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PURPOSE: Recent studies on the utilization of antidepressant drugs in minors are scarce, methodologically limited, and do not factor in off‐label use sufficiently. Beyond that, little is known about the short treatment durations that have been observed for many young antidepressant users. The present study examined antidepressant use in pediatric patients aged 0 to 17 years over time, investigated changes regarding the prescribed drugs, analyzed underlying diagnoses, and assessed the rate of off‐label use. METHODS: We used claims data of roughly two million individuals to calculate annual prevalence and incidence rates of antidepressant prescriptions for the years 2004 to 2011. Analyses were stratified by age, sex, and drug type. For antidepressant users, numbers of prescriptions, frequencies of disorders/diseases, and specialties of the prescribing physicians were examined. The share of off‐label prescriptions was calculated for each year. RESULTS: The prescription prevalence of antidepressants ranged between 1.7 and 2.1 per 1000 minors. The use of tricyclic antidepressants decreased from 0.9 to 0.6 prescriptions per 1000 minors, while the use of selective serotonin reuptake inhibitors increased from 0.5 to 1.1. Of the patients with an antidepressant prescription, 46.4% only received one prescription. Depression was by far the most frequent diagnosis among all antidepressant users as well as among subjects with only one prescription. In 2011, 36.3% of all prescriptions were off‐label. CONCLUSION: The high proportion of single prescriptions, even in patients with a diagnosed depression, and the high rate of off‐label use are particularly noteworthy and should be further investigated in future studies.

Background: Off-label use of drugs in children and adolescents, at variance from the approved use by the regulatory authorities, is widespread due to the lack of clinical trials in children and adolescents. In paediatric wards, off-label use is common, but also in general practice a considerable number[for full text, please go to the a.m. URL], 21. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie, 9. Deutscher Pharmakovigilanztag

Titelseiten und Inhaltsverzeichnis Einleitung 1 Material und Methoden 3 Ergebnisse 24 Diskussion 45 Zusammenfassung 66 Literatur 68, Fünf quantitative Methoden zur Diagnose von prävalenten osteoporotischen Wirbelkörperfrakturen (Felsenberg mit Schwellenwerten von 0.75 und 0.80, Eastell, Melton, McCloskey und Minne) wurden verglichen und bewertet. Grundlage der Untersuchung bildeten Röntgenbilder von 2435 postmenopausalen Frauen einer multizentrischen, europäischen Querschnittsstudie (OPUS Studie). Die Röntgenbilder wurden quantitativ und qualitativ ausgewertet und eine differentialdiagnostische Einteilung der mit den quantitativen Methoden erkannten Deformationen durchgeführt. Es wurden Prävalenzraten, Kontigenztabellen, Sensitivität, Spezifität und Kappa Schätzwerte errechnet. Die Methoden ergaben deutlich unterschiedliche Ergebnisse: Prävalenzraten lagen zwischen 13% (Felsenberg 0.75) und 34% (Minne), Kappa Schätzwerte der quantitativen Methoden im Vergleich zur qualitativen Auswertung waren zwischen 0.43 (Minne) und 0.86 (Melton) und es ergaben sich Unterschiede in der Verteilung der Deformationen über die Wirbelsäule inbesondere in der mittleren BWS und unteren LWS. Zwischen 9% (Felsenberg 0.75) und 69% (Minne) der quantitativ erkannten Deformationen konnten nicht als osteoporotische Frakturen bestätigt werden. Es handelte sich bei ihnen zB um degenerative Deformationen oder traumatische Frakturen bzw die Deformation konnte in der qualitativen Auswertung nicht bestätigt werden. Es gibt keine perfekte quantitative Methode zur Erkennung von prävalenten osteoporotischen Wirbelkörperfrakturen. Allen Methoden fehlt die Spezifität für osteoporotische Frakturen, da alle Methoden auf Höhenminderungen zur Erkennung von Deformationen beruhen und Höhenminderungen nicht spezifisch für osteoporotische Frakturen sind. Zur Erkennung von prävalenten osteoporotischen Wirbelkörperfrakturen ist die Kombination einer hoch sensitiven quantitativen Methode ohne Schwellenwerte aus einer Referenzpopulation (Felsenberg 0.80) mit einer anschließenden differentialdiagnostischen Beurteilung der von der quantitativen Methode erkannten Deformationen zu empfehlen., A comparison was performed between quantitative methods (Felsenberg with thresholds of 0.75, 0.80, Eastell, Melton, McCloskey, and Minne) for the detection of prevalent osteoporotic vertebral fractures. Spinal radiographs of a cross section population (2435 cases) were analyzed. Morphometric measurements, a differential diagnosis of all quantitatively detected deformation, and a qualitative evaluation for osteoporotic fractures were performed. Prevalence rates, contingency tables, sensitivity, specificity, and kappa scores were calculated. The methods yield differing results: prevalence rates vary between 13% (Felsenberg 0.75) and 34% (Minne), kappa scores of quantitative methods compared with the qualitative one vary between 0.43 (Minne) and 0.86 (Melton), and the spatial distribution of vertebral deformations differs in the mid thoracic spine and lower lumbar spine. Between 9% (Felsenberg 0.75) and 69% (Minne) of the quantitatively detected deformations could not be confirmed as osteoporotic fractures. They were classified as degenerative deformations, traumatic fractures, or no deformation could be confirmed at all. There is no perfect quantitative method to detect osteoporotic vertebral fractures. All quantitative methods lack specificity for osteoporotic fractures because detection of deformations is only based on vertebral height reduction which is not specific for osteoporotic fractures. A combination of a highly sensitive quantitative method without threshold values from a reference population (Felsenberg 0.80) combined with a differential diagnosis of all quantitatively detected deformations is currently the best method to detect osteoporotic vertebral fractures.

Cilostazol; Intermittent claudication; Drug utilization study; Database study; Pharmacoepidemiology; Peripheral artery disease Purpose To describe the characteristics of new users of cilostazol in Europe with the aim to support the evaluation of its benefit/risk as used in regular clinical practice before the implementation of labeling changes recommended by the European Medicines Agency. Methods New users of cilostazol were identified in populations enrolled in five European health automated databases in the UK (The Health Improvement Network [THIN]), Spain (EpiChron cohort and Information System for the Improvement of Research in Primary Care [SIDIAP]), Sweden (National Registers), and Germany (German Pharmacoepidemiological Research Database [GePaRD]) between 2002 and 2012. New users were characterized according to t he prevalence of cardiovascular disease and other comorbidities, concurrent use of interacting medications, new contraindications, duration of use, and potential off-label prescribing. Results We identified 22 593 new users of cilostazol. The median age was between 68.0 (THIN) and 73.7 (Sweden) years. More than 78% of users had concomitant cardiovascular disease, and between 78.8% (GePaRD) and 91.6% (THIN) were treated with interacting medications. Prevalence of new cardiovascular contraindications ranged from 1.5% (THIN) to 11.6% (GePaRD), and concurrent use of two or more antiplatelet drugs ranged from 6.3% (SIDIAP) to 13.5% (EpiChron cohort). Between 39.4% (Sweden) and 52.9% (THIN) of users discontinued cilostazol in the first 3 months. Between 41.0% (SIDIAP) and 93.4% (THIN) were considered to have received cilostazol according to the European Medicines Agency labeling. Conclusions In this collaborative European study,most cilostazol users were elderly patients with a high prevalence of cardiovascular diseases and other comorbidity and concurrent use of interacting drugs, indicating that this is a vulnerable population at high risk of complications, especially cardiovascular events.