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Clinical Therapeutics

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https://www.readbyqxmd.com/read/28438353/the-role-of-vitamin-d-in-the-immune-system-as-a-pro-survival-molecule
#1
REVIEW
Salvatore Chirumbolo, Geir Bjørklund, Andrea Sboarina, Antonio Vella
PURPOSE: Vitamin D is a fascinating and attractive molecule that has gained particular attention in medicine in recent years. Its immunomodulatory and anti-inflammatory potential might resemble the activity of many nature-derived molecules (eg, flavonoids), but its role in biology was selected during a long evolutionary pathway to dampen the damaging effect of cell stress response and of the immune reaction. In this sense, this molecule can be considered an ancient hormone that serves, in its primary role, as a pro-survival agent...
April 21, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28433400/an-in-home-advanced-robotic-system-to-manage-elderly-home-care-patients-medications-a-pilot-safety-and-usability-study
#2
Pekka Rantanen, Timo Parkkari, Saija Leikola, Marja Airaksinen, Alan Lyles
PURPOSE: We examined the safety profile and usability of an integrated advanced robotic device and telecare system to promote medication adherence for elderly home-care patients. METHODS: There were two phases. Phase I aimed to verify under controlled conditions in a single nursing home (n = 17 patients) that no robotic malfunctions would hinder the device's safe use. Phase II involved home-care patients from 3 sites (n = 27) who were on long-term medication. On-time dispensing and missed doses were recorded by the robotic system...
April 19, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28431767/the-new-drug-conditional-approval-process-in-china-challenges-and-opportunities
#3
REVIEW
Xuefang Yao, Jinxi Ding, Yingfang Liu, Penghui Li
PURPOSE: Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration. METHODS: We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google...
April 18, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28431766/analysis-of-2-week-data-from-two-randomized-controlled-trials-conducted-in-subjects-with-frequent-heartburn-treated-with-esomeprazole-20-mg
#4
Philip O Katz, Anne Le Moigne, Charles Pollack
PURPOSE: These secondary analyses used data from 2 similarly designed studies in subjects experiencing frequent heartburn to evaluate the efficacy of esomeprazole 20 mg once daily for 2 weeks, which reflects the approved over-the-counter dosage and duration. METHODS: Subjects without endoscopically identified erosive esophagitis who were experiencing heartburn for ≥6 months and ≥4 of 7 days prior to baseline (study 1, N = 368; study 2, N = 349) were randomly assigned to receive double-blind treatment with esomeprazole 40 or 20 mg (administered as esomeprazole magnesium trihydrate 44...
April 18, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28431765/immune-modulation-by-vitamin-d-special-emphasis-on-its-role-in-prevention-and-treatment-of-cancer
#5
REVIEW
Franco Pandolfi, Laura Franza, Claudia Mandolini, Pio Conti
PURPOSE: Vitamin D has been known to be involved in mineral and bone homeostasis for many years. In the past its main use was in treating osteoporosis and rickets. In recent years it was found that vitamin D is an immune-modulating agent and may also have a role in several diseases, including autoimmune diseases. The immune-modulating effects appear to be mediated by vitamin D interaction with the vitamin D receptor (VDR) that has transcriptional effects and is expressed on various cell types, especially those of the immune system...
April 18, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28420486/vitamins-c-and-d
#6
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
April 15, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28416374/comparing-originator-biologics-and-biosimilars-a-review-of-the-relevant-issues
#7
REVIEW
Corrado Blandizzi, Pier Luigi Meroni, Giovanni Lapadula
PURPOSE: We provide a review of current knowledge on comparability between biosimilars and originator biologics in view of the continuous evolution occurring in this highly dynamic area. METHODS: English-language literature indexed in MEDLINE was explored, without time limits, to July 31, 2016, using the terms biosimilar, biotechnologic drug, biologic drug, monoclonal antibody, fusion protein, and anti-tumor necrosis factor. The reference lists of identified articles were examined carefully for additional pertinent publications...
April 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28413148/incorporating-site-less-clinical-trials-into-drug-development-a-framework-for-action
#8
Irl B Hirsch, Joe Martinez, E Ray Dorsey, Gerald Finken, Alexander Fleming, Chris Gropp, Philip Home, Daniel I Kaufer, Spyros Papapetropoulos
PURPOSE: Options for leveraging available telemedicine technologies, ranging from simple webcams and telephones to smartphone apps and medical-grade wearable sensors, are evolving faster than the culture of clinical research. Until recently, most clinical trials relied on paper-based processes and technology. This cost- and labor-intensive system, while slowly changing, remains an obstacle to new drug development. Alternatives that use existing tools and processes for collecting real-world data in home settings warrant closer examination...
April 13, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28392076/postmarketing-surveillance-studies-an-industry-perspective-on-changing-global-requirements-and-implications
#9
REVIEW
Arshadul Haque, Sajjan Daniel, Tricia Maxwell, Mariette Boerstoel
PURPOSE: This article describes postmarketing surveillance (PMS) study regulations and expectations of the regulatory agencies in 5 countries. With a focus on postapproval drug safety, there is a continuous need for understanding the benefit-risk profile of an approved drug. In addition to spontaneous adverse-event reporting, regulatory agencies seem to be more reliant on PMS studies. The opportunity to systematically monitor use in special populations, such as elderly patients and those with comorbid conditions, also presents itself during postmarketing use...
April 6, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28366596/risk-communication-in-a-pharmacovigilance-environment
#10
EDITORIAL
Paul Beninger
No abstract text is available yet for this article.
March 30, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28366595/risk-evaluation-and-mitigation-strategies-rems-pemoline-and-what-is-a-signal
#11
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
March 30, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28366594/opportunities-for-collaboration-at-the-interface-of-pharmacovigilance-and-manufacturing
#12
Paul Beninger
A case can be made that much common ground exists between pharmacovigilance and pharmaceutical manufacturing. Of the 8 major US statutes that shaped the pharmaceutical industry since early in the 20th Century, 7 followed fatally catastrophic events related to the use of a manufactured product, and 1 followed the discovery of a counterfeit product. To facilitate an understanding of the interplay between pharmacovigilance and manufacturing, it is convenient to divide manufacturing into 3 categories: (1) upstream sourcing of materials: pharmacovigilance plays an important role when adverse event clusters are seen during routine vigilance detection processes and the suspicion turns to possibly contaminated source material, (2) the manufacturing process itself: pharmacovigilance may be called on to conduct a health hazard evaluation if a manufacturing deviation is detected after product release (the assessment can inform the depth of a recall), and (3) downstream distribution and product use: there is only light regulation of the interval between product distribution after manufacturing release and just before administration to patients, a time during which product may be subject to an out-of-specification determination for environmental controls or subject to malfeasant activities, such as counterfeit substitution or product diversion...
March 30, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28366593/cost-effectiveness-of-evolocumab-in-patients-with-high-cardiovascular-risk-in-spain
#13
Guillermo Villa, Mickael Lothgren, Lucie Kutikova, Peter Lindgren, Shravanthi R Gandra, Gregg C Fonarow, Francesc Sorio, Lluis Masana, Antoni Bayes-Genis, Ben van Hout
PURPOSE: Our objective was to assess the cost-effectiveness of evolocumab in patients at high risk of cardiovascular (CV) events from the Spanish National Health System perspective. METHODS: A Markov model was used to assess the cost-effectiveness (incremental [∆] cost per ∆ quality-adjusted life-year [QALY]; or cost utility) of evolocumab plus standard of care (SoC; statins) versus SoC, assuming lifetime treatment. Cohorts with baseline LDL-C >100 mg/dL and familial hypercholesterolemia (FH) or CV event history (secondary prevention [SP]) were considered...
March 30, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28366592/patients-preferences-for-the-treatment-of-metastatic-castrate-resistant-prostate-cancer-a-discrete-choice-experiment
#14
Lina Eliasson, Hayley M de Freitas, Lindsay Dearden, Brian Calimlim, Andrew J Lloyd
PURPOSE: Patient treatment preferences are increasingly being used to inform health care decision making. This discrete choice experiment assessed how men perceive the risks and benefits of hypothetical treatment options for metastatic castrate-resistant prostate cancer (mCRPC). METHODS: Treatment attributes for inclusion were identified through a review of the literature and product labels. Expert interviews confirmed clinical appropriateness and patient relevance of the attributes, which included effectiveness (delay in months before chemotherapy), steroid use, possible drug interactions (additional hospital visits for monitoring), fogginess (effects on cognition and memory), fatigue (extreme tiredness), food restrictions, and bone pain...
March 30, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28365035/efficacy-of-varenicline-for-cigarette-reduction-before-quitting-in-japanese-smokers-a-subpopulation-analysis-of-the-reduce-to-quit-trial
#15
Masakazu Nakamura, Masaaki Abe, Masayuki Ohkura, Joan Treadow, Ching-Ray Yu, Peter W Park
PURPOSE: This prospective analysis of the Japanese subpopulation of the varenicline reduce to quit study was conducted to evaluate whether results for Japanese participants were consistent with the full study population. METHODS: Patients received varenicline or placebo for a 24-week treatment period (12-week smoking reduction phase then a 12-week smoking abstinence phase) followed by a 28-week nontreatment, follow-up phase. Participants were to reduce the daily number of cigarettes smoked by at least 50% by week 4 and by a further 50% by week 8, with the goal of achieving complete abstinence by week 12...
March 29, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28365034/capsaicin-8-patch-versus-oral-neuropathic-pain-medications-for-the-treatment-of-painful-diabetic-peripheral-neuropathy-a-systematic-literature-review-and-network-meta-analysis
#16
Floortje van Nooten, Maarten Treur, Krystallia Pantiri, Malcolm Stoker, Mata Charokopou
PURPOSE: A network meta-analysis (NMA) was performed, aiming to assess the relative efficacy and tolerability of the capsaicin 179-mg (8% weight for weight) cutaneous patch (capsaicin 8% patch) compared with oral, centrally acting agents (ie, pregabalin, gabapentin, duloxetine, amitriptyline) in patients with painful diabetic peripheral neuropathy (PDPN). METHODS: A systematic search of EMBASE/MEDLINE, Cochrane Library, and the National Health Service Centre for Reviews and Dissemination Database of Abstracts of Reviews of Effects was conducted to identify all randomized controlled trials...
March 29, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28365033/pharmacokinetics-and-tolerability-of-lorcaserin-in-special-populations-elderly-patients-and-patients-with-renal-or-hepatic-impairment
#17
Ronald J Christopher, Michael E Morgan, Yong Tang, Christen Anderson, Matilde Sanchez, William Shanahan
PURPOSE: To determine whether dosage adjustment is likely to be necessary for effective and well-tolerated use of a pharmaceutical agent, guidance documents from the US Food and Drug Administration recommend pharmacokinetics studies in patients with impaired renal or impaired hepatic function and in the elderly population. Three studies were conducted to evaluate the pharmacokinetic properties and tolerability of lorcaserin in these populations. METHODS: Lorcaserin was evaluated in single-dose pharmacokinetics studies of 3 overweight/obese populations: (1) elderly (aged >65 years) patients; (2) patients with impaired renal function; and (3) those with impaired hepatic function...
March 29, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28363696/clinical-outcomes-associated-with-switching-or-discontinuation-from-anti-tnf-inhibitors-for-nonmedical-reasons
#18
Douglas Wolf, Martha Skup, Hongbo Yang, Anna P Fang, Andrew Kageleiry, Jingdong Chao, Manish Mittal, Mark Lebwohl
PURPOSE: This study evaluated clinical outcomes and health care resource utilization associated with nonmedical switching from or discontinuation of anti-tumor necrosis factor (TNF) therapies in US clinical practice. METHODS: Responding physicians extracted data from the medical charts of patients with Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, or psoriatic arthritis who achieved response on an anti-TNF therapy...
March 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28363695/in-vitro-anaerobic-pharmacokinetic-pharmacodynamic-model-to-simulate-the-bactericidal-activity-of-levornidazole-against-bacteroides-fragilis
#19
Jiali Hu, Jing Zhang, Yuancheng Chen, Wang Liang, Shi Wu
PURPOSE: This study was designed to correlate the pharmacokinetic/pharmacodynamic (PK/PD) parameters with PD indices of levornidazole against Bacteroides fragilis and to calculate the PK/PD target value for levornidazole to attain its expected maximal bactericidal effect using an in vitro anaerobic dynamic PK/PD model. METHODS: An anaerobic dynamic PK/PD model was developed in vitro. The scheme for PK modeling was designed according to the PK parameters of levornidazole in the human body...
March 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28363694/cost-effectiveness-of-eob-mri-for-hepatocellular-carcinoma-in-japan
#20
Akihiro Nishie, Satoshi Goshima, Hiroki Haradome, Etsuro Hatano, Yasuharu Imai, Masatoshi Kudo, Masanori Matsuda, Utaroh Motosugi, Satoshi Saitoh, Kengo Yoshimitsu, Bruce Crawford, Eliza Kruger, Graeme Ball, Hiroshi Honda
PURPOSE: The objective of the study was to evaluate the cost-effectiveness of gadoxetic acid-enhanced magnetic resonance imaging (EOB-MRI) in the diagnosis and treatment of hepatocellular carcinoma (HCC) in Japan compared with extracellular contrast media-enhanced MRI (ECCM-MRI) and contrast media-enhanced computed tomography (CE-CT) scanning. METHODS: A 6-stage Markov model was developed to estimate lifetime direct costs and clinical outcomes associated with EOB-MRI...
March 28, 2017: Clinical Therapeutics
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