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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/28150516/efficacy-and-safety-of-fixed-ratio-combination-of-insulin-degludec-and-liraglutide-ideglira-for-the-treatment-of-type-2-diabetes
#1
Louise Vedtofte, Filip K Knop, Tina Vilsbøll
Abstracts Introduction: Type 2 diabetes (T2D) is a progressive disease with increasing prevalence in most countries. The majority of patients with T2D have inadequate glycaemic control, which increases the risk of diabetic complications later in life. New therapies with improved safety profiles are required to tackle the progressive nature of T2D. Areas covered: The efficacy and safety profile of IDegLira - a once-daily, fixed-ratio combination of insulin degludec and liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), for the treatment of T2D - has been extensively evaluated...
February 2, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28103444/efficacy-and-safety-of-a-recombinant-factor-viii-produced-from-a-human-cell-line-simoctocog-alfa
#2
Massimo Franchini, Pier Mannuccio Mannucci
The development of inhibitors against infused factor VIII (FVIII) has a detrimental impact on health and quality of life of patients with hemophilia A. Several observational studies and a recently published randomized trial indicate that the inhibitor risk in previously untreated patients (PUPs) is higher following the use of recombinant FVIII (rFVIII) products compared with plasma-derived FVIII concentrates. There is currently a great interest towards newer rFVIII products that adopt various technological solutions to reduce the inhibitor risk...
February 1, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28140680/paliperidone-for-the-treatment-of-schizophrenia-and-schizoaffective-disorders-a-drug-safety-evaluation
#3
M C Mauri, A Reggiori, S Paletta, C Di Pace, A C Atamura
INTRODUCTION: Paliperidone, the major active metabolite of risperidone, is a second-generation antipsychotic that has been developed as an extended-release (ER) oral formulation and a long-acting injectable paliperidone palmitate (PP) formulation. Paliperidone has demonstrated efficacy in the reduction of acute schizophrenia symptoms and clinical benefits were maintained also in the long-term treatments. Paliperidone ER and PP are generally well tolerated with a predictable adverse event profile...
January 31, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28132578/safety-evaluation-of-apremilast-for-the-treatment-of-psoriasis
#4
A Dattola, E Del Duca, R Saraceno, T Gramiccia, L Bianchi
Psoriasis (PSo) is a chronic inflammatory skin disease associated with co-morbidities such as hypertension, diabetes, dyslipidemia and metabolic syndrome. It is a typothypical Th1/Th17 disease that affects from 2 to 3% of the world population. Numerous are the drugs that can be used in our clinical practice; the choice of these drugs depends on the characteristics of the patient. Areas covered: Apremilast is the first oral small molecules to receive FDA approval for the treatment of adults with active psoriasis and psoriatic arthritis...
January 30, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28116937/the-safety-of-mepolizumab-for-the-treatment-of-asthma
#5
E Leung, K Al Efraij, J FitzGerald
Asthma is an airway disease characterized by airway inflammation. It is associated with significant morbidity, mortality, and costs to the healthcare system and society. Interleukin-5 (IL-5) was identified for its role in eosinophil development, maturation, and survival in tissues, which has been related to disease severity and airway eosinophilia. Areas covered: In this review, we will present the pharmacokinetics and dynamics of mepolizumab in addition to efficacy and safety data. Expert Opinion: Mepolizumab is novel, new, first-in-class therapy targeting IL-5...
January 24, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28102093/cardiovascular-safety-and-benefits-of-glp-1-receptor-agonists
#6
Niels B Dalsgaard, Andreas Brønden, Tina Vilsbøll, Filip K Knop
Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1RAs) constitute a class of drugs for the treatment of type 2 diabetes, and currently, six different GLP-1RAs are approved. Besides improving glycemic control, the GLP-1RAs have other beneficial effects such as weight loss and a low risk of hypoglycemia. Treatment with the GLP-1RA lixisenatide has been shown to be safe in patients with type 2 diabetes and recent acute coronary syndrome. Furthermore, liraglutide and semaglutide have been shown to reduce cardiovascular (CV) disease (CVD) risk in type 2 diabetes patients with established and/or high risk of CVD...
January 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28095258/the-safety-of-treatment-options-available-for-gout
#7
Naomi Schlesinger
Gout is the most common inflammatory arthritis in humans. Gout treatment includes rapid initiation of anti-inflammatory medications for acute attacks and chronically treating with urate lowering drugs as well as chronic anti-inflammatory prophylaxis. Areas covered: This review aims to provide an overview and discussion of the safety concerns of current treatment options available for gout. Expert opinion: Gout is a curable disease with appropriate treatment. The advent of new therapies provides encouraging opportunities to improve gout management...
January 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28094583/signal-detection-activity-on-eudravigilance-data-analysis-of-the-procedure-and-findings-from-an-italian-regional-centre-for-pharmacovigilance
#8
Luca Monaco, Mauro Melis, Chiara Biagi, Monia Donati, Ester Sapigni, Alberto Vaccheri, Domenico Motola
BACKGROUND: In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV). Our aim is to describe the procedure of signal detection on EV data and to present results obtained by the our pharmacovigilance centre. METHOD: Data are extracted from EV database, which collects suspected Adverse Drug Reactions (ADRs) of medicinal products in Europe...
January 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28060563/efficacy-and-safety-of-elotuzumab-for-the-treatment-of-multiple-myeloma
#9
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 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28068848/the-safety-of-emerging-biosimilar-drugs-for-the-treatment-of-rheumatoid-arthritis
#10
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/28060547/the-safety-of-sacubitril-valsartan-for-the-treatment-of-chronic-heart-failure
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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