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British Journal of Clinical Pharmacology

Angela L Chiew, Daniel F B Wright, Nicola M Dobos, Kylie McArdle, Ahmed A Mostafa, Annemarie Newth, Michael S Roberts, Geoffrey K Isbister
Massive metformin overdose can cause metabolic acidosis with hyperlactatemia. A 55-year-old female presented 5h post multi-drug overdose, including 132 g extended-release metformin. Continuous venovenous haemodiafiltration (CVVHDF) and noradrenaline were commenced due to metabolic acidosis (pH 7.0, lactate 17 mmol/L) and shock. Despite 3 hours of CVVHDF, her acidosis worsened (pH 6.83, lactate 24 mmol/L). Intermittent haemodialysis(IHD) improved acidosis (pH 7.13, lactate 26 mmol/l), but again worsened (pH 6...
March 13, 2018: British Journal of Clinical Pharmacology
J F Golding, K A Wesnes, B R Leaker
AIMS: The aim of this study was to compare the effects of the selective M3 muscarinic acetylcholine receptor antagonist Darifenacin, oral Hyoscine hydrobromide and Placebo on motion sickness induced by cross-coupled stimulation. METHODS: The effects of Darifenacin 10 mg or 20 mg, Hyoscine hydrobromide 0.6 mg and Placebo were assessed in a randomised, double-blind, 4-way cross over trial of 16 healthy subjects. Motion sickness, skin conductance (a measure of sweating) and psychomotor cognitive function tests were investigated...
March 9, 2018: British Journal of Clinical Pharmacology
A L Sennesael, A S Larock, B Devalet, V Mathieux, F Verschuren, X Muschart, O Dalleur, J M Dogné, A Spinewine
AIMS: To determine the preventability of serious adverse drug reactions (ADR) related to the use of direct oral anticoagulants (DOAC), and to explore contributing factors to preventable ADRs. Results were compared with vitamin K antagonists (VKA). METHODS: We conducted a prospective observational study in the emergency departments of two teaching hospitals from July 2015 to January 2016. Patients admitted with a thrombotic or bleeding event while under DOAC or VKA were included...
March 9, 2018: British Journal of Clinical Pharmacology
Xu Steven Xu, Min Yuan, Hao Zhu, Yaning Yang, Hui Wang, Honghui Zhou, Jinfeng Xu, Liping Zhang, Jose Pinheiro
OBJECTIVE: To clarify the hypothesis tests associated with the full covariate modeling (FCM) approach in population pharmacokinetic (PPK) analysis, investigate the potential impact of multiplicity in PPK analysis, and evaluate simultaneous confidence intervals (SCI) as an approach to control multiplicity. METHODS: Clinical trial simulations were performed using a simple one-compartment PK model. Different numbers of covariates, sample sizes, effect sizes of covariates, and correlations among covariates were explored...
March 9, 2018: British Journal of Clinical Pharmacology
Luke E Grzeskowiak, Catherine Leggett, Lynn Costi, Claire T Roberts, Lisa H Amir
AIMS: To examine the association between late pregnancy exposure to serotonin reuptake inhibitor (SRI) antidepressants and difficulties in achieving an adequate breast milk supply in women who gave birth to preterm infants, while accounting for the potential impacts of underlying maternal psychiatric illness. METHODS: Retrospective cohort study of 3,024 women delivering liveborn preterm infants (<37 weeks' gestation) between January 2004 and December 2008. The primary outcome was postnatal domperidone use, considered a valid proxy for presence and pharmacological management of low milk supply...
March 9, 2018: British Journal of Clinical Pharmacology
Leàn Rolfes, Florence van Hunsel, Ola Caster, Henric Taavola, Katja Taxis, Eugène van Puijenbroek
OBJECTIVE: To explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug-adverse drug reaction (ADR) associations which led to drug safety signals. DESIGN: This was a retrospective comparison of time to reporting selected drug-ADR associations which led to drug safety signals between patients and healthcare professionals. SETTING: ADR reports were selected from the World Health Organization Global database of individual case safety reports, VigiBase...
March 9, 2018: British Journal of Clinical Pharmacology
Malak M Alame, Dina J Chamsy, Hassan Zaraket
A 30-year-old pregnant female presented with a 2-week history of pityriasis rosea-like eruption. The rash started 2 days after the patient had started taking ondansetron 8 mg for alleviation of moderate-to-severe nausea and vomiting of pregnancy. Physical examination revealed erythematous papulosquamous lesions characterized by annular scaly margins and a dusky centre over the arms, chest, abdomen, lower back and legs. The rash did not involve the palms, sole or mucous membranes, and no lesions were observed on the lymph nodes...
March 9, 2018: British Journal of Clinical Pharmacology
Saul Shiffman, Deena R Battista, Judith P Kelly, Mary K Malone, Rachel B Weinstein, David W Kaufman
AIMS: To estimate prevalence of excess intake of acetaminophen, and investigate seasonal variations therein. METHODS: Between 2011 and 2016, 14,481 US adults who used acetaminophen in the preceding 30 days were sampled from national online panels and completed a detailed online daily diary of acetaminophen medication use for 7 days. Respondents were not told the study concerned acetaminophen. Cold/flu season (CFS), identified using Google© Trends data, was contrasted to off-season in symptoms, use of acetaminophen medications, and consumption exceeding 4 grams (the recommended daily maximum)...
March 7, 2018: British Journal of Clinical Pharmacology
Karima Hider-Mlynarz, Philippe Cavalié, Patrick Maison
AIMS: To describe consumption trends of three groups of analgesics (non-opioids, mild and strong opioids) between 2006 and 2015 in France, and compare this pattern of use with six European countries in 2015. METHODS: Annual drugs sales were extracted from the French national authority's consumption database and from the IMS-MIDAS and national databases for European countries. RESULTS: The use of mild opioids in France decreased by 53% during the last 10 years due to the declining use of dextropropoxyphene combinations, along with an increase in the use of non-opioids and strong opioids (from 72 to 93 and 2 to 2...
March 7, 2018: British Journal of Clinical Pharmacology
V Pauly, E Frauger, M Lepelley, M Mallaret, Q Boucherie, J Micallef
AIM: The aim was to characterize patterns of Methylphenidate (MPH) use in France in both children and adults over a three year period. METHODS: Using the French General Health Insurance database limited to two areas covering approximately 4 million individuals, we made up a cohort of incident MPH users between July 2010 and June 2013. Splitting them into distinct age groups ( [18-24]; [25;49]; >=50 years olds for adults and less than 6 years old, [6-11] and [12;17] for children), we described these populations at MPH initiation and during follow-up according to duration of treatment, quantities dispensed, and co-prescription with Central Nervous System (CNS) drugs...
March 7, 2018: British Journal of Clinical Pharmacology
Theodora Bejan-Angoulvant, Thibaud Genet, Laura Vrignaud, Denis Angoulvant, Laurent Fauchier
No abstract text is available yet for this article.
March 6, 2018: British Journal of Clinical Pharmacology
P Riera, J Salazar, A Virgili, M Tobeña, A Sebio, P Gallano, A Barnadas, D Páez
AIM: Severe irinotecan-induced toxicity is associated with UGT1A1 polymorphisms. However, some patients develop side-effects despite harbouring a normal UGT1A1 genotype. As CYP3A4 is also an irinotecan-metabolizing enzyme, our study aimed to elucidate the influence of the CYP3A4*20 loss-of-function allele in the toxicity profile of these patients. METHODS: Three-hundred and eight metastatic colorectal cancer patients treated with an irinotecan-containing chemotherapy were studied...
March 5, 2018: British Journal of Clinical Pharmacology
P N Taylor, J S Davies
Vitamin D is a particularly important sterol hormone with evidence emerging of its beneficial effects well beyond bone. In consequence of this and increased global recognition of vitamin D deficiency in the general population, there has been a resurgence in treatment with vitamin D preparations. However, the increasing use of vitamin D treatments has also seen a substantial increase in the numbers of reports of vitamin D intoxication with the majority (75%) of reports published since 2010. Many of these cases are a consequence of inappropriate prescribing, the use of high dose over-the-counter preparations or unlicensed preparations...
March 2, 2018: British Journal of Clinical Pharmacology
Pekka Talke, Brian J Anderson
AIMS: Alpha-2 agonists are direct peripheral vasoconstrictors by activation of vascular smooth muscle alpha-2 adrenoceptors. The impact of this response during dexmedetomidine infusion remains poorly quantified. Our goal was to investigate the pharmacokinetic (PK) and pharmacodynamic (PD, vasoconstriction) effects of a computer controlled dexmedetomidine infusion in healthy volunteers. METHODS: After local ethics committee approval, we studied 10 healthy volunteers...
March 1, 2018: British Journal of Clinical Pharmacology
Stina Schultz Ormhøj, Anton Pottegård, Christiane Gasse, Lotte Rasmussen
AIM: Knowledge on the use of attention-deficit/hyperactivity disorder (ADHD) medication among older adults is limited. We hypothesized that ADHD medication is used off-label in adults ≥50 years as part of palliative care in e.g. cancer patients. The aim of this study was to describe the use of ADHD medication among adults ≥50 years in Denmark. METHODS: Using the Danish health registries, we identified new users ≥50 years of ADHD medication during 2000-2012...
March 1, 2018: British Journal of Clinical Pharmacology
M Naveed Shaik, Brian Hee, Hua Wei, Robert R LaBadie
AIMS: This study aimed to evaluate the effect of a strong CYP3A inducer, rifampin, on glasdegib pharmacokinetics in healthy volunteers. METHODS: In an open-label, fixed-sequence, two-period Phase 1 study, subjects received a single 100-mg oral dose glasdegib alone or following once-daily pre-treatment with 600 mg rifampin administered once daily. Glasdegib pharmacokinetics were calculated using a noncompartmental analysis. RESULTS: Twelve healthy male volunteers (3 whites, 5 blacks and 4 others) were enrolled in the study...
February 28, 2018: British Journal of Clinical Pharmacology
Cathal A Cadogan, Cristín Ryan, Caitriona Cahir, Colin P Bradley, Kathleen Bennett
AIMS: To examine prescribing trends for benzodiazepines and Z-drugs to General Medical Services (GMS) patients in Ireland. METHODS: A repeated cross-sectional analysis of the national pharmacy claims database was conducted for GMS patients aged ≥16 years from 2005-2015. Prescribing rates per 1000 eligible GMS population were calculated with 95% confidence intervals (CIs). Negative binomial regression was used to determine longitudinal trends and compare prescribing rates across years, gender and age groups...
February 28, 2018: British Journal of Clinical Pharmacology
Charles Khouri, François Arbib, Bruno Revol, Jean-Louis Pepin, Renaud Tamisier
Nalmefene, an opioid antagonist, has recently been approved for the treatment of alcohol dependence. We describe here the first case of a 52-year-old woman who developed a severe central sleep apnoea (CSA) 5 months after initiation of nalmefene. Scoring of ventilation during sleep recording revealed an apnoea-hypopnoea index of 67/h with 98.7% of central events and an apnoea index of 65/h. Nalmefene was withdrawn and a new polysomnography was performed which concluded that CSA has disappeared. Pathophysiology is still unclear but could involve the κ-opioid receptors...
February 26, 2018: British Journal of Clinical Pharmacology
Jiachang Gong, Lisa Iacono, Ramaswamy A Iyer, W Griffith Humphreys, Ming Zheng
AIMS: Previous studies demonstrated direct correlation between CYP2C19 genotype and BMS-823778 clearance in healthy volunteers. The objective of the present study was to develop a PBPK model for BMS-823778 and utilize the model to predict PK and DDI in virtual populations with multiple polymorphic genes. METHODS: The PBPK model was built and verified utilizing existing clinical data. The verified model was simulated to predict PK of BMS-823778 and significance of DDI with a strong CYP3A4 inhibitor in subjects with various CYP2C19 and UGT1A4 genotypes...
February 22, 2018: British Journal of Clinical Pharmacology
T Nava, N Kassir, M A Rezgui, C R S Uppugunduri, P Huezo-Diaz Curtis, M Duval, Y Théoret Y, L E Daudt, C Litalien, M Ansari, M Krajinovic, H Bittencourt
AIMS: To develop a population pharmacokinetic (PopPK) model for intravenous busulfan in children that incorporates variants of GSTA1, gene coding for the main enzyme in busulfan imetabolism. METHODS: Busulfan concentration-time data was collected from 112 children and adolescents (median 5.4 years old, range: 0.1 to 20) who received intravenous busulfan during the conditioning regimen prior to stem cell transplantation. Weight, sex, baseline disease (malignant vs...
February 22, 2018: British Journal of Clinical Pharmacology
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