Clinical safety of the selective PKC-beta inhibitor, ruboxistaurin.

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：: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

authors： Aragona P,Di Pietro R

更新日期：2007-01-01 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

authors： Knechtel SA,Klepser ME

更新日期：2007-09-01 00:00:00

abstract：INTRODUCTION:Hydroxychloroquine (HCQ) is an alkalinizing lysosomatropic drug that accumulates in lysosomes where it inhibits some important functions by increasing the pH. HCQ has proved to be effective in a number of autoimmune diseases including systemic lupus erythematosus (SLE). Areas covered: In this review the me...

journal_title：Expert opinion on drug safety

authors： Ponticelli C,Moroni G

更新日期：2017-03-01 00:00:00

abstract：INTRODUCTION:The polycystic ovary syndrome (PCOS) is a very prevalent disorder in premenopausal women. Cardiovascular risk factors cluster in these patients, raising concern about the safety of the drugs commonly used to ameliorate symptoms of androgen excess in in this population at risk of cardiovascular morbidity. ...

journal_title：Expert opinion on drug safety

authors： Luque-Ramírez M,Ortiz-Flores AE,Nattero-Chávez L,Escobar-Morreale HF

更新日期：2020-12-01 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

authors： Swenson ER

更新日期：2014-04-01 00:00:00

abstract：:Given the fact that as many as 9% of all adverse drug reactions involve toxic effects on the liver and with upwards of 50% of all cases of fulminant hepatic failure being ascribed to acetaminophen and other agents, the safe use of medications takes on an even greater importance whenever the prescription of potentially...

journal_title：Expert opinion on drug safety

authors： Lewis JH

更新日期：2002-07-01 00:00:00

abstract：:Psychosis in Alzheimer's disease is common and troublesome. The impact on the quality of life of both patients and caregivers is high and drug treatments raise concern in terms of both efficacy and safety. Therefore, identifying the risk factors that play an important role in the onset of psychosis is mandatory for th...

journal_title：Expert opinion on drug safety

authors： Cancelli I,Beltrame M,D'Anna L,Gigli GL,Valente M

更新日期：2009-09-01 00:00:00

abstract：INTRODUCTION:Pomalidomide, a derivative of thalidomide and member of the immunomodulatory drugs is licenced for use in relapsed and refractory multiple myeloma (RRMM) in Europe, USA, Canada and Japan. AREAS COVERED:This review details all published trials in which pomalidomide has been used in the treatment of myeloma...

journal_title：Expert opinion on drug safety

authors： Jones JR,Pawlyn C,Davies FE,Morgan GJ

更新日期：2016-01-01 00:00:00

abstract：OBJECTIVE:The aim of this study was to investigate whether the use of statins was associated with breast cancer risk. BACKGROUND:Experimental studies have shown that statins have potential protective effects against cancer. METHODS:We conducted a population-based case-control study in Taiwan. Cases consisted of all p...

journal_title：Expert opinion on drug safety

authors： Chan TF,Wu CH,Lin CL,Yang CY

更新日期：2014-03-01 00:00:00

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：OBJECTIVES:To describe the cumulative incidences of adverse drug reactions (ADRs) associated with disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients from real-world data (RWD), using the DREAM-RA registry, and to compare these with incidence frequencies mentioned in the Summary of Pro...

journal_title：Expert opinion on drug safety

authors： Giraud EL,Jessurun NT,van Hunsel FPAM,van Puijenbroek EP,van Tubergen A,Ten Klooster PM,Vonkeman HE

更新日期：2020-12-01 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

authors： Mugwanya KK,John-Stewart G,Baeten J

更新日期：2017-07-01 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

authors： Mirkin S,Komm BS,Pickar JH

更新日期：2014-01-01 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

authors： Martin DP,Bhalla T,Beltran R,Veneziano G,Tobias JD

更新日期：2014-01-01 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：: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:Although antidepressant (AD) monotherapy is recommended first-line for major depressive disorder (MDD), AD + AD co-treatment is common. AREAS COVERED:We conducted the first systematic review searching PubMed/MEDLINE/PsycInfo/Embase from database inception until 1 June 2015 for acute randomized trials in ≥...

journal_title：Expert opinion on drug safety

authors： Galling B,Calsina Ferrer A,Abi Zeid Daou M,Sangroula D,Hagi K,Correll CU

更新日期：2015-10-01 00:00:00

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 ...

journal_title：Expert opinion on drug safety

authors： Roth EM

更新日期：2018-01-01 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

authors： van Soest EM,Dieleman JP,Kuipers EJ

更新日期：2008-03-01 00:00:00

abstract：INTRODUCTION:Adult onset Still disease (AOSD) is a rare systemic inflammatory condition. The clinical spectrum of this disease ranges from self-limiting forms with mild symptoms to life-threatening cases. Glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) represent the first line of therapy for AOSD, wi...

journal_title：Expert opinion on drug safety

authors： Cavalli G,Farina N,Campochiaro C,Baldissera E,Dagna L

更新日期：2020-12-01 00:00:00

abstract：:The widespread application of protocols using gonadotropin-releasing hormone (GnRH) agonists or antagonists in assisted reproduction treatment has led to an increasing number of pregnancies exposed to these drugs. This issue has raised scepticism as to the safety of these medications, concerning both pregnant women an...

journal_title：Expert opinion on drug safety

authors： Tarlatzis BC,Bili H

更新日期：2004-01-01 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: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：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

authors： Ceschi A,Gregoriano C,Rauber-Lüthy C,Kupferschmidt H,Banner NR,Krähenbühl S,Taegtmeyer AB

更新日期：2014-05-01 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：:This review examines current knowledge regarding the safety of probiotic bacteria in man. Tighter and more comprehensive standards and regulations will be developed as probiotic therapy moves from a limited number of products used in the food industry, into more defined therapeutic categories and more complex organism...

journal_title：Expert opinion on drug safety

authors： Henriksson A,Borody T,Clancy R

更新日期：2005-11-01 00:00:00

abstract：:Introduction: Lacosamide has been used in epilepsy patients in the United States, Europe and Asia since it was approved by the FDA in 2008. Many patients have benefited from this drug as a new generation of sodium channel blocker. With the worldwide use of this drug, its adverse effects have gradually emerged, especia...

journal_title：Expert opinion on drug safety

authors： Li J,Sun M,Wang X

更新日期：2020-02-01 00:00:00

abstract：IMPORTANCE OF THE FIELD:HIV-infection has become a chronic disease in paediatric patients with the potential for long-term survival and exposure to antiretroviral (ARV) therapies for 2 decades longer than HIV-infected adults. On the other hand, the administration of ARV to HIV-infected pregnant women has greatly increa...

journal_title：Expert opinion on drug safety

authors： Viganò A,Cerini C,Pattarino G,Fasan S,Zuccotti GV

更新日期：2010-05-01 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

authors： El Kassas M,Elbaz T,Hafez E,Esmat G

更新日期：2016-12-01 00:00:00