Abstract:
OBJECTIVE:Further understand the safety profile of celecoxib and provide safety information for important adverse events (AEs). METHODS:Analysis of randomized controlled trials from the Pfizer clinical trial repository (final study reports completed by 31 July 2011) in which celecoxib was compared with placebo or non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) for treatment of pain or inflammation in adults. Safety end points comprised 18 terms that had been identified as important AEs among all NSAIDs. RESULTS:There was a greater risk of edema (risk difference (95% confidence interval) 0.77% (0.45, 1.09)); hypertension (0.28% (-0.01, 0.57)); angioedema (0.16% (-0.06, 0.39) and allergic reactions (0.15% (-0.10, 0.40)) with celecoxib than with placebo, while a greater risk of gastrointestinal (GI) hemorrhage (-0.15% (-0.47, 0.16)) was seen with placebo. There was a greater risk of GI hemorrhage (-0.53% (-0.72, -0.33)), GI ulceration (-0.46% (-0.60, -0.33)), edema (-0.62% (-0.89, -0.35)) and hypertension (-0.57% (-0.82, -0.33)) with nsNSAIDs than with celecoxib. CONCLUSIONS:The magnitude of risks associated with NSAIDs is small and similar in celecoxib-, nsNSAID- and placebo-treated patients. This analysis provides safety information that will allow physicians to make informed treatment decisions for patients who are appropriate candidates for celecoxib use.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Essex MN,Zhang RY,Berger MF,Upadhyay S,Park PWdoi
10.1517/14740338.2013.780595subject
Has Abstractpub_date
2013-07-01 00:00:00pages
465-77issue
4eissn
1474-0338issn
1744-764Xjournal_volume
12pub_type
杂志文章,meta分析abstract:INTRODUCTION:Cardiovascular disease remains the major contributor to morbidity and mortality in diabetes. From the need to reduce cardiovascular risk in diabetes and to ensure that such risk is not exacerbated by drug treatments, governmental regulators and drug manufacturers have focused on clinical trials evaluating ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1195368
更新日期:2016-09-01 00:00:00
abstract::Medication-induced oesophageal distress and injury have become increasingly common conditions. First, smooth muscle relaxants may worsen or produce symptoms of pre-existing gastro-oesophageal reflux disease; notable examples include certain calcium antagonists (nifedipine), nitrates, sildenafil, nicotine, theophylline...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2.5.495
更新日期:2003-09-01 00:00:00
abstract::Introduction: Treatment for chronic pruritus ranges from use of topical formulations to newer biologic agents. Targeting treatment to the underlying etiology is key in reducing the burden of disease while avoiding systemic or adverse effects.Areas covered: This review details the effective medical treatments used in v...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2020.1728252
更新日期:2020-04-01 00:00:00
abstract:INTRODUCTION:The goal of antiviral therapy in patients with chronic hepatitis C is to slow or halt the progression of fibrosis and prevent the development of cirrhosis. Accordingly, antiviral treatment is proposed for a large population of patients with chronic hepatitis. AREAS COVERED:The standard-of-care for chronic...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.559161
更新日期:2011-05-01 00:00:00
abstract:INTRODUCTION:Carbonic anhydrase (CA) inhibitors have an impressive safety record despite the multiple functions that CA isozymes serve because they are not fully inhibited with most dosing. While reducing the targeted CA-dependent process sufficiently for disease control, residual activity and uncatalyzed rates in comb...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.897328
更新日期:2014-04-01 00:00:00
abstract:INTRODUCTION:Trabectedin gained the approval by the European Medicines Agency (EMA) in 2007 for the treatment of patients affected by soft-tissue sarcomas (STS). Its safety and activity profiles have been assessed in many clinical trials as well as in standard clinical practice for > 10 years. AREAS COVERED:This artic...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2013.829037
更新日期:2013-11-01 00:00:00
abstract:BACKGROUND:Possible relationship between drug exposure and multiple sclerosis (MS) development is insufficiently investigated, and further challenged by the incomplete understanding of MS etiopathogenesis. The study aims to investigate whether drug exposure could contribute to MS, by analyzing worldwide spontaneous rep...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2018.1506763
更新日期:2018-09-01 00:00:00
abstract:OBJECTIVE:To review long-term safety data from the rollover study ETV-901, focusing on adverse events (AEs) with a potential nucleos(t)ide association. METHODS:The open-label study ETV-901 (AI463901) assessed the safety of entecavir in chronic hepatitis B patients who received entecavir, lamivudine or adefovir monothe...
journal_title:Expert opinion on drug safety
pub_type: 临床试验,杂志文章
doi:10.1517/14740338.2012.653340
更新日期:2012-05-01 00:00:00
abstract:OBJECTIVE:The aim of this study is to evaluate the safety of cephalosporins, based on utilization and adverse drug events (ADEs). METHODS:This is a retrospective study using data on cephalosporins, obtained from Yangtze River hospital drug information and the Wuhan adverse drug reactions monitoring center database, fr...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,多中心研究
doi:10.1517/14740338.2012.699037
更新日期:2012-09-01 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
pub_type: 杂志文章,评审
doi:10.1080/14740338.2020.1792442
更新日期:2020-08-01 00:00:00
abstract:INTRODUCTION:In settings where HIV is prevalent in heterosexual populations, pregnancy and postpartum breastfeeding periods can be associated with substantial HIV acquisition risk. Pre-exposure prophylaxis (PrEP) with daily oral tenofovir disoproxil fumarate (TDF)/emtricitabine is an attractive HIV prevention option fo...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1338271
更新日期:2017-07-01 00:00:00
abstract:INTRODUCTION:Niacin is one of the oldest drugs used in the treatment of dyslipidemia. Previously its use has been limited because of excessive flushing. Now an agent laropiprant (LRP) has been developed, which blocks the flushing pathway. Therefore, it is time to collate available information to assess the safety and t...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.638281
更新日期:2012-01-01 00:00:00
abstract::Introduction: Secukinumab is a fully human monoclonal antibody which targets and neutralizes interleukin (IL)-17A, a cytokine that plays an important role in the pathophysiology of ankylosing spondylitis (AS). Secukinumab is the first IL-17A inhibitor approved for the treatment of AS. Areas covered: This paper aimed t...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2021.1851363
更新日期:2021-01-20 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: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::Aspirin use is associated with gastroduodenal mucosal damage and increased risk of upper gastrointestinal (GI) bleeding. Many aspirin users should receive prophylactic treatment since they often have several risk factors for upper GI complications. The best therapeutic approach for reducing GI toxicity in low-dose asp...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.1.3.245
更新日期:2002-09-01 00:00:00
abstract::Methadone is an interesting analgesic for multiple reasons. The unique properties of the agent, low cost and widespread availability have led to increases in methadone prescribing. Despite advantages, methadone is challenging to work with, particularly in patients with high opioid requirements. Recent concerns regardi...
journal_title:Expert opinion on drug safety
pub_type: 社论
doi:10.1517/14740338.7.1.5
更新日期:2008-01-01 00:00:00
abstract:INTRODUCTION:To discuss the significance of the recent observational case series from the Swiss Toxicological Information Centre (STIC). Mycophenolic acid (MPA) and its prodrug mycophenolate mofetil are immunosuppressive agents that are frequently prescribed in renal transplant recipients, and their safety profiles mus...
journal_title:Expert opinion on drug safety
pub_type: 评论,社论
doi:10.1517/14740338.2014.905540
更新日期:2014-05-01 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:Conjugated equine estrogens (CEE) are widely used for the treatment of menopausal symptoms, such as vasomotor symptoms and vulvovaginal atrophy, and for the prevention of bone loss, in postmenopausal women. The safety profile of CEE has been extensively published over the past 20 years. AREAS COVERED:Data...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2013.824965
更新日期:2014-01-01 00:00:00
abstract:INTRODUCTION:Approximately 40-50% of patients with cutaneous melanoma harbor point mutations in BRAF. BRAF and MEK inhibitors in combination are now a standard therapy for advanced BRAFV600-mutated melanoma. Nevertheless, survival rates with the combination are limited, highlighting the need for further therapeutic imp...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1817376
更新日期:2020-10-01 00:00:00
abstract:INTRODUCTION:Alemtuzumab is a humanised anti-CD52 mAb which has recently been licensed for the treatment of relapsing multiple sclerosis in Europe. AREAS COVERED:The efficacy and safety of alemtuzumab from open label, Phase II and Phase III trials is reported. EXPERT OPINION:Alemtuzumab causes rapid and profound comp...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.928691
更新日期:2014-08-01 00:00:00
abstract::Millions of women worldwide use the combined oral contraceptive pill as an effective form of contraception. However, the focus on its side effects to date has mainly been on physical aspects, even though the most commonly stated reason for discontinuation is depression. There are surprisingly few large studies investi...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.4.371
更新日期:2007-07-01 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: Patients living with schizophrenia have a marked risk of clinically significant weight gain and obesity compared to the general population. The risks have been highlighted following the introduction of second-generation antipsychotics. In turn, obesity is associated with a higher prevalence of cardiovasc...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1674809
更新日期:2019-12-01 00:00:00
abstract::Drug-induced aseptic meningitis (DIAM) is an important entity. This article reviews the literature on this rare idiosyncratic event which may occur after local or systemic drug administration. The data on this adverse reaction is predominantly collated from anecdotal case reports and case series. ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.2.285
更新日期:2005-03-01 00:00:00
abstract:INTRODUCTION:The Annual Meeting of the Safety Pharmacology (SP) Society is a yearly event designed to keep attendees abreast of how to best identify and mitigate organ function liabilities of candidate drugs selected for clinical assessment. AREAS COVERED:Heart rate (HR) and blood pressure (BP) effects of candidate dr...
journal_title:Expert opinion on drug safety
pub_type:
doi:10.1517/14740338.2015.1034104
更新日期:2015-06-01 00:00:00
abstract:BACKGROUND:The abuse and diversion of pharmacological agents with CNS mechanisms of action is an important concern from governmental, regulatory, public health and safety perspectives. In recent years, there have been an increased number of reports concerning the abuse and diversion of quetiapine in forensic population...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740330802496883
更新日期:2008-11-01 00:00:00
abstract:INTRODUCTION:A growing number of children globally are being treated for multidrug-resistant tuberculosis (MDR-TB). The second-line injectable antituberculosis medications amikacin, kanamycin and capreomycin, traditionally a mainstay of MDR-TB treatment, cause important adverse effects including permanent sensorineural...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1223623
更新日期:2016-11-01 00:00:00
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 appli...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2018.1535592
更新日期:2018-11-01 00:00:00