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European Journal of Clinical Pharmacology

Mustafa E Ibrahim, Cara Chang, Yichun Hu, Susan L Hogan, Nickie Mercke, Madeleine Gomez, Cindy L O'Bryant, Daniel W Bowles, Blessy George, Xia Wen, Brian Buckley, Lauren Aleksunes, Melanie S Joy
PURPOSE: The ability to predict and detect clinical and subclinical nephrotoxicity early in the course of therapy has the potential to improve long-term outcomes in cancer patients receiving cisplatin chemotherapy. Pharmacokinetic parameters could serve as predictors of cisplatin-induced nephrotoxicity. METHODS: Participants [n = 13] were treated with a 1-h cisplatin infusion [30-75 mg/m2 ]. Blood was collected pre-dose and up to 6 h post-dose. Urinary biomarkers [KIM-1, calbindin, clusterin, GST-pi, β2M, albumin, NGAL, osteopontin, clusterin, MCP-1, cystatin C, and TFF3] were measured at baseline, days 3 and 10...
September 15, 2018: European Journal of Clinical Pharmacology
Koen P Grootens, Anna Meijer, Erwin G Hartong, Bennard Doornbos, P Roberto Bakker, Asmar Al Hadithy, Kirsten N Hoogerheide, Frans Overmeire, Radboud M Marijnissen, Henricus G Ruhe
In the original version of this article unfortunately two tables have been missing. By mistake they have been published as Supplementary Material. We apologize for any inconvenience caused. The original article has been corrected.
September 14, 2018: European Journal of Clinical Pharmacology
Zhuo Wu, Qinxia Xu, Xiaoyan Qiu, Luyang Xu, Zheng Jiao, Ming Zhang, Mingkang Zhong
AIM: To investigate the potential impact of single-nucleotide polymorphisms (SNPs) in the FK506-binding protein (FKBP)-calcineurin (CaN)-nuclear factor of activated T cells (NFAT) signaling pathway on the efficacy and safety of tacrolimus (TAC) in Chinese renal transplant patients. METHODS: Seventy-seven tag SNPs were detected in 146 patients who were on TAC-based maintenance immunosuppression and who followed up for at least 2 years. The relationships of these polymorphisms with clinical outcomes such as acute rejection, acute nephrotoxicity, pneumonia, and estimated glomerular filtration rate (eGFR) were explored...
September 13, 2018: European Journal of Clinical Pharmacology
Vivien Weiß, Roland Nau, Gerd Glaeske, Eva Hummers, Wolfgang Himmel
PURPOSE: Non-medical or contextual factors strongly influence physicians' prescribing behavior and may explain why drugs, such as benzodiazepines and Z-drugs, are still frequently prescribed in spite of well-known adverse effects. This study aimed to explore which contextual factors influence the prescription of hypnotics and sedatives and to compare their role in primary and secondary care. METHODS: Understanding medical practices as games with specific rules and strategies and performed in a largely habitual, not fully conscious manner, we asked a maximum variation sample of 12 hospital doctors and 12 general practitioners (GPs) about their use of hypnotics and sedatives...
September 13, 2018: European Journal of Clinical Pharmacology
Renato De Vecchis, Carmelina Ariano, Angelos Rigopoulos, Michel Noutsias
No abstract text is available yet for this article.
September 10, 2018: European Journal of Clinical Pharmacology
Shih-Wei Lai
No abstract text is available yet for this article.
September 10, 2018: European Journal of Clinical Pharmacology
François Montastruc, Farzin Khosrow-Khavar, Agnès Sommet, Christel Renoux, Jean-Louis Montastruc
No abstract text is available yet for this article.
September 10, 2018: European Journal of Clinical Pharmacology
Anna Elgart, Arik A Zur, Dorit Mimrod, Vered Dror, Oren Bar-Ilan, Tjeerd Korver, Ofer Spiegelstein
PURPOSE: Laquinimod is an orally dosed immuno-modulator currently under development for Huntington's disease (HD). Preclinical findings suggest potential teratogenicity of laquinimod, thus the reproductive ability of females with HD treated with laquinimod needs to be closely managed. Because combined oral contraceptives (COC) are often used in this context, the pharmacokinetics of COC containing ethinylestradiol (EE) and levonorgestrel (LNG) in combination with laquinimod (0.6 mg/day) was evaluated...
September 6, 2018: European Journal of Clinical Pharmacology
J O'Callaghan, S P Barry, M Bermingham, J M Morris, B T Griffin
Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be seen. Educational initiatives relating to the use of biosimilar medicines are currently being undertaken by regulators, policy makers and industry. The debate on biosimilars has moved on from the appropriateness of the regulatory framework which governs their approval, to the practice of interchangeability...
September 5, 2018: European Journal of Clinical Pharmacology
G Bourdenet, E Saussereau, J P Goullé, M Guerbet, J Doucet
No abstract text is available yet for this article.
August 31, 2018: European Journal of Clinical Pharmacology
Mari Fihlman, Tuija Hemmilä, Nora M Hagelberg, Janne T Backman, Jouko Laitila, Kari Laine, Pertti J Neuvonen, Klaus T Olkkola, Teijo I Saari
PURPOSE: Buprenorphine has low oral bioavailability. Regardless of sublingual administration, a notable part of buprenorphine is exposed to extensive first-pass metabolism by the cytochrome P450 (CYP) 3A4. As drug interaction studies with buprenorphine are limited, we wanted to investigate the effect of voriconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics and pharmacodynamics of oral buprenorphine. METHODS: Twelve healthy volunteers were given either placebo or voriconazole (orally, 400 mg twice on day 1 and 200 mg twice on days 2-5) for 5 days in a randomized, cross-over study...
August 30, 2018: European Journal of Clinical Pharmacology
Hannah Yejin Kim, Gareth J Veal, Fanfan Zhou, Alan V Boddy
BACKGROUND: Actinomycin D is used for treatment of paediatric cancers; however, a large inter-patient pharmacokinetic (PK) variability and hepatotoxicity are significant limitations to its use and warrant further investigation. Elimination of actinomycin D may be mediated by transporters, as the drug does not seem to undergo significant metabolism. We investigated the role of solute carrier (SLC) transporters in actinomycin D PK. METHODS: Fourteen key SLCs were screened through probe substrate uptake inhibition by actinomycin D in HEK293 cells...
August 30, 2018: European Journal of Clinical Pharmacology
Dana Clarissa Muhlack, Liesa Katharina Hoppe, Christian Stock, Walter E Haefeli, Hermann Brenner, Ben Schöttker
PURPOSE: To assess the changes in use of potentially inappropriate medication (PIM) as defined by the 2015 Beers criteria, the EU(7)-PIM, and the PRISCUS list over a 6-year period and to identify determinants for current and future PIM use with a particular focus on geriatric syndromes. METHODS: In a German cohort of 2878 community-dwelling adults aged ≥ 60 years, determinants of the use of ≥ 1 PIM were identified in multivariable logistic regression (cross-sectional analysis) and weighted generalized estimating equation models (longitudinal analysis)...
August 29, 2018: European Journal of Clinical Pharmacology
Ida Tylleskar, Arne Kristian Skulberg, Sissel Skarra, Turid Nilsen, Ola Dale
PURPOSE: Pharmacodynamic studies of naloxone require opioid agonism. Steady state condition may be achieved by remifentanil TCI (target controlled infusion). Opioid agonism can be measured by pupillometry. It is not known whether there are arteriovenous concentration differences for naloxone. The aim was thus to further develop a model for studying pharmacokinetic/pharmacodynamic aspects of naloxone and to explore whether a significant arteriovenous concentration difference for naloxone in humans was present...
August 24, 2018: European Journal of Clinical Pharmacology
Soyoung Lee, Yun Kim, Janice Ji Sung Lee, Guangjin Im, Joo-Youn Cho, Jae-Yong Chung, Seonghae Yoon
PURPOSE: Combination therapy of pregabalin and tramadol is used to treat chronic neuropathic pain; however, the pharmacokinetic (PK) interactions of these drugs has not been studied. This study aimed to evaluate PK interactions between pregabalin and tramadol and the safety of combination therapy. METHODS: A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence cross-over study was conducted in healthy subjects. All subjects received the following three treatments for 4 days in each period: pregabalin 150 mg twice daily; tramadol extended-release (ER) 200 mg in the morning, and 100 mg in the evening; and co-administration of pregabalin 150 mg and tramadol ER 200 mg in the morning, and pregabalin 150 mg and tramadol ER 100 mg in the evening...
August 22, 2018: European Journal of Clinical Pharmacology
Manuela Moreno Santamaría, José Javier Arenas Villafranca, Jimena Abilés, Alberto Fernández López, Lucia Visiedo Rodas, Begoña Tortajada Goitia, Pilar Utrilla Navarro
PURPOSE: Inter- and intraindividual pharmacokinetics variability in humans affects the way in which drugs act on the body. Gastrointestinal surgery has an impact on this variability and significantly alters the kinetics of drugs in post-surgical patients. The way in which pharmacokinetic profiles are modified depends on the type of operative procedure performed. The extent to which the absorption of different groups of drugs is affected varies according to the site and length of intestinal resections...
August 22, 2018: European Journal of Clinical Pharmacology
Jinshuang Li, Yuansheng Fan, Tiantian Zhu, Jun Chen, Deyu Kong, Haoyu Meng, Jing Zhang, Ke Xu, Sen Ye, Yuqin Ji, Chunjian Li
PURPOSE: Form II clopidogrel bisulfate (Plavix) has been extensively used in patients with acute coronary syndrome. However, the efficacy of form I clopidogrel bisulfate (Talcom) was less investigated. The aim of this study was to investigate the efficacy and safety of Talcom compared with Plavix. METHOD: Two hundred and forty-eight patients were recruited after receiving percutaneous coronary intervention (PCI). Participants were randomly assigned to Talcom or Plavix group, and administered with Talcom or Plavix 75 mg od respectively in combination with aspirin 100 mg od for 12 months...
August 20, 2018: European Journal of Clinical Pharmacology
Lars J Kjerpeseth, Hanne Ellekjær, Randi Selmer, Inger Ariansen, Kari Furu, Eva Skovlund
PURPOSE: To investigate risk factors for stroke in patients initiating oral anticoagulants for atrial fibrillation in Norway and their association with receiving DOACs versus warfarin. METHODS: From nationwide registries, we identified naïve users initiating treatment with warfarin, dabigatran, rivaroxaban, or apixaban for atrial fibrillation from 2010 to 2015 in Norway. We studied temporal changes in the CHA2 DS2 -VASc score and its component risk factors. We used multiple logistic regressions to identify CHA2 DS2 -VASc risk factors associated with receiving DOACs versus warfarin in 2015...
August 16, 2018: European Journal of Clinical Pharmacology
Renato De Vecchis, Carmelina Ariano, Giuseppina Di Biase, Michel Noutsias
INTRODUCTION: Several drug classes (antiarrhythmics, antimicrobials, antidepressants, phenothiazines, opiates, prokinetics of digestive tract, etc.) have been related to ventricular hyperkinetic arrhythmias such as torsade de pointes (TdP). TdPs are usually heralded by an abnormal prolongation of heart rate-corrected QT interval on the electrocardiogram, so-called drug-induced long heart rate-corrected QT (diLQTc). We do not know to what extent the drug-induced QTc prolongation is able to predict malignant arrhythmias...
August 15, 2018: European Journal of Clinical Pharmacology
Anne Gardin, Cathy Gray, Srikanth Neelakantham, Felix Huth, Antonia M Davidson, Swati Dumitras, Eric Legangneux, Kasra Shakeri-Nejad
PURPOSE: To assess the potential pharmacokinetic (PK) interactions between siponimod and rifampin, a strong CYP3A4/moderate CYP2C9 inducer, in healthy subjects. METHODS: This was a confirmatory, open-label, multiple-dose two-period study in healthy subjects (aged 18-45 years). In Period 1 (Days 1-12), siponimod was up-titrated from 0.25 to 2 mg over 5 days (Days 1-6) followed by 2 mg once daily on days 7-12. In Period 2, siponimod 2 mg qd was co-administered with rifampin 600 mg qd (Days 13-24)...
August 13, 2018: European Journal of Clinical Pharmacology
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