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Clinical Drug Investigation

Lesley J Scott
Intravenous gadobutrol [Gadovist™ (EU); Gadavist® (USA)] is a second-generation, extracellular non-ionic macrocyclic gadolinium-based contrast agent (GBCA) that is approved for use in paediatric (including term neonates) and adult patients undergoing diagnostic contrast-enhanced (CE) MRI for visualization of pathological lesions in all body regions or for CE MRA to evaluate perfusion and flow-related abnormalities. Its unique physicochemical profile, including its high thermostability and proton relaxation times, means that gadobutrol is formulated at twice the gadolinium ion concentration of other GBCAs, resulting in a narrower bolus and consequently, improved dynamic image enhancement...
July 13, 2018: Clinical Drug Investigation
Seuk Keun Choi, Chan Wha Kim, Jong-Tak Kim, Young Seomun, Min Soo Park, Choon Ok Kim
BACKGROUND AND OBJECTIVE: Batroxobin, a snake venom thrombin-like enzyme, converts fibrinogen into fibrin by cleaving fibrinopeptide A. It is used for hemostasis; however, the supply of native batroxobin is limited. Therefore, we developed a recombinant batroxobin (r-batroxobin) from Pichia pastoris and evaluated its pharmacodynamics and safety in humans. METHODS: A randomized, double-blind, placebo-controlled, single ascending-dose study was performed. Eight healthy subjects were enrolled in each r-batroxobin dose group (2...
July 5, 2018: Clinical Drug Investigation
Sze-Wen Ting, Yi-Cheng Chen, Yu-Huei Huang
BACKGROUND AND OBJECTIVES: Ustekinumab is used to treat moderate-to-severe psoriasis by blocking the interleukin-12/23 pathway, which is also essential against intracellular pathogens. Because there is a high prevalence of hepatitis B viral infection in Taiwan, the expected risk of reactivation is higher among ustekinumab-treated patients. We performed this study to investigate the risk of hepatitis reactivation. SUBJECTS AND METHODS: Patients with psoriasis treated with ustekinumab from October 2011 to June 2016 were enrolled in a prospective cohort study...
July 2, 2018: Clinical Drug Investigation
Takashi Hamada, Noriyoshi Iriyama, Hiromichi Takahashi, Katsuhiro Miura, Yoshihito Uchino, Masaru Nakagawa, Yoshihiro Hatta, Masami Takei
BACKGROUND AND OBJECTIVE: Although it is well known that platelet depletion is one of the major adverse events related to tyrosine kinase inhibitor (TKI) therapy, the effect of TKIs on thrombopoietin (TPO), a stimulating factor for thrombopoiesis, has not been examined to date. In this study, we investigated the effect of TKIs on the levels of plasma TPO concentration in patients with well-controlled chronic myeloid leukemia receiving imatinib or dasatinib and those in treatment-free remission (TFR)...
June 25, 2018: Clinical Drug Investigation
Josep Darbà, Meritxell Ascanio
BACKGROUND: Iron deficiency is a frequent complication of chronic kidney disease (CKD) that is associated with a decrease in the quality of life of patients and an increase in the risk of other clinical complications. Iron therapy represents one of the fundamentals of patients with CKD. Sucrosomial® oral iron allows Fisiogen Ferro Forte® to be used in all patients who are intolerant to treatment by the oral route of administration, or who present with malabsorption of conventional oral iron preparations...
June 22, 2018: Clinical Drug Investigation
Rashid Kazerooni, Edward P Armstrong
INTRODUCTION: Published literature on overdoses related to botulinum toxin A (BtxA) agents is scarce. OBJECTIVE: The aim of this study was to assess the BtxA drug class' respective agents for associations with overdose. METHODS: United States Food and Drug Administration (FDA) adverse event reporting system (FAERS) database was utilized to search for overdoses. The analysis was conducted on data between second quarter 2014 and third quarter 2017...
June 20, 2018: Clinical Drug Investigation
Akiko Matsusaki, Masayuki Kaneko, Mamoru Narukawa
In the original publication, the Estimate column with values under Multivariate meta-regression (LOCF) in Table 1 was missed. The corrected table is shown below.
June 19, 2018: Clinical Drug Investigation
Richard L Rauck, D Alexander Oh, Neil Singla, Christian Koch, Neha Parikh, Srinivas Nalamachu, Jin Yu, Steven James
BACKGROUND AND OBJECTIVES: Fentanyl sublingual spray may be a viable alternative to intravenous (IV) opioids for the treatment of acute pain. As patients with acute pain may include those who have limited prior exposure to opioids, this phase 1, open-label, randomized, multiple ascending-dose study was conducted to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of multiple doses of fentanyl sublingual spray in opioid-naïve participants. This article primarily reports the pharmacokinetics results...
June 16, 2018: Clinical Drug Investigation
Luca Loprete, Chiara Leuratti, Valeria Frangione, Milko Radicioni
BACKGROUND: Sildenafil was the first selective drug available on the market as oral therapy for erectile dysfunction (ED). A novel sildenafil orodispersible film (ODF) for ED treatment, containing sildenafil citrate, has recently been marketed. OBJECTIVES: Study objective was to investigate sildenafil bioavailability of the novel ODF formulation after sublingual and supralingual administration. METHODS: In this randomised, two-way cross-over study, 12 healthy male volunteers received a single 50 mg sildenafil dose by the sublingual and supralingual administration routes...
June 16, 2018: Clinical Drug Investigation
Alison B Fleming, Stephen P Mayock, Said Saim
No abstract text is available yet for this article.
June 12, 2018: Clinical Drug Investigation
Nancy Crudele, Jennifer Giordano
No abstract text is available yet for this article.
June 12, 2018: Clinical Drug Investigation
William B Smith, Jesse Hall, Jolene K Berg, Michal Kazimir, Amy Yamamoto, Susan Walker, Caroline A Lee, Zancong Shen, David M Wilson, Dongmei Zhou, Michael Gillen, Thomas C Marbury
BACKGROUND AND OBJECTIVE: Verinurad (RDEA3170) is a high-affinity, selective URAT1 transporter inhibitor in development for treating gout and asymptomatic hyperuricemia. This Phase I, single-dose study investigated the pharmacokinetics, pharmacodynamics, and safety of verinurad in adults with renal impairment and controls with normal renal function. METHODS: Males aged 18-85 years were enrolled with serum urate (sUA) 4.5-10 mg/dl and creatinine clearance 60- < 90, 30- < 60, 15- < 30, or ≥ 90 ml/min (mild, moderate, severe renal impairment and controls, respectively; n = 7/8)...
June 11, 2018: Clinical Drug Investigation
Maju Mathews, Huiling Pei, Adam Savitz, Isaac Nuamah, David Hough, Larry Alphs, Srihari Gopal
BACKGROUND AND OBJECTIVE: Paliperidone palmitate 3-monthly (PP3M) injectable formulation offers an advantage of improved medication adherence and lower relapse risk in patients with schizophrenia. This post hoc analysis compared outcomes following PP3M versus paliperidone palmitate 1-monthly (PP1M) treatment in patients with schizophrenia treated/untreated with oral risperidone/paliperidone (RIS/PALI). METHODS: Patients were treated with PP1M (50, 75, 100, or 150 mg equivalent [eq...
June 7, 2018: Clinical Drug Investigation
Akiko Matsusaki, Masayuki Kaneko, Mamoru Narukawa
BACKGROUND AND OBJECTIVE: Schizophrenia treatment has been shifting to resocialization by efficacious antipsychotic drugs. However, even some of the pivotal studies of approved new antipsychotic drugs with proven efficacy had failed due to high placebo response. The aim of this study was to identify the potential factors affecting placebo response by meta-analysis for randomized clinical trials for antipsychotic drugs using Positive and Negative Syndrome Scale (PANSS) focusing on the current methodological change in the handling of missing data [from last observation carried forward (LOCF) to mixed-effect models for repeated measures (MMRM)] for successful future clinical trials...
June 1, 2018: Clinical Drug Investigation
Zahid Hussain, Colin Curtain, Corinne Mirkazemi, Syed Tabish Razi Zaidi
BACKGROUND: Despite the increasing numbers of obese patients undergoing elective surgery, there is a lack of evidence-based dosing guidelines for peri-operative medications in obesity. OBJECTIVE: The objective was to systematically review the dosing and outcomes of peri-operative medications used in obese elective surgical patients. METHODS: Medical subject headings and general keywords were used to systematically search multiple databases (PubMed, EMBASE, Cochrane Library and CINAHL)...
June 1, 2018: Clinical Drug Investigation
Viktoria Moschetti, Christina Schlecker, Sven Wind, Sophia Goetz, Holger Schmitt, Armin Schultz, Karl-Heinz Liesenfeld, Glen Wunderlich, Michael Desch
BACKGROUND AND OBJECTIVE: Schizophrenia and Alzheimer's disease are characterised by abnormalities in glutamatergic pathways related to N-methyl-D-aspartate receptor hypofunction. Glycine is an N-methyl-D-aspartate receptor co-agonist; inhibition of glycine transporter 1 may improve N-methyl-D-aspartate receptor function. This phase I, randomised, two-part study evaluated the safety, tolerability and pharmacokinetic profile of BI 425809, a novel glycine transporter 1 inhibitor, in healthy male and female volunteers...
May 30, 2018: Clinical Drug Investigation
Sung-Hyun Hong, Jae-Yeon Lee, Sun-Kyeong Park, Jin Hyun Nam, Hyun Jin Song, Sun-Young Park, Eui-Kyung Lee
BACKGROUND AND OBJECTIVE: Utility provides a preference for specific health state in economic evaluation, and they obtained from general population could be useful in respect of societal resource allocation. We aimed to investigate the utilities of health states for heart failure (HF), a major and growing public health problem, related to hospitalization and adverse drug effects by interrogating the general Korean population. METHODS: Five health states for patients with HF were developed based on literature reviews: stable chronic heart failure (SCHF), hospitalization, SCHF + cough, SCHF + hypotension, and SCHF + hyperkalemia...
May 26, 2018: Clinical Drug Investigation
Ekaterini C Tampaki, Athanasios Tampakis, Constantinos E Alifieris, Dimitrios Krikelis, Anastasia Pazaiti, Michalis Kontos, Dimitrios T Trafalis
BACKGROUND: In the era of personalized therapy, targeted treatment in specific patient populations is mandated. OBJECTIVE: We evaluated the efficacy and safety of neoadjuvant treatment on locally advanced breast cancer (LABC) with a monoclonal agent against vascular endothelial growth factor (VEGF), bevacizumab plus chemotherapy combination of liposomal doxorubicin, cyclophosphamide and paclitaxel (PLAC-B). METHODS: Patients enrolled were at premenopausal status and characterized by human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor positive (estrogen receptor/progesterone receptor-positive [ER/PR+]) or triple-negative (TNBC), LABC (T > 3 cm), with high-grade ductal carcinoma...
May 9, 2018: Clinical Drug Investigation
Domenico Plantone, Tatiana Koudriavtseva
The process of finding new therapeutic indications for currently used drugs, defined as 'repurposing', is receiving growing attention. Chloroquine and hydroxychloroquine, with an original indication to prevent or cure malaria, have been successfully used to treat several infectious (HIV, Q fever, Whipple's disease, fungal infections), rheumatological (systemic lupus erythematosus, antiphospholipid antibody syndrome, rheumatoid arthritis, Sjögren's syndrome), and other immunological diseases. Indeed, they have anti-inflammatory, immunomodulating, anti-infective, antithrombotic, and metabolic effects...
May 8, 2018: Clinical Drug Investigation
Nevio Cimolai
No abstract text is available yet for this article.
May 7, 2018: Clinical Drug Investigation
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