Methodische Aspekte bei der Durchführung von Arzneimittelsicherheits- und Utilisationsstudien basierend auf Routinedaten der gesetzlichen Krankenversicherung

At the time of approval, the safety and utilization of drugs in routine clinical practice cannot be fully assessed. Therefore, active post-marketing surveillance including the determination of the safety but also the utilization of the drugs as part of risk management plans is required by regulatory agencies. Pharmacoepidemiological studies based on claims data from statutory health insurance (SHI) providers are increasingly used to address these questions. These studies require a comprehensive knowledge of the healthcare system including reimbursement policies as well as specifics of the data source. Based on several safety and utilization studies using claims data, this thesis discusses methodological aspects relevant to conducting these studies. Considering regulations of the German health care system, the assessment of exposure, outcomes, and confounders as well as the determination of potential indications are described. Further, this thesis discusses approaches for addressing confounders which either cannot be measured in databases or if, only inadequately. Since even large electronic healthcare databases may not provide a sufficient sample size to examine rare outcomes or rare exposures, multinational database studies including databases with different structures are conducted. This thesis characterizes challenges arising from the analysis of these different databases. Pharmacoepidemiological studies based on SHI claims data are an important instrument to assess the safety and utilization of drugs following approval. The development of pharmacoepidemiology is characterized by the implementation of suitable data sources as well as the development of methodological instruments. This thesis depicts the current status and outlines future challenges

Bollywood, the Indian Cinema and it’s characteristics : by the example of movie „Dilwale Dulhania Le Jayenge“ - The Big Hearted will Take The Bride by Adit yaChopra

Diese Bachelorarbeit befasst sich mit den Besonderheiten der indischen Filmindustrie. Alle reden von Bollywood-Filmen, seit diese Musik- und Tanzsstreifen auch in die amerikaische und europäischen Kinos gekommen sind und ihr Publikum entzücken. Die Besonderheiten eines „Bollywood-Films“ sollen in dieser Arbeit aufgezeichnet werden. Anhand des Films „Dilwale Dulhania Le Jayenge“ vom Regisseur Adity Chopra sollen die verschiedenen Merkmale untersucht und ausgewertet werden. Es wird dargestellt, wie ein Bollywood-Film inszeniert wird und welche cinematographischen Besonderheiten er aufweist

Predictors of NOAC versus VKA use for stroke prevention in patients with newly diagnosed atrial fibrillation: Results from GARFIELD-AF.

INTRODUCTION: A principal aim of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) was to document changes in treatment practice for patients with newly diagnosed atrial fibrillation during an era when non-vitamin K antagonist oral anticoagulants (NOACs) were becoming more widely adopted. In these analyses, the key factors which determined the choice between NOACs and vitamin K antagonists (VKAs) are explored. METHODS: Logistic least absolute shrinkage and selection operator regression determined predictors of NOAC and VKA use. Data were collected from 24,137 patients who were initiated on AC ± antiplatelet (AP) therapy (NOAC [51.4%] or VKA [48.6%]) between April 2013 and August 2016. RESULTS: The most significant predictors of AC therapy were country, enrolment year, care setting at diagnosis, AF type, concomitant AP, and kidney disease. Patients enrolled in emergency care or in the outpatient setting were more likely to receive a NOAC than those enrolled in hospital (OR 1.16 [95% CI: 1.04-1.30], OR: 1.15 [95% CI: 1.05-1.25], respectively). NOAC prescribing seemed to be favored in lower-risk groups, namely, patients with paroxysmal AF, normotensive patients, and those with moderate alcohol consumption, but also the elderly and patients with acute coronary syndrome. By contrast, VKAs were preferentially used in patients with permanent AF, moderate to severe kidney disease, heart failure, vascular disease, and diabetes and with concomitant AP. CONCLUSION: GARFIELD-AF data highlight marked heterogeneity in stroke prevention strategies globally. Physicians are adopting an individualized approach to stroke prevention where NOACs are favored in patients with a lower stroke risk but also in the elderly and patients with acute coronary syndrome

Old and new oral anticoagulants : food, herbal medicines and drug interactions

The most commonly prescribed oral anticoagulants worldwide are the vitamin K antagonists (VKAs) such as warfarin. Factors affecting the pharmacokinetics of VKAs are important because deviations from their narrow therapeutic window can result in bleedings due to over-anticoagulation or thrombosis because of under-anticoagulation. In addition to pharmacodynamic interactions (e.g., augmented bleeding risk for concomitant use of NSAIDs), interactions with drugs, foods, herbs, and over-the-counter medications may affect the risk/benefit ratio of VKAs. Direct oral anticoagulants (DOACs) including Factor Xa inhibitors (rivaroxaban, apixaban and edoxaban) and thrombin inhibitor (dabigatran) are poised to replace warfarin. Phase-3 studies and real-world evaluations have established that the safety profile of DOACs is superior to those of VKAs. However, some pharmacokinetic and pharmacodynamic interactions are expected. Herein we present a critical review of VKAs and DOACs with focus on their potential for interactions with drugs, foods, herbs and over-the-counter medications

Methodological aspects relevant to conducting safety and utilization studies based on claims data

At the time of approval, the safety and utilization of drugs in routine clinical practice cannot be fully assessed. Therefore, active post-marketing surveillance including the determination of the safety but also the utilization of the drugs as part of risk management plans is required by regulatory agencies. Pharmacoepidemiological studies based on claims data from statutory health insurance (SHI) providers are increasingly used to address these questions. These studies require a comprehensive knowledge of the healthcare system including reimbursement policies as well as specifics of the data source. Based on several safety and utilization studies using claims data, this thesis discusses methodological aspects relevant to conducting these studies. Considering regulations of the German health care system, the assessment of exposure, outcomes, and confounders as well as the determination of potential indications are described. Further, this thesis discusses approaches for addressing confounders which either cannot be measured in databases or if, only inadequately. Since even large electronic healthcare databases may not provide a sufficient sample size to examine rare outcomes or rare exposures, multinational database studies including databases with different structures are conducted. This thesis characterizes challenges arising from the analysis of these different databases. Pharmacoepidemiological studies based on SHI claims data are an important instrument to assess the safety and utilization of drugs following approval. The development of pharmacoepidemiology is characterized by the implementation of suitable data sources as well as the development of methodological instruments. This thesis depicts the current status and outlines future challenges