Safety and survival of docetaxel and cabazitaxel in metastatic castration-resistant prostate cancer.

OBJECTIVES: To investigate real-world haematological toxicity, overall survival (OS) and the treatment characteristics of docetaxel and cabazitaxel chemotherapy in metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: This retrospective claims data study followed patients with mCRPC receiving cabazitaxel or docetaxel from their first chemotherapy infusion. Haematological toxicities were measured using treatment codes and inpatient diagnoses. OS was estimated using the Kaplan-Meier method. A multivariable Cox regression analysis was used to identify OS predictors. RESULTS: Data from 539 patients administered docetaxel and 240 administered cabazitaxel were analysed. Regarding adverse events, within 8 months of treatment initiation, some kind of treatment for haematological toxicity was documented in 31% of patients given docetaxel and in 61% of patients given cabazitaxel. In the same period, hospitalization associated with haematological toxicity was documented in 11% of the patients in the docetaxel cohort and in 15% of the patients in the cabazitaxel cohort. In the docetaxel cohort, 9.9% of patients required reverse isolation and 13% were diagnosed with sepsis during hospitalization. In the cabazitaxel cohort, the cumulative incidence was 7.9% and 15%, respectively. The median OS was reached at 21.9 months in the docetaxel cohort and, because of a later line of therapy, at 11.3 months in the cabazitaxel cohort. A multivariate Cox regression revealed that indicators of locally advanced and metastatic disease, severe comorbidities, and prior hormonal/cytotoxic therapies were independent predictors of early death. CONCLUSION: Cabazitaxel patients face an increased risk of haematological toxicities during treatment. Together with their short survival time, this calls for a strict indication when using cabazitaxel in patients with mCRPC.

Prevalence and Medications of Atopic Dermatitis in Germany: Claims Data Analysis.

BACKGROUND: Information on the prevalence of atopic dermatitis (AD) varies greatly, and so far, only a few studies describe the healthcare of patients with AD in Germany. OBJECTIVE: The aim of the study is to describe the prevalence and medications of people with AD in Germany. METHODS: Health insurance data for the year 2019 were examined. Prevalence rates, the severity of disease, comorbidities and pharmaceutical supply were analyzed. Insured persons with AD were identified with at least one outpatient or inpatient International Classification Code of Diseases (L20). RESULTS: In 2019, 4.21% [95% CI 4.21-4.22%] of insured persons had AD (3.6 million). Women were affected slightly more frequently than men (4.74% [95% CI 4.73-4.74%] and 3.64% [95% CI 3.64-3.65%]). Adolescents and children under the age of 15 had the highest prevalence of AD compared to other age groups (9.44% [95% CI 9.42-9.46%]). Majority of the insured persons with AD were affected by a mild to moderate form of the disease. The most common co-morbidity was infections of the skin (RR 5.00 [95% CI 4.97-5.02%]). Some patients were treated by a dermatologist, while others by a general practitioner, 39.10% and 36.74%, respectively. Of the anti-inflammatory drugs, systemic glucocorticosteroids preparations were used most frequently and were most frequently prescribed by the general practitioner. With a total of 42,841 prescriptions (1.53%), methotrexate (third-line treatment option) was prescribed more frequently than ciclosporin with 19,628 prescriptions (0.70%) or azathioprine with 25,696 prescriptions (0.92%). Ciclosporin (first-line treatment option) was prescribed much more frequently by a dermatologist (44.00% versus 14.32% by general practitioner). The biological dupilumab was prescribed 30,801 times (1,10%) and was also primarily prescribed by a dermatologist (66.67%). CONCLUSION: The present results reveal that a specialist treats approximately one-third of the patients with AD and that there is still a drug undersupply in some cases, especially concerning innovative drugs.

Treatment-Related Healthcare Costs of Metastatic Castration-Resistant Prostate Cancer in Germany: A Claims Data Study.

PURPOSE: Treatments for patients with metastatic castration-resistant prostate cancer (mCRPC) have expanded rapidly. They include the chemotherapies docetaxel and cabazitaxel, hormonal drugs abiraterone and enzalutamide, and best supportive care (BSC). Cabazitaxel has proven to be the last life-prolonging option, associated with a significant risk of serious adverse events. Given the lack of real-world evidence, we aimed to compare healthcare resource utilization (HRU) and costs in patients with mCRPC treated with cabazitaxel, docetaxel, abiraterone, enzalutamide, and BSC. METHODS: We used 2014-2017 claims data from a large German statutory health insurance fund, the Techniker Krankenkasse, to identify patients with mCRPC. Patient allocation to individual therapy regimens was based on clinical knowledge and included therapy cycles, duration of therapy, and continuous treatment. The study period lasted from the first claim until death, the end of data availability, a drug switch, or discontinuation of therapy, whichever came first. Multivariate regression models were used to compare monthly all-cause and mCRPC-related HRU and costs across cohorts by adjusting for baseline covariates (including age and comorbidities). RESULTS: The 3944 identified patients with mCRPC initiated treatment with cabazitaxel (n = 240), docetaxel (n = 539), abiraterone (n = 486), enzalutamide (n = 351), or BSC (n = 2328). In most domains, HRU was highest in the cabazitaxel cohort and lowest in the BSC group. Accordingly, the highest all-cause and mCRPC-related costs per month, respectively, were observed in patients receiving cabazitaxel (€7631/€6343), followed by abiraterone (€5226/€4579), enzalutamide (€5079/€4416), docetaxel (€2392/€1580), and BSC (€959/€438). Cost variations were mostly attributable to drugs, inpatient treatment, and sick leave payments. CONCLUSION: mCRPC treatment imposes a high economic burden on statutory health insurance. Cabazitaxel is associated with substantially higher expenses, resulting from higher drug costs and a greater need for inpatient treatment. As mCRPC continues to be incurable, decision makers and clinician leaders should carefully evaluate public access to innovative agents and optimal treatment strategies.

The interplay of context factors in hypnotic and sedative prescription in primary and secondary care-a qualitative study.

PURPOSE: Non-medical or contextual factors strongly influence physicians' prescribing behavior and may explain why drugs, such as benzodiazepines and Z-drugs, are still frequently prescribed in spite of well-known adverse effects. This study aimed to explore which contextual factors influence the prescription of hypnotics and sedatives and to compare their role in primary and secondary care. METHODS: Understanding medical practices as games with specific rules and strategies and performed in a largely habitual, not fully conscious manner, we asked a maximum variation sample of 12 hospital doctors and 12 general practitioners (GPs) about their use of hypnotics and sedatives. The interviews were analyzed by qualitative content analysis. RESULTS: Hospital doctors' and GPs' use of hypnotics and sedatives was influenced by a variety of contextual factors, such as the demand of different patient groups, aims of management, time resources, or the role of nurses and peers. Negotiating patient demands, complying with administrative regulations, and finding acceptable solutions for patients were the main challenges, which characterized the game of drug use in primary care. Maintaining the workflow in the hospital and finding a way to satisfy both nurses and patients were the main challenges in secondary care. CONCLUSIONS: Even if doctors try to act rationally, they cannot escape the interplay of contextual factors such as handling patient needs, complying with administrative regulations, and managing time resources. Doctors should balance these factors as if they were challenges in a complex game and reflect upon their own practices.

A multi-national comparison of antipsychotic drug use in children and adolescents, 2005-2012.

Over the last decades, an increase in antipsychotic (AP) prescribing and a shift from first-generation antipsychotics (FGA) to second-generation antipsychotics (SGA) among youth have been reported. However, most AP prescriptions for youth are off-label, and there are worrying long-term safety data in youth. The objective of this study was to assess multinational trends in AP use among children and adolescents. A repeated cross-sectional design was applied to cohorts from varied sources from Denmark, Germany, the Netherlands, the United Kingdom (UK) and the United States (US) for calendar years 2005/2006-2012. The annual prevalence of AP use was assessed, stratified by age group, sex and subclass (FGA/SGA). The prevalence of AP use increased from 0.78 to 1.03% in the Netherlands' data, from 0.26 to 0.48% in the Danish cohort, from 0.23 to 0.32% in the German cohort, and from 0.1 to 0.14% in the UK cohort. In the US cohort, AP use decreased from 0.94 to 0.79%. In the US cohort, nearly all ATP dispensings were for SGA, while among the European cohorts the proportion of SGA dispensings grew to nearly 75% of all AP dispensings. With the exception of the Netherlands, AP use prevalence was highest in 15-19 year-olds. So, from 2005/6 to 2012, AP use prevalence increased in all youth cohorts from European countries and decreased in the US cohort. SGA were favoured in all countries' cohorts.

Trends in ADHD medication use in children and adolescents in five western countries, 2005-2012.

Over the last two decades, the use of ADHD medication in US youth has markedly increased. However, less is known about ADHD medication use among European children and adolescents. A repeated cross-sectional design was applied to national or regional data extracts from Denmark, Germany, the Netherlands, the United Kingdom (UK) and the United States (US) for calendar years 2005/2006-2012. The prevalence of ADHD medication use was assessed, stratified by age and sex. Furthermore, the most commonly prescribed ADHD medications were assessed. ADHD medication use prevalence increased from 1.8% to 3.9% in the Netherlands cohort (relative increase: +111.9%), from 3.3% to 3.7% in the US cohort (+10.7%), from 1.3% to 2.2% in the German cohort (+62.4%), from 0.4% to 1.5% in the Danish cohort (+302.7%), and from 0.3% to 0.5% in the UK cohort (+56.6%). ADHD medication use was highest in 10-14-year olds, peaking in the Netherlands (7.1%) and the US (8.8%). Methylphenidate use predominated in Europe, whereas in the US amphetamines were nearly as common as methylphenidate. Although there was a substantially greater use of ADHD medications in the US cohort, there was a relatively greater increase in ADHD medication use in youth in the four European countries. ADHD medication use patterns in the US differed markedly from those in western European countries.

Epidemiology and use of compression treatment in venous leg ulcers: nationwide claims data analysis in Germany.

Chronic venous diseases are the most common causes of leg ulcers. Compression treatment (CT) is a central component of venous leg ulcer (VLU) therapy along with prevention based on guidelines and clinical evidence. However, large-scale data on the use of CT are rare. In particular, there have not yet been published nationwide data for Germany. We analysed data from a large German statutory health insurance (SHI) on incident VLU between 2010 and 2012. VLUs were identified by ICD-10 diagnoses. The status of active disease was defined by wound-specific treatments. Compression stockings and bandages were identified by SHI medical device codes. The overall estimated incident rate of active VLU of all insured persons was 0·34% from 2010 to 2012. Adapted to the overall German population, n = 229 369 persons nationwide had an incident VLU in 2010-2012. Among all VLU patients, only 40·6% received CT within 1 year, including 83·3% stockings, 31·8% bandages and 3·1% multi-component compression systems. Compression rates showed significant differences by gender and age. Large regional variations were observed. Validity of data is suggested by high concordance with a primary cohort study. Although recommended by guidelines, there is still a marked under-provision of care, with CT in incident VLUs in Germany requiring active measures.

[Trends in pharmaceutical care for men]. / Trends in der Arzneimittelversorgung von Männern.

Over the past few years, perceptible changes - both fundamental and specific - have taken place in pharmaceutical care for men. While the most striking difference persists, namely that between somatic drug therapies for men and drugs for the treatment of psychological disorders and diseases, the large discrepancies that long existed between the quantities prescribed for men and women have meanwhile not only evened out, but men are even prescribed larger quantities than women if they undergo drug therapy. An analysis of the drugs prescribed particularly for men revealed that they are primarily prescribed for the treatment of cardiovascular diseases (hypertension and cardiac insufficiency) and metabolic disorders (diabetes, gout), especially in elderly patients. The evaluation also showed that the drugs prescribed most frequently for younger men also included psychostimulants and antidepressants, such as SSRIs, for diagnoses of ADHD and depression.Besides these prescribed medicaments, other drugs must also be taken into account that reflect men's gender-specific everyday needs. These include drugs for treating erectile dysfunction, hair growth products or drugs for male menopause or to build muscle. The sometimes serious undesired effects of these products are often given small attention because of the desired benefit of supporting the perceived male role. While hormones are widely used in anabolic steroids, the use of hormones in contraceptive pills for men is evidently still far away from the aforementioned trends in pharmaceutical care for men.

Cross-border comparison of antibiotic prescriptions among children and adolescents between the north of the Netherlands and the north-west of Germany.

BACKGROUND: Antibiotic resistance is a worldwide problem and inappropriate prescriptions are a cause. Especially among children, prescriptions tend to be high. It is unclear how they differ in bordering regions. This study therefore examined the antibiotic prescription prevalence among children in primary care between northern Netherlands and north-west of Germany. METHODS: Two datasets were used: The Dutch (IADB) comprises representative data of pharmacists in North Netherland and the German (BARMER GEK) includes nationwide health insurance data. Both were filtered using postal codes to define two comparable bordering regions with patients under 18 years for 2010. RESULTS: The proportion of primary care patients receiving at least one antibiotic was lower in northern Netherlands (29.8 %; 95 % confidence interval [95 % CI]: 29.3-30.3), compared to north-west Germany (38.9 %; 95 % CI: 38.2-39.6). Within the respective countries, there were variations ranging from 27.0 to 44.1 % between different areas. Most profound was the difference in second-generation cephalosporins: for German children 25 % of the total prescriptions, while for Dutch children it was less than 0.1 %. CONCLUSIONS: This study is the first to compare outpatient antibiotic prescriptions among children in primary care practices in bordering regions of two countries. Large differences were seen within and between the countries, with overall higher prescription prevalence in Germany. Considering increasing cross-border healthcare, these comparisons are highly valuable and help act upon antibiotic resistance in the first line of care in an international approach.

Trends and patterns of antidepressant use in children and adolescents from five western countries, 2005-2012.

Following the FDA black box warning in 2004, substantial reductions in antidepressant (ATD) use were observed within 2 years in children and adolescents in several countries. However, whether these reductions were sustained is not known. The objective of this study was to assess more recent trends in ATD use in youth (0-19 years) for the calendar years 2005/6-2012 using data extracted from regional or national databases of Denmark, Germany, the Netherlands, the United Kingdom (UK), and the United States (US). In a repeated cross-sectional design, the annual prevalence of ATD use was calculated and stratified by age, sex, and according to subclass and specific drug. Across the years, the prevalence of ATD use increased from 1.3% to 1.6% in the US data (+26.1%); 0.7% to 1.1% in the UK data (+54.4%); 0.6% to 1.0% in Denmark data (+60.5%); 0.5% to 0.6% in the Netherlands data (+17.6%); and 0.3% to 0.5% in Germany data (+49.2%). The relative growth was greatest for 15-19 year olds in Denmark, Germany and UK cohorts, and for 10-14 year olds in Netherlands and US cohorts. While SSRIs were the most commonly used ATDs, particularly in Denmark (81.8% of all ATDs), Germany and the UK still displayed notable proportions of tricyclic antidepressant use (23.0% and 19.5%, respectively). Despite the sudden decline in ATD use in the wake of government warnings, this trend did not persist, and by contrast, in recent years, ATD use in children and adolescents has increased substantially in youth cohorts from five Western countries.

Epidemiology of chronic wounds in Germany: Analysis of statutory health insurance data.

Epidemiologic analyses in routine care of chronic wounds are scarce, and published studies show wide variations. This study analyzes the population-based prevalence and incidence of chronic wounds in Germany. Secondary analyses of data from a German statutory health insurance with about 9 million insured persons were examined (2010 to 2012). Internal diagnostic validations were used to control for different inclusion criteria. In 2012, 1.04% (95% CI 1.03-1.05) of insured patients had a wound diagnosis, including 0.70% with leg ulcers and 0.27% with diabetic ulcers. Wound treatment was received by 0.43% (0.43-0.44) of patients. Prevalence and incidence increased over 3 years. Extrapolated to the German population, there were 786,407 prevalent and 196,602 incident chronic wounds, including 326,334/172,026 patients who underwent wound-relevant treatment in 2012. There is an annually increasing frequency of chronic wounds in Germany. Chronic wound epidemiology is sensitive to wound treatment as a filter criterion.

Epidemiology and Comorbidity in Children with Psoriasis and Atopic Eczema.

BACKGROUND: First studies have shown that juvenile psoriasis is associated with an increased prevalence of comorbidity. OBJECTIVES: We carried out a data analysis to characterise the profiles of comorbidity in children with psoriasis and atopic eczema. METHODS: Prevalence data were derived from the database of a German statutory health insurance company according to ICD-10 codes L40 (psoriasis) and L20 (atopic eczema) of children up to 18 years insured in 2009. RESULTS: Data sets included 1.64 million persons and 293,181 children. 1,313 children = 0.45% (0.42-0.47) had a diagnosis of psoriasis and 30,354 = 10.35% (10.24-10.47) had a diagnosis of atopic eczema. Obesity, hyperlipidaemia, arterial hypertension and diabetes were more often diagnosed in children with psoriasis in comparison to all children without psoriasis and to those with atopic eczema. CONCLUSION: Children with psoriasis and atopic eczema show different and specific patterns of comorbidity which should be detected early and treated adequately.

Trends in psychopharmacologic treatment of tic disorders in children and adolescents in Germany.

Data on medical treatment of children and adolescents with tic disorders are scarce. This study examined the administrative prevalence of psychopharmacological prescriptions in this patient group in Germany. Data of the largest German health insurance fund were analysed. In outpatients aged 0-19 years with diagnosed tic disorder, psychotropic prescriptions were evaluated for the years 2006 and 2011. In 2011, the percentage of psychotropic prescriptions was slightly higher than in 2006 (21.2 vs. 18.6%). The highest prescription prevalence was found in Tourette syndrome (51.5 and 53.0%, respectively). ADHD drugs were most frequently prescribed, followed by antipsychotics. In 2011, prescriptions of second generation antipsychotics (SGA) were higher and prescriptions of first generation antipsychotics (FGA) lower than in 2006. Concerning prescribed antipsychotic substances, in 2011 risperidone prescriptions were higher and tiapride prescriptions lower. Paediatricians issued 37.4%, and child and adolescent psychiatrists issued 37.1% of psychotropic prescriptions. The FGA/SGA ratio was highest in GPs (1.25) and lowest in child and adolescent psychiatrists (0.96). From 2006 to 2011, there was only a slight increase in psychotropic prescriptions for children and adolescents with a diagnosis of tic disorder in Germany, which stands in contrast towards the significant increase in psychotropic prescriptions in other child and adolescent psychiatric disorders (e.g. ADHD). There were marked differences in treatment patterns by tic disorder subgroups, with Tourette syndrome patients receiving most frequently psychopharmacotherapy. Risperidone prescriptions increased, probably reflecting a switch in prescribing practice towards up-to-date treatment guidelines. In primary care physicians, dissemination of current tic disorder treatment guidelines might constitute an important educational goal.

Multimorbidity and long-term care dependency--a five-year follow-up.

BACKGROUND: Not only single, but also multiple, chronic conditions are becoming the normal situation rather than the exception in the older generation. While many studies show a correlation between multimorbidity and various health outcomes, the long-term effect on care dependency remains unclear. The objective of this study is to follow up a cohort of older adults for 5 years to estimate the impact of multimorbidity on long-term care dependency. METHODS: This study is based on claims data from a German health insurance company. We included 115,203 people (mean age: 71.5 years, 41.4% females). To identify chronic diseases and multimorbidity, we used a defined list of 46 chronic conditions based on ICD-10 codes. Multimorbidity was defined as three or more chronic conditions from this list. The main outcome was "time until long-term care dependency". The follow-up started on January 1st, 2005 and lasted for 5 years until December 31st, 2009. To evaluate differences between those with multimorbidity and those without, we calculated Kaplan-Meier curves and then modeled four distinct Cox proportional hazard regressions including multimorbidity, age and sex, the single chronic conditions, and disease clusters. RESULTS: Mean follow-up was 4.5 years. People with multimorbidity had a higher risk of becoming care dependent (HR: 1.85, CI 1.78-1.92). The conditions with the highest risks for long-term care dependency are Parkinson's disease (HR: 6.40 vs. 2.68) and dementia (HR: 5.70 vs. 2.27). Patients with the multimorbidity pattern "Neuropsychiatric disorders" have a 79% higher risk of care dependency. CONCLUSIONS: The results should form the basis for future health policy decisions on the treatment of patients with multiple chronic diseases and also show the need to introduce new ways of providing long-term care to this population. A health policy focus on chronic care management as well as the development of guidelines for multimorbidity is crucial to secure health services delivery for the older population.

Trends in antidepressant prescriptions for children and adolescents in Germany from 2005 to 2012.

PURPOSE: Longitudinal data on prescriptions of antidepressants (AD) in children and adolescents depression are scarce. This study aimed to examine AD prescription trends in children and adolescents in Germany. METHODS: Data of a large statutory health insurance company were analyzed for the period 2005-2012, and outpatients aged 0-19 years with AD prescriptions were identified. Prescriptions were evaluated with respect to age, sex, region of residence (East vs. West Germany) and substance class. RESULTS: Our study population comprised 1.4-1.6 million children and adolescents per year; between 4790 and 6849 of them received AD prescriptions. From 2005 to 2012, the prevalence of AD prescriptions rose from 0.32% to 0.48% (+49.2%), with a significant increase only in the age group 15-19 years (from 0.83% to 1.41%; +71.0%). The prevalence of AD prescriptions rose from 0.41% to 0.63% (+53.3%) for women and from 0.24% to 0.35% (+43.1%) for men. Regarding substance classes, serotonin reuptake inhibitors (SSRI) prescriptions increased from 37.7% to 54.4% of all AD prescriptions, whereas tricyclic antidepressants (TCA) significantly decreased (from 39.6% to 23.0%). In all years, fluoxetine was the substance most frequently prescribed (2005: 12.2% and 2012: 24.3% of all AD prescriptions). CONCLUSIONS: During an 8-year period, prescriptions of AD to children and adolescents in Germany have markedly increased, but almost exclusively in adolescents. Fortunately, in accordance with guidelines, both fluoxetine and SSRI prescriptions have risen over recent years. Yet, there still remain a significant proportion of TCA prescriptions.

Prevalence of dementia in nursing home and community-dwelling older adults in Germany.

BACKGROUND/AIM: We compared the prevalence of dementia in nursing home residents and community-dwelling older adults . METHODS: Using health insurance claims data for the year 2009, we estimated the prevalence of at least three of four quarters with a diagnosis of dementia in persons aged ≥65 years. RESULTS: Of 213,694 persons aged 65+ years, 4,584 (2.2 %) lived in nursing homes. The prevalence of dementia was 51.8 % (95 % CI 50.4-53.3) in nursing home residents and 2.7 % (95 % CI 2.6-2.8) in community-dwelling elderly. Increasing prevalences with age were found in both sexes in community-dwelling elderly. These trends were not seen in nursing home residents where prevalences were already high for the age group 65-69 years (35.7 % in males and 40.9 % in females, respectively). CONCLUSIONS: More than half of nursing home residents suffer from dementia, which is about 19-fold higher than the prevalence in insured living in the community.