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https://www.readbyqxmd.com/read/28521923/safety-and-efficacy-of-transcatheter-aortic-valve-replacement-in-the-treatment-of-pure-aortic-regurgitation-in-native-valves-and-failing-surgical-bioprostheses-results-from-an-international-registry-study
#1
Fadi J Sawaya, Marcus-André Deutsch, Moritz Seiffert, Sung-Han Yoon, Pablo Codner, Upul Wickramarachchi, Azeem Latib, A Sonia Petronio, Josep Rodés-Cabau, Maurizio Taramasso, Marco Spaziano, Johan Bosmans, Luigi Biasco, Darren Mylotte, Mikko Savontaus, Peter Gheeraert, Jason Chan, Troels H Jørgensen, Horst Sievert, Marco Mocetti, Thierry Lefèvre, Francesco Maisano, Antonio Mangieri, David Hildick-Smith, Ran Kornowski, Raj Makkar, Sabine Bleiziffer, Lars Søndergaard, Ole De Backer
OBJECTIVES: The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR). BACKGROUND: Limited data are available about the "off-label" use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR. METHODS: The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers...
May 22, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28515706/research-priorities-in-limb-and-task-specific-dystonias
#2
REVIEW
Sarah Pirio Richardson, Eckart Altenmüller, Katharine Alter, Ron L Alterman, Robert Chen, Steven Frucht, Shinichi Furuya, Joseph Jankovic, H A Jinnah, Teresa J Kimberley, Codrin Lungu, Joel S Perlmutter, Cecília N Prudente, Mark Hallett
Dystonia, which causes intermittent or sustained abnormal postures and movements, can present in a focal or a generalized manner. In the limbs, focal dystonia can occur in either the upper or lower limbs and may be task-specific causing abnormal motor performance for only a specific task, such as in writer's cramp, runner's dystonia, or musician's dystonia. Focal limb dystonia can be non-task-specific and may, in some circumstances, be associated with parkinsonian disorders. The true prevalence of focal limb dystonia is not known and is likely currently underestimated, leaving a knowledge gap and an opportunity for future research...
2017: Frontiers in Neurology
https://www.readbyqxmd.com/read/28515503/drug-monographs-olaratumab-and-rucaparib
#3
Dominic A Solimando, J Aubrey Waddell
The complexity of cancer chemotherapy requires pharmacists be familiar with the complicated regimens and highly toxic agents used. This column reviews various issues related to preparation, dispensing, and administration of antineoplastic therapy, and the agents, both commercially available and investigational, used to treat malignant diseases. Questions or suggestions for topics should be addressed to Dominic A. Solimando, Jr, President, Oncology Pharmacy Services, Inc., 4201 Wilson Blvd #110-545, Arlington, VA 22203, e-mail: OncRxSvc@comcast...
April 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28511545/fosfomycin-tromethamine-for-the-treatment-of-cystitis-in-abdominal-solid-organ-transplant-recipients-with-renal-dysfunction
#4
Luiza Kerstenetzky, Margaret R Jorgenson, Jillian L Descourouez, Glen Leverson, Warren E Rose, Robert R Redfield, Jeannina A Smith
BACKGROUND: Urinary tract infection (UTI) after abdominal solid organ transplantation (SOT) is associated with significant morbidity and mortality. Fosfomycin tromethamine (FOS), a uroselective antibiotic, is FDA approved for uncomplicated UTIs in women and is used off-label for complicated UTIs and prostatitis in men. Literature supporting the use of FOS in the SOT population is limited, and efficacy is questioned in the setting of renal dysfunction. OBJECTIVE: To evaluate the success of FOS for the treatment of cystitis in SOT patients with renal dysfunction...
May 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28510298/drugs-for-children
#5
S Ito
The "Therapeutic Orphan" status of children is gradually improving, but our efforts to eliminate off-label/off-evidence use must be sustained for safer and more effective pediatric drug therapy. This is even more important in resource-scarce settings, because of the increasing child population in those regions. The juncture of pediatric pharmacology and global child health represents an emerging field of clinical pharmacology illuminating a crucial societal need on a global scale.
June 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28508222/lassa-virus-reverse-genetics
#6
Luis Martínez-Sobrido, Slobodan Paessler, Juan Carlos de la Torre
The Old World (OW) arenavirus Lassa (LASV ) is estimated to infect several hundred thousand people yearly in West Africa, resulting in high numbers of Lassa fever (LF), a viral hemorrhagic fever (HF) disease associated with high morbidity and mortality. To date, no licensed vaccines are available to LASV infections, and anti-LASV drug therapy is limited to an off-label use of ribavirin (Rib) that is only partially effective. The development of reverse genetics has provided investigators with a novel and powerful approach for the investigation of the molecular, cell biology, and pathogenesis of LASV...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28508096/-off-label-biologic-therapy-of-anca-associated-and-non-anca-associated-small-vessel-vasculitis-efficacy-and-safety-analysis-of-a-national-registry-graid2
#7
N Venhoff, F Proft, H Schulze-Koops, J Holle, R E Voll, C Iking-Konert, A M Jacobi, J Henes, L Unger, O Kneitz, T Dörner, J Thiel
OBJECTIVE: To evaluate the clinical efficacy and safety of off-label biological therapies in patients with ANCA-associated vasculitis (AAV) and non-ANCA-associated small-vessel vasculitis (nAAV) in clinical practice. METHODS: The German Registry in Autoimmune Diseases 2 (GRAID2) is a national, retrospective, non-interventional, multicentre observational study (August 2006 until December 2013) on patients with autoimmune diseases refractory to standard immunosuppressive therapy treated with off-label biologicals...
May 15, 2017: Zeitschrift Für Rheumatologie
https://www.readbyqxmd.com/read/28504901/tale-of-two-erythropoiesis-stimulating-agents-utilization-dosing-litigation-and-costs-of-darbepoetin-and-epoetin-among-south-carolina-medicaid-covered-patients-with-cancer-and-chemotherapy-induced-anemia
#8
Virginia Noxon, Kevin B Knopf, LeAnn B Norris, Brian Chen, Y Tony Yang, Zaina P Qureshi, William Hrushesky, Akida A Lebby, Benjamin Schooley, Neset Hikmet, Michael Dickson, Mae Thamer, Dennis Cotter, Paul R Yarnold, Charles L Bennett
PURPOSE: The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and weekly, respectively, although off-label, less frequent scheduling was common. In 2004, 2007, and 2008, a US Food and Drug Administration Advisory Committees warned of risks associated with erythropoiesis-stimulating agents. During this period, lawsuits alleging illegal darbepoetin marketing practices have concluded, resulting in $1...
May 15, 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28501350/first-in-man-prolonged-pressure-controlled-intermittent-coronary-sinus-occlusion-to-treat-refractory-left-ventricular-dysfunction-and-ischemia-with-patent-epicardial-coronary-arteries
#9
Federico Pappalardo, Marco B Ancona, Francesco Giannini, Damiano Regazzoli, Antonio Mangieri, Matteo Montorfano, Michele De Bonis, Ottavio Alfieri, Alberto Zangrillo, Anna Mara Scandroglio, Antonio Colombo, Azeem Latib
AIMS: Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) intermittently increases the pressure in the cardiac venous outflow tract using a balloon-tipped catheter introduced percutaneously into the coronary sinus. It aims to improve microvascular perfusion in STEMI patients during PCI, thus improving infarct healing. Its successful administration was associated with an improvement in myocardial recovery four months after primary-PCI as compared to control. However, it has never been used in other settings or for a prolonged period...
May 9, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28498553/fundamentals-of-clinical-pharmacology-with-application-for-pregnant-women
#10
REVIEW
Avinash S Patil, Jessica Sheng, Sarah K Dotters-Katz, Maria S Schmoll, Mitchell Onslow, Rebecca C Pierson
Medication use is common in pregnancy, yet for most medications the optimal formulation and dosage have not been described specifically for pregnant women. Often, adverse effects are only discovered anecdotally or after extensive off-label use occurs. Since pharmacologic research that includes pregnant women is sparse and animal studies are often not applicable to the human fetus, providers must use knowledge of drug behavior and normal physiologic changes of pregnancy to personalize treatment for pregnant women...
May 12, 2017: Journal of Midwifery & Women's Health
https://www.readbyqxmd.com/read/28495944/what-does-the-boxed-warning-tell-us-safe-practice-of-using-ferumoxytol-as-an-mri-contrast-agent
#11
C G Varallyay, G B Toth, R Fu, J P Netto, J Firkins, P Ambady, E A Neuwelt
BACKGROUND AND PURPOSE: Despite the label change and the FDA's boxed warning added to the Feraheme (ferumoxytol) label in March 2015, radiologists have shown increasing interest in using ferumoxytol as an MR imaging contrast agent as a supplement or alternative to gadolinium. The goals of this study were to provide information regarding ferumoxytol safety as an imaging agent in a single center and to assess how the Feraheme label change may affect this potential, currently off-label indication...
May 11, 2017: AJNR. American Journal of Neuroradiology
https://www.readbyqxmd.com/read/28494776/aggregated-n-of-1-trials-for-unlicensed-medicines-for-small-populations-an-assessment-of-a-trial-with-ephedrine-for-myasthenia-gravis
#12
Stephanie S Weinreich, Charlotte Vrinten, Marja R Kuijpers, Alexander F Lipka, Kirsten J M Schimmel, Erik W van Zwet, Christine Gispen-de Wied, Yechiel A Hekster, Jan J G M Verschuuren, Martina C Cornel
BACKGROUND: Inexpensive medicines with a long history of use may currently be prescribed off-label for rare indications. Reimbursement is at the discretion of health insurance companies, and may be unpredictable. The example addressed was ephedrine as add-on treatment for myasthenia gravis. Stakeholders from academia, a patient organization, the Dutch National Health Care Institute (NHCI) and Dutch Medicines Evaluation Board (MEB) advised on the trial design. The NHCI and MEB agreed to provide scientific advice on the suitability of the evidence generated by the trial, for regulatory decisions...
May 12, 2017: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/28493231/-drug-therapy-of-fibromyalgia-syndrome-updated-guidelines-2017-and-overview-of-systematic-review-articles
#13
C Sommer, R Alten, K-J Bär, M Bernateck, W Brückle, E Friedel, P Henningsen, F Petzke, T Tölle, N Üçeyler, A Winkelmann, W Häuser
BACKGROUND: The regular update of the guidelines on fibromyalgia syndrome, AWMF number 145/004, was scheduled for April 2017. METHODS: The guidelines were developed by 13 scientific societies and 2 patient self-help organizations coordinated by the German Pain Society. Working groups (n =8) with a total of 42 members were formed balanced with respect to gender, medical expertise, position in the medical or scientific hierarchy and potential conflicts of interest...
May 10, 2017: Der Schmerz
https://www.readbyqxmd.com/read/28492910/effect-of-bevacizumab-vs-aflibercept-on-visual-acuity-among-patients-with-macular-edema-due-to-central-retinal-vein-occlusion-the-score2-randomized-clinical-trial
#14
Ingrid U Scott, Paul C VanVeldhuisen, Michael S Ip, Barbara A Blodi, Neal L Oden, Carl C Awh, Derek Y Kunimoto, Dennis M Marcus, John J Wroblewski, Jacqueline King
Importance: Studies have established the efficacy and safety of aflibercept for the treatment of macular edema due to central retinal vein occlusion. Bevacizumab is used off-label to treat this condition despite the absence of supporting data. Objective: To investigate whether bevacizumab is noninferior to aflibercept for the treatment of macular edema secondary to central retinal or hemiretinal vein occlusion. Design, Setting, and Participants: The SCORE2 randomized noninferiority clinical trial was conducted at 66 private practice or academic centers in the United States, and included 362 patients with macular edema due to central retinal or hemiretinal vein occlusion who were randomized 1:1 to receive aflibercept or bevacizumab...
May 9, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28491276/antiangiogenic-effects-in-patients-with-progressive-desmoplastic-small-round-cell-tumor-data-from-the-french-national-registry-dedicated-to-the-use-of-off-labeled-targeted-therapy-in-sarcoma-outc-s
#15
Sarah Bétrian, Christophe Bergeron, Jean-Yves Blay, Emmanuelle Bompas, Philippe A Cassier, Laure Chevallier, Jérome Fayette, Magali Girodet, Cécile Guillemet, Axel Le Cesne, Perrine Marec-Berard, Isabelle Ray-Coquard, Christine Chevreau
BACKGROUND: Desmoplastic small round cell tumor (DSRCT) is a very rare mesenchymal tumor that mainly affects teenagers and young adults with a mean age at diagnosis around 20-25 years. Although initial management still needs standardization, many centers will use multimodal treatment including intensive chemotherapy, extensive surgical resection followed by radiotherapy. Despite this, prognosis remains very poor and the median overall survival is 25 months. Recurrent disease is mainly treated by chemotherapy...
2017: Clinical Sarcoma Research
https://www.readbyqxmd.com/read/28491214/prescribing-pattern-of-psychotropic-medications-in-child-psychiatric-practice-in-a-mental-referral-hospital-in-botswana
#16
Anthony Olashore, James Ayugi, Philip Opondo
INTRODUCTION: There is a growing preference for psycho-pharmacological therapy over non-pharmacological care. The prescription pattern and the choice of psychotropic medications vary in different settings. Whilst newer agents and rational prescribing are favored in the more specialized settings, the pattern remains unclear in less specialized units, largely due to lack of data. The aims were to conduct a treatment audit in the only mental referral hospital in Botswana, which is a non-specialized child and adolescent care setting and see how it conforms to best practice...
2017: Pan African Medical Journal
https://www.readbyqxmd.com/read/28490912/update-on-the-treatment-of-narcolepsy-clinical-efficacy-of-pitolisant
#17
REVIEW
Michael W Calik
Narcolepsy is a neurological disease that affects 1 in 2,000 individuals and is characterized by excessive daytime sleepiness (EDS). In 60-70% of individuals with narcolepsy, it is also characterized by cataplexy or a sudden loss of muscle tone that is triggered by positive or negative emotions. Narcolepsy decreases the quality of life of the afflicted individuals. Currently used drugs treat EDS alone (modafinil/armodafinil, methylphenidate, and amphetamine), cataplexy alone ("off-label" use of antidepressants), or both EDS and cataplexy (sodium oxybate)...
2017: Nature and Science of Sleep
https://www.readbyqxmd.com/read/28490005/opposing-effects-of-valproic-acid-treatment-mediated-by-histone-deacetylase-inhibitor-activity-in-four-transgenic-x-laevis-models-of-retinitis-pigmentosa
#18
Ruanne Y J Vent-Schmidt, Runxia H Wen, Zusheng Zong, Colette N Chiu, Beatrice M Tam, Christopher G May, Orson L Moritz
Retinitis pigmentosa (RP) is an inherited retinal degeneration (RD) that leads to blindness for which no treatment is available. RP is frequently caused by mutations in Rhodopsin; in some animal models, RD is exacerbated by light. Valproic acid (VPA) is a proposed treatment for RP and other neurodegenerative disorders, with a phase II trial for RP under way. However, the therapeutic mechanism is unclear, with minimal research supporting its use in RP. We investigated the effects of VPA on Xenopus laevis models of RP expressing human P23H, T17M, T4K, and Q344ter rhodopsins, which are associated with RP in humans...
January 25, 2017: Journal of Neuroscience: the Official Journal of the Society for Neuroscience
https://www.readbyqxmd.com/read/28487867/non-ischemic-cardiomyopathy-after-rituximab-treatment-for-membranous-nephropathy
#19
Wisit Cheungpasitporn, Stephen L Kopecky, Ulrich Specks, Kharmen Bharucha, Fernando C Fervenza
Rituximab is an anti-CD20 monoclonal antibody frequently used for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and anti-neutrophilic cytoplasmic antibody (ANCA)-associated vasculitis. In addition, rituximab has recently been increasingly used as an off-label treatment in a number of inflammatory and systemic autoimmune diseases. It is advised that rituximab infusion may cause infusion reactions and adverse cardiac effects including arrhythmia and angina, especially in patients with prior history of cardiovascular diseases...
2017: Journal of Renal Injury Prevention
https://www.readbyqxmd.com/read/28486841/accuracy-of-a-cgm-sensor-in-pediatric-subjects-with-type-1-diabetes-comparison-of-three-insertion-sites-arm-abdomen-and-gluteus
#20
Simone Faccioli, Simone Del Favero, Roberto Visentin, Riccardo Bonfanti, Dario Iafusco, Ivana Rabbone, Marco Marigliano, Riccardo Schiaffini, Daniela Bruttomesso, Claudio Cobelli
BACKGROUND: Patients with diabetes, especially pediatric ones, sometimes use continuous glucose monitoring (CGM) sensor in different positions from the approved ones. Here we compare the accuracy of Dexcom® G5 CGM sensor in three different sites: abdomen, gluteus (both approved) and arm (off-label). METHOD: Thirty youths, 5-9 years old, with type 1 diabetes (T1D) wore the sensor during a clinical trial where frequent self-monitoring of blood glucose (SMBG) measurements were obtained...
May 1, 2017: Journal of Diabetes Science and Technology
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