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https://www.readbyqxmd.com/read/28735357/promoting-and-protecting-public-health-how-the-european-union-pharmacovigilance-system-works
#1
Aniello Santoro, Georgy Genov, Almath Spooner, June Raine, Peter Arlett
This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks...
July 22, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28735109/design-and-rationale-for-a-real-world-observational-cohort-of-patients-with-nonalcoholic-fatty-liver-disease-the-target-nash-study
#2
A Sidney Barritt, Norman Gitlin, Samuel Klein, Anna S Lok, Rohit Loomba, Laura Malahias, Margaret Powell, Miriam B Vos, L Michael Weiss, Kenneth Cusi, Brent A Neuschwander-Tetri, Arun Sanyal
Nonalcoholic fatty liver disease (NAFLD) is highly prevalent and can lead to cirrhosis, hepatocellular carcinoma, and end-stage liver disease. NAFLD comprises the spectrum from simple steatosis (nonalcoholic fatty liver, NAFL), to steatosis with inflammation (nonalcoholic steatohepatitis, NASH). Current primary therapy recommended for NAFLD is weight loss induced by lifestyle modification. The difficulty in achieving this has led to robust pharmacological therapy development. While new drugs may show efficacy in selected phase II/III clinical trial populations, their real-world effectiveness is unknown...
July 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28735014/initial-clinical-experience-with-testosterone-undecanoate-therapy-aveed-%C3%A2-in-testosterone-deficient-men-in-the-united-states
#3
Abraham Morgentaler, Yonah Krakowsky, William Conners, Emily Davidson, Alex Rawji
OBJECTIVE: To report our initial experiences with TU 750mg in testosterone-deficient men. METHODS: All patients receiving TU 750mg at our center between July 1 2014 to August 1 2016 were identified. Clinical response was assessed via structured interviews and laboratory evaluations. Adverse events were documented, including increases in prostate specific antigen (PSA), hematocrit (Hct), and the development of post-injection cough. RESULTS: More than two injections were received by 147 men, with mean age 63...
July 19, 2017: Urology
https://www.readbyqxmd.com/read/28734880/dual-versus-single-antiplatelet-regimen-with-or-without-anticoagulation-in-transcatheter-aortic-valve-replacement-indirect-comparison-and-meta-analysis
#4
Monica Verdoia, Lucia Barbieri, Matteo Nardin, Harry Suryapranata, Giuseppe De Luca
INTRODUCTION AND OBJECTIVES: There is uncertainty on the correct management of antithrombotic therapies after transcatheter aortic valve replacement (TAVR), with dual antiplatelet therapy (DAPT) being currently recommended on an empirical basis. The aim of the present meta-analysis was to assess the safety and effectiveness of DAPT in patients undergoing TAVR. METHODS: Studies comparing different antithrombotic regimens after TAVR were included. The primary endpoint was 30-day overall mortality...
July 19, 2017: Revista Española de Cardiología
https://www.readbyqxmd.com/read/28734860/the-expanding-field-of-biologics-in-the-management-of-chronic-urticaria
#5
Shyam Joshi, David A Khan
Chronic urticaria (CU) is the occurrence of urticaria with or without angioedema for at least 6 weeks. Management has traditionally involved antihistamines as first-line therapy with various alternative therapies for refractory cases. Largely based on the success of biologics for various diseases, this class of drugs has come to the forefront of medical research. The first and only Food and Drug Administration-approved biologic for the management of CU is omalizumab (humanized anti-IgE mAb). In the past decade, a substantial amount of research has been centered on the mechanism of action, efficacy, dosing, and safety of omalizumab...
July 19, 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/28734773/epico-4-0-total-quality-in-the-management-of-invasive-candidiasis-in-critically-ill-patients-by-analysing-the-integrated-process
#6
Rafael Zaragoza, Ricard Ferrer, Pedro Llinares, Emilio Maseda, Alejandro Rodríguez, Santiago Grau, Guillermo Quindós
BACKGROUND: A high quality integrated process in the clinical setting of non-neutropenic critically ill patients at risk for invasive candidiasis is a necessary tool to improve the management of these patients. AIMS: To identify the key points on invasive candidiasis in order to develop a set of recommendations with a high level of consensus required for the creation of a total quality integrated process for the management of non-neutropenic critically ill patients at risk of invasive candidiasis...
July 19, 2017: Revista Iberoamericana de Micología
https://www.readbyqxmd.com/read/28734727/treatment-of-pharyngotympanic-tube-dysfunction
#7
REVIEW
Holger H Sudhoff, Stefan Mueller
Eustachian tube dysfuntion intends to describe a variety of signs, symptoms, and physical findings that result from the impairment of ET function. A large variety of methods have been employed to assess ET function in the literature. Due to the lack of high level evidence, it is difficult to draw conclusions on the effectiveness of medical and surgical treatments. There are various medical and surgical interventions available for chronic obstructive ET dysfunction including balloon Eustachian tuboplasty (BET) and laser or microdebrider tuboplasty...
July 19, 2017: Auris, Nasus, Larynx
https://www.readbyqxmd.com/read/28734706/emerging-minimally-invasive-treatment-options-for-male-lower-urinary-tract-symptoms
#8
REVIEW
Giuseppe Magistro, Christopher R Chapple, Mostafa Elhilali, Peter Gilling, Kevin T McVary, Claus G Roehrborn, Christian G Stief, Henry H Woo, Christian Gratzke
CONTEXT: Lower urinary tract symptoms (LUTS) are one of the most common and troublesome nonmalignant conditions affecting quality of life in aging men. A spectrum of established medical and surgical options is available to provide relief of bothersome LUTS. Both the adverse events of medication and the morbidity with surgical treatment modalities have to be counterbalanced against efficacy. Novel minimally invasive treatment options aim to be effective, ideally to be performed in an ambulatory setting under local anaesthesia and to offer a more favourable safety profile than existing reference techniques...
July 19, 2017: European Urology
https://www.readbyqxmd.com/read/28733910/a-review-study-to-evaluate-holmium-yag-laser-lithotripsy-with-flexible-ureteroscopy-in-patients-on-ongoing-oral-anticoagulant-therapy
#9
Bulent Altay, Bulent Erkurt, Selami Albayrak
The objective of this study was to evaluate the safety and efficacy of flexible ureteroscopy (FURS) and holmium:YAG laser lithotripsy for the treatment of upper urinary tract stones in patients on active oral anticoagulants. The records of 1081 patients who underwent flexible ureteroscopic holmium:YAG (Ho:YAG) laser lithotripsy for upper ureteral and renal calculi from 1999 to 2015 were retrospectively reviewed. A total of 84 patients on continuous oral anticoagulation or antiplatelet therapy (warfarin, aspirin, or clopidogrel) were identified...
July 22, 2017: Lasers in Medical Science
https://www.readbyqxmd.com/read/28733378/is-it-time-to-change-the-type-2-diabetes-treatment-paradigm-no-metformin-should-remain-the-foundation-therapy-for-type-2-diabetes
#10
Silvio E Inzucchi
Most treatment guidelines, including those from the American Diabetes Association/European Association for the Study of Diabetes and the International Diabetes Federation, suggest metformin be used as the first-line therapy after diet and exercise. This recommendation is based on the considerable body of evidence that has accumulated over the last 30 years, but it is also supported on clinical grounds based on metformin's affordability and tolerability. As such, metformin is the most commonly used oral antihyperglycemic agent in the U...
August 2017: Diabetes Care
https://www.readbyqxmd.com/read/28733377/is-it-time-to-change-the-type-2-diabetes-treatment-paradigm-yes-glp-1-ras-should-replace-metformin-in-the-type-2-diabetes-algorithm
#11
Muhammad Abdul-Ghani, Ralph A DeFronzo
Most treatment guidelines, including those from the American Diabetes Association/European Association for the Study of Diabetes and the International Diabetes Federation, suggest metformin be used as the first-line therapy after diet and exercise. This recommendation is based on the considerable body of evidence that has accumulated over the last 30 years, but it is also supported on clinical grounds based on metformin's affordability and tolerability. As such, metformin is the most commonly used oral antihyperglycemic agent in the U...
August 2017: Diabetes Care
https://www.readbyqxmd.com/read/28732252/update-on-medical-treatment-of-uterine-fibroids
#12
REVIEW
Fátima Faustino, Margarida Martinho, José Reis, Fernanda Águas
OBJECTIVES: In this review paper, the pros and cons of the available pharmacological options for the treatment of uterine fibroids are explored, including oral progestogens, levonorgestrel intra-uterine device, gonadotropin-releasing hormone analogs and progesterone receptor modulators with an emphasis on ulipristal acetate. STUDY DESIGN: The choice of the appropriate therapeutic approach for uterine fibroids depends on several factors, including women's age, parity, childbearing aspirations and wish to preserve fertility, extent and severity of symptoms, size, number and location of myomas, risk of malignancy and proximity to menopause...
July 8, 2017: European Journal of Obstetrics, Gynecology, and Reproductive Biology
https://www.readbyqxmd.com/read/28731833/the-dishwater-menace-and-the-compromising-solution-healthy-drinking-spaces-and-the-public-good-in-post-prohibition-ontario
#13
Dan Malleck
This paper examines inter-bureaucracy tension, negotiation, and resolution in the case of the oversight of beverage room sanitation in Ontario in the 1930s and 1940s. Both the Liquor Control Board of Ontario (LCBO) and various public health authorities claimed authority over the health status of public drinking spaces. But the LCBO had legislative priority. The ensuing debates regarding health and cleanliness linked issues of beverage room glass sanitation to a biopolitical approach to public drinking. Developing a more scientifically sophisticated approach to beverage glass cleaning required a balancing of administrative priorities...
July 21, 2017: Canadian Bulletin of Medical History, Bulletin Canadien D'histoire de la Médecine
https://www.readbyqxmd.com/read/28731777/induction-and-maintenance-adjuvant-mitomycin-c-topical-therapy-for-upper-tract-urothelial-carcinoma-tolerability-and-intermediate-term-outcomes
#14
Michael Metcalfe, Gavin Wagenheim, Lianchun Xiao, John Papadopoulos, Neema Navai, John W Davis, Jose A Karam, Ashish M Kamat, Christopher G Wood, Colin P Dinney, Surena F Matin
PURPOSE: Endoscopic management of upper tract urothelial carcinoma (UTUC) is associated with higher recurrences, which could be reduced by application of topical therapy. Adjuvant induction Bacillus Calmette-Guerin has shown inferior outcomes for UTUC compared to bladder cancer, and maintenance regimens for UTUC are unexplored. We report on the efficacy, safety, and tolerability of Mitomycin C (MMC) induction and maintenance adjuvant topical therapy for UTUC. MATERIALS AND METHODS: Patients with UTUC who received adjuvant topical therapy after complete endoscopic control of Ta/T1 tumors were retrospectively reviewed...
July 21, 2017: Journal of Endourology
https://www.readbyqxmd.com/read/28731509/keeping-safe-continuous-glucose-monitoring-cgm-in-persons-with-type-1-diabetes-and-impaired-awareness-of-hypoglycaemia-a-qualitative-study
#15
A F Vloemans, C A J van Beers, M de Wit, W Cleijne, S M Rondags, P H Geelhoed-Duijvestijn, M H H Kramer, E H Serné, F J Snoek
AIM: To further our understanding of individual use and experience of continuous glucose monitoring (CGM) in adults with Type 1 diabetes and impaired awareness of hypoglycaemia, we conducted a qualitative study supplementary to a randomized controlled trial, using semi-structured interviews. METHODS: Twenty-three participants of the IN CONTROL trial were interviewed within 4 weeks after the last study visit. The interview centred around experiences of CGM, taking into account the person's expectations prior to the trial...
July 21, 2017: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/28730908/electrical-stimulation-for-the-treatment-of-obstructive-sleep-apnoea-a-review-of-the-evidence
#16
Valeria Bisogni, Martino F Pengo, Andrea De Vito, Giuseppe Maiolino, Gian Paolo Rossi, John Moxham, Joerg Steier
Obstructi ve sleep apnoea is an increasingly prevalent clinical condition with significant impact on individuals and public health. Continuous positive airway pressure therapy is the standard treatment, but adherence is limited and alternative treatments are needed. In this context, non-invasive and invasive methods for the electrical stimulation of upper airway dilator muscles have been demonstrated to be effective in selected patients. Areas covered: This review will cover investigations on the clinical effects, safety, and tolerability of non-invasive and invasive electrical stimulation of the upper airway for the management of obstructive sleep apnoea...
July 21, 2017: Expert Review of Respiratory Medicine
https://www.readbyqxmd.com/read/28730853/dengue-in-the-elderly-a-review
#17
Ray Junhao Lin, Tau Hong Lee, Yee Sin Leo
Changing dengue epidemiological trends have resulted in a shift in the disease burden to the adult population. Older adults suffer from poorer outcomes as compared to their younger counterparts, making clinical management of this sub-population particularly challenging. Areas covered: We present a review of the current literature on the changing epidemiology of dengue in the elderly, the atypical features of the clinical disease in this population with emphasis on severe disease presentations and challenges in the current management strategies...
July 21, 2017: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/28730735/effectiveness-safety-and-comfort-of-statlock-securement-for-peripherally-inserted-central-catheters-a-systematic-review-and-meta-analysis
#18
REVIEW
Xianwu Luo, Yi Guo, Huidan Yu, Sheng Li, Xiaohong Yin
In this systematic review and meta-analysis, we evaluated the effectiveness, safety and comfort of StatLock for the securement of peripherally-inserted central catheters. PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, WanFang Database, and China Science and Technology Journal Database were searched. Randomized, controlled trials comparing StatLock with tape or suture on the performance of securing peripherally-inserted central catheters were selected. Meta-analysis was performed using Review Manager 5...
July 21, 2017: Nursing & Health Sciences
https://www.readbyqxmd.com/read/28730562/therapeutical-approaches-to-paroxysmal-hemicrania-hemicrania-continua-and-short-lasting-unilateral-neuralgiform-headache-attacks-a-critical-appraisal
#19
Carlo Baraldi, Lanfranco Pellesi, Simona Guerzoni, Maria Michela Cainazzo, Luigi Alberto Pini
BACKGROUND: Hemicrania continua (HC), paroxysmal hemicrania (PH) and short lasting neuralgiform headache attacks (SUNCT and SUNA) are rare syndromes with a difficult therapeutic approach. The aim of this review is to summarize all articles dealing with treatments for HC, PH, SUNCT and SUNA, comparing them in terms of effectiveness and safety. METHODS: A survey was performed using the pubmed database for documents published from the 1st January 1989 onwards. All types of articles were considered, those ones dealing with symptomatic cases and non-English written ones were excluded...
December 2017: Journal of Headache and Pain
https://www.readbyqxmd.com/read/28730368/safety-of-cold-polypectomy-for-small-colorectal-neoplastic-lesions-a-prospective-cohort-study-in-japan
#20
Yuichi Shimodate, Motowo Mizuno, Rio Takezawa, Mami Kobayashi, Tatsuhiro Yamazaki, Akira Doi, Naoyuki Nishimura, Hirokazu Mouri, Kazuhiro Matsueda, Hiroshi Yamamoto
BACKGROUND: Cold polypectomy has been widely accepted for removal of small colorectal polyps. However, no large-scale prospective study exists as for its safety in Japan. We investigated this issue in this single-center, prospective cohort study in a total of 1198 colorectal polyps resected with cold polypectomy. PATIENTS AND METHODS: Four hundred and seventy-four patients who underwent cold polypectomy for colorectal neoplastic lesions less than 10-mm diameter between September 2014 and October 2016 were enrolled...
July 20, 2017: International Journal of Colorectal Disease
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