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Effects of 27 CYP3A4 Protein Variants on saxagliptin metabolism in vitro.

Fundam Clin Pharmacol 2021 May 7. Epub 2021 May 7.

Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor widely used in patients with type 2 diabetes. It can increase the amount of insulin after meals and lower blood sugar. CYP450 3A4 (CYP3A4) can metabolize about 30% to 40% of therapeutic drugs. Read More

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Evaluation system for cell-permeable CYP3A4 inhibitory activity using 1α,25-dihydroxy-vitamin D-induced intestinal cell lines.

Xenobiotica 2021 May 4:1-24. Epub 2021 May 4.

Graduate School of Pharmaceutical Sciences, Takasaki University of Health and Welfare, 60, Nakaorui-machi, Takasaki, Gunma 370-0033, Japan.

We developed an assay system to evaluate the cytochrome P450 (CYP) 3A4-inhibitory activity of compounds, taking account of their cellular permeability, using intestine-derived cell lines pretreated with the CYP3A4 inducer 1α,25-dihydroxy-vitamin D (250 nM).Ketoconazole (KTZ), saquinavir (SQV), naringin, naringenin (NGE), bergamottin (BG), 6,7-dihydroxybergamotin (DHBG), epigallocatechin gallate (EGCG), and resveratrol (RES) were evaluated as known CYP3A4 inhibitors. The apparent IC (IC) values of known inhibitors were determined in Caco-2 cells with 10 µM midazolam as a CYP3A4 substrate, and compared with the IC values in a human liver microsome assay. Read More

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Evaluation of the Effects of Repeat-Dose Dabrafenib on the Single-Dose Pharmacokinetics of Rosuvastatin (OATP1B1/1B3 Substrate) and Midazolam (CYP3A4 Substrate).

Clin Pharmacol Drug Dev 2021 May 1. Epub 2021 May 1.

Novartis Pharma AG, Basel, Switzerland.

Dabrafenib is an oral BRAF kinase inhibitor approved for the treatment of various BRAF V600 mutation-positive solid tumors. In vitro observations suggesting cytochrome P450 (CYP) 3A induction and organic anion transporting polypeptide (OATP) inhibition prompted us to evaluate the effect of dabrafenib 150 mg twice daily on the pharmacokinetics of midazolam 3 mg (CYP3A substrate) and rosuvastatin 10 mg (OATP1B1/1B3 substrate) in a clinical phase 1, open-label, fixed-sequence study in patients with BRAF V600 mutation-positive tumors. Repeat dabrafenib dosing resulted in a 2. Read More

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Mechanistic Modelling Identifies and Addresses the Risks of Empiric Concentration-Guided Sorafenib Dosing.

Pharmaceuticals (Basel) 2021 Apr 21;14(5). Epub 2021 Apr 21.

College of Medicine and Public Health, Flinders University, Bedford Park, SA 5042, Australia.

The primary objective of this study is to evaluate the capacity of concentration-guided sorafenib dosing protocols to increase the proportion of patients that achieve a sorafenib maximal concentration (C) within the range 4.78 to 5.78 μg/mL. Read More

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Herb-drug interactions in diabetes mellitus: A review based on pre-clinical and clinical data.

Phytother Res 2021 Apr 28. Epub 2021 Apr 28.

Department of Pharmaceutical Chemistry, Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pune, Maharashtra, India.

Global diabetes epidemic is the major cause of fatality and lethality. As per IDF 2019 report, diabetes caused 4.2 million deaths, approximately 463 million people are living with diabetes and by 2045, this will rise to 700 million. Read More

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Investigating Intestinal Transporter Involvement in Rivaroxaban Disposition through Examination of Changes in Absorption.

Pharm Res 2021 Apr 13. Epub 2021 Apr 13.

Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco, San Francisco, California, 94143-0912, USA.

Purpose: The involvement of the intestinally expressed xenobiotic transporters P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP) have been implicated in rivaroxaban disposition based on in vitro studies, similar to what had previously been proposed for apixaban. We recently showed that these efflux transporters were not clinically relevant for apixaban disposition and examine here their relevance for this second Factor Xa inhibitor.

Methods: Using recently published methodologies to discern metabolic- from transporter- mediated drug interactions, a critical evaluation was undertaken of 9 rivaroxaban studies reporting 12 DDIs, one study of food effects and one study of hepatic function. Read More

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Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial.

Trials 2021 Apr 9;22(1):262. Epub 2021 Apr 9.

School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.

Objectives: The primary objective is to determine the effect of a daily dose of ivermectin administered in three consecutive days to non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of SARS-CoV-2 RNA by PCR from nasopharyngeal swabs at day seven post-treatment initiation. The secondary objectives are: 1. To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab on days 4, 7, 14 and 21 post-treatment initiation 2. Read More

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Influence of Genetic Polymorphisms on the Response to Tramadol, Ibuprofen, and the Combination in Patients With Moderate to Severe Pain After Dental Surgery.

Clin Ther 2021 Apr 1. Epub 2021 Apr 1.

Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Facultad de Medicina, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain; UICEC Hospital Universitario de La Princesa, Plataforma SCReN (Spanish Clinical Reseach Network), Instituto de Investigación Sanitaria La Princesa, Madrid, Spain. Electronic address:

Purpose: We aimed to elucidate the influence on analgesic effect of genetic polymorphisms in enzymes responsible for biotransformation of tramadol and ibuprofen or other possible genes involved in their mechanism of action.

Methods: The study population comprised 118 patients from a multicenter, randomized, double-blind, placebo-controlled, Phase III clinical trial that assessed the analgesic efficacy and tolerability of a single dose of ibuprofen (arginine)/tramadol 400/37.5 mg compared with ibuprofen arginine 400 mg alone, tramadol 50 mg alone, and placebo in patients with moderate to severe pain after dental surgery. Read More

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In vitro cytochrome P450- and transporter-mediated drug interaction potential of 6β-hydroxy-21-desacetyl deflazacort-A major human metabolite of deflazacort.

Pharmacol Res Perspect 2021 Apr;9(2):e00748

PTC Therapeutics Inc., South Plainfield, NJ, USA.

6β-Hydroxy-21-desacetyl deflazacort (6β-OH-21-desDFZ) is a major circulating but not biologically active metabolite of deflazacort (DFZ). In vitro studies were performed to evaluate cytochrome P450 (CYP)- and transporter-mediated drug interaction potentials of 6β-OH-21-desDFZ. Up to 50 µM, the highest soluble concentration in the test system, 6β-OH-21-desDFZ weakly inhibited (IC  > 50 µM) the enzyme activity of CYPs 1A2, 2B6, 2C8, 2C9, and 2D6, while moderately inhibiting CYP2C19 and CYP3A4 with IC values of approximately 50 and 35 μM, respectively. Read More

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Potential metabolic resistance mechanisms to ivermectin in Anopheles gambiae: a synergist bioassay study.

Parasit Vectors 2021 Mar 20;14(1):172. Epub 2021 Mar 20.

ISGlobal, Hospital Clínic-Universitat de Barcelona, Rosello 132, 5ª 2ª, 08036, Barcelona, Spain.

Background: Despite remarkable success obtained with current malaria vector control strategies in the last 15 years, additional innovative measures will be needed to achieve the ambitious goals for malaria control set for 2030 by the World Health Organization (WHO). New tools will need to address insecticide resistance and residual transmission as key challenges. Endectocides such as ivermectin are drugs that kill mosquitoes which feed on treated subjects. Read More

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Comprehensive PBPK model to predict drug interaction potential of Zanubrutinib as a victim or perpetrator.

CPT Pharmacometrics Syst Pharmacol 2021 Mar 9. Epub 2021 Mar 9.

BeiGene USA, Inc, San Mateo, CA, USA.

A physiologically based pharmacokinetic (PBPK) model was developed to evaluate and predict (1) the effect of concomitant cytochrome P450 3A (CYP3A) inhibitors or inducers on the exposures of zanubrutinib, (2) the effect of zanubrutinib on the exposures of CYP3A4, CYP2C8, and CYP2B6 substrates, and (3) the impact of gastric pH changes on the pharmacokinetics of zanubrutinib. The model was developed based on physicochemical and in vitro parameters, as well as clinical data, including pharmacokinetic data in patients with B-cell malignancies and in healthy volunteers from two clinical drug-drug interaction (DDI) studies of zanubrutinib as a victim of CYP modulators (itraconazole, rifampicin) or a perpetrator (midazolam). This PBPK model was successfully validated to describe the observed plasma concentrations and clinical DDIs of zanubrutinib. Read More

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Immunization and Drug Metabolizing Enzymes: Focus on Hepatic Cytochrome P450 3A.

Expert Rev Vaccines 2021 Mar 18:1-12. Epub 2021 Mar 18.

Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas, Austin, Texas, USA.

Objective: Infectious disease emergencies like the 2013-2016 Ebola epidemic and the 2009 influenza and current SARS-CoV-2 pandemics illustrate that vaccines are now given to diverse populations with preexisting pathologies requiring pharmacological management. Many natural biomolecules (steroid hormones, fatty acids, vitamins) and ~60% of prescribed medications are processed by hepatic cytochrome P450 (CYP) 3A4. The objective of this work was to determine the impact of infection and vaccines on drug metabolism. Read More

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When Multidrug-Resistant Organism (MDRO)-Positive ICU Patient Isolation and Cohorting Is Not Feasible, What Comes Next?

Cureus 2021 Mar 1;13(3):e13636. Epub 2021 Mar 1.

HIV Surveillance Division, Hellenic National Public Health Organization, Athens, GRC.

Background The need for the implementation of an infection prevention strategy that included patient isolation and a cohorting procedure emerged in our ICU. Yet, isolation, as well as cohorting, were not feasible due to certain barriers associated with a high colonization pressure, open-plan ICU, inadequate bed separation, a limited number of isolation rooms, and nursing shortage. Despite these limitations, we tried to upgrade our ICU's infection prevention efforts by developing the "universal use of contact precautions approach" for infection prevention and control for all the patients with and without multidrug-resistant organisms (MDROs), cohorting, and single room isolation. Read More

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In vitro and in silico studies of interaction of synthetic 2,6,9-trisubstituted purine kinase inhibitors BPA-302, BP-21 and BP-117 with liver drug-metabolizing cytochromes P450

Physiol Res 2020 12;69(Suppl 4):S627-S636

Department of Pharmacology, Faculty of Medicine, Palacký University Olomouc, Czech Republic.

An evaluation of possible interactions with enzymes of drug metabolism (cytochromes P450, CYP) is an important part of studies on safety and, in general, on the properties of any drug or biologically active compound. The article is focused on the preliminary metabolic study of selected 2,6,9-trisubstituted purine kinase inhibitors with significant anticancer activities which we have developed. The compounds BP-21 and BP-117 represent strong CDK inhibitors and the compound BPA-302 was developed as selective FLT3-ITD kinase inhibitor. Read More

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December 2020

Comparative pharmacokinetic profile of cimicoxib in dogs and cats after IV administration.

Vet J 2021 Apr 1;270:105625. Epub 2021 Feb 1.

Scientific Division of Vetoquinol, 70200 Lure, France.

Cimicoxib is a selective COX-2 inhibitor (coxib) registered for the treatment of pain and inflammation in dogs. Pharmacokinetics of some coxibs have been described in dogs and cats. In cats, total body clearance values are lower and terminal half-lives of the coxibs are longer than those in dogs. Read More

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Preliminary approach to evaluate the drug-drug interaction potential of EST73502, a dual µ-opioid receptor partial agonist and σ1 receptor antagonist.

Xenobiotica 2021 May 23;51(5):501-512. Epub 2021 Feb 23.

WELAB, Parc Científic Barcelona, Baldiri Reixac 4-8, Barcelona 08028, Spain.

The potential for drug-drug interactions (DDI) of EST73502 was preliminary explored . EST73502 is a new chemical entity intended for oral pain treatment with dual sigma-1 receptor (σR) antagonism and μ-opioid receptor (MOR) partial agonism, that presents a promising potent analgesic activity.Several enzymes were involved in EST73502 metabolism catalysing the formation of different metabolites, CYP3A4 and CYP2D6 being the main ones. Read More

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Modulatory effect of fructooligosaccharide against triphenyltin-induced oxidative stress and immune suppression in goldfish (Carassius auratus).

Ecotoxicol Environ Saf 2021 Apr 26;212:111966. Epub 2021 Jan 26.

College of Animal Science and Technology, Henan University of Scientific and Technology, Luoyang 471003, People's Republic of China.

Triphenyltin (TPT) is a widely used pesticide that is highly toxic to a variety of organisms, including humans, and is a potential contributor to environmental pollution. The present study was conducted to evaluate the oxidative stress and immunotoxicity induced by TPT in goldfish (Carassius auratus) and the protective effects of fructooligosaccharide (FOS). Goldfish (mean weight of 13. Read More

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Application of Individualized PBPK Modeling of Rate Data to Evaluate the Effect of Hemodialysis on Nonrenal Clearance Pathways.

J Clin Pharmacol 2021 Jun 16;61(6):769-781. Epub 2021 Feb 16.

Department of Pharmacy and Therapeutics, Center for Clinical Pharmaceutical Sciences, University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania, USA.

The aim of this study was to apply individualized, physiologically based pharmacokinetic modeling of CO production rates (iPBPK-R) measured by the erythromycin breath test to characterize the effect of hemodialysis on the function of nonrenal clearance pathways in patients with end-stage renal disease. Twelve patients previously received C-erythromycin intravenously pre- and post-hemodialysis. Serial breath samples were collected after each dose over 2 hours. Read More

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Characterization of cytochrome P450 (CYP) 2D6 drugs as substrates of human organic cation transporters and multidrug and toxin extrusion proteins.

Br J Pharmacol 2021 Mar 23;178(6):1459-1474. Epub 2021 Feb 23.

Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany.

Background And Purpose: The metabolic activity of cytochrome P450 (CYP) 2D6 is highly variable and CYP2D6 genotypes insufficiently explain the extensive and intermediate metabolic phenotypes, limiting the prediction of drug response plus adverse drug reactions. Since CYP2D6 prototypic substrates are positively charged, the aim of this study was to evaluate the organic cation transporters (OCTs) and multidrug and toxin extrusion proteins (MATEs) as potential contributors to the variability of CYP2D6 hydroxylation of debrisoquine, dextromethorphan, diphenhydramine, perhexiline and sparteine.

Experimental Approach: OCT1/SLC22A1-, OCT2/SLC22A2-, OCT3/SLC22A3-, MATE1/SLC47A1-, and MATE2K/SLC47A2-overexpressing cell lines were used to investigate the transport of the selected drugs. Read More

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Verification of a cocktail approach for quantitative drug-drug interaction assessment: a comparative analysis between the results of a single drug and a cocktail drug.

Xenobiotica 2021 Apr 13;51(4):404-412. Epub 2021 Jan 13.

Departments of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.

A cocktail approach is a method to comprehensively evaluate the activity of cytochrome P450 enzymes (CYPs) by co-administering multiple CYP substrates. This is the first report that compares the results from a cocktail study to a single substrate separate administration study (single study) with concomitant administration of CYP inducers/inhibitors. The validity of a cocktail study for use as a quantitative drug-drug interactions (DDIs) assessment was evaluated. Read More

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Discovery of highly potent and selective influenza virus neuraminidase inhibitors targeting 150-cavity.

Eur J Med Chem 2021 Feb 13;212:113097. Epub 2020 Dec 13.

Department of Medicinal Chemistry, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, 44 West Culture Road, 250012, Jinan, Shandong, PR China; China-Belgium Collaborative Research Center for Innovative Antiviral Drugs of Shandong Province, 44 West Culture Road, 250012, Jinan, Shandong, PR China. Electronic address:

Encouraged by our earlier discovery of N1-selective inhibitors, the 150-cavity of influenza virus neuraminidases (NAs) could be further exploited to yield more potent oseltamivir derivatives. Herein, we report the design, synthesis and biological evaluation of a series of novel oseltamivir derivatives via the structural modifications at C-NH of oseltamivir targeting 150-cavity. Among them, compound 5c bearing 4-(3-methoxybenzyloxy)benzyl group exhibited the most potent activity, which was lower or modestly improved activities than oseltamivir carboxylate (OSC) against N1 (H1N1), N1 (H5N1) and N1 (H5N1-H274Y). Read More

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February 2021

Drug interactions of natural supplements in dermatology: a review.

Int J Dermatol 2020 Dec 23. Epub 2020 Dec 23.

Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami, Miller School of Medicine, Miami, FL, USA.

Limited information is available on the drug-drug interactions of natural supplements in dermatology. Many natural supplements are available over the counter, but drug-drug interactions can occur. This study reviews the clinical use and drug interactions of six natural supplements commonly recommended in dermatology: nicotinic acid (nicotinamide), polypodium leucotomos (heliocare), turmeric, horse chestnut seed extract, zinc, and N-acetylcysteine. Read More

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December 2020

Expression of cytochrome P450 isozyme transcripts and activities in human livers.

Xenobiotica 2021 Mar 28;51(3):279-286. Epub 2020 Dec 28.

Department of Pharmacology, Toxicology & Therapeutics, University of Kansas Medical Center, Kansas City, KS, USA.

Individual differences in cytochrome P450 (CYP) enzymes contribute to responses to drugs and environmental chemicals. The expression of CYPs is influenced by sex, age, and ethnicity. Human CYP studies are often conducted with human liver microsomes and liver cells to evaluate chemical induction and drug interactions. Read More

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The utility of CYP3A activity endogenous markers for evaluating drug-drug interaction between sildenafil and CYP3A inhibitors in healthy subjects.

Drug Metab Pharmacokinet 2021 Feb 12;36:100368. Epub 2020 Nov 12.

Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea; Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address:

Cytochrome P450 (CYP) 3A-related drug-drug interaction (DDI) studies are needed during drug development to determine clinical interaction effects. We aimed to evaluate DDI between sildenafil and two CYP3A inhibitors, clarithromycin and itraconazole, regarding the changes in pharmacokinetics and endogenous markers. An open-label, one-sequence, one-period, two-treatment parallel study was conducted in 32 healthy Korean subjects. Read More

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February 2021

Impact of Acute Inflammation on Cytochromes P450 Activity Assessed by the Geneva Cocktail.

Clin Pharmacol Ther 2020 Dec 20. Epub 2020 Dec 20.

Division of Clinical Pharmacology and Toxicology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.

Cytochromes P450 (CYP) are subject to important interindividual variability in their activity due to genetic and environmental factors and some diseases. Limited human data support the idea that inflammation downregulates CYP activities. Our study aimed to evaluate the impact of orthopedic surgery (acute inflammation model) on the activity of six human CYP. Read More

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December 2020

Frequent occurrence of triclosan hydroxylation in mammals: A combined theoretical and experimental investigation.

J Hazard Mater 2021 Apr 9;407:124803. Epub 2020 Dec 9.

State Key Laboratory of Environmental and Biological Analysis, Department of Chemistry, Hong Kong Baptist University, 999077 Hong Kong, China. Electronic address:

Triclosan (TCS) is a widespread antimicrobial agent with many adverse health risks. Its hepatoxicity invariably points to the activation of constitutive androstane receptor (CAR), which regulates cytochrome P450 (CYP) genes that are critical for oxidative metabolism. Here, we provide the theoretical and experimental evidences showing that metabolic activation of TCS frequently occurs through aromatic hydroxylation in mammals. Read More

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Downregulation of redox imbalance and iNOS/NF-ĸB/caspase-3 signalling with zinc supplementation prevents urotoxicity of cyclophosphamide-induced hemorrhagic cystitis in rats.

Life Sci 2021 Feb 16;266:118913. Epub 2020 Dec 16.

Department of Biochemistry, Faculty of Science, Ebonyi State University, Abakaliki, Nigeria.

Aim: Cyclophosphamide (CYP) chemotherapy induces bladder toxicity and hemorrhagic cystitis in cancer patients constituting a current clinical concern. Oxidative inflammatory cascades have been implicated as the mechanism contributing to CYP bladder urotoxicity. We thus assayed to explore whether zinc (Zn) supplementation could mitigate CYP-induced urotoxicity and evaluate the possible underlying mechanism in rats. Read More

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February 2021

Assessment of Vedolizumab Disease-Drug-Drug Interaction Potential in Patients With Inflammatory Bowel Diseases.

Clin Pharmacol Drug Dev 2020 Dec 16. Epub 2020 Dec 16.

Takeda, Cambridge, Massachusetts, USA.

Disease-drug-drug interactions (DDDIs) have been identified in some inflammatory diseases in which elevated proinflammatory cytokines can downregulate the expression of cytochrome P450 (CYP) enzymes, potentially increasing systemic exposure to drugs metabolized by CYPs. Following anti-inflammatory treatments, CYP expression may return to normal, resulting in reduced drug exposure and diminished clinical efficacy. Vedolizumab has a well-established positive benefit-risk profile in patients with ulcerative colitis (UC) or Crohn's disease (CD) and has no known systemic immunosuppressive activity. Read More

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December 2020

Pharmacogenetic and safety analysis of cinacalcet hydrochloride in healthy Chinese subjects.

Ann Transl Med 2020 Nov;8(21):1385

Research Division of Clinical Pharmacology, the First Affiliated Hospital of Nanjing Medical University & Jiangsu Province Hospital, Nanjing, China.

Background: Our study aims to explore the effect of genetics on the pharmacodynamics (PD) and pharmacokinetics (PK) of cinacalcet in healthy Chinese subjects; to investigate the effect of dietary factors on cinacalcet, and to evaluate the safety of cinacalcet under fasting and non-fasting conditions using a bioequivalence trial.

Methods: We investigated the relationship of cinacalcet PK with single nucleotide polymorphisms (SNPs) of CYP3A4, CYP1A2 and CYP2D6, and of cinacalcet PD with SNPs of calcium-sensitive receptors (CASR) and vitamin D receptors (VDR) in 65 healthy Chinese subjects recruited to participate in this study. Our study was a phase I, open-label, randomized, two-period, two-sequence crossover, a single-center clinical study designed under both fasting and non-fasting conditions to investigate the effect of dietary factors on cinacalcet. Read More

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November 2020

DYNAMIC: Dynamic glucose management strategies delivered through a structured education program improves time in range in a socioeconomically deprived cohort of children and young people with type 1 diabetes with a history of hypoglycemia.

Pediatr Diabetes 2021 Mar 15;22(2):249-260. Epub 2021 Jan 15.

Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.

Objectives: Create and evaluate the effectiveness of a structured education program in children and young people (CYP) with type 1 diabetes using continuous glucose monitoring (CGM).

Design And Methods: Step 1: CGM devices were evaluated for predetermined criteria using a composite score. Step 2: The education program was developed following review of international structured education guidance, dynamic glucose management (DynamicGM) literature, award-winning diabetes educators' websites, and CGM user feedback. Read More

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