Subsequent 1-year fracture incidence was generally higher in older patients. Index fracture type, age, epilepsy/use of antiepileptics, and heart failure were all independently associated with subsequent fracture risk. CONCLUSION: Osteoporosis patients in Germany are at imminent risk of subsequent fracture during the first year following an initial fracture. They should be targeted for immediate post-fracture treatment to reduce the risk of further fractures, especially in the presence of specific risk factors such as old age or index vertebral fracture.

Poststroke epilepsy incidence, risk factors and treatment: German claims analysis.

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 <.001) vs those with cerebral infarction. Seizure claim during index hospitalization was a risk factor for seizure claims after hospital discharge (HR =6.97; p <.001) and early death (HR =1.78; p <.001). In the first year of follow-up, AEDs were prescribed in 73.75% of patients with seizure claims. CONCLUSIONS: Incidence of PSE was in line with previous studies. Hemorrhagic stroke and seizure claim during index hospitalization were risk factors for seizure claims after hospital discharge. Most patients with seizure claims received AED treatment.

Real-world treatment and fracture incidence in postmenopausal women with severe osteoporosis at high risk of fracture: a retrospective claims data analysis.

Background: Osteoporosis (OP) and its associated fractures have a significant impact on patients' quality of life and are impacting their morbidity and mortality. For OP patients at high risk of fracture, guidelines recommend a pharmacological OP treatment. The aim of this study was to describe the real-world medication treatment of postmenopausal women with severe OP at high risk of fracture, their risk to experience a new fracture after having at least one previous fracture, and to assess the associated healthcare resource use (HCRU). Methods: This retrospective cohort study was based on anonymized German claims data (AOK PLUS). All included OP patients were female, ≥55 years old, and had a vertebral and/or femoral fracture. We conducted a cross-sectional analysis in 2018 and a longitudinal analysis, starting with an incident vertebral/femoral fracture (after or simultaneously with the first observed OP diagnosis). In both analyses, patient characteristics, rate of new incident fractures, OP treatment patterns, and HCRU associated with the treatment of patients were investigated. Results: In the cross-sectional setting, 12,180 patients with a mean age of 83.59 years were observed. Of these patients, 14.30% sustained at least one new incident fracture and 34.54% received a pharmaceutical OP treatment during 2018. In this year, 58.50% of the patients had at least one OP-related outpatient visit, and 26.35% had a fracture-related visit. In 160 patients (1.31%), at least one OP-related hospitalization was documented, and in 1,293 patients (10.62%) a fracture-related hospitalization in 2018. In the longitudinal setting, 10,323 patients with a mean age of 83.22 years were included. Of these, 18.96% experienced at least one new incident fracture within the first 12 months after the index fracture, and in total 30.85% in the entire follow-up period (mean 2.03 years). During the 12-month baseline period, 22.12% of the patients received an OP treatment. Three months after the index fracture, the proportion of treated patients remained at 22.30%. During the total follow-up time, 35.54% were prescribed with an OP treatment. Conclusion: We observed a considerable proportion of untreated patients and a high rate of subsequent fractures. The awareness for a proper risk assessment and the appropriate use of available treatments should be increased.

Estimated epidemiology of osteoporosis diagnoses and osteoporosis-related high fracture risk in Germany: a German claims data analysis.

In 2016, an estimated 143,967 female and 25,315 male patients had a diagnosis of osteoporosis, accounting for 4.44% of the German population. Due to an aging population, an increase in the number of osteoporosis patients and osteoporotic fractures can be expected, posing a substantial burden on healthcare systems. PURPOSE: Osteoporosis is one of the most prevalent diseases in developed countries, mainly affecting older adults. It leads to decreased bone mass, bone microarchitecture deterioration, and increased risk of fracture. This epidemiological study investigated the prevalence and incidence of osteoporosis diagnoses and assessed the number of osteoporosis patients who are at high risk of vertebral/femoral fracture. METHODS: We analyzed German claims data (AOK PLUS) covering 2010-2016. All included patients were diagnosed with osteoporosis (ICD-10 M80.*/M81.*). Vertebral/femoral and other fractures were identified based on respective ICD-10 codes. Patient numbers were extrapolated to the entire German population, based on patient age and gender. RESULTS: In 2016, 169,282 patients (143,967 females and 25,315 males) had prevalent osteoporosis, 25,996 (20,425 females and 5571 males) of which were newly diagnosed that year. Extrapolated prevalence for Germany was 3.61 million patients (4.44% of the German population). Extrapolated incidence was 0.62 million patients. Of patients with prevalent osteoporosis, 13,613 experienced an incident vertebral/femoral fracture in 2016 (German extrapolation: 258,957 patients). Of these, 36.88% received an osteoporosis treatment that year. CONCLUSION: Our study identified a high number of prevalent and incident patients with osteoporosis claims in Germany. The increasing age of the German population will likely lead to a significant increase in the number of patients with osteoporosis over the next decades. Treatment of osteoporosis patients with high fracture risk, especially those with a recent vertebral/femoral fracture, should be of particular focus, as a substantial proportion does not receive a guideline-based treatment.

Real life pharmaceutical treatment patterns for adult patients with focal epilepsy in Germany: a longitudinal and cross-sectional analysis of recently approved anti-epileptic drugs.

Objectives: The aim of this study was to investigate the antiepileptic drug (AED) treatment of adults suffering from focal epilepsies (FE) in Germany. Of special interest was the number and percentage of the patients 16 years and older receiving no treatment with an AED, treatment with one AED (monotherapy), treatment with more than one AED, and treatment with a novel AED. The definition for "novel" was newly approved at the time of market entry since 2006 (last 10 years): eslicarbazepine (ESL), lacosamide (LCM), perampanel (PER), and retigabine (RTG). Methods: The analysis was based on a claims data set covering the years 2007 to 2014, provided by AOK PLUS, a German statutory health insurance. Two patient samples were defined: (1) prevalent patients suffering from FE (at least one in- or outpatient diagnosis of FE and at least one prescription of an AED), and (2) incident FE patients (first in- or outpatient diagnosis of FE without any previous diagnoses/AED prescriptions in the preceding 6 months). Patient observation started at date of first observed inpatient or outpatient focal epilepsy diagnosis within the analyzed period. Each patient was classified as a "no AED therapy", "AED monotherapy" or "more than one AED therapy". Patients were analyzed by number and type of concomitantly prescribed AEDs in yearly tranches (no, one, two, three, four, more than four AEDs; novel versus non-novel AEDs). Results: A total of 34,422 patients diagnosed with FE aged 16 year or older (mean age 59.6 years, 48.7% female) were identified. The mean follow-up period was 1,891 days (5.2 years) since first confirmed diagnosis. The percentage of prevalent patients diagnosed with FE who received one AED (monotherapy) was stable overall and ranged between a minimum of 66.2% (2007) and a maximum of 68.9% (2010). The percentage of patients who received two AEDs ranged from 23.6% (2012) to 25.8% (2007). The remaining patients received therapies with three (6.0% in 2010 to 6.7% in 2007), four (1.0% in 2010 to 1.2% in 2009) or more than four AEDs (0.1% in 2014 to 0.3% in 2013). Between 8.1%-16.6% (2007; 2014) of the patients received no AED therapy in the observed period. In the first year after the diagnosis of FE (incident patients), 9.7% of patients didn't receive any AED therapy. Of those treated with at least one AED, 80.0% received one AED (monotherapy) only, 17.0% received therapy with two AEDs, 2.6% with three AEDs, 0.3% with four AEDs, and 0.1% with >4 AEDs during the respective observation time window and remained stable throughout the four-year follow-up period. Of prevalent patients with a diagnosis of FE, 1,889 (5.5%) received at least one prescription of a novel AED during the observation period; 98.6% of these patients received the novel AED in combination with at least one other AED. Of those patients, 269 (14.2%) received >1 novel AED. The analysis of the patients receiving novel AEDs by the time from the first confirmed diagnosis of FE until the prescription of a novel AED resulted in a mean duration of 4.0 years (SD 2.0) for ESL, 3.6 years (SD 2.2) for LCM, 5.7 years (SD 1.2) for PER, and 4.6 years (SD 0.8 years) for RTG. The mean number of AEDs prescribed before the novel AEDs were 3.2 for ESL, 2.4 for LCM, 5.0 for PER and 5.2 for RTG. Conclusions: Most patients aged 16 years or older, suffering from focal seizures, received AED monotherapy. Novel AEDs were prescribed in a small proportion of patients (<6%) and relatively late in the treatment course. These results are consistent with the recommendations of the German Society for Epileptology (Deutsche Gesellschaft für Epileptologie, DGfE) which suggests a number of monotherapy options - these options do not include the novel AEDs described in this study.