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 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.

The quality of oral anticoagulation in general practice in patients with atrial fibrillation.

BACKGROUND: The aims of this study were to evaluate the quality of oral anticoagulation (OAC) in AF patients in the practices of general practitioners (GPs) in Germany and to investigate possible causal factors which influence OAC quality. METHODS: We conducted a multi-center, non-interventional, prospective observational cohort study among general practitioners (GPs) in Germany. To assess the quality of OAC on the basis of the prospectively documented international normalized ratio (INR) values, the time in therapeutic range (TTR) was calculated using the Rosendaal linear trend method. The causes of poor OAC quality were identified by a multivariate analysis model (logistical regression; poor OAC quality: TTR <60%). RESULTS AND CONCLUSIONS: For 525 OAC patients (66.8%; patients with at least 2 prospectively documented INR values) the average TTR (target range of 2.0-3.0) was 67.6%. About 34.7% of the patients had a TTR <60%. None of the variables representing characteristics of the medical practices were capable of explaining the occurrence of poor OAC quality. However, with regard to care provision-based variables, the existence of a brief discontinuation of medication was important. As the existence of adherence barriers increased, the probability of poor anticoagulation quality increased. In conclusion, the provision of OAC in the German health care system is to be regarded as good, but far from ideal. Our causal analysis shows that patient-based factors should be addressed through the provision of improved training and that the rationale behind the interruption of OAC treatment should be critically examined.

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.

Nonadherence in outpatient thrombosis prophylaxis with low molecular weight heparins after major orthopaedic surgery.

BACKGROUND: According to some current guidelines, extended thromboprophylaxis after hip and knee arthroplasties is recommended. Outpatient prophylaxis with low molecular weight heparins (LMWH) is an important part of this prophylaxis, although the rates of adherence to these regimens is not known. QUESTIONS/PURPOSES: We determined (1) the degree of nonadherence (NA) of patients with LMWH outpatient prophylaxis, and (2) whether specific independent factors explain NA. METHODS: NA was determined by syringe count and by indirect and direct questions to patients. We defined six different NA indicators. To identify factors explaining LMWH NA, we used three different logistic regression models. RESULTS: NA rates ranged between 13% and 21% depending on the indicator used for measurement. Patients who were nonadherent missed between 38% and 53% of their outpatient LMWH injections. If patients attended an outpatient rehabilitation program, the probability for their NA increased substantially. Moreover, the NA probability increased with each additional day between acute hospitalization and start of rehabilitation (linking days). NA was lower for patients who feared thrombosis or who believed antithrombotic drugs to be the most important measure in thromboprophylaxis. LEVEL OF EVIDENCE: Level II, prognostic study. See the Guidelines for Authors for a complete description of levels of evidence.

The effect of introducing rebate contracts to promote generic drug substitution, on doctors' prescribing practices.

BACKGROUND: As of 1 April 2007, pharmacists in Germany filling prescriptions covered by the statutory health insurance system (Gesetzliche Krankenversicherung, GKV) are required, whenever possible, to dispense a preparation that contains the same active substance and for which a rebate contract is in effect. The physician can block drug substitution by crossing out "aut idem" ("or the like") on the prescription form. The latter option has existed since 2002. We studied the possible effect of the introduction of rebate contracts on the use of the no-substitution option. METHODS: Three independent random samples were taken from the routine data of the Gmünder ErsatzKasse (GEK, a statutory health insurance carrier). The samples consisted of 0.5% of the insured adult population in the month of October in the years 2006, 2007, and 2008 (n = 6195; n = 6300; n = 6845). Within these sample groups, all medication orders in which the physician could potentially have exercised a no-substitution option were selected, and the corresponding prescriptions were examined. RESULTS: The percentage of no-substitution prescriptions rose from October 2006 to October 2007, and then rose still further to October 2008 (14.4%, 18.4%, 19.0%; p for trend < 0.0001). Considerable differences were seen between physicians belonging to different regional Associations of Statutory Health Insurance Physicians (Kassenärztliche Vereinigungen). In about one-quarter of the no-substitution prescriptions for 2007 and 2008 (25.1%, 25.7%), the prescribed medication was itself included in a rebate contract. CONCLUSIONS: The use of the no-substitution option is not uniform across Germany at present. Rebate contracts and the no-substitution option require further evaluation. Moreover, the dispensing of medications urgently needs a more stable regulatory framework.