Volume 55 (2017), No. 8/2017(August)
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The 10-D assessment and evidence-based medicine tool for authors and peer reviewers in clinical pharmacology
Barry Woodcock and Sebastian Harder
Page No. 639
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (639-642)
The 10-D assessment and evidence-based medicine tool for authors and peer reviewers in clinical pharmacology
Barry Woodcock1 and Sebastian Harder2
1Dustri Medical Science Publications, Dustri-Verlag Dr. Karl Feistle GmbH & Co. KG, Deisenhofen-Munich, Germany, and Dustri-Verlag, Inc., Rockledge, FL, USA, and 2Institute of Clinical Pharmacology, pharmazentrum frankfurt, University Hospital, Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany
Background: Peer reviewers and authors of clinical pharmacology manuscripts need to meet the standards for Evidence-Based Medicine (EBM) and Good Publication Practices (GPP), and editors of clinical pharmacology journals have to maintain an overview of the peer review process. Methods and results: The peer review process can be monitored and facilitated using the 10-D assessment, which comprises peer review criteria to determine if: 1. design of the study, 2. diagnoses employed, 3. drug molecules involved, 4. dosages applied, 5. data collected, 6. discussion of the findings, 7. deductions made, 8. documentation, 9. declarations, and 10. dHS (drug hypersensitivity syndrome) risk assessment is in accord with the objectives of the study and meet the requirements of EBM and GPP. Conclusions: The 10-D assessment tool, although easy to apply, requires a high level of clinical pharmacology expertise, especially in the fields of drug disposition, pharmacokinetics, and drug action. Its application will facilitate the peer review of clinical research and clinical trial reports and thus promote safety in drug development and pharmacotherapy and meet the needs of Good Publication Practices.
Correspondence to:
Barrington (Barry) G. Woodcock
P.O.Box 200232
63308 Rödermark, Germany
Email: woodcockbgscolopax@t-online.de
Original
Prevalence and predictors of prescription of antibiotics in pregnant women treated by gynecologists in Germany
Louis Jacob, Matthias Kalder, and Karel Kostev
Price
42.00 $
Page No. 643
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (643-649)
Prevalence and predictors of prescription of antibiotics in pregnant women treated by gynecologists in Germany
Louis Jacob1, Matthias Kalder2, and Karel Kostev3
1Faculty of Medicine, University of Paris 5, Paris, France, 2Department of Gynecology and Obstetrics, Philipps-University of Marburg, Marburg, and 3Epidemiology, IMS Health, Frankfurt am Main, Germany
Aim: The aim of this study is to estimate the prevalence and potential predictors of the prescription of antibiotics in pregnant women treated by gynecologists in Germany. Methods: The current study included 90,312 women aged between 18 and 45 years with a full-term documented pregnancy during the index period (2005 – 2014). The primary outcome was the proportion of pregnant women with antibiotic prescriptions. Potential predictors of antibiotic prescriptions considered in the present analysis were age, index year, and gynecological/urinary disorders. Disorders included in this analysis were frequent gynecological and urinary conditions that are often treated with antibiotics. Multivariate logistic regression models were used to estimate the probability of antibiotic use depending on age, index year, and codiagnoses. Results: In this population, 14.7% of pregnant women had antibiotic prescriptions. Pregnant women in the age groups ≤ 20 and 21 – 25 years were more likely to be prescribed antibiotics than pregnant women in the age group 41 – 45 years (odds ratios equal to 1.55 and 1.27, respectively). Pregnant women analyzed in 2009 – 2011 and 2012 – 2014 received prescriptions for antibiotics more frequently compared to those analyzed in 2005 – 2008 (odds ratios equal to 1.12 and 1.08, respectively). Finally, being affected by chlamydial infection, cystitis, urinary tract infection (site not specified), genitourinary tract infections in pregnancy, acute vaginitis, and other noninflammatory disorders of the vagina was associated with a higher chance of being prescribed antibiotics. Conclusions: Approximately 15% of pregnant women received antibiotic prescriptions. Age, index year, and gynecological/urinary disorders were all found to be associated with these prescriptions.
Correspondence to:
Prof. Dr. rer. med. Karel Kostev
Epidemiology, IMS Health
Darmstädter Landstraße 108
60598 Frankfurt am Main, Germany
Email: [email protected]
Original
Population pharmacokinetics of lyophilized recombinant glucagon-like peptide-1 receptor agonist (recombinant exendin-4, rE-4) in Chinese patients with type 2 diabetes mellitus
Yan-Nan Zang, Min-Jie Zhang, Yi-Tong Wang, Chen Wang, Qian Wang, Qing-Shan Zheng, Li-Nong Ji, Wei Guo, and Yi Fang
Price
42.00 $
Page No. 650
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (650-658)
Population pharmacokinetics of lyophilized recombinant glucagon-like peptide-1 receptor agonist (recombinant exendin-4, rE-4) in Chinese patients with type 2 diabetes mellitus
*
Yan-Nan Zang1, Min-Jie Zhang2, Yi-Tong Wang2, Chen Wang3, Qian Wang2, Qing-Shan Zheng3, Li-Nong Ji4, Wei Guo1*, and Yi Fang2*
1Department of Pharmacy, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, 2Department of Pharmacy, Peking University People’s Hospital, Beijing, 3Center for Drug Clinical Research, Shanghai University of Chinese Medicine, Shanghai, and 4Department of Endocrinology and Metabolism, Peking University People’s Hospital, Beijing, China
Objective: To investigate the population pharmacokinetics of lyophilized recombinant glucagon-like peptide-1 receptor agonist (rE-4) in Chinese patients with type 2 diabetes mellitus (T2DM) for plasma concentration estimation and individualized treatment. Methods: Twelve patients with T2DM were enrolled to receive subcutaneous injections of rE-4 at 5 µg twice daily for 84 days. Administration dosage was adjusted from 5 µg to 10 µg twice daily at day 29 in case of glycated albumin (GA) ≥ 17%. The population pharmacokinetic model was developed in the nonlinear mixed-effects modeling software NONMEM. Results: The data were best described by a two-compartment model with first-order absorption and elimination. The outcome parameters were as follows: apparent clearance (CL/F) 6.67 L/h, apparent distribution volume of central compartment (Vc/F) 19.4 L, absorption rate constant (Ka) 1.39 h–1, apparent distribution volume of peripheral compartment (Vp/F) 22.6 L, intercompartmental clearance (Q/F) 1.28 L/h. The interindividual variabilities for CL/F, Vc/F, Ka, and Q/F were 64.4%, 57.7%, 45.5%, and 153.3%, respectively. The intra-individual variability of proportional error model was 41.7%. No covariate was screened out that showed significant influence on the model parameters. Conclusions: The established two-compartment model with first-order absorption and elimination successfully described the pharmacokinetic characteristics of rE-4 in Chinese patients with T2DM.
*These authors contributed equally to this work.Correspondence to:
Wei Guo, MSc
Department of Pharmacy
Beijing Key Laboratory of Mental Disorders
Beijing Anding Hospital, Capital Medical University
5 Ankang Lane, Dewai Avenue
Beijing, 100088, China
and
Yi Fang, PhD
Department of Pharmacy
Peking University People’s Hospital
No.11, Xizhimen South Street, Beijing, 100044, China
Email: [email protected] and [email protected]
Original
Effects of genetic variants in UGT1A1, SLCO1B3, ABCB1, ABCC2, ABCG2, ORM1 on PK/PD of telmisartan in Chinese patients with mild to moderate essential hypertension
Qi Pei, Liu Yang, Hong-yi Tan, Shi-kun Liu, Yang Liu, Lu Huang, Rong-hui Li, Qian Wan, Jie Huang, Cheng-xian Guo, Xiao-cong Zuo, Jingle Li, and Guo-ping Yang
Price
42.00 $
Page No. 659
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (659-665)
Effects of genetic variants in UGT1A1, SLCO1B3, ABCB1, ABCC2, ABCG2, ORM1 on PK/PD of telmisartan in Chinese patients with mild to moderate essential hypertension
Qi Pei1*, Liu Yang2#4*, Hong-yi Tan4, Shi-kun Liu1, Yang Liu3, Lu Huang1, Rong-hui Li4, Qian Wan4, Jie Huang4, Cheng-xian Guo4, Xiao-cong Zuo1, Jingle Li3*, and Guo-ping Yang4
1Department of Pharmacy & Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, 2Reproductive & Genetic Hospital of Citic-Xiangya, 3Department of Cardiology, Third Xiangya Hospital, and
4Center of Clinical Pharmacology & Department of Pharmacy, the Third Xiangya Hospital, Central South University, Changsha, China
Purpose: This study aimed to understand the effects of single nucleotide polymorphisms (SNPs) in UGT1A1, SLCO1B3, ABCB1, ABCC2, ABCG2, and ORM1 on the pharmacokinetics (PK) (plasma concentration) and pharmacodynamics (PD) (blood pressure) of telmisartan in Chinese patients. Methods: 58 Han Chinese patients (aged 45 – 72 years) with mild to moderate essential hypertension were included and received 80 mg/day telmisartan for 4 weeks. The plasma concentration and genetic variants were determined by LC/MS/MS and MALDI-TOF mass spectrometry, respectively. Multivariable linear analysis was used to examine the relationships between PK/PD and genetic variants. Results: Females showed a significantly higher AUClast than males (n = 22, 4,879.48 ± 3,449.33 h×ng/mL vs. n = 36, 2,715.59 ± 2,223.77 h×ng/mL, p = 0.047). Amongst all genetic variants investigated, the patients with UGT1A1 rs4124874 AA (n = 11, 1,730.51 ± 1,325.79 h×ng/mL) had a significantly lower AUClast compared with patients with UGT1A1 rs4124874 CC+AC (n = 19 + 28, 4,177.44 ± 3,222.11 h×ng/mL and 3,810.82 ± 2,960.43 h×ng/mL, p = 0.027). None of the SNPs investigated was associated with the PD responses to telmisartan. Conclusion: Variation of UGT1A1 (rs4124874) affects PK of telmisartan in Chinese patients, highlighting the value of genetic testing in precision medicine as the telmisartan dose could be adjusted based on UGT1A1 genetic variations.
*Contributed equally to this work.Correspondence to:
Prof. Guo-ping Yang, PhD
Center of Clinical Pharmacology
The Third Xiangya Hospital
Central South University
Changsha, Hunan 410013, China
Email: [email protected]
Original
Comparison of three estimators for determining cyclosporine dosing in infants after liver transplantation
Dzhem Farandzha, Veneta Dimitrova, Ivanka Atanasova, Lubomir Spassov, and Dimiter Terziivanov
Price
42.00 $
Page No. 666
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (666-671)
Comparison of three estimators for determining cyclosporine dosing in infants after liver transplantation
*
Dzhem Farandzha1, Veneta Dimitrova1, Ivanka Atanasova2, Lubomir Spassov3, and Dimiter Terziivanov2
1Medical Faculty, Sofia University St. Kliment Ohridski, 2Department of Pharmacology and Clinical Pharmacology, and 3Department of Cardiovascular Surgery, University Hospital Lozenetz, Sofia, Bulgaria
Objective: To compare and analyze how allometrically- and linearly-scaled daily doses of cyclosporine could affect the therapeutic drug monitoring concentrations when applied to 8 infants with liver transplants. Materials and methods: Eight infants who underwent liver transplantations were put on twice-daily oral cyclosporine immunosuppressive regimens. After starting therapy, the adjustments of individual daily doses were determined by using therapeutic monitoring of plasma cyclosporine levels by measuring trough concentrations (C0) and concentrations at 2 hours after drug administration (C2). These doses were analyzed and compared with the hypothetical doses estimated by allometric and linear scaling in order to compare which of the two methods would yield closer estimates to the actual doses applied. Results: The median therapeutic drug monitoring (TDM)-based dose (n = 53) was 70.00 mg (10.9 mg/kg/day) (5.00 – 190.00 mg), whereas the median allometric (n = 53) and linear (n = 53) doses were 65.21 mg (10.11 mg/kg/day) (57.17 – 79.25 mg) and 35.63 mg (5.52 mg/kg/day) (29.89 – 46.20 mg), respectively. The median allometric dose was significantly different than the median linear dose (p < 0.0001), whereas there was no statistical difference between the median TDM-based dose and median allometric dose (p = 0.72). Conclusions: The allometric approach, when used to estimate cyclosporine doses in this cohort of liver transplant infants, yielded closer estimates to actually applied daily doses in comparison to linear scaling. Allometric scaling could be employed in calculating starting doses for drugs that lack specific dosing recommendations for infants, in order to achieve therapeutic levels faster, lowering the need for constant monitoring and dose adjustment.
*The results of this study were partially presented at the 27th European Students’ Conference in Berlin and at the Medical University Plovdiv in 2016.Correspondence to:
Ivanka Atanasova, MD, PhD
Department of Pharmacology and Clinical Pharmacology
University Hospital Lozenetz Sofia, Bulgaria
Kozyak 1, Sofia, 1407, Bulgaria
Email: [email protected]
Original
Evaluation of factors associated with the achievement of an optimal teicoplanin trough concentration
Kenshi Takechi, Hiroaki Yanagawa, Yoshito Zamami, Keisuke Ishizawa, Akihiro Tanaka, and Hiroaki Araki
Price
42.00 $
Page No. 672
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (672-677)
Evaluation of factors associated with the achievement of an optimal teicoplanin trough concentration
Kenshi Takechi1, Hiroaki Yanagawa1, Yoshito Zamami2#3, Keisuke Ishizawa2#3, Akihiro Tanaka4, and Hiroaki Araki4
1Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto, 2Department of Clinical Pharmacology and Therapeutics, Institute of Biomedical Sciences, Tokushima University Graduate School, 3Department of Pharmacy, Tokushima University Hospital, Kuramoto, Tokushima, and 4Division of Pharmacy, Ehime University Hospital, Shitsukawa, Toon-shi, Ehime, Japan
Objective: Because teicoplanin has a long serum half-life, a longer period of time is needed to achieve a steady-state concentration compared with vancomycin. The administration of an initial loading dose has been recommended to reach an effective teicoplanin serum concentration for the treatment of methicillin-resistant Staphylococcus aureus (MRSA). However, little is known regarding factors that affect teicoplanin concentration. This study aimed to retrospectively determine which factors are associated with achieving an optimal teicoplanin trough level. Methods: We analyzed patients with MRSA infections who were treated with teicoplanin intravenously between January 2010 and July 2014. The effect of loading dose administration was evaluated in patients treated with 1,200 mg or 1,600 mg of teicoplanin, respectively. Results: Approximately 32% (31/97) of patients achieved the trough concentration target (≥ 15 µg/mL) on the 3rd or 4th day. Multivariate analysis showed that loading doses and body surface area (BSA) were associated with trough concentration > 15 µg/mL on the 3rd or 4th day. Moreover, patients treated with the 2-day loading dose (1,600 mg group: 800 mg/day on 2 days) promptly achieved a trough concentration > 15 µg/mL on the 3rd or 4th day compared with those receiving a 1-day loading dose (1,200 mg group: 800 mg/day on only 1 day). The receiver operating characteristic curve showed that the optimal cut-off point of estimated glomerular filtration rate (eGFR) was 56 mL/min with 1-day loading dose to achieve a trough concentration target > 15 µg/mL. Conclusion: These results suggested that patients with decreased renal function (eGFR < 56 mL/min) can safely achieve an optimal trough level with the 1-day loading dose. In patients with normal renal function (eGFR ≥ 56 mL/min), administration of a 2-day loading dose may be needed to rapidly achieve a trough concentration ≥ 15 µg/mL.
Correspondence to:
Akihiro Tanaka, PhD
Division of Pharmacy, Ehime University Hospital
Shitsukawa, Toon-shi, Ehime 791-0295, Japan
Email: [email protected]
Annual Meeting of the Central European Society for Anticancer Drug Research-EWIV (CESAR) in Innsbruck, Austria, September 17 – 19, 2015
Editorial
Günther Gastl and Heinz Zwierzina
Page No. 678
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (678)
Editorial
Günther Gastl and Heinz Zwierzina
CESAR Communications
Development of human albumin-based nanoparticles for diagnostic optical
molecular imaging of early inflammation
and adenocarcinoma
Alshaimaa Abdelmoez, Gudrun Thurner, and Paul Debbage
Price
42.00 $
Page No. 679
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (679-681)
Development of human albumin-based nanoparticles for diagnostic optical
molecular imaging of early inflammation
and adenocarcinoma
Alshaimaa Abdelmoez1#2, Gudrun Thurner1, and Paul Debbage1
1Innsbruck Medical University, Department of Anatomy, Histology, and Embryology, Innsbruck, Austria, and 2Assiut University, Faculty of Pharmacy, Department of Pharmaceutical Organic Chemistry, Assiut, Egypt
Correspondence to:
Prof. Dr. Paul Debbage,
Innsbruck Medical University
Department of Anatomy, Histology and Embryology
Müllerstraße 59, 6020 Innsbruck, Austria
Email: Paul.Debbage@
i-med.ac.at
CESAR Communications
The matricellular ligand Cyr61 contributes to the metastatic spread of tumors by activating integrin VLA-4, independently of thiol redox modulation
Sebastian Hoß, Martin Schlesinger, and Gerd Bendas
Price
42.00 $
Page No. 682
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (682-685)
The matricellular ligand Cyr61 contributes to the metastatic spread of tumors by activating integrin VLA-4, independently of thiol redox modulation
Sebastian Hoß, Martin Schlesinger, and Gerd Bendas
Department of Pharmacy, Rheinische Friedrich-Wilhelms-University Bonn, Bonn, Germany
Correspondence to:
Sebastian G. Hoß,
Department of
Pharmacy
Rheinische Friedrich-Wilhelms-University Bonn
An der Immenburg 4,
53121 Bonn, Germany
Email: [email protected]
CESAR Communications
Knowledge-based approach to identify key determinants of cisplatin sensitivity
Navin Sarin, Florian Engel, Ganna Kalayda, Roland Frötschl, Jindrich Cinatl jr., Florian Rothweiler, Martin Michaelis, Holger Fröhlich, and Ulrich Jaehde
Price
42.00 $
Page No. 686
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (686-689)
Knowledge-based approach to identify key determinants of cisplatin sensitivity
Navin Sarin1, Florian Engel2, Ganna Kalayda1, Roland Frötschl2, Jindrich Cinatl jr.3, Florian Rothweiler3, Martin Michaelis4, Holger Fröhlich5, and Ulrich Jaehde1
1Institute of Pharmacy, Clinical Pharmacy, University of Bonn, 2Federal Institute for Drugs and Medical Devices (BfArM), Bonn, 3Institute of Medical Virology, Goethe University Hospital Frankfurt, Frankfurt/Main, Germany, 4Center for Molecular Processing and School of Biosciences, University of Kent, Canterbury, UK, and 5Algorithmic Bioinformatics, University of Bonn, Germany
Correspondence to:
Prof. Dr. Ulrich Jaehde
Institute of Pharmacy, Clinical Pharmacy
University of Bonn
An der Immenburg 4, 53121 Bonn, Germany
Email: [email protected]
CESAR Communications
Making use of modeling and simulations: Towards individualized tamoxifen therapy in breast cancer
Lena Klopp-Schulze, Markus Joerger, Sebastian Wicha, Charlotte Parra-Guillen
Price
42.00 $
Page No. 690
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (690-691)
Making use of modeling and simulations: Towards individualized tamoxifen therapy in breast cancer
Lena Klopp-Schulze1, Markus Joerger2, Sebastian Wicha1, Zinnia P. Parra-Guillen1, and Charlotte Kloft1
1Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy,
Freie Universität Berlin, Germany, and 2Department of Medical Oncology
and Hematology, Cantonal Hospital St. Gallen, Switzerland
Correspondence to:
Prof. Dr. Charlotte Kloft
Institute of Pharmacy
Clinical Pharmacy and Biochemistry
Freie Universität Berlin
Kelchstr. 31,
12169 Berlin, Germany
Email: charlotte.kloft@
fu-berlin.de
CESAR Communications
Agonistic anti-CD40 therapy synergizes with LAG-3-blocking antibodies
Philipp Müller, Daniela Thommen, and Alfred Zippelius
Price
42.00 $
Page No. 692
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (692-694)
Agonistic anti-CD40 therapy synergizes with LAG-3-blocking antibodies
Philipp Müller1, Daniela Thommen1#2, and Alfred Zippelius1#2
1Laboratory of Cancer Immunology, Department of Biomedicine, and 2Department of Medical Oncology, University Hospital Basel, Basel, Switzerland
Correspondence to:
Philipp Müller PhD or Alfred Zippelius, MD
Department of Medical Oncology
University Hospital Basel
Petersgraben 4,
4031 Basel, Switzerland
Email: [email protected] or [email protected]
CESAR Communications
Novel clinical trial designs for targeted therapies
Shu-Fang Hsu Schmitz
Price
42.00 $
Page No. 695
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (695-697)
Novel clinical trial designs for targeted therapies
Shu-Fang Hsu Schmitz
Institute of Mathematical Statistics and Actuarial Science, University of Bern, Switzerland
Correspondence to:
Shu-Fang Hsu Schmitz, PhD
Institute of Mathematical Statistics and Actuarial Science
University of Bern
Sidlerstrasse 5, 3012 Bern, Switzerland
Email: [email protected]
CESAR Communications
Animal models for personalized treatment options
Iduna Fichtner, Konrad Klinghammer, Diana Behrens, Susanne Flechsig, Jana Rolff, Michael Becker, Annika Wulf-Goldenberg, Maria Stecklum, Maria Rivera, Bernadette Brzezicha, Burkhard Jandrig, and Jens Hoffmann
Price
42.00 $
Page No. 698
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 8/2017 (698-700)
Animal models for personalized treatment options
Iduna Fichtner1#2, Konrad Klinghammer3, Diana Behrens1, Susanne Flechsig1, Jana Rolff1, Michael Becker1, Annika Wulf-Goldenberg1, Maria Stecklum1, Maria Rivera1, Bernadette Brzezicha1, Burkhard Jandrig4, and Jens Hoffmann1
1Experimental Pharmacology & Oncology GmbH, 2Max Delbrück Center for Molecular Medicine, 3Charité University Medicine, Department of Hematology and Oncology, Berlin, and 4 Department of Urology, University Clinics Magdeburg, Magdeburg, Germany
Correspondence to:
Dr. habil. nat. Iduna Fichtner
Experimenta Pharmacology & Oncology Berlin-Buch GmbH
Rpbert-Rössle-Str. 10, 13125 Berlin, Germany
Email: [email protected]
