Abstract:
INTRODUCTION:Apatinib is an orally administered small-molecule vascular endothelial growth factor receptor 2 inhibitor. It has been approved and indicated for advanced gastric cancer after the failure of two or more lines of systemic therapy in China. Areas covered: This review summarizes the mechanisms, clinical applications and safety evaluations of apatinib. Apatinib is well tolerated, and its most common adverse effects include hand-foot syndrome, hypertension, proteinuria and neutropenia. Its major grade 3/4 adverse effect is hand-foot syndrome. Expert opinion: Apatinib is an effective and safe drug for advanced gastric cancer patients that shows tolerable and manageable toxicity. However, it should be avoided in patients with a bleeding tendency or at risk of perforation. Worldwide assessments of its efficacy and safety are needed. Additionally, the early presence of antiangiogenesis-related adverse events may predict the drug efficacy of apatinib. List of Abbreviations: GC: gastric cancer; mOS: median overall survival; TKI: tyrosine kinase inhibitor; EGFR: epidermal growth factor receptor; HER2: human epidermal growth factor receptor 2; VEGFR: vascular endothelial growth factor receptor; mTOR: mammalian target of rapamycin; HGFR: hepatocyte growth factor receptor; HR: hazard ratio; CI: confidence interval; mPFS: median progression-free survival; Tmax: median time to peak drug concentration; Cmax: maximum plasma drug concentration; AUC0-24h: areas under the concentration-time curve 0-24 h; CFDA: China Food and Drug Administration; FAS: full analysis set; ORR: objective response rate; DCR: disease control rate; PR: partial response; SD: stable disease; MTD: maximum tolerated dose; AEs: adverse events; IC50: 50% median inhibitory concentration.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Geng R,Song L,Li J,Zhao Ldoi
10.1080/14740338.2018.1535592subject
Has Abstractpub_date
2018-11-01 00:00:00pages
1145-1150issue
11eissn
1474-0338issn
1744-764Xjournal_volume
17pub_type
杂志文章,评审abstract::Self-medication, using non-prescription drugs, is beneficial to patients, healthcare professionals, the pharmaceutical industry and governments. Although many non-prescription medications are effective, misuse and abuse of these products can arise. Monitoring of specific populations and products, in addition to data r...
journal_title:Expert opinion on drug safety
pub_type: 社论
doi:10.1517/14740338.2.1.1
更新日期:2003-01-01 00:00:00
abstract::Sjögren's syndrome dry eye is an inflammatory disease accompanied by an impairment of the autonomous nervous system of the ocular surface. The therapy for this condition is shifting from the mere tear replacement to a more complex approach including an anti-inflammatory treatment. Clinical trials have evidenced that t...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.1.33
更新日期:2007-01-01 00:00:00
abstract:INTRODUCTION:The prevalence of depression in pregnancy is over 10% and a significant proportion of pregnant women use antidepressant medication. The safety of antidepressants in pregnancy is controversial, partly due to methodological challenges. The conflicting results in the literature may, however, also be due to di...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1341872
更新日期:2017-08-01 00:00:00
abstract::Recombinant activated Factor VII (rFVIIa) has been successfully used in the treatment of haemophilia A and B with associated inhibitors for some years. Activated Factor VII binds to activated platelets independently of tissue factor. The resulting stimulation of an exaggerated early thrombin burst at sites of vascular...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.3.557
更新日期:2005-05-01 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
pub_type: 杂志文章
doi:10.1080/14740338.2019.1668373
更新日期:2019-11-01 00:00:00
abstract:BACKGROUND:To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patients previously treated with benzalkonium chloride (BAK)-preserved Latanoprost. METHODS:Cohort 6-month study on open-angle glaucoma or ocular hypertension patients. Complete ophthalmic examination, intraocular pr...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2015.1017467
更新日期:2015-05-01 00:00:00
abstract:INTRODUCTION:Guselkumab is a fully human monoclonal IgG1λ antibody for the treatment of plaque psoriasis that inhibits interleukin (IL)-23p19 subunit, reducing the proliferation of type 17 helper T (Th-17) cells and thus production of Th-17-derived pro-inflammatory cytokines, especially IL-17 and IL-22. Areas covered: ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2018.1488963
更新日期:2018-07-01 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
pub_type: 杂志文章
doi:10.1080/14740338.2020.1806234
更新日期:2020-09-01 00:00:00
abstract::Aerosolized delivery of a number of antimicrobial agents has been studied. Despite a theoretical soundness behind this strategy, full consideration of the potential toxicities associated with this mode of administration is imperative. Aerosolized amphotericin B, as both deoxycholate and lipid formulations, has been st...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.5.523
更新日期:2007-09-01 00:00:00
abstract::Osteonecrosis of the jaw is a new disease, partly caused by bisphosphonates. It is commonly assumed that the bisphosphonates somehow cause cell death (osteocyte necrosis) within the jawbone, which makes it prone to chronic infection. In this article, an alternative pathogenetic theory is suggested, based on the normal...
journal_title:Expert opinion on drug safety
pub_type: 社论
doi:10.1517/14740338.5.6.743
更新日期:2006-11-01 00:00:00
abstract:INTRODUCTION:Hyperhidrosis affects 4.8% of the U.S. population and has been underestimated by physicians for long time despite considerable interference with quality of life. Many patients suffer from primary (idiopathic) hyperhidrosis which results from over-activity of sympathetic nerves and is restricted to specific...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1354983
更新日期:2017-09-01 00:00:00
abstract:INTRODUCTION:Albiglutide is a marketed long acting GLP-1 receptor agonist (GLP-1 RA) administered by weekly injection. It has significantly less gastrointestinal side effects than other GLP-1 RAs in current use but does not improve HbA1c or promote weight loss to the same extent as competitor agents such as liraglutide...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1351538
更新日期:2017-09-01 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
pub_type:
doi:10.1517/14740338.6.4.465
更新日期:2007-07-01 00:00:00
abstract:IMPORTANCE OF THE FIELD:Bisphosphonates are the most widely used antiresorptive agents for the treatment of osteoporosis. However, the cumulative bisphoshonate exposure and its association with atypical fragility fractures, and the optimum duration of treatment remain obscure. AREAS COVERED IN THIS REVIEW:This review ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2010.517192
更新日期:2011-01-01 00:00:00
abstract::The most important risk factor of oesophageal adenocarcinoma is gastro-oesophageal reflux disease. Gastro-oesophageal reflux disease is in itself a common disorder, giving bothersome symptoms. In daily clinical practice, anticholinergic drugs are believed to increase the risk of gastro-oesophageal reflux through effec...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.7.2.173
更新日期:2008-03-01 00:00:00
abstract:INTRODUCTION:Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel solvent-free formulation of paclitaxel, which was developed to avoid toxicities associated with Cremophor EL® vehicle used in solvent-based paclitaxel. It is approved as monotherapy for treatment of metastatic breast cancer (MBC) in Europe a...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.893293
更新日期:2014-04-01 00:00:00
abstract:INTRODUCTION:Amiodarone is the most widely used antiarrhythmic agent, with demonstrated effectiveness against all the spectrum of cardiac tachyarrhythmias. The risk of adverse effects acts as a limiting factor to its utilization especially in the long term. This article systematically reviews the published evidence on ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.660915
更新日期:2012-03-01 00:00:00
abstract:INTRODUCTION:Neuroendocrine neoplasms (NEN) represent a heterogeneous group of malignancies generally characterized by low proliferation and indolent course. However, about half of the newly diagnosed cases are metastatic and require long-term systemic therapies. Areas covered: This review revises the literature to sum...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1354984
更新日期:2017-10-01 00:00:00
abstract::Folic acid supplementation has drawn much attention in recent years for the prevention of Alzheimer's disease and cognitive decline. In this review, the authors describe how current evidence does not support the use of folic acid supplements to protect against cognitive decline. Although a few studies suggest that fol...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析
doi:10.1517/14740338.5.4.511
更新日期:2006-07-01 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
pub_type: 杂志文章
doi:10.1080/14740338.2020.1805428
更新日期:2020-09-01 00:00:00
abstract:INTRODUCTION:Drug-induced parkinsonism (DIP) is the second most common cause of parkinsonism after idiopathic Parkinson's disease (iPD). Initially reported as a complication of antipsychotics, it was later recognized as a common complication of antidepressants, calcium channel antagonists, gastrointestinal prokinetics,...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2013.787065
更新日期:2013-07-01 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
pub_type: 杂志文章
doi:10.1080/14740338.2019.1604682
更新日期:2019-05-01 00:00:00
abstract:INTRODUCTION:Aripiprazole is a third generation antipsychotic approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia. Aripiprazole is available as oral and long-acting injectable (LAI) depot formulations, with a unique mechanism of action comprising partial D2 and serotonin 5-HT1A agon...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1832990
更新日期:2020-12-01 00:00:00
abstract:INTRODUCTION:Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta s...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1247806
更新日期:2017-01-01 00:00:00
abstract::Treating bipolar disorder in women during reproduction presents a significant challenge to the physician. The pharmaceutical agents most commonly used for treating bipolar disorder have been associated with adverse effects when used during pregnancy and breastfeeding. Of particular concern has been the association of ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/eods.3.3.221.31074
更新日期:2004-05-01 00:00:00
abstract:INTRODUCTION:Pain management has become a widely discussed topic throughout all medical subspecialties. Although pediatric pain management has evolved significantly in its recent history, there is continued interest in the adequacy of pain treatment, both in the acute inpatient setting as well as the postoperative and ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2013.834045
更新日期:2014-01-01 00:00:00
abstract::Introduction: Clozapine remains the most effective antipsychotic for treatment-refractory schizophrenia. However, ~40% of the patients respond insufficiently to clozapine. Clozapine's effects, both beneficial and adverse, have been proposed to be partially attributable to its main metabolite, N-desmethylclozapine (NDM...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2020.1698545
更新日期:2020-01-01 00:00:00
abstract:INTRODUCTION:Many commonly used drugs have primary or secondary anticholinergic effects contributing to adverse outcomes ranging from mild-to-severe to potentially lethal. Anticholinergic adverse effects frequently occur with medications prescribed with other intended mechanisms of action, including antihistamines, ant...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.579899
更新日期:2011-09-01 00:00:00
abstract::NSAIDs are used extensively worldwide at a cost of billions of dollars annu-ally. Adverse side effects, especially in the gastrointestinal (GI) tract, are uncommon but cause a substantial burden of illness because of the volume of use. Important upper GI complications include dyspepsia, gastric erosions and peptic ulc...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.2.157
更新日期:2005-03-01 00:00:00
abstract:INTRODUCTION:Various limitations of unfractionated heparin (UFH) have triggered a search for new antithrombotic therapies for patients with coronary artery disease (CAD). Bivalirudin is a direct thrombin inhibitor with several pharmacological advantages over UFH and is currently endorsed by practice guidelines, particu...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.628312
更新日期:2012-01-01 00:00:00