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Post marketing surveillance

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https://www.readbyqxmd.com/read/29025285/safety-and-efficacy-of-canagliflozin-in-elderly-patients-with-type-2-diabetes-mellitus-a-1-year-post-marketing-surveillance-in-japan
#1
Maki Goda, Tomoko Yamakura, Kazuyo Sasaki, Takumi Tajima, Makoto Ueno
Objective To evaluate the safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus (T2DM) in clinical settings. Methods We conducted a 1-year post-marketing surveillance (PMS) of canagliflozin in almost all the elderly patients (≥65 years old) with T2DM who began taking canagliflozin during the first 3 months after its launch in Japan. The main outcomes included the incidences of adverse drug reactions (ADRs), serious ADRs and the changes of laboratory tests as well as efficacy variables...
October 13, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28988455/safety-profiles-of-percutaneous-left-atrial-appendage-closure-devices-an-analysis-of-the-food-and-drug-administration-manufacturer-and-user-facility-device-experience-maude-database-from-2009-2016
#2
Mohammad-Ali Jazayeri, Venkat Vuddanda, Mohit K Turagam, Valay Parikh, Madhav Lavu, Donita Atkins, Matthew Earnest, Luigi Di Biase, Andrea Natale, David Wilber, Yeruva Madhu Reddy, Dhanunjaya Lakkireddy
BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long term oral anticoagulation (OAC). OBJECTIVE: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc...
October 8, 2017: Journal of Cardiovascular Electrophysiology
https://www.readbyqxmd.com/read/28981338/heart-toxicity-related-to-herbs-and-dietary-supplements-online-table-of-case-reports-part-4-of-5
#3
Amy C Brown
BACKGROUND: The purpose of this review was to create an online research summary table of heart toxicity case reports related to dietary supplements (DS; includes herbs). METHODS: Documented PubMed case reports of DS appearing to contribute to heart-related problems were used to create a "Toxic Table" that summarized the research (1966 to April, 2016, and cross-referencing). Keywords included "herb," "dietary supplement," and cardiac terms. Case reports were excluded if they were herb combinations (some exceptions), Chinese herb mixtures, teas of mixed herb contents, mushrooms, poisonous plants, self-harm (e...
October 5, 2017: Journal of Dietary Supplements
https://www.readbyqxmd.com/read/28976217/drugs-approved-for-the-treatment-of-multiple-sclerosis-review-of-their-safety-profile
#4
Fabiana Auricchio, Cristina Scavone, Daniela Cimmaruta, Gabriella di Mauro, Annalisa Capuano, Liberata Sportiello, Concetta Rafaniello
Multiple sclerosis (MS) is a chronic immune-mediated inflammatory disorder of the brain and spinal cord characterized by inflammation, demyelination, and axonal degeneration. Area covered: Even though the pharmacological armamentarium for MS treatment is considerably improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking. In order to analyze the safety profile of drugs used for the treatment of MS, a literature review of pre-marketing, post-marketing studies and case reports was performed...
October 4, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28965304/piloting-a-livestock-identification-and-traceability-system-in-the-northern-tanzania-narok-nairobi-trade-route
#5
Florence Mutua, Absolomon Kihara, Jason Rogena, Nicholas Ngwili, Gabriel Aboge, James Wabacha, Bernard Bett
We designed and piloted a livestock identification and traceability system (LITS) along the Northern Tanzania-Narok-Nairobi beef value chain. Animals were randomly selected and identified at the primary markets using uniquely coded ear tags. Data on identification, ownership, source (village), and the site of recruitment (primary market) were collected and posted to an online database. Similar data were collected in all the markets where tagged animals passed through until they got to defined slaughterhouses...
September 30, 2017: Tropical Animal Health and Production
https://www.readbyqxmd.com/read/28960089/efficacy-and-safety-of-dronedarone-in-the-treatment-of-patients-with-atrial-fibrillation
#6
Mohammed Hasan Khan, Yogita Rochlani, Wilbert S Aronow
Dronedarone, a derivative of amiodarone with structural modifications, was designed to have similar electrophysiological properties with a less toxic profile. Areas covered: Brief overview of the pharmacology of dronedarone followed by a summary of randomized clinical trials testing the efficacy of dronedarone in maintaining normal sinus rhythm and clinical outcomes associated with these trials. In depth discussion and commentary on trial findings which may seem contradictory at first approach and brief discussion of post-marketing surveillance studies...
October 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28956684/correction-to-wolf-et-al-effectiveness-and-tolerability-of-parenteral-testosterone-undecanoate-a-post-marketing-surveillance-study
#7
(no author information available yet)
No abstract text is available yet for this article.
December 2017: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
https://www.readbyqxmd.com/read/28952470/-the-efficacy-and-safety-of-pitavastatin
#8
Vedat Sansoy
In short-term, phase III or IV studies in Asian and European patients, pitavastatin 1, 2 and 4 mg once daily reduced LDL-Cholesterol (LDL-C) 34%, 42% and 47%, respectively. Pitavastatin provided sustained LDL-C-lowering efficacy over up to 60 weeks' therapy in extension studies. In comparative studies pitavastatin 4 mg and simvastatin 40 mg reduced LDL-C similarly, reduction in triglycerides and increase in HDL-Cholesterol (HDL-C) was more prominent with pitavastatin. In comparative studies with atorvastatin, pitavastatin 4mg was found to be more effective than 20 mg of atorvastatin, and a little less effective than 40 mg of atorvastatin...
April 2017: Türk Kardiyoloji Derneği Arşivi: Türk Kardiyoloji Derneğinin Yayın Organıdır
https://www.readbyqxmd.com/read/28951381/classification-of-twitter-users-who-tweet-about-e-cigarettes
#9
Annice Kim, Thomas Miano, Robert Chew, Matthew Eggers, James Nonnemaker
BACKGROUND: Despite concerns about their health risks, e‑cigarettes have gained popularity in recent years. Concurrent with the recent increase in e‑cigarette use, social media sites such as Twitter have become a common platform for sharing information about e-cigarettes and to promote marketing of e‑cigarettes. Monitoring the trends in e‑cigarette-related social media activity requires timely assessment of the content of posts and the types of users generating the content. However, little is known about the diversity of the types of users responsible for generating e‑cigarette-related content on Twitter...
September 26, 2017: JMIR Public Health and Surveillance
https://www.readbyqxmd.com/read/28950812/idarucizumab-what-should-we-know
#10
Francesca Cortese, Michele Gesualdo, Annagrazia Cecere, Annapaola Zito, Fiorella De Vito, Rossella Carbonara, Santa Carbonara, Anna Maria Cortese, Marco Matteo Ciccone
BACKGROUND: Idarucizumab, a humanized monoclonal antibody fragment acting as specific antidote for dabigatran, is approved for reversing the dabigatran-associated possible bleeding from critical sites or bleeding persisting despite local post-procedure haemostasis, moreover it can also be applied to reverse the dabigatran anticoagulant activity in emergency surgery or in other invasive procedure at high risk of bleeding. OBJECTIVE: In this manuscript, we discuss idarucizumab in light of the available literature data by conducting extensive research in the PubMed, EMBASE and Cochrane Library on the topic, using as Mesh terms idarucizumab, dabigatran and their combinations, and focusing on high impact investigations...
September 25, 2017: Current Drug Targets
https://www.readbyqxmd.com/read/28948642/type-i-error-probability-spending-for-post-market-drug-and-vaccine-safety-surveillance-with-binomial-data
#11
Ivair R Silva
Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected...
September 25, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28943977/barriers-to-reporting-of-adverse-drugs-reactions-a-cross-sectional-study-among-community-pharmacists-in-united-kingdom
#12
Ejaz Cheema, Abdul Haseeb, Tahir M Khan, Paul Sutcliffe, Donald R Singer
BACKGROUND: Adverse Drug Reactions (ADRs) are a major public health problem. Prompt reporting of suspected ADRs is fundamental in the post-marketing surveillance of medicines and helps in ensuring medicine safety. However, fewer ADRs are reported in general and in particular by community pharmacists. There is limited knowledge about the factors which are preventing community pharmacists in the UK from reporting an ADR. OBJECTIVES: To identify the barriers to ADR reporting among community pharmacists practicing in the UK...
July 2017: Pharmacy Practice
https://www.readbyqxmd.com/read/28941622/epidemiology-of-childhood-intussusception-in-bangladesh-findings-from-an-active-national-hospital-based-surveillance-system-2012-2016
#13
Syed M Satter, Negar Aliabadi, Catherine Yen, Paul A Gastañaduy, Makhdum Ahmed, Abdullah Mamun, Khaleda Islam, Meerjady S Flora, Mahmudur Rahman, K Zaman, Mustafizur Rahman, James D Heffelfinger, Stephen P Luby, Emily S Gurley, Umesh D Parashar
INTRODUCTION: Rotavirus vaccines have significantly decreased the burden of diarrheal diseases in countries that have introduced them into their immunization programs. In some studies, there has been a small association between rotavirus vaccines and intussusception in post-marketing surveillance, highlighting the importance of tracking incidence before and after vaccine introduction. The objective of this study was to describe the epidemiology of intussusception among Bangladeshi children pre-vaccine introduction...
September 20, 2017: Vaccine
https://www.readbyqxmd.com/read/28936827/-core-elements-of-safety-monitoring-report-of-medicines-chinese-patent-medicines
#14
Gui-Qian Wang, Xing Liao, Yan-Ming Xie
Studies on post-marketing drug surveillance have become increasingly important in recent years. In particular, many researchers for traditional Chinese medicine have paid more attention to the safety of post-marketing Chinese patent medicines. Observational studies, like cohort study, registry study, and intensive hospital monitoring, were conducted to collect data on safety information. How to accurately report and assess these studies and let readers to completely understand relevant published reports and obtain transparent information about its methodology and findings remain unsolved...
December 2016: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28903542/reviewing-the-evidence-for-biosimilars-key-insights-lessons-learned-and-future-horizons
#15
REVIEW
Till Uhlig, Guro L Goll
Biologic therapies have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Over recent years, the development and licensing pathways for biosimilars have become more standardized, and several biosimilars have been made available for patients with inflammatory rheumatic diseases, such as RA. Pre-licensing requirements for biosimilars mandate the demonstration of comparability with reference products in terms of clinical activity, safety and immunogenicity, whereas post-marketing surveillance and risk minimization requirements are set in place to ensure that long-term, real-world safety data are collected to assess biosimilars in clinical practice...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28895096/palivizumab-prophylaxis-against-respiratory-syncytial-virus-infection-in-children-with-immunocompromised-conditions-or-down-syndrome-a-multicenter-post-marketing-surveillance-in-japan
#16
Tomoko Kashiwagi, Yukiko Okada, Ken Nomoto
OBJECTIVE: The aim of this study was to assess the safety and effectiveness of palivizumab for the prevention of lower respiratory tract infection (LRI) caused by respiratory syncytial virus (RSV) in children with immunocompromised conditions or Down syndrome. METHODS: In this multicenter, post-marketing surveillance study (December 2013 to December 2015), children aged ≤24 months with immunocompromised conditions or Down syndrome (without hemodynamically significant congenital heart disease) receiving palivizumab immunoprophylaxis during two RSV seasons were observed until 30 days after the final palivizumab injection...
September 11, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28879692/safety-and-effectiveness-of-once-daily-tadalafil-5-mg-therapy-in-korean-men-with-benign-prostatic-hyperplasia-lower-urinary-tract-symptoms-in-a-real-world-clinical-setting-results-from-a-post-marketing-surveillance-study
#17
Ji Eon Won, Ji Yeon Chu, Hyunah Caroline Choi, Yun Chen, Hyun Jun Park, Héctor José Dueñas
PURPOSE: The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD) among Korean men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in a real-world clinical setting. MATERIALS AND METHODS: This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance...
September 6, 2017: World Journal of Men's Health
https://www.readbyqxmd.com/read/28863867/results-on-exposure-during-pregnancy-from-a-pregnancy-registry-for-as04-hpv-16-18-vaccine
#18
Marta López-Fauqued, Julia Zima, Maria-Genalin Angelo, Jens-Ulrich Stegmann
OBJECTIVE: To assess pregnancy outcomes after exposure to AS04-HPV-16/18 vaccine (Cervarix, GSK, Belgium) prior to, or during pregnancy, as reported to a pregnancy registry. METHODS: A pregnancy exposure registry was established to collect data in the United Kingdom and the United States. Exposure was defined as vaccination with AS04-HPV-16/18 within 60days before the estimated conception date and delivery. Reporting was voluntary. RESULTS: Between September 2007 and November 2015, 306 pregnancy exposure reports were received of which 181 were prospective, evaluable reports...
September 25, 2017: Vaccine
https://www.readbyqxmd.com/read/28860779/erratum-assessment-of-safety-and-efficacy-of-lamotrigine-over-the-course-of-1-year-observation-in-japanese-patients-with-bipolar-disorder-post-marketing-surveillance-study-report-corrigendum
#19
(no author information available yet)
[This corrects the article on p. 1441 in vol. 13, PMID: 28652744.].
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28846490/post-marketing-surveillance-study-to-assess-the-safety-and-tolerability-of-an-inactivated-poliomyelitis-vaccine-in-indian-children
#20
Hitt Sharma, Rajeev Dhere, Sameer Parekh, Sunil Shewale
OBJECTIVE: To evaluate the incidence of adverse events following administration of an Inactivated poliomyelitis vaccine (IPV) manufactured by Serum Institute of India Pvt. Ltd., Pune, India. METHODS: A single 0.5 ml dose of the IPV was administered intramuscularly to children attending private clinics or out-patient department of hospitals for routine immunization across different cities in India. They were observed over a period of 30 days for local or systemic adverse events and rare case of anaphylaxis, if any...
August 28, 2017: Human Vaccines & Immunotherapeutics
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