Abstract:
INTRODUCTION:Evolocumab is an injectable, fully human monoclonal antibody and a member of the newest class of low density lipoprotein cholesterol (LDL-C) lowering agents called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. The PCSK9 inhibitors are the most significant advance in lipid therapy since the introduction of the first statin 30 years ago. Areas covered: The PCSK9 monoclonal antibodies have demonstrated a consistently high LDL-C lowering efficacy with and without statins and/or other lipid lowering therapies (LLT). LDL-C levels achieved with these agents are lower than has ever been possible before. This review will focus on the overall safety of evolocumab including cognitive impairment, very low LDL-C levels, new onset diabetes and glucose abnormalities, effect on vitamin E and steroid hormones, liver and muscle abnormalities, and immunogenicity and injection site reactions. The phase II and III clinical trials had relatively low patient-years of exposure, but the open label extension studies and the recently published outcomes trial, FOURIER, will be the focus of this paper. The safety profile of evolocumab to date is remarkable and extremely encouraging as will be demonstrated. Expert opinion: The PCSK9 inhibitors will be responsible for a new era in lipid therapy that will expand our knowledge of lipid levels and cardiovascular disease (CVD) prevention with an efficacy and safety profile not previously available in clinical practice.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Roth EMdoi
10.1080/14740338.2018.1389892subject
Has Abstractpub_date
2018-01-01 00:00:00pages
99-106issue
1eissn
1474-0338issn
1744-764Xjournal_volume
17pub_type
杂志文章,评审abstract:BACKGROUND:To perform an international comparison and analysis of celecoxib spontaneous adverse event reports (AERs) from Canada, Australia and the United States, focusing on gastrointestinal, renal and cardiovascular events. This study also examined concomitant medicines use which may have potentiated the risk of the ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1589447
更新日期:2019-03-01 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:Over 39,000 diabetic patients are surgically treated for trauma and orthopaedic injuries annually in the UK, yet the effects of diabetic medications on the skeletal system is an under researched and under acknowledged field. AREAS COVERED:This review covers all English language novel experimental data rep...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.639359
更新日期:2012-03-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.2016.1167186
更新日期:2016-06-01 00:00:00
abstract::This review aims to give an updated overview of the worldwide situation of off-label and unlicensed drug use in the paediatric field, also taking into account the safety of this kind of treatment. A Medline and Embase search was performed between 1990 and 2006 and a total of 52 studies were identified and included in ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.5.5.703
更新日期:2006-09-01 00:00:00
abstract::Introduction: Psoriasis is a chronic inflammatory systemic disease that affects 2% of the population and is associated with an important physical and physiological burden. About 0.5-2% of psoriatic cases onset during the pediatric age range, and often it's not diagnosed until adulthood. Adalimumab is an antitumor necr...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2020.1752659
更新日期:2020-04-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.7.5.579
更新日期:2008-09-01 00:00:00
abstract::Background: The safety and effectiveness of vonoprazan-based Helicobacter pylori (H. pylori) eradication therapy in routine clinical practice, and patient characteristics that influence safety and effectiveness, have not been well investigated.Methods: H. pylori-positive patients with gastric ulcer, duodenal ulcer, id...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1676722
更新日期:2019-12-01 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:INTRODUCTION:Secondary preventative therapies are essential for patients undergoing coronary artery bypass graft (CABG) surgery to optimize perioperative and long-term outcomes. Beta-blockers are commonly used to treat patients with coronary artery disease and congestive heart failure (CHF), but their role for CABG pat...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2018.1504019
更新日期:2018-08-01 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::The epidemiology, natural history and efficacy of treatment for chronic hepatitis C in children are presented. An increase in the number of vertical infections of this etiology is suggested. In children, especially in those vertically infected, spontaneous elimination of hepatitis C virus (HCV) is observed more often ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2015.1005599
更新日期:2015-03-01 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: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: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 schizoph...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1288716
更新日期:2017-03-01 00:00:00
abstract:BACKGROUND:Clinical data on the long-term safety and efficacy of infliximab on psoriatic patients who are older than 65 years are limited. OBJECTIVES:The aim is to report the long-term efficacy, safety and tolerance of infliximab in geriatric patients. METHODS:This was a retrospective study conducted at the Departmen...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2016.1226279
更新日期:2016-11-01 00:00:00
abstract:INTRODUCTION:Over the past decade, increased prescription supply has facilitated an epidemic of nonmedical use of controlled substances, including predominantly opioids, as well as benzodiazepines, z-hypnotics, and stimulants. Areas covered: More recently, misuse of noncontrolled prescriptions, such as gabapentin, has ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2017.1390081
更新日期:2018-05-01 00:00:00
abstract:BACKGROUND:Literature regarding acute human toxicity of mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS) is limited. OBJECTIVES:Our objectives were to describe all cases of overdose with MMF or EC-MPS reported to the Swiss Toxicological Information Centre (STIC) or in the literature between...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析,评审
doi:10.1517/14740338.2014.903032
更新日期:2014-05-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.1.1.53
更新日期:2002-05-01 00:00:00
abstract::Objectives: Bullous pemphigoid, an autoimmune dermatological disease, may be associated with the use of a relatively new anti-cancer drug class, PD-1 inhibitors, which includes pembrolizumab and nivolumab. This paper analyzes the signals between PD-1 inhibitors and bullous pemphigoid based upon the reported real-world...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1619693
更新日期:2019-07-01 00:00:00
abstract:INTRODUCTION:The approval of sofosbuvir (SOF), a nucleotide analogue NS5B polymerase inhibitor, and ledipasvir (LDV), a NS5A inhibitor, marked a new chapter in IFN and ribavirin-free treatment of hepatitis C virus (HCV). This drug reduces adverse events associated with IFN therapy. AREAS COVERED:The purpose of this pa...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2015.1053868
更新日期:2015-08-01 00:00:00
abstract:INTRODUCTION:Cardiac injury is one of the most impairing side effects of anticancer treatment. The extension of the range of available drugs, the use of combination regimens and the association with radiation therapy have improved life expectancy; however, they have also caused a rising typology of cardiac toxicities, ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.705826
更新日期:2012-09-01 00:00:00
abstract:INTRODUCTION:Hepatitis C virus is a hepatotropic virus that generally leads to chronic hepatitis and various harmful sequelae. The lone standard of treatment has been pegylated interferon and ribavirin, which produces a modest response and many side effects. However, a new era of management was declared with the introd...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1240781
更新日期:2016-12-01 00:00:00
abstract:INTRODUCTION:Nephrotoxicity is generally considered as the most clinically significant adverse reaction of amphotericin B, and has been reported in up to 80% of amphotericin B recipients during the first 2 weeks of treatment. Numerous experimental and clinical investigations have been performed over the past 4 decades,...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.721775
更新日期:2012-11-01 00:00:00
abstract:OBJECTIVE:To analyze the extent to which Spanish leaflets and drug information on the Net met quality criteria. RESEARCH DESIGN AND METHODS:A descriptive study was conducted comparing readability (REA) and comprehensibility (COM) criteria of a random sample of 77 marketed products of the 12 active ingredients most fre...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2013.744965
更新日期:2013-01-01 00:00:00
abstract::Most available antimalarial drugs induce cardiac side effects. These side effects include various mild heart rate changes (amodiaquine) to excessive prolongation of the QT interval (halofantrine) which may lead to lethal arrhythmias such as Torsade de Pointes (TdP). The cellular mechanism of such events during antimal...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.3.421
更新日期:2005-05-01 00:00:00
abstract:INTRODUCTION:The MAPK pathway is a signaling network that plays a key role in many normal cellular processes and in a large number of human malignancies. One of its effectors, MEK, is essential for the carcinogenesis of different tumors. In recent years, several drugs able to inhibit MEK have been assessed in clinical ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.892578
更新日期:2014-04-01 00:00:00
abstract::The use of warfarin in the elderly, particularly for stroke prevention in chronic atrial fibrillation, is steadily increasing. Although the benefits of warfarin are greatest in the elderly, so are the risk of adverse outcomes and the difficulties of anticoagulant management. Clinical systems need to improve to counter...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.5.3.417
更新日期:2006-05-01 00:00:00
abstract::The non-nucleoside analogue inhibitor of the reverse transcriptase, efavirenz (EFV), has become commonly used in highly active antiretroviral combination therapy in the treatment of HIV infection. Although being effective in suppressing plasma viral load, neuropsychiatric side effects have been reported in individuals...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.2.147
更新日期:2007-03-01 00:00:00
abstract:INTRODUCTION:Bone strength determinants such as bone mineral density and bone quality parameters are determined by life-long remodeling of skeletal tissue. Denosumab is a fully human mAb receptor activator of NF-κB ligand, which selectively inhibits osteoclastogenesis, the end product of a cascade interaction among num...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2010.516249
更新日期:2011-03-01 00:00:00