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European Journal of Clinical Pharmacology

Sabina Mugusi, Eliford Ngaimisi, Mohammed Janabi, Ferdinand Mugusi, Omary Minzi, Eric Aris, Muhammad Bakari, Leif Bertilsson, Juergen Burhenne, Eric Sandstrom, Eleni Aklillu
PURPOSE: Efavirenz-based combination antiretroviral therapy (cART) is associated with neuropsychiatric adverse events. We investigated the time to onset, duration, clinical implications, impact of pharmacogenetic variations, and anti-tuberculosis co-treatment on efavirenz-associated neuropsychiatric manifestations. METHODS: Prospective cohort study of cART naïve HIV patients with or without tuberculosis (HIV-TB) co-infection treated with efavirenz-based cART. Rifampicin-based anti-tuberculosis therapy was initiated 4 weeks prior to efavirenz-based cART in HIV-TB patients...
July 12, 2018: European Journal of Clinical Pharmacology
Lanfranco Pellesi, Manuela Licata, Patrizia Verri, Daniele Vandelli, Federica Palazzoli, Filippo Marchesi, Maria Michela Cainazzo, Luigi Alberto Pini, Simona Guerzoni
PURPOSE: The recent release of a medical cannabis strain has given a new impulse for the study of cannabis in Italy. The National Health Service advises to consume medical cannabis by vaporizing, in decoction or oil form. This is the first study that explores the pharmacokinetics and tolerability of a single oral dose of cannabis as decoction (200 ml) or in olive oil (1 ml), as a first step to improve the prescriptive recommendations. METHODS: This is a single-center, open-label, two-period crossover study designed to assess the pharmacokinetics and tolerability of oral cannabis administered to 13 patients with medication overuse headache (MOH)...
July 6, 2018: European Journal of Clinical Pharmacology
Teerachat Saeheng, Kesara Na-Bangchang, Juntra Karbwang
PURPOSE: Physiologically based pharmacokinetic (PBPK) modeling, a mathematical modeling approach which uses a pharmacokinetic model to mimick human physiology to predict drug concentration-time profiles, has been used for the discover and development of drugs in various fields, including oncology, since 2000. There have been a few general review articles on the utilization of PBPK in the development of oncology drugs, but these do not include an evaluation of model prediction accuracy...
July 5, 2018: European Journal of Clinical Pharmacology
Uwe Schuehly, Surya Ayalasomayajula, Jeppe Buchbjerg, Parasar Pal, Georg Golor, Margaret F Prescott, Gangadhar Sunkara, Markus Hinder, Thomas H Langenickel
PURPOSE: Sacubitril/valsartan (LCZ696) and nitroglycerin share the second messenger cGMP and lower blood pressure. Given the potential for co-administration of both drugs in patients with heart failure, this study was designed to investigate the potential for a pharmacodynamic drug interaction affecting blood pressure. METHODS: In this double-blind, placebo-controlled, randomised, crossover study, 40 healthy subjects received sacubitril/valsartan 200 mg bid (97/103 mg bid) or placebo for 5 days...
July 4, 2018: European Journal of Clinical Pharmacology
Sylvie Mesrine, Gaëlle Gusto, Françoise Clavel-Chapelon, Marie-Christine Boutron-Ruault, Agnès Fournier
PURPOSE: To assess the association between use of benzodiazepines (including the Z-drugs zopiclone and zolpidem) and cardiovascular mortality in women aged over 50 years. METHODS: We used data from the E3N cohort. Data self-reported in biennial questionnaires was matched with drug reimbursement and vital status/causes of death data. In Cox models, exposure to benzodiazepines was fitted using time-varying variables, the reference category being women with no benzodiazepine delivery since January 2004...
July 4, 2018: European Journal of Clinical Pharmacology
Eva Sönnerstam, Maria Sjölander, Hugo Lövheim, Maria Gustafsson
PURPOSE: Increased numbers of drugs and changes in pharmacokinetic and pharmacodynamic parameters among elderly people contribute to increased prevalence of adverse drug reactions. Drug-drug interactions (DDIs) are an important reason for admission to hospital and elderly people with dementia are particularly vulnerable. The aims of the present study were to assess the occurrence and characteristics of clinically relevant DDIs and to investigate potential risk factors associated with DDIs among elderly people with dementia...
July 2, 2018: European Journal of Clinical Pharmacology
Warangkana Saengram, Somratai Vadcharavivad, Nalinee Poolsup, Wiwat Chancharoenthana
PURPOSE: To compare the estimated glomerular filtration rate (eGFR) at 12 months together with other outcomes among adult kidney transplant recipients (KTRs) who received extended release, once daily tacrolimus (ER-Tac) compared to those who received the immediate release, twice daily tacrolimus (IR-Tac) administration. METHODS: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement, we systematically reviewed all randomized controlled trials (RCTs) that compared clinical outcomes between ER-Tac versus IR-Tac in KTRs...
June 30, 2018: European Journal of Clinical Pharmacology
Anna L Eriksson, Susanna M Wallerstedt
PURPOSE: To investigate if increased focus on pharmacotherapy during medical school can increase students' confidence in basic prescribing skills, that is, performing medication reviews and writing medication discharge summaries. METHODS: In 2016, the clinical pharmacology course in medical school in Gothenburg, Sweden, was modified to facilitate the students' acquisition of prescribing skills, with (i) clarified learning outcomes; (ii) supply of a list of common drugs for self-completion; (iii) instructions to practice medication reviews/discharge summaries during the ward-based education; and (iv) a concluding compulsory seminar where the students were to present prescribing-related experiences from their ward-based attendance...
June 28, 2018: European Journal of Clinical Pharmacology
Sourav Kalra, Raman Preet Kaur, Abhilash Ludhiadch, Gowhar Shafi, Rajesh Vashista, Raj Kumar, Anjana Munshi
PURPOSE: Cyclophosphamide and doxorubicin (adjuvant chemotherapy) are commonly used to treat breast cancer patients. Variation in the genes involved in pharmacodynamics and pharmacokinetics of these drugs plays an important role in prediction of drug response and survival. The present study was carried out with an aim to evaluate the variation in all the genes involved in pharmacokinetic and pharmacodynamics pathways of cyclophosphamide and doxorubicin, and correlate specific variants with disease outcome in breast cancer patients from the Malwa region of Punjab...
June 24, 2018: European Journal of Clinical Pharmacology
S S Kumar, H McManus, T Radovich, J R Greenfield, A Viardot, K M Williams, P Cronin, R O Day
PURPOSE: The management of type 2 diabetes mellitus (T2DM) is complex. The aim of this work is to explore factors that predict the need for add-on therapy in patients with T2DM in the community. METHODS: We accessed longitudinal, pharmacy payment claim records from the national Pharmaceutical Benefits Scheme (PBS) (Subsidises costs of medicines: government pays difference between patient co-payments, lower in concessional patients, and additional cost of drug.) for the period January 2006 to September 2014 (EREC/MI3127) from a 10% random sample of the Australian population validated to be representative of the population by the Australian Bureau of Statistics (ABS)...
June 24, 2018: European Journal of Clinical Pharmacology
Lucas Morin, Marie-Laure Laroche, Davide L Vetrano, Johan Fastbom, Kristina Johnell
BACKGROUND: Clinical guidance is needed to initiate, continue, and discontinue drug treatments near the end of life. AIM: To identify drugs and drug classes most often adequate, questionable, or inadequate for older people at the end of life. DESIGN: Delphi consensus survey. SETTING/PARTICIPANTS: Forty European experts in geriatrics, clinical pharmacology, and palliative medicine from 10 different countries. Panelists were asked to characterize drug classes as "often adequate," "questionable," or "often inadequate" for use in older adults aged 75 years or older with an estimated life expectancy of ≤ 3 months...
June 23, 2018: European Journal of Clinical Pharmacology
Michael Reumerman, J Tichelaar, B Piersma, M C Richir, M A van Agtmael
OBJECTIVES: Pharmacovigilance education is essential since adverse drug reactions (ADRs) are a serious health problem and contribute to unnecessary patient burden and hospital admissions. Healthcare professionals have little awareness of pharmacovigilance and ADR reporting, and only few educational interventions had durable effects on this awareness. Our future healthcare providers should therefore acquire an adequate set of pharmacovigilance competencies to rationally prescribe, distribute, and monitor drugs...
June 20, 2018: European Journal of Clinical Pharmacology
Camille Riff, Aurélie Bourgoin, Amelie Marsot, Laurent Allanioux, Marc Leone, Olivier Blin, Romain Guilhaumou
PURPOSE: Tumescent lidocaine anesthesia (TLA) is an opportunity to perform mastectomy for breast cancer without general anesthesia in elderly women. Few reports are available on the pharmacokinetics of lidocaine in a context of TLA during a unilateral mastectomy. The aim of this study was to describe lidocaine pharmacokinetics in elderly women undergoing breast cancer surgery after TLA and to explore the risk of the toxicity of this technique. METHODS: A prospective study was conducted to examine the pharmacokinetics of lidocaine in women undergoing TLA...
June 16, 2018: European Journal of Clinical Pharmacology
Mariam Ujeyl, Ingrid Köster, Hans Wille, Thomas Stammschulte, Rebecca Hein, Sebastian Harder, Ursula Gundert-Remy, Julian Bleek, Peter Ihle, Helmut Schröder, Gerhard Schillinger, Anette Zawinell, Ingrid Schubert
PURPOSE: The pivotal trials for stroke prevention in non-valvular atrial fibrillation (NVAF) compared rivaroxaban, dabigatran, and apixaban with warfarin, as did most claims-based studies. Comparisons with phenprocoumon, the most frequently used vitamin K antagonist (VKA) in Germany, are scarce. METHODS: Risk of bleeding, ischemic stroke, and all-cause mortality in patients with NVAF were analyzed using data for 2010 to 2014 from a large German claims database. New users of oral anticoagulants from January 2012 to December 2013 were included and observed over 1 year...
June 16, 2018: European Journal of Clinical Pharmacology
Eunwoo Kim, Anhye Kim, Sojeong Yi, Yu Kyong Kim, Seong Bok Jang, Hae Mi Byun, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu, SeungHwan Lee
PURPOSE: YH4808 is a potassium-competitive acid blocker, developed for the treatment of acid-related disorders. Two clinical studies in healthy male subjects were conducted to evaluate the effect of food on the pharmacokinetics of YH4808. METHODS: The first study, a randomized, three-treatment, three-period, crossover study, compared pharmacokinetics of YH4808 (300 mg) after a single dose at fed state with a standard or a high-fat meal to those at fasted state...
June 15, 2018: European Journal of Clinical Pharmacology
Esther Letícia Amorim Ribeiro, Tácio de Mendonça Lima, Marcio Eduardo Bergamini Vieira, Sílvia Storpirtis, Patricia Melo Aguiar
PURPOSE: To conduct an overview to summarize the efficacy and safety of aripiprazole for the treatment of schizophrenia. METHODS: A literature search was performed in PubMed, the Cochrane Library, LILACS, and the Centre for Reviews and Dissemination, for articles published until March 31, 2017. We included systematic reviews with meta-analyses of randomized controlled trials assessing the efficacy, and/or the safety of aripiprazole, for patients with schizophrenia...
June 15, 2018: European Journal of Clinical Pharmacology
Kyoung-Ah Kim, In-Bae Park, Ji-Young Park
PURPOSE: Tamsulosin is one of the most potent drugs currently available to treat benign prostatic hyperplasia. Cytochrome P450 (CYP) 2D6 and CYP3A are the two major enzymes responsible for tamsulosin metabolism. The purpose of this study was to evaluate the effects of CYP2D6 and CYP3A5 genetic polymorphisms on the pharmacokinetics and hemodynamic effects of tamsulosin in humans. METHODS: Twenty-nine male subjects were enrolled and their CYP2D6 (*2,*4,*5,*10,*14,*21,*41, and *xN) and CYP3A5 (*5) genotypes were screened...
June 13, 2018: European Journal of Clinical Pharmacology
Marina Senek, Dag Nyholm, Elisabet I Nielsen
OBJECTIVES: Low dose, dispersible, levodopa/carbidopa microtablets with an automatic dose dispenser have been developed to facilitate individualized levodopa treatment. The aim of this study was to characterize the pharmacokinetics (PK) of levodopa and carbidopa after microtablet administration, and evaluate the impact of potential covariates. METHODS: The population PK analysis involved data from 18 healthy subjects and 18 Parkinson's disease patients included in two single-dose, open-label levodopa/carbidopa microtablet studies...
June 7, 2018: European Journal of Clinical Pharmacology
François Montastruc, Farzin Khosrow-Khavar, Sibylle de Germay, Christel Renoux, Vanessa Rousseau, Geneviève Durrieu, Marion Montastruc, Olivier Rascol, Agnès Sommet, Maryse Lapeyre-Mestre, Justine Benevent, Jean-Louis Montastruc
BACKGROUND: Three studies have suggested a potential positive association between the use of tamoxifen in breast cancer and Parkinsonism, mainly after long-term exposure. OBJECTIVES: To explore this potential signal, we performed a case/non-case study using the World Health Organization Global Individual Case Safety Reports (ICSRs) database, VigiBase® between 1979 and 2018. METHODS: Among women ≥ 55 years, we measured the risk of reporting "Parkinsonism" compared with all other adverse drug reactions [as a reporting odds ratio (ROR 95% CI)] for tamoxifen compared to all other drugs or aromatase inhibitors...
June 3, 2018: European Journal of Clinical Pharmacology
Preet Mohinder Singh, Anuradha Borle, Rajesh Panwar, Jeetinder Kaur Makkar, Ian McGrath, Anjan Trikha, Ashish Sinha
BACKGROUND: Dexamethasone has many desirable pharmacologic properties for perioperative use. Its antiemetic potential has been a focus of many recent trials. METHODS: Trials comparing dexamethasone to 5-HT3-receptor antagonists (5HT3-RA) for 24 h postoperative vomiting incidences published till August 2017 were searched in the medical database. Comparisons for antiemetic efficiency variables (vomiting incidence, nausea incidence, rescue antiemetic need, and patients with complete response) during early (until 6 h) and late postoperative phase were made...
June 1, 2018: European Journal of Clinical Pharmacology
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