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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/28068848/the-safety-of-emerging-biosimilar-drugs-for-the-treatment-of-rheumatoid-arthritis
#1
J Braun, J Kay
Biological disease-modifying anti-rheumatic drugs (bDMARDs), often administered in combination with methotrexate, target specific inflammatory mediators and have transformed the treatment of rheumatic diseases, especially rheumatoid arthritis (RA) but also the spondyloarthritides. However, the high cost of these drugs in many countries restricts patient access. As many bDMARDs have reached or are near to patent expiration, numerous biosimilar drugs are in development and some have already been approved. Biosimilars are generally priced lower than their reference products (RPs), or bio-originators, and as prices come down it is hoped that patient access to these drugs will increase, making the safety of these drugs an area of major interest...
January 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28060563/efficacy-and-safety-of-elotuzumab-for-the-treatment-of-multiple-myeloma
#2
Maria Gavriatopoulou, Evangelos Terpos, Efstathios Kastritis, Meletios A Dimopoulos
Multiple myeloma (MM) is the second most common hematologic malignancy and despite significant outcome improvements with novel agents, the majority of patients will eventually relapse and develop treatment resistance. Immunotherapy is emerging as a promising therapeutic approach in MM. Areas covered: Elotuzumab is a monoclonal antibody directly targeting the SLAMF7 receptor, expressed on normal and malignant plasma cells. Elotuzumab has no meaningful antimyeloma activity when given as monotherapy to patients with relapsed or refractory MM (RRMM)...
January 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28060547/the-safety-of-sacubitril-valsartan-for-the-treatment-of-chronic-heart-failure
#3
Jeffrey M Tyler, John R Teerlink
Sacubitril-valsartan is a combination drug that contains the neprilysin inhibitor sacubitril and angiotensin II receptor blocker valsartan. In 2015, the US Food and Drug Administration approved sacubitril-valsartan for treatment of heart failure patients with reduced ejection fraction and New York Heart Association class II-IV symptoms following a large, Phase III clinical trial (PARADIGM-HF) that demonstrated a 20% reduction in the combined primary end-point of death from cardiovascular cause or hospitalization for heart failure compared to enalapril...
January 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27989218/the-safety-of-available-immunotherapy-for-the-treatment-of-glioblastoma
#4
S Harrison Farber, Aladine A Elsamadicy, Ahmet Fatih Atik, Carter M Suryadevara, Pakawat Chongsathidkiet, Peter E Fecci, John H Sampson
Glioblastoma (GBM) is the most common malignant primary brain tumor in adults. Current standard of care involves maximal surgical resection combined with adjuvant chemoradiation. Growing support exists for a role of immunotherapy in treating these tumors with the goal of targeted cytotoxicity. Here we review data on the safety for current immunotherapies being tested in GBM. Areas covered: Safety data from published clinical trials, including ongoing clinical trials were reviewed. Immunotherapeutic classes currently under investigation in GBM include various vaccination strategies, adoptive T cell immunotherapy, immune checkpoint blockade, monoclonal antibodies, and cytokine therapies...
January 3, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28005449/clinical-benefits-and-drawbacks-of-local-corticosteroids-injections-in-tendinopathies
#5
Michele Abate, Vincenzo Salini, Cosima Schiavone, Isabel Andia
local glucocorticoids injections are widely administered for the treatment of tendinopathies. positive results have been observed in some tendinopathies but not in others. moreover, worsening of symptoms, and even spontaneous tendon ruptures has been reported. the characteristics of the tendinopathies, the clinical peculiarities of the patient, and the technique used to administer glucocorticoids, can influence the therapeutic response. Areas covered: After reviewing the pertinent literature on the clinical results, basic information, both on the pathogenesis of tendinopathies and the effects of glucocorticoids on tendons, is reported...
December 28, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27989216/the-safety-of-talimogene-laherparepvec-for-the-treatment-of-advanced-melanoma
#6
Alexandra Gangi, Jonathan S Zager
Talimogene laherparepvec (T-VEC, IMLYGIC) is an oncolytic herpes virus type I used as intralesional therapy for the treatment of unresectable metastatic melanoma in a cutaneous, subcutaneous, or nodal location. Talimogene laherparepvec selectively replicates within and lyses tumor cells while producing granulocyte macrophage colony-stimulating factor (GM-CSF), which may promote an immune mediated antitumor response. Areas covered: The US Food and Drug Administration approved Talimogene laherparepvec in late 2015 following the completion of phase I, II and III trials that demonstrated safety and efficacy...
December 28, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28004589/an-update-on-the-safety-and-interactions-of-antifungal-drugs-in-stem-cell-transplant-recipients
#7
Corrado Girmenia, Anna Paola Iori
Invasive fungal diseases (IFDs) are a major cause of morbidity and mortality in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). Improvement in the management of IFDs have been achieved with the availability of new effective and safe antifungal drugs, however, many of these newer treatments have some limitations in their variable toxicity and unique predisposition for pharmacokinetic drug-drug interactions. Areas covered: This article is an update of a previous review published in this journal evaluating the safety profile of the antifungal drugs...
December 26, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28002970/comparison-of-medication-adherence-in-diabetes-mellitus-patients-on-human-versus-analogue-insulins
#8
Jorge Enrique Machado-Alba, Diego Alejandro Medina-Morales, Luis Felipe Echeverri-Cataño
: Objetive: This study evaluated the results of treatment adherence scales in two cohorts of patients with diabetes mellitus treated either with human or analogue insulins. METHODS: A cohort study was conducted in diabetes mellitus patients older than 18 that were being treated with human or analogue insulins. Two instruments were applied to each patient [medication possession ratio, Morisky-Green test] to evaluate treatment adherence. RESULTS: A total of 238 patients, were included...
December 26, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27984921/deprescribing-a-new-goal-focused-on-the-patient
#9
Jorge Enrique Machado-Alba, Andrés Gaviria-Mendoza, Manuel Enrique Machado-Duque, Laura Chica
It is estimated that one-fifth of adult patients are treated with polypharmacy (five or more drugs) and the prevalence of this phenomenon in the elderly is even higher, ranging from 30% to 70%, even reaching 90% in residents of residential aged care facilities. Polypharmacy in the elderly increases the risk of adverse reactions, inappropriate prescriptions, drug interactions, number of hospitalizations, costs, and even death. In a recent systematic review, the authors proposed defining deprescribing as 'the process of withdrawal of inappropriate medication supervised by a health care professional with the goal of managing polypharmacy and improving outcomes'...
December 26, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27976952/challenges-in-molecular-targeted-therapy-for-gastric-cancer-considerations-for-efficacy-and-safety
#10
Yukiya Narita, Kei Muro
The Cancer Genome Atlas Research Network recently proposed a molecular classification for gastric cancer (GC) into four subtypes based on comprehensive evaluation. While the mechanisms of molecular targeted therapies in GC were confirmed by multiple clinical studies, only a limited number of therapeutics for GC have been approved to date. Areas covered: In this systematic review of the available literature, we discuss the completed and ongoing clinical trials of molecular targeted therapies in patients with GC, with a focus on their efficacy and safety profiles...
December 25, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27922765/therapeutic-drug-monitoring-of-anti-tumour-necrosis-factor-%C3%AE-agents-in-inflammatory-bowel-disease
#11
Nikola Mitrev, Rupert W Leong
Anti-TNFα therapy has revolutionised treatment of inflammatory bowel disease, however primary non-response and secondary loss of response are a significant problem. Therapeutic drug monitoring (TDM) has recently emerged as a means of optimising use of anti-TNFα agents. Areas covered: TDM of anti-TNFα agents can guide clinical decisions during treatment failure events, prevent treatment failure events, and potentially result in significant healthcare cost saving. TDM for anti-TNFα agent involves measurement of drug levels and anti-drug antibodies, and can be performed reactively or proactively...
December 22, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27984918/phone-based-safety-monitoring-of-the-first-year-of-baclofen-treatment-for-alcohol-use-disorder-the-baclophone-cohort-study-protocol
#12
Benjamin Rolland, Marine Auffret, Julien Labreuche, Maryse Lapeyre-Mestre, Malek Dib, Aomar Kemkem, Isabelle Grit, Marie Drelon, Alain Duhamel, Nicolas Cabe, François Vabret, Olivier Guillin, Alexandre Baguet, Céline Masquelier, Alain Dervaux, Sylvie Deheul, Régis Bordet, Louise Carton, Olivier Cottencin, Renaud Jardri, Sophie Gautier
BACKGROUND: In France, baclofen is frequently used off-label for alcohol use disorder (AUD). Baclofen has been associated with diverse adverse events (AEs), but the causality of these AEs has never been properly assessed. METHODS/DESIGN: BACLOPHONE is a prospective multicenter cohort study conducted in the Hauts-de-France and Normandie French regions. BACLOPHONE consists of the phone-based monitoring of 792 patients during their first year of baclofen treatment for AUD...
December 21, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27936971/drug-reaction-with-eosinophilia-and-systemic-symptoms-dress-incidence-pathogenesis-and-management
#13
Tetsuo Shiohara, Yoko Kano
Drug-induced hypersensitivity syndrome(DiHS), often referred to as drug reaction with eosinophilia and systemic symptoms (DRESS), is a life-threatening multi-organ system reaction induced by drugs and associated with sequential reactivations of herpesviruses. This syndrome has several unique features, creating uncertainty over whether it represents true drug eruption. Areas covered: A literature review of all the cases was made by a Pub Med search. The delayed onset, paradoxical worsening of clinical symptoms after withdrawal of the causative drug and unexplained cross-reactivity to multiple drugs are unique features of this syndrome, which could prompt infection to be an initial consideration...
December 21, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27989217/long-term-safety-and-tolerability-of-glatiramer-acetate-20-mg-in-the-treatment-of-relapsing-forms-of-multiple-sclerosis
#14
Tjalf Ziemssen, Natalia Ashtamker, Svetlana Rubinchick, Volker Knappertz, Giancarlo Comi
Glatiramer acetate (GA) is a first-line therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS). It has a well-characterized long-term safety profile and established efficacy, with over 2 million patient-years of exposure. Areas Covered: To present long-term safety and tolerability findings for GA 20 mg/mL daily in the management of patients with multiple sclerosis (MS). A database analysis of all patients with MS who have ever been exposed to GA 20 mg/mL daily in clinical trials, including patients with up to 20 years of continuous treatment...
December 17, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27927037/clinical-hepatotoxicity-associated-with-antifungal-agents
#15
Ioannis Kyriakidis, Athanasios Tragiannidis, Silke Munchen, Andreas H Groll
Invasive fungal diseases (IFDs) are a leading cause of morbidity and mortality among immunocompromised patients with bone marrow failure syndromes, hematological malignancies, hematopoietic stem cell transplantation (HSCT), those admitted in intensive care units (ICUs) and those with prolonged febrile neutropenia. IFDs occur in a setting of multiple morbidities and are associated with case fatality rates between 30 and 70%. Along with the development of classes and compounds, the last two decades have seen substantial improvements in the prevention and management of these infections and an overall increased use of antifungal agents...
December 16, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27927040/hydroxychloroquine-in-systemic-lupus-erythematosus-sle
#16
C Ponticelli, G Moroni
Hydroxychloroquine (HCQ) is an alkalinizing lysosomatropic drug that accumulates in lysosomes where it inhibits some important functions by increasing the pH. HCQ has proved to be effective in a number of autoimmune diseases including systemic lupus erythematosus (SLE). Areas covered: In this review the mechanisms of action, the efficacy, and the safety of HCQ in the management of patients with SLE have been reviewed. HCQ may reduce the risk of flares, allow the reduction of the dosage of steroids, reduce organ damage, and prevent the thrombotic effects of anti-phospholipid antibodies...
December 14, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27924636/safety-and-tolerability-of-glucagon-like-peptide-1-receptor-agonists-unresolved-and-emerging-issues
#17
Denis Raccah
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a mainstay of treatment options for type 2 diabetes. They contribute to lowering blood glucose levels, generally have a favorable tolerability profile, and can be used alone or in combination with other antidiabetic agents. Based on the duration of their effects, GLP-1 RAs can be divided into two classes: short-acting and long-acting. Differences exist between these sub-classes, and between each drug, in terms of pharmacokinetic and pharmacodynamic profiles...
December 11, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27885844/guidance-to-manage-inappropriate-polypharmacy-in-older-people-systematic-review-and-future-developments
#18
Derek Stewart, Alpana Mair, Martin Wilson, Przemyslaw Kardas, Pawel Lewek, Albert Alonso, Jennifer McIntosh, Katie MacLure
Single disease state led evidence-based guidelines do not provide sufficient coverage of issues of multimorbidities, with the cumulative impact of recommendations often resulting in overwhelming medicines burden. Inappropriate polypharmacy increases the likelihood of adverse drug events, drug interactions and non-adherence. Areas covered: A detailed description of a pan-European initiative, 'Stimulating Innovation Management of Polypharmacy and Adherence in the Elderly, SIMPATHY', which is a project funded by the European Commission to support innovation across the European Union...
December 4, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27880061/the-safety-profile-of-monoclonal-antibodies-for-chronic-lymphocytic-leukemia
#19
Anna Korycka-Wołowiec, Dariusz Wołowiec, Tadeusz Robak
Monoclonal antibodies (MoAbs), non-chemotherapeutic agents targeting the antigens present on chronic lymphocytic leukemia (CLL) lymphocytes, are being implemented increasingly more often as treatment options. Areas covered: This article reviews the similarities and differences in the structure, mechanism of action, efficacy and safety profile of commercially-available MoAbs and prevents new agents potentially useful for CLL treatment. Publications in English before June 2016 were surveyed on the MEDLINE database for articles...
December 4, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27813420/exploiting-heterogeneous-publicly-available-data-sources-for-drug-safety-surveillance-computational-framework-and-case-studies
#20
Vassilis G Koutkias, Agnès Lillo-Le Louët, Marie-Christine Jaulent
OBJECTIVE: Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance. METHODS: Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data...
December 1, 2016: Expert Opinion on Drug Safety
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