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European Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28921395/analysis-of-integrated-clinical-trial-protocols-in-early-phases-of-medicinal-product-development
#1
Kevin Fruhner, Gunther Hartmann, Thomas Sudhop
PURPOSE: While in the past, most clinical trial applications (CTAs) following non-integrated (standard) protocols were used to investigate one primary objective concerning a (new) drug, nowadays, the use of integrated protocols investigating multiple objectives within the same CTA becomes more and more popular. The aims of the present study were to investigate the usage and the impact of integrated protocols on regulatory activities and to find the motivation for their increasing use...
September 18, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28921380/relationship-between-drug-burden-and-physical-and-cognitive-functions-in-a-sample-of-nursing-home-patients-with-dementia
#2
L M J Sanders, T Hortobágyi, G van Staveren, K Taxis, F Boersma, H C Klein, W J R Bossers, C G Blankevoort, E J A Scherder, E A Van der Zee, M J G van Heuvelen
PURPOSE: The Drug Burden Index (DBI) is a tool to quantify the anticholinergic and sedative load of drugs. Establishing functional correlates of the DBI could optimize drug prescribing in patients with dementia. In this cross-sectional study, we determined the relationship between DBI and cognitive and physical functions in a sample of patients with dementia. METHODS: Using performance-based tests, we measured physical and cognitive functions in 140 nursing home patients aged over 70 with all-cause dementia...
September 18, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28920183/number-of-medications-or-number-of-diseases-what-influences-underprescribing
#3
Eva Cedilnik Gorup, Marija Petek Šter
PURPOSE: An increasing number of older adults suffer from multimorbidity and receive multiple medications. Despite that, underprescribing of potentially beneficial medications is widespread in this population. Our aim was to examine influence of polypharmacy and multimorbidity on the presence of prescribing omissions (PO) in general practice attenders. METHODS: We conducted a cross-sectional study of older adults attending general practices in Slovenia who were regularly prescribed at least one medication...
September 17, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28920154/pharmacokinetics-of-doripenem-in-plasma-and-epithelial-lining-fluid-elf-comparison-of-two-dosage-regimens
#4
Zoe Oesterreicher, Iris Minichmayr, Robert Sauermann, Daniela Marhofer, Edith Lackner, Walter Jäger, Alexandra Maier-Salamon, Richard Schwameis, Charlotte Kloft, Markus Zeitlinger
PURPOSE: In 2014, FDA released a warning for prescription of doripenem for ventilator-associated bacterial pneumonia due to unsatisfactory clinical cure rates. The present study explores if the observed lack of efficacy might be explained by insufficient target site pharmacokinetics in intensive care patients after two different infusion schemes. METHODS: Plasma and bronchoalveolar lavage sampling was performed in 16 intubated patients with pneumonia receiving doripenem either as 1-h or as 4-h infusion...
September 17, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28914344/influence-of-genetic-co-factors-on-the-population-pharmacokinetic-model-for-clopidogrel-and-its-active-thiol-metabolite
#5
Dorota Danielak, Marta Karaźniewicz-Łada, Anna Komosa, Paweł Burchardt, Maciej Lesiak, Łukasz Kruszyna, Agnieszka Graczyk-Szuster, Franciszek Główka
PURPOSE: A high interindividual variability is observed in the pharmacokinetics of clopidogrel, a widely used antiplatelet drug. In the present study, a joint parent-metabolite population pharmacokinetic model was developed to adequately describe observed concentrations of clopidogrel and its active thiol metabolite (H4). METHODS: The study included 63 patients undergoing elective coronarography or percutaneous coronary intervention. The population pharmacokinetic model was developed in the NONMEM 7...
September 15, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28914335/regulatory-experience-of-tops-an-internet-based-system-to-prevent-healthy-subjects-from-over-volunteering-for-uk-clinical-trials
#6
C Allen, G Francis, J Martin, M Boyce
PURPOSE: The aim was to review the use of The Over-volunteering Prevention System (TOPS) since the HRA began hosting it in 2013, and the Medicines and Healthcare products Regulatory Agency (MHRA) experience of monitoring its use by UK clinical research units. METHODS: The HRA searched the TOPS database for the number, type and location of units and the number of entries. The MHRA inspectors reviewed their findings from routine inspections. RESULTS: Twenty-two additional UK units registered to use TOPS during 2013-2016, making a total of 84 units since TOPS was established in 2002...
September 15, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28905092/drug-induced-oral-lichenoid-reactions-a-real-clinical-entity-a-systematic-review
#7
REVIEW
Giulio Fortuna, Massimo Aria, Julie H Schiavo
PURPOSE: Drug-induced oral lichenoid reactions (DIOLRs) have been extensively reported in the literature, but the validity of the causality relationship between any drug and the oral lichenoid lesions (OLLs) still remains questionable. We sought to determine whether this causality relationship really exists, whether a resolution of the oral lesions upon withdrawal occurs, and what the most common alleged offending medications are. METHODS: Nine electronic databases from January 1966 to December 2016 were systematically searched to identify all relevant studies selected with specific inclusion criteria (a clinical and histopathological diagnosis of DIOLRs, and clearly statement on the systemic offending medication)...
September 13, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28900674/who-is-willing-to-participate-in-low-risk-pragmatic-clinical-trials-without-consent
#8
Rafael Dal-Ré, Antonio J Carcas, Xavier Carné
PURPOSE: General notification offers a possible alternative to written informed consent for pragmatic randomized controlled trials (pRCTs). It involves patients being informed through brochures, posters, and letters that research is being conducted simultaneously to providing clinical care and that patients will be enrolled in pRCTs without study-specific consent. A previous survey found that a substantial minority of respondents endorsed general notification. We aimed to know who is willing to enroll in this type of trials using general notification rather than written consent...
September 12, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28894907/challenges-in-translational-drug-research-in-neuropathic-and-inflammatory-pain-the-prerequisites-for-a-new-paradigm
#9
REVIEW
A Taneja, O Della Pasqua, M Danhof
AIM: Despite an improved understanding of the molecular mechanisms of nociception, existing analgesic drugs remain limited in terms of efficacy in chronic conditions, such as neuropathic pain. Here, we explore the underlying pathophysiological mechanisms of neuropathic and inflammatory pain and discuss the prerequisites and opportunities to reduce attrition and high-failure rate in the development of analgesic drugs. METHODS: A literature search was performed on preclinical and clinical publications aimed at the evaluation of analgesic compounds using MESH terms in PubMed...
September 11, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28894902/development-and-validation-of-a-medicines-comorbidity-index-for-older-people
#10
Sujita W Narayan, Prasad S Nishtala
PURPOSE: An index for estimating multimorbidity based on prescription claims data is important for predicting health outcomes for older people in pharmacoepidemiological studies. We aimed to develop a Medicines Comorbidity Index (MCI) based on nationwide prescription claims data and evaluate its performance in predicting adverse outcomes in older individuals. METHODS: The index was developed on a retrospective cohort comprising of all individuals aged ≥ 65 years old, captured in the claims dataset from 1st January to 31st December 2012...
September 11, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28871436/the-prevalence-of-medication-related-adverse-events-in-inpatients-a-systematic-review-and-meta-analysis
#11
REVIEW
Outi Laatikainen, J Miettunen, S Sneck, H Lehtiniemi, O Tenhunen, M Turpeinen
PURPOSE: Adverse drug events (ADEs) have been internationally recognized as a major threat to patient safety. The purpose of this study was to conduct a meta-analysis focusing on inpatient ADEs in the Western World to provide better estimate of the current state of medication safety in these countries. METHODS: The studies for meta-analysis were identified through electronic search in Cochrane, Scopus, Medline, and Web of science databases. Included articles focused on adult inpatient ADEs, had commonly accepted definition for ADE, and were conducted between 2000 and 2016...
September 5, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28866826/impact-of-pioglitazone-regulatory-withdrawal-on-antidiabetic-drug-use-and-health-in-diabetic-patients
#12
Antoine Pariente, Yohann Mansiaux, Ana Jarné, Francesco Salvo, Cécile Pageot, Julien Bezin, Andy Smith, Bernard Bégaud
PURPOSE: In 2011, pioglitazone was withdrawn from the French market owing to a potential risk of bladder cancer. This study aimed at assessing the impact of this pioglitazone withdrawal (PW) considering (i) trends in antidiabetic uses and (ii) changes in hospitalization/death rates in diabetic patients following PW. METHODS: We first considered the general population of the Echantillon Généraliste des Bénéficiaires (EGB), a 1/97th representative sample of the French healthcare insurance system beneficiaries, for the 2010-2014 period...
September 2, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28866743/effects-of-oral-%C3%AE-9-tetrahydrocannabinol-on-the-cerebral-processing-of-olfactory-input-in-healthy-non-addicted-subjects
#13
Carmen Walter, Bruno G Oertel, Lisa Felden, Ulrike Nöth, Johannes Vermehren, Ralf Deichmann, Jörn Lötsch
BACKGROUND: Considering the increasing acknowledgment of the human sense of smell as a significant component of the quality of life, olfactory drug effects gain potential clinical importance. A recent observation in a human experimental context indicated that Δ(9)-tetrahydrocannabinol (THC) impaired the subject's performance in olfactory tests. To further analyze the role of THC in human olfaction, the present report addresses its effects on the central processing of olfactory stimuli...
September 2, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28856398/association-of-use-of-selective-serotonin-reuptake-inhibitors-with-risk-of-acute-pancreatitis-a-case-control-study-in-taiwan
#14
Hsien-Feng Lin, Kuan-Fu Liao, Ching-Mei Chang, Cheng-Li Lin, Shih-Wei Lai
BACKGROUND AND OBJECTIVES: Few studies have reported the association of the use of selective serotonin reuptake inhibitors (SSRIs) with acute pancreatitis. We conducted a population-based case-control study to explore this relationship. METHODS: In this study, 4631 cases with first attack of acute pancreatitis and 4631 controls without acute pancreatitis were selected using a randomly sampled cohort of one million health insurance enrollees from 2000 to 2013. Both cases and controls were aged 20-84 years and were matched with sex, age, comorbidities, and index year of diagnosis of acute pancreatitis...
August 30, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28849406/plasma-and-cerebrospinal-fluid-population-pharmacokinetics-of-vancomycin-in-postoperative-neurosurgical-patients-after-combined-intravenous-and-intraventricular-administration
#15
Xingang Li, Shusen Sun, Xi Ling, Kai Chen, Qiang Wang, Zhigang Zhao
PURPOSE: Combined intravenous and intraventricular administration of vancomycin into the cerebrospinal fluid (CSF) has been increasingly utilized for neurosurgical patients, but little is known about the population pharmacokinetics of vancomycin in the plasma and CSF. The aim of our study was to identify significant factors associated with plasma and CSF vancomycin concentrations to guide clinicians with vancomycin dosing. METHODS: Patients with an indwelling ventricular drainage catheter who received intravenous and intraventricular vancomycin were enrolled in this study...
August 29, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28849250/effect-of-cyp3a4-22-cyp3a5-3-and-cyp3a-combined-genotypes-on-tamoxifen-metabolism
#16
A B Sanchez Spitman, D J A R Moes, H Gelderblom, V O Dezentje, J J Swen, H J Guchelaar
BACKGROUND: Tamoxifen is one of the cornerstones of endocrine therapy for breast cancer. Recently, the decreased activity CYP3A4*22 allele and the loss of function CYP3A5*3 allele have been described as potential factors that could help to explain the inter-patient variability in tamoxifen metabolism. The aim of this study is to investigate the effect of CYP3A4*22, CYP3A5*3, and CYP3A combined genotypes on tamoxifen metabolism. METHODS: DNA from 667 women enrolled in the CYPTAM study (NTR1509) was genotyped (CYP2D6, CYP3A4*22, and CYP3A5*3)...
August 28, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28831566/a-western-diet-induced-mouse-model-reveals-a-possible-mechanism-by-which-metformin-decreases-obesity
#17
LETTER
Frank J Gonzalez, Changtao Jiang
No abstract text is available yet for this article.
August 22, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28831528/association-between-infection-and-severe-drug-adverse-reactions-an-analysis-using-data-from-the-japanese-adverse-drug-event-report-database
#18
Takuya Imatoh, Kimie Sai, Chisato Fukazawa, Yasushi Hinomura, Ryosuke Nakamura, Yoshimi Okamoto-Uchida, Katsunori Segawa, Yoshiro Saito
PURPOSE: It has been reported recently that immune reactions are involved in the pathogenesis of certain types of adverse drug reactions (ADRs). We aimed to determine the associations between infections and drug-induced interstitial lung disease (DILD), rhabdomyolysis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), or drug-induced liver injury (DILI) using a spontaneous adverse drug event reporting database in Japan. METHODS: The reported cases were classified into three categories (anti-infectious drug group, concomitant infection group, and non-infection group) based on the presence of anti-infectious drugs (either as primary suspected drug or concomitant drug) and infectious disease...
August 22, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28831527/use-of-antihistamines-and-risk-of-ventricular-tachyarrhythmia-a-nested-case-control-study-in-five-european-countries-from-the-aritmo-project
#19
Elisabetta Poluzzi, I Diemberger, M De Ridder, A Koci, M Clo, A Oteri, S Pecchioli, I Bezemer, T Schink, S Pilgaard Ulrichsen, G Boriani, M C J Sturkenboom, F De Ponti, G Trifirò
PURPOSE: After regulatory restrictions for terfenadine and astemizole in '90s, only scarce evidence on proarrhythmic potential of antihistamines has been published. We evaluate the risk of ventricular tachyarrhythmia (VA) related to the use of individual antihistamines. METHODS: A matched case-control study nested in a cohort of new users of antihistamines was conducted within the EU-funded ARITMO project. Data on 1997-2010 were retrieved from seven healthcare databases: AARHUS (Denmark), GEPARD (Germany), HSD and ERD (Italy), PHARMO and IPCI (Netherlands) and THIN (UK)...
August 22, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28819675/pharmacoepidemiology-resources-in-ireland-an-introduction-to-pharmacy-claims-data
#20
Sarah-Jo Sinnott, Kathleen Bennett, Caitriona Cahir
INTRODUCTION: Administrative health data, such as pharmacy claims data, present a valuable resource for conducting pharmacoepidemiological and health services research. Often, data are available for whole populations allowing population level analyses. Moreover, their routine collection ensures that the data reflect health care utilisation in the real-world setting compared to data collected in clinical trials. SETTING AND METHODS: The Irish Health Service Executive-Primary Care Reimbursement Service (HSE-PCRS) community pharmacy claims database is described...
August 17, 2017: European Journal of Clinical Pharmacology
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