Patients ’ experiences on adverse drug reactions reporting: a qualitative study
ConclusionsMost participants were unaware of MedEffect and reported ADRs to physicians and pharmacists. Several barriers and motives affected patients ’ reporting of ADRs. MedEffect form could be simplified for use by patients. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - July 13, 2020 Category: Drugs & Pharmacology Source Type: research

Durvalumab and multiple sclerosis: a causal link or simple unmasking?
(Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - July 13, 2020 Category: Drugs & Pharmacology Source Type: research

A drug –drug interaction study to evaluate the impact of peficitinib on OCT1- and MATE1-mediated transport of metformin in healthy volunteers
ConclusionSlight changes in AUCinf, Cmax and CLR of metformin were observed when co-administered with peficitinib; however, these changes were considered not clinically relevant. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - July 11, 2020 Category: Drugs & Pharmacology Source Type: research

Correct use of non-indexed eGFR for drug dosing and renal drug-related problems at hospital admission
AbstractPurposeTwo to seven percent of the German adult population has a renal impairment (RI) with an estimated glomerular filtration rate (eGFR)
Source: European Journal of Clinical Pharmacology - July 10, 2020 Category: Drugs & Pharmacology Source Type: research

Pain severity and analgesics use in the community-dwelling older population: a drug utilization study from Germany
ConclusionsA significant number of older German adults are affected by high-intensity and disabling chronic pain despite receiving analgesics. Long-term studies are needed to compare the effectiveness and safety of different treatments for chronic pain in older adults. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - July 10, 2020 Category: Drugs & Pharmacology Source Type: research

Use of the French healthcare insurance database to estimate the prevalence of exposure to potential drug-drug interactions
ConclusionExposures to potential DDIs in France are not uncommon with a high proportion resulting from a co-prescription by the same physician. Monitoring the prevalence of exposure to DDIs is needed to implement prevention measures. Administrative data enable this surveillance in large and representative cohorts. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - July 7, 2020 Category: Drugs & Pharmacology Source Type: research

Body weight, CYP2C19 , and P2Y12 receptor polymorphisms relate to clopidogrel resistance in a cohort of Chinese ischemic stroke patients with aspirin intolerance
ConclusionsThe patients with high body weight, theCYP2C19 phenotypes, andP2Y12 receptor (52 G>T) variant alleles are at risk of CR during clopidogrel treatment in Chinese IS patients with aspirin intolerance. The higher body weight and relevant polymorphisms may help to predict CR in Chinese IS patients with aspirin intolerance. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - July 6, 2020 Category: Drugs & Pharmacology Source Type: research

Validation of self-reported adherence in chronic patients visiting pharmacies and factors associated with the overestimation and underestimation of good adherence
AbstractBackgroundStudies validating indirect methods to identify nonadherence in chronic patients who visit pharmacies are lacking. The aim of this study was to validate self-reported adherence and assess the variables associated with both overestimation and underestimation of good adherence when using this method.Materials and methodsAn observational, cross-sectional study was undertaken to validate self-reported adherence in 132 community pharmacies throughout Spain in 6237 chronic patients. The Morisky-Green test was used as the validation method and through a 2  × 2 table, the validity indicators, ...
Source: European Journal of Clinical Pharmacology - July 1, 2020 Category: Drugs & Pharmacology Source Type: research

Adverse drug reactions to anti-diabetic drugs are commonest in patients whose treatment do not adhere to diabetes management clinical guidelines: cross-sectional study in a tertiary care service in sub-Saharan Africa
AbstractAimsThe study aimed to identify and describe adverse drug reactions and adherence to clinical guidelines in patients receiving treatment for type 2 diabetes mellitus (T2DM) in Cameroon.MethodsThe method used was a cross-sectional study at a tertiary diabetes care service in Yaound é, Cameroon. Adult T2DM patients attending the diabetes clinic were interviewed using a pre-structured data collection form. Adverse drug reactions (ADRs) were self-reported by the patients. Naranjo’s algorithm and Hartwig and Siegel’s scale were used for assessment of causality and severity of ADRs, respectively. A bli...
Source: European Journal of Clinical Pharmacology - June 30, 2020 Category: Drugs & Pharmacology Source Type: research

Can iron chelation as an adjunct treatment of COVID-19 improve the clinical outcome?
(Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 30, 2020 Category: Drugs & Pharmacology Source Type: research

The added value of pirfenidone to fight inflammation and fibrotic state induced by SARS-CoV-2
ConclusionIn this article, we consider the role of antifibrotic therapy with pirfenidone in patients with SARS-CoV-2 infection on going or in the stage of postinfection with pulmonary fibrotic consequences. The scientific rationale for its use is also described. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 27, 2020 Category: Drugs & Pharmacology Source Type: research

Optimizing the MIC breakpoints of amoxicillin and tetracycline for antibiotic selection in the rescue therapy of H. pylori with bismuth quadruple regimen
AbstractPurposeH. pylori with triple-drug resistance (TR) to clarithromycin, metronidazole, and levofloxacin limits the success of rescue therapy. We aimed to identify the optimal breakpoints of antibiotic minimal inhibitory concentration (MIC) to predict the success of rescue therapy for TRH. pylori infection.MethodsWe consecutively enrolled 430 patients with at least one course of failedH. pylori eradications to receive anH. pylori culture for antibiotic MIC test. Seventy-three (17%) had TRH. pylori infection (MIC of clarithromycin>  0.5, levofloxacin>  1, and metronidazole>  8 mg/L, re...
Source: European Journal of Clinical Pharmacology - June 27, 2020 Category: Drugs & Pharmacology Source Type: research

Serotonin transporter gene and escitalopram: depressing medical science
(Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 26, 2020 Category: Drugs & Pharmacology Source Type: research

Population pharmacokinetic analysis of bisoprolol in type 2 diabetic patients with hypertension
ConclusionRoutine assessment of renal function should be carried out before the initiation of treatment with bisoprolol in order to individualize the dose and to prevent possible accumulation and adverse drug reactions. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 25, 2020 Category: Drugs & Pharmacology Source Type: research

What about COVID-19 and arachidonic acid pathway?
ConclusionsPGE2 levels and other PGs levels should be measured in patients with COVID-19. Lowering the PGE2 levels through inhibition of human microsomal prostaglandin E synthase-1 (mPGES-1) can enhance the host immune response against COVID-19. In addition, the hybrid compounds, such as COX-2 inhibitors/TP antagonists, can be an innovative treatment to control the overall balance between AA mediators in patients with COVID-19. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 25, 2020 Category: Drugs & Pharmacology Source Type: research

Population pharmacokinetics and dose optimization of ceftriaxone for children with community-acquired pneumonia
ConclusionPopulation pharmacokinetics of ceftriaxone was evaluated in children and an optimum dosing regimen was constructed on the basis of the pharmacokinetics-pharmacodynamics model-based approach. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 25, 2020 Category: Drugs & Pharmacology Source Type: research

Better survival in impaired renal function patients with metastatic non-small cell lung cancer treated by cisplatin-pemetrexed
ConclusionThe better survival rate in G2 and its correlation with pemetrexed and cisplatin treatments suggest that, until other therapeutic choices become available, a cautious increase in dosage could be investigated as a way to improve poor prognoses. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 21, 2020 Category: Drugs & Pharmacology Source Type: research

ABCB1 and ERCC1 gene polymorphisms are associated with nephro- and hepatotoxicity to carboplatin/paclitaxel-based chemotherapy in patients with gynecologic cancers
ConclusionsABCB1 c.1236C>T andERCC1 c.118C>T might serve as potential biomarkers for the risk of moderate-to-severe toxicities to carboplatin/paclitaxel chemotherapy of gynecological cancers. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 20, 2020 Category: Drugs & Pharmacology Source Type: research

A survey about label enhancement methods for parenteral medication in European hospital pharmacies
ConclusionLabel-enhancement methods for parenteral medication in hospital pharmacies do not seem to be widely implemented and acknowledged in European hospitals, but response rates were limited for two countries. Greater standardization in conjunction with research for evidence-based enhancement techniques is needed to guide improvement in labeling practices across Europe. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 20, 2020 Category: Drugs & Pharmacology Source Type: research

Accuracy of freely available online GFR calculators using the CKD-EPI equation
ConclusionsErroneous calculations that might lead to inappropriate clinical decision-making were found in 8 of 47 calculators. Thus, online calculators should be evaluated more thoroughly after implementation. Conversion of eGFR units that might be needed for drug dose adjustments should be implemented more often. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 19, 2020 Category: Drugs & Pharmacology Source Type: research

Absence of QTc prolongation in a thorough QT study with imeglimin, a first in class oral agent for type 2 diabetes mellitus
ConclusionThis thorough QT study demonstrated that therapeutic and supratherapeutic exposures of imeglimin did not induce a QT/QTc prolongation with a strong confidence as evidenced by the assay sensitivity.Trial registration number/dateNCT02924337/ October 5, 2016 (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 18, 2020 Category: Drugs & Pharmacology Source Type: research

The parent drugs chloroquine and hydroxychloroquine do not inhibit human CYP3A activity in vitro
(Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 18, 2020 Category: Drugs & Pharmacology Source Type: research

Novel method to estimate the appropriate dosing interval for activated charcoal to avoid interaction with other drugs
ConclusionThe developed method enabled estimation of the amplitude of DDI by activated charcoal administered in a certain dosing interval, whereas overestimation of AUCRe was observed for drugs that undergo extensive enterohepatic circulation. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 17, 2020 Category: Drugs & Pharmacology Source Type: research

Alliance between selective serotonin reuptake inhibitors and fracture risk: an updated systematic review and meta-analysis
AbstractPurposeIn the past few years, several fracture-related events have been reported with chronic use of selective serotonin reuptake inhibitors (SSRIs) throughout the globe. Hence, an updated systematic review and meta-analysis was necessary to ascertain the risk involved. The present work evaluated the association of SSRIs with the risk of fracture in adults.MethodsWe systematically searched PubMed, Cochrane library, and Google Scholar for observational studies on the same from inception to April 2019. Screening, data extraction, and risk of bias assessment were conducted independently by 2 authors.ResultsWe assessed...
Source: European Journal of Clinical Pharmacology - June 16, 2020 Category: Drugs & Pharmacology Source Type: research

Calling for an exponential escalation scheme in vaccine development for COVID-19
ConclusionA COVID-19 vaccine would be rapidly available at a slightly increased risk for undetected late side effects or insufficient efficacy if compared with standard vaccine development schemes. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 16, 2020 Category: Drugs & Pharmacology Source Type: research

The association between acid-suppressive agent use and the risk of cancer: a systematic review and meta-analysis
ConclusionsASAs were significantly associated with an increased risk of gastric and liver cancer; therefore, special attention of ASA use considering the potential risk of gastric and liver cancer is needed. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 16, 2020 Category: Drugs & Pharmacology Source Type: research

Patient safety incidents and medication errors during a clinical trial: experience from a pre-hospital randomized controlled trial of emergency medication administration
ConclusionThe overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs. A similar number of patients had documentation errors. This study is the first to provide data on patient safety incidents relating to medication errors encountered during a pre-hospital trial of emergency medication administration and will provide supporting data for planning future trials in this area. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 14, 2020 Category: Drugs & Pharmacology Source Type: research

A decision support tool to find the best cyclosporine dose when switching from intravenous to oral route in pediatric stem cell transplant patients
ConclusionThe final model allows the prediction of the most likely cyclosporine oral dose to reach the therapeutic target specified by the clinician. The clinical impact of using this model needs to be prospectively warranted. Respecting the decision support tool terms of use is necessary as well as remaining critical about the prediction by confronting it with the clinical context. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 12, 2020 Category: Drugs & Pharmacology Source Type: research

Safety and CSF distribution of high-dose erlotinib and gefitinib in patients of non –small cell lung cancer (NSCLC) with brain metastases
ConclusionsHDG was better tolerated than HDE. CSF disposition of gefitinib was found to be saturable at a higher dose. Based on these findings, the dose of 750 mg OD should be considered for further evaluation in this setting. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 11, 2020 Category: Drugs & Pharmacology Source Type: research

Drug-drug interactions with metronidazole and itraconazole in patients using acenocoumarol
ConclusionCo-trimoxazole, metronidazole, and itraconazole increase the risk of overanticoagulation in patients using acenocoumarol. These combinations should be avoided if possible or otherwise acenocoumarol doses should be reduced and INR measured more frequently. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 10, 2020 Category: Drugs & Pharmacology Source Type: research

Professor Folke Sj öqvist peacefully passed away on March 30, 2020
(Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 10, 2020 Category: Drugs & Pharmacology Source Type: research

Evaluation of dose-tapering strategies for intravenous tocilizumab in rheumatoid arthritis patients using model-based pharmacokinetic/pharmacodynamic simulations
ConclusionWe demonstrated that the TDM-guided strategy using model-based algorithms performed similarly to mild empirical dose-tapering strategies in overall remission/LDA rates but is superior in cost-savings. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 9, 2020 Category: Drugs & Pharmacology Source Type: research

Case report: tolvaptan-associated creatine kinase elevation in two patients with autosomal dominant polycystic kidney disease (ADPKD)
(Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 8, 2020 Category: Drugs & Pharmacology Source Type: research

Hepatotoxicity in patients with solid tumors treated with PD-1/PD-L1 inhibitors alone, PD-1/PD-L1 inhibitors plus chemotherapy, or chemotherapy alone: systematic review and meta-analysis
AbstractBackgroundThis meta-analysis examined the risk of hepatotoxicity in patients with solid tumors who received a PD-1/PD-L1 inhibitor alone, a PD-1/PD-L1 inhibitor plus chemotherapy, or chemotherapy alone.MethodsPotentially eligible studies were identified by searches of Embase and PubMed. All included studies were randomized controlled trials (RCTs) that examined patients with solid tumors who received a PD-1/PD-L1 inhibitor and/or chemotherapy.ResultsWe included 20 clinical trials (11,634 patients). Thirteen trials compared PD-1/PD-L1 inhibitor monotherapy with chemotherapy. These two groups had similar risk for ele...
Source: European Journal of Clinical Pharmacology - June 8, 2020 Category: Drugs & Pharmacology Source Type: research

Stakeholders ’ knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study
ConclusionThis study highlights key factors that influence the reporting of ADRs in clinical trials. Although the findings are specifically related to the clinical trial environment in Ireland, they may provide a useful platform for optimising the future conduct of trials. This research suggests that ADR reporting may be improved through provision of enhanced pharmacovigilance training to clinical trial staff. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 7, 2020 Category: Drugs & Pharmacology Source Type: research

Serious adverse drug reactions with hydroxychloroquine: a pharmacovigilance study in Vigibase ®
(Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 6, 2020 Category: Drugs & Pharmacology Source Type: research

Use of selective serotonin reuptake inhibitors, other antidepressant medication, and risk of cataract: a case-control study based on Swiss claims data
ConclusionsAccording to our study, use of SSRI does not change the risk of cataract in the overall population. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 6, 2020 Category: Drugs & Pharmacology Source Type: research

Personalised medicine and the decision to withhold chemotherapy in early breast cancer with intermediate risk of recurrence – a systematic review and meta-analysis
ConclusionRegarding the use of gene expression assays in breast cancer, evidence on patient effects, informing patient-level chemotherapy decision making, is available. However, evidence for prioritisation at the overall health care level, i.e. use of, versus no use of, such assays, is largely lacking. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 5, 2020 Category: Drugs & Pharmacology Source Type: research

Age-dependent association of CYP2C19 polymorphisms with clinical outcome of clopidogrel therapy in minor stroke patients with large-artery atherosclerosis
ConclusionsCarriage of the CYP2C19 LOF allele may prevent expected clinical outcome during clopidogrel therapy in young LAA-associated minor stroke patients, whereas not in older patients. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 5, 2020 Category: Drugs & Pharmacology Source Type: research

A novel mechanism of ACE inhibition –associated enhanced platelet reactivity: disproof of the ARB-MI paradox?
ConclusionACEI enhanced platelet reactivity. This can be reversed by changing to ARB. The mechanism behind RAAS influencing platelet function seems to be associated with PAR-1 expression. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 5, 2020 Category: Drugs & Pharmacology Source Type: research

External evaluation of population pharmacokinetic models for continuous administration of meropenem in critically ill adult patients
ConclusionWhile performing external evaluations on some populations may confirm a model ’s suitability to diverse groups of patients, there is still some variability that cannot be explained nor solved by the procedure. This brings to light the difficulty to develop only one model for ICU patients and the need to develop one specific model to each population of critically ill patient s. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 4, 2020 Category: Drugs & Pharmacology Source Type: research

Establishment of reference intervals of biochemical analytes for healthy Chinese volunteers during the screening process in clinical pharmacology trials
ConclusionsThe RIs in this study can serve as a powerful clinical tool during the screening process in clinical pharmacology trials. However, these RIs should be re-verified if any condition changes. The results also emphasize the importance re-establishing RIs which are more applicable to local trial populations. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 3, 2020 Category: Drugs & Pharmacology Source Type: research

No association between hydrochlorothiazide use and uveal melanoma
(Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 3, 2020 Category: Drugs & Pharmacology Source Type: research

Aggregation and analysis of indication-symptom relationships for drugs approved in the USA
ConclusionThe drug-indication associations and disease-symptom associations collected in this study may be useful in identifying confounders in other datasets, such as safety reports. With further refinement and additional drugs, indications, and symptoms, this dataset may become a quality resource for disease symptoms. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 3, 2020 Category: Drugs & Pharmacology Source Type: research

First-in-human dose: current status review for better future perspectives
ConclusionEarly phase clinical trials are basically foundation stones on which lies the entire onus of the later stages of development. Deciding FIH dose is a crucial step that necessitates the incorporation of detailed data from the preclinical stages and application of the most conservative approach for the safety/benefit of the volunteers in these studies. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 3, 2020 Category: Drugs & Pharmacology Source Type: research

Response and Adherence to Nilotinib in Daily practice (RAND study): an in-depth observational study of chronic myeloid leukemia patients treated with nilotinib
AbstractIntroductionThis comprehensive observational study aimed to gain insight into adherence to nilotinib and the effect of (non)adherence on exposure (Cmin) and treatment outcomes.MethodsChronic myeloid leukemia (CML) patients using nilotinib were followed for 12 months. Adherence was measured by Medication Event Monitoring System (MEMS), pill count, and Medication Adherence Report Scale (MARS-5). NilotinibCmin and patient-reported outcomes (i.e., quality of life, side effects, beliefs, satisfaction) were measured at baseline, 3, 6, and 12 months.ResultsSixty-eight patients (57.5 ± 15.0 years, 49% female) partic...
Source: European Journal of Clinical Pharmacology - June 2, 2020 Category: Drugs & Pharmacology Source Type: research

Effect of a rabeprazole half-dose twice daily on acid inhibition in patients with different CYP2C19 alleles
ConclusionRabeprazole 5 mg bid provided no therapeutic advantage for acid inhibition compared with rabeprazole 10 mg qd, regardless of CYP2C19 genotype status. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 2, 2020 Category: Drugs & Pharmacology Source Type: research

Borrowing external information to improve Bayesian confidence propagation neural network
ConclusionsThe proposed method is a novel criterion for early detection of signals if similar drugs have the same tendencies. The proposed BCPNN tends to have higher sensitivity when the true difference is greater than 0. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 1, 2020 Category: Drugs & Pharmacology Source Type: research

Role of serotonin and norepinephrine transporters in antidepressant-induced arterial hypertension: a pharmacoepidemiological-pharmacodynamic study
ConclusionThe present study found a positive association between the NET/SERT pKi ratio and the occurrence of arterial hypertension with SRI and SNRI antidepressants. These results are important for the selection of antidepressants in hypertensive and/or at risk depressive patients as well as for future development of antidepressants devoid of hypertensive effect. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - June 1, 2020 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics of imipenem in both plasma and peritoneal draining liquid in elder patients with perforated upper gastrointestinal tract
(Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - May 30, 2020 Category: Drugs & Pharmacology Source Type: research