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renal dose adjustment

Hideaki Kagaya, Takenori Niioka, Mitsuru Saito, Takamitsu Inoue, Kazuyuki Numakura, Ryohei Yamamoto, Yumiko Akamine, Tomonori Habuchi, Shigeru Satoh, Masatomo Miura
While tacrolimus and everolimus have common metabolic pathways through CYP3A4/5, tacrolimus is metabolized solely by CYP3A4 in recipients with the CYP3A5*3 / *3 . The purpose of this study was to evaluate how the area under the blood concentration-time curves (AUC) of tacrolimus could be predicted based on CYP3A5 genotype and the AUC of everolimus in renal transplant patients taking both drugs. The dose-adjusted AUC (AUC/D) of tacrolimus and everolimus were calculated at one month and one year after transplantation...
March 16, 2018: International Journal of Molecular Sciences
D Czock, V Schwenger, D Kindgen-Milles, M Joannidis, S John, M Schmitz, A Jörres, A Zarbock, M Oppert, J T Kielstein, C Willam
BACKGROUND: Many anti-infective drugs require dose adjustments in critically ill patients with acute kidney injury (AKI) and renal replacement therapy, in order to achieve adequate therapeutic drug concentrations. OBJECTIVES: The fundamental pharmacokinetic and pharmacodynamic principles of drug dose adjustment are presented. Recommendations on anti-infective drug dosage in intensive care are provided. MATERIALS AND METHODS: We established dose recommendations of selected anti-infective drugs based on information in the summary of product characteristics, published studies and recommendations, pharmacokinetic and pharmacodynamic considerations, and the experience and expert opinion of the authors...
March 15, 2018: Medizinische Klinik, Intensivmedizin und Notfallmedizin
Franck Maunoury, Aurore Clément, Chizoba Nwankwo, Laurie Levy-Bachelot, Armand Abergel, Vincent Di Martino, Eric Thervet, Isabelle Durand-Zaleski
OBJECTIVE: To assess the cost-effectiveness of the elbasvir/grazoprevir (EBR/GZR) regimen in patients with genotype 1 chronic hepatitis C virus (HCV) infection with severe and end-stage renal disease compared to no treatment. DESIGN: This study uses a health economic model to estimate the cost-effectiveness of treating previously untreated and treatment experienced chronic hepatitis C patients who have severe and end stage renal disease with the elbasvir-grazoprevir regimen versus no treatment in the French context...
2018: PloS One
Alexander Buchholz, Laura Ueberham, Kaja Gorczynska, Borislav Dinov, Sebastian Hilbert, Nikolaos Dagres, Daniela Husser, Gerhard Hindricks, Andreas Bollmann
BACKGROUND: Apixaban is a non-vitamin K oral anticoagulant and has been approved for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). Current labelling recommends dose reduction based on patients age, weight and renal function. OBJECTIVES: The aim of this study was to analyze adherence to current labeling instructions concerning initial apixaban dosing in clinical practice and to identify factors associated with inappropriate dose reduction...
March 15, 2018: Clinical Cardiology
Julio Rosenstock, Vlado Perkovic, John H Alexander, Mark E Cooper, Nikolaus Marx, Michael J Pencina, Robert D Toto, Christoph Wanner, Bernard Zinman, David Baanstra, Egon Pfarr, Michaela Mattheus, Uli C Broedl, Hans-Juergen Woerle, Jyothis T George, Maximilian von Eynatten, Darren K McGuire
BACKGROUND: Cardiovascular (CV) outcome trials in type 2 diabetes (T2D) have underrepresented patients with chronic kidney disease (CKD), leading to uncertainty regarding their kidney efficacy and safety. The CARMELINA® trial aims to evaluate the effects of linagliptin, a DPP-4 inhibitor, on both CV and kidney outcomes in a study population enriched for cardio-renal risk. METHODS: CARMELINA® is a randomized, double-blind, placebo-controlled clinical trial conducted in 27 countries in T2D patients at high risk of CV and/or kidney events...
March 14, 2018: Cardiovascular Diabetology
Andra E Duncan, Daniel I Sessler, Hiroaki Sato, Tamaki Sato, Keisuke Nakazawa, George Carvalho, Roupen Hatzakorzian, Takumi Codere-Maruyama, Alaa Abd-Elsayed, Somnath Bose, Tamer Said, Maria Mendoza-Cuartas, Hyndhavi Chowdary, Edward J Mascha, Dongsheng Yang, A Marc Gillinov, Thomas Schricker
BACKGROUND: Hyperinsulinemic normoglycemia augments myocardial glucose uptake and utilization. We tested the hypothesis that hyperinsulinemic normoglycemia reduces 30-day mortality and morbidity after cardiac surgery. METHODS: This dual-center, parallel-group, superiority trial randomized cardiac surgical patients between August 2007 and March 2015 at the Cleveland Clinic, Cleveland, Ohio, and Royal Victoria Hospital, Montreal, Canada, to intraoperative glycemic management with (1) hyperinsulinemic normoglycemia, a fixed high-dose insulin and concomitant variable glucose infusion titrated to glucose concentrations of 80 to 110 mg · dl; or (2) standard glycemic management, low-dose insulin infusion targeting glucose greater than 150 mg · dl...
March 14, 2018: Anesthesiology
Yong-Soon Cho, Yook-Hwan Noh, Hyeong-Seok Lim, Sang-Heon Cho, Jong-Lyul Ghim, Sangmin Choe, Soon-Bae Kim, Jung-Sik Park, Sang-Koo Lee, Won-Seok Yang, Jai-Won Chang, Mi-Young Bahng, Kyun-Seop Bae
Udenafil is a phosphodiesterase-5 inhibitor used to treat erectile dysfunction. Although udenafil is not predominantly eliminated by the kidney, renal impairment can alter its secretion/transport pathways. Drug pharmacokinetics and safety must therefore be assessed in subjects with a renal impairment. We investigated the effects of impaired renal function on the pharmacokinetics and safety of a single 100-mg oral dose of udenafil in a single-dose, open-label, parallel-group study of 31 subjects. Cockcroft-Gault creatinine clearance was used to stratify these subjects into healthy controls (>80 mL·min-1 ) and individuals with mild (50 to ≤80 mL·min-1 ), moderate (30 to ≤50 mL·min-1 ), and severe (<30 mL·min-1 ) renal impairment...
March 14, 2018: Journal of Clinical Pharmacology
Delphine Barnoud, Claire Pinçon, Bénédicte Bruno, Johana Béné, Sophie Gautier, Annie Lahoche, Nadine Petitpain, Michèle Vasseur, Christine Barthélémy, Bertrand Décaudin, Nicolas Simon, Pascal Odou
BACKGROUND: Etoposide phosphate (EP; single injection, 60 mg/kg) followed by total body irradiation (TBI) at 12 Gy has been used as an allogeneic stem cell transplantation (allo-SCT) conditioning regimen for children since 2010. In our institution, EP has been suspected of leading to acute nephrotoxicity. The aim of this study was to assess the potential renal toxicity of EP in this context. MATERIALS AND METHODS: A retrospective study was carried out on children hospitalized between 2007 and 2015 for allo-SCT with TBI-based myeloablative conditioning associated with cyclophosphamide (CY, 60 mg/kg/day × 2 days) or EP...
March 12, 2018: Pediatric Blood & Cancer
Yusuf Menda, Mark T Madsen, Thomas M O'Dorisio, John Sunderland, Leonard G Watkins, Joseph S Dillon, Sarah L Mott, Michael King Schultz, Gideon K D Zamba, David L Bushnell, M Sue O'Dorisio
Pre-therapy PET imaging with86 Y-DOTATOC PET is considered the ideal dosimetry protocol for90 Y-DOTATOC therapy; however, its cost, low availability and the need for infusion of amino acids to mimic the therapy administration limit its use in the clinical setting. Objectives: To develop a dosimetric method for90 Y-DOTATOC therapy using90 Y-DOTATOC PET/CT and Bremsstrahlung SPECT/CT imaging and to determine if dosimetry-based administered activities differed significantly from standard administered dosages. Materials and Methods: This is a prospective Phase 2 trial of90 Y-DOTATOC therapy in patients with somatostatin receptor positive tumors...
March 9, 2018: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
Victoria Thwaites, Julia Colston, Jose Lomas-Cabeza, Zsolt Orosz
We report a case of an 88-year-old man with osteomyelitis of the right ankle, with histopathology demonstrating a Mycobacterium spindle cell pseudotumor. The Mycobacterium contained in this spindle cell pseudotumor was Mycobacterium chelonae. M. chelonae spindle cell pseudotumors are rare and have only been reported twice previously in the literature. Similarly, M. chelonae presenting as the pathogen in bone infection is rare. Due to this unusual presentation of M. chelonae, the antibiotic rationale was based largely on case reports and consisted of imipenem, clarithromycin, and linezolid...
January 2018: International Journal of Mycobacteriology
Abdul Aziz Al Wazzan, Eline Tommelein, Katrien Foubert, Stefano Bonassi, Graziano Onder, Annemie Somers, Mirko Petrovic, Koen Boussery
BACKGROUND: Renal function progressively worsens with age. Potentially inappropriate prescribing (PIP) of renally excreted active drugs (READs) is common in older adults, leading to an increased rate of iatrogenic illness. The Ghent Older People's Prescription community Pharmacy Screening (GheOP3 S-) tool is an effective, explicit instrument that was developed for community pharmacists (CPs) to detect PIP. So far, this tool does not assess PIP of the frequently used READs in older patients with renal impairment...
March 5, 2018: Drugs & Aging
Pierre Marquet, Anne Bedu, Caroline Monchaud, Franck Saint-Marcoux, Jean-Philippe Rérolle, Isabelle Etienne, Nassim Kamar, Bruno Moulin, Elisabeth Cassuto, Marie Essig, Jean-Baptiste Woillard
BACKGROUND: ISBA is an online expert system, routinely used by approximately 140 transplantation centers in the world for the dose adjustment of immunosuppressive drugs in transplant patients. This system determines the drug area-under-the-curve (AUC) by PK modeling and Bayesian estimation. The purpose of this study was to analyze tacrolimus exposure after administration of its modified-release formulation (Advagraf) in kidney allograft recipients, in order to optimize its therapeutic drug monitoring...
March 2, 2018: Therapeutic Drug Monitoring
Chih-Ning Cheng, Shu-Wen Lin, Chien-Chih Wu
Linezolid, an oxazolidinone antibiotic, does not required dose adjustment in patients with Child's class A and B liver cirrhosis. The dose adjustment data for Child's class C liver cirrhosis is inadequate. We reported a case of Child's class C liver cirrhosis, in which lactic acidosis, an adverse effect related to prolonged use, occurred only after two weeks of linezolid treatment. A 63-year old male had underlying diseases, such as end-stage renal disease (ESRD) and Child's class C liver cirrhosis, and was admitted for hepatic encephalopathy management and liver transplantation evaluation...
March 1, 2018: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
Alexandra Rehfuss, Joseph Mahon, Igor Sorokin, Cynthia Smith, Barry S Stein
OBJECTIVE: To identify difficult to see ureteral orifices (UOs), urologists need a method to stain the urine. Phenazopyridine, a urinary analgesic which discolors the urine orange, can be administered orally pre-operatively. We evaluated the usefulness of phenazopyridine in identifying the UOs and optimal timing of administration. METHODS: Adult patients undergoing endoscopic procedures at the Stratton VA were prospectively enrolled. Preoperative metabolic panels were reviewed...
March 1, 2018: Urology
Salman Khan, Timothy Sullivan, Mohsin Ali, Dallas Dunn, Gopi Patel, Shirish Huprikar
BACKGROUND: Liver transplant recipients (LTR) who are seropositive for cytomegalovirus (CMV) (R+) are at intermediate-risk for CMV disease. A preventive strategy following transplant is considered standard of care. Current guidelines recommend high-dose valganciclovir (VGCV) (900 mg/day adjusted for renal function) for prophylaxis given limited data on the efficacy and safety of low-dose VGCV (450 mg/day adjusted for renal function). We describe our experience using low-dose VGCV prophylaxis for R+ LTR at our institution...
March 3, 2018: Liver Transplantation
Takahiro Kobayashi, Masatomo Miura, Takenori Niioka, Maiko Abumiya, Fumiko Ito, Isuzu Kobayashi, Sho Ikeda, Tomoko Yoshioka, Yoshihiro Kameoka, Naoto Takahashi
BACKGROUND: The authors conducted a phase II clinical trial of lenalidomide and dexamethasone combination therapy in Japanese elderly patients with newly diagnosed multiple myeloma to evaluate its safety and efficacy and to determine whether safety and efficacy correlate with the plasma concentration of lenalidomide. METHODS: Forty patients received oral lenalidomide on days 1-21 of a 28-day cycle in addition to weekly doses of dexamethasone. Plasma concentrations of lenalidomide were measured, and the area under the concentration-time curve from 0 to 24 h (AUC0-24) of lenalidomide was predicted using a formula the authors previously reported in this journal...
February 27, 2018: Therapeutic Drug Monitoring
Takuya Aoki, Yosuke Yamamoto, Tatsuyoshi Ikenoue, Yoshihiro Onishi, Shunichi Fukuhara
In the present study, we aimed to identify multimorbidity patterns in a Japanese population and investigate whether these patterns have differing effects on polypharmacy and dosage frequency. Data was collected on 17 chronic health conditions via nationwide cross-sectional survey of 3,256 adult Japanese residents. Factor analysis was performed to identify multimorbidity patterns, and associations were determined with excessive polypharmacy [concurrent use of ≥ 10 prescription or over-the-counter (OTC) medications] and higher dosage frequency ( ≥ 3 doses per day)...
February 28, 2018: Scientific Reports
W A C Kristine Koekkoek, C H Coralien van Setten, Laura E Olthof, J C N Hans Kars, Arthur R H van Zanten
BACKGROUND & AIMS: Optimal protein intake during critical illness is unknown. Conflicting results on nutritional support during the first week of ICU stay have been published. We addressed timing of protein intake and outcomes in ICU patients requiring prolonged mechanical ventilation. METHODS: We retrospectively collected nutritional and clinical data on the first 7 days of ICU admission of adult critically ill patients, who were mechanically ventilated in our ICU for at least 7 days and admitted between January 1st 2011 and December 31st 2015...
February 17, 2018: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
Masateru Okazaki, Hisanori Kobayashi, Yutaka Ishii, Masayoshi Kanbori, Tsutomu Yajima
INTRODUCTION: The aim of this study was to investigate real-world treatment patterns for use of golimumab and concomitant medications in Japanese patients with rheumatoid arthritis. METHODS: This study was a post hoc retrospective analysis from post-marketing surveillance data on 2350 Japanese patients with moderate/severe rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided based on initiation treatment or dose adjustment patterns with golimumab, methotrexate, or oral glucocorticoids...
February 22, 2018: Rheumatology and Therapy
Kristen B McCullough, Miriam A Hobbs, Jithma P Abeykoon, Prashant Kapoor
PURPOSE OF REVIEW: The purpose of this review was to evaluate management strategies for common adverse effects of novel therapies in multiple myeloma (MM), including immunomodulatory drugs, proteasome inhibitors, monoclonal antibodies, and a histone deacetylase inhibitor. RECENT FINDINGS: There are several adverse effects that occur across multiple classes of antimyeloma drugs, including rash, peripheral neuropathy, infusion reactions, and cardiotoxicity, but most can be managed without complete discontinuation of the agent or abandonment of the class...
February 15, 2018: Current Hematologic Malignancy Reports
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