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British Journal of Clinical Pharmacology

Merja Kokki, Marja Heikkinen, Pyry Välitalo, Heidi Hautajärvi, Juho Hokkanen, Hanna Pitkänen, Ulla Sankilampi, Veli-Pekka Ranta, Hannu Kokki
BACKGROUND AND OBJECTIVES: This study aimed to characterize the pharmacokinetics of oxycodone and its major metabolites in infants and covered the age range between extremely preterm neonates and 2-year old infants. METHODS: Seventy-nine infants (gestational age 23-42 weeks; postnatal age 0-650 days) received intravenous oxycodone hydrochloride trihydrate at a dose of 0.1 mg/kg during or after surgery. Three to seven blood samples were taken from each infant, and plasma concentrations of oxycodone, noroxycodone, oxymorphone, and noroxymorphone were quantified...
October 25, 2016: British Journal of Clinical Pharmacology
Lenneke Schrier, Rob Zuiker, Frans W H M Merkus, Erica S Klaassen, Zheng Guan, Bert Tuk, Joop M A van Gerven, Ronald van der Geest, Geert Jan Groeneveld
AIM: To evaluate the pharmacokinetics, pharmacodynamics, nasal tolerance and effects on sedation of a highly concentrated aqueous intranasal midazolam formulation (Nazolam) and to compare these to intravenous midazolam. METHODS: In this four-way crossover, double-blind, double-dummy, randomized, placebo-controlled study, 16 subjects received 2.5 mg Nazolam, 5.0 mg Nazolam, 2.5 mg intravenous midazolam or placebo on different occasions. Pharmacokinetics of midazolam and α-hydroxy-midazolam were characterized and related to outcome variables for sedation (Saccadic Peak Velocity, the Bond and Lader Visual Analogue Scale for sedation, the Simple Reaction Time Task and the Observer's Assessment of Alertness/Sedation)...
October 25, 2016: British Journal of Clinical Pharmacology
P Engel, M F Almas, M L De Bruin, K Starzyk, S Blackburn, N A Dreyer
AIM: To describe and characterise the first cohort of Post-Authorisation Safety Study (PASS) protocols reviewed under the recent European Pharmacovigilance Legislation. METHODS: A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages...
October 25, 2016: British Journal of Clinical Pharmacology
J H M Driessen, F de Vries, H van Onzenoort, N C Harvey, C Neef, J van den Bergh, P Vestergaard, R M A Henry
The aim of the present study was to estimate the effect of incretins on fracture risk in the real world situation by meta-analysis of the available population-based cohort data. Pubmed and Embase were searched for original articles investigating use of incretin agents, and fracture risk up to December 2015. Adjusted results were extracted and results were pooled by use of generic inverse variance methods, assuming a random-effects model. Neither current dipeptidyl peptidase 4 - inhibitors use, nor current glucagon-like peptide 1 receptor agonists use was associated with a decreased risk of fracture: pooled relative risk [pooled RR (95% CI): 1...
October 25, 2016: British Journal of Clinical Pharmacology
Arne Ring, Tom Morris, Marcin Wozniak, Nikol Sullo, William Dott, Veerle Verheyden, Tracy Kumar, Nigel Brunskill, Rakesh Vaja, Gavin J Murphy
BACKGROUND: Acute kidney injury (AKI) is a common and severe complication of cardiac surgery. There is no effective prevention or treatment. Sildenafil citrate (Revatio®, Pfizer Inc), a phosphodiesterase type 5 inhibitor, prevents post cardiac surgery AKI in pre-clinical studies, however its use is contraindicated in patients with symptomatic cardiovascular disease. METHODS: To assess the safety and pharmacokinetics of intravenous sildenafil in cardiac surgery patients we conducted an open label, dose escalation study with 6 patients per dose level...
October 25, 2016: British Journal of Clinical Pharmacology
Zi-Qi Shen, Shan-Yan Gao, Shawn Xiang Li, Tie-Ning Zhang, Cai-Xia Liu, Hai-Chen Lv, Yuan Zhang, Ting-Ting Gong, Xin Xu, Chao Ji, Qi-Jun Wu, Da Li
AIM: To perform a meta-analysis of available cohort studies on the association between sertraline use by pregnant women in the first trimester and the findings of congenital anomalies in infants. METHODS: A comprehensive search of articles published from the index date through December 31, 2015 investigating the aforementioned associations was conducted on PubMed and Web of Science. Mesh headings used included the terms "serotonin reuptake inhibitor," "sertraline," "congenital anomalies" and "obstetrical outcome...
October 22, 2016: British Journal of Clinical Pharmacology
Eva Germovsek, Charlotte Barker, Mike Sharland, Joseph F Standing
AIM(S): When different models for weight and age are used in paediatric pharmacokinetic studies it is difficult to compare parameters between studies or perform model-based meta-analysis. This study aimed to compare published models with the proposed standard (allometric weight(0.75) and sigmoidal maturation function). METHODS: A systematic literature search was undertaken to identify published clearance (CL) reports for gentamicin and midazolam and all published models for scaling clearance in children...
October 21, 2016: British Journal of Clinical Pharmacology
José-Francisco Rocha, Éric Sicard, Nicolas Fauchoux, Amílcar Falcão, Ana Santos, Ana I Loureiro, Roberto Pinto, Maria João Bonifácio, Teresa Nunes, Luís Almeida, Patrício Soares-da-Silva
AIMS: To compare the levodopa/carbidopa (LC) and levodopa/benserazide (LB) pharmacokinetic profiles following repeated doses of opicapone (OPC) administered apart from levodopa. METHODS: Two randomized, double blind, sex-balanced, placebo-controlled studies in 4 groups of 12 or 18 healthy subjects each. In each group, enrolled subjects received a once-daily morning (5, 15 and 30 mg) or evening (5, 15 and 50 mg) administration of OPC or placebo for up to 28 days...
October 20, 2016: British Journal of Clinical Pharmacology
Ling Xue, Nick Holford, Xiao-Liang Ding, Zhen-Ya Shen, Chen-Rong Huang, Hua Zhang, Jing-Jing Zhang, Zhe-Ning Guo, Cheng Xie, Ling Zhou, Zhi-Yao Chen, Lin-Sheng Liu, Li-Yan Miao
AIMS: The aims of this study are to apply a theory based mechanistic model to describe the pharmacokinetics (PK) and pharmacodynamics (PD) of S- and R-warfarin. METHODS: Clinical data were obtained from 264 patients. Total concentrations for S- and R-warfarin were measured by ultra-high performance liquid tandem mass spectrometry. Genotypes were measured using pyrosequencing. A sequential population pharmacokinetic parameter with data method was used to describe the international normalized ratio (INR) time course...
October 20, 2016: British Journal of Clinical Pharmacology
Ilana Levy, Samuel Attias, Eran Ben-Arye, Lee Goldstein, Elad Schiff
BACKGROUND: Dietary and herbal supplements (DHS) are commonly used among inpatients and may cause interactions with drugs or other DHS. The study explored whether adverse events were actually associated with such interactions and examined specific characteristics among inpatient DHS users prone to such adverse events. METHODS: This was a cross-sectional study of 947 patients hospitalized in 12 departments of a tertiary academic medical centre in Haifa, Israel. It evaluated the rate of DHS use among inpatients, the potential for interactions, and actual adverse events during hospitalization associated with DHS use...
October 19, 2016: British Journal of Clinical Pharmacology
Jiang-Tao Tang, Brenda C de Winter, Dennis A Hesselink, Ferdi Sombogaard, Lan-Lan Wang, Teun van Gelder
AIM: Elderly transplant recipients have a lower incidence of acute rejection, and a higher risk to die from infectious complications. Potentially this may be caused by differences in the pharmacokinetics (PK) or pharmacodynamics (PD) of the immunosuppressive drugs they are taking. This study was designed to comprehensively evaluate the influence of age on the PK and PD of mycophenolic acid (MPA). METHODS: In this study the PK and PD of MPA was studied in 26 elderly and 54 younger renal transplant recipients treated with mycophenolate mofetil and tacrolimus...
October 18, 2016: British Journal of Clinical Pharmacology
Guillermo Gervasini, Carlos Jara, Clara Olier, Nuria Romero, Ruth Martínez, Juan Antonio Carrillo
AIMS: Anastrozole, an aromatase inhibitor widely used in breast cancer, has recently been indicated to be a P-glycoprotein (ABCB1) substrate. We have aimed to determine whether ABCB1 single-nucleotide polymorphisms (SNPs) can affect anastrozole plasma concentrations in these patients. In addition, we assessed the impact of SNPs in CYP19A1 and TCL1A on the development of arthralgia and cancer recurrence in our series. METHODS: This study included 110 postmenopausal women with hormone receptor-positive breast cancer...
October 17, 2016: British Journal of Clinical Pharmacology
Isla S Mackenzie, Steven V Morant, Li Wei, Alastair M Thompson, Thomas M MacDonald
AIMS: Spironolactone is widely used to treat heart failure, hypertension and liver disease with increased usage in recent years. Spironolactone has endocrine effects that could influence cancer risks and historical reports suggest possible links with increased risk of certain types of cancer. The aim of this study was to assess the effect of spironolactone exposure on cancer incidence. METHODS: A pharmacoepidemiological propensity score-matched cohort study was performed to assess the effect of spironolactone exposure on cancer incidence...
October 13, 2016: British Journal of Clinical Pharmacology
I Jullian-Desayes, B Revol, E Chareyre, P Camus, C Villier, J C Borel, J L Pepin, M Joyeux-Faure
Obstructive sleep apnea (OSA) is characterized by repeated episodes of apnea and hypopnea during sleep. Little is known about the potential impact of therapy drugs on the underlying respiratory disorder. Any influence should be taken into account and appropriate action taken, including drug withdrawal if necessary. Here, we review drugs in terms of their possible impact on OSA; drugs which 1) may worsen OSA; 2) are unlikely to have an impact on OSA; 3) those for which data are scarce or contradictory, and 4) drugs with a potentially improving effect...
October 13, 2016: British Journal of Clinical Pharmacology
Joris Komen, Tomas Forslund, Paul Hjemdahl, Morten Andersen, Björn Wettermark
AIMS: To assess the effect of policy interventions, i.e. reimbursement decisions, guidelines, and regional recommendations, on the prescribing of oral anticoagulant treatment in patients with atrial fibrillation (AF). METHODS: Interrupted time series analyses using monthly data on all patients with a recorded diagnosis of AF newly initiated (both switchers and anticoagulant naïve patients) on either warfarin, dabigatran, rivaroxaban or apixaban in the Stockholm region from April 2011 until February 2016...
October 11, 2016: British Journal of Clinical Pharmacology
Anna K Stalder, Dominik Lott, Daniel S Strasser, Hans G Cruz, Andreas Krause, Peter M A Groenen, Jasper Dingemanse
AIMS: The main objectives of these two Phase 1 studies were to investigate safety and tolerability as well as the pharmacokinetic/pharmacodynamic profile of the novel potent and selective FPR2/ALX agonist ACT-389949. A challenge model was used to assess the drug's anti-inflammatory potential with the aim of selecting a dosing regimen for future patient studies. METHODS: Two double-blind, randomized Phase 1 studies investigated safety, tolerability, pharmacokinetics, and pharmacodynamics of ACT-389949 at different doses and dosing regimens...
October 11, 2016: British Journal of Clinical Pharmacology
Yongjie Zhang, Nico P E Vermeulen, Jan N M Commandeur
AIMS: Oxidative bioactivation of amodiaquine (AQ) by cytochrome P450s to a reactive quinoneimine is considered as an important mechanism underlying its idiosyncratic hepatotoxicity. However, because internal exposure to its major metabolite N-desethylamodiaquine (DEAQ) is up to 240 fold higher than AQ, bioactivation of DEAQ might significant contribute to covalent binding. The aim of the present study was to compare the kinetics of bioactivation of AQ and DEAQ by human liver microsomes and to characterize the CYPs involved in bioactivation of AQ and DEAQ...
October 8, 2016: British Journal of Clinical Pharmacology
Zohaib Akram, Tariq Abduljabbar, Sergio Varela Kellesarian, Mohamed Ibrahim Abu Hassan, Fawad Javed, Fahim Vohra
AIMS: The aim of this systematic review was to assess the efficacy of bisphosphonate therapy as an adjunct to scaling and root planing (SRP) in the management of periodontitis. METHODS: Databases (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Cochrane Oral Health Group Trials Register databases) were searched up to and including July 2016. The primary outcome was probing depth (PD), and the secondary outcomes were changes in clinical attachment level (CAL) and bone defect (BD) fill...
October 8, 2016: British Journal of Clinical Pharmacology
Malcolm Boyce, Andrew R Moore, Liv Sagatun, Bryony N Parsons, Andrea Varro, Fiona Campbell, Reidar Fossmark, Helge L Waldum, David M Pritchard
AIMS: Netazepide, a gastrin/CCK2 receptor antagonist, once daily for 12 weeks reduced the number of tumours and size of the largest one in 16 patients with autoimmune chronic atrophic gastritis (CAG), achlorhydria, hypergastrinaemia and multiple gastric neuroendocrine tumours (type 1 gastric NETs), and normalised circulating chromogranin A (CgA) produced by enterochromaffin-like cells, the source of the tumours. The aim was to assess whether longer-term netazepide treatment can eradicate type 1 gastric NETs...
October 4, 2016: British Journal of Clinical Pharmacology
Tim Johansson, Maria Flamm, Andreas Sönnichsen
No abstract text is available yet for this article.
October 4, 2016: British Journal of Clinical Pharmacology
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