Thijs van Iersel, Jocelyn Courville, Cathalijne van Doorne, Remco A Koster, Christina Fawcett
BACKGROUND: It is increasingly recognized that patients should be involved in the design of clinical trials. However, there is a lack in agreement of what patient-centricity means. METHODS: In this article a Patient Motivation Pyramid based on Maslow's theory of human motivation is introduced as a tool to identify patient needs. This pyramid is used to make a comprehensive overview of options to implement patient-centric trial design. The Pyramid with the described options can help to identify patient-centric activities suitable for a given drug development...
April 26, 2021: Current Clinical Pharmacology
Erica Winter, Scott Schliebner
Characterized by small, highly heterogeneous patient populations, rare disease trials magnify the challenges often encountered in traditional clinical trials. In recent years, there have been increased efforts by stakeholders to improve drug development in rare diseases through novel approaches to clinical trial designs and statistical analyses. We highlight and discuss some of the current and emerging approaches aimed at overcoming challenges in rare disease clinical trials, with a focus on the ultimate stakeholder, the patient...
March 16, 2021: Current Clinical Pharmacology
Renju Ravi, Harshad V Kesari
The concept of 'one size fits all' - one treatment for patients with a particular disease, seems to be outdated. The advent of precision medicine has prompted profound changes in clinical research and it allows researchers to predict, more accurately, the prevention and treatment strategies for a specific disease population. Novel study designs are, therefore, essential to establish safe and effective personalized medicine. Basket, umbrella and platform trial designs (collectively referred to as master protocols) are biomarker enrichment designs that allow for testing more than one hypothesis within a protocol, thus accelerating drug development...
March 16, 2021: Current Clinical Pharmacology
Ad Roffel, Jan Jaap van Lier, Gerk Rozema, Ewoud-Jan van Hoogdalem
BACKGROUND: We assessed the extent to which urinary and fecal excretion of 14C-labeled drug material in animal ADME studies was predictive of human ADME studies. We compared observed plasma elimination half lives for total drug related radioactivity in humans to pre-study predictions, and we estimated the impact of any major differences on human dosimetry calculations. METHODS: We included 34 human ADME studies with doses of 14C above 0.1 MBq. We calculated ratios of dosimetry input parameters (percentage fecal excretion in humans versus animals; observed half life in humans versus predicted pre-study) and output parameters (effective dose post-study versus pre study) and assessed their relationship...
March 8, 2021: Current Clinical Pharmacology
Luca Gallelli, Erika Cione, Leiming Zhang, Wang Tian
We suggest that enteral formulation of escin could be used instead of enteral formulation, if it is not available.
March 8, 2021: Current Clinical Pharmacology
Lynn R Webster, Erik Hansen, Gregory J Stoddard, Austin Rynders, David Ostler, Harley Lennon
BACKGROUND: Opioid analgesics used to treat pain can cause respiratory depression. However, this effect has not been extensively studied, and life- threatening, opioid-induced respiratory depression remains difficult to predict. We tested the ventilatory response to hypercapnia for evaluating the pharmacodynamic effect of a drug on respiratory depression. METHODS: We conducted a randomized, placebo-controlled, double-blind, crossover, study in 12 healthy adult males...
February 24, 2021: Current Clinical Pharmacology
Tomohito Wakabayashi, Takahiro Nakatsuji, Hiroko Kambara, Iku Niinomi, Saki Oyama, Ayaka Inada, Sayaka Ueno, Mayako Uchida, Kazunori Iwanaga, Tatsuya Iida, Keiko Hosohata
BACKGROUND: Several studies reported that abnormal behavior was noted in pediatric patients receiving several drugs, including neuraminidase inhibitors (NIs). However, the information on drugs associated with abnormal behavior in a real-world setting remains limited. The purpose of this study was to clarify the drugs associated with abnormal behavior using a spontaneous reporting system database. METHODS: We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report database...
February 14, 2021: Current Clinical Pharmacology
Lukas J Lehner, Klaus Kalb, Karl Weigand, Ulrich Pein, Peter Schenker, Wolfgang Seeger, Robert Roehle, Kerstin Dienes, Fabian Halleck, Klemens Budde
BACKGROUND/OBJECTIVE: Tacrolimus HEXAL®/Crilomus® is an approved generic immunosuppressant for the prevention and treatment of rejection following renal transplantation. For safe and socioeconomically efficient conversion from the innovator to generic formulation, high-quality data are necessary, in view of the different and country-specific comorbidities and pharmacokinetics in kidney transplant recipients. PATIENTS AND METHODS: From 2014 to 2017, we enrolled 32 kidney transplant recipients, receiving newly prescribed Tacrolimus HEXAL®/Crilomus® in 5 German centers...
February 14, 2021: Current Clinical Pharmacology
Farahnaz Rohani, Arash Akhavan Rezayat, Ahmadreza Zarifian, Mohammad Ghasemi Nour, Farveh Vakilian, Amirhossein Sahebkar, Maliheh Dadgarmoghaddam
BACKGROUND: Coronary artery disease is a major cause of morbidity and mortality worldwide. A major health concern in developing countries is opioid addiction, which has controversial cardiovascular side effects. We aimed to investigate whether myocardial infarction (MI) and its risk factors are associated with morphine dependency in the Iranian population. METHODS: Electronic databases, including PubMed, Medline, Scopus, SID, Elmnet, and Magiran were searched to find published articles including the keywords morphine, coronary artery disease, hypertension, hyperlipidemia, and diabetes mellitus...
January 28, 2021: Current Clinical Pharmacology
Zia Abdullah, Arvind Kumar, M A Khan, Uma Kumar, Surabhi Vyas, Vishal Kumar Vishwakarma, Piyush Ranjan, Ashutosh Biswas, Naveet Wig
OBJECTIVE: The study was conducted to determine whether synthetic disease modifying Anti Rheumatic drugs (DMARDs) suppresses the latency of Tuberculosis (TB) infection in Rheumatoid Arthritis (RA) patients along with other variables. METHODS: This was done through Tuberculin Skin Test (TST) using Purified protein derivative (PPD) in cohort of RA Patients. The TST was taken positive when induration post PPD injection was  5mm and negative or anergic when it was < 5mm...
December 31, 2020: Current Clinical Pharmacology
Sjoerd Meenks, Jos le Noble, Norbert Foudraine, Frank de Vries, Paddy Janssen
BACKGROUND: Ceftriaxone is recommended for empiric antimicrobial therapy in patients with sepsis. Therapeutic drug monitoring (TDM) guided dose optimisation could elucidate pharmacokinetic variabilities, improving treatment efficacy. However, detailed data on ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) for unbound ceftriaxone quantification in serum are scarce. OBJECTIVE: The authors aimed to develop a reliable UPLC-MS/MS method for serum ceftriaxone quantification and exhibit its application potential in routine hospital settings...
December 27, 2020: Current Clinical Pharmacology
Alessio Gasperetti, Marco Schiavone, Claudio Tondo, Gianfranco Mitacchione, Maurizio Viecca, Massimo Galli, Piercarlo Sarzi-Puttini, Giovanni Battista Forleo
While facing potentially high morbidity from COVID-19 without known effective therapies, the off-label use of several non-specific drugs has been advocated, including re-purposed anti-virals (e.g. remdesivir or the lopinavir/ritonavir combination), biologic agents (e.g. tocilizumab), and antimalarial drugs such as chloroquine and hydroxychloroquine, in association with or without azithromycin. Data regarding the effectiveness of these drugs in treating COVID-19 has been shown in some trials and clinical settings, but further randomised controlled trials are still being carried out...
December 24, 2020: Current Clinical Pharmacology
Štefan Alušík, Zoltán Paluch
BACKGROUND: The prevalence of cholelithiasis in developed countries is high and its cause multifactorial, with a negligible proportion of drug-induced cholelithiasis. METHODS: Relevant studies were identified by PubMed, Google Scholar and Science Direct. Reference lists of retrieved articles were also reviewed. The most relevant and up-to-date information was incorporated. RESULTS: There is a wide range of drugs that can induce lithiasis. While the risk of developing lithiasis is high with some drugs (ceftriaxone, atazanavir, somatostatin analogues), it is lower or even questionable with others...
December 17, 2020: Current Clinical Pharmacology
Meresa Berwo Mengesha, Hagos Degefa Hidru, Fissaha Tekulu Welay, Tsige Shushay Gebremedhin
BACKGROUND: Iron-folic acid supplementation is a central preventive measure for maternal anemia, so a consideration of the factors leading to or deterring from adherence is important. This review aims to establish if there is a correlation between increasing maternal education and adherence of iron-folic acid supplementation in Ethiopia. METHODS: An electronic database search was conducted using PubMed, Google Scholar, Cochrane Library and African Journals Online...
November 10, 2020: Current Clinical Pharmacology
Constantinos D Georgakopoulos, Athina Pallikari, Panagiotis Plotas, Konstantinos Kagkelaris, Stylianos Mastronikolis, Maria Plota, Andreas Emmanuil, Olga E Makri
OBJECTIVE: Systemic administration of anti-vascular endothelial growth factors (anti-VEGFs) has been associated with severe cardiovascular adverse events in oncologic patients. The purpose of this pilot study is to evaluate the short-term effect of a single intravitreal injection of aflibercept on biomarkers related to increased risk of cardiovascular disease. PATIENTS AND METHODS: Forty-seven treatment naïve patients with neovascular age related macular degeneration in one eye were enrolled in the study...
October 16, 2020: Current Clinical Pharmacology
Claudio Daniel Gonzalez, Victoria Insussarry Perkins, Agustina Alves de Lima, Rocio Fogar, Gustavo D Frechtel, Guillermo Di Girolamo
BACKGROUND: Monogenic diabetes (MFD) represents close to 2% of all the cases of dia- betes diagnosed in people younger than 45 years old. Maturity-onset diabetes of the young (MODY), neonatal diabetes, and several syndromic forms of diabetes are included among the most accounts for about typical forms of MDF. MODY is the most frequent type of MFD, with MODY 1, 2, 3, and 5 being the most prevalent forms. The aim of this narrative review is to describe preg- nancy associated changes in the pharmacological profile of the antidiabetic drugs used in women with the most frequent MODY subtypes...
September 10, 2020: Current Clinical Pharmacology
Zaineh M Shahrure, Yacoub M Irshaid, Khader N Mustafa, Mousa A Abujbara, Mohammad Al Shhab, Mohammed S El-Khateeb, Kamel M Ajlouni
BACKGROUND: The use of statins to lower high serum cholesterol levels may be associated with a number of adverse reactions, including severe myopathy. The solute carrier organic anion transporter 1B1 (SLCO1B1) gene, which encodes the organic anion-transporting polypeptide OATP1B1 is related to the intracellular transport of statins. The aim of this research is to study the association of rs2306283 and rs4149056 genetic polymorphism of SLCO1B1 gene with the development of statin-induced myopathy in Jordanian diabetics receiving statins...
August 26, 2020: Current Clinical Pharmacology
Asieh Karimani, Hasan Abedi, Fatemeh Nazemian, Atena Poortaji, Amir Hooshang Mohammad Pour
BACKGROUND: The area under the concentration-time curve (AUC) of mycophenolic acid (MPA), is a valid prognosticator of the risk of rejection and the gold standard in its therapeutic drug monitoring (TDM), over time posttransplantation. OBJECTIVE: This study aimed to investigate MPA pharmacokinetic parameters, as well as developing a limited sampling strategy (LSS) to estimate an abbreviated MPA AUC, in the stable phase post-renal transplantation. METHODS: In this study 19 patients with normal graft function (glomerular filtration rate >70 ml/min) who fulfilled inclusion & exclusion criteria were involved...
August 26, 2020: Current Clinical Pharmacology
Jan H Beumera, Jianxia Guo, Evan C Ray, Jonas Scemama, Robert A Parise, Berthony Deslouches, Jonathan D Steckbeck, Ronald C Montelaro, Julie L Eiseman
BACKGROUND: To address multidrug resistance we developed engineered cationic antimicrobial peptides (eCAPs). Lead eCAP WLBU2 displays potent activity against drug-resistant bacteria and effectively treats lethal bacterial infections in mice reducing bacterial loads to undetectable levels in diverse organs. OBJECTIVE: To support development of WLBU2, we conducted a mass balance study. METHODS: CD1 mice were administered 10, 15, 20 and 30 mg/kg QDx5 WLBU2 or a single dose of [14C]-WLBU2 at 15 mg/kg IV...
August 9, 2020: Current Clinical Pharmacology
Esra' Taybeh, Rawan Kokash, Ahmad Talhouni, Mervat Alsous
BACKGROUND: Knowledge of medication use during pregnancy presents a concern to pharmacists upon graduation since they will be responsible for drug related inquiries and counselling pregnant women about their medications. The present study aimed to assess undergraduate senior pharmacy students' knowledge about medication use during pregnancy in Jordan. METHODS: A cross-sectional survey was conducted in Jordanian universities. A total of 409 senior pharmacy students participated in the study...
July 16, 2020: Current Clinical Pharmacology
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