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https://www.readbyqxmd.com/read/28738449/pbpk-modeling-of-the-effect-of-reduced-kidney-function-on-the-pharmacokinetics-of-drugs-excreted-renally-by-organic-anion-transporters
#1
C-H Hsueh, V Hsu, P Zhao, L Zhang, K M Giacomini, S-M Huang
Altered pharmacokinetics (PK) in subjects with chronic kidney disease (CKD) may lead to dosing adjustment of certain drugs in subjects with CKD. It can be valuable to quantitatively predict PK in CKD for the management of drug dosing in these subjects. We developed physiologically based pharmacokinetic (PBPK) models of seven renally eliminated drugs: adefovir, avibactam, entecavir, famotidine, ganciclovir, oseltamivir carboxylate, and sitagliptin. These drugs are all substrates of renal organic anion transporters (OATs)...
July 24, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28736028/association-between-tacrolimus-pharmacokinetics-and-cytochrome-p450-3a5-and-multidrug-resistance-protein-1-exon-21-polymorphisms
#2
M Soda, M Fujitani, R Michiuchi, A Shibayama, K Kanamori, S Yoshikuni, Y Ohno, T Tsuchiya, A Suzuki, K Horie, T Deguchi, Y Itoh, K Kitaichi
BACKGROUND: Individual differences in the pharmacokinetics (PK) of tacrolimus (TAC), an immunosuppressive drug, are reportedly associated with single-nucleotide polymorphisms (SNPs) of cytochrome P450 (CYP) 3A5 and multidrug resistance protein 1 (MDR1). We determined the effect of SNPs in CYP3A5 and MDR1 exons 21 and 26 on TAC PK parameters. METHODS: Thirty-eight Japanese patients who underwent renal transplantation were genotyped for CYP3A5 and exons 21 and 26 of MDR1 with the use of polymerase chain reaction-restriction fragment length polymorphism analysis...
July 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28733204/the-polymorphism-xrcc1-arg194trp-and-8-hydroxydeoxyguanosine-increased-susceptibility-to-arsenic-related-renal-cell-carcinoma
#3
Yu-Mei Hsueh, Ying-Chin Lin, Wei-Jen Chen, Chao-Yuan Huang, Horng-Sheng Shiue, Yeong-Shiau Pu, Chi-Hung Chen, Chien-Tien Su
This study was designed to explore the relationship between X-ray repair cross-complementing group 1 (XRCC1) gene polymorphisms and renal cell carcinoma (RCC) and to investigate whether individuals with an XRCC1 risk genotype, a high level of 8-OHdG or a high urinary total arsenic concentration have a modified odds ratio (OR) of RCC. We recruited 180 RCC patients and 360 age- and sex-matched controls from a hospital-based pool. Image-guided biopsy or surgical resection of renal tumors was performed on RCC patients for pathological verification...
July 18, 2017: Toxicology and Applied Pharmacology
https://www.readbyqxmd.com/read/28729289/class-ii-eplet-mismatch-modulates-tacrolimus-trough-levels-required-to-prevent-donor-specific-antibody-development
#4
Chris Wiebe, David N Rush, Thomas E Nevins, Patricia E Birk, Tom Blydt-Hansen, Ian W Gibson, Aviva Goldberg, Julie Ho, Martin Karpinski, Denise Pochinco, Atul Sharma, Leroy Storsley, Arthur J Matas, Peter W Nickerson
Despite more than two decades of use, the optimal maintenance dose of tacrolimus for kidney transplant recipients is unknown. We hypothesized that HLA class II de novo donor-specific antibody (dnDSA) development correlates with tacrolimus trough levels and the recipient's individualized alloimmune risk determined by HLA-DR/DQ epitope mismatch. A cohort of 596 renal transplant recipients with 50,011 serial tacrolimus trough levels had HLA-DR/DQ eplet mismatch determined using HLAMatchmaker software. We analyzed the frequency of tacrolimus trough levels below a series of thresholds <6 ng/ml and the mean tacrolimus levels before dnDSA development in the context of HLA-DR/DQ eplet mismatch...
July 20, 2017: Journal of the American Society of Nephrology: JASN
https://www.readbyqxmd.com/read/28728162/realistic-lenalidomide-dose-adjustment-strategy-for-transplant-ineligible-elderly-patients-with-relapsed-refractory-multiple-myeloma-japanese-real-world-experience
#5
Aya Nakaya, Shinya Fujita, Atsushi Satake, Takahisa Nakanishi, Yoshiko Azuma, Yukie Tsubokura, Masaaki Hotta, Hideaki Yoshimura, Kazuyoshi Ishii, Tomoki Ito, Shosaku Nomura
Lenalidomide is an immunomodulatory drug administered orally in the treatment of multiple myeloma. Some elderly patients require a reduced lenalidomide dose because of comorbidities and/or adverse events. This study investigated the actual dose of lenalidomide in elderly patients, finding that most received reduced (5-10 mg) doses. The most common reasons for dose reduction were renal dysfunction (54% of patients), fatigue (grade ≥3; 20%), hematologic disorder (grade ≥3; 14%), and rash (grade ≥3; 9%)...
July 21, 2017: Acta Haematologica
https://www.readbyqxmd.com/read/28719505/prevalence-of-persistent-renal-dysfunction-in-perinatally-hiv-infected-thai-adolescents
#6
Torsak Bunupuradah, Tanit Phupitakphol, Jiratchaya Sophonphan, Wasana Prasitsuebsai, Suvaporn Anugulruengkitt, Watsamon Jantarabenjakul, Bunruan Sopa, Kiat Ruxrungtham, Ankanee Chanakul, Thanyawee Puthanakit
BACKGROUND: Persistent renal dysfunction (PRD) has been reported in up to 22% of perinatally HIV-infected adolescents (PHA) in the US and Europe. There is limited data available on PRD among PHAs in resource-limited settings regarding access to antiretroviral therapy (ART) at more advanced HIV stages. METHODS: We retrospectively described the prevalence of PRD and associated factors in a Thai PHA cohort. Inclusion criteria were current age >10 years and at least 2 serum creatinine (Cr) measurements after ART initiation...
July 13, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28717107/human-plasma-and-urinary-metabolic-profiles-of-trimethylamine-and-trimethylamine-n-oxide-extrapolated-using-a-simple-physiologically-based-pharmacokinetic-model
#7
Makiko Shimizu, Hiroshi Yamazaki
Trimethylamine, a dietary- and medicinal carnitine-derived amine, is extensively metabolized by liver to non-malodorous trimethylamine N-oxide. Although trimethylamine and trimethylamine N-oxide under daily dietary consumption or carnitine treatment are generally regarded as nontoxic, they have been, and remain, of toxicological and clinical interest because of their potential association with atherosclerosis. The aim of the current study was to model the pharmacokinetics of trimethylamine after oral administration of trimethylamine in humans and compare the results with reported measured values...
2017: Journal of Toxicological Sciences
https://www.readbyqxmd.com/read/28704257/the-combination-of-cyp3a4-22-and-cyp3a5-3-single-nucleotide-polymorphisms-determines-tacrolimus-dose-requirement-after-kidney-transplantation
#8
Nuria Lloberas, Laure Elens, Ines Llaudó, Ariadna Padullés, Teun van Gelder, Dennis A Hesselink, Helena Colom, Franc Andreu, Joan Torras, Oriol Bestard, Josep M Cruzado, Salvador Gil-Vernet, Ron van Schaik, Josep M Grinyó
INTRODUCTION: Tacrolimus (Tac) has a narrow therapeutic window and shows large between-patient pharmacokinetic variability. As a result, over-immunosuppression and under-immunosuppression are frequently encountered in daily clinical practice. Unraveling the impact of genetic polymorphisms on Tac pharmacokinetics may help to refine therapy. In this study, the associations of single-nucleotide polymorphisms (SNPs) in drug-metabolizing enzymes (CYP3A) with Tac pharmacokinetics were investigated in renal transplant recipients...
July 12, 2017: Pharmacogenetics and Genomics
https://www.readbyqxmd.com/read/28693837/-should-doses-of-antibiotics-be-adjusted
#9
V de Lastours
While we are confronted with the major increase in antibiotic resistance, the preservation of existing antibiotics has become an absolute necessity both to achieve therapeutic success and to limit the risks of the emergence of resistance. The optimization of antibiotic use and dosages must have a threefold objective: guarantee antibacterial efficacy, limit toxicities and limit emergence of resistant strains. However, with the increase in the number of multipathological patients, particularly those with renal or hepatic impairment, the increase in the number of patients with extreme weights and the use of antibiotics with narrower therapeutic margins, the adaptation of antibiotic dosages is becoming increasingly important...
July 7, 2017: La Revue de Médecine Interne
https://www.readbyqxmd.com/read/28693440/serum-lactate-level-and-mortality-in-metformin-associated-lactic-acidosis-requiring-renal-replacement-therapy-a-systematic-review-of-case-reports-and-case-series
#10
Hung-Chieh Yeh, I-Wen Ting, Ching-Wei Tsai, Jenn-Yu Wu, Chin-Chi Kuo
BACKGROUND: The current practice concerning timing, mode, and dose of renal replacement therapy (RRT) in patients with metformin-associated lactic acidosis (MALA) with renal failure remains unknown. To investigate whether serum lactate level and prescription pattern of RRT are associated with mortality in patients with MALA requiring RRT. METHODS: We searched PubMed/Medline and EMBASE from inception to Sep 2014 and applied predetermined exclusion criteria. Case-level data including case's demographics and clinical information related to MALA were abstracted...
July 10, 2017: BMC Nephrology
https://www.readbyqxmd.com/read/28690465/thrombotic-and-infectious-morbidity-are-associated-with-transfusion-in-posterior-spine-fusion
#11
Daniel J Johnson, Christine C Johnson, David B Cohen, Joshua A Wetzler, Khaled M Kebaish, Steven M Frank
BACKGROUND: Although previous investigators have established an association between blood transfusion and adverse outcomes, the relative frequency of different morbid events and the association with transfusion dose are not well understood. QUESTIONS/PURPOSES: The purpose of the study is to characterize the relationship between blood transfusion and different types of morbidity after posterior spine fusion. METHODS: We retrospectively analyzed electronic medical records for 963 patients who underwent posterior spinal fusion surgery at a single institution, of which 603 (62...
July 2017: HSS Journal: the Musculoskeletal Journal of Hospital for Special Surgery
https://www.readbyqxmd.com/read/28687262/renal-function-and-direct-oral-anticoagulant-treatment-for-venous-thromboembolism
#12
REVIEW
John Fanikos, Allison E Burnett, Charles E Mahan, Paul P Dobesh
As differences in renal function can affect the efficacy and safety of direct oral anticoagulants, prescribing an appropriate dose based on renal function is critical, especially in patient populations with a high incidence of renal impairment. In patients with nonvalvular atrial fibrillation and mild or moderate renal impairment, direct oral anticoagulants are associated with a better risk-benefit profile compared with warfarin. However, less is known regarding outcomes in patients with venous thromboembolism and renal impairment...
July 4, 2017: American Journal of Medicine
https://www.readbyqxmd.com/read/28685516/comparison-between-atorvastatin-and-rosuvastatin-in-renal-function-decline-among-patients-with-diabetes
#13
Eugene Han, Gyuri Kim, Ji Yeon Lee, Yong Ho Lee, Beom Seok Kim, Byung Wan Lee, Bong Soo Cha, Eun Seok Kang
BACKGROUND: Although the beneficial effects of statin treatment in dyslipidemia and atherosclerosis have been well studied, there is limited information regarding the renal effects of statins in diabetic nephropathy. We aimed to investigate whether, and which, statins affected renal function in Asian patients with diabetes. METHODS: We enrolled 484 patients with diabetes who received statin treatment for more than 12 months. We included patients treated with moderate-intensity dose statin treatment (atorvastatin 10 to 20 mg/day or rosuvastatin 5 to 10 mg/day)...
June 2017: Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28681225/a-population-pharmacokinetic-model-to-predict-the-individual-starting-dose-of-tacrolimus-following-pediatric-renal-transplantation
#14
Louise M Andrews, Dennis A Hesselink, Teun van Gelder, Birgit C P Koch, Elisabeth A M Cornelissen, Roger J M Brüggemann, Ron H N van Schaik, Saskia N de Wildt, Karlien Cransberg, Brenda C M de Winter
BACKGROUND: Multiple clinical, demographic, and genetic factors affect the pharmacokinetics of tacrolimus in children, yet in daily practice, a uniform body-weight based starting dose is used. It can take weeks to reach the target tacrolimus pre-dose concentration. OBJECTIVES: The objectives of this study were to determine the pharmacokinetics of tacrolimus immediately after kidney transplantation and to find relevant parameters for dose individualization using a population pharmacokinetic analysis...
July 5, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28675584/does-secretory-clearance-follow-glomerular-filtration-rate-in-chronic-kidney-diseases-reconsidering-the-intact-nephron-hypothesis
#15
A Chapron, D D Shen, B R Kestenbaum, C Robinson-Cohen, J Himmelfarb, C K Yeung
Drug-dose modification in chronic kidney disease (CKD) utilizes glomerular filtration rate (GFR) with the implicit assumption that multiple renal excretory processes decline in parallel as CKD progresses. We compiled published pharmacokinetic data to evaluate if GFR predicts renal clearance changes as a function of CKD severity. For each drug, we calculated ratio of renal clearance to filtration clearance (Rnf). Of 21 drugs with Rnf >0.74 in subjects with GFR >90 mL/min (implying filtration and secretion), 13 displayed significant change in Rnf vs...
July 4, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28674057/population-pharmacokinetics-and-dose-optimization-of-teicoplanin-during-venoarterial-extracorporeal-membrane-oxygenation
#16
Jin Wi, Hayeon Noh, Kyoung Lok Min, Seungwon Yang, Byung Hak Jin, Jongsung Hahn, Soo Kyung Bae, Jiseon Kim, Min Soo Park, Donghoon Choi, Min Jung Chang
Pharmacokinetics (PK) of drugs are known to be significantly altered in patients receiving extracorporeal membrane oxygenation (ECMO). However, clinical PK studies of drugs administered during ECMO are scarce and proper dosing adjustment is yet to be established. We developed a population PK model for teicoplanin, investigated covariates influencing teicoplanin exposure, and suggested an optimal dosing regimen for ECMO patients. PK samples were collected from ten adult patients, and a population PK analysis as well as simulations were performed to identify an optimal teicoplanin dose needed to provide a >50% probability of target attainment at 72 hours using a trough concentration target of >10 μg/mL for mild to moderate infections and of >15 μg/mL for severe infections...
July 3, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28667664/tacrolimus-and-mycophenolate-regimen-and-subclinical-tubulo-interstitial-inflammation-in-low-immunological-risk-renal-transplants
#17
Irina B Torres, Anna V Reisaeter, Francesc Moreso, Anders Åsberg, Marta Vidal, Clara Garcia-Carro, Karsten Midtvedt, Finn P Reinholt, Helge Scott, Eva Castellà, Maite Salcedo, Christina Dörje, Joana Sellarés, Maria A Azancot, Manel Perello, Hallvard Holdaas, Daniel Serón
The aim was to evaluate the relationship between maintenance immunosuppression, subclinical tubulo-interstital inflammation and interstitial fibrosis/tubular atrophy (IF/TA) in surveillance biopsies performed in low immunological risk renal transplants at two transplant centers. The Barcelona cohort consisted of 109 early and 66 late biopsies in patients receiving high tacrolimus (TAC-C0 target at 1-year 6-10 ng/mL) and reduced MMF dose (500 mg bid at 1-year). The Oslo cohort consisted of 262 early and 237 late biopsies performed in patients treated with low TAC-C0 (target 3-7 ng/mL) and standard MMF dose (750 mg bid)...
July 1, 2017: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/28667460/prediction-of-the-effect-of-renal-impairment-on-the-pharmacokinetics-of-new-drugs
#18
Elisa Borella, Italo Poggesi, Paolo Magni
INTRODUCTION: Renal impairment may have a significant impact on the pharmacokinetics of drugs. Ad hoc studies in subjects with renal impairment are required by the regulatory authorities to propose dose adjustments in these subjects, to find a dosing regimen able to provide a systemic exposure similar to those in subjects with a normal renal function given the relevant clinical dose. METHODS: To evaluate the main descriptors and establish a predictive model of the effect of renal impairment on the exposure of new drugs, we considered 73 marketed drugs, for which studies in subjects with different degrees of renal impairment were available in the literature...
June 30, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28667459/clinical-pharmacokinetics-and-pharmacodynamics-of-panobinostat
#19
REVIEW
Mathilde Van Veggel, Elsbeth Westerman, Paul Hamberg
Histone deacetylase (HDAC) inhibitors cause an increase in acetylation that leads to an increase in DNA transcription and accumulation of different proteins, reducing cell proliferation and inducing cell death. Panobinostat is a first-in-line HDAC inhibitor approved for treating multiple myeloma in combination with bortezomib and dexamethasone. It is a pan-deacetylase inhibitor and therefore inhibits not only HDAC but also other deacetylases. The main mechanism of action of panobinostat is to inhibit HDAC, which causes cell cycle arrest and apoptosis, leading to it being an antineoplastic drug...
June 30, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28667354/dose-individualization-of-sunitinib-in-metastatic-renal-cell-cancer-toxicity-adjusted-dose-or-therapeutic-drug-monitoring
#20
Dhanusha Sabanathan, Alison Zhang, Peter Fox, Sally Coulter, Val Gebski, Bavanthi Balakrishnar, Mathew Chan, Christopher Liddle, Howard Gurney
PURPOSE: Dose individualization of sunitinib has been proposed using therapeutic drug monitoring (TDM) or toxicity-adjusted dose (TAD). We prospectively studied aspects of TDM and TAD to inform future trials, namely (1) intrapatient variability (CV) of sunitinib and (2) feasibility of a TAD protocol. METHODS: Sunitinib dose was adjusted to ensure grade 1 or 2 toxicity on 10-20 days of each 42-day cycle. Total trough levels (TTL) C min of sunitinib and its active metabolite were measured every 6 weeks...
June 30, 2017: Cancer Chemotherapy and Pharmacology
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