Falk Hoffmann

Incidence of lower-limb amputations in the diabetic compared to the non-diabetic population. Findings from nationwide insurance data, Germany, 2005-2007.

INTRODUCTION One major objective is to reduce the risk of lower limb amputation in diabetes mellitus. Nationwide data to incidences of amputations in the diabetic and non-diabetic populations in Germany as well as relative and attributable risks due to diabetes are lacking so far. MATERIAL AND METHODS Using data of a nationwide statutory health insurance (1.6 million members), we assessed all first non-traumatic lower-limb amputations between 2005 and 2007. We estimated sex-age-specific and standardized incidences of amputations in the diabetic and non-diabetic populations, and relative and attributable risks due to diabetes. RESULTS Of all subjects with a first amputation in the study period 2005-2007 (n=994), 66% had diabetes, 76% were male, mean age (SD) was 67 (13) years. Incidences per 100 000 person years (standardized to the 2004 German population) in the diabetic and the non-diabetic populations: 176.5 (95% confidence interval 156.0-196.9) and 20.0 (17.0-23.1) in men, and 76.9 (61.9-91.8) and 13.4 (10.7-16.2) in women. Standardized relative risks: 8.8 (7.3-10.7) in men and 5.7 (4.3-7.6) in women. Attributable risks among exposed: 0.89 and 0.83 and population attributable risks 0.59 and 0.40, each in men and women, respectively. DISCUSSION In our first German nationwide study, we found the relative risk of lower limb amputation in the diabetic compared to the non-diabetic to be lower than in earlier regional studies in Germany, supporting results of regional reductions of the excess amputation risk due to diabetes. A repetition of the study is warranted to further evaluate trends according to the St. Vincent goals.

Antipsychotic prescription in children and adolescents: an analysis of data from a German statutory health insurance company from 2005 to 2012.

BACKGROUND Despite sparse documentation of their long-term therapeutic effects and side effects, antipsychotic drugs have come to be prescribed more frequently for children and adolescents in recent years, both in the USA and in Europe. No current data are available about antipsychotic prescriptions for this age group in Germany. METHODS Data from the largest statutory health insurance fund in Germany (BARMER GEK) were studied to identify antipsychotic prescriptions for children and adolescents (age 0-19 years) from 2005 to 2012 and analyze them with respect to age, sex, drug prescribed, prescribing medical specialty, and any observable secular trends. RESULTS The percentage of children and adolescents receiving a prescription for an antipsychotic drug rose from 0.23% in 2005 to 0.32% in 2012. In particular, atypical antipsychotic drugs were prescribed more frequently over time (from 0.10% in 2005 to 0.24% in 2012). The rise in antipsychotic prescriptions was particularly marked among 10- to 14-year-olds (from 0.24% to 0.43%) and among 15- to 19-year-olds (from 0.34% to 0.54%). The prescribing physicians were mostly either child and adolescent psychiatrists or pediatricians; the most commonly prescribed drugs were risperidone and pipamperone. Risperidone was most commonly prescribed for patients with hyperkinetic disorders and conduct disorders. CONCLUSION In Germany as in other industrialized countries, antipsychotic drugs have come to be prescribed more frequently for children and adolescents in ecent years. The German figures, while still lower than those from North America, are in the middle range of figures from European countries. The causes of the increase should be critically examined; if appropriate, the introduction of prescribing guidelines of a more restrictive nature could be considered.

Impact of safety warnings on antipsychotic prescriptions in dementia: Nothing has changed but the years and the substances

Dementia patients suffering from behavioral and psychological symptoms (BPSD) are often treated with antipsychotics. Trial results document an increased risk for serious adverse events and mortality in dementia patients taking these agents. Furthermore, the efficacy of treating BPSD with antipsychotics seems to be only modest. Using data of a German statutory health insurance company, we examined prescription trends of antipsychotics in prevalent dementia patients in the context of official warnings. The study period is 2004-2009. We studied trends in demographics, age and sex, as well as need of care and the intake of typical and atypical antipsychotics. Seeking for linear trends adjusted for age, sex and level of care between 2004 and 2009, we obtained p-values from a multivariate logistic regression. Prescription volumes were calculated by number of packages as well as defined daily doses (DDDs) using multiple linear regressions for trends in prescriptions amount. We included 3460-8042 patients per year (mean age 80 years). The prescription prevalence of antipsychotics decreased from 35.5% in 2004 to 32.5% in 2009 (multivariate analysis for linear trend: p=0.1645). Overall prescriptions for typical antipsychotics decreased (from 27.2% in 2004 to 23.0% in 2009, p<0.0001) and prescriptions for atypical antipsychotics increased from 17.1% to 18.9% (p<0.0001). The mean DDD per treated patient increased from 80.5 to 91.2 (2004-2009; p=0.0047). Our findings imply that warnings of international drug authorities and manufacturers against adverse drug events in dementia patients receiving antipsychotics did not impact overall prescription behavior.

Diabetes prevalence based on health insurance claims: large differences between companies

Diabet. Med. 28, 919–923 (2011)

Time-dependent impact of diabetes on mortality in patients after major lower extremity amputation: survival in a population-based 5-year cohort in Germany.

OBJECTIVE To estimate the impact of diabetes on mortality in patients after first major lower extremity amputation (LEA). RESEARCH DESIGN AND METHODS Using claims data of a nationwide statutory health insurance, we assessed all deaths in a cohort of all 444 patients with a first major LEA since 2005 (71.8% male; mean age 69.1 years; 58.3% diabetic; 43% with amputation above the knee) up to 2009. Using Cox regression, we estimated the time-dependent hazard ratios to compare patients with and without diabetes. RESULTS The cumulative 5-year mortality was 68% in diabetic and 59% in nondiabetic individuals. In the first course, mortality was lower in diabetic compared with nondiabetic patients. Later, the diabetes risk increased yielding crossed survival curves after 2 to 3 years (time dependency of diabetes; P = 0.003). Age- and sex-adjusted hazard ratios for diabetes were as follows: 0–30 days: 0.50 [95% CI 0.31–0.84]; 31–60 days: 0.60 [0.25–1.41]; 61 days to 6 months: 0.75 [0.38–1.48]; >6–12 months: 1.27 [0.63–2.53]; >12–24 months: 1.65 [0.88–3.08]; >24–36 months: 2.02 [0.80–5.09]; and >36–60 months: 1.91 [0.70–5.21]. The pattern was similar in both sexes. In the full model, significant risk factors for mortality were age (1.05; 1.03–1.06), amputation above the knee (1.50; 1.16–1.94), and quartile category 3 or 4 of the number of prescribed medications (1.64; 1.12–2.40 and 1.76; 1.20–2.59). Further adjustment for comorbidity did not alter the results. CONCLUSIONS In this population-based study, we found a time-dependent mortality risk of diabetes following first major LEA, which may be in part a result of a healthier lifestyle in diabetic patients or the access to specific treatment structures in diabetic individuals.

Review on use of German health insurance medication claims data for epidemiological research.

The objective was to evaluate the use of German health insurance claims data on medications over the last 10 years by a review of published studies.

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.

The effect of diabetes on incidence and mortality in end-stage renal disease in Germany

BACKGROUND We aimed to examine the epidemiology and mortality risk of patients with incident end-stage renal disease (ESRD) in diabetic and non-diabetic individuals and to determine differences between sexes. METHODS We used the claims data of a statutory health insurance company. Patients aged 30 years and older who started dialysis or had pre-emptive kidney transplantation between 1 April 2006 and 7 October 2008 were included. We estimated incidence rates of ESRD according to diabetes status, sex and age as well as relative and attributable risks due to diabetes. Using Cox regression, we studied survival and estimated time-dependent hazard ratios (HR). RESULTS We included 623 patients with incident ESRD (n = 254 had diabetes); 477 (76.6%) were male, and the mean age was 66.5 years. Standardized to the German population, incidences of ESRD in patients with and without diabetes were 157.9 and 25.6 per 100,000 person-years respectively (6.2-fold increased risk). The impact of diabetes on mortality was time-dependent. Diabetics had an increased mortality risk after the first year. An interaction of diabetes with time (per additional year of follow-up) was found in the whole population (HR 2.01, 95% CI 1.21-3.33) and in females (HR 3.27, 95% CI 1.03-10.39); however, males did not reach statistical significance (HR 1.78, 95% CI 0.99-3.18). The fixed baseline effect of diabetes in these models was non-significant (HR ~ 0.7-0.8). CONCLUSIONS Diabetes is an important risk factor for ESRD. We provide further evidence that the impact of diabetes on survival after ESRD is time-dependent and that differences between sexes might exist.

Impact of geriatric comorbidity and polypharmacy on cholinesterase inhibitors prescribing in dementia

BackgroundAlthough most guidelines recommend the use of cholinesterase inhibitors (ChEIs) for mild to moderate Alzheimers Disease, only a small proportion of affected patients receive these drugs. We aimed to study if geriatric comorbidity and polypharmacy influence the prescription of ChEIs in patients with dementia in Germany.MethodsWe used claims data of 1,848 incident patients with dementia aged 65 years and older. Inclusion criteria were first outpatient diagnoses for dementia in at least three of four consecutive quarters (incidence year). Our dependent variable was the prescription of at least one ChEI in the incidence year. Main independent variables were polypharmacy (defined as the number of prescribed medications categorized into quartiles) and measures of geriatric comorbidity (levels of care dependency and 14 symptom complexes characterizing geriatric patients). Data were analyzed by multivariate logistic regression.ResultsOn average, patients were 78.7 years old (47.6% female) and received 9.7 different medications (interquartile range: 6-13). 44.4% were assigned to one of three care levels and virtually all patients (92.0%) had at least one symptom complex characterizing geriatric patients. 13.0% received at least one ChEI within the incidence year. Patients not assigned to the highest care level were more likely to receive a prescription (e.g., no level of care dependency vs. level 3: adjusted Odds Ratio [OR]: 5.35; 95% CI: 1.61-17.81). The chance decreased with increasing numbers of symptoms characterizing geriatric patients (e.g., 0 vs. 5+ geriatric complexes: OR: 4.23; 95% CI: 2.06-8.69). The overall number of prescribed medications had no influence on ChEI prescription and a significant effect of age could only be found in the univariate analysis. Living in a rural compared to an urban environment and contacts to neurologists or psychiatrists were associated with a significant increase in the likelihood of receiving ChEIs in the multivariate analysis.ConclusionsIt seems that not age as such but the overall clinical condition of a patient including care dependency and geriatric comorbidities influences the process of decision making on prescription of ChEIs.

Psychopharmacological treatment in children and adolescents with autism spectrum disorders in Germany.

Data on psychopharmacological treatment of individuals with autism spectrum disorder (ASD) are scarce, especially for European countries. This study evaluated psychopharmacotherapy utilisation in children and adolescents with a diagnosis of ASD in Germany. Data of a large statutory health insurance company were analysed and outpatients aged 0-24 years with a diagnosis of ASD during a 1-year-period (2009) were identified. For this cohort, the prescription of psychopharmacotherapy was evaluated. Aditionally, we analysed time trends in prescriptions from 2004 to 2009. One thousand one hundred twenty-four patients (75.4% male; mean age: 11.1 years) matched the inclusion criteria. The prevalence of ASD was 0.37% in males and 0.12% in females, respectively. Of all ASD patients, 33.0% were prescribed psychotropic drugs in 2009. 12.5% of ASD patients were treated with stimulants or atomoxetine, 11.7% with antipsychotics, 9.1% with antiepileptics, 6.8% with benzodiazepines, and 3.8% with antidepressants/SSRI. Regarding substances, methylphenidate (24.4% of all psychotropic prescriptions), risperidone (13.3%) and valproate (9.1%) were most frequently prescribed. Psychopharmacologic treatment prevalence was age-related and increased from 16.3% in individuals aged 0-4 years to 55.1% in 20-24 year olds. From 2004 to 2009, the proportion of ASD patients treated with psychotropic drugs rose from 25.9% to 33.0%. This naturalistic study furnishes evidence that the proportion of ASD patients treated with psychotropic drugs has grown considerably in Germany over the least years, with methylphenidate and risperidone being the most frequently prescribed substances. Compared with data from the USA, the proportion of ASD patients with psychopharmacological treatment is noticeably lower in Germany.