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Clinical Drug Investigation

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https://www.readbyqxmd.com/read/28229305/erratum-to-the-efficacy-and-safety-of-tolvaptan-in-patients-with-hyponatremia-a-meta-analysis-of-randomized-controlled-trials
#1
Benlei Li, Dong Fang, Cheng Qian, Hongliang Feng, Yanggan Wang
No abstract text is available yet for this article.
February 22, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28224371/can-disproportionality-analysis-of-post-marketing-case-reports-be-used-for-comparison-of-drug-safety-profiles
#2
Christiane Michel, Emil Scosyrev, Michael Petrin, Robert Schmouder
Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs...
February 21, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28213743/development-of-cer-001-preclinical-dose-selection-through-to-phase-i-clinical-findings
#3
Constance H Keyserling, Ronald Barbaras, Renee Benghozi, Jean-Louis Dasseux
BACKGROUND: CER-001 comprises recombinant human apolipoprotein A-I complexed with phospholipids that mimics natural, nascent, pre-β high-density lipoprotein (HDL). We present animal model data showing dose-dependent increases in cholesterol efflux with CER-001 and its subsequent elimination by reverse lipid transport, together with inhibition of atherosclerotic plaque progression. We report the first phase I study results with CER-001 in humans, starting at 0.25 mg/kg, which is 1/80th of the safe dose (20 mg/kg) established in 4-week multiple-dose animal studies dosed every second day...
February 17, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28205121/effect-of-n-acetylcysteine-on-mortality-and-liver-transplantation-rate-in-non-acetaminophen-induced-acute-liver-failure-a-multicenter-study
#4
Samar K Darweesh, Mona F Ibrahim, Mahmoud A El-Tahawy
INTRODUCTION AND AIM: Previous studies and systematic reviews have not provided conclusive evidence on the effect of N-acetylcysteine (NAC) in non-acetaminophen-induced acute liver failure (NAI-ALF). We aimed to study the value of intravenous NAC in reducing liver transplantation and mortality in NAI-ALF. PATIENTS AND METHODS: In a prospective, multicenter, observational study, acute liver failure patients without clinical or historical evidence of acetaminophen overdose were enrolled...
February 15, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28197902/neuropsychiatric-effects-of-antimicrobial-agents
#5
REVIEW
Nicholas Zareifopoulos, George Panayiotakopoulos
Antimicrobial drugs used in clinical practice are selected on the basis of their selective toxicity against bacterial cells. However, all exhibit multiple offsite interactions with eukaryotic cell structures, resulting in adverse reactions during antimicrobial pharmacotherapy. A multitude of these side effects involve the nervous system as antimicrobials at clinically relevant concentrations seem to interact with many of the same molecules usually implicated in the action of psychotropic drugs. The importance of such events cannot be overstated, as the misdiagnosis of an adverse drug reaction as a symptom of a primary psychiatric or neurological disorder entails great suffering for the patient affected as well as significant costs for the healthcare system...
February 14, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28197901/safety-and-efficacy-of-brodalumab-for-moderate-to-severe-plaque-psoriasis-a-systematic-review-and-meta-analysis
#6
REVIEW
Attia Attia, Abdelrahman Ibrahim Abushouk, Hussien Ahmed, Mohamed Gadelkarim, Ahmed Elgebaly, Zeinab Hassan, Mohamed M Abdel-Daim, Ahmed Negida
BACKGROUND: Psoriasis is an inflammatory skin disease that affects 2-3% of the worldwide population. The interleukin-17 cytokine family has been proven to play a central role in the pathogenesis of psoriasis. Brodalumab is a novel biologic agent that targets interleukin-17 molecules and their receptors. We aimed to evaluate the safety and efficacy of brodalumab as a therapeutic agent for moderate-to-severe psoriasis in a meta-analysis framework. METHODS: A computer literature search of PubMed, OVID, Cochrane Central, EMBASE, EBSCO, Scopus, and Web of Science was conducted using relevant keywords...
February 14, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28185141/pharmacokinetic-properties-of-fast-acting-insulin-aspart-administered-in-different-subcutaneous-injection-regions
#7
Ulrike Hövelmann, Tim Heise, Leszek Nosek, Bettina Sassenfeld, Karen Margrete Due Thomsen, Hanne Haahr
BACKGROUND: Fast-acting insulin aspart (faster aspart) is insulin aspart set in a new formulation with faster initial absorption after subcutaneous administration. This study investigated the pharmacokinetic properties, including the absolute bioavailability, of faster aspart when administered subcutaneously in the abdomen, upper arm or thigh. METHODS: In a randomised, open-label, crossover trial, 21 healthy male subjects received a single injection of faster aspart at five dosing visits: 0...
February 10, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28185140/cost-utility-analysis-of-three-iron-chelators-used-in-monotherapy-for-the-treatment-of-chronic-iron-overload-in-%C3%AE-thalassaemia-major-patients-an-italian-perspective
#8
Alessia Pepe, Giuseppe Rossi, Anthony Bentley, Maria Caterina Putti, Ludovica Frizziero, Domenico Giuseppe D'Ascola, Liana Cuccia, Anna Spasiano, Aldo Filosa, Vincenzo Caruso, Aishah Hanif, Antonella Meloni
PURPOSE: Deferiprone (DFP), deferasirox (DFX) and deferoxamine (DFO) are used in thalassaemia major (TM) patients to treat chronic iron overload. We evaluated the cost-effectiveness of DFP, compared with DFX and DFO monotherapy, from an Italian healthcare system perspective. METHODS: A Markov model was used over a time horizon of 5 years. Italian-specific cost data were combined with Italian efficacy data. Costs and quality-adjusted life years (QALYs) were calculated for each treatment, with cost-effectiveness expressed as cost per QALY...
February 10, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28161756/safety-profile-of-finasteride-distribution-of-adverse-effects-according-to-structural-and-informational-dichotomies-of-the-mind-brain
#9
Ion G Motofei, David L Rowland, Mirela Manea, Simona R Georgescu, Ioana Păunică, Ioanel Sinescu
Finasteride is currently used extensively for male androgenic alopecia and benign prostatic hyperplasia; however, some adverse effects are severe and even persistent after treatment cessation, the so-called 'post-finasteride syndrome'. The following most severe adverse effects-sexual dysfunction and depression-often occur together and may potentiate one other, a fact that could explain (at least in part) the magnitude and persistence of finasteride adverse effects. This paper presents the pharmacological action of finasteride and the corresponding adverse effects, the biological base explaining the occurrence, persistence and distribution of these adverse effects, and a possible therapeutic solution for post-finasteride syndrome...
February 4, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28160190/changes-in-cardiac-function-after-a-single-intravenous-administration-of-ckd-712-in-healthy-male-volunteers
#10
Sang-In Park, JaeWoo Kim, Kyung-Sang Yu, In-Jin Jang, SeungHwan Lee
BACKGROUND AND OBJECTIVES: CKD-712, a candidate treatment for septic shock, acts by increasing cardiac output. This study investigated changes in the pharmacodynamics, pharmacokinetics, and tolerability of CKD-712 after a single intravenous administration. METHODS: A dose-block-randomized, double-blind, placebo-controlled, single-dose escalation study was conducted in 44 healthy subjects receiving 20, 40, 80, 160, 240, or 320 μg/kg CKD-712 or placebo. Pharmacodynamics were evaluated using computerized impedance cardiography, vital signs, platelet aggregation, and bleeding time...
February 3, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28155129/drug-interaction-potential-of-osilodrostat-lci699-based-on-its-effect-on-the-pharmacokinetics-of-probe-drugs-of-cytochrome-p450-enzymes-in-healthy-adults
#11
Sara Armani, Lillian Ting, Nicholas Sauter, Christelle Darstein, Anadya Prakash Tripathi, Lai Wang, Bing Zhu, Helen Gu, Dung Yu Chun, Heidi J Einolf, Swarupa Kulkarni
BACKGROUND AND OBJECTIVES: Osilodrostat (LCI699) is an adrenal steroidogenesis inhibitor currently in late-phase clinical development as a potential treatment for Cushing's disease. This study evaluated the inhibitory effect of osilodrostat on the pharmacokinetics of probe substrates of the cytochrome P450 (CYP) enzymes CYP1A2, CYP2C19, CYP2D6, and CYP3A4. METHODS: Healthy adult volunteers received single-dose cocktail probe substrates [caffeine (100 mg), omeprazole (20 mg), dextromethorphan (30 mg), and midazolam (2 mg)] followed by a 6-day washout...
February 2, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28102520/us-fda-perspective-on-elbasvir-grazoprevir-treatment-for-patients-with-chronic-hepatitis-c-virus-genotype-1-or-4-infection
#12
Sarita D Boyd, LaRee Tracy, Takashi E Komatsu, Patrick R Harrington, Prabha Viswanathan, Jeff Murray, Adam Sherwat
Elbasvir/grazoprevir demonstrated high sustained virologic response rates 12 weeks after the end of treatment (SVR12) across five clinical trials in subjects infected with chronic hepatitis C virus (HCV) genotype 1, including those with advanced chronic kidney disease (CKD), and GT4. Despite favorable results overall, the US Food and Drug Administration (FDA) encountered challenging regulatory issues due to the limitations of clinical trial data in certain subpopulations. In GT1a-infected subjects, baseline NS5A resistance-associated polymorphisms emerged as the strongest baseline characteristic associated with diminished SVR12 rates following 12 weeks of elbasvir/grazoprevir treatment...
January 19, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28101697/predictors-of-the-usefulness-of-corticosteroids-for-cancer-related-fatigue-in-end-of-life-patients
#13
Yuko Kanbayashi, Toyoshi Hosokawa
BACKGROUND AND OBJECTIVES: Although some studies have examined the use of corticosteroids, their effectiveness in treating cancer-related fatigue (CRF) has yet to be established. Therefore, this retrospective study attempted to identify factors that would predict the usefulness of corticosteroids in treating CRF. METHODS: We examined 87 hospitalized end-of-life cancer patients who were given betamethasone for relief of CRF at our hospital between January 2008 and January 2014...
January 18, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28074337/economic-burden-of-rheumatoid-arthritis-in-italy-possible-consequences-on-anti-citrullinated-protein-antibody-positive-patients
#14
Francesco Saverio Mennini, Andrea Marcellusi, Lara Gitto, Florenzo Iannone
BACKGROUND: Rheumatoid arthritis (RA) is an autoimmune disease with a substantial medical and economic burden. In Italy, it affects approximately 280,000 people, therefore representing the musculoskeletal disease with the highest economic impact in terms of costs for the National Health Service and the social security system. OBJECTIVE: The aim of this study was to estimate the annual economic burden of RA in Italy and determine the potential cost reduction considering the most effective biologic treatment for early rapidly progressing RA (ERPRA) patients...
January 10, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28066878/safety-and-effectiveness-of-sodium-stibogluconate-and-paromomycin-combination-for-the-treatment-of-visceral-leishmaniasis-in-eastern-africa-results-from-a-pharmacovigilance-programme
#15
Robert Kimutai, Ahmed M Musa, Simon Njoroge, Raymond Omollo, Fabiana Alves, Asrat Hailu, Eltahir A G Khalil, Ermias Diro, Peninah Soipei, Brima Musa, Khalid Salman, Koert Ritmeijer, Francois Chappuis, Juma Rashid, Rezika Mohammed, Asfaw Jameneh, Eyasu Makonnen, Joseph Olobo, Lawrence Okello, Patrick Sagaki, Nathalie Strub, Sally Ellis, Jorge Alvar, Manica Balasegaram, Emilie Alirol, Monique Wasunna
INTRODUCTION: In 2010, WHO recommended a new first-line treatment for visceral leishmaniasis (VL) in Eastern Africa. The new treatment, a combination of intravenous (IV) or intramuscular (IM) sodium stibogluconate (SSG) and IM paromomycin (PM) was an improvement over SSG monotherapy, the previous first-line VL treatment in the region. To monitor the new treatment's safety and effectiveness in routine clinical practice a pharmacovigilance (PV) programme was developed. METHODS: A prospective PV cohort was developed...
January 9, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28035616/effects-of-renal-function-on-crizotinib-pharmacokinetics-dose-recommendations-for-patients-with-alk-positive-non-small-cell-lung-cancer
#16
Weiwei Tan, Shinji Yamazaki, Theodore R Johnson, Rong Wang, Melissa T O'Gorman, Leonid Kirkovsky, Tanya Boutros, Nicoletta M Brega, Akintunde Bello
BACKGROUND AND OBJECTIVES: Crizotinib (250 mg twice daily) is the first anaplastic lymphoma kinase (ALK) inhibitor approved for treatment of ALK-positive non-small-cell lung cancer (NSCLC). The objectives of the current study were to evaluate the effects of mild, moderate, and severe renal impairment on crizotinib pharmacokinetics and to make crizotinib dosing recommendations for ALK-positive NSCLC patients with renal impairment on the basis of the findings. METHODS: The effects of varying degrees of renal impairment on crizotinib pharmacokinetics were evaluated by: (1) analysis of mild and moderate renal impairment on multiple-dose pharmacokinetics of crizotinib in ALK-positive NSCLC patients from the PROFILE 1001 and PROFILE 1005 trials; (2) analysis of severe renal impairment on single-dose pharmacokinetics of crizotinib in volunteers (Study 1020); and (3) prediction of the effect of severe renal impairment on multiple-dose crizotinib pharmacokinetics using a physiologically-based pharmacokinetic model of crizotinib...
December 29, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27995521/efficacy-and-safety-of-calcipotriol-plus-betamethasone-dipropionate-aerosol-foam-compared-with-betamethasone-17-valerate-medicated-plaster-for-the-treatment-of-psoriasis
#17
Catherine Queille-Roussel, Monika Rosen, Fabrice Clonier, Kasper Nørremark, Jean-Philippe Lacour
BACKGROUND: Fixed combination calcipotriol as hydrate (Cal) 50 µg/g plus betamethasone as dipropionate (BD) 0.5 mg/g aerosol foam is an alcohol-free treatment for psoriasis. Betamethasone 17-valerate 2.25 mg (BV)-medicated plasters are recommended for treating psoriasis plaques localized in difficult-to-treat (DTT; elbow, knee, anterior face of the tibia) areas. OBJECTIVE: The aim of this study was to compare the efficacy of Cal/BD foam with BV-medicated plaster in patients with plaque psoriasis...
December 19, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27988835/cost-effectiveness-analysis-of-apixaban-dabigatran-rivaroxaban-and-warfarin-for-stroke-prevention-in-atrial-fibrillation-in-taiwan
#18
Chieh-Yu Liu, Hui-Chun Chen
BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate the cost effectiveness of novel oral anticoagulants (NOACs) for stroke prevention among atrial fibrillation (AF) patients by incorporating Taiwanese demographic information derived from a population-based database, the National Health Insurance Research Database (NHIRD), into cost-effectiveness analysis. METHODS: From 1 January to 31 December 2012, 98,213 AF patients were selected from the NHIRD database...
December 17, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27928739/cost-effectiveness-comparison-between-the-response-guided-therapies-and-monotherapies-of-nucleos-t-ide-analogues-for-chronic-hepatitis-b-patients-in-china
#19
Keng Lai, Chi Zhang, Weixia Ke, Yanhui Gao, Shudong Zhou, Li Liu, Yi Yang
BACKGROUND AND OBJECTIVE: Nucleos(t)ide analogue (NA) monotherapies are typically used as the primary treatment for chronic hepatitis B (CHB) patients, including lamivudine (LAM), telbivudine (TBV), adefovir (ADV), entecavir (ETV) and tenofovir (TDF). For high-resistance NAs (LAM, TBV, ADV), they can generate excellent clinical outcomes by using response-guided therapy; however, their pharmacoeconomic profiles remain unclear in China. We aimed to evaluate the cost effectiveness between response-guided therapies and monotherapies of NAs for Chinese hepatitis B e-antigen (HBeAg)-positive and -negative CHB patients...
December 7, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27910036/evaluation-of-the-pharmacokinetic-interaction-between-venetoclax-a-selective-bcl-2-inhibitor-and-warfarin-in-healthy-volunteers
#20
Ahmed Hamed Salem, Beibei Hu, Kevin J Freise, Suresh K Agarwal, Dilraj S Sidhu, Shekman L Wong
BACKGROUND AND OBJECTIVE: Venetoclax is a selective, B-cell lymphoma-2 inhibitor that has demonstrated clinical efficacy in a variety of hematological malignancies. In vitro data indicated weak cytochrome P450 (CYP) 2C9 inhibition by venetoclax; however, it is not predicted to cause clinically relevant inhibition due to high plasma protein binding. A Phase 1 study was conducted in healthy volunteers to evaluate the effect of venetoclax on warfarin pharmacokinetics. METHODS: Subjects received a single oral dose of 5 mg warfarin on day 1 of both periods 1 and 2, separated by a 14 days washout...
December 2, 2016: Clinical Drug Investigation
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