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Drugs—Real World Outcomes

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https://www.readbyqxmd.com/read/30105744/patient-understanding-of-the-neuropsychiatric-risks-associated-with-branded-bupropion-hydrochloride-products-used-for-smoking-cessation
#1
John Ascher, Annette Stemhagen, Monika Stender, Beta Win, Christina Winter
BACKGROUND: Bupropion hydrochloride (Zyban) is an effective aid to smoking cessation; however, its use has previously been associated with neuropsychiatric adverse events. Here we report results of the patient Knowledge, Attitudes, and Behavior survey that forms part of the Year 7 Risk Evaluation and Mitigation Strategy (REMS) assessment for Zyban. OBJECTIVE: Assess participants' understanding of the neuropsychiatric risks associated with branded bupropion hydrochloride products that are used for smoking cessation, as described in the Medication Guides...
August 13, 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/30073580/persistence-with-biological-disease-modifying-antirheumatic-drugs-and-its-associated-resource-utilization-and-costs
#2
Rosarin Sruamsiri, Hideto Kameda, Jörg Mahlich
OBJECTIVE: The study assessed persistence rates of biological disease-modifying antirheumatic drugs (bDMARDs) for the treatment of rheumatoid arthritis in Japan and compared resource utilization and treatment costs between persistence and non-persistence groups. METHODS: Data were extracted from a Japanese claims database between 2009 and 2015. bDMARD-naïve patients were identified and included in the final analysis. Survival analysis was used to estimate 1-year persistence rates for current bDMARDs...
August 2, 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29946913/clinical-outcomes-with-first-line-chemotherapy-in-a-large-retrospective-study-of-patients-with-metastatic-pancreatic-cancer-treated-in-a-us-community-oncology-setting
#3
Thomas H Cartwright, Monika Parisi, Janet L Espirito, Thomas W Wilson, Corey Pelletier, Manish Patel, Hani M Babiker
BACKGROUND: The combination chemotherapy regimens of nab-paclitaxel plus gemcitabine (nab-p + G) and FOLFIRINOX (FFX) have each demonstrated improved survival compared with gemcitabine monotherapy in clinical trials for metastatic pancreatic cancer; however, limited comparative data exist. OBJECTIVE: The objective of this study was to compare patient characteristics and clinical outcomes including time to treatment failure and overall survival in patients with metastatic pancreatic cancer receiving first-line chemotherapy in the community...
June 26, 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29934933/real-world-adverse-effects-of-capecitabine-toxicity-in-an-elderly-population
#4
Michiel W H van Beek, Monique Roukens, Wilco C H Jacobs, Johanna N H Timmer-Bonte, Cees Kramers
BACKGROUND: Few studies have assessed the safety and effectiveness of the numerous available chemotherapeutic therapies for geriatric oncology patients. Most safety studies are conducted in large trials, and there is some uncertainty surrounding whether the results would be the same in typical daily use. OBJECTIVE: This retrospective study aims to assess the adverse effects of real-world capecitabine use in elderly patients. METHODS: We reviewed the records of patients treated with capecitabine in an oncology department of a University Clinic in Nijmegen, The Netherlands...
June 22, 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29916196/recent-trends-in-the-practice-of-procedural-sedation-under-local-anesthesia-for-catheter-ablation-gastrointestinal-endoscopy-and-endoscopic-surgery-in-japan-a-retrospective-database-study-in-clinical-practice-from-2012-to-2015
#5
Akiko Matsui, Michihiro Morimoto, Hiroshi Suzuki, Thomas Laurent, Yoko Fujimoto, Yoshimi Inagaki
OBJECTIVES: To investigate changes in sedation practice during 2012-2015, using a large health claims database, for catheter ablation (CA), gastrointestinal endoscopic examination (EE), and surgery (ES) after dexmedetomidine (DEX) was approved for procedural sedation in 2013. We assessed the trends of sedative utilization, sedative-analgesic combinations, and, additionally, incidence of complications from 2012 to 2015. METHODS: Using the database provided by Medical Data Vision Co...
June 18, 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29790022/compliance-with-pregnancy-prevention-recommendations-for-isotretinoin-in-estonia-in-2012-2016
#6
Anneli Uusküla, Heti Pisarev, Katrin Kurvits, Ott Laius, Made Laanpere, Maia Uusküla
BACKGROUND: Isotretinoin is an effective treatment for severe acne; no alternative treatment has an equal therapeutic effect. The teratogenic effects of isotretinoin can be avoided, and numerous recommendations and regulations are in force to minimize the risk of pregnancy during treatment. OBJECTIVES: To describe isotretinoin prescription patterns for women aged 15-45 years, assess the concomitancy of isotretinoin and contraceptive use, and determine the rate of potential isotretinoin-exposed pregnancies in Estonia...
June 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29725886/spontaneous-reporting-on-adverse-events-by-consumers-in-the-united-states-an-analysis-of-the-food-and-drug-administration-adverse-event-reporting-system-database
#7
Tadashi Toki, Shunsuke Ono
BACKGROUND: Voluntary reports on adverse events (AEs) submitted by consumers have been facilitated through the MedWatch program in the United States (US), but few studies have described the characteristics of voluntary reports. OBJECTIVE: The aim of this study was to reveal the characteristics of current voluntary reports on AEs reported by consumers and healthcare professionals. METHODS: We performed analysis on voluntary reports of AEs in the US Food and Drug Administration AE Reporting System (FAERS) database submitted in 2016...
June 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29651691/pattern-of-antimicrobial-resistance-among-bacterial-isolates-from-urogenital-clinical-specimens-a-descriptive-study-from-the-buea-health-district-cameroon
#8
Elvis Tajoache Amin, Charles Njumkeng, Belmond T Kika, Akemfua Fualefac, Patrick Njukeng
INTRODUCTION: Antimicrobial resistance has become a global concern and is particularly affecting developing countries where infectious diseases and poverty are endemic. The effectiveness of currently available antimicrobials is decreasing as a result of increasing resistant strains among clinical isolates. OBJECTIVES: The aim of this study was to determine the resistance pattern of bacterial isolates from different clinical urogenital specimens at different hospitals in the Buea Health District, Cameroon...
June 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29476420/an-evaluation-of-drug-ineffective-postmarketing-reports-in-drug-safety-surveillance
#9
Takashi Misu, Cindy M Kortepeter, Monica A Muñoz, Eileen Wu, Gerald J Dal Pan
INTRODUCTION: The most commonly reported adverse event, based on frequency of Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs), in the US FDA Adverse Event Reporting System (FAERS) database is "drug ineffective" (DI). This study aimed to describe the DI reports and provide data to support recommendations on how to best evaluate these reports. METHODS: We characterized all FAERS reports coded with the MedDRA PT "drug ineffective" received between 1 September 2012 and 31 August 2016 using all other FAERS reports as a comparator...
June 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29736842/use-of-topical-tacrolimus-and-topical-pimecrolimus-in-four-european-countries-a-multicentre-database-cohort-study
#10
Josephina G Kuiper, Myrthe P P van Herk-Sukel, Jordi Castellsague, Anton Pottegård, Ingegärd Anveden Berglind, Daniel Dedman, Lia Gutierrez, Brian Calingaert, Jesper Hallas, Anders Sundström, Arlene M Gallagher, James A Kaye, Carolina Pardo, Kenneth J Rothman, Susana Perez-Gutthann
BACKGROUND: Despite the concerns about a potential increased risk of skin cancer and lymphoma with the use of topical tacrolimus and pimecrolimus, no population-based studies have given an overview of the use of these drugs in Europe. OBJECTIVE: To assess the use of topical tacrolimus and pimecrolimus in children and adults in Europe. METHODS: Multicentre database cohort study comprising data from the Netherlands, Denmark, Sweden and the UK...
May 7, 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29363022/economic-impact-in-medicaid-beneficiaries-with-schizophrenia-and-cardiometabolic-comorbidities-treated-with-once-monthly-paliperidone-palmitate-vs-oral-atypical-antipsychotics
#11
Marie-Hélène Lafeuille, Neeta Tandon, Sean Tiggelaar, Rhiannon Kamstra, Patrick Lefebvre, Edward Kim, Yong Yue, Kruti Joshi
OBJECTIVE: The objective of this study was to compare persistence, costs, and healthcare resource utilization in patients with schizophrenia and cardiometabolic comorbidities treated with once-monthly paliperidone palmitate or an oral atypical antipsychotic. METHODS: Medicaid data from six states (07/2009-03/2015) were used to identify adults with schizophrenia and cardiometabolic comorbidities initiated on once-monthly paliperidone palmitate or an oral atypical antipsychotic (index date) on 01/2010 or after...
March 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29305714/diagnoses-of-cardiovascular-disease-or-substance-addiction-abuse-in-us-adults-treated-for-adhd-with-stimulants-or-atomoxetine-is-use-consistent-with-product-labeling
#12
Kathleen A Fairman, Lindsay E Davis, Alyssa M Peckham, David A Sclar
BACKGROUND: Among US adults, utilization of pharmacotherapy for attention-deficit hyperactivity disorder (ADHD) has increased more than ninefold since 1995-1996. Potential contraindications to ADHD pharmacotherapy include serious cardiovascular disease (CVD) and, for stimulants, addictions and bipolar disorder (BPD). OBJECTIVE: To assess the prevalence of potential contraindications among adults treated with ADHD pharmacotherapy. METHODS: A retrospective cohort analysis was performed using the Truven Health MarketScan® database...
March 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29218595/quantitative-testing-of-prescriber-knowledge-regarding-the-risks-and-safe-use-of-albiglutide
#13
Carol Koro, Janet Pientka, Veronica Bainbridge, Natalie O'Donnell, Monika Stender, Annette Stemhagen
BACKGROUND: The risk of pancreatitis and potential risk of medullary thyroid carcinoma associated with glucagon-like peptide-1 receptor agonists prompted the US Food and Drug Administration to require a Risk Evaluation and Mitigation Strategy for albiglutide, including education for prescribers and subsequent assessment of their knowledge of the risks and safe use of albiglutide via a quantitative survey. OBJECTIVE: The objective of this study was to assess prescribers' knowledge of the risks related to medullary thyroid carcinoma, pancreatitis, and the appropriate patient population for albiglutide...
March 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29188591/contact-dermatitis-after-prescription-of-an-ophthalmic-ointment-containing-fradiomycin-sulfate-a-retrospective-database-study-using-japanese-health-insurance-claims-data
#14
Naomi Sugimoto, Kazuhiko Kuribayashi, Yuji Yamamoto, Satoshi Nagayasu, Osamu Suga, Yoko Fujimoto
BACKGROUND: Topical ointments containing fradiomycin sulfate, such as fradiomycin sulfate/methylprednisolone (F/M) and fradiomycin sulfate/betamethasone sodium phosphate (F/B), are known to cause allergic contact dermatitis (CD) in some patients, especially when used for the periocular region. F/M is commonly prescribed to patients for various conditions; however, there are no reports with respect to the incidence of CD caused by F/M in actual practice. OBJECTIVE: The aim was to investigate the incidence of CD using a data-based retrospective cohort study...
March 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29185233/estimating-prevalence-and-healthcare-utilization-for-treatment-resistant-depression-in-japan-a-retrospective-claims-database-study
#15
Jörg Mahlich, Sunny Tsukazawa, Frank Wiegand
BACKGROUND: Major depressive disorders (MDDs) including treatment-resistant depression (TRD) are common disabling conditions, but data on their epidemiology in Japan are limited. This study investigated the incidence, epidemiology, and direct medical costs of TRD and pharmaceutically-treated depression (PTD) in Japan to increase our health economic understanding of this phenotype of MDD. METHODS: A retrospective cohort study from a private health insurance claims database estimated the 1-year incidence of PTD and TRD and described the health services used and direct medical costs associated with these conditions...
March 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29138993/adverse-drug-events-and-medication-errors-in-african-hospitals-a-systematic-review
#16
REVIEW
Alemayehu B Mekonnen, Tariq M Alhawassi, Andrew J McLachlan, Jo-Anne E Brien
BACKGROUND: Medication errors and adverse drug events are universal problems contributing to patient harm but the magnitude of these problems in Africa remains unclear. OBJECTIVE: The objective of this study was to systematically investigate the literature on the extent of medication errors and adverse drug events, and the factors contributing to medication errors in African hospitals. METHODS: We searched PubMed, MEDLINE, EMBASE, Web of Science and Global Health databases from inception to 31 August, 2017 and hand searched the reference lists of included studies...
March 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29134621/replication-of-mini-sentinel-study-assessing-mirabegron-and-cardiovascular-risk-in-non-mini-sentinel-databases
#17
Jason C Simeone, Beth L Nordstrom, Kwame Appenteng, Samuel Huse, Milbhor D'Silva
BACKGROUND: In 2014, the US Food and Drug Administration (FDA) initiated a prospective routine surveillance using the Mini-Sentinel (M-S) program to assess potential signals of acute myocardial infarction (AMI) and stroke with use of mirabegron, indicated for the treatment of overactive bladder (OAB), compared with oxybutynin. PURPOSE: To replicate the FDA M-S analysis of mirabegron using datasets that did not contribute to the M-S program. METHODS: IMS PharMetrics Plus and Truven MarketScan claims data from 2012-2015 were converted to the M-S Common Data Model...
March 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29119486/potentially-harmful-medication-use-and-decline-in-health-related-quality-of-life-among-community-dwelling-older-adults
#18
Kenya Ie, Eric Chou, Richard D Boyce, Steven M Albert
BACKGROUND: Several scales to quantify the impact of potentially harmful medications (PHMs) have been shown to predict mortality and functional decline; however, the effect of PHMs on quality of life (QoL) has not been well-studied. OBJECTIVE: The aims of this study were to investigate an association between PHM use and change in health-related QoL among community-dwelling older adults, and to compare the predictive capacity of PHM scales. METHODS: We conducted a retrospective cohort study using prescription claims data and survey responses...
December 2017: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29110295/prevalence-and-variability-in-medications-contributing-to-polypharmacy-in-long-term-care-facilities
#19
Natali Jokanovic, Kris M Jamsen, Edwin C K Tan, Michael J Dooley, Carl M Kirkpatrick, J Simon Bell
BACKGROUND: Research into which medications contribute to polypharmacy and the variability in these medications across long-term care facilities (LTCFs) has been minimal. OBJECTIVE: Our objective was to investigate which medications were more prevalent among residents with polypharmacy and to determine the variability in prescribing of these medications across LTCFs. METHODS: This was a cross-sectional study of 27 LTCFs in regional and rural Victoria, Australia...
December 2017: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/28988331/economic-burden-of-herpes-zoster-and-post-herpetic-neuralgia-in-adults-60-years-of-age-or-older-results-from-a-prospective-physician-practice-based-cohort-study-in-kushiro-japan
#20
Hiroyuki Nakamura, Akiko Mizukami, Koichi Adachi, Sean Matthews, Katsiaryna Holl, Kazuhiro Asano, Akihiro Watanabe, Riri Adachi, Mariko Kiuchi, Keiju Kobayashi, Keiko Sato, Taizo Matsuki, Toshihiko Kaise, Desmond Curran
BACKGROUND AND OBJECTIVE: Herpes zoster has a high incidence rate among people aged ≥ 60 years and can lead to serious complications such as post-herpetic neuralgia. There are currently no data on the economic burden of herpes zoster and post-herpetic neuralgia in Japan, and the objective of this study was to address this gap. METHODS: A total of 412 patients aged ≥ 60 years diagnosed with herpes zoster were recruited. Demographic, clinical, and healthcare resource utilization data on patients with herpes zoster or post-herpetic neuralgia collected via case report forms were used to estimate direct medical cost...
December 2017: Drugs—Real World Outcomes
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