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Adverse drug

Francesca Palandri, Elena Sabattini, Margherita Maffioli
Myelofibrosis (MF) is a Philadelphia chromosome-negative myeloproliferative neoplasm associated with bone marrow fibrosis, splenomegaly, a high symptom burden, and poor prognosis. Treatment is based on a risk-adapted approach, with treatment guidelines generally recommending allogeneic stem cell transplant or drug-based therapy for patients with higher-risk or more advanced disease and recommending observation or the "watch-and-wait" strategy for those with lower-risk or early-stage MF. With the advent of targeted therapies, such as the Janus kinase inhibitors, many patients have experienced substantial clinical benefits, including reduction in splenomegaly and symptoms and, in some instances, improvement or stabilization of bone marrow fibrosis and reduction of JAK2 V617F allele burden...
October 20, 2018: Annals of Hematology
Ishita P Miah, Dana C Holl, Wilco C Peul, Robert Walchenbach, Nyika Kruyt, Karlijn de Laat, Radboud W Koot, Victor Volovici, Clemens M F Dirven, Fop van Kooten, Kuan H Kho, Heleen M den Hertog, Joukje van der Naalt, Bram Jacobs, Rob J M Groen, Hester F Lingsma, Ruben Dammers, Korné Jellema, Niels A van der Gaag
BACKGROUND: Chronic subdural haematoma (CSDH) is a common neurological disease with a rapidly rising incidence due to increasing age and widespread use of anticoagulants. Surgical intervention by burr-hole craniotomy (BHC) is the current standard practice for symptomatic patients, but associated with complications, a recurrence rate of up to 30% and increased mortality. Dexamethasone (DXM) therapy is, therefore, used as a non-surgical alternative but considered to achieve a lower success rate...
October 20, 2018: Trials
Inês L Martins, João Nunes, Catarina Charneira, Judit Morello, Sofia A Pereira, João P Telo, M Matilde Marques, Alexandra M M Antunes
Carbamazepine (CBZ) is one of the most widely used antiepileptic drugs by both adults and children. Despite its widespread use, CBZ is associated with central nervous system toxicity and severe hypersensitivity reactions, which raise concerns about its chronic use. While the precise mechanisms of CBZ-induced adverse events are still unclear, metabolic activation to the epoxide (CBZ-EP) has been thought to play a significant role. This work reports first-hand evidence that CBZ reacts readily with biologically relevant thiyl radicals with no need for bioactivation...
October 17, 2018: Free Radical Biology & Medicine
Nasser Hashemi Goradel, Masoud Najafi, Eniseh Salehi, Bagher Farhood, Keywan Mortezaee
Cyclooxygenase-2 (COX-2) is frequently expressed in many types of cancers exerting a pleiotropic and multifaceted role in genesis or promotion of carcinogenesis and cancer cell resistance to chemo- and radiotherapy. COX-2 is released by cancer-associated fibroblasts (CAFs), macrophage type 2 (M2) cells, and cancer cells to the tumor microenvironment (TME). COX-2 induces cancer stem cell (CSC)-like activity, and promotes apoptotic resistance, proliferation, angiogenesis, inflammation, invasion, and metastasis of cancer cells...
October 20, 2018: Journal of Cellular Physiology
Antonia M Joussen, Sebastian Wolf, Peter K Kaiser, David Boyer, Thomas Schmelter, Rupert Sandbrink, Oliver Zeitz, Gesa Deeg, Annett Richter, Torsten Zimmermann, Joachim Hoechel, Ulf Buetehorn, Walter Schmitt, Brigitte Stemper, Michael K Boettger
AIMS: This program investigated topical regorafenib, a multikinase inhibitor, in patients with neovascular age-related macular degeneration (nAMD). METHODS: Topical regorafenib was investigated in an open-label, phase IIa/b study in which patients with choroidal neovascularization (CNV) secondary to nAMD received regorafenib (25 μL, 30 mg/mL TID) for 12 weeks. The primary endpoint of the phase II/a/b study was mean change in best-corrected visual acuity (BCVA) from baseline to weeks 4 and 12...
October 20, 2018: British Journal of Clinical Pharmacology
Chiara Russo, Franziska Ferk, Miroslav Mišík, Nathalie Ropek, Armen Nersesyan, Doris Mejri, Klaus Holzmann, Margherita Lavorgna, Marina Isidori, Siegfried Knasmüller
Cannabidiol (CBD) and cannabidivarin (CBDV) are natural cannabinoids which are consumed in increasing amounts worldwide in cannabis extracts, as they prevent epilepsy, anxiety, and seizures. It was claimed that they may be useful in cancer therapy and have anti-inflammatory properties. Adverse long-term effects of these drugs (induction of cancer and infertility) which are related to damage of the genetic material have not been investigated. Therefore, we studied their DNA-damaging properties in human-derived cell lines under conditions which reflect the exposure of consumers...
October 19, 2018: Archives of Toxicology
Claire Conway
PURPOSE: The United States' Food and Drug Administration (FDA) recommends that device manufacturers demonstrate 10 years of equivalent life duration for endovascular stents. Yet since the early 2000s clinical evidence of stent strut fracture defies the recommendations for these FDA approved devices. Stent strut fracture has been correlated with a higher incidence of adverse clinical events, such as in-stent thrombosis and in-stent restenosis. METHODS: This paper reviews the current clinical evidence, computational modelling relating to fatigue lifetimes, experimental testing of coronary stents, and the related regulatory guidance and standards...
October 19, 2018: Cardiovascular Engineering and Technology
Cristina Scavone, Maurizio Sessa, Emilio Clementi, Giovanni Corrao, Roberto Leone, Alessandro Mugelli, Francesco Rossi, Edoardo Spina, Annalisa Capuano
BACKGROUND: In recent years, several biosimilar drugs, including those of infliximab, have obtained marketing authorization from the European Medicines Agency (EMA). Given the peculiarity of the safety profile of biological medical products (originator and biosimilars), the evaluation of their tolerability represents an important component of pre-marketing and post-marketing clinical development. For example, infliximab products may cause adverse drug reactions (ADRs) including acute infusion reactions, delayed hypersensitivity reactions, and loss of efficacy, as a direct consequence of immunogenicity...
October 20, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Ricardo F Savaris, Daniele G Fuhrich, Rui V Duarte, Sebastian Franik, Jonathan D C Ross
OBJECTIVE: To assess the effectiveness and safety of antibiotic regimens used to treat pelvic inflammatory disease (PID). DESIGN: This is a systematic review and meta-analysis of randomised controlled trials (RCTs). Risk of bias was assessed using the criteria outlined in the Cochrane guidelines. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation. DATA SOURCES: Eight electronic databases were searched from date of inception up to July 2016...
October 19, 2018: Sexually Transmitted Infections
Kannan Sridharan, Gowri Sivaramakrishnan, Reginald Paul Sequeira, Abdelaziz Elamin
AIM: Several drugs have been used for treating non-alcoholic fatty liver disease (NAFLD). The present study is a network meta-analysis of such drugs. DESIGN, SETTING AND PATIENTS: Randomised clinical trials comparing drug interventions in patients with NAFLD were analysed. OR and weighted mean difference (95 % CI) were the effect estimates for categorical and numerical outcomes, respectively. Random-effects model was used to generate pooled estimates. Surface under the cumulative ranking curve was used to rank the treatments...
October 19, 2018: Postgraduate Medical Journal
Danielle B Rice, Brian Hutton, Patricia Poulin, Beth A Sproule, Dianna Wolfe, David Moher, Kednapa Thavorn, Gary Garber, Sheena Taha, Amy Porath, Melanie Willows, Leila Esmaeilisaraji, Fatemeh Yazdi, Beverley Shea, Becky Skidmore, Kimberly Corace
INTRODUCTION: The opioid crisis has resulted in increasing rates of death caused by problematic opioid use. Current clinical guidelines recommend that individuals with persons with opioid use disorder (OUD) receive pharmacological (eg, opioid agonist therapy) and psychosocial (eg, cognitive behavioural therapy) therapy; however, the best combination of pharmacologic and psychosocial components is not known. Our objective of the planned study is to conduct a comprehensive systematic review to assess the relative benefits of psychosocial interventions as an adjunct to opioid agonist therapy among persons with OUD...
October 18, 2018: BMJ Open
Sikander Ailawadhi, Kevin R Kelly, Robert A Vescio, Sundar Jagannath, Jeffrey Wolf, Mecide Gharibo, Taimur Sher, Leyla Bojanini, Maurice Kirby, Asher Chanan-Khan
BACKGROUND: Despite therapeutic advancements that have significantly improved outcomes in multiple myeloma (MM), it remains an incurable disease. Patients with relapsed and/or refractory MM have an aggressive disease course, with inferior outcomes, necessitating the need for agents with novel therapeutic mechanisms. We present the results of a completed phase I trial of single-agent lorvotuzumab mertansine, a unique antibody-drug conjugate targeting CD56, which is frequently expressed in MM...
September 5, 2018: Clinical Lymphoma, Myeloma & Leukemia
K Sanders, H S Kooistra, S Galac
Naturally occurring hypercortisolism, also known as Cushing's syndrome, is a common endocrine disorder in dogs that can be caused by an adenocorticotrophic hormone (ACTH)-producing pituitary adenoma (pituitary-dependent hypercortisolism, PDH; 80-85% of cases), or by an adrenocortical tumor (ACT; 15-20% of cases). To determine the optimal treatment strategy, differentiating between these two main causes is essential. Good treatment options are surgical removal of the causal tumor, i.e. hypophysectomy for PDH and adrenalectomy for an ACT, or radiotherapy in cases with PDH...
November 2018: Veterinary Journal
Thibault Ledieu, Guillaume Bouzillé, Frantz Thiessard, Karine Berquet, Pascal Van Hille, Eric Renault, Elisabeth Polard, Marc Cuggia
BACKGROUND: Pharmacovigilance consists in monitoring and preventing the occurrence of adverse drug reactions (ADR). This activity requires the collection and analysis of data from the patient record or any other sources to find clues of a causality link between the drug and the ADR. This can be time-consuming because often patient data are heterogeneous and scattered in several files. To facilitate this task, we developed a timeline prototype to gather and classify patient data according to their chronology...
October 19, 2018: BMC Medical Informatics and Decision Making
Junzhi Yang, Bianca G Reilly, Thomas P Davis, Patrick T Ronaldson
Opioids are highly effective analgesics that have a serious potential for adverse drug reactions and for development of addiction and tolerance. Since the use of opioids has escalated in recent years, it is increasingly important to understand biological mechanisms that can increase the probability of opioid-associated adverse events occurring in patient populations. This is emphasized by the current opioid epidemic in the United States where opioid analgesics are frequently abused and misused. It has been established that the effectiveness of opioids is maximized when these drugs readily access opioid receptors in the central nervous system (CNS)...
October 18, 2018: Pharmaceutics
Joanne L Parrott, Chris D Metcalfe
Antidepressant drugs have been detected in municipal wastewater effluents (MWWEs) at ng/L to low μg/L concentrations. We exposed fathead minnow (Pimephales promelas) over a full lifecycle to a mixture of five antidepressants at concentrations similar to a MWWE (1× AntiD Mix); venlafaxine at 2400 ng/L, citalopram at 240 ng/L, fluoxetine at 90 ng/L, sertraline at 20 ng/L, and bupropion at 90 ng/L, and 10× these concentrations (i.e. 10× AntiD Mix). Mean measured concentrations of venlafaxine, citalopram, fluoxetine, sertraline, and bupropion were 2300, 160, 110, 7 ng/L, and below detection limits, respectively, for the 1× AntiD Mix, and 33,000, 2900, 1000, 210, and 100 ng/L, respectively for the 10× AntiD Mix...
January 15, 2019: Science of the Total Environment
Ivan Surya Pradipta, Lina Davies Forsman, Judith Bruchfeld, Eelko Hak, Jan-Willem Alffenaar
OBJECTIVES: Since the risk of multidrug-resistant tuberculosis (MDR-TB) may depend on the setting, we aimed to determine the associations of risk factors of MDR-TB across different regions. METHODS: A systematic review and meta-analysis was performed with Pubmed and Embase databases. Information was retrieved on 37 pre-defined risk factors of MDR-TB. We estimated overall Mantel-Haenszel odds ratio as a measure of the association. RESULTS: Factors of previous TB disease and treatment are the most important risk factors associated with MDR-TB...
October 16, 2018: Journal of Infection
Agne Paner, Tochukwu M Okwuosa, Kristin J Richardson, Edward N Libby
Multiple three drug combination regimens have been approved for the treatment of multiple myeloma in the last few years. Triplets have become the new standard of care for transplant eligible and ineligible patients with newly diagnosed as well as relapsed multiple myeloma. Novel agents have a unique profile of side effects. The management of toxicities is important to maintain quality of life and maximize treatment duration and benefit. Areas covered: This article reviews efficacy data, incidence of key adverse events and provide recommendations and expert opinion regarding how to manage common toxicities in triplet therapies...
October 19, 2018: Expert Review of Hematology
Xiaoli Wang, Elizabeth A Ludwig, Julie Passarell, Akintunde Bello, Amit Roy, Matthew W Hruska
Nivolumab, a fully human immunoglobulin G4 monoclonal anti-programmed death-1 antibody, has demonstrated clinical benefits in multiple tumors, including classical Hodgkin lymphoma. The aim of this study was to characterize the pharmacokinetics (PK) of nivolumab in patients with classical Hodgkin lymphoma using a population approach and to assess the exposure-response (E-R) relationship for safety, thereby supporting the dose recommendation in patients with classical Hodgkin lymphoma. Nivolumab PK and the effect of covariates were consistent with that observed in solid tumors, except that baseline clearance of nivolumab was lower in patients with classical Hodgkin lymphoma by 28%...
October 19, 2018: Journal of Clinical Pharmacology
Andrés Rodríguez, Cynthia Zavala
INTRODUCTION: Cannabis stands as the most used illegal drug in the world. Currently there are no pharmacologic alternatives to treat its addiction, so the use of Cannabinoids has been postulated as a therapeutic tool. They would act mainly through decrease in abstinence and craving symptoms but its effectiveness remains unclear. METHODS: To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others...
October 11, 2018: Medwave
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