European Journal of Clinical Pharmacology (EUR J CLIN PHARMACOL)

Publisher: Springer Verlag

Journal description

The European Journal of Clinical Pharmacology publishes original papers short communications and letters to the editors on all aspects of clinical pharmacology and drug therapy in humans. Data from animal experiments are accepted only in the context of parallel experiments in man reported in the same paper. The Journal also accepts review articles on special problems related to these areas and encourages debate on controversial issues.

Current impact factor: 2.97

Impact Factor Rankings

2016 Impact Factor Available summer 2017
2014 / 2015 Impact Factor 2.966
2013 Impact Factor 2.697
2012 Impact Factor 2.741
2011 Impact Factor 2.845
2010 Impact Factor 3.032
2009 Impact Factor 2.743
2008 Impact Factor 2.497
2007 Impact Factor 2.177
2006 Impact Factor 2.029
2005 Impact Factor 2.298
2004 Impact Factor 2.083
2003 Impact Factor 1.972
2002 Impact Factor 1.955
2001 Impact Factor 1.922
2000 Impact Factor 1.729
1999 Impact Factor 1.771
1998 Impact Factor 1.42
1997 Impact Factor 1.219
1996 Impact Factor 1.308
1995 Impact Factor 1.233
1994 Impact Factor 1.038
1993 Impact Factor 1.006
1992 Impact Factor 1.204

Impact factor over time

Impact factor
Year

Additional details

5-year impact 2.96
Cited half-life 8.40
Immediacy index 0.51
Eigenfactor 0.01
Article influence 0.81
Website European Journal of Clinical Pharmacology website
Other titles European journal of clinical pharmacology (Online), EJCP, Eur j clin pharmacol
ISSN 0031-6970
OCLC 41916239
Material type Document, Periodical, Internet resource
Document type Internet Resource, Computer File, Journal / Magazine / Newspaper

Publisher details

Springer Verlag

  • Pre-print
    • Author can archive a pre-print version
  • Post-print
    • Author can archive a post-print version
  • Conditions
    • Author's pre-print on pre-print servers such as arXiv.org
    • Author's post-print on author's personal website immediately
    • Author's post-print on any open access repository after 12 months after publication
    • Publisher's version/PDF cannot be used
    • Published source must be acknowledged
    • Must link to publisher version
    • Set phrase to accompany link to published version (see policy)
    • Articles in some journals can be made Open Access on payment of additional charge
  • Classification
    green

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Aims: Thiazolidinediones administration is assumed to be related with an improvement of endothelial dysfunction (ED); nevertheless, previous studies have been inconsistent. For this reason, the present meta-analysis was directed to estimate if thiazolidinediones were related to endothelial dysfunction improvement by using flow-mediated dilation (FMD) measurement. Methods: Literature search of the PubMed, the Cochrane Library, the Web of Science, and the Scopus databases was performed covering the period until July 01, 2015, for randomized clinical trials that investigated an influence of thiazolidinediones on FMD. For the calculation of the pooled overall effect, a random effect model was used. Meta-regression and subgroup analyses were performed to evaluate the impact of study characteristics on the effect of thiazolidinediones administration on FMD. Results: This meta-analysis included 16 studies with 812 subjects. The obtained results demonstrated an improvement of endothelial dysfunction measured with FMD (16 studies, 812 subjects; WMD: 2.4 %, 95 % CI = 1.1 to 3.69 %; p = 0.0003). The significant heterogeneity was noted (I (2) = 95 %, p < 0.00001). Subgroup analysis demonstrated that pioglitazone and rosiglitazone were able to improve FMD. Also, thiazolidinediones improved FMD if treatment was longer than 12 weeks and if patients were younger than 65 years. Additionally, a lipid profile was found to influence thiazolidinediones effect on FMD. Conclusion: The results of this meta-analysis demonstrated that thiazolidinediones were able to improve FMD, which in clinical terms can be further translated to the improvement of an impaired endothelial function. Nevertheless, the link between FMD and its predictive clinical relevance still requires further clarification.
    No preview · Article · Apr 2016 · European Journal of Clinical Pharmacology
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    ABSTRACT: Purpose: To assess the efficacy and safety of empagliflozin (EMPA) as add-on to metformin (MET) in patients with type 2 diabetes mellitus (T2DM). Methods: We searched PubMed, Embase, Medline, OVID, Cochrane Library and Web of Science. Randomized controlled trials of EMPA as add-on to MET for T2DM were included. Two investigators independently selected studies, extracted data and assessed the risk of bias. A meta-analysis was conducted by using RevMan 5.3 software and Stata 12 software. Results: Seven trials including 4256 patients were analysed. Compared with placebo, two different doses of EMPA significantly reduced glycated haemoglobin (HbA1c) [10 mg: weighted mean difference (WMD) -0.57 %; 95 % confidence interval (CI) -0.65 to -0.49 %, P < 0.00001; 25 mg: WMD -0.65 %; 95 % CI -0.72 to -0.57 %, P < 0.00001]. Compared with active comparators (two sitagliptin, one linagliptin and one glimepiride), 10 mg of EMPA provided a similar reduction in HbA1c [WMD -0.10 %; 95 % CI -0.23 to 0.03 %, P = 0.13], while 25 mg of EMPA provided a significantly greater reduction in HbA1c [WMD -0.13 %; 95 % CI -0.20 to -0.06 %, P = 0.0005]. In addition, EMPA as add-on to MET also had a favourable effect on body weight and blood pressure. The risk of hypoglycaemia in the EMPA group was similar to the placebo group or active comparator group. Conclusions: EMPA as add-on to MET was well tolerated and provided additional benefits beyond glucose lowering, such as weight loss and blood pressure reduction. However, high-quality trials with large samples are still needed in order to confirm their long-term safety.
    No preview · Article · Feb 2016 · European Journal of Clinical Pharmacology
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    ABSTRACT: Purpose The purposes of this study were to investigate the treatments used for nausea and vomiting of pregnancy (NVP) according to NVP severity among Norwegian women and to assess whether maternal characteristics and attitudes were related to the use of pharmacological treatment of NVP. Methods This is a cross-sectional Web-based study. Pregnant women and mothers with children ≤1 year of age were eligible to participate. Data were collected through an anonymous online questionnaire accessible from November 10th, 2014 to January 31st, 2015. Results In total, 712 women were included in the study, of which 62 (8.7 %), 439 (61.7 %) and 210 (29.5 %) had mild, moderate and severe NVP, respectively, according to the Pregnancy-Unique Quantification of Emesis (PUQE) classification. A total of 277 (38.9 %) women had used one or more antiemetics, of which meclizine, closely followed by metoclopramide, was the most commonly used. Different drug utilisation patterns were found between the groups of women with mild, moderate and severe NVP. Many with moderate or severe symptoms did not use any pharmacological treatment (70.2 and 32.9 %, respectively). Sick leave was given without initiating medical treatment in 266 (62.1 %) women. The women’s beliefs about medicines had an important impact on their use of medicines for NVP. Conclusions A large proportion of women suffered from moderate to severe symptoms of NVP, many of whom did not receive any pharmacological treatment. Many women, who had been on sick leave due to NVP, were not prescribed medicines.
    No preview · Article · Jan 2016 · European Journal of Clinical Pharmacology
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    ABSTRACT: Purpose The success of chemotherapy in ovarian cancer (OC) is directly associated with the broad variability in platinum response, with implications in patients survival. This heterogeneous response might result from inter-individual variations in the platinum-detoxification pathway due to the expression of glutathione-S-transferase (GST) enzymes. We hypothesized that GSTM1 and GSTT1 polymorphisms might have an impact as prognostic and predictive determinants for OC. Methods We conducted a hospital-based study in a cohort of OC patients submitted to platinum-based chemotherapy. GSTM1 and GSTT1 genotypes were determined by multiplex PCR. Results GSTM1-null genotype patients presented a significantly longer 5-year survival and an improved time to progression when compared with GSTM1-wt genotype patients (log-rank test, P = 0.001 and P = 0.013, respectively). Multivariate Cox regression analysis indicates that the inclusion of genetic information regarding GSTM1 polymorphism increased the predictive ability of risk of death after OC platinum-based chemotherapy (c-index from 0.712 to 0.833). Namely, residual disease (HR, 4.90; P = 0.016) and GSTM1-wt genotype emerged as more important predictors of risk of death (HR, 2.29; P = 0.039; P = 0.036 after bootstrap). No similar effect on survival was observed regarding GSTT1 polymorphism, and there were no statistically significant differences between GSTM1 and GSTT1 genotypes and the assessed patients’ clinical-pathological characteristics. Conclusion GSTM1 polymorphism seems to have an impact in OC prognosis as it predicts a better response to platinum-based chemotherapy and hence an improved survival. The characterization of the GSTM1 genetic profile might be a useful molecular tool and a putative genetic marker for OC clinical outcome.
    No preview · Article · Jan 2016 · European Journal of Clinical Pharmacology
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    ABSTRACT: Introduction Regulation EU 536/2014 EU introduces a separation between two parts (technical-scientific aspects and locally relevant ethical aspects) in the assessment of applications for approval of trials and provides for each ‘Member State concerned’ to arrive at ‘one single decision’ regarding the application for authorisation to conduct a trial. Proposals The Regulation should be implemented in such a way as to avoid a separation between scientific assessment and ethical assessment; guarantee the absence of conflicts of interest in the institutions responsible for decision-making; promote efficiency on the part of ethics committees. In particular, (i) it is not appropriate to assess Parts I and II of the application for approval to conduct a trial separately (scientific soundness is the principal requisite for ethical soundness); (ii) conflicts of interest should be avoided, especially as regards links with the national authority responsible for drugs regulation; (iii) decision-making in each state should be the responsibility of a single coordinating ethics committee divided into sections specialising in different therapeutic fields; (iv) local committees affiliated to institutions where trial participants are recruited should be able to interact with the coordinating committee, provide consultation services—including on issues of clinical ethics—and promote training in the field of biomedical ethics.
    No preview · Article · Jan 2016 · European Journal of Clinical Pharmacology

  • No preview · Article · Jan 2016 · European Journal of Clinical Pharmacology
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    ABSTRACT: Purpose: Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview of publications on different monitoring methods and their impact on subject safety data, data integrity, and monitoring cost. Methods: The literature search was performed by keyword searches in MEDLINE and hand search of key journals. All publications were reviewed for details on how a monitoring approach impacted subject safety data, data integrity, or monitoring costs. Results: Twenty-two publications were identified. Three publications showed that SDV has some value for detection of not initially reported adverse events and centralized statistical monitoring (CSM) captures atypical trends. Fourteen publications showed little objective evidence of improved data integrity with traditional monitoring such as 100 % SDV and sponsor queries as compared to reduced SDV, CSM, and remote monitoring. Eight publications proposed a potential for significant cost reductions of monitoring by reducing SDV without compromising the validity of the trial results. Conclusions: One hundred percent SDV is not a rational method of ensuring data integrity and subject safety based on the high cost, and this literature review indicates that reduced SDV is a viable monitoring method. Alternative methods of monitoring such as centralized monitoring utilizing statistical tests are promising alternatives but have limitations as stand-alone tools. Reduced SDV combined with a centralized, risk-based approach may be the ideal solution to reduce monitoring costs while improving essential data quality.
    No preview · Article · Jan 2016 · European Journal of Clinical Pharmacology
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    ABSTRACT: Purpose: This open-label, multicenter, single-dose study characterized the pharmacokinetics and short-term safety of azilsartan medoxomil (AZL-M) in hypertensive pediatric subjects (12-16 years [cohort 1a; n = 9]; 6-11 years [cohort 2; n = 8]; 4-5 years [cohort 3; n = 3]). Methods: Model-based simulations were performed to guide dosing, especially in 1-5-year olds, who were difficult to enroll. AZL-M was dosed according to body weight (20-60-mg tablet, cohorts 1a and 2; 0.66 mg/kg granule suspension, cohort 3). In cohort 1, gender-matched healthy adults (cohort 1b; n = 9) received AZL-M 80 mg. Results: Exposure to AZL (active moiety of AZL-M), measured by dose-/body weight-normalized C max and AUC0-∞, was ∼15-30 % lower in pediatric subjects versus adults. In simulations, exposure with 0.66 mg/kg AZL-M in pediatric subjects weighing 8-25 kg approximated to AZL-M 40 mg (typical starting dose) in adults. The simulations suggest that 25-50-kg subjects require half the adult dose (10-40 mg), whereas 50-100-kg subjects can use the same dosing as adults. Adverse events were mild in intensity, apart from one moderate event (migraine). Conclusions: This dosing strategy should be safe in pediatric patients, as AZL exposure would not exceed that seen in adults with the highest approved AZL-M dose (80 mg).
    No preview · Article · Jan 2016 · European Journal of Clinical Pharmacology

  • No preview · Article · Dec 2015 · European Journal of Clinical Pharmacology
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    ABSTRACT: Introduction Stroke is a major health problem with important morbidity and mortality. Various risk factors and cardiovascular medication groups are known to have an influence on stroke incidence, but less is known about the relation between medication use and stroke severity. Aim To determine if relationships exist between the pre-stroke cardiovascular medication use and stroke severity. Methods A retrospective study was conducted on a database with anonymized data of 1974 patients with a suspected stroke, admitted to the Universitair Ziekenhuis (UZ) Brussel. Stroke severity was quantified using the National Institute of Health Stroke Scale (NIHSS). Cardiovascular medication groups were first included in a multivariable linear regression model. Second, to obtain clinically interpretable results, all variables that were retained in the final linear regression model were introduced in a cumulative odds ordinal logistic regression model with proportional odds. Results Angiotensin II receptor blockers (ARBs), statins, and antiarrhythmics were significantly associated with stroke severity at the 10 % α level in a multivariable linear regression model, suggesting a possible effect of these medication groups on stroke severity. Only pre-stroke statin use showed a significant relationship with the NIHSS score in the ordinal logistic regression model with an adjusted odds ratio of 0.740 (95 % CI 0.580–0.944; p = 0.015). Conclusion Pre-stroke use of statins is significantly associated with lower stroke severity. No significant relationship was detected between pre-stroke use of other medication groups and stroke severity, defined by the NIHSS score.
    No preview · Article · Dec 2015 · European Journal of Clinical Pharmacology
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    ABSTRACT: Purpose: The purpose of this study was to describe the prescription of antibacterial agents for acute upper respiratory tract infections (URIs) in Beijing. Methods: A total of 8,588,699 outpatient cases in tertiary hospitals with acute upper respiratory tract infections (URIs) were selected from the Beijing Medical Claim Data for Employees (BMCDE) from Oct 2010 to Sep 2012. Second-generation cephalosporins, third-generation cephalosporins, fourth-generation cephalosporins, fluoroquinolones, macrolides (except for erythromycin), combinations of penicillins (including β-lactamase inhibitors), and streptomycins were classified as broad-spectrum antibacterial agents. The rates for antibiotic prescriptions and broad-spectrum antibiotic use were calculated in all cases as well as in various URI diagnosis subgroups and age (18-44, 45-64, and ≥65 years) subgroups. The most frequently prescribed antibiotic classes were identified by calculating the proportions of the different agents in all prescribed antibiotic agents. Results: Overall, the rate of antibiotic prescription is 39.0 %, and cases diagnosed with acute tonsillitis, sinusitis, and epiglottitis have the highest prescription rate (73.6 %), followed by acute laryngitis and bronchitis (52.3 %), acute pharyngitis (40.1 %), and acute nasopharyngitis (37.2 %). Broad-spectrum agents were chosen in 82.4 % of the cases that were prescribed antibiotics, ranging from 81.9 % of cases with naspharyngitis to 87.1 % of the cases with tonsillitis, sinusitis, and epiglottitis. Second-generation cephalosporins, macrolides, fluoroquinolones, third-generation cephalosporins, and combinations of penicillins were most frequently prescribed, accounting for more than 80 % of all prescribed antibacterials. Conclusions: Antibacterial drug prescription for outpatients with acute URIs is common in tertiary hospitals in Beijing, and the prescribed antibacterials are usually broad-spectrum agents.
    No preview · Article · Dec 2015 · European Journal of Clinical Pharmacology
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    ABSTRACT: Purpose: In pharmacogenetic research, genetic variation in non-responders and high responders is compared with the aim to identify the genetic loci responsible for this variation in response. However, an important question is whether the non-responders are truly biologically non-responsive or actually non-adherent? Therefore, the aim of this study was to describe, within the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER), characteristics of both non-responders and high responders of statin treatment in order to possibly discriminate non-responders from non-adherers. Methods: Baseline characteristics of non-responders to statin therapy (≤10 % LDL-C reduction) were compared with those of high responders (>40 % LDL-C reduction) through a linear regression analysis. In addition, pharmacogenetic candidate gene analysis was performed to show the effect of excluding non-responders from the analysis. Results: Non-responders to statin therapy were younger (p = 0.001), more often smoked (p < 0.001), had a higher alcohol consumption (p < 0.001), had lower LDL cholesterol levels (p < 0.001), had a lower prevalence of hypertension (p < 0.001), and had lower cognitive function (p = 0.035) compared to subjects who highly responded to pravastatin treatment. Moreover, excluding non-responders from pharmacogenetic studies yielded more robust results, as standard errors decreased. Conclusion: Our results suggest that non-responders to statin therapy are more likely to actually be non-adherers, since they have more characteristics that are viewed as indicators of high self-perceived health and low disease awareness, possibly making the subjects less adherent to study medication. We suggest that in pharmacogenetic research, extreme non-responders should be excluded to overcome the problem that non-adherence is investigated instead of non-responsiveness.
    No preview · Article · Dec 2015 · European Journal of Clinical Pharmacology
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    ABSTRACT: Objectives The purpose of this study was to compare approved first-line therapies for patients with multiple myeloma. Methods A systematic literature search for phase III randomized controlled trials (RCTs) comparing first-line chemotherapies approved in Germany and recommended by guidelines at the time of study design was conducted. Random-effects meta-analysis (MA) was used for direct and the Bucher method for adjusted indirect treatment comparison. Results One RCT comparing melphalan and prednisone plus bortezomib (VMP) vs. melphalan and prednisone (MP) and six RCTs comparing MP plus thalidomide (MPT) vs. MP were analysed. For MPT vs. MP, an individual patient data (IPD) MA was used for sensitivity analyses. VMP and MPT were superior to MP regarding efficacy endpoints (VMP vs. MP, overall survival (OS): hazard ratio (HR) 0.70, 95 % confidence interval (CI) 0.57–0.86; progression-free survival (PFS): HR 0.56, 0.39–0.79; complete response (CR), risk-ratio (RR) for non-response: 0.70, 0.65–0.75; MPT vs. MP, OS: HR 0.83, 0.66–1.03; PFS: HR 0.67, 0.56–0.81; CR, RR for non-response 0.92, 0.88–0.95); but had a higher risk of developing any grade 3–4 adverse events (AEs) (VMP vs. MP: RR 1.13, 1.06–1.20; MPT vs. MP: RR 2.06, 1.43–2.98). The indirect comparison of VMP vs. MPT via MP showed a statistically not significant advantage for VMP regarding survival outcomes (OS: HR 0.85, 0.63–1.14; PFS: HR 0.83, 0.56–1.23) and a significant advantage regarding CR (RR for non-response 0.76, 0.70–0.83) and AEs (RR 0.55, 0.38–0.80). Treatment comparisons using results of IPD MA yielded similar effect sizes. Conclusions VMP and MPT seem more effective than MP, VMP was superior to MPT regarding response criteria and AEs. Our results may best be confirmed by a head-to-head trial of VMP vs. MPT.
    No preview · Article · Dec 2015 · European Journal of Clinical Pharmacology
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    ABSTRACT: Purpose: The purpose of this study is to determine the impacts of CYP3A5 polymorphism on tacrolimus concentration and the proportion of patients within a target therapeutic range during the first week after transplantation together with the 3-month acute rejection rate in kidney transplant patients receiving a minimized tacrolimus regimen. Methods: A total of 164 patients participated in the study. All received oral tacrolimus twice daily starting on the day of surgery with the target pre-dose (trough) concentration of 4-8 ng/ml for prevention of allograft rejection. Cytochrome P450 (CYP) 3A5 genotypes were determined. The patients were divided into CYP3A5 expressers (CYP3A5*1 allele carriers) and CYP3A5 nonexpressers (homozygous CYP3A5*3). Whole blood tacrolimus concentrations on days 3 and 7 posttransplantation and the incidence of biopsy-proven acute rejection (BPAR) at 3-month posttransplantation were compared between groups. Results: On day 3, the median (IQR) dose-and-weight-normalized trough concentration in expressers and nonexpressers were 54.61 (31.98, 78.87) and 91.80 (57.60, 130.20) ng/ml per mg/kg/day, respectively (p < 0.001). Although only 47 and 42 % of expressers and nonexpressers were within the target range on day 3, approximately 60 % of both groups were within the target range on day 7. Proportions of BPAR among expressers and nonexpressers were 6.0 and 7.4 %, respectively (p = 0.723). The median (IQR) times to the first rejection in CYP3A5 expressers and nonexpressers were 32 (12, 68) and 15 (12, 37) days, respectively (p = 0.410). Conclusions: Although CYP3A5 polymorphism significantly influenced the tacrolimus dose required to achieve the target concentration, the impact of CYP3A5 polymorphism on BPAR was not observed in this study.
    No preview · Article · Dec 2015 · European Journal of Clinical Pharmacology

  • No preview · Article · Dec 2015 · European Journal of Clinical Pharmacology