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European Journal of Clinical Pharmacology

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https://read.qxmd.com/read/31001654/safety-aspects-of-antiepileptic-drugs-a-population-based-study-of-adverse-effects-relative-to-changes-in-utilisation
#1
Arton Baftiu, Maren H Lima, Kristian Svendsen, Pål G Larsson, Svein I Johannessen, Cecilie Johannessen Landmark
PURPOSE: Antiepileptic drugs (AEDs) are increasingly used, and knowledge about adverse effects is scarce based on clinical studies. The purpose of the present study was to characterise adverse effects reports of AEDs in Norway relative to changes in utilisation in various indications from population-based data to elucidate important safety aspects of use of AEDs. METHODS: Aggregated data of adverse effects reported for AEDs in Norway from the EudraVigilance-database (2004-2013) in addition to indication-specific use of AEDs during 2004-2015 from the Norwegian Prescription Database were used...
April 18, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30982083/effects-of-guggulsterones-containing-thermogenic-complex-on-elvitegravir-plasma-concentrations-a-case-report
#2
LETTER
Dario Cattaneo, Annalisa Ridolfo, Sara Baldelli, Cristina Gervasoni
No abstract text is available yet for this article.
April 13, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30972452/retraction-note-to-effect-of-n-acetyl-cysteine-nac-supplementation-on-positive-and-negative-syndrome-scale-in-schizophrenia-a-systematic-review-and-meta-analysis-of-randomised-controlled-trials
#3
Amir Ghaderi, Anna Bussu, Catherine Tsang, Sadegh Jafarnejad
The authors have retracted this article [1] because there are fundamental errors in the data presented that undermine the conclusions drawn. All authors agree with this retraction. The authors are re-analysing their data and intend to submit a new manuscript for peer review in due course.
April 11, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30972451/hepatotoxicity-risk-factors-and-acetaminophen-dose-adjustment-do-prescribers-give-this-issue-adequate-consideration-a-french-university-hospital-study
#4
Astrid Bacle, Charlotte Pronier, Helene Gilardi, Elisabeth Polard, Sophie Potin, Lucie-Marie Scailteux
BACKGROUND: The hepatotoxicity of acetaminophen is recognised worldwide. Unfavourable prognoses relating to overdose include liver transplantation and/or death. Several hepatotoxicity risk factors (HRFs) should motivate the adjustment of acetaminophen daily intake (to < 4 g/day): advanced age, weight < 50 kg, malnutrition, chronic alcoholism, chronic hepatitis B and C and HIV infection, severe chronic renal failure and hepatocellular insufficiency. METHOD: Over a 7-day period in Rennes University Hospital in December 2017, using DxCare® software, with an odds ratio estimation, we analysed all acetaminophen prescriptions, to assess to what extent the presence of HRFs altered the prescribers' choice of acetaminophen dose (< 4 g/day versus 4 g/day)...
April 10, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30968172/pharmacokinetics-of-venlafaxine-in-treatment-responders-and-non-responders-a-retrospective-analysis-of-a-large-naturalistic-database
#5
Georgios Schoretsanitis, Ekkehard Haen, Gerhard Gründer, Christoph Hiemke, Katharina Endres, Florian Ridders, Christoph U Correll, Michael Paulzen
PURPOSE: To assess in a large naturalistic sample, whether clinical response to a treatment with venlafaxine is associated with different patterns of plasma concentrations of active moiety, AM (sum of venlafaxine (VEN) and its active metabolite O-desmethylvenlafaxine (ODVEN)). METHODS: Applying a regression model, plasma concentrations and plasma concentrations corrected-by-dosage (C/D) for AM were included as independent variable with Clinical Global Impressions-Improvement (CGI-I) scale ratings as dependent variable...
April 9, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30949726/use-of-prescription-drugs-in-the-older-adult-population-a-nationwide-pharmacoepidemiological-study
#6
Line Due Christensen, Mette Reilev, Helle Gybel Juul-Larsen, Lillian Mørch Jørgensen, Susanne Kaae, Ove Andersen, Anton Pottegård, Janne Petersen
PURPOSE: Multi-morbidity and polypharmacy are common among older people. It is essential to provide a better understanding of the complexity of prescription drug use among older adults to optimise rational pharmacotherapy. Population-based utilisation data in this age group is limited. Using the Danish nationwide health registries, we aimed to characterise drug use among Danish individuals ≥ 60 years. METHODS: This is a descriptive population-based study assessing drug prescription patterns in 2015 in the full Danish population aged ≥ 60 years...
April 4, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30937470/population-pharmacokinetic-analysis-of-vancomycin-in-pediatric-continuous-renal-replacement-therapy
#7
Brady S Moffett, Jennifer Morris, Flor Munoz, Ayse Akcan Arikan
BACKGROUND AND OBJECTIVES: Dosing of vancomycin in pediatric patients undergoing continuous venous-venous hemodiafiltration (CVVHDF) is challenging. Characterization of vancomycin pharmacokinetics can assist with dosing and attainment of goal serum concentrations. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: Patients less than 19 years of age who received vancomycin and had post-dose vancomycin concentrations while undergoing CVVHDF were identified. Data collection included the following: patient demographics, vancomycin dosing and serum concentrations, CVVHDF variables, serum creatinine (SCR), blood urea nitrogen (BUN), albumin, hematocrit, and urine output...
April 1, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30918988/adverse-drug-reaction-causality-assessment-tools-for-drug-induced-stevens-johnson-syndrome-and-toxic-epidermal-necrolysis-room-for-improvement
#8
Jennifer L Goldman, Wen-Hung Chung, Brian R Lee, Chun-Bing Chen, Chun-Wei Lu, Wolfram Hoetzenecker, Robert Micheletti, Sally Usdin Yasuda, David J Mariolis, Neil H Shear, Jeffery P Struewing, Munir Pirmohamed
PURPOSE: Establishment of causality between drug exposure and adverse drug reactions (ADR) is challenging even for serious ADRs such as Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN). Several causality assessment tools (CAT) exist, but the reliability and validity of such tools is variable. The objective of this study was to compare the reliability and validity of existing ADR CATs on SJS/TEN cases. METHODS: Seven investigators completed three CAT (ALDEN, Naranjo, Liverpool) for 10 SJS/TEN cases...
March 27, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30915521/the-effect-of-l-carnitine-on-inflammatory-mediators-a-systematic-review-and-meta-analysis-of-randomized-clinical-trials
#9
REVIEW
F Haghighatdoost, M Jabbari, Mitra Hariri
AIM AND BACKGROUND: Reducing inflammation by nutritional supplements may help to reduce the risk of many chronic diseases. Our aim in this meta-analysis was to determine the effect of L-carnitine on inflammatory mediators including C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6). METHODS: Our systematic search to find relevant randomized clinical trials (RCTs) was performed up to October 2018 using ISI Web of Science, Google Scholar, PubMed/Medline, and SCOPUS...
March 26, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30915520/medication-and-medical-diagnosis-as-risk-factors-for-falls-in-older-hospitalized-patients
#10
Fabian Wedmann, Wolfgang Himmel, Roland Nau
OBJECTIVE: To examine the impact of medication and medical conditions on the fall risk in older hospitalized patients. DESIGN: Matched case-control study. SETTING: Large regional hospital in a mid-sized German city. SUBJECTS: Four hundred eighty-one inpatients aged ≥ 65 years who fell during hospitalization ("cases") and a control group of 481 controls, matched for age, gender, and hospital department...
March 26, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30915519/the-misleading-use-of-the-term-pragmatic-in-pre-licensing-medicine-trials
#11
EDITORIAL
Rafael Dal-Ré
No abstract text is available yet for this article.
March 26, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30903196/discontinuation-of-therapy-among-copd-patients-who-experience-an-improvement-in-exacerbation-status
#12
Mette Reilev, Kasper Bruun Kristensen, Jens Søndergaard, Daniel Pilsgaard Henriksen, Wade Thompson, Anton Pottegård
PURPOSE: A subset of patients with chronic obstructive pulmonary disease (COPD) experience a decrease in exacerbation frequency, leading to a diminished need for treatment with inhaled corticosteroids (ICS). We investigated prescribing and discontinuation patterns of long-acting bronchodilators and ICS in COPD patients according to exacerbation frequency. METHODS: Using the nationwide Danish health registries, we conducted a drug utilization study among patients who had at least two exacerbations or one hospitalization due to an exacerbation during 2011-2012...
March 22, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30899989/a-pharmacist-physician-intervention-model-using-a-computerized-alert-system-to-reduce-high-risk-medication-use-in-primary-care
#13
Benoit Cossette, Ryeyan Taseen, Jacynthe Roy-Petit, Marie-Pier Villemure, Martine Grondin, Geneviève Ricard, François Goyer, Caroline Blanchard, Thomas Joly-Mischlich, Jean-François Éthier
PURPOSE: Potentially inappropriate medications (PIMs) have been associated with a greater risk of adverse drug events and hospitalizations. To reduce PIMs use, a family health team (FHT) implemented a knowledge translation (KT) strategy that included a pharmacist-physician intervention model based on alerts from a computerized alert system (CAS). METHODS: Our pragmatic, single-site, pilot study was conducted in an FHT clinic in Quebec, Canada. We included community-dwelling older adults (≥ 65 years), with at least 1 alert for selected PIMs and a medical appointment during the study period...
March 21, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30888462/correction-to-risk-factors-for-vancomycin-nephrotoxicity-and-time-course-of-renal-function-during-vancomycin-treatment
#14
Toshinori Hirai, Kazuhiko Hanada, Ayako Kanno, Megumi Akashi, Toshimasa Itoh
After online publication, we found a typographical error in Table 2. We consider correcting "VCM trough concentration > 20 g/mL" to "VCM trough concentration > 20 μg/mL".
March 19, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30877328/impact-of-health-technology-assessment-and-managed-entry-schemes-on-reimbursement-decisions-of-centrally-authorised-medicinal-products-in-belgium
#15
Philippe Van Wilder, Magali Pirson, Alain Dupont
PURPOSE: Centrally authorised medicinal products (CAMPs) in the European Union may offer added therapeutic value (ATV) but may be linked to high prices and limited efficiency. Health technology assessment (HTA) and managed entry schemes (MES) may facilitate the reimbursement decision by providing reliable estimates of the medicinal product's value and costs and by controlling the remaining uncertainty, respectively. We investigated the impact of HTA criteria and the initiation of a MES on the reimbursement decision of CAMPs in Belgium...
March 15, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30877327/the-effect-of-neutropenia-on-the-clinical-pharmacokinetics-of-vancomycin-in-adults
#16
Didi Bury, Rob Ter Heine, Ewoudt M W van de Garde, Marten R Nijziel, Rene J Grouls, Maarten J Deenen
AIM: There is accumulating evidence that neutropenic patients require higher dosages of vancomycin. To prevent sub-therapeutic drug exposure, it is of utmost importance to obtain adequate exposure from the first dose onwards. We aimed to quantify the effect of neutropenia on the pharmacokinetics of vancomycin. METHODS: Data were extracted from a matched patient cohort of patients known with (1) hematological disease, (2) solid malignancy, and (3) patients not known with cancer...
March 15, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30868193/relationship-between-hemoglobin-levels-and-vancomycin-clearance-in-patients-with-sepsis
#17
Masayuki Chuma, Makoto Makishima, Toru Imai, Naohiro Tochikura, Shinichiro Suzuki, Tsukasa Kuwana, Nami Sawada, So Iwabuchi, Masao Sekimoto, Takahiro Nakayama, Takako Sakaue, Norikazu Kikuchi, Yoshikazu Yoshida, Kosaku Kinoshita
PURPOSE: It is important to accurately estimate accurate vancomycin (VCM) clearance (CLvcm) for appropriate VCM dosing in the treatment of patients with sepsis. However, the pathophysiology of sepsis can make CLvcm prediction less accurate. Clearance of hydrophilic antibiotics is disturbed by organ dysfunction, and hemoglobin levels are negatively correlated with sequential organ function assessment scores. We investigated whether hemoglobin levels are associated with CLvcm in sepsis patients...
March 14, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30868192/influence-of-body-weight-and-ugt2b7-polymorphism-on-varenicline-exposure-in-a-cohort-of-smokers-from-the-general-population
#18
Anaïs Glatard, Monia Guidi, Maria Dobrinas, Jacques Cornuz, Chantal Csajka, Chin B Eap
PURPOSE: The abstinence rate to tobacco after varenicline treatment is moderate and might be partially affected by variability in varenicline concentrations. This study aimed at characterizing the sources of variability in varenicline pharmacokinetics and to relate varenicline exposure to abstinence. METHODS: The population pharmacokinetic analysis (NONMEM®) included 121 varenicline concentrations from 82 individuals and tested the influence of genetic and non-genetic characteristics on apparent clearance (CL/F) and volume of distribution (V/F)...
March 13, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30859243/tacrolimus-exposure-early-after-lung-transplantation-and-exploratory-associations-with-acute-cellular-rejection
#19
David R Darley, Lilibeth Carlos, Stefanie Hennig, Zhixin Liu, Richard Day, Allan R Glanville
AIMS: To (i) describe tacrolimus (TAC) pre-dose concentrations (C0 ), (ii) calculate apparent oral TAC clearance (CL/FHCT ) adjusted for measured haematocrit (HCTi) and standardised to a HCT of 45%, across three observation time points and (iii) explore if low TAC C0 or high mean CL/FHCT are associated with an increased risk of rejection episodes early after lung transplantation. METHODS: TAC whole blood concentration-time profiles and transbronchial biopsies were performed prospectively at weeks 3, 6 and 12 after lung transplantation...
March 12, 2019: European Journal of Clinical Pharmacology
https://read.qxmd.com/read/30852642/verification-of-pharmacogenomics-based-algorithms-to-predict-warfarin-maintenance-dose-using-registered-data-of-japanese-patients
#20
Maki Sasano, Masako Ohno, Yuya Fukuda, Shinpei Nonen, Sachiko Hirobe, Shinichiro Maeda, Yoshihiro Miwa, Junya Yokoyama, Hiroyuki Nakayama, Shigeru Miyagawa, Yoshiki Sawa, Yasushi Fujio, Makiko Maeda
PURPOSE: Large inter-individual differences in warfarin maintenance dose are mostly due to the effect of genetic polymorphisms in multiple genes, including vitamin K epoxide reductase complex 1 (VKORC1), cytochromes P450 2C9 (CYP2C9), and cytochrome P450 4F2 (CYP4F2). Thus, several algorithms for predicting the warfarin dose based on pharmacogenomics data with clinical characteristics have been proposed. Although these algorithms consider these genetic polymorphisms, the formulas have different coefficient values that are critical in this context...
March 9, 2019: European Journal of Clinical Pharmacology
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