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https://read.qxmd.com/read/30773345/pharmacoepidemiological-research-for-the-development-and-evaluation-of-drugs-in-pediatrics
#1
Florentia Kaguelidou, Geneviève Durrieu, Antonio Clavenna
New regulations have come into force in Europe and the US establishing the pediatric development as an integral part of the early development of medicinal products. Parallel to the advances in pediatric clinical research, it became obvious that all available sources and research tools to gather valuable information for the safe and efficacious prescription of medicines in children should be used. Real-life, pharmacoepidemiological studies provide information that contribute to the better knowledge of drug utilization, effects and safety in the pediatric population and thereby, a better prescribing in children...
January 31, 2019: Thérapie
https://read.qxmd.com/read/30773344/case-non-case-studies-principle-methods-bias-and-interpretation
#2
Jean-Luc Faillie
Case-non-case studies are among the methods used to assess drug safety by analyzing the disproportionality of adverse drug reaction reports in pharmacovigilance databases. First used in the 1980s, the last few decades have seen a significant increase in the use of this study design. The principle of case-non-case studies is to compare the drug exposure of cases of an adverse reaction of interest with that of cases with other reported reactions and called "non-cases". Their results are presented in the form of reporting odds ratio (ROR), the interpretation of which makes it possible to highlight pharmacovigilance signals...
January 31, 2019: Thérapie
https://read.qxmd.com/read/30773343/pharmacoepidemiology-in-older-people-purposes-and-future-directions
#3
Marie-Laure Laroche, Caroline Sirois, Emily Reeve, Danijela Gnjidic, Lucas Morin
Knowledge of the benefit/risk ratio of drugs in older adults is essential to optimise medication use. While randomised controlled trials are fundamental to the process of drug development and bringing new drugs to the market, they often exclude older adults, especially those suffering from frailty, multimorbidity and/or receiving polypharmacy. Therefore, it is generally unknown whether the benefits and harms of drugs established through pre-marketing clinical trials are translatable to the real-word population of older adults...
January 31, 2019: Thérapie
https://read.qxmd.com/read/30737052/the-french-levothyrox-%C3%A2-crisis-we-did-the-best-we-could-but%C3%A2
#4
EDITORIAL
Stéphane Mouly, Matthieu Roustit, Haleh Bagheri, Marie-Christine Perault-Pochat, Mathieu Molimard, Régis Bordet
No abstract text is available yet for this article.
January 19, 2019: Thérapie
https://read.qxmd.com/read/30704765/pharmacoepidemiology-of-statins
#5
Julien Bezin, Nicholas Moore
The evaluation of the real-life benefits and risks of statins in population is a major pharmacoepidemiological issue, given their widespread use for cardiovascular prevention. The purpose of this review was not to be exhaustive but to show the contributions of pharmacoepidemiology for various aspects of the evaluation of statins such as real-life drug use, effectiveness and risk. Statins are among the most used drugs in the world, but recent data show a slight decrease in use. Actual statin users are older, and have more comorbidities than those studied in clinical trials, but this does not seem to compromise their effectiveness, unlike the compliance issues that are common with these drugs...
January 18, 2019: Thérapie
https://read.qxmd.com/read/30686638/pharmacoepidemiology-the-new-paradigm-of-drug-evaluation
#6
EDITORIAL
Bernard Bégaud, Jean-Louis Montastruc
No abstract text is available yet for this article.
January 16, 2019: Thérapie
https://read.qxmd.com/read/30683443/interest-of-pharmacoepidemiology-for-the-study-of-anticoagulants
#7
Haleh Bagheri
Anticoagulants are essential for the treatment of cardiovascular illnesses. With the ageing population in the West countries, and the consequent increase in the frequency of thrombogenic heart diseases oral anticoagulants represent a not insignificant portion of drug consumption. Over the past few years, direct oral anticoagulants (DOACs) have been marketed because they are easier to use than vitamine K antagonists (VKAs). The introduction of these drugs has raised two main issues: (1) progress of the switch from VKAs to DOACs; (2) the comparison of adverse drug reactions (primarily hemorrhagic) on DOACs compared to indirect oral anticoagulants (IOAs)...
January 16, 2019: Thérapie
https://read.qxmd.com/read/30704764/pantoprazole-reduces-serum-ferritin-in-patients-with-thalassemia-major-and-intermedia-a-randomized-controlled-study
#8
Aziz Eghbali, Atefeh Khalilpour, Hassan Taherahmadi, Bahador Bagheri
AIM: Complications due to iron overload exert a problematic situation in patients with thalassemia. Proton pump inhibitors (PPIs) like pantoprazole are effective agents to reduce acid gastric acid secretion and perhaps to interrupt iron absorption in conditions with increased iron absorption. Our purpose was to study effects of pantoprazole addition to chelators on iron levels in patients with thalassemia major and intermedia. METHODS: This randomized, controlled, and single center trial was performed on 60 patients with thalassemia major and intermedia in Amir Kabir hospital, Iran...
January 14, 2019: Thérapie
https://read.qxmd.com/read/30686639/tintin-in-the-land-of-drugs-a-pharmacological-pharmacovigilance-approach
#9
LETTER
Jean-Louis Montastruc, François Montastruc, Justine Benevent, Isabelle Lacroix, Geneviève Durrieu, Jean-Michel Du Plantier, Haleh Bagheri, Agnès Sommet, Christine Damase-Michel
No abstract text is available yet for this article.
January 14, 2019: Thérapie
https://read.qxmd.com/read/30704766/interest-of-pharmacoepidemiology-in-pharmacovigilance-post-authorization-safety-studies-in-regulatory-pharmacovigilance-activity
#10
Malak Abou Taam, Claire Ferard, Pauline Rocle, Patrick Maison
During the past few decades, it has been stated that a paradigm shift has occurred in the assessment and management of patient related drug safety. Some of these changes have resulted in a significant increase in the importance of pharmacoepidemiology and its use in pharmacovigilance. For European member states, the Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols and results of imposed and non-imposed post-authorization safety studies (PASS). Between 2013 and 2017, the total number of PASS during this 5-years period of the different products, including protocols and results, was 1062...
January 9, 2019: Thérapie
https://read.qxmd.com/read/30678847/interest-of-pharmacoepidemiology-for-the-study-of-antibiotic-drugs
#11
Agnès Sommet
Antibiotics (ABs) exposure of population is known as the main driving force for the emergence and spread of bacterial resistance in the community. Pharmacoepidemiology is the study of interactions between drugs and human populations, investigating, in real conditions of life, benefits, risks and use of drugs. Thus, pharmacoepidemiology is particularly of interest to monitor ABs use in both hospital and community settings. This can help to better understanding determinants of ABs use and to evaluate their impact...
January 9, 2019: Thérapie
https://read.qxmd.com/read/30665738/interferon-%C3%AE-induced-acute-pancreatitis-about-two-cases-with-literature-review
#12
LETTER
Imen Aouinti, Imen Hamza, Ons Charfi, Ghozlane Lakhoua, Sihem El Aidli, Riadh Daghfous, Ahmed Zaiem, Sarrah Kastalli
No abstract text is available yet for this article.
January 2, 2019: Thérapie
https://read.qxmd.com/read/30661720/-guillain-barr%C3%A3-syndrome-to-meningococcal-conjugate-vaccine-menveo-%C3%A2
#13
LETTER
Badreddine Moukafih, Zineb Lachhab, Youssef Moutaouakkil, Hicham Fettah, Aziz Ahizoune, Yasmina Tadlaoui, Ahmed Bennana, Jamal Lamsaouri, Yassir Bousliman
No abstract text is available yet for this article.
January 1, 2019: Thérapie
https://read.qxmd.com/read/30683444/experimentation-to-favor-innovation-promoting-the-success-of-article-51-transformation-projects
#14
Adeline Townsend, Hervé de Trogoff, Karine Szwarcensztein
Article 51 of the French social security financing act for 2018 creates a derogatory funding system to support experimentation with new ways of organizing care pathways. The growing interest local leaders have expressed for this very open framework has led to a large number of candidate projects presented to public authorities in charge of the system. In order to sustain this dynamic movement and favor the success of these experimental projects, our work focused on clarifying the roles and responsibilities of project leaders and the need for a specific evaluation system that takes into account the evolving nature of these projects and the need for operational adaptability...
December 21, 2018: Thérapie
https://read.qxmd.com/read/30638855/the-contribution-of-genomics-in-the-medicine-of-tomorrow-clinical-applications-and-issues
#15
Bruno Laviolle, Patrice Denèfle, François Gueyffier
Fifteen years after the completion of first human genome sequencing, the technique is almost a commodity but there is still little evidence of its usefulness as a diagnostic, prognostic or therapeutic tool. In France, the France genomics plan 2025 was launched in 2015 with the goal of integrating genomic tests into clinical practice and developing a National genomics network including industrial partnerships. Reflection on scientific applications and operational or societal issues is needed to make recommendations to help better associate Genomics and the medicine of tomorrow...
December 21, 2018: Thérapie
https://read.qxmd.com/read/30660377/how-to-improve-vaccine-acceptability-evaluation-pharmacovigilance-communication-public-health-mandatory-vaccination-fears-and-beliefs
#16
Alain Dutilleul, Jacques Morel, Clémentine Shilte, Odile Launay
A flagship recommendation of the citizen's steering committee on immunization, the mandatory immunization for infants extended to 11 vaccines, introduced in January 2018, is part of a set of recommendations that must be considered as a whole, each component being indispensable to the achievement of objectives: restore confidence in vaccination and increase immunization coverage. Roundtable # 6 participants identified a decade of concrete initiatives that could address, at least in part, the committee's recommendations, including: developing information systems and data generation; simplify the vaccination journey and increase vaccination opportunities; developing training of health professionals; learning vaccines at school; using motivational interviewing in educational intervention; undertaking local initiatives; improving supply and communicate on the value of vaccines...
December 20, 2018: Thérapie
https://read.qxmd.com/read/30642661/how-the-new-european-data-protection-regulation-affects-clinical-research-and-recommendations
#17
Jacques Demotes-Mainard, Catherine Cornu, Aurélie Guérin
Clinical research on human subjects or their data is confronted with conflicting requirements with, on one hand, the principle of open science (transparency and data sharing), the possibilities offered by big data and the reuse of healthcare or research data, and on the other, changes to the regulatory and legislative framework, including the general data protection regulation (GDPR). A roundtable was organized in Giens, France in October 2018 to identify problem areas, the need for clarification and streamlining, and to make recommendations to promote clinical research while ensuring a high level of patient protection...
December 20, 2018: Thérapie
https://read.qxmd.com/read/30616902/apport-de-la-g%C3%A3-nomique-dans-la-m%C3%A3-decine-de-demain-applications-cliniques-et-enjeux
#18
Bruno Laviolle, Olivier Perche, François Gueyffier
No abstract text is available yet for this article.
December 16, 2018: Thérapie
https://read.qxmd.com/read/30745156/early-access-to-health-products-in-france-major-advances-of-the-french-conseil-strat%C3%A3-gique-des-industries-de-sant%C3%A3-csis-to-be-implemented-modalities-regulations-funding
#19
Nicolas Albin, Frédéric Chassagnol, Jean-François Bergmann
In a context of perpetual evolution of treatments, access to therapeutic innovation is a major challenge for patients and the various players involved in the procedures of access to medicines. The revolutions in genomic and personalized medicine, artificial intelligence and biotechnology will transform the medicine of tomorrow and the organization of our health system. It is therefore fundamental that France prepares for these changes and supports the development of its companies in these new areas. The recent "Conseil stratégique des industries de santé" launched by Matignon makes it possible to propose a regulatory arsenal conducive to the implementation and diffusion of therapeutic innovations...
December 13, 2018: Thérapie
https://read.qxmd.com/read/30686640/-artificial-intelligence-which-services-which-applications-which-results-and-which-development-today-in-clinical-research-which-impact-on-the-quality-of-care-which-recommendations
#20
Vincent Diebolt, Isaac Azancot, François-Henri Boissel
Artificial intelligence (AI), beyond the concrete applications that have already become part of our daily lives, makes it possible to process numerous and heterogeneous data and knowledge, and to understand potentially complex and abstract rules in a manner human intelligence can but without human intervention. AI combines two properties, self-learning by the successive and repetitive processing of data as well as the capacity to adapt, that is to say the possibility for a scripted program to deal with multiple situations likely to vary over time...
December 13, 2018: Thérapie
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