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Journal Expert Opin Drug Saf

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Cardiovascular safety risks associated with gout treatments.

Giovanna Rosas, Angelo Gaffo, Elizabeth J Rahn, Kenneth G Saag,

INTRODUCTION:Uric acid is the final byproduct of purine metabolism. Along the evolutionary process, the loss of the enzyme that hydrolyzes uric acid to allantoin was lost, leading to a decrease in uric acid excretion and its further accumulation. The buildup of uric acid leads to damage in different organ systems, ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :]

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A real-world disproportionality analysis of FDA Adverse Event Reporting System (FAERS) events for baricitinib.

Ling Peng, Kui Xiao, Silvia Ottaviani, Justin Stebbing, Ying-Jie Wang,

BACKGROUND:Baricitinib is approved for the treatment of rheumatoid arthritis (RA). The authors retrospectively investigated adverse events (AEs) by data-mining a self-reporting database to better understand toxicities, especially since it has been used during the coronavirus disease 2019 (COVID-19) pandemic. METHODS:A reporting odds ratio (ROR) was used to detect the risk ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-7]

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Statin use and safety concerns: an overview of the past, present, and the future.

Rubina Mulchandani, Tanica Lyngdoh, Ashish Kumar Kakkar,

INTRODUCTION:Dyslipidemia is a significant risk factor for cardiovascular disorders and contributes to significant morbidity and mortality associated with CAD and stroke worldwide. Statins are the most commonly prescribed drugs for the prevention and management of dyslipidemia globally. Although they provide immense therapeutic benefit, they are associated with clinically significant adverse ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-14]

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Safety considerations with targeted therapy drugs for B-cell non-Hodgkin lymphoma.

Shinichi Makita, Rika Hosoba, Kensei Tobinai,

INTRODUCTION:B-cell non-Hodgkin lymphomas (B-NHLs) are the most frequent hematologic malignant cancers. Molecular targeted therapy is an important aspect of B-NHL treatment alongside cytotoxic chemotherapy, radiotherapy, and immunotherapy. AREAS COVERED:Molecular targeted therapies have changed the landscape of treatment strategies for B-NHLs since the approval of rituximab, an anti-CD20 monoclonal antibody, by ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :]

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Stakeholders' perspectives on a patient-reported outcome measure-based drug safety monitoring system for immune-mediated inflammatory diseases.

Leanne J Kosse, Naomi T Jessurun, Harald E Vonkeman, Sander W Tas, Mike T Nurmohamed, Frank Hoentjen, Martijn B A van Doorn, Eugène P van Puijenbroek, Bart J F van den Bemt, Marieke de Vries,

BACKGROUND:Biologics are used as effective therapeutics to treat a variety of diseases. Even though biologics are widely used, knowledge on the post-marketing experience of patients is limited. Therefore, a framework was established for a patient-reported outcome measure (PROM)-based drug safety monitoring system for ADRs attributed to biologics, known as the ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :]

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Impact of adverse event reports from marketing authorization holder-sponsored patient support programs on the performance of signal detection in pharmacovigilance.

Inyoung Lee, Todd A Lee, Stephanie Y Crawford, Ryan D Kilpatrick, Gregory S Calip, Jeremy D Jokinen,

OBJECTIVES:Marketing authorization holder (MAH)-sponsored patient support programs (PSPs) are a major source of adverse event (AE) reports. The impact of reports from PSPs on the ability to detect AE signals is unclear. We compared signal detection performance using data from PSPs vs. non-PSP sources, and between PSPs providing clinical services ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-10]

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Safety, efficacy, and tolerability of systemic therapies in male breast cancer: are there sex-specific differences?

Siddhartha Yadav, Karthik V Giridhar, Jodi Taraba, Roberto Leon-Ferre, Kathryn J Ruddy,

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-4]

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Rationale and design of a European epidemiological post-authorization safety study (PASS) program: rivaroxaban use in routine clinical practice.

Luis Alberto García-Rodríguez, Mari-Ann Wallander, Leif Friberg, Ana Ruigomez, Tania Schink, Irene Bezemer, Ron Herings, Saad Shakir, Alison Evans, Miranda Davies, Kiliana Suzart-Woischnik, Pareen Vora, Yanina Balabanova, Montse Soriano-Gabarró, Gunnar Brobert,

BACKGROUND:Rivaroxaban is a highly selective factor Xa inhibitor approved for use in Europe for multiple indications. STUDY DESIGN AND METHODS:The European rivaroxaban epidemiological post-authorization safety study (PASS) program consists of seven complementary observational studies. For four of the studies, data are obtained from healthcare databases in the UK, the Netherlands, ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :]

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Cilastatin as a protective agent against drug-induced nephrotoxicity: a literature review.

Mersedeh Shayan, Sepideh Elyasi,

INTRODUCTION:Cilastatin, a dehydropeptidase I inhibitor, has been used alongside imipenem, a broad spectrum antibiotic, in order to reduce its renal metabolism, consequently increasing its urinary recovery and effectiveness for many years. However, this measure could be useful in preventing imipenem-induced renal damage and decreasing the number of nephrotoxicity reports with ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-11]

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The HLA-B*13:01 and the dapsone hypersensitivity syndrome in Korean and Asian populations: genotype- and meta-analyses.

Hye Jung Park, Jung-Won Park, Sae Hoon Kim, So-Yun Choi, Hee-Kyoo Kim, Chang-Gyu Jung, Min-Suk Yang, Dong Yoon Kang, Min-Kyoung Cho, Hyouk-Soo Kwon, Hye-Ryun Kang, Yong Won Lee,

BACKGROUND:The human leukocyte antigen (HLA)-B*13:01 were reported as an important risk factor for dapsone hypersensitivity syndrome (DHS) in Chinese and Thai populations. RESEARCH DESIGN AND METHODS:From the Korean nationwide registry, seven subjects with previous DHS were included. Their HLA allele/phenotype frequencies were compared with 8 dapsone-tolerant subjects recruited from a ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :]

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Up-to-date expert opinion on the safety of recently developed antipsychotics.

Laura Orsolini, Domenico De Berardis, Umberto Volpe,

Introduction There are several new and emerging antipsychotic medication strategies recently marketed or under clinical development for the treatment of several mental disorders. There is the need to provide an up-to-date overview on the safety of this new generation of antipsychotic medications, which includes also the third-generation antipsychotics (TGA). Areas ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-17]

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Wound healing adverse events in kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care: insights from the 24-month TRANSFORM study.

Franco Citterio, Mitchell Henry, Dean Y Kim, Myoung Soo Kim, Duck-Jong Han, Takashi Kenmochi, Eytan Mor, Giuseppe Tisone, Peter Bernhardt, Maria Pilar Hernandez Gutierrez, Yoshihiko Watarai,

OBJECTIVES:In TRANSFORM, de novo kidney transplant recipients received either everolimus in combination with reduced-exposure calcineurin inhibitor (EVR+rCNI) at standard EVR pre-dose concentrations of 3-8 ng/mL or mycophenolic acid plus standard-exposure CNI (MPA+sCNI). The authors analyzed the incidence of wound healing adverse events (WHAEs) over the 2-year study period. METHODS:Patients were randomized ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-10]

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A drug safety evaluation of atezolizumab in locally advanced or metastatic urothelial carcinoma.

Panagiota Economopoulou, Ioannis Kotsantis, Aristotelis Bamias,

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 criteria for cisplatin ineligibility. Atezolizumab is a monoclonal antibody ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-6]

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Postmenopausal hormone therapy in BRCA gene mutation carriers: to whom and which?

Giovanni Grandi, Martina Caroli, Laura Cortesi, Angela Toss, Giovanni Tazzioli, Fabio Facchinetti,

INTRODUCTION:Risk-reducing-salpingo-oophorectomy (RRSO) inevitably leads BRCA mutation carriers to premature menopause. AREAS COVERED:To evaluate the existing evidence for use of postmenopausal hormone therapy (HT) in BRCAmc, after RRSO or menopause occurring naturally, for both breast cancer (BC) survivors and those without BC. EXPERT OPINION:All BC survivors are excluded from any HT ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-6]

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Psychotropic drug concentrations and clinical outcomes in children and adolescents: a systematic review.

Sanne M Kloosterboer, Denise Vierhout, Jana Stojanova, Karin M Egberts, Manfred Gerlach, Gwen C Dieleman, Manon H J Hillegers, Kimberly M Passe, Teun van Gelder, Bram Dierckx, Birgit C P Koch,

INTRODUCTION:The use of psychotropic drugs in children and adolescents is widespread but associated with suboptimal treatment effects. Therapeutic drug monitoring (TDM) can improve safety of psychotropic drugs in children and adolescents but is not routinely performed. A major reason is that the relationship between drug concentrations and effects is not ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-17]

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Immune-mediated inflammatory disease patients' preferences in adverse drug reaction information regarding biologics.

Leanne J Kosse, Gerda Weits, Harald E Vonkeman, Phyllis I Spuls, Bart J F Van Den Bemt, Sander W Tas, Frank Hoentjen, Mike T Nurmohamed, Martijn B A Van Doorn, Eugène P Van Puijenbroek, Naomi T Jessurun,

OBJECTIVES:Patient-reported outcomes (PROs) are increasingly used in studies and medical practice to obtain information on patients' perspectives toward their treatment or disease. However, most study outcomes are primarily directed at healthcare professionals. It was aimed to obtain insight in which type of information immune-mediated inflammatory disease (IMID) patients prefer to ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-5]

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Correction.

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1]

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The effects of atorvastatin and rosuvastatin on exercise tolerance in patients with coronary heart disease.

Dan Liu, Tao Shen, Chuan Ren, Shunlin Xu, Lequn Zhou, Jin Bai, Nan Li, Wei Zhao, Wei Gao,

OBJECTIVES:This study was aimed to analyze the effects of atorvastatin and rosuvastatin and different lipid-lowering intensity treatments on exercise tolerance in patients with coronary heart disease (CHD). METHODS:A retrospective analysis was conducted in 549 patients with CHD who underwent cardiopulmonary exercise testing (CPET) from February 2014 to August 2018. The ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-6]

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Biologics in the treatment of pustular psoriasis.

Wen-Ming Wang, Hong-Zhong Jin,

INTRODUCTION:Pustular psoriasis is a group of skin diseases characterized by neutrophil infiltration in the epidermis and formation of sterile pustules. Conventional treatments, such as retinoids and immunosuppressive drugs, have improved the clinical manifestations; however, many patients suffer from drug-related toxicity or are resistant to therapy. AREAS COVERED:In this review, the ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-11]

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Safety and tolerability of empagliflozin and linagliptin combination therapy in patients with type 2 diabetes mellitus: a pooled analysis of data from five randomized, controlled clinical trials.

Hirotaka Watada, Toshimasa Yamauchi, Fumiko Yamamoto, Atsushi Taniguchi, Larisa Yarush, Clemens Heilmann, Atsutaka Yasui,

OBJECTIVES:The fixed-dose combination of empagliflozin and linagliptin, two glucose-lowering drugs prescribed for type 2 diabetes mellitus, has demonstrated good tolerability in phase III clinical trials. To further evaluate the safety profile of this combination, the data from these trials were pooled and analyzed. METHODS:This was a post-hoc pooled analysis of ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-10]

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Correction.

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-3]

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Utilizing drug-target-event relationships to unveil safety patterns in pharmacovigilance.

Alexander Sebastian Hauser, Albert Jelke Kooistra, Eva Sverrisdóttir, Maurizio Sessa,

INTRODUCTION:Signal detection is the most pivotal activity of signal management to guarantee that drugs maintain a positive risk-benefit ratio during their lifetime on the market. Signal detection is based on the systematic evaluation of available data sources, which have recently been extended in order to improve timely and comprehensive signal ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-7]

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Abemaciclib: safety and effectiveness of a unique cyclin-dependent kinase inhibitor.

Vittorio Gebbia, Maria Rosaria Valerio, Alberto Firenze, Paolo Vigneri,

INTRODUCTION:The discovery and the clinical availability of novel cyclin-dependent kinases 4 and 6 inhibitors have profoundly changed the therapeutic scenario of metastatic hormone receptor-positive breast carcinoma. Among these inhibitors, abemaciclib can induce potent and sustained cell cycle arrest and immune system stimulation. AREAS COVERED:This review summarizes the safety profile and ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-9]

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Adverse drug reactions in adolescents: a review of reporting to a national pharmacovigilance system.

Eva Rebelo Gomes, Inês Ribeiro-Vaz, Cristina Costa Santos, Maria Teresa Herdeiro,

OBJECTIVE:Adverse drug reactions (ADR) cause significant morbidity, mortality and health costs and have an important prevalence in all ages. Few studies focus on ADR in adolescents. The goal of this study was to characterize a case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) of the National Authority ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-8]

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Neonatal fluid and electrolytes profile effect on amphotericin B associated nephrotoxicity in neonatal tertiary care unit of Karachi-Pakistan.

Gul Ambreen, Arshalooz Rehman, Kashif Hussain, Mehreen Sohail, Saba Javed, Syed Shamim, Umer Ali, Khalil Ahmad, Arjumand Rizvi,

OBJECTIVES:Amphotericin-B (d-AmB) has a broader anti-fungal spectrum and is used for neonatal invasive-fungal-infections especially invasive-candidiasis (IC). To prevent d-AmB-induced nephrotoxicity, renal protective effect of fluid and electrolyte management has been established among adults; in this study, the authors determined this effect among neonates. METHODS:In this retrospective cohort study, the authors ... Read more >>

Expert Opin Drug Saf (Expert opinion on drug safety)
[2020, :1-9]

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