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Clinical Drug Investigation

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https://www.readbyqxmd.com/read/30219951/multicenter-open-label-study-of-long-term-topiroxostat-fyx-051-administration-in-japanese-hyperuricemic-patients-with-or-without-gout
#1
Tatsuo Hosoya, Tomohiko Ishikawa, Yoshimi Ogawa, Ryusuke Sakamoto, Tetsuo Ohashi
BACKGROUND AND OBJECTIVES: Topiroxostat-a novel selective xanthine oxidoreductase inhibitor-has been reported to reduce serum urate levels. The purpose of this study was to assess the efficacy and safety of long-term topiroxostat administration in Japanese hyperuricemic patients with or without gout. METHODS: This multicenter, open-label study evaluated the efficacy and safety of long-term twice-daily oral topiroxostat administration in patients with or  without gout...
September 15, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30219950/replacement-effects-and-budget-impacts-of-insurance-coverage-for-sodium-glucose-co-transporter-2-inhibitors-on-oral-antidiabetic-drug-utilization
#2
Hsiang-Yin Chen, Pei-Yin Chiu, Ching-Jun Chang, Lih-Ling Tsai, Ya-Lan Huang, Jason C Hsu
BACKGROUND AND OBJECTIVES: A new oral antidiabetic drug class, sodium-glucose co-transporter-2 inhibitors (SGLT-2 inhibitors), has been covered by national health insurance in Taiwan since May 2016. This study estimated the impacts of insurance coverage for SGLT-2 inhibitors on the replacement effects of antidiabetic drug use and the overall budget for antidiabetic drugs in Taiwan. METHODS: Antidiabetic drugs were divided into nine categories based on the American Diabetes Association guidelines...
September 15, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30209743/safety-profile-of-high-dose-botulinum-toxin-type-a-in-post-stroke-spasticity-treatment
#3
REVIEW
Alessio Baricich, Alessandro Picelli, Andrea Santamato, Stefano Carda, Alessandro de Sire, Nicola Smania, Carlo Cisari, Marco Invernizzi
Botulinum toxin type A (BoNT-A) is considered the gold standard for the treatment of focal post-stroke spasticity (PSS). However, a recently published study estimated that a significant percentage of patients affected by PSS could benefit from higher doses of BoNT-A than those permitted by current directives in the countries studied. Several studies have reported the use of high doses of BoNT-A in the management of patients affected by severe PSS; however, the most important adverse effect of this drug might be systemic diffusion of the toxin, which could potentially be related to its dose...
September 12, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30203387/correction-to-gadobutrol-a-review-in-contrast-enhanced-mri-and-mra
#4
Lesley J Scott
The article Gadobutrol: A Review in Contrast-Enhanced MRI and M.
September 10, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30203386/evaluation-of-drug-drug-interaction-potential-between-baloxavir-marboxil-and-oseltamivir-in-healthy-subjects
#5
Nao Kawaguchi, Hiroki Koshimichi, Toru Ishibashi, Toshihiro Wajima
BACKGROUND AND OBJECTIVE: Baloxavir marboxil is a prodrug that is metabolized to baloxavir acid, which suppresses viral replication by inhibiting cap-dependent endonuclease with a single oral administration. As the mode of action of baloxavir marboxil is different from that of neuraminidase inhibitors, such as oseltamivir, combination treatment with these drugs can be a treatment option, particularly for severe influenza infection. The aim of this study was to assess the drug-drug interaction between baloxavir marboxil and oseltamivir...
September 10, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30194585/pharmacokinetics-and-safety-after-a-single-dose-of-imarikiren-in-subjects-with-renal-or-hepatic-impairment
#6
Yukio Shimasaki, Masashi Sakaki, Minoru Itou, Tokurou Kobayashi, Masako Aso, Tomoya Kagawa, Takuya Saiki, Kumi Matsuno, Yuhei Sano, Kohei Shimizu, Shingo Kuroda, Emiko Koumura
BACKGROUND AND OBJECTIVE: Imarikiren hydrochloride (TAK-272; SCO-272) is a novel direct renin inhibitor. The objective of this study was to determine the effects of renal impairment (RI) or hepatic impairment (HI) on the pharmacokinetics and safety of imarikiren. METHODS: This phase I, open-label, parallel-group comparative study evaluated the pharmacokinetics and safety of a single 40 mg oral dose of imarikiren in RI [mild, moderate, severe, or end-stage renal disease (ESRD), and on hemodialysis] or HI (mild or moderate) subjects compared with subjects with normal renal or hepatic function...
September 7, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30194584/cost-effectiveness-of-elbasvir-grazoprevir-versus-daclatasvir-plus-asunaprevir-in-patients-with-chronic-hepatitis-c-virus-genotype-1b-infection-in-china
#7
Pingyu Chen, Aixia Ma, Qiang Liu
BACKGROUND AND OBJECTIVE: New direct-acting antivirals (DAAs) have high efficacy and tolerability in the treatment of hepatitis C virus (HCV) infection. The objective of this study was to assess the cost-effectiveness of elbasvir/grazoprevir (EBR/GZR) versus daclatasvir plus asunaprevir (DCV + ASV) in Chinese patients with chronic HCV genotype (GT) 1b infection stratified by cirrhosis status and treatment history. METHODS: A cohort state-transition model was constructed to simulate the course of chronic HCV infection in patients stratified by cirrhosis status and treatment history...
September 7, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30191509/safety-of-edoxaban-30-mg-in-elderly-patients-with-severe-renal-impairment
#8
Giovanni Fazio, Ilaria Dentamaro, Rosanna Gambacurta, Pasquale Alcamo, Paolo Colonna
BACKGROUND AND OBJECTIVE: Patients with atrial fibrillation (AF) and advanced chronic kidney disease (CKD) are at high risk of adverse events and are complicated to manage. There is little evidence on the effects of non-vitamin K oral anticoagulants in patients with severe CKD. Preliminary data in patients taking edoxaban whose creatinine clearance fell below 30 mL/min showed a low risk of stroke and major bleeding. The aim of our study is to test the safety of edoxaban 30 mg/day in patients with severe renal impairment with an estimated glomerular filtration rate (eGFR) of 15-29 mL/min...
September 6, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30191508/direct-and-indirect-costs-of-immunoglobulin-replacement-therapy-in-patients-with-common-variable-immunodeficiency-cvid-and-x-linked-agammaglobulinemia-xla-in-italy
#9
Raffaella Viti, Andrea Marcellusi, Alessandro Capone, Andrea Matucci, Alessandra Vultaggio, Claudio Pignata, Giuseppe Spadaro, Angelo Vacca, Carolina Marasco, Carlo Agostini, Francesco Saverio Mennini
BACKGROUND: In Italy, there is scarce evidence on the epidemiological and economic burden induced by primary antibody deficiencies. OBJECTIVE: The aim of this study was to elaborate the available epidemiological and cost data in order to estimate the annual expenditure induced by the management of patients affected by the common variable immunodeficiency (CVID) and X-linked agammaglobulinemia (XLA) requiring immunoglobulin (Ig) replacement therapy. METHODS: A probabilistic cost-of-illness model was developed to estimate the number of patients with CVID and XLA, and the economic burden associated with their therapy in terms of direct or indirect costs...
September 6, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30187361/unexpected-benefit-from-alpelisib-and-fulvestrant-in-a-woman-with-highly-pre-treated-er-positive-her2-negative-pik3ca-mutant-metastatic-breast-cancer
#10
Griet Hoste, Laurence Slembrouck, Lynn Jongen, Kevin Punie, Tom Matton, Sara Vander Borght, Isabelle Vanden Bempt, Johan Menten, Hans Wildiers, Giuseppe Floris, Carlos Arteaga, Patrick Neven
We present the case of a postmenopausal patient with a secondary metastatic ER-positive, HER2-negative breast cancer who was successfully treated with fulvestrant and alpelisib following six lines of therapy. The tumour showed two uncommon PIK3CA mutations, and with the combination of alpelisib and fulvestrant the patient went from ECOG grade 3, before the start of this therapy, to ECOG grade 1 during treatment until progressive disease after 6 months. This unexpected benefit emphasizes the importance of performing a Next Generation Sequencing (NGS)-based assay to screen for several cancer genes in the metastatic setting, even after more than four lines of therapy and a high ECOG grade...
September 5, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30178220/regression-and-genomic-analyses-on-the-association-between-dose-normalized-mycophenolic-acid-exposure-and-absolute-neutrophil-count-in-steroid-free-de-novo-kidney-transplant-recipients
#11
Tony K L Kiang, Nilufar Partovi, R Jean Shapiro, Jacob M Berman, Abby C Collier, Mary H H Ensom
BACKGROUND AND OBJECTIVES: The hematological side effects associated with mycophenolic acid (MPA) are relatively common and have severe consequences. The majority of literature data have not shown clear consistency in the MPA exposure-neutropenia relationship. We hypothesized that (i) adult de novo kidney transplant recipients who develop neutropenia have relatively higher dose-normalized MPA exposure than patients without neutropenia, and (ii) the observed neutropenia may be explained by polymorphisms in metabolism and/or transporter genes responsible for MPA disposition...
September 3, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30171457/open-label-single-dose-study-to-assess-the-effect-of-mild-and-moderate-hepatic-impairment-on-the-pharmacokinetics-of-mirogabalin
#12
Kenneth Duchin, Giorgio Senaldi, Vance Warren, Thomas Marbury, Kenneth Lasseter, Hamim Zahir
BACKGROUND AND OBJECTIVES: Mirogabalin is an α2 δ ligand being developed to treat neuropathic pain. A small fraction of mirogabalin is metabolized by the liver, where hepatic impairment may affect exposure. The objective of this phase I, open-label single-dose study was to determine if mild or moderate hepatic impairment alters the pharmacokinetics of mirogabalin. METHODS: Serial blood samples were collected for determination of maximum observed concentration, time to maximum concentration, and area under the concentration-time curve until the last quantifiable concentration of the active free form (A200-700) and inactive lactam metabolite (A204-4455) of mirogabalin...
August 31, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30168004/pharmacokinetics-pharmacodynamics-and-safety-of-the-novel-calcimimetic-agent-evocalcet-in-healthy-japanese-subjects-first-in-human-phase-i-study
#13
Tadao Akizawa, Ryutaro Shimazaki, Masanari Shiramoto, Masafumi Fukagawa
BACKGROUND AND OBJECTIVES: Evocalcet is a novel calcimimetic agent with potential to improve the treatment of secondary hyperparathyroidism in patients with chronic kidney disease. This study aimed to determine the pharmacokinetics, pharmacodynamics, and safety of evocalcet in healthy Japanese subjects. METHODS: This was a single-blind, placebo-controlled, single-dose study and an 8-day multiple-dose study of evocalcet (MT-4580/KHK7580) in 66 healthy Japanese subjects...
August 30, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30151614/successful-response-to-osimertinib-rechallenge-after-intervening-chemotherapy-in-an-egfr-t790m-positive-lung-cancer-patient
#14
Giulio Metro, Sara Baglivo, Annamaria Siggillino, Vienna Ludovini, Rita Chiari, Alberto Rebonato, Guido Bellezza
Osimertinib is the best treatment choice for patients with epidermal growth factor receptor (EGFR)-mutated advanced non-small-cell lung cancer (NSCLC) whose disease progresses on a first- or second-generation EGFR-tyrosine kinase inhibitor due to acquired T790M mutation. On the other hand, there is a lack of therapeutic strategies with proven efficacy at the time of progression on osimertinib. If not administered previously, platinum-based chemotherapy can provide some clinical benefit, while immunotherapy does not seem to work in this setting...
August 27, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30143953/cost-estimate-of-immune-related-adverse-reactions-associated-with-innovative-treatments-of-metastatic-melanoma
#15
Francesco S Mennini, Chiara Bini, Andrea Marcellusi, Michele Del Vecchio
BACKGROUND AND OBJECTIVE: Immuno-oncology therapies represent a new treatment opportunity for patients affected by metastatic melanoma. The purpose of this study was to estimate the costs of immune-related adverse events (irAEs) associated with the new anti-PD1 immuno-oncology therapies, with the anti-CTLA-4 immuno-oncology therapy and with the combined therapy (CTLA4 + anti-PD1) in patients affected by metastatic melanoma. MATERIALS AND METHODS: A probabilistic cost-of-illness (COI) model was developed to estimate the management costs of grade ≥ 3 adverse events associated with the new anti-PD1 therapies (pembrolizumab and nivolumab), the anti-CTLA-4 therapy (ipilimumab) and the combined therapy CTLA4 + anti-PD1 (nivolumab + ipilimumab) for the treatment of patients with metastatic melanoma from the National Health Service (NHS) perspective in Italy...
August 24, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30143952/indications-for-systemic-fluoroquinolone-therapy-in-europe-and-prevalence-of-primary-care-prescribing-in-france-germany-and-the-uk-descriptive-population-based-study
#16
Daniel R Morales, Jim Slattery, Luis Pinheiro, Xavier Kurz, Karin Hedenmalm
BACKGROUND AND OBJECTIVES: In the USA the benefit-risk profile of fluoroquinolones for treating patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections (uUTIs) is considered unfavorable. However, the number of fluoroquinolone products in the EU indicated and prescribed for these infections is uncertain. The objective of this study was to provide data on indications for fluoroquinolones in Europe and examine the prevalence of prescribing in France, Germany and the UK...
August 24, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30141093/correction-to-gadobutrol-a-review-in-contrast-enhanced-mri-and-mra
#17
Lesley J Scott
The cell entry in the "Gadobenate dimeglumine" column, which previously read.
August 23, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30128748/a-review-on-imiquimod-therapy-and-discussion-on-optimal-management-of-basal-cell-carcinomas
#18
REVIEW
Preetha Kamath, Evan Darwin, Harleen Arora, Keyvan Nouri
Basal cell carcinoma (BCC) is the most common type of skin cancer with an increasing incidence. However, it is still poorly researched compared to many other human diseases. Today, cutaneous neoplasms are a frequent, major problem faced by medical professionals. BCC tumors can cause extensive cosmetic distress as well as disfigurement to patients especially when on the face. Treatment options include surgery, systemic agents, and topical agents. Over the past few decades more studies have been performed to evaluate the utility of topical imiquimod therapy for treatment of BCC...
August 20, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30117129/non-compartmental-pharmacokinetics-and-safety-of-single-dose-eldecalcitol-ed-71-in-healthy-chinese-adult-males
#19
Qian Zhao, Hongzhong Liu, Ji Jiang, Yiwen Wu, Wen Zhong, Lili Li, Kazuhiro Miya, Masaichi Abe, Pei Hu
BACKGROUND AND OBJECTIVES: Eldecalcitol (ED-71) is a novel active vitamin D3 derivative, used for the treatment of osteoporosis. This is the first clinical study to investigate the pharmacokinetics and safety of eldecalcitol in Chinese subjects. METHODS: This was an open, single-center, randomized, two-dose level, two-period crossover phase I study in 24 healthy Chinese adult males. Eligible subjects received a single oral dose of eldecalcitol capsule 0.5 or 0.75 μg at period 1 or period 2, monitored over a 144-h observation period for pharmacokinetics and a 14-day observation period for safety...
August 16, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/30105549/potential-for-cost-saving-with-iclaprim-owing-to-avoidance-of-vancomycin-associated-acute-kidney-injury-in-hospitalized-patients-with-acute-bacterial-skin-and-skin-structure-infections
#20
Nimish Patel, David Huang, Thomas Lodise
BACKGROUND AND OBJECTIVE: Vancomycin is the most prescribed antibiotic for hospitalized adults with skin and skin structure infections. Vancomycin is associated with acute kidney injury. Iclaprim is an antibiotic under development for the treatment of patients with acute bacterial skin and skin structure infections and is not associated with acute kidney injury. This economic model sought to determine the potential cost saving with iclaprim owing to avoidance of vancomycin-associated acute kidney injury among hospitalized patients with acute bacterial skin and skin structure infections...
August 13, 2018: Clinical Drug Investigation
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