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Post marketing surveillance

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https://www.readbyqxmd.com/read/29674237/eslicarbazepine-acetate-exposure-in-pregnant-women-with-epilepsy
#1
Raquel Costa, Luís M Magalhães, Joana Graça, Mariana Vieira, Helena Gama, Joana Moreira, José F Rocha, Patrício Soares-da-Silva
PURPOSE: Epilepsy is a common neurologic disorder requiring continued treatment during pregnancy. Treatment with antiepileptic drugs (AEDs) is needed for seizure control, but the risk of adverse events has to be minimized for both mother and foetus. Available data on pregnancy and foetal/postnatal outcomes following eslicarbazepine acetate (ESL) exposure via parent is herein presented for the first time. METHODS: ESL's global safety database was reviewed to identify pregnancy cases with exposure to ESL reported up to October 21st, 2017...
April 10, 2018: Seizure: the Journal of the British Epilepsy Association
https://www.readbyqxmd.com/read/29668449/budgetary-impact-of-medicinal-therapies-for-rare-diseases-in-bulgaria
#2
Georgi G Iskrov, Mihajlo Michael Jakovljevic, Rumen S Stefanov
BACKGROUND: Rare diseases have been continually outlined as one of the causes for the National Health Insurance Fund's (NHIF) deficit spending in Bulgaria. AIM: To estimate the budgetary impact of rare disease medicinal therapies from NHIF perspective for 2014 and 2016. MATERIALS AND METHODS: Budgetary impact of rare diseases is calculated as a percentage of NHIF total pharmaceutical spending. Total expenditure per ICD-10 code, mean annual number of patients reimbursed and mean annual cost per patient are analysed...
March 1, 2018: Folia Medica
https://www.readbyqxmd.com/read/29663959/quality-assurance-of-rifampicin-containing-fixed-drug-combinations-in-south-africa-dosing-implications
#3
R Court, M T Chirehwa, L Wiesner, B Wright, W Smythe, N Kramer, H McIlleron
SETTING: Rifampicin (RMP) drives treatment response in drug-susceptible tuberculosis. Low RMP concentrations increase the risk of poor outcomes, and drug quality needs to be excluded as a contributor to low RMP exposure. OBJECTIVES AND DESIGN: We performed an open-label, three-way cross-over study of three licensed RMP-containing formulations widely used in South Africa to evaluate the bioavailability of RMP in a two-drug fixed-dose combination tablet (2FDC) and a four-drug FDC (4FDC) against a single-drug reference...
May 1, 2018: International Journal of Tuberculosis and Lung Disease
https://www.readbyqxmd.com/read/29600661/-post-marketing-surveillance-on-guizhi-fuling-jiaonang-based-on-literature-review
#4
Gui-Qian Wang, Yang Gao, Fu-Mei Liu, Rui-Li Wei, Yan-Ming Xie
To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study...
February 2018: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29598886/mapping-existing-hip-and-knee-replacement-registries-in-europe
#5
REVIEW
A Lübbeke, A J Silman, C Barea, D Prieto-Alhambra, A J Carr
The general shortage of evidence regarding benefits and harms of medical devices has been highlighted following the serious safety concerns with metal-on-metal hip replacements and silicone breast implants and was again pointed out in a recent survey of European Health Technology Assessment institutions. In this context the new European medical device regulation will enforce post-marketing surveillance of existing and new implants. The usefulness of registry data as a source of information for medical device real-world clinical performance and safety has been demonstrated...
March 17, 2018: Health Policy
https://www.readbyqxmd.com/read/29587555/discovery-and-development-of-varenicline-for-smoking-cessation
#6
Chloe J Jordan, Zheng-Xiong Xi
Tobacco use causes one premature death every six seconds. Current smoking cessation aids include nicotine replacement therapies, bupropion, and varenicline. Although more than 70% of smokers express a desire to quit, fewer than 3% remain abstinent for more than one year, highlighting a critical need for more efficacious smoking cessation treatments. Areas covered: The authors discuss the rationale, preclinical and clinical development of varenicline for smoking cessation. They cover the formulation of varenicline as a partial agonist at α4 β2 receptors, the primary neural substrate for nicotine reward...
March 28, 2018: Expert Opinion on Drug Discovery
https://www.readbyqxmd.com/read/29582392/benefit-risk-monitoring-of-vaccines-using-an-interactive-dashboard-a-methodological-proposal-from-the-advance-project
#7
Kaatje Bollaerts, Tom De Smedt, Katherine Donegan, Lina Titievsky, Vincent Bauchau
INTRODUCTION: New vaccines are launched based on their benefit-risk (B/R) profile anticipated from clinical development. Proactive post-marketing surveillance is necessary to assess whether the vaccination uptake and the B/R profile are as expected and, ultimately, whether further public health or regulatory actions are needed. There are several, typically not integrated, facets of post-marketing vaccine surveillance: the surveillance of vaccination coverage, vaccine safety, effectiveness and impact...
March 26, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29505866/periodic-benefit-risk-assessment-using-bayesian-stochastic-multi-criteria-acceptability-analysis
#8
Kan Li, Sammy Yuan, William Wang, ShuyanSabrina Wan, Paulette Ceesay, Joseph F Heyse, Shahrul Mt-Isa, Sheng Luo
Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle...
March 2, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29500791/safety-effectiveness-and-treatment-persistence-of-golimumab-in-elderly-patients-with-rheumatoid-arthritis-in-real-world-clinical-practice-in-japan
#9
Masateru Okazaki, Hisanori Kobayashi, Hirohito Shimizu, Yutaka Ishii, Tsutomu Yajima, Masayoshi Kanbori
INTRODUCTION: Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials. However, there is a scarcity of data regarding its use in elderly patients in a real-world setting. This study aims to evaluate the safety, effectiveness, and treatment persistence of golimumab in elderly Japanese patients (≥ 75 years) with rheumatoid arthritis. METHODS: This study was a post hoc analysis of post-marketing surveillance data on 5137 Japanese patients with active rheumatoid arthritis who received golimumab for 24 weeks...
March 2, 2018: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29484580/five-year-clinical-outcomes-of-everolimus-eluting-stents-from-the-post-marketing-study-of-cocr-ees-xience-v-promus-in-japan
#10
Jiro Aoki, Ken Kozuma, Masaki Awata, Mamoru Nanasato, Nobuo Shiode, Kengo Tanabe, Junichi Yamaguchi, Hajime Kusano, Hong Nie, Takeshi Kimura
The Cobalt Chromium Everolimus-Eluting Stent (CoCr-EES) Post Marketing Surveillance (PMS) Japan study is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2010 consecutive patients (2649 lesions) who underwent percutaneous coronary intervention using CoCr-EES. Clinical outcomes were evaluated through 5 years. Mean age was 68.8 years, 41...
February 26, 2018: Cardiovascular Intervention and Therapeutics
https://www.readbyqxmd.com/read/29483794/recommendations-for-the-use-of-rotavirus-vaccines-in-infants
#11
Nicole Le Saux
The present statement provides information concerning the clinical rotavirus disease and rotavirus vaccines in Canada. Since the implementation of publically funded rotavirus vaccine programs in Canada, increasing evidence has been accumulating globally as to the effectiveness of rotavirus vaccines in the prevention of acute gastroenteritis. Current data estimate vaccine effectiveness to be in the order of 85% for preventing severe disease, including hospitalizations and emergency department visits, when vaccine coverage is high...
August 2017: Paediatrics & Child Health
https://www.readbyqxmd.com/read/29482765/safety-and-tolerability-of-prescription-omega-3-fatty-acids-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#12
Cheng-Ho Chang, Ping-Tao Tseng, Nai-Yu Chen, Pei-Chin Lin, Pao-Yen Lin, Jane Pei-Chen Chang, Feng-Yu Kuo, Jenshinn Lin, Ming-Chang Wu, Kuan-Pin Su
BACKGROUND: Omega-3 fatty acids [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] are widely recommended for health promotion. Over the last decade, prescription omega-3 fatty acid products (RxOME3FAs) have been approved for medical indications. Nonetheless, there is no comprehensive analysis of safety and tolerability of RxOME3FAs so far. METHODS: A systematic review of randomized controlled trials (RCTs) was carried out based on searches in six electronic databases...
February 2018: Prostaglandins, Leukotrienes, and Essential Fatty Acids
https://www.readbyqxmd.com/read/29470834/worldwide-3-year-post-marketing-surveillance-experience-with-tofacitinib-in-rheumatoid-arthritis
#13
Stanley Cohen, Jeffrey R Curtis, Ryan DeMasi, Yan Chen, Haiyun Fan, Arif Soonasra, Roy Fleischmann
INTRODUCTION: Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. METHODS: Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed...
February 22, 2018: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29470832/real-world-treatment-patterns-for-golimumab-and-concomitant-medications-in-japanese-rheumatoid-arthritis-patients
#14
Masateru Okazaki, Hisanori Kobayashi, Yutaka Ishii, Masayoshi Kanbori, Tsutomu Yajima
INTRODUCTION: The aim of this study was to investigate real-world treatment patterns for use of golimumab and concomitant medications in Japanese patients with rheumatoid arthritis. METHODS: This study was a post hoc retrospective analysis from post-marketing surveillance data on 2350 Japanese patients with moderate/severe rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided based on initiation treatment or dose adjustment patterns with golimumab, methotrexate, or oral glucocorticoids...
February 22, 2018: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29468916/the-safety-of-gliptins-updated-data-in-2018
#15
REVIEW
André Jacques Scheen
Dipeptidyl peptidase-4 inhibitors (DPP-4is) are generally considered as glucose-lowering agents with a safe profile in type 2 diabetes. Areas covered: An updated review of recent safety data from randomised controlled trials, observational studies, meta-analyses, pharmacovigilance reports regarding alogliptin, linagliptin, saxagliptin, sitagliptin, and vildagliptin, with a special focus on risks of hypoglycemia, pancreatitis and pancreatic cancer, major cardiovascular events, hospitalisation for heart failure and other new safety issues, such as bone fractures and arthralgia...
April 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29429483/a-cost-benefit-analysis-and-the-potential-trade-effects-of-the-bovine-viral-diarrhoea-eradication-programme-in-styria-austria
#16
T Marschik, W Obritzhauser, P Wagner, V Richter, M Mayerhofer, C Egger-Danner, A Käsbohrer, B Pinior
This study evaluated the voluntary and compulsory implementation of a bovine viral diarrhoea virus (BVDV) eradication programme in the Austrian Federal State of Styria, Austria, from an economic point of view using ex-post assessment of costs and benefits (disease losses avoided). An economic net benefit (benefit:cost ratio, BCR=1.18) of the programme was demonstrated during the voluntary programme phase (January 1998-July 2004). The break-even point was reached in 2003. If investments in the compulsory programme (August 2004-December 2016) were taken into account, a net economic loss (BCR=0...
January 2018: Veterinary Journal
https://www.readbyqxmd.com/read/29428441/the-role-of-external-quality-assessment-in-the-verification-of-in-vitro-medical-diagnostics-in-the-traceability-era
#17
Federica Braga, Sara Pasqualetti, Mauro Panteghini
Once an in-vitro diagnostic (IVD) measuring system has been marketed and introduced into daily practice, the possible sources of degradation of its performance are numerous. It is therefore essential to put in place a continuous post-market surveillance of the quality of performance of the IVD system and of the laboratories that perform measurements in clinical setting. The participation to external quality assessment (EQA) schemes that meet specific metrological criteria is central to the evaluation of performance of clinical laboratories in terms of standardization and clinical suitability of their measurements...
February 8, 2018: Clinical Biochemistry
https://www.readbyqxmd.com/read/29425340/clinical-review-of-delafloxacin-a-novel-anionic-fluoroquinolone
#18
Bryan T Mogle, Jeffrey M Steele, Stephen J Thomas, KarenBeth H Bohan, Wesley D Kufel
Delafloxacin is a novel anionic fluoroquinolone (FQ) approved for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by a number of Gram-positive and Gram-negative organisms including MRSA and Pseudomonas aeruginosa. The unique chemical structure of delafloxacin renders it a weak acid and results in increased potency in acidic environments. In Phase III studies, delafloxacin had similar outcomes to comparator regimens for treatment of ABSSSIs, and was well tolerated overall. Similar to other FQs, delafloxacin is available in both intravenous and oral formulations, but differs in that delafloxacin exerts a minimal effect on cytochrome P450 enzymes and on the corrected QT interval...
February 7, 2018: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29415382/one-year-outcomes-after-rapid-deployment-aortic-valve-replacement
#19
Christopher Young, Günther Laufer, Alfred Kocher, Marco Solinas, Francesco Alamanni, Gianluca Polvani, Bruno K Podesser, Jose Ignacio Aramendi, Jose Arribas, Olivier Bouchot, Ugolino Livi, Massimo Massetti, Kim Terp, Christophe Giot, Mattia Glauber
OBJECTIVE: The goals of rapid-deployment aortic valve replacement include facilitation of minimally invasive surgery and reduced aortic crossclamp time. We report the short-term outcomes of a series of 493 patients undergoing rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system (Edwards Lifesciences, LLC, Irvine, Calif). METHODS: Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study was a prospective, multicenter (n = 26) European registry designed to evaluate the safety and performance of the valve system...
February 2018: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/29412117/strategies-empowering-paediatric-drug-safety
#20
Marta Gentili, Marco Pozzi, Gabrielle Peeters, Sonia Radice, Carla Carnovale
Background Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterise fully the safety profiles of drugs. Addionally, information about rare adverse drug reactions (ADRs) in special groups or drug-drug interactions (DDIs) is often incomplete or not available for most of the drugs commonly used in the daily clinical practice...
February 6, 2018: Current Clinical Pharmacology
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