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Lamiae Grimaldi-Bensouda, Nicolas Danchin, Jean Dallongeville, Bruno Falissard, Alain Furber, Yves Cottin, Laurent Bonello, Olivier Morel, Florence Leclercq, Etienne Puymirat, Fahmi Ghanem, Nicolas Delarche, Jacques Benichou, Lucien Abenhaim
OBJECTIVE: To compare ticagrelor and prasugrel with clopidogrel for recurrent fatal and non-fatal myocardial infarction (reMI) in real-life conditions. METHODS: Case-referent study using the Pharmacoepidemiological General Research eXtension (PGRx)-acute coronary syndrome (ACS) registry. Cases were patients with reMI from a cohort with index ACS or external to the cohort (same sites). Referents from the cohort, without recurrent event, were matched on index ACS type and date, age and sex with reMI cases...
March 13, 2018: Heart: Official Journal of the British Cardiac Society
Graziano Onder, Davide L Vetrano, Alessandra Marengoni, J Simon Bell, Kristina Johnell, Katie Palmer
Chronic diseases are considered to be major determinants of frailty and it could be hypothesized that their treatment may counteract the development of frailty. However, the hypothesis that intensive treatment of chronic diseases might reduce the progression of frailty is poorly supported by existing studies. In contrast, some evidence suggests that intensive treatment of chronic diseases may increase negative health outcomes in frail older adults. In particular, if treatment of symptoms related to chronic diseases (i...
March 8, 2018: European Journal of Internal Medicine
V Pauly, E Frauger, M Lepelley, M Mallaret, Q Boucherie, J Micallef
AIM: The aim was to characterize patterns of Methylphenidate (MPH) use in France in both children and adults over a three year period. METHODS: Using the French General Health Insurance database limited to two areas covering approximately 4 million individuals, we made up a cohort of incident MPH users between July 2010 and June 2013. Splitting them into distinct age groups ( [18-24]; [25;49]; >=50 years olds for adults and less than 6 years old, [6-11] and [12;17] for children), we described these populations at MPH initiation and during follow-up according to duration of treatment, quantities dispensed, and co-prescription with Central Nervous System (CNS) drugs...
March 7, 2018: British Journal of Clinical Pharmacology
Gaby Danan, Rolf Teschke
Launched in 1993 and partially based on the results of an international consensus meeting organized under the auspices of the Council of International Organizations of Medical Sciences (CIOMS), the Roussel Uclaf Causality Assessment Method (RUCAM) is the most used causality assessment tool worldwide for the diagnosis of drug-induced liver injury (DILI) and herb-induced liver injury (HILI) in a large number of epidemiological studies, case reports, and case series. The 25-year experience of RUCAM use confirmed that the success was due to its objective, standardized, and liver-injury-specific approach structured with defined key elements derived from a series of DILI cases with positive rechallenge...
March 3, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Thomas Bo Jensen, Espen Jimenez-Solem, Rikke Cortes, Cecilie Betzer, Sara Bøge Breinholt, Kasper Meidahl Petersen, Tonny Studsgaard Petersen, Jakob Kjellberg, Hanne Rolighed Christensen, Jon Trærup Andersen
AIMS: Registries on in-hospital drug use are sparse, especially those that can be linked to nationwide registries. In this study, we present and validate the Electronic Patient Medication module (EPM)-the electronic administrative database on in-hospital drug use covering the Capital Region of Denmark. METHODS: The research database (EPM-research) is an adaptation of the database underlying the electronic administrative database for in-hospital drug use (EPM-clinic)...
February 1, 2018: Scandinavian Journal of Public Health
Cécile Conte, Aurore Palmaro, Pascale Grosclaude, Laetitia Daubisse-Marliac, Fabien Despas, Maryse Lapeyre-Mestre
The use of claims database to study lymphomas in real-life conditions is a crucial issue in the future. In this way, it is essential to develop validated algorithms for the identification of lymphomas in these databases. The aim of this study was to assess the validity of diagnosis codes in the French health insurance database to identify incident cases of lymphomas according to results of a regional cancer registry, as the gold standard.Between 2010 and 2013, incident lymphomas were identified in hospital data through 2 algorithms of selection...
January 2018: Medicine (Baltimore)
(no author information available yet)
[This corrects the article DOI: 10.1371/journal.pone.0191185.].
2018: PloS One
Yoko Hirano, Yuko Asami, Kazuhiko Kuribayashi, Shigeru Kitazaki, Yuji Yamamoto, Yoko Fujimoto
BACKGROUND: Many pharmacoepidemiologic studies using large-scale databases have recently been utilized to evaluate the safety and effectiveness of drugs in Western countries. In Japan, however, conventional methodology has been applied to postmarketing surveillance (PMS) to collect safety and effectiveness information on new drugs to meet regulatory requirements. Conventional PMS entails enormous costs and resources despite being an uncontrolled observational study method. This study is aimed at examining the possibility of database research as a more efficient pharmacovigilance approach by comparing a health care claims database and PMS with regard to the characteristics and safety profiles of sertraline-prescribed patients...
June 20, 2017: Value in Health Regional Issues
Olesya Ajnakina, Henriette Thisted Horsdal, John Lally, James H MacCabe, Robin M Murray, Christiane Gasse, Theresa Wimberley
Large-scale pharmacoepidemiological research on treatment resistance relies on accurate identification of people with treatment-resistant schizophrenia (TRS) based on data that are retrievable from administrative registers. This is usually approached by operationalising clinical treatment guidelines by using prescription and hospital admission information. We examined the accuracy of an algorithm-based definition of TRS based on clozapine prescription and/or meeting algorithm-based eligibility criteria for clozapine against a gold standard definition using case notes...
February 19, 2018: Schizophrenia Research
Taeho Greg Rhee, Somaia Mohamed, Robert A Rosenheck
OBJECTIVE: A recent moderately long-term study found an antipsychotic to be more effective than an antidepressant as the next-step treatment of unresponsive major depressive disorder (MDD). It is thus timely to examine recent trends in the pharmacoepidemiology of antipsychotic treatment of MDD. METHODS: Data from the 2006-2015 National Ambulatory Medical Care Survey, nationally representative samples of office-based outpatient visits in adults with MDD (ICD-9-CM codes 296...
February 13, 2018: Journal of Clinical Psychiatry
John W Jackson, Ian Schmid, Elizabeth A Stuart
Purpose of review: Propensity score methods have become commonplace in pharmacoepidemiology over the past decade. Their adoption has confronted formidable obstacles that arise from pharmacoepidemiology's reliance on large healthcare databases of considerable heterogeneity and complexity. These include identifying clinically meaningful samples, defining treatment comparisons, and measuring covariates in ways that respect sound epidemiologic study design. Additional complexities involve correctly modeling treatment decisions in the face of variation in healthcare practice, and dealing with missing information and unmeasured confounding...
December 2017: Current Epidemiology Reports
Tingting Li, Yan Xie, Ziyad Al-Aly
PURPOSE OF REVIEW: To discuss whether the recently described relationship between proton pump inhibitor (PPI) use and the risk of adverse kidney outcomes represents a causal relationship or is merely the result of confounding. RECENT FINDINGS: A wave of observational studies has described an association between PPI use and the risk of development of chronic kidney disease and its progression to end-stage renal disease. The results are generally robust and remarkably consistent across different studies...
February 9, 2018: Current Opinion in Nephrology and Hypertension
Stuart McTaggart, Clifford Nangle, Jacqueline Caldwell, Samantha Alvarez-Madrazo, Helen Colhoun, Marion Bennie
Background: Efficient generation of structured dose instructions that enable researchers to calculate drug exposure is central to pharmacoepidemiology studies. Our aim was to design and test an algorithm to codify dose instructions, applied to the NHS Scotland Prescribing Information System (PIS) that records about 100 million prescriptions per annum. Methods: A natural language processing (NLP) algorithm was developed that enabled free-text dose instructions to be represented by three attributes - quantity, frequency and qualifier - specified by three, three and two variables, respectively...
February 6, 2018: International Journal of Epidemiology
Marta Gentili, Marco Pozzi, Gabrielle Peeters, Sonia Radice, Carla Carnovale
Background Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterise fully the safety profiles of drugs. Addionally, information about rare adverse drug reactions (ADRs) in special groups or drug-drug interactions (DDIs) is often incomplete or not available for most of the drugs commonly used in the daily clinical practice...
February 6, 2018: Current Clinical Pharmacology
Sun-Kyeong Park, Yeon-Hee Baek, Nicole Pratt, Lisa Kalisch Ellett, Ju-Young Shin
INTRODUCTION: Studies have found an association between the use of proton pump inhibitors (PPIs) and dementia, but these findings may have been confounded by selection biases. OBJECTIVE: We used prescription sequence symmetry analysis (PSSA) to estimate the sequence ratio (SR) between PPI use and dementia compared with an active comparator, the use of histamine-2 receptor antagonists (H2RAs). METHODS: We conducted a PSSA on a nationwide South Korean database between 2002 and 2013...
February 3, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Ingo Langner, Volker Krieg, Oliver Heidinger, Hans Werner Hense, Hajo Zeeb
BACKGROUND: Claims data of the statutory health insurance (SHI) are an important data source for the evaluation of cancer prevention programs. However, this source does not contain relevant information on cause of death. This study examined whether individual claims data can be enriched with data on the required cause of death using record linkage procedures with suitable external data sources. METHODS: In the German pharmacoepidemiologic research database (GePaRD) we identified a sample of 25,528 deceased female residents of North Rhine Westphalia (NRW) who, according to GePaRD information, died between 2006 and 2013...
February 1, 2018: Das Gesundheitswesen
Megan H Noe, Joel M Gelfand
Clinical trials have several important limitations for evaluating the safety of new medications, leading to many adverse events not being identified until the postmarketing period. Descriptive studies, including case reports, case series, cross-sectional, and ecologic studies, help identify potential safety signals and generate hypotheses. Further research using analytic study methods, including case-control studies and cohort studies, are necessary to determine if an association truly exists and to better understand the potential for causation...
February 2018: Journal of Investigative Dermatology
Xiang Zhang, Douglas E Faries, Hu Li, James D Stamey, Guido W Imbens
PURPOSE: Observational pharmacoepidemiological studies can provide valuable information on the effectiveness or safety of interventions in the real world, but one major challenge is the existence of unmeasured confounder(s). While many analytical methods have been developed for dealing with this challenge, they appear under-utilized, perhaps due to the complexity and varied requirements for implementation. Thus, there is an unmet need to improve understanding the appropriate course of action to address unmeasured confounding under a variety of research scenarios...
January 30, 2018: Pharmacoepidemiology and Drug Safety
Helen Strongman, Solomon Christopher, Maila Majak, Rachael Williams, Shahram Bahmanyar, Marie Linder, Edith M Heintjes, Dimitri Bennett, Pasi Korhonen, Fabian Hoti
Objectives: Describe and compare the risk of cardiovascular and non-cardiovascular mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage of disease progression. Research design and methods: This exploratory linked database cohort analysis used pooled health and mortality data from three European countries: Finland, Sweden and the UK. Propensity score together with exact matching was used to match 31 133 patients with type 2 diabetes first prescribed pioglitazone from 2000 to 2011, to 31 133 patients never prescribed pioglitazone...
2018: BMJ Open Diabetes Research & Care
Kazuki Ide, Norihiro Matsuoka, Koji Kawakami
Proton-pump inhibitors (PPIs), such as omeprazole, lansoprazole, and rabeprazole, are used for the treatment of gastroesophageal reflux disease and peptic ulcer disease. The use of PPIs has increased, especially in older individuals, and a pharmacoepidemiological study indicated that the use of PPIs peaks in people aged 80 years or older. In this population, Alzheimer's disease (AD) is a common neurological disorder and type of dementia, occurring with a frequency of approximately 10%. Currently, over 45 million people are estimated to have dementia worldwide, and it is a major cause of death in the elderly...
January 28, 2018: Current Medicinal Chemistry
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