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Journals Pharmacoepidemiology and Drug ...

Pharmacoepidemiology and Drug Safety

https://read.qxmd.com/read/38724471/describing-diversity-of-real-world-data-sources-in-pharmacoepidemiologic-studies-the-diverse-scoping-review
#21
REVIEW
Rosa Gini, Romin Pajouheshnia, Helga Gardarsdottir, Dimitri Bennett, Lin Li, Claudia Gulea, Angelika Wientzek-Fleischmann, Marloes T Bazelier, Mehmet Burcu, Caitlin Dodd, Carlos E Durán, Sigal Kaplan, Stephan Lanes, Karine Marinier, Giuseppe Roberto, Kanaka Soman, Xiaofeng Zhou, Robert Platt, Soko Setoguchi, Gillian C Hall
PURPOSE: Real-world evidence (RWE) is increasingly used for medical regulatory decisions, yet concerns persist regarding its reproducibility and hence validity. This study addresses reproducibility challenges associated with diversity across real-world data sources (RWDS) repurposed for secondary use in pharmacoepidemiologic studies. Our aims were to identify, describe and characterize practices, recommendations and tools for collecting and reporting diversity across RWDSs, and explore how leveraging diversity could improve the quality of evidence...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38720425/emulation-of-randomized-trials-of-direct-oral-anticoagulants-with-claims-data-and-implications-for-new-factor-xi-inhibitors
#22
JOURNAL ARTICLE
Shirley V Wang, Kueiyu Joshua Lin, Sebastian Schneeweiss
Direct oral anticoagulants (DOACs) revolutionized the management of thromboembolic disorders. Clinical care may be further improved as Factor XIs undergo large-scale outcome trials. What role can non-randomized database studies play in expediting understanding of these drugs in clinical practice? The RCT-DUPLICATIVE Initiative emulated the design of eight DOAC randomized clinical trials (RCT) using non-randomized claims database studies. RCT study design parameters and measurements were closely emulated by the database studies and produced highly concordant results...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38720413/the-impact-of-hospitalization-on-inappropriate-prescribing-and-polypharmacy-in-older-patients-a-descriptive-cross-sectional-study
#23
JOURNAL ARTICLE
Ori Weiss, Andy Eyre, Danny Alon Ellenbogen, Gideon Y Stein
BACKGROUND: Polypharmacy and the use of potentially inappropriate medications (PIMs) in older individuals are widespread phenomena that are associated with an increase in morbidity and mortality. The Beers Criteria is a tool that helps to identify patients that are prescribed with PIMs, thereby reducing the risk of associated harm. Amongst other populations, the criteria identify drugs that should not be used by the majority of older patients. AIM: Determining the proportion of older inpatients who were discharged from hospitalization with polypharmacy (a prescription for more than seven drugs), or with a PIM as defined by the Beers Criteria...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38720409/do-efficacy-results-obtained-from-randomized-controlled-trials-translate-to-effectiveness-data-from-observational-studies-for-relapsing-remitting-multiple-sclerosis
#24
REVIEW
Stefan Verweij, Wouter Ahmed, Guiling Zhou, Dimitris Mavridis, Stavros Nikolakopoulos, Andre J Elferink, Katrien Oude Rengerink, Maarten J Bijlsma, Peter G M Mol, Eelko Hak
BACKGROUND: Randomized controlled trials are considered the gold standard in regulatory decision making, as observational studies are known to have important methodological limitations. However, real-world evidence may be helpful in specific situations. This review investigates how the effect estimates obtained from randomized controlled trials compare to those obtained from observational studies, using drug therapy for relapsing-remitting multiple sclerosis as an example. STUDY DESIGN AND SETTING: A systematic review of randomized controlled trials and observational studies was conducted...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38720405/application-of-multiple-validated-algorithms-for-identifying-incident-breast-cancer-among-individuals-with-atopic-dermatitis
#25
JOURNAL ARTICLE
Adriana Campos, Ramya Ramasubramanian, Cherise Wong, Andrea Fleisch Marcus
PURPOSE: Validated algorithms (VAs) in insurance claims databases are often used to estimate the prevalence and incidence of comorbidities and evaluate safety signals. However, although they are then used in different data sources or subpopulations from those in which they were developed the replicability of these VAs are rarely tested, making their application and performance in these settings potentially unknown. This paper describes testing multiple VAs used to identify incident breast cancer cases in a general population and in an indication-specific population, patients with atopic dermatitis (AD)...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38720402/matching-study-design-to-prescribing-intention-the-prevalent-new-user-design-for-studying-abuse-deterrent-formulations-of-opioids
#26
JOURNAL ARTICLE
Bethany L DiPrete, GYeon Oh, Daniela C Moga, Nabarun Dasgupta, Svetla Slavova, Emily Slade, Chris Delcher, Brian W Pence, Shabbar I Ranapurwala
PURPOSE: In drug studies, research designs requiring no prior exposure to certain drug classes may restrict important populations. Since abuse-deterrent formulations (ADF) of opioids are routinely prescribed after other opioids, choice of study design, identification of appropriate comparators, and addressing confounding by "indication" are important considerations in ADF post-marketing studies. METHODS: In a retrospective cohort study using claims data (2006-2018) from a North Carolina private insurer [NC claims] and Merative MarketScan [MarketScan], we identified patients (18-64 years old) initiating ADF or non-ADF extended-release/long-acting (ER/LA) opioids...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38719731/risk-of-acute-pancreatitis-among-new-users-of-empagliflozin-compared-to-sulfonylureas-in-patients-with-type-2-diabetes-a-post-authorization-safety-study
#27
COMPARATIVE STUDY
Soulmaz Fazeli Farsani, Kristy Iglay, Ling Zhang, Christian Niyonkuru, Laurieann Nessralla, Cynthia J Girman
PURPOSE: This study was undertaken to evaluate the potential risk of acute pancreatitis with empagliflozin in patients with type 2 diabetes (T2D) newly initiating empagliflozin. METHODS: Data from two large US claims databases were analyzed in an observational study of patients with T2D receiving metformin who were newly prescribed empagliflozin versus sulfonylurea (SU). Because dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists have been associated with the risk of acute pancreatitis in some studies, patients on these agents were excluded...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38685851/validation-of-new-medication-use-algorithms-as-proxies-for-worsening-disease-activity-in-patients-with-juvenile-idiopathic-arthritis
#28
MULTICENTER STUDY
Kyoko Saito, Avinash Gabbeta, Evan Mulvihill, Lina Al-Jaberi, Timothy Beukelman, James D Lewis, Carlos D Rose, Brian L Strom, Daniel B Horton
PURPOSE: To facilitate claims-based research on populations with juvenile idiopathic arthritis (JIA), we sought to validate an algorithm of new medication use as a proxy for worsening JIA disease activity. METHODS: Using electronic health record data from three pediatric centers, we defined new JIA medication use as (re)initiation of disease-modifying antirheumatic drugs or glucocorticoids (oral or intra-articular). Data were collected from 201 randomly selected subjects with (101) or without (100) new medication use...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38680119/sex-disparities-in-medication-changes-after-metformin-initiation-are-associated-with-small-clinically-non-relevant-sex-differences-in-hba1c-levels-during-follow-up
#29
LETTER
Sieta T de Vries, Stijn de Vos, Monika P Oktora, Petra Denig
No abstract text is available yet for this article.
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38680111/comparing-survival-in-trial-versus-routine-care-advanced-urothelial-cancer-patients-on-immune-checkpoint-blockade
#30
COMPARATIVE STUDY
Lucy S Wang, Rebecca A Hubbard, Ronac Mamtani
PURPOSE: Although recent trials involving first-line immune checkpoint inhibitors have expanded treatment options for patients with advanced urothelial carcinoma (aUC) who are ineligible for standard cisplatin-based chemotherapy, there exists limited evidence for whether trial efficacy translates into real-world effectiveness for patients seen in routine care. This retrospective cohort study compares differences in overall survival (OS) between KEYNOTE-052 trial participants and routine-care patients receiving first-line pembrolizumab monotherapy...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38680102/lessons-learned-from-a-multi-data-source-research-collaboration-the-mirabegron-post-authorization-safety-study-program
#31
REVIEW
Stefan de Vogel, John D Seeger, Alejandro Arana, Andrea V Margulis, Lisa J McQuay, Susana Perez-Gutthann, Jesper Hallas, Nina Sahlertz Kristiansen, Marie Linder, Ingvild Odsbu, Brandon Suehs, Yihua Xu, Claudia Uribe, Kwame Appenteng, Noah Jamie Robinson
BACKGROUND: Many factors contribute to developing and conducting a successful multi-data source, non-interventional, post-authorization safety study (NI-PASS) for submission to multiple health authorities. Such studies are often large undertakings; evaluating and sharing lessons learned can provide useful insights to others considering similar studies. OBJECTIVES: We discuss challenges and key methodological and organizational factors that led to the delivery of a successful post-marketing requirement (PMR)/PASS program investigating the risk of cardiovascular and cancer events among users of mirabegron, an oral medication for the treatment of overactive bladder...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38680101/rising-cases-of-drug-induced-pulmonary-fibrosis-analysis-of-the-food-and-drug-administration-adverse-event-reporting-system-faers-database-2000-2022
#32
JOURNAL ARTICLE
Kenneth L McCall, Kelsey R Hennig, Zachary T Abe, Danielle N Dattler, Karyssa L Hurd, Sophie L Portnoy, Zoey J Zagoria
PURPOSE: Pulmonary fibrosis (PF) is a severe, progressive disease, which may be caused by exposure to certain medications. METHODS: We queried the U.S. FDA Adverse Event Reporting System (FAERS) from 2000 to 2022, using the search terms "pulmonary fibrosis" and "idiopathic pulmonary fibrosis" and excluded reports with patients under the age of 18 years, and patients with unknown sex or age. Reports were sorted by generic drug names, counted, and plotted over time using a best-fit trendline based on an exponential function...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38680093/use-of-quantitative-bias-analysis-to-evaluate-single-arm-trials-with-real-world-data-external-controls
#33
JOURNAL ARTICLE
Christen Gray, Eleanor Ralphs, Matthew P Fox, Timothy L Lash, Geoffrey Liu, Tzuyung Doug Kou, Donna R Rivera, Jaclyn Bosco, Kim Van Naarden Braun, Fiona Grimson, Deborah Layton
PURPOSE: Use of real-world data (RWD) for external controls added to single-arm trials (SAT) is increasingly prevalent in regulatory submissions. Due to inherent differences in the data-generating mechanisms, biases can arise. This paper aims to illustrate how to use quantitative bias analysis (QBA). METHODS: Advanced non-small cell lung cancer (NSCLC) serves as an example, where many small subsets of patients with molecular tumor subtypes exist. First, some sources of bias that may occur in oncology when comparing RWD to SAT are described...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38680090/structured-benefit-risk-assessment-for-enoxaparin-in-the-context-of-its-label-extension-for-the-extended-treatment-of-deep-vein-thrombosis-and-pulmonary-embolism-and-prevention-of-its-recurrence-in-patients-with-active-cancer
#34
COMPARATIVE STUDY
Marie-Laure Kürzinger, Chantal El-Haddad, Tatiana Gouin-Soboleva, Zita Fazekas, Denis Granados, Elizabeth Benito-Garcia, Yasmina Djoudi
PURPOSE: Guidelines recommend low-molecular-weight heparins (LMWHs) for patients with cancer-associated thrombosis. However, until recently, only dalteparin and tinzaparin were approved in the European Economic Area (EEA) for these patients. This study compares the benefit-risk profile of enoxaparin with dalteparin and tinzaparin for the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrence in adult patients with active cancer. METHODS: A semi-quantitative structured benefit-risk assessment was conducted for the label-extension application of enoxaparin based on the benefit-risk action team descriptive framework: define decision context; determine key benefit and risk outcomes; identify data sources; extract data; interpret results...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38680080/risk-of-bleeding-amongst-warfarin-and-direct-oral-anticoagulant-users-prescribed-immediate-antibiotics-for-respiratory-tract-infection-cohort-study
#35
JOURNAL ARTICLE
Haroon Ahmed, Nicola Reeve, Daniel Farewell, Fergus Hamilton, Mark Ponsford, Julia Hippisley-Cox, Simon Noble
PURPOSE: Incidence of bleeding amongst warfarin and direct oral anticoagulant (DOAC) users is greater following a respiratory tract infection (RTI). It is unclear whether immediate antibiotics modify this association. We estimated the risk of bleeding amongst warfarin and DOAC users with RTI by antibiotic treatment. METHODS: This retrospective cohort study used data from the Clinical Practice Research Datalink (CPRD) GOLD for adults in England prescribed warfarin or a DOAC, who sought primary care for an RTI between 1st January 2011 and 31st December 2019...
May 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38629241/comorbidity-influence-in-observational-studies-why-ignore-the-real-world
#36
JOURNAL ARTICLE
Victor A Kiri, Maurille Feudjo -Tepie
No abstract text is available yet for this article.
April 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38629216/updated-core-competencies-in-pharmacoepidemiology-to-inform-contemporary-curricula-and-training-for-academia-government-and-industry
#37
JOURNAL ARTICLE
Vicki Osborne, Amie Goodin, Joshua Brown, Almut G Winterstein, Andrew Bate, Catherine Cohet, Lisa Pont, David Moeny, Olaf Klungel, Simone Pinheiro, John Seeger, K Arnold Chan, Stanley Edlavitch, Hugh Tilson, Deborah Layton
PURPOSE: The first paper to specify the core content of pharmacoepidemiology as a profession was published by an ISPE (International Society for Pharmacoepidemiology) workgroup in 2012 (Jones JK et al. PDS 2012; 21[7]:677-689). Due to the broader and evolving scope of pharmacoepidemiology, ISPE considers it important to proactively identify, update and expand the list of core competencies to inform curricula of education programs; thus, better positioning pharmacoepidemiologists across academic, government (including regulatory), and industry positions...
April 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38575389/clarifying-the-causal-contrast-an-empirical-example-applying-the-prevalent-new-user-study-design
#38
JOURNAL ARTICLE
Jessica C Young, Michael Webster-Clark, Shahar Shmuel, Elizabeth M Garry, Panagiotis Mavros, Til Stürmer, Cynthia J Girman
PURPOSE: The prevalent new user design extends the active comparator new user design to include patients switching to a treatment of interest from a comparator. We examined the impact of adding "switchers" to incident new users on the estimated hazard ratio (HR) of hospitalized heart failure. METHODS: Using MarketScan claims data (2000-2014), we estimated HRs of hospitalized heart failure between patients initiating GLP-1 receptor agonists (GLP-1 RA) and sulfonylureas (SU)...
April 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38566351/validation-of-alopecia-coding-in-us-claims-data-among-women-of-childbearing-age
#39
REVIEW
Maria C Schneeweiss, Arash Mostaghimi, Stephanie Chiuve, Sebastian Schneeweiss, Priyanka Anand, Katharina Schoder, Theresa Oduol, Carrie Huisingh, Kueiyu Joshua Lin
BACKGROUND: Accurately identifying alopecia in claims data is important to study this rare medication side effect. OBJECTIVES: To develop and validate a claims-based algorithm to identify alopecia in women of childbearing age. METHODS: We linked electronic health records from a large healthcare system in Massachusetts (Mass General Brigham) with Medicaid claims data from 2016 through 2018 to identify all women aged 18 to 50 years with an ICD-10 code for alopecia, including alopecia areata, androgenic alopecia, non-scarring alopecia, or cicatricial alopecia, from a visit to the MGB system...
April 2024: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/38565527/prevalence-of-self-medication-practices-among-pregnant-women-in-india-a-systematic-review-and-meta-analysis
#40
REVIEW
Vaibhav Chaudhary, Sweta Kumari, Navneet Khurana, Mohammad Azharuddin, Aditya Pratap Singh, Varsha Devi, Deepali Dhir, Biplab Pal
BACKGROUND: Self-medication practice among pregnant women is a global concern. However, its understanding in the Indian context is limited due to a lack of comprehensive studies. PURPOSE: This study aimed to comprehensively assess the prevalence of self-medication, the medications used for self-medication, diseases/conditions associated with self-medication, and the reasons for self-medication among Indian pregnant women. METHODS: This study was carried out following the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)...
April 2024: Pharmacoepidemiology and Drug Safety
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