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https://www.readbyqxmd.com/read/28538045/donor-derived-infections-in-solid-organ-transplant-patients-toward-a-holistic-approach
#1
Esther Benamu, Cameron R Wolfe, Jose G Montoya
PURPOSE OF REVIEW: Solid organ demand far exceeds organ supply. Strategies to increase the donor pool include the liberalization of selection criteria without increasing the risk of unexpected donor-derived infection (DDI), a rare complication of transplantation carrying high morbidity and mortality. We review the challenging aspects in the prevention of DDI, focusing on the complexities of data sharing and efficient communication and the role infectious diseases specialists play in the process...
May 19, 2017: Current Opinion in Infectious Diseases
https://www.readbyqxmd.com/read/28535410/effect-of-enzyme-inhibition-on-perampanel-pharmacokinetics-why-study-design-matters
#2
Barry E Gidal, Rama Maganti, Antonio Laurenza, Haichen Yang, David A Verbel, Edgar Schuck, Jim Ferry
OBJECTIVES: Perampanel, a selective, noncompetitive AMPA receptor antagonist, is indicated as adjunctive therapy for the treatment of partial seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy aged 12years and older. In vitro studies and Phase I trials indicate that perampanel is metabolized almost exclusively by CYP3A, with an elimination half-life (t1/2) averaging approximately 105h. Understanding of pharmacokinetic (PK) interactions-enzyme inhibition or induction-and anticipating their occurrence are important for management of patients with epilepsy...
April 26, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28513856/the-utility-of-a-population-approach-in-drug-drug-interaction-assessments-a-simulation-evaluation
#3
Diane D Wang, Yanke Yu, Nastya Kassir, Min Zhu, William D Hanley, Justin C Earp, Andrew T Chow, Manish Gupta, Chuanpu Hu
This study aims at evaluating the utility of the population pharmacokinetics approach in therapeutic protein drug-drug-interaction (DDI) assessment. Simulations were conducted for 2 representative victim drugs, methotrexate and trastuzumab, using a parallel-group design with and without the interaction drug. The effect of a perpetrator on the exposure of the victim drug is described as the ratio of clearance/apparent clearance of the victim drug given with or without the perpetrator. The power of DDI assessment was calculated as the percentage of runs with 90% confidence interval of the estimated DDI effect within 80% to 125% for the scenarios of no DDI, benchmarked with the noncompartmental approach with intensive sampling...
May 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28511403/a-prospective-analysis-of-drug-interactions-in-patients-of-intensive-cardiac-care-unit
#4
Shipra Jain, Pushpawati Jain, Kopal Sharma, Pushpendra Saraswat
INTRODUCTION: Drug-Drug Interaction (DDI) is a serious concern in cardiac patients due to polypharmacy. AIM: The present study was aimed to identify the potential DDI among hospitalized cardiac patients and evaluate the mechanism and severity of such interactions. MATERIALS AND METHODS: A prospective observational study was conducted in intensive cardiac care unit of a tertiary care hospital for six months. Patients aged 18 years and above and taking two or more drugs were included in the study...
March 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28503751/in-vitro-evaluation-of-potential-transporter-mediated-drug-interactions-of-evogliptin
#5
Dae Y Lee, Hye W Chae, Hyunjoo Shim
To date, little is known about the transporter-mediated drug-drug interaction (DDI) potential of evogliptin, a novel DPP-4 inhibitor. The objective of this study was to evaluate the DDI potential of evogliptin using various in vitro assays in transporter-expressing cell lines. After incubating evogliptin with cells overexpressing OAT1, OAT3, OCT2, OATP1B1, and OATP1B3, there was no notable cellular accumulation of evogliptin (fold accumulation, 0.41-1.86). In bidirectional transport assays using Caco-2 cell monolayer, a high efflux ratio (ER, 522) of evogliptin was observed, which was significantly decreased (97...
May 14, 2017: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/28495568/quantitative-analyses-of-the-influence-of-parameters-governing-rate-determining-process-of-hepatic-elimination-of-drugs-on-the-magnitudes-of-drug-drug-interactions-via-hepatic-oatps-and-cyp3a-using-physiologically-based-pharmacokinetic-models
#6
Takashi Yoshikado, Maeda Kazuya, Hiroyuki Kusuhara, Ken-Ichi Furihata, Yuichi Sugiyama
Physiologically-based pharmacokinetic (PBPK) models were constructed for hepatic organic anion transporting polypeptides (OATPs) and cytochrome P450 3A (CYP3A) substrates (bosentan, repaglinide, clarithromycin, and simeprevir), a CYP3A probe substrate (midazolam), and selective inhibitors for OATPs (rifampicin) and CYP3A (itraconazole), though the role of OATPs in the hepatic uptake of clarithromycin is unclear. The pharmacokinetic data were obtained from our previous clinical drug-drug interaction (DDI) study...
May 8, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28489843/-non-cirrhotic-portal-hypertension-due-to-didanosina-a-rare-case
#7
María T Gamero, María Susana Gallardo, Víctor Aguilar, Eduar Bravo, Julissa Guevara, Fernando Mejia
Liver involvement is usually seen in patients infected with the human immunodeficiency virus (HIV), especially in patients coinfected with hepatitis B or C, in alcohol abuse, etc. However, there is a group of patients who develop liver involvement and portal hypertension of unspecified cause. Non-cirrhotic portal hypertension (NCPH) is a liver disorder recently described, but potentially serious. It has been reported in HIV-infected patients with highly active antiretroviral therapy (HAART), specifically didanosine (DDI)...
January 2017: Revista de Gastroenterología del Perú: órgano Oficial de la Sociedad de Gastroenterología del Perú
https://www.readbyqxmd.com/read/28484975/a-clinical-cassette-dosing-study-for-evaluating-the-contribution-of-hepatic-oatps-and-cyp3a-to-drug-drug-interactions
#8
Takashi Yoshikado, Kazuya Maeda, Sawako Furihata, Hanano Terashima, Takeshi Nakayama, Keiko Ishigame, Kazunobu Tsunemoto, Hiroyuki Kusuhara, Ken-Ichi Furihata, Yuichi Sugiyama
PURPOSE: To demonstrate the relative importance of organic anion-transporting polypeptides (OATPs) and cytochrome P450 3A (CYP3A) in the hepatic elimination of substrate drugs. METHODS: A cocktail of subtherapeutic doses of bosentan, repaglinide, clarithromycin, darunavir, simeprevir, and midazolam (CYP3A probe) was administered orally to eight healthy volunteers. Rifampicin (OATP inhibitor; 600 mg, p.o.) and itraconazole (CYP3A inhibitor; 200 mg, i.v.) were coadministered with the cocktail in the second and third phases, respectively...
May 8, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28483778/mechanisms-and-predictions-of-drug-drug-interactions-of-the-hepatitis-c-virus-3-direct-acting-antiviral-3d-regimen-paritaprevir-ritonavir-ombitasvir-and-dasabuvir
#9
Mohamad Shebley, Jinrong Liu, Olga Kavetskaia, Jens Sydor, Sonia M de Morais, Volker Fischer, Marjoleen Jma Nijsen, Daniel Aj Bow
To assess drug-drug interaction (DDI) potential for the 3 direct-acting antiviral (3D) regimen of ombitasvir, dasabuvir and paritaprevir, in vitro studies profiled drug metabolizing enzyme and transporter interactions. Using mechanistic static and dynamic models, DDI potential was predicted for CYP3A, CYP2C8, UGT1A1, OATP1B1/1B3, BCRP and P-gp. Perpetrator static model DDI predictions for metabolizing enzymes were within 2-fold of the clinical observations but for drug transporters, additional PBPK modeling was necessary to achieve the same...
May 8, 2017: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/28483425/risk-assessment-using-cytochrome-p450-time-dependent-inhibition-assays-at-single-time-and-concentration-in-the-early-stage-of-drug-discovery
#10
Mai Kosaka, Yohei Kosugi, Hideki Hirabayashi
In this article, we proposed a risk assessment strategy for CYP3A time-dependent inhibition (TDI) during drug discovery based on a through retrospective study of 13 reference drugs, some of which are known to have in vitro TDI potential, but have unknown clinical relevance. First, the traditional parameter kinact/KI, recommended by regulatory authorities for necessity decision-making in clinical drug-drug interaction (DDI) studies, was investigated as a predictive index for clinical TDI liability. The cutoff value of 1...
May 5, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28480783/pharmacogenetics-of-drug-drug-interaction-and-drug-drug-gene-interaction-a-systematic-review-on-cyp2c9-cyp2c19-and-cyp2d6
#11
Muh Akbar Bahar, Didik Setiawan, Eelko Hak, Bob Wilffert
Currently, most guidelines on drug-drug interaction (DDI) neither consider the potential effect of genetic polymorphism in the strength of the interaction nor do they account for the complex interaction caused by the combination of DDI and drug-gene interaction (DGI) where there are multiple biotransformation pathways, which is referred to as drug-drug-gene interaction (DDGI). In this systematic review, we report the impact of pharmacogenetics on DDI and DDGI in which three major drug-metabolizing enzymes - CYP2C9, CYP2C19 and CYP2D6 - are central...
May 8, 2017: Pharmacogenomics
https://www.readbyqxmd.com/read/28479352/determinants-of-intestinal-availability-for-p-glycoprotein-substrate-drugs-estimated-by-extensive-simulation-with-mathematical-absorption-models
#12
Hirotaka Ando, Hiroto Hatakeyama, Hiromi Sato, Akihiro Hisaka, Hiroshi Suzuki
In this study, intestinal drug-drug interactions (DDIs) for substrate drugs of P-glycoprotein were simulated extensively using the extended QGut model (EQM) and translocation model (TLM) to explore the determinants of DDI. The results of analyses using both models suggested that permeability and active efflux clearance were the major factors that influenced the fraction absorbed (FA). The results of simulation for 100 virtual drugs in which parameters were generated considering the actual values of commercially available drugs suggested that the ratio of the pH-corrected passive permeability to the intrinsic efflux clearance (Pu/CLeff) relative to that of digoxin would be a useful and quantitative index of P-gp-mediated DDI risk at lower doses...
May 4, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28471915/incidence-of-delayed-diagnosis-of-orthopaedic-injury-in-pediatric-trauma-patients
#13
Jeremy D Podolnick, Daniel S Donovan, Alfred W Atanda
TITLE: Incidence of delayed diagnosis of orthopaedic injury in pediatric trauma patients OBJECTIVE:: Determine the incidence of the delayed diagnosis of orthopaedic injuries in pediatric trauma patients. DESIGN: Cross-sectional retrospective analysis. SETTING: Level I pediatric trauma center. PATIENTS/PARTICIPANTS: All patients with an orthopaedic consultation following a trauma activation with a diagnosis of fracture, dislocation, traumatic arthrotomy, neurovascular injury, amputation, and tendon or ligament injury requiring intervention...
April 29, 2017: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/28457720/quantitative-analysis-of-the-transporter-mediated-drug-drug-interaction-between-atorvastatin-and-rifampicin-using-a-stable-isotope-iv-method
#14
Shinji Yamashita, Tsubasa Hasegawa, Masaki Tachihara, Keiko Minami, Haruki Higashino, Kazutaka Togashi, Kuninori Mutaguchi, Makoto Kataoka
This study aims to investigate the drug-drug interactions (DDIs) between orally administered atorvastatin (ATV) and rifampicin (RIF) in rats. The isotope-IV method was used for the analysis of the increased systemic exposure (AUCpo) of ATV, in which a small amount of deuterium-labeled ATV (ATV-d5) was intravenously injected after oral administration of ATV. By assuming ATV-d5 showed same pharmacokinetic properties with ATV, this method enabled to calculate the systemic clearance (CLtot) and the oral bioavailability (Foral) of ATV for each individual rat in a single experiment...
April 27, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28456729/in-vitro-in-vivo-extrapolation-of-metabolism-and-transporter-mediated-drug-drug-interactions-overview-of-basic-prediction-methods
#15
Kenta Yoshida, Ping Zhao, Lei Zhang, Darrell R Abernethy, Dinko Rekić, Kellie S Reynolds, Aleksandra Galetin, Shiew-Mei Huang
Evaluation of drug-drug interaction (DDI) risk is vital to establish benefit-risk profiles of investigational new drugs during drug development. In vitro experiments are routinely conducted as an important first step to assess metabolism- and/or transporter-mediated DDI potential of investigational new drugs. Results from these experiments are interpreted, often with the aid of in vitro-in vivo extrapolation (IVIVE) methods, to determine whether and how DDI should be evaluated clinically to provide the basis for proper DDI management strategies, including dosing recommendations, alternative therapies, or contraindications under various DDI scenarios and in different patient population...
April 26, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28450932/echocardiographic-characterization-of-hypertrophic-cardiomyopathy-in-chinese-patients-with-myosin-binding-protein-c3-mutations
#16
Bei Zhao, Shouli Wang, Jinsong Chen, Yali Ji, Jing Wang, Xiaoli Tian, Guang Zhi
Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant cardiac disease, affecting 1 in 500 people. Myosin-binding protein C3 (MyBPC3) gene mutations are the most common genetic cause of HCM. However, the prevalence of the MyBPC3 gene mutation in Chinese patients with HCM, and their echocardiographic characteristics, remain unknown. In the present study, 48 Chinese patients with HCM were sequenced to identify the MyBPC3 gene and were characterized by their clinical features using 2-dimensional echocardiography and real-time 3-dimensional echocardiography...
March 2017: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/28447323/observation-of-clinically-relevant-drug-interaction-in-chimeric-mice-with-humanized-livers-the-case-of-valproic-acid-and-carbapenem-antibiotics
#17
Eiko Suzuki, Kumiko Koyama, Daisuke Nakai, Ryoya Goda, Hiroshi Kuga, Kan Chiba
BACKGROUND AND OBJECTIVE: Human in vitro and dog in vitro/in vivo researches indicate that the drug-drug interaction (DDI) of decreased plasma valproic acid (VPA) concentration by co-administration of carbapenem antibiotics is caused by inhibition of acylpeptide hydrolase (APEH)-mediated VPA acylglucuronide (VPA-G) hydrolysis by carbapenems. In this study, we investigated VPA disposition and APEH activities in TK-NOG chimeric mice, whose livers were highly replaced with human hepatocytes, to evaluate the utility of this animal model and the clinical relevance of the DDI mechanism...
April 26, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28444890/utilizing-pbpk-modeling-to-evaluate-the-potential-of-a-significant-drug-drug-interaction-between-clopidogrel-and-dasabuvir-a-scientific-perspective
#18
V Arya, P Zhao, K S Reynolds, P Mishra, I R Younis
Dasabuvir, a component of VIEKIRA PAK, is a substrate of CYP2C8 enzymes. Prescribing information for VIEKIRA PAK contraindicates gemfibrozil, a strong CYP2C8 inhibitor, because coadministration significantly increases dasabuvir exposures, which may increase the risk of QT prolongation. Clopidogrel may increase dasabuvir exposures primarily due to CYP2C8 inhibition by clopidogrel-acyl-β-D-glucuronide. This commentary outlines the US Food and Drug Administration (FDA) interdisciplinary review team's scientific perspective to address the potential for a significant drug-drug interaction (DDI) between clopidogrel and VIEKIRA PAK...
April 26, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28443803/a-strategy-for-early-risk-predictions-of-clinical-drug-drug-interactions-involving-the-gastroplus-tm-ddi-module-for-time-dependent-cyp-inhibitors
#19
Anna-Karin Sohlenius-Sternbeck, Gabrielle Meyerson, Ann-Louise Hagbjörk, Sanja Juric, Ylva Terelius
1. A set of reference compounds for time-dependent inhibition (TDI) of cytochrome P450 with available literature data for kinact and KI was used to predict clinical implications using the GastroPlus(TM) software. Comparisons were made to in vivo literature interaction data. 2. The predicted AUC ratios (AUC+inhibitor/AUCcontrol) could be compared with the observed ratios from literature for all compounds with detailed information about in vivo administration, pharmacokinetics and in vivo interactions (N = 21)...
April 26, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
https://www.readbyqxmd.com/read/28437284/a-retrospective-study-on-mycophenolic-acid-drug-interactions-effect-of-prednisone-sirolimus-and-tacrolimus-with-mpa
#20
Ana C Alvarez-Elías, Elisa C Yoo, Ekaterina K Todorova, Ram N Singh, Guido Filler
Mycophenolic acid (MPA), the active compound of mycophenolate mofetil (MMF), is widely used as an antirejection drug after renal transplantation. There is growing evidence supporting the notion that there is substantial variability in the intra- and interpatient exposure to MPA. Drug interactions involving MPA with tacrolimus, steroids, and sirolimus have been understudied. The objective of this study was to determine the relationship between MPA, steroids, tacrolimus, and sirolimus. MPA trough concentrations from 37 pediatric renal transplant recipients (mean age 7...
June 2017: Therapeutic Drug Monitoring
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