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Drugs in R&D

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https://www.readbyqxmd.com/read/28229376/the-pharmacogenetics-of-tacrolimus-in-corticosteroid-sparse-pediatric-and-adult-kidney-transplant-recipients
#1
Mads Juul Madsen, Troels K Bergmann, Kim Brøsen, Helle Charlotte Thiesson
INTRODUCTION: Tacrolimus is a calcineurin inhibitor used as an immunosuppressant drug in solid organ transplantation, and is mainly metabolized by cytochrome P450 (CYP) 3A4 and CYP3A5. Studies have shown an association between the CYP3A5 genotype and tacrolimus dose-adjusted trough concentrations. Variants in the genes PPARA, POR and CYP3A4 have recently been shown to influence tacrolimus metabolism. Furthermore, pharmacokinetic interaction between corticosteroid treatment and tacrolimus has been shown...
February 22, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28160230/risk-evaluation-and-mitigation-strategies-remss-are-they-improving-drug-safety-a-critical-review-of-remss-requiring-elements-to-assure-safe-use-etasu
#2
REVIEW
Pol F Boudes
Risk Evaluation and Mitigation Strategies (REMSs) with Elements to Assure Safe Use (ETASU) are requested for drugs with significant safety risks. We reviewed REMS programs issued since 2011 to evaluate their rationales, characteristics, and consistencies, and evaluated their impact on improving drug safety. We conducted a literature search and a survey of relevant websites (FDA, manufacturers, and REMSs). ETASU characteristics were summarized. REMS risks were compared with labeled risks, including black box warnings...
February 3, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28124232/effectiveness-and-risk-factors-for-virological-outcome-of-raltegravir-based-therapy-for-treatment-experienced-hiv-infected-patients
#3
José Antonio Mata-Marín, Ariane Estrella Weiser Smeke, Mariana Rotzinger Rodriguez, Marcelino Chávez-García, Marco Isaac Banda-Lara, Alma Minerva Pérez Rios, Nohemí Nuñez-Rodríguez, Juan Carlos Domínguez-Hermosillo, Alberto Chaparro Sánchez, Irene Juarez-Kasusky, Javier Enrique Cruz Herrera, Jorge Luis Sandoval Ramírez, Jesús Gaytán-Martínez
OBJECTIVE: We evaluated the effectiveness of a raltegravir (RAL)-containing regimen plus an optimized background regimen in HIV-1 highly treatment-experienced patients. DESIGN: A retrospective cohort, multicentre study was conducted. METHODS: Adult (>16 years old) HIV treatment-experience patients starting therapy with a RAL-containing regimen were included. Effectiveness was evaluated as the percentage of patients with an undetectable HIV-1 RNA viral load (<50 and <200 copies/mL) after 48 weeks, and changes in CD4+ cell counts...
January 25, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28105610/antithyroid-drug-induced-agranulocytosis-state-of-the-art-on-diagnosis-and-management
#4
Nuno Vicente, Luís Cardoso, Luísa Barros, Francisco Carrilho
Agranulocytosis is a rare but serious complication of antithyroid drug therapy, and an up-to-date understanding of this topic is important. Both direct toxicity and immune-mediated responses have been described as possible mechanisms. Some major susceptibility loci have recently been identified, which may lead the diagnosis of agranulocytosis into a genomic era. Onset is acute and patients present with symptoms and signs of infection together with high fever. Clinical suspicion is pivotal and should prompt blood sampling...
January 19, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28101837/drug-exposure-and-the-risk-of-microscopic-colitis-a-critical-update
#5
Alfredo J Lucendo
A variety of luminal antigens, including a wide range of drugs, have been associated with the still little-known pathophysiology of microscopic colitis (MC), with variable evidence suggesting causality. This article aims to review the aspects related to drugs as potential triggers of MC; to discuss the most commonly identified associations between drugs and MC; and to analyze the limitations of the studies currently available. A literature search was performed in PubMed combining the search terms 'drug exposure', 'drug consumption', and 'risk factors' with 'microscopic colitis', 'lymphocytic colitis', and 'collagenous colitis', with no language restrictions...
January 18, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28101836/a-review-of-clinical-outcomes-associated-with-two-meropenem-dosing-strategies
#6
REVIEW
Kyle John Wilby, Ziad Ghantous Nasr, Shereen Elazzazy, Tim T Y Lau, Anas Hamad
Meropenem is a carbapenem antibiotic that exhibits time-dependent bactericidal activity, traditionally dosed intravenously at 1 g every 8 h. In order to maximize its pharmacodynamic activity and reduce costs, an alternative regimen employed by many institutions is 500 mg every 6 h. The objective of this review was to summarize and evaluate published literature comparing clinical outcomes associated with these two meropenem dosing regimens. The literature was searched up to October 2016 using the MEDLINE, EMBASE, and Google Scholar databases...
January 18, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28078600/net-budgetary-impact-of-ferric-citrate-as-a-first-line-phosphate-binder-for-the-treatment-of-hyperphosphatemia-a-markov-microsimulation-model
#7
Steven M Brunelli, Scott P Sibbel, David Van Wyck, Amit Sharma, Andrew Hsieh, Glenn M Chertow
Ferric citrate (FC) has demonstrated efficacy as a phosphate binder and reduces the requirements for erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron in dialysis patients. We developed a net budgetary impact model to evaluate FC vs. other phosphate binders from the vantage of a large dialysis provider. We used a Markov microsimulation model to simulate mutually referential longitudinal effects between serum phosphate and phosphate binder dose; categories of these defined health states. Health states probabilistically determined treatment attendance and utilization of ESA and IV iron...
January 11, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28078599/besifloxacin-ophthalmic-suspension-0-6-compared-with-gatifloxacin-ophthalmic-solution-0-3-for-the-treatment-of-bacterial-conjunctivitis-in-neonates
#8
Christine M Sanfilippo, Catherine M Allaire, Heleen H DeCory
PURPOSE: The aim of this study was to evaluate the safety and efficacy of topical besifloxacin ophthalmic suspension 0.6% compared with gatifloxacin ophthalmic solution 0.3% in the treatment of bacterial conjunctivitis in neonates. METHODS: This was a multicenter, randomized, double-masked, parallel group study. Subjects ≤31 days of age with severity grade ≥1 (scale 0-3) for both conjunctival discharge and conjunctival hyperemia were randomized to besifloxacin or gatifloxacin instilled three times daily for 7 days, and completed five study visits (three clinic visits and two phone calls)...
January 11, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28074335/clinical-effects-of-topiroxostat-on-renal-and-endothelial-function-in-a-patient-with-chronic-kidney-disease-and-hyperuricemic-arteriolopathy-a-case-report
#9
Atsushi Tanaka, Tsukasa Nakamura, Eiichi Sato, Koichi Node
Hyperuricemia is associated with the progression of chronic kidney disease (CKD) and cardiovascular diseases. Topiroxostat, a selective xanthine oxidase inhibitor, effectively reduces serum uric acid (UA) levels and urinary albumin excretion (UAE) in CKD patients. A 50-year-old Japanese man was referred to our hospital due to albuminuria and hyperuricemia, and renal biopsy showed a typical hyperuricemic arteriolopathy. Treatment with topiroxostat decreased serum UA levels (9.2 mg/dL at baseline to 6.4 mg/dL after 6 months), UAE (388 to 88 mg/g...
January 10, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28074334/saliva-versus-plasma-bioequivalence-of-azithromycin-in-humans-validation-of-class-i-drugs-of-the-salivary-excretion-classification-system
#10
Nasir Idkaidek, Tawfiq Arafat, Hazim Hamadi, Salim Hamadi, Ibrahim Al-Adham
AIM: The aim of this study was to compare human pharmacokinetics and bioequivalence metrics in saliva versus plasma for azithromycin as a model class I drug of the Salivary Excretion Classification System (SECS). METHODS: A pilot, open-label, two-way crossover bioequivalence study was done, and involved a single 500-mg oral dose of azithromycin given to eight healthy subjects under fasting conditions, followed by a 3-week washout period. Blood and unstimulated saliva samples were collected over 72 h and deep frozen until analysis by a validated liquid chromatography with mass spectroscopy method...
January 10, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28074333/rosiglitazone-metabolism-in-human-liver-microsomes-using-a-substrate-depletion-method
#11
Maryam Bazargan, David J R Foster, Andrew K Davey, Beverly S Muhlhausler
BACKGROUND: Elimination of rosiglitazone in humans is via hepatic metabolism. The existing studies suggest that CYP2C8 is the major enzyme responsible, with a minor contribution from CYP2C9; however, other studies suggest the involvement of additional cytochrome P450 enzymes and metabolic pathways. Thus a full picture of rosiglitazone metabolism is unclear. OBJECTIVE: This study aimed to improve the current understanding of potential drug-drug interactions and implications for therapy by evaluating the kinetics of rosiglitazone metabolism and examining the impact of specific inhibitors on its metabolism using the substrate depletion method...
January 10, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28063023/vorapaxar-the-current-role-and-future-directions-of-a-novel-protease-activated-receptor-antagonist-for-risk-reduction-in-atherosclerotic-disease
#12
REVIEW
Rebecca J Gryka, Leo F Buckley, Sarah M Anderson
INTRODUCTION: Despite the current standard of care, patients with cardiovascular disease remain at a high risk for recurrent events. Inhibition of thrombin-mediated platelet activation through protease-activated receptor-1 antagonism may provide reductions in atherosclerotic disease beyond those achievable with the current standard of care. OBJECTIVE: Our primary objective is to evaluate the clinical literature regarding the role of vorapaxar (Zontivity™) in the reduction of cardiovascular events in patients with a history of myocardial infarction and peripheral artery disease...
January 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28063022/identification-of-a-syndrome-class-of-neuropsychiatric-adverse-reactions-to-mefloquine-from-latent-class-modeling-of-fda-adverse-event-reporting-system-data
#13
Remington L Nevin, Jeannie-Marie Leoutsakos
INTRODUCTION: Although mefloquine use is known to be associated with a risk of severe neuropsychiatric adverse reactions that are often preceded by prodromal symptoms, specific combinations of neurologic or psychiatric reactions associated with mefloquine use are not well described in the literature. This study sought to identify a distinct neuropsychiatric syndrome class associated with mefloquine use in reports of adverse events. METHODS: Latent class modeling of US Food and Drug Administration Adverse Event Reporting System (FAERS) data was performed using indicators defined by the Medical Dictionary for Regulatory Activities neurologic and psychiatric high-level group terms, in a study dataset of FAERS reports (n = 5332) of reactions to common antimalarial drugs...
January 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28063021/hepatotoxicity-with-vismodegib-an-md-anderson-cancer-center-and-research-on-adverse-drug-events-and-reports-project
#14
Beatrice J Edwards, Dennis W Raisch, Smita S Saraykar, Ming Sun, Josh A Hammel, Hai T Tran, Nathaniel Wehr, Rasha Arabyat, Dennis P West
BACKGROUND: On 30 January 2012, the US FDA approved vismodegib (Erivedge(®), Genentech, CA, USA) for the management of both metastatic and locally advanced basal cell carcinoma. OBJECTIVE: Our objective was to identify evidence of hepatotoxicity with vismodegib in the FDA Adverse Event Reporting System (FAERS) in treated patients in two National Cancer Institute Comprehensive Cancer Centers. METHODS: FAERS was searched for reports dated 1 January 2009 through 31 December 2015 using terms including hedgehog pathway and vismodegib and hepatic-related terms such as liver, jaundice, and hepatitis, among others...
January 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28063020/evaluation-of-amikacin-pharmacokinetics-and-pharmacodynamics-for-optimal-initial-dosing-regimen
#15
Hideo Kato, Mao Hagihara, Jun Hirai, Daisuke Sakanashi, Hiroyuki Suematsu, Naoya Nishiyama, Yusuke Koizumi, Yuka Yamagishi, Katsuhiko Matsuura, Hiroshige Mikamo
Amikacin has been one of the important antimicrobial agents against Gram-negative pathogens. However, there is discrepancy regarding the amikacin initial dosage, with some reports recently recommending ≥25 mg/kg and others the conventional dosage (15-20 mg/kg). Hence, we evaluated the optimal initial dosing regimen of amikacin. Pharmacokinetic (PK) parameters were estimated using a population PK analysis. The pharmacodynamic (PD) target was a ratio of ≥8 between the concentration achieved 1 h after beginning the infusion (C peak) and the minimal inhibitory concentration (MIC) of the liable bacteria...
January 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28025727/efficacy-of-switching-from-infliximab-to-subcutaneous-golimumab-in-patients-with-rheumatoid-arthritis-to-control-disease-activity-or-adverse-events
#16
Hiroki Wakabayashi, Hitoshi Inada, Yosuke Nishioka, Masahiro Hasegawa, Kusuki Nishioka, Akihiro Sudo
BACKGROUND: Some rheumatoid arthritis (RA) patients initially respond to treatment with infliximab (IFX), but subsequently their responsiveness decreases. OBJECTIVES: Our objective was to evaluate the efficacy and safety of switching from IFX to subcutaneous golimumab (GLM-SC) in RA patients. METHODS: Thirty-three patients who had been treated for a mean 4.4 years with IFX (3-6 mg/kg/8 weeks) were switched to GLM-SC to control disease activity or adverse events...
December 26, 2016: Drugs in R&D
https://www.readbyqxmd.com/read/28004376/population-pharmacokinetics-and-pharmacodynamics-modelling-of-dilmapimod-in-severe-trauma-subjects-at-risk-for-acute-respiratory-distress-syndrome
#17
Shuying Yang, Teodora Pene Dumitrescu
INTRODUCTION: Dilmapimod is a potent p38 mitogen-activated protein kinase (MAPK) inhibitor and was investigated in a study (NCT00996840) for its anti-inflammatory effect in non-head injury trauma patients at risk for developing acute respiratory distress syndrome (ARDS). The purpose of this paper is to present the details of the development of a population pharmacokinetic (PK) model, an empirical population placebo response model, and the exploration of a PK/pharmacodynamic (PD) model of dilmapimod...
December 21, 2016: Drugs in R&D
https://www.readbyqxmd.com/read/27995532/safety-profile-based-on-concordance-of-nonclinical-toxicity-and-clinical-adverse-drug-reactions-for-blood-cancer-drugs-approved-in-japan
#18
Sachie Kubota, Kazuyuki Saito, Shunsuke Ono, Yasuo Kodama
BACKGROUND: In drug development, animal toxicology data are very important for the evaluation of clinical safety. We quantitatively assessed the safety profiles of blood cancer drugs approved in Japan from category I (high) to V (low). We examined the ratios of drug exposure in animals at the no observed adverse effect level to those in humans at the expected therapeutic dose. In addition, qualitative analysis of the relationship between toxicological findings and adverse drug reactions (ADRs) is one of the primary approaches for determining the risk-benefit profile of a pharmaceutical...
December 19, 2016: Drugs in R&D
https://www.readbyqxmd.com/read/27988913/baseline-characteristics-and-changes-in-bone-mineral-density-t-scores-of-bulgarian-women-with-postmenopausal-osteoporosis-receiving-denosumab-in-routine-clinical-practice
#19
Mihail Boyanov, Alexander Shinkov, Emi Psachoulia, Michele Intorcia, Reneta Petkova
BACKGROUND: Postmenopausal osteoporosis (PMO) is common among women over 50 years of age and is associated with an increased risk of fracture. Bone-targeted agents, such as denosumab, can reduce fracture risk in patients with PMO. OBJECTIVE: The aim was to describe baseline characteristics and changes in bone mineral density (BMD) T-scores among women with PMO receiving denosumab in Bulgaria. METHODS: This multicenter chart review included women with PMO receiving denosumab for ≥1 year in Bulgaria (October 2011-August 2013)...
December 17, 2016: Drugs in R&D
https://www.readbyqxmd.com/read/27943146/retrospective-study-of-patients-switched-from-tablet-formulations-to-a-gel-cap-formulation-of-levothyroxine-results-of-the-control-switch-study
#20
Frank R Ernst, Walter Sandulli, Riad Elmor, Jennifer Welstead, Arnold B Sterman, MaryKate Lavan
INTRODUCTION: Medication changes involving levothyroxine-either dose titrations or switching formulations-occur frequently in patients with erratic thyroid-stimulating hormone (TSH) levels and persistent hypothyroid symptoms. We investigated whether switching patients from levothyroxine tablets to a gel cap formulation of levothyroxine might reduce dose adjustments and improve tolerability and efficacy outcomes. OBJECTIVES: Primary study objectives included quantifying the percentage of patients achieving TSH levels within a pre-specified range, median dose changes experienced, and the percentage of patients with improved hypothyroid symptom control after switching from levothyroxine tablets to levothyroxine gel caps...
December 9, 2016: Drugs in R&D
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