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Pharmacoepidemiology

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https://www.readbyqxmd.com/read/28332362/signal-detection-of-imipenem-compared-to-other-drugs-from-korea-adverse-event-reporting-system-database
#1
Kyounghoon Park, Mick Soukavong, Jungmee Kim, Kyoung Eun Kwon, Xue Mei Jin, Joongyub Lee, Bo Ram Yang, Byung Joo Park
PURPOSE: To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD). MATERIALS AND METHODS: We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem...
May 2017: Yonsei Medical Journal
https://www.readbyqxmd.com/read/28301639/association-of-repeated-intravitreous-bevacizumab-injections-with-risk-for-glaucoma-surgery
#2
Brennan D Eadie, Mahyar Etminan, Bruce C Carleton, David A Maberley, Frederick S Mikelberg
Importance: Intravitreous injections of anti-vascular endothelial growth factor (VEGF) agents are associated with a sustained increase in intraocular pressure. This sustained elevated intraocular pressure could lead to higher rates of glaucoma surgery to lower this pressure. Objective: To determine the risk of glaucoma surgery following repeated intravitreous bevacizumab injections. Design, Setting, Participants: This nested, case-control study acquired and analyzed data from large, population-based, linked health databases supported by the British Columbia Ministry of Health in Canada...
March 16, 2017: JAMA Ophthalmology
https://www.readbyqxmd.com/read/28291833/tamoxifen-use-and-acute-pancreatitis-a-population-based-cohort-study
#3
Fan-Gen Hsu, Yow-Wen Hsieh, Ming-Jyh Sheu, Che-Chen Lin, Cheng-Li Lin, Chung Y Hsu, Chang-Yin Lee, Mei-Yin Chang, Kuang-Hsi Chang
BACKGROUND: Several case reports have indicated that tamoxifen induced acute pancreatitis (AP); but no pharmacoepidemiological data support the claim. Therefore, we investigated whether tamoxifen use is correlated with the risk of AP in patients with breast cancer. METHODS: This population-based cohort study used the Taiwan National Health Insurance Research Database. A cohort of 22 005 patients aged ≥20 years with breast cancer from January 1, 2000 to December 31, 2009 was identified and the date of cancer diagnosis was set as the index date...
2017: PloS One
https://www.readbyqxmd.com/read/28276585/electronic-case-report-forms-and-electronic-data-capture-within-clinical-trials-and-pharmacoepidemiology
#4
REVIEW
David A Rorie, Robert W V Flynn, Kerr Grieve, Alexander Doney, Isla Mackenzie, Thomas M MacDonald, Amy Rogers
AIMS: Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underutilised despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research. METHODS: The review used PubMed and the Institute of Electrical and Electronic Engineers library (IEEE). Search terms used were agreed by the authors and documented...
March 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28266748/immeasurable-time-bias-due-to-hospitalization-in-medico-administrative-databases-which-impact-for-pharmacoepidemiological-studies
#5
Aurore Palmaro, Quentin Boucherie, Julie Dupouy, Joëlle Micallef, Maryse Lapeyre-Mestre
PURPOSE: Drugs administered to hospitalized patients are not available within almost all health insurance databases. However, this unobservable exposure time bias is very rarely taken into account in pharmacoepidemiology. The objective was to model unobservable periods due to hospitalization and to assess their impact on risk estimates in the context of the association between benzodiazepines and mortality. METHODS: A cohort study was identified using the General Sample of Beneficiaries in France for the period 2006-2012...
March 7, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28266092/six-year-multi-centre-observational-post-marketing-surveillance-of-the-safety-of-the-hpv-16-18-as04-adjuvanted-vaccine-in-women-aged-10-25%C3%A2-years-in-korea
#6
Chul-Jung Kim, Rok Song, Jing Chen, Fernanda Taveres Da Silva, Kusuma B Gopala, Joon Hyung Kim, Dan Bi, Jong Sup Park
PURPOSE: To evaluate the safety of HPV-16/18 AS04-adjuvanted vaccine when administered as per the PI in Korea. METHODS: A total of 3084 women aged 10-25 years were enrolled in this post-marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose...
March 7, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28252630/-pharmacoepidemiological-study-of-the-course-of-influenza-and-other-acute-respiratory-viral-infections-in-risk-groups
#7
V A Bulgakova, A A Poromov, A I Grekova, N Yu Pshenichnaya, E P Selkova, N I Lvov, I A Leneva, I V Shestakova, V V Maleev
AIM: To identify risk factors (RFs) for the development of bacterial complications and the prolonged course of influenza and other acute respiratory viral infections (ARVIs) among inpatients treated in Russian healthcare facilities in the post-pandemic period; to determine the clinical presentation of the disease (flu-like syndrome) in risk-group people and to evaluate the efficacy of antiviral therapy with arbidol (umifenovir). MATERIAL AND METHODS: The investigators retrospectively analyzed randomly selected medical records of inpatients with influenza and other ARVI in 88 hospitals from 50 regions of the Russian Federation: those of 3532 and 1755 patients in the 2010-2011 and 2014-2015 seasons, respectively, by applying parametric and nonparametric statistical methods...
2017: Terapevticheskiĭ Arkhiv
https://www.readbyqxmd.com/read/28239929/a-tutorial-on-the-use-of-instrumental-variables-in-pharmacoepidemiology
#8
REVIEW
Ashkan Ertefaie, Dylan S Small, James H Flory, Sean Hennessy
PURPOSE: Instrumental variable (IV) methods are used increasingly in pharmacoepidemiology to address unmeasured confounding. In this tutorial, we review the steps used in IV analyses and the underlying assumptions. We also present methods to assess the validity of those assumptions and describe sensitivity analysis to examine the effects of possible violations of those assumptions. METHODS: Observational studies based on regression or propensity score analyses rely on the untestable assumption that there are no unmeasured confounders...
February 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28239922/diverging-approaches-of-pharmacovigilance-and-pharmacoepidemiology-to-assessing-drug-safety-epistemological-and-ethical-implications
#9
Joël Coste
No abstract text is available yet for this article.
February 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28236988/-what-can-we-expect-from-clinical-trials-in-psychiatry
#10
A Marsot, Q Boucherie, F Kheloufi, C Riff, D Braunstein, J Dupouey, R Guilhaumou, X Zendjidjian, S Bonin-Guillaume, E Fakra, M Guye, V Jirsa, J-M Azorin, R Belzeaux, M Adida, J Micallef, O Blin
Clinical trials in psychiatry allow to build the regulatory dossiers for market authorization but also to document the mechanism of action of new drugs, to build pharmacodynamics models, evaluate the treatment effects, propose prognosis, efficacy or tolerability biomarkers and altogether to assess the impact of drugs for patient, caregiver and society. However, clinical trials have shown some limitations. Number of recent dossiers failed to convince the regulators. The clinical and biological heterogeneity of psychiatric disorders, the pharmacokinetic and pharmacodynamics properties of the compounds, the lack of translatable biomarkers possibly explain these difficulties...
December 2016: L'Encéphale
https://www.readbyqxmd.com/read/28231678/-application-of-disease-risk-score-in-pharmacoepidemiologic-studies
#11
H Y Zhao, S Y Zhan
Disease risk score (DRS) can be used to adjust the confounding effects on data with high dimensions and can reduce related bias through balancing the risk or probability, regarding the development of some specific diseases, between the two compared groups. The DRS approach thus can be applied to studies of pharmacoepidemiology when administrative medical database is used for data analysis. Although DRS functions are similarly to the propensity scores (PS) under many situations, even with some advantages over PS or conventional analytical methods in some special exposure settings, the usage of DRS is far limited than the PS method...
February 10, 2017: Zhonghua Liu Xing Bing Xue za Zhi, Zhonghua Liuxingbingxue Zazhi
https://www.readbyqxmd.com/read/28231495/drug-induced-panic-attacks-analysis-of-cases-registered-in-the-french-pharmacovigilance-database
#12
Delphine Abadie, Anaïs Essilini, Virginie Fulda, Aurore Gouraud, Mélissa Yéléhé-Okouma, Joëlle Micallef, François Montastruc, Jean Louis Montastruc
BACKGROUND: The potential role of drugs in the onset of panic attacks (PAs) is poorly understood. AIM: The objective of our study was to characterize drug-induced PAs. METHOD: We performed an analysis of PAs registered in the French pharmacovigilance database between 01/01/1985 and 05/11/2014. RESULTS: Among the 163 recorded cases, 136 (83.4%) were directly related to drugs, mainly antidepressants (11.3%, mainly serotonin reuptake inhibitors), mefloquine (7...
February 9, 2017: Journal of Psychiatric Research
https://www.readbyqxmd.com/read/28224612/clopidogrel-paclitaxel-drug-drug-interaction-a-pharmacoepidemiologic-study
#13
K Agergaard, M Mau-Sørensen, T B Stage, T L Jørgensen, R E Hassel, K D Steffensen, J W Pedersen, M L H Milo, S H Poulsen, A Pottegård, J Hallas, K Brøsen, T K Bergmann
Paclitaxel is mainly eliminated by CYP2C8 in the liver. CYP2C8 is strongly inhibited by the clopidogrel metabolite acyl-β-D-glucuronide. To determine if this interaction has clinical relevance, we identified 48 patients treated with clopidogrel and paclitaxel using databases and a prescription register. Peripheral sensory neuropathy was retrospectively evaluated from medical charts and compared to that of 88 age and sex matched controls treated with paclitaxel and low dose aspirin. By a cumulative dose of 1500 mg paclitaxel, 35% of the patients had developed severe neuropathy...
February 22, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28214924/characteristics-and-outcomes-of-rheumatoid-arthritis-patients-who-started-biosimilar-infliximab
#14
Yoon-Kyoung Sung, Soo-Kyung Cho, Dam Kim, Soyoung Won, Chan-Bum Choi, So-Young Bang, Seung-Jae Hong, Hyoun Ah Kim, Eun-Mi Koh, Hye-Soon Lee, Chang-Hee Suh, Dae-Hyun Yoo, Sang-Cheol Bae
To compare the characteristics of rheumatoid arthritis (RA) patients receiving either biosimilar or originator infliximab and to identify the effectiveness and safety of biosimilar infliximab in RA patients in real-world practice. RA patients who started either biosimilar or originator infliximab were selected using the prospective biologic disease-modifying anti-rheumatic drugs (DMARDs) registry: BIOlogics Pharmacoepidemiologic StudY (BIOPSY). Baseline characteristics of the two groups were compared, and short-term treatment outcomes, including DAS28-ESR and HAQ-DI scores, were compared after initiation of biosimilar or originator infliximab...
February 18, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28201528/pharmacoepidemiology-for-nephrologists-do-proton-pump-inhibitors-cause-chronic-kidney-disease
#15
Laurie A Tomlinson, Damian G Fogarty, Ian Douglas, Dorothea Nitsch
No abstract text is available yet for this article.
February 11, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28195856/pharmacoepidemiologic-analyses-of-opioid-use-among-oef-oif-ond-veterans
#16
Teresa J Hudson, Jacob T Painter, Brad C Martin, Mark A Austen, James S Williams, John Fortney, Mark D Sullivan, Mark J Edlund
There is a great deal of concern about opioid use in Veterans, particularly those that served in Afghanistan (OEF) and Iraq (OIF and OND). The current study provides a detailed pharmacoepidemiologic analysis of opioid use among OEF/OIF/OND Veterans from FY09 to FY12. Data from three data repositories from the Veterans Health Administration (VHA) were used to describe demographic, clinical, and medication characteristics associated with opioid use among OEF/OIF/OND Veterans and among those with TBI. Logistic regression models were used to identify risks associated with chronic opioid use in FY12...
February 11, 2017: Pain
https://www.readbyqxmd.com/read/28194654/the-risk-of-ischemic-cardio-and-cerebrovascular-events-associated-with-oxycodone-naloxone-and-other-extended-release-high-potency-opioids-a-nested-case-control-study
#17
Kathrin Jobski, Bianca Kollhorst, Edeltraut Garbe, Tania Schink
INTRODUCTION: In Germany, an extended-release (ER) combination of the high-potency opioid (HPO) oxycodone and the antagonist naloxone was approved in 2006. In recent years, the cardio- and cerebrovascular safety of opioid antagonists and of opioids themselves has been discussed. OBJECTIVES: The objective of this study was to estimate the risk of major ischemic cardio- and cerebrovascular events in patients receiving ER oxycodone-naloxone compared with those receiving other ER HPOs...
February 13, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28190508/navigating-the-clinical-trial-pathway-conception-design-execution-and-results-dissemination
#18
John S Sampalis, Joanne Watson, Stella Boukas, Marianna Boukas, Natalie Harvey, Sanjay Machado, Michel Bordeleau, Emmanouil Rampakakis
Dr Sampalis is founder, Chief Executive Officer, and Chief Scientific Officer of JSS Medical Research Inc, founded in 1997. He is a tenured professor of Surgery and Epidemiology & Biostatistics of McGill University, the University of Montreal and University of Laval. Recognized as a leading clinical epidemiologist and one of the top trauma researchers in Canada, he possesses extensive expertise in health services research, clinical trials, and offers services as a Research and Epidemiological Consultant for numerous pharmaceutical companies, hospitals and government organizations and agencies...
March 2017: Surgery
https://www.readbyqxmd.com/read/28178924/self-controlled-designs-in-pharmacoepidemiology-involving-electronic-healthcare-databases-a-systematic-review
#19
Nathalie Gault, Johann Castañeda-Sanabria, Yann De Rycke, Sylvie Guillo, Stéphanie Foulon, Florence Tubach
BACKGROUND: Observational studies are widely used in pharmacoepidemiology. Several designs can be used, in particular self-controlled designs (case-crossover and self-controlled case series). These designs offer the advantage of controlling for time-invariant confounders, which may not be collected in electronic healthcare databases. They are particularly useful in pharmacoepidemiology involving healthcare database. To be valid, they require the presence of some characteristics (key validity assumptions), and in such situations, these designs should be preferred...
February 8, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28178730/an-overview-of-pharmacoepidemiology-in-new-zealand-medical-databases-registries-and-research-achievements
#20
Prasad Nishtala, Henry Ndukwe, Te-Yuan Chyou, Mohammed Salahudeen, Sujita Narayan
Pharmacoepidemiology is an eclectic blend of epidemiology, clinical pharmacology and biostatistics. In New Zealand there have been recent advances in pharmacoepidemiology to examine drug utilisation, monitor adverse drug events and complement pharmacovigilance. This paper attempts to describe the past, present and future of pharmacoepidemiology, particularly in the area of translational research with a particular focus on medicine use and safety. New Zealand is well-positioned globally to make significant contributions to the knowledge base of drug safety in real-world settings...
January 27, 2017: New Zealand Medical Journal
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