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Post marketing surveillance

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https://www.readbyqxmd.com/read/28726115/the-impact-of-coronary-calcification-on-angiographic-and-3-year-clinical-outcomes-of-everolimus-eluting-stents-results-of-a-xience-v-promus-post-marketing-surveillance-study
#1
Nobuo Shiode, Ken Kozuma, Jiro Aoki, Masaki Awata, Mamoru Nanasato, Kengo Tanabe, Junichi Yamaguchi, Hajime Kusano, Hong Nie, Takeshi Kimura
Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography. In these 1546 patients, renal function data were unknown in 26 patients...
July 19, 2017: Cardiovascular Intervention and Therapeutics
https://www.readbyqxmd.com/read/28725912/sglt2-inhibitors-and-risk-of-cancer-in-type-2-diabetes-a-systematic-review-and-meta-analysis-of-randomised-controlled-trials
#2
REVIEW
Huilin Tang, Qi Dai, Weilong Shi, Suodi Zhai, Yiqing Song, Jiali Han
AIMS/HYPOTHESIS: The association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and the risk of cancer in individuals with type 2 diabetes remains uncertain. This study aimed to evaluate the risk of cancer associated with SGLT2 inhibitor treatment of type 2 diabetes. METHODS: We systematically searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov from inception to 15 February 2017 to identify eligible randomised controlled trials (RCTs) that report cancer events in individuals with type 2 diabetes treated with SGLT2 inhibitors for at least 24 weeks...
July 19, 2017: Diabetologia
https://www.readbyqxmd.com/read/28723841/military-civilian-partnership-in-device-innovation-development-commercialization-and-application-of-resuscitative-endovascular-balloon-occlusion-of-the-aorta-reboa
#3
Todd E Rasmussen, Jonathan L Eliason
Noncompressible torso hemorrhage (NCTH) and shock is a leading cause of trauma-related mortality and evidence suggests that survival from this injury pattern has not improved in decades. As such, innovating new approaches and devices, including technologies which can be used by providers within a short of time after severe injury, is a priority for the military. Guided by wartime observations, and through partnerships with civilian academia and private investment, the military has led an effort to define resuscitative endovascular balloon occlusion of the aorta (REBOA) and assess its potential to address this problem...
July 19, 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28722500/post-marketing-surveillance-study-of-the-long-term-use-of-mizoribine-for-the-treatment-of-lupus-nephritis-2-year-results
#4
Tsutomu Takeuchi, Kenya Okada, Hisao Yoshida, Nobuyuki Yagi
OBJECTIVES: To understand the status of mizoribine use in patients with lupus nephritis (LN) and to collect safety- and efficacy-related data on 2-year treatment with mizoribine. METHODS: A continuous survey was conducted between March 2010 and July 2015. RESULTS: The analysis set included 559 patients (mean age 39.5 years, females 82.6%, mean duration of systemic lupus erythematosus (SLE) 8.4 years, mean duration of LN 5.9 years). Renal function was satisfactory for 6 months, but worsened from 12 months, with significant worsening at 24 months...
July 19, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28699846/safety-and-effectiveness-of-tadalafil-in-pediatric-patients-with-pulmonary-arterial-hypertension-a-subgroup-analysis-based-on-japan-post-marketing-surveillance
#5
Hiroyoshi Yamazaki, Noriko Kobayashi, Masanori Taketsuna, Koyuki Tajima, Nahoko Suzuki, Masahiro Murakami
OBJECTIVE: To evaluate the long-term safety and effectiveness of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. METHODS: This is an observational surveillance of PAH patients receiving tadalafil in the contracted sites. We performed a subgroup analysis of 391 pediatric PAH patients (<18 years) who were included from 1,704 total patients in this surveillance. Safety was assessed from the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs)...
July 12, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28697849/post-market-surveillance-in-the-german-medical-device-sector-current-state-and-future-perspectives
#6
Claus Zippel, Sabine Bohnet-Joschko
Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%...
June 24, 2017: Health Policy
https://www.readbyqxmd.com/read/28676471/patterns-of-twitter-behavior-among-networks-of-cannabis-dispensaries-in-california
#7
Nicholas C Peiper, Peter M Baumgartner, Robert F Chew, Yuli P Hsieh, Gayle S Bieler, Georgiy V Bobashev, Christopher Siege, Gary A Zarkin
BACKGROUND: Twitter represents a social media platform through which medical cannabis dispensaries can rapidly promote and advertise a multitude of retail products. Yet, to date, no studies have systematically evaluated Twitter behavior among dispensaries and how these behaviors influence the formation of social networks. OBJECTIVES: This study sought to characterize common cyberbehaviors and shared follower networks among dispensaries operating in two large cannabis markets in California...
July 4, 2017: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/28658800/a-post-marketing-surveillance-study-to-evaluate-performance-of-the-eximo%C3%A2-blood-glucose-monitoring-system
#8
Sonia R Chandnani, C D Ramakrishna, Bhargav A Dave, Pankaj S Kothavade, Ashok S Thakkar
INTRODUCTION: The performance of Blood Glucose Monitoring System (BGMS) is critical as the information provided by the system guide the patient or health care professional in making treatment decisions. However, besides evaluating accuracy of the BGMS in laboratory setting, it is equally important that the intended users (healthcare professionals and patients) should be able to achieve blood glucose measurements with similar level of high accuracy. AIM: To assess the performance of EXIMO™ (Meril Diagnostics Pvt...
May 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28653782/changes-in-drug-use-patterns-reported-on-the-web-after-the-introduction-of-adf-oxycontin-findings-from-the-researched-abuse-diversion-and-addiction-related-surveillance-radars-system-web-monitoring-program
#9
Suzanne Vosburg, Colleen Haynes, Andrea Besharat, Jody L Green
This qualitative study summarizes information that individuals shared online about use of OxyContin following the August 2010 introduction of the abuse deterrent formulation (ADF). PURPOSE: The primary objective was to study online posts that endorsed continued use of OxyContin or a switch from OxyContin to another formulation of oxycodone or another substance altogether following the introduction of the ADF. A secondary objective was to determine whether posts revealed that the ADF led to cessation of OxyContin use...
June 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28652744/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
#10
Takeshi Terao, Atsuko Ishida, Toshifumi Kimura, Mitsuhiro Yoshida, Terufumi Hara
BACKGROUND: A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD). PATIENTS AND METHODS: Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28649878/safety-and-effectiveness-of-tacrolimus-add-on-therapy-for-rheumatoid-arthritis-patients-without-an-adequate-response-to-biological-disease-modifying-anti-rheumatic-drugs-dmards-post-marketing-surveillance-in-japan
#11
Tsutomu Takeuchi, Kota Ishida, Katsuhisa Shiraki, Takashi Yoshiyasu
OBJECTIVES: Post-marketing surveillance (PMS) was conducted to assess the safety and effectiveness of tacrolimus (TAC) add-on therapy for patients with rheumatoid arthritis (RA) and an inadequate response to biological disease-modifying anti-rheumatic drugs (DMARDs). METHODS: Patients with RA from 180 medical sites across Japan were registered centrally with an electronic investigation system. The observational period was 24 weeks from the first day of TAC administration concomitantly with biological DMARDs...
June 26, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28646580/biosimilars-for-psoriasis-worldwide-overview-of-regulatory-guidelines-uptake-and-implications-for-dermatology-clinical-practice
#12
REVIEW
A D Cohen, J J Wu, L Puig, S Chimenti, R Vender, M Rajagopalan, R Romiti, C de la Cruz, L Skov, C Zachariae, H S Young, P Foley, J M van der Walt, L Naldi, A Blauvelt
The introduction of biologic drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologic drugs for patients with psoriasis...
June 24, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28641055/long-term-safety-evaluation-of-natalizumab-for-the-treatment-of-multiple-sclerosis
#13
Marinella Clerico, Carlo Alberto Artusi, Alessandra Di Liberto, Simona Rolla, Valentina Bardina, Pierangelo Barbero, Stefania Federica De Mercanti, Luca Durelli
Natalizumab is a humanized monoclonal antibody highly effective in relapsing-remitting multiple sclerosis (MS). Important concerns about its safety have been pointed out mainly because of the risk of progressive multifocal leukoencephalopathy (PML), caused by the opportunistic John-Cunningham virus (JCV). Areas covered: This review analyzes all the safety aspects related to the use and safety of natalizumab in MS patients. Other than PML, post-marketing, safety red-flags have been reported, as liver or haematological serious adverse events...
July 5, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28632830/-declaration-of-the-chilean-academy-of-medicine-of-law-20-850-on-clinical-trials-of-pharmaceutical-products-and-medical-devices-and-of-the-bylaw-that-will-regulate-its-application
#14
Gloría López, Gloría Valdés, Emilio Roessler, Vicente Valdivieso
In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1) The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2) The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3) Individuals submitted to the trials are entitled to free post trial access to the treatment received during the study, financed by the trial supporting entities and as long as the drug or devise is considered to be useful...
April 2017: Revista Chilena de Infectología: órgano Oficial de la Sociedad Chilena de Infectología
https://www.readbyqxmd.com/read/28627937/the-safety-of-intra-articular-injections-for-the-treatment-of-knee-osteoarthritis-a-critical-narrative-review
#15
Christelle Nguyen, François Rannou
International guidelines recommend that the management of knee osteoarthritis (OA) combine both nonpharmacological and pharmacological interventions. Intra-articular (IA) therapies are considered part of this multimodal approach and are well-established Food and Drug Administration (FDA) and European Medicines Agency (EMA)-approved treatments. Areas covered. Safety data for knee OA, including IA corticosteroids, hyaluronic acid, platelet-rich plasma and botulinum toxin are critically reviewed, and evidence- and pratice-based measures to improve safety of IA therapies are discussed...
June 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28582563/participant-centred-active-surveillance-of-adverse-events-following-immunisation-a-narrative-review
#16
Patrick Cashman, Kristine Macartney, Gulam Khandaker, Catherine King, Michael Gold, David N Durrheim
The importance of active, participant-centred monitoring of adverse events following immunisation (AEFI) is increasingly recognised as a valuable adjunct to traditional passive AEFI surveillance. The databases OVID Medline and OVID Embase were searched to identify all published articles referring to AEFI. Only studies which sought participant response after vaccination were included. A total of 6060 articles published since the year 2000 were identified. After the application of screening inclusion and exclusion criteria, 25 articles describing 23 post-marketing AEFI systems were identified...
May 1, 2017: International Health
https://www.readbyqxmd.com/read/28580889/phosphodiesterase-5-inhibitors-and-their-analogues-as-adulterants-of-herbal-and-food-products-analysis-of-the-malaysian-market-in-2014-2016
#17
Nur Baizura Bujang, Chin Fei Chee, Choon Han Heh, Noorsaadah Abd Rahman, Michael J C Buckle
Adulteration of herbal health supplements with phosphodiesterase-5 (PDE-5) inhibitors and their analogues is becoming a worldwide problem. The aim of this study was to investigate herbal and food products sold in the Malaysian market for the presence of these adulterants. Sixty-two products that claim to enhance men's sexual health were sampled between April 2014 and April 2016. These products included unregistered products seized by the Pharmacy Enforcement Division of the Ministry of Health (n = 39), products sent to the National Pharmaceutical Regulatory Agency for pre-registration testing (n = 9) and products investigated under the post-registration market surveillance programme (n = 14)...
June 5, 2017: Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment
https://www.readbyqxmd.com/read/28571476/the-safety-and-tolerability-of-nintedanib-in-the-treatment-of-idiopathic-pulmonary-fibrosis
#18
REVIEW
Vincent Cottin
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease that primarily affects older individuals. Nintedanib, a tyrosine kinase inhibitor, has been approved for the treatment of IPF in several countries. The safety and tolerability of nintedanib have been investigated in clinical trials and in real-world studies (compassionate use programs and post-marketing surveillance). Areas covered: Most frequent adverse events reported in patients treated with nintedanib (gastrointestinal); additional adverse events of special interest (elevations in liver enzymes, bleeding, cardiovascular adverse events); recommendations for managing adverse events...
July 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28552510/post-marketing-safety-surveillance-for-inactivated-and-live-attenuated-japanese-encephalitis-vaccines-in-china-2008-2013
#19
Wendi Wu, Dawei Liu, Keli Li, J Pekka Nuorti, Hanna M Nohynek, Disha Xu, Jiakai Ye, Jingshan Zheng, Huaqing Wang
INTRODUCTION: Two types of Japanese encephalitis (JE) vaccines, inactivated JE vaccine (JE-I) and live-attenuated JE vaccine (JE-L), are available and used in China. In particular, one JE-L, produced by a domestic manufacturer in China, was prequalified by WHO in 2013. We assessed the safety of JE vaccines in China during 2008-2013 using the Chinese National Adverse Events Following Immunization Information System (CNAEFIS) data. METHODS: We retrieved AEFI reporting data about JE vaccines from CNAEFIS, 2008-2013, examined demographic characteristics of AEFI cases, and used administrative data on vaccine doses as denominator to calculate and compare crude reporting rates...
June 22, 2017: Vaccine
https://www.readbyqxmd.com/read/28548196/-declaration-of-the-chilean-academy-of-medicine-of-law-20-850-%C3%A2-on-clinical-trials-of-pharmaceutical-products-and-medical-devices%C3%A2-and-of-the-bylaw-that-will-regulate-its-application
#20
Gloria López S, Gloria Valdés S, Emilio Roessler B, Vicente Valdivieso D
In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1. The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2.The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3...
March 2017: Revista Médica de Chile
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