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https://www.readbyqxmd.com/read/27858342/physiologically-based-pharmacokinetic-pbpk-modeling-of-pitavastatin-and-atorvastatin-to-predict-drug-drug-interactions-ddis
#1
Peng Duan, Ping Zhao, Lei Zhang
BACKGROUND: The disposition of statins varies and involves both metabolizing enzymes and transporters, making predictions of statin drug-drug interactions (DDIs) challenging. Physiologically based pharmacokinetic (PBPK) models have, however, demonstrated ability to predict complex DDIs. OBJECTIVE: In this study, PBPK models of two statins (pitavastatin and atorvastatin) were developed and applied to predict pitavastatin and atorvastatin associated DDIs. METHOD: Pitavastatin and atorvastatin PBPK models were developed using in vitro and human pharmacokinetic data in a population-based PBPK software (SimCYP(®)) by considering the contribution of both metabolizing enzymes and transporters to their overall pharmacokinetics...
November 17, 2016: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/27796467/an-evaluation-of-the-completeness-of-drug-drug-interaction-related-information-in-package-inserts
#2
Giok Qin Ng, Grant Edward Sklar, Hui Ting Chng
PURPOSE: The project aimed to evaluate the completeness of drug-drug interaction (DDI)-related information in package inserts (PIs) and develop a systematic approach to conduct the evaluation. METHODS: DDI-related information in the branded PIs of statins, macrolides, protease inhibitors and selected drugs of narrow therapeutic index (DNTI) were evaluated against the criteria distilled from the Food and Drug Administration (FDA) labelling recommendation guidance document...
October 29, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27430348/rhabdomyolysis-caused-by-the-moderate-cyp3a4-inhibitor-fluconazole-in-a-patient-on-stable-atorvastatin-therapy-a-case-report-and-literature-review
#3
S-H Hsiao, H-J Chang, T-H Hsieh, S-M Kao, P-Y Yeh, T-J Wu
WHAT IS KNOWN AND OBJECTIVE: Rhabdomyolysis is a severe potential adverse drug reaction of statin therapy. We report a case of rhabdomyolysis due to drug-drug interaction (DDI) between atorvastatin and fluconazole and review the literature. CASE SUMMARY: A 70-year-old woman received atorvastatin for hyperlipidaemia without any problem for 4 years. When intravenous fluconazole was added for treating a fungal infection, rhabdomyolysis developed 2 weeks later. Removal of atorvastatin led to the resolution of her rhabdomyolysis...
October 2016: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/27385183/transporter-enzyme-interplay-deconvoluting-effects-of-hepatic-transporters-and-enzymes-on-drug-disposition-using-static-and-dynamic-mechanistic-models
#4
Manthena V Varma, Ayman F El-Kattan
A large body of evidence suggests hepatic uptake transporters, organic anion-transporting polypeptides (OATPs), are of high clinical relevance in determining the pharmacokinetics of substrate drugs, based on which recent regulatory guidances to industry recommend appropriate assessment of investigational drugs for the potential drug interactions. We recently proposed an extended clearance classification system (ECCS) framework in which the systemic clearance of class 1B and 3B drugs is likely determined by hepatic uptake...
July 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27298338/vx-509-decernotinib-mediated-cyp3a-time-dependent-inhibition-an-aldehyde-oxidase-metabolite-as-a-perpetrator-of-drug-drug-interactions
#5
Craig Zetterberg, Francois Maltais, Leena Laitinen, Shengkai Liao, Hong Tsao, Ananthsrinivas Chakilam, Niresh Hariparsad
(R)-2-((2-(1H-pyrrolo[2,3-b]pyridin-3-yl)pyrimidin-4-yl)amino)-2-methyl-N-(2,2,2-trifluoroethyl)butanamide (VX-509, decernotinib) is an oral Janus kinase 3 inhibitor that has been studied in patients with rheumatoid arthritis. Patients with rheumatoid arthritis often receive multiple medications, such as statins and steroids, to manage the signs and symptoms of comorbidities, which increases the chances of drug-drug interactions (DDIs). Mechanism-based inhibition is a subset of time-dependent inhibition (TDI) and occurs when a molecule forms a reactive metabolite which irreversibly binds and inactivates drug-metabolizing enzymes, potentially increasing the systemic load to toxic concentrations...
August 2016: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/26700956/solitary-inhibition-of-the-breast-cancer-resistance-protein-efflux-transporter-results-in-a-clinically-significant-drug-drug-interaction-with-rosuvastatin-by-causing-up-to-a-2-fold-increase-in-statin-exposure
#6
Robert Elsby, Paul Martin, Dominic Surry, Pradeep Sharma, Katherine Fenner
The intestinal efflux transporter breast cancer resistance protein (BCRP) restricts the absorption of rosuvastatin. Of the transporters important to rosuvastatin disposition, fostamatinib inhibited BCRP (IC50 = 50 nM) and organic anion-transporting polypeptide 1B1 (OATP1B1; IC50 > 10 μM), but not organic anion transporter 3, in vitro, predicting a drug-drug interaction (DDI) in vivo through inhibition of BCRP only. Consequently, a clinical interaction study between fostamatinib and rosuvastatin was performed (and reported elsewhere)...
March 2016: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/26116278/physiologically-based-pharmacokinetic-modeling-of-disposition-and-drug-drug-interactions-for-atorvastatin-and-its-metabolites
#7
Tao Zhang
Atorvastatin is the most commonly used of all statins to lower cholesterol. Atorvastatin is extensively metabolized in both gut and liver to produce several active metabolites. The purpose of the present study is to develop a physiologically based pharmacokinetic (PBPK) model for atorvastatin and its two primary metabolites, 2-hydroxy-atorvastatin acid and atorvastatin lactone, using in vitro and in vivo data. The model was used to predict the pharmacokinetic profiles and drug-drug interaction (DDI) effect for atorvastatin and its metabolites in different DDI scenarios...
September 18, 2015: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/25996489/application-of-the-extended-clearance-concept-classification-system-ecccs-to-predict-the-victim-drug-drug-interaction-potential-of-statins
#8
Annett Kunze, Birk Poller, Jörg Huwyler, Gian Camenisch
BACKGROUND: During drug development, it is an important safety factor to identify the potential of new molecular entities to become a victim of drug-drug interactions (DDIs). In preclinical development, however, anticipation of clinical DDIs remains challenging due to the lack of in vivo human pharmacokinetic data. METHODS: We applied a recently developed in vitro-in vivo extrapolation method, including hepatic metabolism and transport processes, herein referred to as the Extended Clearance Concept Classification System (ECCCS)...
September 2015: Drug Metabolism and Personalized Therapy
https://www.readbyqxmd.com/read/25989893/dehydroepiandrosterone-sulfate-a-useful-endogenous-probe-for-evaluation-of-drug-drug-interaction-on-hepatic-organic-anion-transporting-polypeptide-oatp-in-cynomolgus-monkeys
#9
Masaki Watanabe, Takao Watanabe, Masashi Yabuki, Ikumi Tamai
Since drug-drug interaction (DDI) can affect organic anion-transporting polypeptide (OATP) and cause clinical events, prediction of such DDI is important in early clinical development. Although statins are useful probes for OATP-mediated DDI, endogenous probes would be more practical for predicting such DDI. In this study, we investigate the possible use of dehydroepiandrosterone sulfate (DHEAS), an endogenous OATP substrate, in predicting OATP-mediated DDI in cynomolgus monkeys as a first step toward in human assessment...
April 2015: Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/25848291/pharmacokinetic-drug-interactions-with-clopidogrel-updated-review-and-risk-management-in-combination-therapy
#10
REVIEW
Zhi-Yu Wang, Meng Chen, Ling-Ling Zhu, Lu-Shan Yu, Su Zeng, Mei-Xiang Xiang, Quan Zhou
BACKGROUND: Coprescribing of clopidogrel and other drugs is common. Available reviews have addressed the drug-drug interactions (DDIs) when clopidogrel is as an object drug, or focused on combination use of clopidogrel and a special class of drugs. Clinicians may still be ignorant of those DDIs when clopidogrel is a precipitant drug, the factors determining the degree of DDIs, and corresponding risk management. METHODS: A literature search was performed using PubMed, MEDLINE, Web of Science, and the Cochrane Library to analyze the pharmacokinetic DDIs of clopidogrel and new P2Y12 receptor inhibitors...
2015: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/25813937/evaluation-of-cynomolgus-monkeys-for-the-identification-of-endogenous-biomarkers-for-hepatic-transporter-inhibition-and-as-a-translatable-model-to-predict-pharmacokinetic-interactions-with-statins-in-humans
#11
Xiaoyan Chu, Shian-Jiun Shih, Rachel Shaw, Hannes Hentze, Grace H Chan, Karen Owens, Shubing Wang, Xiaoxin Cai, Deborah Newton, Jose Castro-Perez, Gino Salituro, Jairam Palamanda, Aaron Fernandis, Choon Keow Ng, Andy Liaw, Mary J Savage, Raymond Evers
Inhibition of hepatic transporters such as organic anion transporting polypeptides (OATPs) 1B can cause drug-drug interactions (DDIs). Determining the impact of perpetrator drugs on the plasma exposure of endogenous substrates for OATP1B could be valuable to assess the risk for DDIs early in drug development. As OATP1B orthologs are well conserved between human and monkey, we assessed in cynomolgus monkeys the endogenous OATP1B substrates that are potentially suitable to assess DDI risk in humans. The effect of rifampin (RIF), a potent inhibitor for OATP1B, on plasma exposure of endogenous substrates of hepatic transporters was measured...
June 2015: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/25747975/organic-anion-transporting-polypeptide-oatp-1b1-and-oatp1b3-as-important-regulators-of-the-pharmacokinetics-of-substrate-drugs
#12
REVIEW
Kazuya Maeda
Nobody doubts the importance of organic anion transporting polypeptide (OATP)1B1 and 1B3 in the clinical pharmacokinetics of substrate drugs. Based on the theory of pharmacokinetics, even if a drug is eliminated from the body by extensive metabolism, the rate-determining process of the hepatic intrinsic clearance of OATP substrates is often hepatic uptake. Because of their broad substrate specificities, once the functions of OATP1B1 or OATP1B3 are altered by several kinds of special occasions such as drug-drug interactions (DDI) and genetic polymorphisms of transporter genes, the hepatic clearance of many kinds of structurally-unrelated drugs is expected to be changed...
2015: Biological & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/25507231/clinically-significant-drug-interactions-among-hiv-infected-patients-receiving-antiretroviral-therapy
#13
Apichot So-Ngern, Preecha Montakantikul, Weerawat Manosuthi
We conducted a cross sectional study of the outpatient medical records of 1000 HIV-infected patients receiving antiretroviral therapy (ART) in 2011 to determine the incidence of clinically significant drug interactions (CSDI). The severities of the CSDI were graded following the Micromedex" 2.0 database and the Department of Health and Human Services (DHHS) 2012 HIV treatment guidelines. Three hundred thirty-five patients (34%) had 554 episodes of CSDI. Of which 337 episodes (61%), 163 episodes (29%) and 54 episodes (10%) had grades 2, 3 and 4 severity CSDI, respectively...
September 2014: Southeast Asian Journal of Tropical Medicine and Public Health
https://www.readbyqxmd.com/read/25417503/clinically-significant-drug-interactions-among-hiv-infected-patients-receiving-antiretroviral-therapy
#14
Apichot So-Ngern, Preecha Montakantikul, Weerawat Manosuthi
We conducted a cross sectional study of the outpatient medical records of 1000 HIV-infected patients receiving antiretroviral therapy (ART) in 2011 to determine the incidence of clinically significant drug interactions (CSDI). The severities of the CSDI were graded following the Micromedex" 2.0 database and the Department of Health and Human Services (DHHS) 2012 HIV treatment guidelines. Three hundred thirty-five patients (34%) had 554 episodes of CSDI. Of which 337 episodes (61%), 163 episodes (29%) and 54 episodes (10%) had grades 2, 3 and 4 severity CSDI, respectively...
September 2014: Southeast Asian Journal of Tropical Medicine and Public Health
https://www.readbyqxmd.com/read/25312593/understanding-adverse-drug-reactions-in-older-adults-through-drug-drug-interactions
#15
A Marengoni, L Pasina, C Concoreggi, G Martini, F Brognoli, A Nobili, G Onder, D Bettoni
AIMS: The aims of this study are to evaluate prevalence and characteristics of adverse drug reactions (ADRs) and to evaluate the potential contribution of specific medications, therapeutic categories and drug-drug interactions (DDIs) in older adults. METHODS: All ADR reporting forms of persons aged 65+ years collected by the pharmacovigilance of one of the main hospitals in Italy during 2013 were evaluated. DDIs were analysed by a computerized prescription system (INTERCheck) and based on the interactions' database managed by the Istituto di Ricerche Farmacologiche Mario Negri...
November 2014: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/24521363/effect-of-multiple-pharmacy-use-on-medication-adherence-and-drug-drug-interactions-in-older-adults-with-medicare-part-d
#16
COMPARATIVE STUDY
Zachary A Marcum, Julia Driessen, Carolyn T Thorpe, Walid F Gellad, Julie M Donohue
OBJECTIVES: To assess the association between multiple pharmacy use and medication adherence and potential drug-drug interactions (DDIs) in older adults. DESIGN: Cross-sectional propensity score-weighted analysis. SETTING: 2009 claims data. PARTICIPANTS: A nationally representative sample of 926,956 Medicare Part D beneficiaries aged 65 and older continuously enrolled in fee-for-service Medicare and Part D that year who filled one or more prescriptions at a community retail or mail order pharmacy...
February 2014: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/24379677/pharmacokinetic-drug-drug-interactions-between-1-4-dihydropyridine-calcium-channel-blockers-and-statins-factors-determining-interaction-strength-and-relevant-clinical-risk-management
#17
REVIEW
Yi-Ting Zhou, Lu-Shan Yu, Su Zeng, Yu-Wen Huang, Hui-Min Xu, Quan Zhou
BACKGROUND: Coadministration of 1,4-dihydropyridine calcium channel blockers (DHP-CCBs) with statins (or 3-hydroxy-3-methylglutaryl-coenzyme A [HMG-CoA] reductase inhibitors) is common for patients with hypercholesterolemia and hypertension. To reduce the risk of myopathy, in 2011, the US Food and Drug Administration (FDA) Drug Safety Communication set a new dose limitation for simvastatin, for patients taking simvastatin concomitantly with amlodipine. However, there is no such dose limitation for atorvastatin for patients receiving amlodipine...
2014: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/23681436/clinical-perspective-on-drug-drug-interactions-with-the-non-nucleoside-reverse-transcriptase-inhibitor-rilpivirine
#18
REVIEW
Herta Crauwels, Rolf P G van Heeswijk, Marita Stevens, Annemie Buelens, Simon Vanveggel, Katia Boven, Richard Hoetelmans
Rilpivirine (TMC278) is a non-nucleoside reverse transcriptase inhibitor approved in combination with other antiretrovirals for the treatment of HIV-1 infection in treatment-naive adults (Edurant(®) 25 mg once daily; Complera(®) [USA]/Eviplera(®) [EU] once daily single-tablet regimen). Rilpivirine should be administered with a meal to optimize bioavailability. Its solubility is pH dependent. Rilpivirine is primarily excreted via the feces with negligible renal elimination. Rilpivirine is predominantly metabolized by cytochrome P450 3A4...
April 2013: AIDS Reviews
https://www.readbyqxmd.com/read/23047648/understanding-the-critical-disposition-pathways-of-statins-to-assess-drug-drug-interaction-risk-during-drug-development-it-s-not-just-about-oatp1b1
#19
REVIEW
R Elsby, C Hilgendorf, K Fenner
The use of statins is widespread across disease areas because many patients have comorbidities. Given that these drugs have become common as comedications, it is essential to have an understanding of the potential risks of drug-drug interactions (DDIs) between statins and candidate drugs in development. Although the hepatic uptake transporter organic anion-transporting polypeptide 1B1 (OATP1B1) is known to play a substantial role in statin-related DDI risk, other transporters and metabolizing enzymes can also be involved...
November 2012: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/22538052/prediction-of-the-in-vivo-oatp1b1-mediated-drug-drug-interaction-potential-of-an-investigational-drug-against-a-range-of-statins
#20
Pradeep Sharma, Caroline J Butters, Veronica Smith, Robert Elsby, Dominic Surry
To support drug development, the drug-drug interaction potential (DDI) of an investigational drug (AZX) was assessed against the probe estradiol 17β-glucuronide as well as against simvastatin acid, atorvastatin, pravastatin, pitavastatin, fluvastatin, rosuvastatin and estrone 3-sulfate. The inhibitory potentials of the OATP1B1 inhibitors rifamycin SV and gemfibrozil were assessed in parallel. Monolayer cellular uptake assays were used to determine inhibition of human OATP1B1. Apparent K(m) values for the OATP1B1-mediated transport of [(3)H] substrates were determined prior to their use as probes in inhibition studies, and ranged from 0...
August 30, 2012: European Journal of Pharmaceutical Sciences
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