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Pharmacoepidemiology and Drug Safety

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https://www.readbyqxmd.com/read/28620909/pregabalin-and-heart-failure-a-population-based-study
#1
Joanne M-W Ho, Erin M Macdonald, Jin Luo, Tara Gomes, Tony Antoniou, Muhammad M Mamdani, David N Juurlink
PURPOSE: The anticonvulsant pregabalin is increasingly prescribed for pain, seizures, and psychiatric disorders. Although evidence suggests pregabalin can cause edema and heart failure, its cardiac safety profile in clinical practice is unknown. We sought to examine the risk of heart failure among older patients receiving pregabalin compared to those receiving gabapentin. METHODS: We conducted a population-based cohort study of Ontarians aged 66 and older with a history of seizure who received pregabalin or gabapentin between April 2013 and March 2014...
June 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28612964/has-cost-inhibited-the-uptake-of-more-potent-statins-in-england
#2
Stephen R Chapman, Raymond W Fitzpatrick, Mohammed I Aladul
BACKGROUND: The use of statins has increased substantially over the last 2 decades in England and represents a significant cost burden to the National Health Service. Therefore, it is important to understand what influences prescribers' choice. OBJECTIVES: This study examines the changes in use pattern of all statins in England (1998-2015). The study focuses on the use of simvastatin and atorvastatin before and after their patent expiry and rosuvastatin, to investigate the impact of the reduced acquisition costs on prescribing...
June 14, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28612945/comparative-study-of-the-number-of-report-and-time-to-onset-of-the-reported-adverse-event-between-the-biosimilars-and-the-originator-of-filgrastim
#3
Tetsu Kobayashi, Izumi Kamada, Junko Komura, Satoshi Toyoshima, Akiko Ishii-Watabe
PURPOSE: The objective of this study is to specify the most reported adverse events as preferred terms (PTs) and to compare the reported adverse events about some properties including the number of report and time-to-onset (TTO) distribution of the originator of filgrastim Neupogen® and its biosimilars in Europe, using VigiBase®. METHODS: We identified the biosimilar which was reported as the suspected drug in more than 100 individual case safety reports in Europe...
June 14, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28608510/agreement-and-validity-of-electronic-health-record-prescribing-data-relative-to-pharmacy-claims-data-a-validation-study-from-a-us-electronic-health-record-database
#4
Christopher G Rowan, James Flory, Tobias Gerhard, John K Cuddeback, Nikita Stempniewicz, James D Lewis, Sean Hennessy
BACKGROUND: Granular clinical and laboratory data available in electronic health record (EHR) databases provide researchers the opportunity to conduct investigations that would not be possible in insurance claims databases; however, for pharmacoepidemiology studies, accurate classification of medication exposure is critical. OBJECTIVE: The aim of this study was to evaluate the validity of classifying medication exposure using EHR prescribing (EHR-Rx) data. METHODS: We conducted a retrospective cohort study among patients with linked claims and EHR data in OptumLabs™ Data Warehouse...
June 12, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28594145/use-of-antidepressant-medication-in-pregnancy-and-adverse-neonatal-outcomes-a-population-based-investigation
#5
Anna Cantarutti, Luca Merlino, Carlo Giaquinto, Giovanni Corrao
BACKGROUND: Untreated depression and antidepressant use during pregnancy may have negative consequences for births. There are still conflicting data on the potential harmful effects of prenatal antidepressant treatment on child health. OBJECTIVE: To investigate the relationship between the use of antidepressant medication during pregnancy and selected neonatal outcomes. METHODS: A population-based cohort study including 9825 deliveries exposed to an antidepressant between 9 months before last menstrual date through to delivery, from January 2005 to December 2010 in the Lombardy region of Italy, was conducted...
June 8, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28594077/trends-in-antidepressant-prescribing-to-children-and-adolescents-in-canadian-primary-care-a-time-series-analysis
#6
Rachael Morkem, Tyler Williamson, Scott Patten, John A Queenan, Sabrina T Wong, Donna Manca, David Barber
PURPOSE: The purpose of this study was to describe the trends and patterns of antidepressant (AD) prescribing to children and adolescents in Canadian primary care before and after the black-box warning in 2004. METHODS: Prescription data from the Canadian Primary Care Sentinel Surveillance Network, a repository of primary care data on over 1 million patients, was used to analyze AD prescribing to children (8-11 y) and adolescents (12-18 y) between 2000 and 2014...
June 8, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28594076/the-future-of-safety-science-is-happening-now-the-modernization-of-the-benefit-risk-paradigm
#7
Fabio Lievano, Linda Scarazzini, Frank Shen, James Duhig, Jeremy Jokinen
The future of safety science is happening now and has the potential to improve patient outcomes through an evolving approach to benefit-risk assessment. Three building blocks for the future of safety science, cognitive and behavioral systems, medical assessment, and data science, individually and collaboratively advance and modernize the benefit-risk paradigm. Incorporating the patient perspective and patient experiences will help identify tools that are useful in real-world practice. Medical assessment teams will bring together the study of toxicity and toxicogenomics, biomarkers, and special populations to personalize the benefit-risk profile...
June 8, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28585776/comparison-of-adverse-events-following-pentavalent-and-diphtheria-tetanus-pertussis-vaccines-among-nigerian-children
#8
Ayebo Evawere Sadoh, Damian Uchechukwu Nwaneri, Bamidele Charity Ogboghodo, Wilson Ehidiamen Sadoh
INTRODUCTION: Adverse events following immunization (AEFI) may follow the use of any vaccine. There is thus a need for documentation of the types and prevalence of AEFIs for each vaccine and early identification of new events or those occurring at rates higher than expected. When one vaccine replaces another, it is important to document the safety of the new vaccine as well as compare to that of the old. In this study, we aimed to document the AEFIs following the use of pentavalent vaccine recently introduced into the National Programme on Immunization and compare with those of diphtheria-tetanus-pertussis (DTwP) vaccine which it replaced...
June 6, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28585409/a-population-based-study-of-risk-perceptions-of-paracetamol-use-among-swedes-with-a-special-focus-on-young-adults
#9
H Håkonsen, T Hedenrud
PURPOSE: The purpose of this study was to investigate risk perceptions of paracetamol use, with a special focus on young adults. METHODS: A web survey was sent to a representative sample (n = 5838) of the Swedish adult population. Altogether, 3120 persons answered the full questionnaire. Risk perceptions of paracetamol use in relation to sex, age, and education were determined using logistic regression. RESULTS: Most respondents (70.5%) reported use of paracetamol in the 3 months prior to the study; the highest proportion was found among those aged 18 to 25 years (75...
June 5, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28573786/real-life-patterns-of-use-safety-and-effectiveness-of-sunitinib-in-first-line-therapy-of-metastatic-renal-cell-carcinoma-the-santorin-cohort-study
#10
Pernelle Noize, Angela Grelaud, Jacques-Olivier Bay, Christine Chevreau, Marine Gross-Goupil, Stéphane Culine, Jean-Marie Ferrière, Flore Moulin, Philip Robinson, Aurelie Balestra, Stéphanie Lamarque, Marie-Agnès Bernard, Régis Lassalle, Magali Rouyer, Cécile Droz-Perroteau, Nicholas Moore, Annie Fourrier-Réglat, Alain Ravaud
PURPOSE: To investigate sunitinib in the real-life first-line treatment of metastatic renal cell carcinoma (mRCC). METHODS: SANTORIN is a French observational multicentre cohort. Patients initiating sunitinib in first-line mRCC therapy were included (January 2008 to April 2010) and followed for 24 months. Data were collected from medical files. The outcomes were 24-month overall survival (OS) and progression-free survival (PFS), response and safety. RESULTS: Three hundred two patients were included: median age, 64...
June 1, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28556303/screening-approach-for-identifying-candidate-drugs-and-drug-drug-interactions-related-to-hip-fracture-risk-in-persons-with-alzheimer-disease
#11
Anna-Maija Tolppanen, Heidi Taipale, Marjaana Koponen, Antti Tanskanen, Piia Lavikainen, Jussi Paananen, Jari Tiihonen, Sirpa Hartikainen
PURPOSE: To assess whether a "drugome-wide" screen with case-crossover design is a feasible approach for identifying candidate drugs and drug-drug interactions. METHODS: All community-dwelling residents of Finland who received a clinically verified Alzheimer disease diagnosis in 2005 to 2011 and experienced incident hip fracture (HF) afterwards (N = 4851). Three scenarios were used to test the sensitivity of this approach (1) hazard period 0 to 30 and control period 31 to 61 days before HF, (2) hazard period 0 to 30 and control period 336 to 366 days before HF, and (3) hazard period 0 to 14 and control period 16 to 30 days before HF...
May 29, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28556206/the-differences-in-the-incidence-of-diabetes-mellitus-and-prediabetes-according-to-the-type-of-hmg-coa-reductase-inhibitors-prescribed-in-korean-patients
#12
Tong Min Kim, Hyunah Kim, Yoo Jin Jeong, Sun Jung Baik, So Jung Yang, Seung-Hwan Lee, Jae-Hyoung Cho, Hyunyong Lee, Hyeon Woo Yim, In Young Choi, Kun-Ho Yoon, Hun-Sung Kim
BACKGROUND: Very few studies conducted in Korea have investigated the relationship between statins and the incidence of diabetes. Therefore, we analyzed the progression from normal blood glucose to prediabetes and then to diabetes mellitus (DM) according to the type, intensity, and dose of statin prescribed. METHODS: Data of patients who were first prescribed statins between 2009 and 2011 were extracted from electronic medical records. Patients with normal blood glucose or prediabetes were observed for 4 years after initiation of statin therapy...
May 29, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28544284/the-national-healthcare-system-claims-databases-in-france-sniiram-and-egb-powerful-tools-for-pharmacoepidemiology
#13
Julien Bezin, Mai Duong, Régis Lassalle, Cécile Droz, Antoine Pariente, Patrick Blin, Nicholas Moore
The French health care system is based on universal coverage by one of several health care insurance plans. The SNIIRAM database merges anonymous information of reimbursed claims from all these plans, linked to the national hospital-discharge summaries database system (PMSI) and the national death registry. It now covers 98.8% of the French population, over 66 million persons, from birth (or immigration) to death (or emigration), making it possibly the world's largest continuous homogeneous claims database...
May 24, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28544026/immobilization-and-high-platelet-count-are-associated-with-thromboembolic-complications-in-heparin-induced-thrombocytopenia
#14
Juliane Bolbrinker, Edeltraut Garbe, Antonios Douros, Matthias Huber, Elisabeth Bronder, Andreas Klimpel, Frank Andersohn, Oliver Meyer, Abdulgabar Salama, Reinhold Kreutz
PURPOSE: Immune-mediated heparin-induced thrombocytopenia (HIT type II, HIT) is a potentially serious adverse drug reaction characterized by an increased risk of venous and arterial thrombosis. This study aimed to identify risk factors associated with the development of these complications. METHODS: Our study cohort included patients with HIT assembled in our pharmacovigilance center by reports from 51 collaborating hospitals in Berlin, Germany. To identify risk factors for thromboembolic complications, patients with thromboembolic events (cases) were compared to those without thromboembolic events (controls) in a case-control design...
May 24, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28543978/the-impact-of-the-boxed-warning-on-the-duration-of-use-for-depot-medroxprogesterone-acetate
#15
Efe Eworuke, Joo-Yeon Lee, Lisa Soule, Vaishali Popat, David G Moeny
OBJECTIVE: The objective of this study was to examine the impact of the Food and Drug Administration's boxed warning on the utilization of depot medroxyprogesterone (DMPA). METHODS: From the IMS Lifelink data (2001-2009), we identified DMPA and oral combined hormonal contraceptive (CHC) users without a prescription claim 6 months before and after the first and last claim. Episodes were defined as all contiguous claims with no more than 90-day DMPA or 30-day CHC between claims...
May 23, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28524293/the-contribution-of-direct-patient-reported-adrs-to-drug-safety-signals-in-the-netherlands-from-2010-to-2015
#16
Florence van Hunsel, Susan de Waal, Linda Härmark
PURPOSE: The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. METHOD: All signals from 2010 until 2015 were included. First, we investigated how many patient reports were present in the signals and the characteristics of these reports compared to the health care professional and marketing authorization holders' reports...
May 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28503870/correcting-hazard-ratio-estimates-for-outcome-misclassification-using-multiple-imputation-with-internal-validation-data
#17
Jiayi Ni, Aaron Leong, Kaberi Dasgupta, Elham Rahme
OBJECTIVE: Outcome misclassification may occur in observational studies using administrative databases. We evaluated a two-step multiple imputation approach based on complementary internal validation data obtained from two subsamples of study participants to reduce bias in hazard ratio (HR) estimates in Cox regressions. METHODS: We illustrated this approach using data from a surveyed sample of 6247 individuals in a study of statin-diabetes association in Quebec...
May 15, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28497594/the-impact-of-regulatory-action-on-the-co-prescribing-of-renin-angiotensin-system-blockers-in-uk-primary-care
#18
Craig Allen, Katherine Donegan
PURPOSE: The aim of this study was to assess the impact of regulatory action taken in June 2014 on the co-prescribing of renin-angiotensin system (RAS) blockers in UK primary care. METHODS: RAS blocker prescriptions, issued between 01/01/2009-30/06/2015, were extracted from the Clinical Practice Research Datalink to estimate the quarterly prevalence (number of patients with at least one co-prescription) and incidence (number of patients first receiving a RAS blocker co-prescription) of co-prescribing...
May 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28493425/law-enforcement-derived-data-on-gabapentin-diversion-and-misuse-2002-2015-diversion-rates-and-qualitative-research-findings
#19
Mance E Buttram, Steven P Kurtz, Richard C Dart, Zachary R Margolin
PURPOSE: Recent limited epidemiologic and case reports suggest that gabapentin is being misused, especially among prescription opioid misusers. However, no apparent studies have reported data from law enforcement on the diversion and misuse of gabapentin. METHODS: Case report data are drawn from a quarterly survey of prescription drug diversion completed by a national sample of law enforcement and regulatory agencies who engage in drug diversion investigations. Rates of gabapentin diversion per 100 000 population were calculated for each quarter from 2002 through 2015...
May 10, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28485129/evaluation-of-algorithms-to-identify-incident-cancer-cases-by-using-french-health-administrative-databases
#20
Aya Ajrouche, Candice Estellat, Yann De Rycke, Florence Tubach
PURPOSE: Administrative databases are increasingly being used in cancer observational studies. Identifying incident cancer in these databases is crucial. This study aimed to develop algorithms to estimate cancer incidence by using health administrative databases and to examine the accuracy of the algorithms in terms of national cancer incidence rates estimated from registries. METHODS: We identified a cohort of 463 033 participants on 1 January 2012 in the Echantillon Généraliste des Bénéficiaires (EGB; a representative sample of the French healthcare insurance system)...
May 9, 2017: Pharmacoepidemiology and Drug Safety
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