Rate of Adverse Events and Associated Health Care Costs for the Management of Inflammatory Bowel Disease in Germany.

PURPOSE: Therapeutic management of inflammatory bowel disease (IBD) is challenging, and available therapies are associated with adverse events (AEs) that may lead to treatment discontinuation. This study evaluated the rate of drug-related AEs of special interest (AESIs) associated with IBD therapies and compare health care costs among patients with IBD who did and did not experience AESIs. METHODS: A retrospective cohort analysis was conducted using claims data from a German Sickness Fund (Allgemeine Ortskrankenkasse PLUS). Patients were diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) and newly initiating treatment with immunosuppressant, anti-tumor necrosis factor α, or anti-integrin therapies from January 1, 2011, to December 31, 2015. Patients were required to have continuous insurance coverage and no evidence of use of these IBD therapies for 12 months before the date of newly initiating therapy (index date). Rates of AESIs were based on 28 different events or chronic conditions associated with IBD treatment. Direct health care costs were reported separately for patients who did or did not experience AESIs. Only treatment periods lasting ≥60 days were considered. AESI rates related to all possible treatment patterns were calculated and reported as the number of events per 10,000 patient-years. Health care costs were calculated based on IBD-related health care resource use. FINDINGS: A total of 1126 (CD, n = 676; UC, n = 450) patients met the inclusion criteria. Mean age was 36.5 years for patients with CD and 42.5 years for patients with UC; 60.5% and 47.6% were female, respectively. Median observed time since the index date was 1460 and 1552 days, for patients with CD and UC. The overall rate for any AESI was 1392.4 and 1917.9 events per 10,000 patient-years in patients with CD and those with UC. Severe infections and diabetes mellitus were the most common AESIs. Significant differences in mean total direct health care costs were found for CD patients with AESIs versus those without (€8920.08 and €6004.86; P < 0.001). A similar trend was observed with mean drug costs and mean medical costs. In UC, total direct health care costs, although generally higher in patients with AESIs, were not significantly different; however, medical costs were (€1946.93 vs €971.28; P < 0.001). IMPLICATIONS: AEs are common in patients with IBD treated with current therapies and associated with substantial health care costs. An urgent need exists for development of IBD treatments that are associated with lower rates of AEs.

Real-world biologic treatment and associated cost in patients with inflammatory bowel disease.

OBJECTIVES: This study aimed to describe biologic treatment of German inflammatory bowel disease (IBD) patients, including biologics' dosage, health care resource use, and treatment-associated cost. METHODS: In this retrospective claims data analysis, all continuously insured adult IBD patients (Crohn's disease [CD] or ulcerative colitis [UC]) who started a new therapy with an anti-tumor necrosis factor alpha (anti-TNF-α) or vedolizumab (VDZ) were included. Observation started with the date of the first prescription of index biologic therapy and lasted 12 months. RESULTS: In the database, 1248 out of 57 296 IBD patients started a biologic treatment of interest (1020 anti-TNF-α, 228 VDZ), and 837 patients were bio-naïve (773 anti-TNF-α, 64 VDZ). The mean age of bio-naïve/bio-experienced anti-TNF-α patients was 39.2/38.1 years (54.9 %/56.7 % female) and 42.6/37.8 years for VDZ patients (56.3 %/54.9 % female). The proportion of patients receiving a maintenance dosage > 150 % compared to SmPC was 15.1 % for Adalimumab, 5.2-39.0 % for Golimumab, 14.7-34.5 % for Infliximab, and 19.7 % for VDZ patients. During the maintenance phase, up to 58.8 % of patients received at least 1 prescription of any CS, and 41.7 %/47.1 % (anti-TNF-α/VDZ) were treated in a hospital due to IBD. The mean IBD-related direct health care cost per patient year was €â€Š30 246 (anti-TNF-α)/ €â€Š28 227 (VDZ) for bio-naïve patients (p = 0.288) and €â€Š34 136 (anti-TNF-α)/ €â€Š32 112 (VDZ) for bio-experienced patients (p = 0.011). CONCLUSIONS: A substantial percentage of patients receive a high biologic dosage in the maintenance phase. Despite biologic therapy, 30-40 % receive a CS therapy and/or experience at least 1 IBD-associated hospitalization within a year, possibly indicating a remaining disease activity.

Primary data, claims data, and linked data in observational research: the case of COPD in Germany.

BACKGROUND: Real-world evidence (RWE) can inform patient management decisions, but RWE studies are associated with limitations. Linkage of different RWE data types could address such limitations by enriching data and improving scientific quality. Using the example of chronic obstructive pulmonary disease (COPD) in Germany, this study assessed the value of data linkage between primary and secondary data sources for RWE. METHODS: Post hoc analysis of data from an observational RWE study, which used prospectively collected data and data from an insurance claims database to assess treatment adherence and persistence in patients with COPD in Germany. Patient-level primary data were collected from the prospective observational study (primary dataset, N = 636), and claims data from the sickness fund AOK Nordost (claims dataset, N = 74,916). Primary and claims data were linked at a patient level using insurance numbers (linked dataset). Patients in the linked dataset were indexed at date of study inclusion for primary data and matched calendar date for claims data. Agreement between primary and claims data was examined for patients in the linked dataset based on comparisons between recorded sociodemographic data at index, comorbidities (primary: any recorded; claims: pre-index), prescriptions for COPD therapies (type and date) and exacerbations in the 12-month post-index period. RESULTS: The linked dataset included primary and claims data for 536 patients. Fewer comorbid patients were reported in primary data compared with claims data (p < 0.001), with overall agreement between 63.6% (hypertension) and 90.5% (osteoporosis). Number of prescriptions for COPD therapies per patient was lower in primary versus claims data (3.7 vs 10.3 prescriptions, respectively), with only 24.5% of prescriptions recorded in both datasets. Only 11.5% of exacerbations (moderate or severe) were recorded in both datasets, with 15.5% recorded only in primary data and 73.0% recorded only in claims data. CONCLUSION: Our study highlighted discrepancies between primary and claims data capture for this population of German patients with COPD, with lower reporting of comorbidities, COPD therapy prescriptions and exacerbations in primary versus claims data. Study findings suggest that data linkage of primary and claims data could provide enrichment and be useful in fully describing COPD endpoints.

Real-world effectiveness and safety of oral anticoagulation strategies in atrial fibrillation: a cohort study based on a German claims dataset.

OBJECTIVE: To compare the real-world effectiveness and safety of non-vitamin-K-antagonist oral anticoagulant (NOAC) treatment in atrial fibrillation (AF) patients with a vitamin-K-antagonist (VKA)-based treatment. METHODS: This was a retrospective analysis of an anonymized claims dataset from 3 German health insurance funds covering the period from January 01, 2010 to June 30, 2014, with a minimum observation time of 12 months. All continuously insured patients with at least 2 outpatient AF diagnoses and/or 1 inpatient respective diagnosis who received at least 1 outpatient prescription of a NOAC or VKA were included. OUTCOMES AND MEASURES: Death, ischemic strokes (IS), non-specified strokes, transient ischemic attacks (TIAs), myocardial infarctions (MIs), arterial embolism (AE), hemorrhagic strokes, severe bleedings, and composite outcomes. Main comparisons were done based on propensity score-matched (PSM) cohorts. Results were reported as incidence rate ratios and hazard ratios (HRs). RESULTS: We assigned 37,439 AF patients to each PSM cohort (NOAC cohort: mean age 78.2 years, mean CHA2DS2VASc score 2.96, mean follow-up 348.5 days; VKA cohort: mean age 78.2 years, mean CHA2DS2VASc 2.95, mean follow-up 365.5 days). NOAC exposure was associated with significantly higher incidence rate ratios; 95% CI/HRs; 95% CI for the following outcomes: death (1.22; 1.17-1.28/1.22; 1.17-1.28), IS (1.90; 1.69-2.15/1.92; 1.69-2.19), non-specified strokes (2.04; 1.16-3.70/1.93; 1.13-3.32), TIAs (1.52; 1.29-1.79/1.44; 1.21-1.70), MIs (1.26; 1.10-1.15/1.31; 1.13-1.52), AE (1.75; 1.32-2.32/1.81; 1.36-2.34) and severe bleeding (1.92; 1.71-2.15/1.95; 1.74-2.20). Multivariable Cox regression analyses and additional sensitivity analysis, including analysis of PSM-matched NOAC/VKA treatment-naive patients, only confirmed the above results. The study was documented under clinicaltrials.gov (NCT02657616). CONCLUSION AND RELEVANCE: A VKA therapy seems to be more effective and safer than a NOAC therapy in a real-world cohort of German AF patients.

Persistence with VKA treatment in newly treated atrial fibrillation patients: an analysis based on a large sample of 38,076 German patients.

PURPOSE: The aim of this study was to describe persistence with vitamin K antagonist (VKA) treatment in German atrial fibrillation (AF) patients and to identify factors which may be associated with early discontinuation of VKA therapy. METHODS: We did a retrospective cohort study based on an anonymized German claims dataset with VKA treatment-naïve AF patients, who received at least one VKA prescription. VKA therapy discontinuation was defined as a gap >180 days. RESULTS: We identified 38,076 VKA patients who started a VKA therapy (mean age 76.13 years; 56.08% female; mean CHA2DS2-VASc-Score 4.49; mean Charlson Comorbidity Index (CCI) 3.91). After four quarters since start of VKA treatment, 14,889 (39.10%) of observed patients had discontinued their VKA treatment (after eight quarters: 54.61%). Mean time until treatment discontinuation was 390.55 days. Risk of VKA discontinuation increased with the diagnosis of dementia within the first two quarters of VKA treatment [HR 1.35 (95% CI 1.29-1.40)], diagnosed alcohol or drug abuse in the baseline period [HR 1.25; 95% CI 1.18-1.33)], female gender [HR 1.08; 95% CI 1.05-1.10)], higher age (HR 1.03; 95% CI 1.03-1.03), higher CCI (HR 1.05; 95% CI 1.04-1.05), any prescription of NSAID (HR 1.07; 95% CI 1.04-1.10), and number of surgeries in the first two quarters of VKA treatment (HR 1.05; 95% CI 1.04-1.05). At least one yearly visit to a cardiologist since start of VKA treatment decreased the risk of non-persistence [HR 0.90; 95% CI 0.88-0.93] and a cancer diagnosis in the baseline period (HR 0.92; 95% CI 0.89-0.96). CONCLUSION: Non-persistence related to VKA therapy is common in AF patients. Older more comorbid female patients as well as patients who face surgeries and who do not visit a cardiologist regularly face a higher therapy discontinuation risk.

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.

Healthcare Burden and Costs Associated with Urinary Tract Infections in Type 2 Diabetes Mellitus Patients: An Analysis Based on a Large Sample of 456,586 German Patients.

OBJECTIVES: We examined the real-world treatment of urinary tract infections (UTIs) in a type 2 diabetes mellitus (T2DM) population, evaluated UTI-related healthcare resource use and direct treatment costs, and assessed factors that may predict UTI-related costs. METHODS: We analyzed an anonymized dataset from a regional German healthcare fund (2010-2012). UTI-associated resource use was described by the number of UTI-associated outpatient visits, the number and length of UTI-related acute hospital visits, and the number of UTI-related antibiotics prescriptions. UTI-related direct treatment costs were studied both based on these resource use numbers and, additionally, based on a comparison of all-cause annual healthcare costs of T2DM-patients who were or were not affected by a UTI. To identify factors that might predict direct treatment costs related to UTI treatment, we conducted generalized linear regression model analyses (based on gamma distribution) using sociodemographic and clinical characteristics of observed patients as available in the database as independent variables. RESULTS: A total of 456,586 T2DM-patients were included with a mean age of 73.8, a percentage of 56.3 female patients, and a mean Charlson comorbidity index of 7.3. In our database, we observed 48,337 UTI events. The direct mean resource-based costs were €315.90 per UTI event. Older age, higher comorbidity status, at least one previous non-UTI infection, and poorer renal function were associated with higher costs, while female gender and at least one previous UTI event were associated with lower costs. In the all-cause cost analysis, healthcare costs per patient year were €3,916 higher in the UTI group than in the non-UTI group. CONCLUSION: Our study confirms that UTI is a common complication in patients with T2DM. Patients with T2DM who have had previous infections, who are older, and who are male, as well as patients who have more comorbidities or severe renal insufficiency, face above-average UTI treatment costs. These patient groups, therefore, should receive special attention in the real-world treatment of T2DM, which should include a regular screening of UTI risk.

Non-Persistence and Non-Adherence of Patients with Type 2 Diabetes Mellitus in Therapy with GLP-1 Receptor Agonists: A Retrospective Analysis.

INTRODUCTION: Our main aim was to assess the level of persistence and adherence to therapy with glucagon-like peptide-1 (GLP-1) receptor agonists in type 2 diabetes mellitus (T2DM) patients in the United Kingdom (UK) and Germany, also by comparing once- (OD) with twice-a-day (BID) therapy. METHODS: We used two large retrospective datasets: a German claims dataset and the UK General Practitioner (GP)-based Clinical Practice Research Datalink (CPRD) dataset (2010-2012). All continuously insured T2DM patients with at least one outpatient/inpatient T2DM diagnosis were observed starting with the first prescription of a GLP-1 receptor agonist. Non-persistence (NP) was defined as treatment gap >90 days. Non-adherence (NA) was defined as medication possession ratio <80%, calculated during a period in which a patient continued therapy (no treatment gap >90 days) only. RESULTS: In the UK sample, 1905 T2DM patients started a treatment with GLP-1 receptor agonists (mean age: 55.5 years, 47.2% female). In the German sample, 1627 T2DM patients started a treatment with GLP-1 receptor agonists (mean age: 56.6 years, 51.4% female). Percentage of NP patients after 12 months was 29.5% in the UK and 36.4% in the German sample. In both countries, a BID treatment was associated with a higher probability to discontinue a treatment with GLP-1 receptor agonists earlier than an OD treatment (hazard ratio [HR] = 1.431 in UK and HR = 1.314 in Germany). The percentages of patients considered NA were 20.2%/20.0%/20.5% (all/OD/BID) for the UK sample, and 19.9%/19.2%/21.8% (all/OD/BID) for the German sample. CONCLUSION: NP and NA to treatment with GLP-1 receptor agonists in both UK and Germany appear to be similar. Persistence to OD treatment is higher than to BID treatment in both the UK and Germany.

Epidemiology of urinary tract infections in type 2 diabetes mellitus patients: An analysis based on a large sample of 456,586 German T2DM patients.

INTRODUCTION: This analysis was conducted to investigate urinary tract infection (UTI) incidence among Type 2 Diabetes mellitus (T2DM) patients in Germany in a real-world setting and to identify risk factors associated with UTI incidence/recurrence. METHODS: Our cohort study was conducted based on an anonymized dataset from a regional German sickness fund (2010-2012). A UTI event was mainly identified through observed outpatient/inpatient UTI diagnoses. We reported the number of UTI events per 1000 patient-years. Furthermore, the proportion of patients affected by ≥1 and ≥2 UTI events in the observational period was separately reported. Finally, three multivariate Cox regression analyses were conducted to identify factors that may be associated with UTI event risk or recurrent UTI event risk. RESULTS: A total of 456,586 T2DM-prevalent patients were identified (mean age 72.8years, 56.1% female, mean Charlson Comorbidity Index (CCI) of 7.3). Overall, the UTI event rate was 87.3 events per 1000 patient-years (111.8/55.8 per 1000 patient-years for women/men (p<0.001)). The highest UTI event rates were observed for those aged >89years. After 730days after first observed T2DM diagnosis, the proportion of women/men still UTI-event-free was 80.9%/90.2% (p<0.001). Most important factors associated with UTI risk in our three models were older age (Hazard Ratio (HR)=1.56-1.70 for >79years), female gender (HR=1.38-1.57), UTIs in the previous two years (HR=2.77-5.94), number of comorbidities as measured by the CCI (HR=1.32-1.52 for CCI>6) and at least one cystoscopy in the previous year (HR=2.06-5.48). Furthermore, high HbA1c values in the previous year (HR=1.29-1.4 referring to HbA1c>9.5%) and a poor kidney function (HR=1.11-1.211 referring to glomerular filtration rate (GFR)<60ml/min) increased the UTI event risk. DISCUSSION: Our study confirms that UTI event risk is high in T2DM patients. Older female patients having experienced previous UTIs face an above-average UTI risk, especially if these risk factors are associated with poor glycemic control and poor kidney function.

Treatment-dependent and treatment-independent risk factors associated with the risk of diabetes-related events: a retrospective analysis based on 229,042 patients with type 2 diabetes mellitus.

BACKGROUND: The aim of this study was to analyse which factors predict the real-world macro-/microvascular event, hospitalisation and death risk in patients with type 2 diabetes mellitus. Furthermore, we aimed to investigate whether there exists both an under- and over-treatment risk of these patients. METHODS: We used a German claims/clinical data set covering the years 2010-12. Diabetes-related events were defined as (1) macro-, (2) microvascular events leading to inpatient hospitalisation, (3) other hospitalisations with type 2 diabetes mellitus as main diagnosis, (4) all-cause death and (5) a composite outcome including all event categories 1-4. Factors associated with event risk were analysed by a Kaplan-Meier curve analysis and by multivariable Cox regression models. RESULTS: 229,042 patients with type 2 diabetes mellitus (mean age 70.2 years; mean CCI 6.03) were included. Among factors that increased the event risk were patients' age, male gender, the adapted Charlson Comorbidity Index, the adapted Diabetes Complication Severity Index, previous events, and number of prescribed chronic medications. For systolic blood pressure/HbA1C, a double-J/U-curve pattern was detected: HbA1C of 6-6.5% (42-48 mmol/mol) and systolic blood pressure of 130-140 mmHg (17.3-18.7kPa) were associated with the lowest event risk, values below/above that range were associated with higher risk. However, this pattern was mainly driven by the death risk and was much less clearly observed for the macrovascular/microvascular/hospitalization risk and for young/less comorbid patients. CONCLUSIONS: Both blood pressure and HbA1C seem to be very important treatment targets, especially in comorbid old patients. It is of particular clinical importance that both over- and under-treatment pose a threat to patients with type 2 diabetes mellitus.

Effectiveness of sulphonylureas in the therapy of diabetes mellitus type 2 patients: an observational cohort study.

BACKGROUND: We compared all-cause mortality, major macrovascular events (MACE) and diabetes-related hospitalizations in T2DM-incident patients newly treated with metformin (MET) versus sulphonylureas (SU) monotherapy and in T2DM-prevalent patients newly treated with MET+SU versus MET+DPP4-inhibitor combination therapy. METHODS: We analysed anonymized data obtained from a German health fund. Patients were included when they had started MET versus SU therapy or MET+SU versus MET+DPP4 therapy between 01/07/2010 and 31/12/2011. Observation started with the first MET/SU prescription or the first prescription of the second agent of a MET+SU/MET+DPP4 combination therapy. Follow-up time lasted until the end of data availability (a minimum of 12 months), death or therapy discontinuation. RESULTS: In total, 434,291 T2DM-prevalent and 35,661 T2DM-incident patients were identified. Of the identified T2DM-incident patients, 904/7,874 started SU/MET monotherapy, respectively, with a mean age of 70.1/61.4 years (54.6/50.3 % female; Charlson Comorbidity Index (CCI) 1.4/2.2; 933/7,350 observed SU/MET patient years). 4,157/1,793 SU+MET/DPP4+MET therapy starters had a mean age of 68.1/62.2 years (53.4/50.8 % female; CCI 2.8/2.6; 4,556/1,752 observed SU+MET/ DPP4+MET patient years). In a propensity score matched (PSM) comparison, the HRs (95 % CIs) associated with SU monotherapy compared to MET monotherapy exposure were 1.4 (0.9-2.3) for mortality, 1.4 (0.9-2.2) for MACE, 4.1 (1.5-10.9) for T2DM hospitalizations and 1.6 (1.2-2.3) for composite event risk. In a multivariable Cox regression model, SU monotherapy was associated with higher mortality (aHR 2.0; 1.5-2.6), higher MACE (aHR 1.3; 1.0-1.7) and higher T2DM hospitalizations (aHR 2.8; 1.8-4.4), which corresponded with a higher composite event risk (aHR 1.8; 1.5-2.1). No significant differences in event rates were observed in the PSM comparison between DPP4+MET/SU+MET combination therapy starters and in the multivariable Cox regression analysis. CONCLUSIONS: Our results show that SU monotherapy may be associated with increased mortality, MACE and T2DM hospitalizations, compared to MET monotherapy. When considering SU therapy, the associated cardiovascular risk should also be taken into account.

Real life anticoagulation treatment of patients with atrial fibrillation in Germany: extent and causes of anticoagulant under-use.

Oral anticoagulation (OAC) with either new oral anticoagulants (NOACs) or Vitamin-K antagonists (VKAs) is recommended by guidelines for patients with atrial fibrillation (AF) and a moderate to high risk of stroke. Based on a claims-based data set the aim of this study was to quantify the stroke-risk dependent OAC utilization profile of German AF patients and possible causes of OAC under-use. Our claims-based data set was derived from two German statutory health insurance funds for the years 2007-2010. All prevalent AF-patients in the period 2007-2009 were included. The OAC-need in 2010 was assumed whenever a CHADS2- or CHA2DS2-VASC-score was >1 and no factor that disfavored OAC use existed. Causes of OAC under-use were analyzed using multivariate logistic regression. 108,632 AF-prevalent patients met the inclusion criteria. Average age was 75.43 years, average CHA2DS2-VASc-score was 4.38. OAC should have been recommended for 56.1/62.9 % of the patients (regarding factors disfavouring VKA/NOAC use). For 38.88/39.20 % of the patient-days in 2010 we could not observe any coverage by anticoagulants. Dementia of patients (OR 2.656) and general prescription patterns of the treating physician (OR 1.633) were the most important factors increasing the risk of OAC under-use. Patients who had consulted a cardiologist had a lower risk of being under-treated with OAC (OR 0.459). OAC under-use still seems to be one of the major challenges in the real-life treatment of AF patients. Our study confirms that both patient/disease characteristics and treatment environment/general prescribing behaviour of physicians may explain the OAC under-use in AF patients.

Real life treatment of diabetes mellitus type 2 patients: an analysis based on a large sample of 394,828 German patients.

OBJECTIVES: The aim of this claims-based data analysis was to describe the care of German T2DM patients and to determine which subgroups could be differentiated in terms of the achieved T2DM-related treatment results, the underlying comorbidities, and the achieved comorbidity-related treatment results. METHODS: We included all T2DM patients insured by a large sickness fund in 2010/2011. We defined 12 subgroups according to observed HbA1C, blood pressure and Charlson Comorbidity Index (CCI). For each subgroup, available sociodemographic and clinical information were reported. Different treatment variables were described. T2DM-related events leading to acute hospitalisations were reported. RESULTS: We included 394,828 T2DM patients in our analysis; for 228,703 patients' detailed data as basis for subgroup classification were available. For 4.5% of these patients, a HbA1C >9% was observed. 21,833 of the T2DM patients were affected by a T2DM-related event; the risk was 5.53% per patient year; 1.74% of the patients suffered from more than one event. Most frequent event types were hospitalisation with T2DM as primary diagnosis (2.39%), vascular interventions/stent implantations (1.92%), and ischaemic stroke (1.19%). There were significant differences between the observed subgroups in terms of T2DM-related event risk. CONCLUSION: Overall, our data indicate that the typically treated T2DM patient has a number of comorbidities and thus treatment focused solely on T2DM is neither possible nor clinically meaningful. Particularly those patients who reached HbA1C goals, but had also achieved relevant additional treatment goals reached low yearly T2DM event rates whereas subgroups failing to achieve one or several treatment goals are facing much higher event risks.

How to use pharmacy claims data to measure patient nonadherence? The example of oral diabetics in therapy of type 2 diabetes mellitus.

INTRODUCTION: The purpose of this study was to describe the methodological framework underlying nonadherence (NA) measurement based on pharmacy claims data, its quantitative impact on the results of NA studies, and to identify those methodological categories most likely to explain diabetes-related clinical outcomes. We use the example of oral antidiabetics in the treatment of diabetes mellitus type 2; 113,108 patients derived from a German statutory health insurance fund were analyzed. METHODS: We identified 12 methodological categories as pervasive features in pharmacy claims data based NA analyses. The influence of the different methodological categories and their parameters on analysis results was tested using sensitivity analysis. To validate alternative methodological framework options, we performed multivariate logistical regression estimates using diabetes-related hospitalization/clinical events as a combined dichotomized dependent variable. RESULTS: The choice of parameters within the identified 12 methodological categories available has exceptional impact on the results of pharmacy data based claims NA analyses. When the full range of theoretically possible cases is considered in our sample, it can be seen that the resulting NA range is between 15.7% and 97.0%. The definition of the required daily dose, the decision to use either a prescription-/interval-based approach, and the classes of medication analyzed exert a notable influence on the study results. In our analysis, 69.4% of the 216 different study design options analyzed significantly explain the likelihood of diabetes-related clinical events. CONCLUSIONS: We recommend strongly that methodological transparency is awarded a much more important role in the conduct of NA analyses made on the basis of pharmacy claims data.

Incidence and prevalence of atrial fibrillation: an analysis based on 8.3 million patients.

AIMS: Based on an analysis of claims-based data of 8.298 million members of two German statutory health insurance funds, the aim of this contribution is to quantify age-/gender-specific prevalence/incidence of atrial fibrillation (AF) in a German setting. METHODS AND RESULTS: Patients were classified as AF prevalent, if they had received at least two outpatient diagnoses of AF (ICD10-Code I48.1-) in two different quarters of the year and/or had received at least one main AF diagnosis during inpatient treatment between 1 January 2007 and 12 December 2008. They were considered to have had new onset AF in 2008 under the following conditions; first, there was no AF diagnosis in 2007; secondly, patients had not received oral anticoagulant medication in 2007; and thirdly, patients had received either one inpatient/two outpatient diagnoses of AF in 2008. In our sample, a total of 176 891 patients had AF. AF prevalence was 2.132%. The average age of these AF patients was 73.1 years, and 55.5% (98 190 patients) were male. The incidence of AF in our sample was 4.358 cases/1000 person-years in men and 3.868 cases/1000 person-years in women. CONCLUSION: A comparison of the distribution of AF prevalence/incidence in our population with that in already published studies showed that our figures were higher, especially in the age groups above 70 years. Our data show that in a large industrial nation such as Germany care provision structures are going to be challenged by a requirement to treat more AF patients in the future.

Oral anticoagulation use by patients with atrial fibrillation in Germany. Adherence to guidelines, causes of anticoagulation under-use and its clinical outcomes, based on claims-data of 183,448 patients.

Atrial fibrillation (AF) is the most common significant cardiac rhythm disorder. Oral anticoagulation (OAC) is recommended by guidelines in the presence of a moderate to high risk of stroke. Based on an analysis of claims-based data, the aim of this contribution is to quantify the stroke-risk dependent OAC utilisation profile of German AF patients as well as the possible causes and the associated clinical outcomes of OAC under-use. Our data set was derived from two large mandatory German medical insurance funds. Risk stratification of patients was based on the CHADS2-score and the CHA2DS2-VASc-score. Two different scenarios were constructed to deal with factors potentially disfavouring OAC use. Causes of OAC under-use and its clinical consequences were analysed using multivariate analysis. Observation year was 2008. A total of 183,448 AF patients met the inclusion criteria. This represents an AF prevalence of 2.21%. The average CHADS2-score was 2.8 (CHA2DS2-VASc-score: 4.3). On between 40.5 and 48.7% of the observed patient-days, there was no antithrombotic protection by OAC, other anticoagulants or aspirin. Older female patients with a high number of comorbidities had a higher risk of OAC under-use. Patients who had already experienced a thromboembolic event had a lower risk of OAC under-use. In the observation year, 3,367 patients experienced a stroke (incidence rate 1.8%). In our multi-level Poisson random effects estimate, OAC use decreases the stroke rate by almost 80% (IRR 0.236). In conclusion, OAC under-use is widespread in the German market. It is associated with severe clinical consequences.