Adverse Drug Event

Kapil K Khadka, Minjun Chen, Zhichao Liu, Weida Tong, Dong Wang
The emergence of high throughput in vitro assays has the potential to significantly improve toxicological evaluations and lead to more efficient, accurate, and less animal-intensive testing. However, directly using all available in vitro assays in a model is usually impractical and inefficient. On the other hand, mechanistic knowledge has always been critical for toxicological evaluations and should not be ignored even with the increasing availability of data. In this paper, we illustrate a promising approach to integrating mechanistic knowledge with multiple data sources for in vitro assays, using drug-induced liver injury (DILI) as an example...
November 2, 2019: ALTEX
Stefan M Nidorf, Aernoud T L Fiolet, John W Eikelboom, Astrid Schut, Tjerk S J Opstal, Willem A Bax, Charley A Budgeon, Jan G P Tijssen, Arend Mosterd, Jan H Cornel, Peter L Thompson
Because patients with stable coronary artery disease are at continued risk of major atherosclerotic events despite effective secondary prevention strategies, there is a need to continue to develop additional safe, effective and well-tolerated therapies for secondary prevention of cardiovascular disease. RATIONALE AND DESIGN: The LoDoCo (Low Dose Colchicine) pilot trial showed that the anti-inflammatory drug colchicine 0.5 mg once daily appears safe and effective for secondary prevention of cardiovascular disease...
October 20, 2019: American Heart Journal
Akifumi Kurata, Takafumi Yoshida, Megumi Inoue, Tomoko Ishizuka, Takafumi Nakatsu, Takako Shimizu, Manabu Kato, Yasuhiro Nishikawa, Hitoshi Ishizuka
INTRODUCTION: The mineralocorticoid receptor (MR) blocker esaxerenone is a new treatment for hypertension in Japan and under development for treatment of diabetic nephropathy. Hepatic impairment is known to impact the pharmacokinetics (PKs) of other MR blocking drugs. The aim of the present study was to characterise the PKs and safety of a single oral dose of esaxerenone in Japanese subjects with mild-moderate hepatic impairment. METHODS: In this open-label, parallel-group study, subjects with mild (Child-Pugh grade A) or moderate (grade B) hepatic impairment, and healthy controls with normal hepatic function matched by age and BMI (all groups n = 6), received a single 2...
November 8, 2019: Advances in Therapy
Nathan Kuehne, Lina Chen, Kate McDonald, Lisa Wang, Anna Spreafico, Aaron Hansen, Albiruni Ryan Abdul Razak, Philippe Lucien Bedard, Lillian L Siu, Daniel Shepshelovich
PURPOSE: Some patients who participate in early phase cancer trials enroll to more than one trial. Whether these patients have different characteristics or outcomes than patients who enroll to a single phase I trial is unknown. METHODS: The study included all patients who participated in the solid tumor drug development program of the Princess Margaret Cancer Centre, a specialized academic cancer center, from July 2014 to January 2017. Patients sequentially enrolled to multiple phase I trials were compared to those enrolled in a single trial according to demographics, clinical characteristics, reported toxicities and prognosis...
November 8, 2019: Cancer Chemotherapy and Pharmacology
Vanessa Mancini, Virginia Pensabene
Microfluidic-based technology attracts great interest in cell biology and medicine, in virtue of the ability to better mimic the in vivo cell microenvironment compared to conventional macroscale cell culture platforms. Recent Organs-on-chip (OoC) models allow to reproduce in vitro tissue and organ-level functions of living organs and systems. These models have been applied for the study of specific functions of the female reproductive tract, which is composed of several organs interconnected through intricate endocrine pathways and communication mechanisms...
November 7, 2019: Bioengineering
Jennifer B Griffin, Kathleen Ridgeway, Elizabeth Montgomery, Kristine Torjesen, Rachel Clark, Jill Peterson, Rachel Baggaley, Ariane van der Straten
The vaginal ring (VR) is a female-initiated drug-delivery platform used for different indications, including HIV pre-exposure prophylaxis (PrEP). We conducted a systematic review of VR acceptability, values and preferences among women in low- and middle-income countries (LMIC) to inform further investment and/or guidance on VR use for HIV prevention. Following PRISMA guidelines, we used structured methods to search, screen, and extract data from randomized controlled trials (RCTs) and observational studies reporting quantitative outcomes of acceptability of the VR for any indication published 1/1970-2/2019 (PROSPERO: CRD42019122220)...
2019: PloS One
Wen-Lei Wang, Na Aru, Zhi Liu, Xun Shen, Yi-Ming Ding, Shi-Ju Wu, Huai-Hai Qin, Wen-Yi Jin
BACKGROUND: Glioblastoma (GB) is one of the most common malignancies with limited standard therapies such as surgery, radiotherapy (RT) plus temozolomide (TMZ). Molecularly targeted drugs have been investigated among various clinical trials and are expected to develop in the field of tumor therapy, while the efficacy remains uncertain due to limited previous results. Thus, we focus on the evaluation of molecularly targeted drugs to clarify its overall effectiveness in terms of treating newly diagnosed GB...
November 2019: Medicine (Baltimore)
Jill S Borchert, Bo Wang, Muzaina Ramzanali, Amy B Stein, Latha M Malaiyandi, Kirk E Dineley
BACKGROUND: Patient online drug reviews are a resource for other patients seeking information about the practical benefits and drawbacks of drug therapies. Patient reviews may also serve as a source of postmarketing safety data that are more user-friendly than regulatory databases. However, the reliability of online reviews has been questioned, because they do not undergo professional review and lack means of verification. OBJECTIVE: We evaluated online reviews of hypnotic medications, because they are commonly used and their therapeutic efficacy is particularly amenable to patient self-evaluation...
November 8, 2019: Journal of Medical Internet Research
SungA Bae, Yongcheol Kim, Bill D Gogas, Min Chul Kim, Doo Sun Sim, Young Joon Hong, Ju Han Kim, Youngkeun Ahn, Myung Ho Jeong
BACKGROUND: Current guidelines recommend newer generation drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ischemic heart disease. However, there is no age-specific recommendation in elderly patients. METHODS: Meta-analysis was performed of 6 randomized studies enrolling 5,042 elderly patients who underwent percutaneous coronary intervention (PCI) with stent implantation (DES, n = 2,579; BMS, n = 2,463). RESULTS: Combined data indicated a significant reduction in major adverse cardiovascular events (MACEs) with use of DES (odds ratio [OR] 0...
November 8, 2019: Cardiology Journal
Peter J Goadsby, Soma Sahai-Srivastava, Eric J Kezirian, Anne H Calhoun, David C Matthews, Peter J McAllister, Peter D Costantino, Deborah I Friedman, John R Zuniga, Laszlo L Mechtler, Saurin R Popat, Ali R Rezai, David W Dodick
BACKGROUND: Chronic cluster headache is the most disabling form of cluster headache. The mainstay of treatment is attack prevention, but the available management options have little efficacy and are associated with substantial side-effects. In this study, we aimed to assess the safety and efficacy of sphenopalatine ganglion stimulation for treatment of chronic cluster headache. METHODS: We did a randomised, sham-controlled, parallel group, double-blind, safety and efficacy study at 21 headache centres in the USA...
December 2019: Lancet Neurology
Yusuke Kajimoto, Tsutomu Kitajima
Dengue guidelines for diagnosis, treatment, prevention, and control (WHO, 2011) recommend acetaminophen and isotonic fluid for patients with dengue infection but do not recommend nonsteroidal anti-inflammatory drugs (NSAIDs) and hypotonic fluid. Other research showed no evidence of efficacy of platelet infusion in prophylactic. This research aims to clarify to what extent dengue patients were managed in accordance with the guidelines in Japan. We extracted claim data of patients with either dengue fever (DF) or dengue hemorrhagic fever (DHF) from the National Database of Health Insurance Claims and Specific Health Checkups of Japan between 2011 and 2015...
November 4, 2019: American Journal of Tropical Medicine and Hygiene
Mohd Ashraf Ganie, Aafia Rashid, Mona Sood, Nighat Yaseen Sofi, Ishfaq A Wani, Sobia Nisar, Tabasum Parvaiz Butt, Nandita Gupta, Dilafroze Bhat, Naseer Choh, Shariq Rashid Masoodi
The aim of this study was to compare the efficacy and safety of adding metformin or spironolactone to rosiglitazone in women with polycystic ovary syndrome (PCOS). This is a prospective non-randomized study in a tertiary care with at in a tertiary care endocrine clinic. Women ( n  = 138) diagnosed with PCOS on the basis of Rotterdam criteria 2003 were categorized into three groups on the basis of drug intake as - rosiglitazone (R), rosiglitazone with spironolactone (R + S), and rosiglitazone with metformin (R + M)...
November 8, 2019: Gynecological Endocrinology
Zhonghan Zhang, Yuanyuan Zhao, Feiteng Lu, Xue Hou, Yuxiang Ma, Fan Luo, Kangmei Zeng, Shen Zhao, Yaxiong Zhang, Ting Zhou, Yunpeng Yang, Wenfeng Fang, Yan Huang, Li Zhang, Hongyun Zhao
Background: Four multi-targeted tyrosine kinase inhibitors (TKIs) including apatinib, anlotinib, fruquintinib and lenvatinib are currently available as third-line regimen for advanced non-small cell lung cancer (NSCLC) patients who failed at least two lines of systemic therapy. Limited evidence was provided to demonstrate the general efficacy and safety profile of these drugs as third-line treatment approach for NSCLC. Methods: Eligible literature was searched from electronic database...
September 2019: Annals of Translational Medicine
Silvio Danese, Ailsa Hart, Axel Dignass, Gionata Fiorino, Edouard Louis, Stefanos Bonovas, Geert D'Haens, Iris Dotan, Gerhard Rogler, Kristine Paridaens, Laurent Peyrin-Biroulet
Background: Cortiment®MMX® (budesonide MMX®) is currently approved for the induction of remission in mild-to-moderate ulcerative colitis (UC) patients when 5-ASA treatment is not sufficient. Data in real-life settings are lacking. Methods: This was a multicentre observational prospective cohort study conducted in Europe and Canada. Effectiveness, safety, and tolerability of Cortiment®MMX® in a real-life setting of patients treated for mild-to-moderate UC was investigated...
November 2019: United European Gastroenterology Journal
Ni Made Hustrini, Parlindungan Siregar, Arini Setiawati, Pringgodigdo Nugroho
BACKGROUND: treatment of erythropoietin (EPO) is essential in chronic kidney disease (CKD) patients to maintain optimal hemoglobin (Hb) level. Renogen is a biosimilar epoetin-α, and Eprex is the originator epoetin-α. This study aimed to compare the efficacy and tolerance of Renogen with Eprex in CKD anemia. METHODS: Renogen and Eprex were compared in a randomized (2:1), open-label study for 8 weeks, proceeded by 4 weeks adjustment (maintenance) phase, in anemic CKD patients undergoing HD in Cipto Mangunkusumo General Hospital, Jakarta, from June 2017 to October 2018...
July 2019: Acta Medica Indonesiana
Erni Juwita Nelwan
Human immunodeficiency virus (HIV) is one example of an emerging infection with total of 386 district of all province in Indonesia reported having such infection; with cumulative number of HIV infected patient from the year 1987 to 2014 is 150,296 while AIDS is 55,799 patients. The access to care only available for 153,887 patients among all HIV/AIDS patients of whom 70% are eligible for anti-retroviral (ARV) treatment and of these only half adhered to ARV treatment. In addition to that, there is an increased risk of other emerging diseases such as Zika virus, Monkey pox or Hanta pulmonary syndrome since a sporadic cases were reported around the region...
July 2019: Acta Medica Indonesiana
Abdullah A Alhifany, Abdulaali R Almutairi, Thamer A Almangour, Alaa N Shahbar, Ivo Abraham, Mohammed Alessa, Faris S Alnezary, Ejaz Cheema
OBJECTIVES: The risk of recurrent Clostridium difficile infections (RCDIs) is high when treated with standard antibiotics therapy (SAT) alone. It is suggested that the addition of faecal microbiota transplantation (FMT) or bezlotoxumab after SAT reduces the risk of RCDI. In the absence of head-to-head randomised controlled trials (RCTs), this review attempts to compare the efficacy and safety of bezlotoxumab with FMT in reducing the risk of RCDI in hospitalised patients. DESIGN: A systematic review and Bayesian network meta-analysis...
November 7, 2019: BMJ Open
Kartik Anand, Ethan A Burns, Joe Ensor, Lawrence Rice, Sai Ravi Pingali
BACKGROUND: Ruxolitinib is a selective Janus kinase inhibitor (JAKI) 1/2 approved for the treatment of myelofibrosis (MF) and polycythemia vera (PV). These patients may be at risk for developing opportunistic infections. We assessed the number of patients that developed typical (Mycobacterium tuberculosis [MTB]) and atypical mycobacterial infections (AMI) while on treatment with ruxolitinib by utilizing the United States Food and Drug Administration (FDA) adverse events reporting system (FAERS)...
August 26, 2019: Clinical Lymphoma, Myeloma & Leukemia
Marie-Line Menard, Susanne Thümmler, Marianna Giannitelli, Coralie Cruzel, Olivier Bonnot, David Cohen, Florence Askenazy
The main objective of ETAPE study was to determine the incidence of adverse events (AEs) potentially related to antipsychotic (AP) during a 12-months observational study of naturalistic treatment. ETAPE is a naturalistic prospective multicenter study conducted between April 2013 and May 2016. 200 patients were included. The mean age was 12 ± 3 years, with 73.6% being males. Patients presented a significant clinical improvement over time. At baseline, 92% of patients received a second generation AP, 74% AP monotherapy and 79...
November 4, 2019: European Neuropsychopharmacology: the Journal of the European College of Neuropsychopharmacology
Jin-Woo Park, Kyoung-Ah Kim, Hankil Son, Jina Jung, Ji-Young Park
BACKGROUND AND OBJECTIVE: Varenicline is an effective drug for smoking cessation. The aim of the present study was to compare the pharmacokinetics and safety profiles of two different varenicline formulations (varenicline tartrate (reference) and varenicline oxalate (test)), each containing 1 mg varenicline base in humans. MATERIALS AND METHODS: A randomized, open-label, two-sequence, two-period, single-dose crossover study with a 2-week washout period was conducted with 30 healthy male participants...
November 8, 2019: International Journal of Clinical Pharmacology and Therapeutics
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