Long-term safety and tolerability of entecavir in patients with chronic hepatitis B in the rollover study ETV-901.

abstract：INTRODUCTION:Acute bacterial skin and skin-structure infections (ABSSSI) may develop in both in-patients and out-patients, possibly with a severe clinical presentation. Since most phase 3 randomized clinical trials have shown non-inferiority in efficacy across different agents, considerations regarding their different ...

journal_title：Expert opinion on drug safety

authors： Bassetti M,Peghin M,Castaldo N,Giacobbe DR

更新日期：2019-08-01 00:00:00

abstract：INTRODUCTION:Gestational diabetes mellitus (GDM), the most frequent medical complication of pregnancy, is associated with several adverse outcomes over the short- and long-term for both mother and offspring. Standard treatment for GDM consists of insulin injections. Oral hypoglycemic agents (OHAs), on the other hand, a...

journal_title：Expert opinion on drug safety

authors： Maymone AC,Baillargeon JP,Ménard J,Ardilouze JL

更新日期：2011-03-01 00:00:00

abstract：INTRODUCTION:The emergence of multidrug-resistant (MDR) infections has been extensively observed worldwide and has become a priority issue over past decade. Tigecycline , a broad spectrum antibiotic covering against many MDR organisms, has been widely used. However, recent meta-analysis studies have raised a concern fo...

journal_title：Expert opinion on drug safety

authors： Kaewpoowat Q,Ostrosky-Zeichner L

更新日期：2015-02-01 00:00:00

abstract：INTRODUCTION:Immune checkpoint inhibitors (ICIs) have rapidly changed the treatment landscape, demonstrating dramatic clinical efficacy in various cancers. AREAS COVERED:In urothelial cancer (UC), several ICIs have been approved in platinum refractory disease and also as first-line therapy in patients that fulfill the...

journal_title：Expert opinion on drug safety

authors： Economopoulou P,Kotsantis I,Bamias A

更新日期：2020-08-01 00:00:00

abstract：:Methotrexate is a commonly prescribed antineoplastic and immune modulating compound that has gained wide acceptance in the management of rheumatoid arthritis, psoriasis, sarcoidosis and a number of neoplastic disorders. Although generally considered safe and easy to use, methotrexate has been associated with a number ...

journal_title：Expert opinion on drug safety

authors： Lateef O,Shakoor N,Balk RA

更新日期：2005-07-01 00:00:00

abstract：INTRODUCTION:Disease-modifying antirheumatic drugs (DMARDs) have significantly improved clinical symptoms and quality of life with reduced disease progression in many patients with rheumatoid arthritis (RA). Short-term glucocorticoid therapy is often used initially in combination with DMARDs, but some patients still ha...

journal_title：Expert opinion on drug safety

authors： Fleischmann R,Furst DE

更新日期：2020-08-01 00:00:00

abstract：INTRODUCTION:Pembrolizumab is a highly selective fully human immunoglobulin 4 monoclonal antibody against programmed death 1 (PD-1). Phase II and III trials have demonstrated that pembrolizumab has antitumor activity in previously treated patients with advanced gastric cancer (AGC). AREA COVERED:Pembrolizumab was appr...

journal_title：Expert opinion on drug safety

authors： Mishima S,Kawazoe A,Shitara K

更新日期：2020-09-01 00:00:00

abstract：:Anthracyclines are among the most active chemotherapeutic agents in cancer treatment. Although infrequent, cumulative dose-dependent cardiotoxicity is nevertheless a significant side effect of this therapy resulting in reduced cardiac reserve or even frank cardiac failure. Although used in several types of malignancy,...

journal_title：Expert opinion on drug safety

authors： Ng R,Green MD

更新日期：2007-05-01 00:00:00

abstract：:Of the numerous topics discussed during the eighth annual meeting of the Safety Pharmacology (SP) Society the author identified the following key topics: i) the impact of hERG (human ether-à-go-go related gene) channel data on drug development, ii) safety evaluation of biological products, iii) opportunities and expec...

journal_title：Expert opinion on drug safety

authors： Cavero I,Safety Pharmacology Society.

更新日期：2009-03-01 00:00:00

abstract：INTRODUCTION:Fingolimod (Gilenya®, FTY720) is an oral sphingosine-1-phosphate analogue that was approved by the FDA in 2010 for the treatment of relapsing forms of multiple sclerosis (MS). Fingolimod's mechanism of action is primarily related to lymphocyte sequestration in primary and secondary lymphoid tissues. Phase ...

journal_title：Expert opinion on drug safety

authors： Ward MD,Jones DE,Goldman MD

更新日期：2014-07-01 00:00:00

abstract：INTRODUCTION:There is a continuing need for an immunosuppressive therapy that offers a high benefit-risk profile for renal transplant recipients, supporting long-term patient and graft survival while minimizing cumulative nephrotoxicity and other side effects. Belatacept , the first biological agent developed for prima...

journal_title：Expert opinion on drug safety

authors： Grinyó JM,Budde K,Citterio F,Charpentier B

更新日期：2013-01-01 00:00:00

abstract：INTRODUCTION:Triamcinolone acetonide (TA) is a steroidal drug that has been widely administered intravitreally for retinal and choroidal conditions. Safety of steroidal products for intraocular use is essential because of their risk of ocular adverse events. This review comprehensively discusses the safety of intravitr...

journal_title：Expert opinion on drug safety

authors： Veritti D,Di Giulio A,Sarao V,Lanzetta P

更新日期：2012-03-01 00:00:00

abstract：:Introduction: Botulinum toxin (BoNT) is a protein secreted by the anaerobic Gram-negative bacterium Clostridium botulinum. Among the seven known subtypes, type A is the most commonly used in women to treat diseases. It primarily blocks presynaptic release of acetylcholine at the neuromuscular junction, resulting in te...

journal_title：Expert opinion on drug safety

authors： Li W,Tang M

更新日期：2020-01-01 00:00:00

abstract：INTRODUCTION:Secukinumab is a human monoclonal antibody that selectively targets and neutralizes interleukin (IL)-17A, a cytokine that is normally involved in mucocutaneous defense against extracellular organisms and is abnormally expressed in psoriasis. In 2015, secukinumab was the first IL-17A inhibitor approved for ...

journal_title：Expert opinion on drug safety

authors： Blauvelt A

更新日期：2016-10-01 00:00:00

abstract：:This meeting was convened to encourage the incorporation of empirical and mechanism-based pharmacokinetic/pharmacodynamic (PK/PD) modelling into safety pharmacology to improve the predictability of nonclinical investigations for human outcomes. These technologies make use of mathematical expressions relating measured ...

journal_title：Expert opinion on drug safety

authors： Cavero I

更新日期：2007-07-01 00:00:00

abstract：INTRODUCTION:Sulfasalazine (SASP) is a drug commonly used in the treatment of inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease (CD) and rheumatoid arthritis (RA). A high incidence of side effects limits therapy with this drug. Getting a wider knowledge of drug pharmacology, indications a...

journal_title：Expert opinion on drug safety

authors： Linares V,Alonso V,Domingo JL

更新日期：2011-03-01 00:00:00

abstract：INTRODUCTION:Obesity is associated with an increased risk of cardiovascular morbidity and mortality. Four medications are approved by the US Food and Drug Administration (FDA) for chronic weight management when used as an adjunct to a reduced-calorie diet and increased physical activity in adults. These medications res...

journal_title：Expert opinion on drug safety

authors： Chao AM,Wadden TA,Berkowitz RI,Quigley K,Silvestry F

更新日期：2020-09-01 00:00:00

abstract：:Introduction: The use of testosterone therapy (TTh) in men with prostate cancer (PCa) is relatively new, and controversial, due to the longstanding maxim that TTh is contraindicated in men with PCa. Scientific advances have prompted a reevaluation of the potential role for TTh in men with PCa, particularly as TTh has ...

journal_title：Expert opinion on drug safety

authors： Morgentaler A,Caliber M

更新日期：2019-11-01 00:00:00

abstract：:Objectives: This study aimed to develop a procedure to explore the adverse drug reaction signals of drug-induced neutropenia (DIN) or drug-induced agranulocytosis (DIA) in children using an electronic health records (EHRs) database. Methods: A two-stage design was presented. First, the suspected drugs to induce DIN or...

journal_title：Expert opinion on drug safety

authors： Wei R,Jia LL,Yu YC,Nie XL,Song ZY,Fan DF,Xie YF,Peng XX,Zhao ZG,Wang XL

更新日期：2019-05-01 00:00:00

abstract：BACKGROUND:Cardiovascular disease is the leading cause of mortality among adults with Type 2 diabetes. The thiazolidinediones including rosiglitazone are approved for the treatment of Type 2 diabetes on the basis of their ability to lower blood sugar and surrogate markers of cardiovascular disease. OBJECTIVES:To ascer...

journal_title：Expert opinion on drug safety

authors： Singh S,Loke YK

更新日期：2008-09-01 00:00:00

abstract：INTRODUCTION:Although anaphylaxis is a relatively common disorder, clinicians and scientists have debated on how to best define and manage this condition. The current recommendations are focused on the central role of adrenaline, but evidence in support of this therapeutic approach is modest, mainly for the lack of wel...

journal_title：Expert opinion on drug safety

authors： Cervellin G,Sanchis-Gomar F,Lippi G

更新日期：2016-06-01 00:00:00

abstract：INTRODUCTION:Traditional Chinese medicine (TCM) is widely used around the world. However, with its wide use has been the identification of a number of toxicological issues that have severely restricted its use in clinical treatment. The identification of these toxic substances within TCM has become somewhat of a hot to...

journal_title：Expert opinion on drug safety

authors： Lv W,Piao JH,Jiang JG

更新日期：2012-11-01 00:00:00

abstract：INTRODUCTION:In 1998, high-dose interleukin-2 (IL-2) was the first immunotherapy approved for the treatment of metastatic melanoma based on durable objective responses documented in a subset of patients but widespread utilization was limited by significant toxicity. Advances in targeted therapy and the emergence of T c...

journal_title：Expert opinion on drug safety

authors： Marabondo S,Kaufman HL

更新日期：2017-12-01 00:00:00

abstract：INTRODUCTION:Dolutegravir (DGV) is the newest integrase inhibitor approved for the treatment of HIV-1 infection in both treatment-naive and experienced adults and adolescents. This article reviews the safety of DGV for the treatment of HIV-1 infection. AREAS COVERED:The PubMed database was searched using the keywords ...

journal_title：Expert opinion on drug safety

authors： Keeshin SW,Feinberg J

更新日期：2015-01-01 00:00:00

abstract：:Objectives: To examine the signals of bullous pemphigoid (BP) with dipeptidyl peptidase-4 inhibitors (DPP-4i) in VigiBase® and the potential role of their pharmacodynamic/pharmacokinetic parameters in the occurrence of BP. Methods: Case/non-case analyses were performed in VigiBase® to examine the signal of BP [reporti...

journal_title：Expert opinion on drug safety

authors： Carnovale C,Mazhar F,Arzenton E,Moretti U,Pozzi M,Mosini G,Leoni O,Scatigna M,Clementi E,Radice S

更新日期：2019-11-01 00:00:00

abstract：INTRODUCTION:Epidural steroid injections (ESI) are a commonly utilized treatment for cervical and lumbar radicular pain. All medical procedures and medications carry an inherent level of risk, that must be balanced with the effectiveness of the treatment to determine the risk to benefit ratio for a patient. AREAS COVE...

journal_title：Expert opinion on drug safety

authors： Schneider B,Zheng P,Mattie R,Kennedy DJ

更新日期：2016-08-01 00:00:00

abstract：:COX-2 selective inhibitors provide analgesia and blunt inflammation while also sparing the gastrointestinal tract from classic NSAID toxicity. Therapeutic effects are thought to result from inhibition of the inflammatory COX-2 isoform. Organ sparing is considered the result of preservation of homeostatic COX-1 enzyme ...

journal_title：Expert opinion on drug safety

authors： Perazella MA

更新日期：2002-05-01 00:00:00

abstract：OBJECTIVE:The aim of this study was to investigate whether the use of statins was associated with a decreased risk of gallstone disease. METHODS:We conducted a population-based case-control study in Taiwan. Cases consisted of all patients who were aged 50 years and older and had a first-time diagnosis of gallstone dis...

journal_title：Expert opinion on drug safety

authors： Chiu HF,Chen CC,Kuo HW,Lee IM,Wu TN,Yang CY

更新日期：2012-05-01 00:00:00

abstract：:The problem of counterfeit drugs is increasingly becoming a top priority of drug regulatory agencies, licit pharmaceutical manufacturers and healthcare professionals, and is of rising concern among consumers. A review of the current literature reveals that counterfeiting is no longer isolated in developing nations, bu...

journal_title：Expert opinion on drug safety

authors： Wertheimer AI,Santella TM

更新日期：2005-07-01 00:00:00

abstract：INTRODUCTION:Monoclonal antibodies such as bevacizumab, ramucirumab, cetuximab and panitumumab play an important role in the treatment of metastatic colorectal cancer (mCRC). With the introduction of these drugs considerable improvements in both progression-free survival (PFS) and overall survival (OS) were achieved. H...

journal_title：Expert opinion on drug safety

authors： Berger MD,Lenz HJ

更新日期：2016-06-01 00:00:00