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https://www.readbyqxmd.com/read/28337673/progression-free-survival-as-a-surrogate-for-overall-survival-in-clinical-trials-of-targeted-therapy-in-advanced-solid-tumors
#1
Stefan Michiels, Everardo D Saad, Marc Buyse
Over the past 15 years, targeted therapy has revolutionized the systemic treatment of cancer. In parallel, there has been a growing debate on the choice of end points in clinical trials in oncology. This debate basically hinges on the choice between overall survival (OS) and progression-free survival (PFS). PFS is advantageous because it is measured earlier than OS, requires a smaller sample size than OS to achieve the desired power, and is not influenced by cross-over. On the other hand, PFS is prone to measurement error and bias, and may not capture the entire treatment effect on the outcomes of most interest to patients with an incurable disease: a prolonged survival and improved quality of life...
March 23, 2017: Drugs
https://www.readbyqxmd.com/read/28337672/fentanyl-formulations-in-the-management-of-pain-an-update
#2
REVIEW
Stephan A Schug, Sonya Ting
Fentanyl is a synthetic, highly selective opioid with many desirable physicochemical properties, including a high lipophilicity and predictable pharmacokinetics. These properties have an established record in the management of pain in a variety of settings, particularly acute pain and breakthrough cancer pain. Fentanyl was initially developed for parenteral use; however, this is invasive and impractical in the outpatient setting. Unfortunately, the high first-pass metabolism of fentanyl makes oral formulations unfeasible...
March 23, 2017: Drugs
https://www.readbyqxmd.com/read/28303449/novel-beta-lactamase-inhibitors-unlocking-their-potential-in-therapy
#3
Darren Wong, David van Duin
Carbapenem-resistant Enterobacteriaceae are amongst the most feared pathogens due to severely limited treatment options. In response to this threat, three novel β-lactamase inhibitors have been developed in an attempt to reinvigorate and sustain our current antimicrobial therapies. Avibactam, vaborbactam, and relebactam are inhibitor agents with high affinity to Ambler class A and C β-lactamases and favorable outcomes in current clinical trials. However, although they do possess key similarities, these agents have unique differences which may have important clinical implications...
March 16, 2017: Drugs
https://www.readbyqxmd.com/read/28293911/delta-9-tetrahydrocannabinol-cannabidiol-oromucosal-spray-sativex-%C3%A2-a-review-in-multiple-sclerosis-related-spasticity
#4
Gillian M Keating
Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (THC/CBD, Sativex(®), nabiximols) is available in numerous countries worldwide for the treatment of multiple sclerosis (MS)-related moderate to severe spasticity in patients who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. Twelve weeks' therapy with THC/CBD improved MS-related spasticity in patients with an inadequate response to other anti-spasticity agents who had undergone a successful initial trial of THC/CBD therapy, according to the results of a pivotal phase 3 trial...
March 14, 2017: Drugs
https://www.readbyqxmd.com/read/28290137/sarilumab-first-global-approval
#5
Lesley J Scott
Sarilumab (Kevzara™) is a fully human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound interleukin (IL)-6 receptors (sIL-6Rα and mIL-6Rα) and thereby inhibits IL-6-mediated signalling through these receptors. Subcutaneous sarilumab is approved in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more biological or non-biological disease-modifying anti-rheumatic drugs. It is under regulatory review for use in rheumatoid arthritis in other countries, including in the EU, USA and Japan...
March 13, 2017: Drugs
https://www.readbyqxmd.com/read/28290136/baricitinib-first-global-approval
#6
Anthony Markham
Baricitinib (Olumiant™) is an orally-administered, small-molecule, janus-associated kinase (JAK) inhibitor developed by Eli Lilly and Incyte Corporation for the treatment of rheumatoid arthritis (RA), atopic dermatitis and systemic lupus erythematosus. JAKs transduce intracellular signals from cell surface receptors for various cytokines and growth factors involved in inflammation and immune function, suggesting JAK inhibitors may be of therapeutic benefit in inflammatory conditions. In February 2017, baricitinib was approved in the EU, as monotherapy or in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs)...
March 13, 2017: Drugs
https://www.readbyqxmd.com/read/28283896/fluocinolone-acetonide-intravitreal-implant-0-19%C3%A2-mg-iluvien-%C3%A2-a-review-in-diabetic-macular-edema
#7
Yahiya Y Syed
Fluocinolone acetonide intravitreal implant 0.19 mg (ILUVIEN(®)) is a nonbiodegradable, injectable, corticosteroid implant that is approved in several countries, including the USA, for the treatment of diabetic macular edema (DME). ILUVIEN(®) releases fluocinolone acetonide at an initial rate of 0.25 µg/day (average rate 0.2 µg/day) and lasts 36 months. In the two pooled pivotal FAME trials in patients with DME previously treated with macular laser photocoagulation, fluocinolone acetonide intravitreal implant 0...
March 10, 2017: Drugs
https://www.readbyqxmd.com/read/28271302/pediatric-osteoporosis-diagnosis-and-treatment-considerations
#8
REVIEW
Edoardo Marrani, Teresa Giani, Gabriele Simonini, Rolando Cimaz
Osteoporosis is now increasingly recognized in children due to the increased prevalence of disorders associated with bone loss. Fragility fractures represent the cardinal clinical features of pediatric osteoporosis and children presenting with fragility fractures deserve an accurate assessment to rule out a secondary cause. Indeed, in the pediatric population, a low bone mass is often a consequence of a chronic disease or its treatment; genetic bone disorders represent the cause of only a small fraction of cases...
March 7, 2017: Drugs
https://www.readbyqxmd.com/read/28258517/the-language-of-biosimilars-clarification-definitions-and-regulatory-aspects
#9
REVIEW
Paul Declerck, Romano Danesi, Danielle Petersel, Ira Jacobs
Biologic therapies have revolutionized treatment of a number of diseases. Patents and exclusivity for a number of biologics are expiring. This has created the opportunity for the development and approval of biosimilars. Biosimilars are biologic products developed using a step-wise approach to result in a biologic that demonstrates no clinically meaningful differences in terms of quality attributes, efficacy, safety, and immunogenicity compared with an existing licensed, originator biologic. As more biosimilars receive regulatory approval and reach the market, it is increasingly important for healthcare providers to understand the terminology about biosimilars...
March 4, 2017: Drugs
https://www.readbyqxmd.com/read/28255962/bringing-stability-to-the-chronic-obstructive-pulmonary-disease-patient-clinical-and-pharmacological-considerations-for-frequent-exacerbators
#10
REVIEW
Swati Gulati, J Michael Wells
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are critical events associated with an accelerated loss of lung function, increased morbidity, and excess mortality. AECOPD are heterogeneous in nature and this may directly impact clinical decision making, specifically in patients with frequent exacerbations. A 'frequent exacerbator' is a sub-phenotype of chronic obstructive pulmonary disease (COPD) and is defined as an individual who experiences two or more moderate-to-severe exacerbations per year...
March 3, 2017: Drugs
https://www.readbyqxmd.com/read/28255960/jak-stat-signaling-as-a-target-for-inflammatory-and-autoimmune-diseases-current-and-future-prospects
#11
REVIEW
Shubhasree Banerjee, Ann Biehl, Massimo Gadina, Sarfaraz Hasni, Daniella M Schwartz
The Janus kinase/signal transduction and activator of transcription (JAK-STAT) signaling pathway is implicated in the pathogenesis of inflammatory and autoimmune diseases including rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Many cytokines involved in the pathogenesis of autoimmune and inflammatory diseases use JAKs and STATs to transduce intracellular signals. Mutations in JAK and STAT genes cause a number of immunodeficiency syndromes, and polymorphisms in these genes are associated with autoimmune diseases...
March 3, 2017: Drugs
https://www.readbyqxmd.com/read/28247267/options-for-treating-pain-in-cancer-patients-with-dysphagia
#12
REVIEW
Sebastiano Mercadante
Patients with chronic pain often develop dysphagia during the course of an advanced disease such as cancer. Opioids are the cornerstone of the management of cancer pain and are commonly administered orally. However, the oral route does not suit patients with dysphagia, who require alternative methods to administer analgesic drugs. Opioids given by parenteral or transdermal routes provide adequate pain control, being at least as efficacious as the oral route, but knowledge and experience in conversion ratios are mandatory when using these routes of administration...
March 1, 2017: Drugs
https://www.readbyqxmd.com/read/28247266/rucaparib-first-global-approval
#13
Yahiya Y Syed
Rucaparib (Rubraca™) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor being developed by Clovis Oncology, Inc. (Boulder, CO, USA) for the treatment of solid tumours. It has been approved in the USA as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. A marketing authorization application for rucaparib for the same indication has been submitted to the European Medicines Agency...
March 1, 2017: Drugs
https://www.readbyqxmd.com/read/28247265/erratum-to-incidence-prevention-and-management-of-anti-drug-antibodies-against-therapeutic-antibodies-in-inflammatory-bowel-disease-a-practical-overview
#14
Pieter Hindryckx, Gregor Novak, Niels Vande Casteele, Reena Khanna, Debby Laukens, Vipul Jairath, Brian G Feagan
No abstract text is available yet for this article.
March 1, 2017: Drugs
https://www.readbyqxmd.com/read/28236169/triazole-resistance-in-aspergillus-species-an-emerging-problem
#15
Rocio Garcia-Rubio, Manuel Cuenca-Estrella, Emilia Mellado
Aspergillus species are ubiquitous fungal saprophytes found in diverse ecological niches worldwide. Among them, Aspergillus fumigatus is the most prevalent and is largely responsible for the increased incidence of invasive aspergillosis with high mortality rates in some immunocompromised hosts. Azoles are the first-line drugs in treating diseases caused by Aspergillus spp. However, increasing reports in A. fumigatus azole resistance, both in the clinical setting and in the environment, are threatening the effectiveness of clinical and agricultural azole drugs...
February 24, 2017: Drugs
https://www.readbyqxmd.com/read/28233275/incidence-prevention-and-management-of-anti-drug-antibodies-against-therapeutic-antibodies-in-inflammatory-bowel-disease-a-practical-overview
#16
REVIEW
Pieter Hindryckx, Gregor Novak, Niels Vande Casteele, Reena Khanna, Debby Laukens, Jairath Vipul, Brian G Feagan
The introduction of biologic therapy has revolutionized the treatment of inflammatory bowel disease (IBD). However, like all therapeutic proteins, monoclonal antibodies have immunogenic potential which is influenced by multiple drug- and patient-related factors. The reported incidence of anti-drug antibodies (ADAs) towards biologic drugs in IBD varies greatly in the literature and depends not only on differences in sensitization but also on the assay methodology and the timepoint of measurement. Sensitization with formation of ADAs is associated with an increased risk of infusion reactions, accelerated drug clearance, and a loss of response (LOR) to drug...
February 23, 2017: Drugs
https://www.readbyqxmd.com/read/28233273/glucagon-like-peptide-1-receptor-agonists-glp-1ras-in-the-brain-adipocyte-axis
#17
Bruno Geloneze, José Carlos de Lima-Júnior, Lício A Velloso
The complexity of neural circuits that control food intake and energy balance in the hypothalamic nuclei explains some of the constraints involved in the prevention and treatment of obesity. Two major neuronal populations present in the arcuate nucleus control caloric intake and energy expenditure: one population co-expresses orexigenic agouti-related peptide (AgRP) and neuropeptide Y and the other expresses the anorexigenic anorectic neuropeptides proopiomelanocortin and cocaine- and amphetamine-regulated transcript (POMC/CART)...
February 23, 2017: Drugs
https://www.readbyqxmd.com/read/28229310/diagnosis-and-treatment-of-non-24-h-sleep-wake-disorder-in-the-blind
#18
REVIEW
Jonathan S Emens, Charmane I Eastman
Non-24-h sleep-wake disorder (non-24) is a circadian rhythm disorder occurring in 55-70% of totally blind individuals (those lacking conscious light perception) in which the 24-h biological clock (central, hypothalamic, circadian pacemaker) is no longer synchronized, or entrained, to the 24-h day. Instead, the overt rhythms controlled by the biological clock gradually shift progressively earlier or later (free run) in accordance with the clock's near-24-h period, resulting in a recurrent pattern of daytime hypersomnolence and night-time insomnia...
February 22, 2017: Drugs
https://www.readbyqxmd.com/read/28211007/daclizumab-a-review-in-relapsing-multiple-sclerosis
#19
Matt Shirley
Daclizumab (Zinbryta(®); previously known as daclizumab high-yield process) is a therapeutic monoclonal antibody that has recently been approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Daclizumab is a humanized IgG1 monoclonal antibody directed against CD25, the alpha subunit of the high-affinity interleukin-2 receptor. As demonstrated in the phase III DECIDE trial, once-monthly subcutaneous daclizumab was superior to once-weekly intramuscular interferon (IFN) β-1a in reducing the clinical relapse rate and radiological measures of disease in patients with relapsing-remitting MS...
February 17, 2017: Drugs
https://www.readbyqxmd.com/read/28205024/immunomodulatory-drugs-in-multiple-myeloma-mechanisms-of-action-and-clinical-experience
#20
REVIEW
Sarah A Holstein, Philip L McCarthy
Over the last two decades, the outcomes for patients with multiple myeloma, a plasma cell malignancy, have dramatically improved. The development of the immunomodulatory drugs (IMiDs), which include thalidomide, lenalidomide, and pomalidomide, has contributed significantly to these improved outcomes. While thalidomide is now less commonly prescribed, lenalidomide is widely used in the treatment of newly diagnosed transplant-eligible and transplant-ineligible patients, in the maintenance setting post-transplant and in the relapsed/refractory setting, while pomalidomide is currently utilized in the relapsed/refractory setting...
February 16, 2017: Drugs
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