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Kathrin Jobski, Niklas Schmedt, Bianca Kollhorst, Jutta Krappweis, Tania Schink, Edeltraut Garbe
PURPOSE: The purpose of this study was to investigate characteristics, drug use patterns, and predictors for treatment choice in older German patients initiating antidepressant (AD) treatment. METHODS: Using the German Pharmacoepidemiological Research Database, we identified a cohort of AD initiators aged at least 65 years between 2005 and 2011. Potential indications, co-morbidity, and co-medication as well as treatment patterns such as the duration of the first treatment episode were assessed...
October 18, 2016: European Journal of Clinical Pharmacology
Silvia Bini, Cesare Cerri, Antonello E Rigamonti, Pietro A Bertazzi, Gianfrancesco Fiorini, Silvano G Cella
We analysed drug dispensation by charitable organisations in a year time. Drugs were grouped according to the Anatomic Therapeutic Chemical classification and the amount dispensed was calculated with the system of the Daily Defined Dose (DDD) and expressed as DDD/1000 subjects/day. A number of 87,550 subjects were studied (13,308 Italians; 74,242 Immigrants). Though we noticed a great sesonal variability, the drugs most frequently dispensed were those for the respiratory, cardiovascular and gastrointestinal system and antibiotics, which is different from the rest of the Italian population and the immigrant population assisted by our National Health Service (NHS)...
August 19, 2016: Journal of Public Health Research
Isla S Mackenzie, Steven V Morant, Li Wei, Alastair M Thompson, Thomas M MacDonald
AIMS: Spironolactone is widely used to treat heart failure, hypertension and liver disease with increased usage in recent years. Spironolactone has endocrine effects that could influence cancer risks and historical reports suggest possible links with increased risk of certain types of cancer. The aim of this study was to assess the effect of spironolactone exposure on cancer incidence. METHODS: A pharmacoepidemiological propensity score-matched cohort study was performed to assess the effect of spironolactone exposure on cancer incidence...
October 13, 2016: British Journal of Clinical Pharmacology
Alexander M Fassmer, Edeltraut Garbe, Niklas Schmedt
The aim of this study was to analyze the population-based frequency of classic (c-) and biologic (b-) disease-modifying antirheumatic drug (DMARD) use over time, selected underlying indications and the specialty of the prescribing physicians in Germany. Based on the claims data of the German Pharmacoepidemiological Research Database (GePaRD), yearly cross-sectional studies were conducted from 2004 to 2011. The prevalence of DMARD use was calculated as the number of persons with at least one dispensation per 1000 persons stratified by sex and age...
October 2016: Pharmacology Research & Perspectives
David Franklin Niedrig, Liesa Hoppe, Sarah Mächler, Heike Russmann, Stefan Russmann
OBJECTIVE: Benzodiazepines and "Z-drug" GABA-receptor modulators (BDZ) are among the most frequently used drugs in hospitals. Adverse drug events (ADE) associated with BDZ can be the result of preventable medication errors (ME) related to dosing, drug interactions and comorbidities. The present study evaluated inpatient use of BDZ and related ME and ADE. METHODS: We conducted an observational study within a pharmacoepidemiological database derived from the clinical information system of a tertiary care hospital...
2016: PloS One
Thi Thu Ha Nguyen, Antoine Pariente, Jean-Louis Montastruc, Maryse Lapeyre-Mestre, Vanessa Rousseau, Olivier Rascol, Bernard Bégaud, François Montastruc
AIMS: Pharmacovigilance databases are usually used to detect new potential signals relevant for drug safety. They are seldom used for explanatory purposes, e.g. to understand the mechanisms of adverse drug reactions (ADRs). The aim of the present study was to combine pharmacovigilance and pharmacodynamic data to investigate the association between D2, 5HT2A, and M1 receptor occupancy and the risks of antipsychotic (AP)-induced movement disorders. METHODS: First, we performed a case non-case analysis using spontaneous reports from the World Health Organization (WHO) Global Individual Case Safety Report (ICSR) database, VigiBase®...
September 30, 2016: British Journal of Clinical Pharmacology
Henrik Støvring, Anton Pottegård, Jesper Hallas
PURPOSE: The purpose of the study is to develop a method to estimate the duration of single prescriptions in pharmacoepidemiological studies when the single prescription duration is not available. METHODS: We developed an estimation algorithm based on maximum likelihood estimation of a parametric two-component mixture model for the waiting time distribution (WTD). The distribution component for prevalent users estimates the forward recurrence density (FRD), which is related to the distribution of time between subsequent prescription redemptions, the inter-arrival density (IAD), for users in continued treatment...
September 26, 2016: Pharmacoepidemiology and Drug Safety
Guttorm Raknes, Lars Småbrekke
PURPOSE: Following a TV documentary in 2013, there was a tremendous increase in low dose naltrexone (LDN) use in a wide range of unapproved indications in Norway. We aim to describe the extent of this sudden and unprecedented increase in LDN prescribing, to characterize patients and LDN prescribers, and to estimate LDN dose sizes. METHODS: LDN prescriptions recorded in the Norwegian Prescription Database (NorPD) in 2013 and 2014, and sales data not recorded in NorPD from the only Norwegian LDN manufacturer were included in the study...
September 26, 2016: Pharmacoepidemiology and Drug Safety
Preeti Datta-Nemdharry, Andrew Thomson, Julie Beynon, Katherine Donegan
PURPOSE: The purpose of this study is to characterise how Type 2 Diabetes Mellitus (T2DM) is treated in England and Wales and whether this adheres to 2009 National Institute for Health and Care Excellence (NICE) guidance on management of T2DM. METHODS: Data for T2DM patients aged 18+ years prescribed at least one anti-diabetic drug between 01/01/2000-30/06/2012 were extracted from the Clinical Practice Research Datalink. We examined the sequences in which anti-diabetic drugs were prescribed and, for patients on the most common anti-diabetic drug pathways, evaluated average HbA1c values at treatment initiation and at progression to a second or third-line anti-diabetic drug class, including insulin...
September 19, 2016: Pharmacoepidemiology and Drug Safety
Jacqueline M Major, Lynne Penberthy, Katherine A McGlynn
No abstract text is available yet for this article.
August 31, 2016: Annals of Epidemiology
Alexander M Walker
No abstract text is available yet for this article.
August 31, 2016: Annals of Epidemiology
Mei Sheng Duh, Pierre Cremieux, Marc Van Audenrode, Francis Vekeman, Paul Karner, Haimin Zhang, Paul Greenberg
PURPOSE: To compare the patient characteristics and the inter-temporal reporting patterns of adverse events (AEs) for atorvastatin (Lipitor(®) ) and sibutramine (Meridia(®) ) in social media ( versus the FDA Adverse Event Reporting System (FAERS). METHODS: We identified clinically important AEs associated with atorvastatin (muscle pain) and sibutramine (cardiovascular AEs), compared their patterns in social media postings versus FAERS and used Granger causality tests to assess whether social media postings were useful in forecasting FAERS reports...
September 7, 2016: Pharmacoepidemiology and Drug Safety
Corinne Willame, Laurence Baril, Judith van den Bosch, Germano L C Ferreira, Rachael Williams, Dominique Rosillon, Catherine Cohet
PURPOSE: Investigational and marketed vaccines are increasingly evaluated, and manufacturers are required to put in place mechanisms to monitor long-term benefit-risk profiles. However, generating such evidence in real-world settings remains challenging, especially when rare adverse events are assessed. Planning of an appropriate study design is key to conducting a valid study. The aim of this paper is to illustrate how feasibility assessments support the generation of robust pharmacoepidemiological data...
September 7, 2016: Pharmacoepidemiology and Drug Safety
Andrea Arfè, Federica Nicotra, Arianna Ghirardi, Monica Simonetti, Francesco Lapi, Miriam Sturkenboom, Giovanni Corrao
PURPOSE: The effect of drug exposure misclassification generally receives little attention in pharmacoepidemiological research. In this paper, we illustrate a probabilistic bias analysis approach for misclassified categorical exposures and apply it in a database study of oral anti-hyperglycaemic drugs (OADs). METHODS: A cohort study based on the Health Search Database general-practice database was carried out by including 12 640 adult (≥40 years) patients newly treated with OADs during 2003-2010...
September 4, 2016: Pharmacoepidemiology and Drug Safety
Jacob N Hunnicutt, Christine M Ulbricht, Stavroula A Chrysanthopoulou, Kate L Lapane
PURPOSE: We systematically reviewed pharmacoepidemiologic and comparative effectiveness studies that use probabilistic bias analysis to quantify the effects of systematic error including confounding, misclassification, and selection bias on study results. METHODS: We found articles published between 2010 and October 2015 through a citation search using Web of Science and Google Scholar and a keyword search using PubMed and Scopus. Eligibility of studies was assessed by one reviewer...
September 5, 2016: Pharmacoepidemiology and Drug Safety
C Ferdynus, L Huiart
AIM: Administrative health databases such as the French National Heath Insurance Database - SNIIRAM - are a major tool to answer numerous public health research questions. However the use of such data requires complex and time-consuming data management. Our objective was to develop and make available a tool to optimize cohort constitution within administrative health databases. METHODS: We developed a process to extract, transform and load (ETL) data from various heterogeneous sources in a standardized data warehouse...
September 2016: Revue D'épidémiologie et de Santé Publique
Carlos A Camargo, Kourtney J Davis, Elizabeth B Andrews, David A Stempel, Michael Schatz
RATIONALE: The increased risk of asthma mortality in association with long-acting β2-agonist (LABA) monotherapy is well documented but the risk associated with LABA plus inhaled corticosteroid (ICS) therapy remains unclear. OBJECTIVE: We assessed the feasibility of a large pharmacoepidemiological study to compare the effect of combined LABA + ICS therapy with non-LABA maintenance therapy on the risk of asthma mortality. METHODS: This observational retrospective study used electronic data from ten US data partners to construct a cohort of patients with persistent asthma (defined as: four or more asthma maintenance medication dispensings in 12 months and a code diagnosis of asthma)...
August 31, 2016: Clinical Drug Investigation
Mahyar Etminan, Ric M Procyshyn, Ali Samii, Bruce C Carleton
Aripiprazole is a unique atypical antipsychotic with partial agonist activity on the dopamine-2 (D2) receptor. This unique pharmacological profile of aripiprazole was thought to lead to a lower incidence of extrapyramidal symptoms (EPSs). However, recent case reports have alluded to an increase in the risk of EPS in aripiprazole users compared with nonusers of the drug. No epidemiologic studies to date have quantified this risk. We conducted a pharmacoepidemiologic study composed of a nested case-control study using a large health claims database (IMS Health) in the United States...
October 2016: Journal of Clinical Psychopharmacology
(no author information available yet)
No abstract text is available yet for this article.
August 2016: Pharmacoepidemiology and Drug Safety
Tiago Sousa-Veloso
Pharmacovigilance is concerned with the detection, assessment, understanding, and prevention of adverse reactions to medicines. It is helpful to prevent undesired harm sustained by the patient due to inappropriate or unsafe use of medicinal agents. As the use of drugs and polypharmacy increase in prevalence, pharmacovigilance gains relevance and momentum. Practice-based research networks have the potential to enhance health research by promoting earlier detection of adverse events at a decreased level of cost...
August 22, 2016: Pain and Therapy
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