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Clinical Therapeutics

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https://www.readbyqxmd.com/read/30217591/beyond-estrogen-treatment-options-for-hot-flashes
#1
Kelly McGarry, Meghan Geary, Vidya Gopinath
Nonhormonal medications and complementary and alternative therapies are used by many women seeking relief from bothersome hot flashes. However, health care professionals may be less familiar with these treatment modalities. Although estrogen remains the most effective medication to reduce hot flashes, its potential harmful effects have led investigators to examine other treatments for hot flashes, and many women seek alternative forms of relief. Most of these trials are limited by a significant placebo effect, which frequently equals the effectiveness of the medication being evaluated...
September 12, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30217592/the-role-of-colchicine-in-treating-postoperative-and-post-catheter-ablation-atrial-fibrillation
#2
REVIEW
Spyridon G Deftereos, Dimitrios A Vrachatis, Christos Angelidis, Agathi-Rosa Vrettou, Eleni K Sarri, Sotiria G Giotaki, Efthymia Varytimiadi, Charalampos Kossyvakis, Eleana Kotsia, Gerasimos S Deftereos, Konstantinos Doudoumis, Georgios Giannopoulos
PURPOSE: The goal of this review was to summarize, analyze, and compare trials studying the efficacy of colchicine in the prevention of atrial fibrillation (AF) post-operatively (POAF) and post-catheter ablation. Ongoing studies and current guidelines are also presented and reviewed. METHODS: Published studies on the field were identified through a literature search of the PubMed and clinicaltrials.gov databases. FINDINGS: Four original studies regarding POAF, two original studies regarding post-catheter ablation AF, and six meta-analyses were identified...
September 11, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30196935/economic-burden-of-veno-occlusive-disease-in-patients-with-b-cell-acute-lymphoblastic-leukemia-in-the-united-states
#3
Xinke Zhang, Xue Song, Lorena Lopez-Gonzalez, Krutika Jariwala-Parikh, Vadim Romanov, Ze Cong
PURPOSE: The goal of this study was to evaluate the incidence, inpatient mortality, and economic burden of hepatic veno-occlusive disease (VOD) in adults with B-cell acute lymphoblastic leukemia (ALL) in the United States. METHODS: Using MarketScan Commercial Claims and Encounters Database and Medicare Supplemental and Coordination of Benefits Database, data for patients with B-cell ALL from April 1, 2009, to October 31, 2016, were extracted by using diagnosis codes...
September 6, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30193749/commentary-on-the-impact-of-obesity-on-pediatric-diabetes
#4
Sungeeta Agrawal, Robert Gensure
While conventionally most children diagnosed with diabetes are thought to have type 1 diabetes mellitus (T1DM), with the increased prevalence of obesity, more are being affected by type 2 (T2) DM. Obesity leads to increased insulin resistance, which over time can lead to progressive β-cell failure and ultimately T2DM. However, patients developing T1DM may also be obese, making both the proper classification and management of diabetes in children more challenging. In this commentary, the authors discuss the impact of obesity on the presentation of pediatric diabetes, how to differentiate between T1DM and T2DM, and the proper management of both diseases...
September 4, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30193748/health-care-resource-use-costs-and-diagnosis-patterns-in-patients-with-schizophrenia-and-bipolar-disorder-real-world-evidence-from-us-claims-databases
#5
Michael S Broder, Mallik Greene, Eunice Chang, Ann Hartry, Maëlys Touya, Jennifer Munday, Tingjian Yan
PURPOSE: Schizophrenia (SCZ) and bipolar disorder (BD) are typically viewed as nonconcurrent psychiatric disorders, yet patients may experience mood and SCZ symptoms simultaneously. Several studies have shown overlap between SCZ and BD symptoms and susceptibility genes. This study explored the following: (1) patterns of administrative claims; (2) demographic characteristics and comorbidities; (3) health care resource use; and (4) health care costs in patients with diagnoses of SCZ, type I BD (BD-I), and both in a real-world setting...
September 4, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30185395/pharmacokinetics-safety-and-tolerability-of-the-direct-acting-hepatitis-c-antiviral-sofosbuvir-in-healthy-chinese-subjects
#6
Xiaojiao Li, Hong Chen, Junqi Niu, Guiling Chen, Gong Shen, Benedetta Massetto, Diana M Brainard, Xiaoxue Zhu, Hong Zhang, Yanhua Ding
PURPOSE: The purpose of this study was to investigate the safety, tolerability, and pharmacokinetic profile of sofosbuvir and its metabolites after a single dose of sofosbuvir 400 mg and once daily dosing of sofosbuvir 400 mg for 7 days in healthy Chinese subjects. METHODS: This Phase I, open-label, single- and multiple-dose study enrolled 14 Chinese subjects aged 18 to 45 years with an approximately even distribution of healthy male (n = 9) and nonpregnant, nonlactating female subjects (n = 5)...
September 2, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30185394/the-safety-and-antiviral-activity-of-bzf961-with-or-without-ritonavir-in-patients-infected-with-hepatitis-c-virus-a-randomized-multicenter-trial
#7
Eric Lawitz, Mohamed Bidair, Thomas Marbury, Christopher T Jones, Avantika Barve, Baldur Magnusson, David T Barkan, Ursula Bodendorf, Kathryn Bracken, Erica Canino, Darlene Chen, Kristina Dabovic, Tycho Heimbach, Marjorie Ison, Catherine L Jones, Steven J Kovacs, Jay P Lakshman, Bin Li, Prakash Raman, Rachael Steiner-Swiat, Sanjeev Thohan, Kelly A Wong, Weidong Zhong, Richard A Colvin
PURPOSE: Infection with hepatitis C virus is the leading cause of infectious disease mortality in the United States. BZF961 is a novel small molecule inhibitor of the hepatitis C virus NS3-4A protease. Here we present the results of a randomized, double-blinded, placebo-controlled, multicentered study in treatment-naïve patients with chronic hepatitis C virus genotype-1 infection. METHODS: Patients were enrolled sequentially in 2 parts and treated for 3 days. BZF961 was administered as monotherapy (500 mg BID for 3 days) or in combination with the cytochrome P450 3A4 inhibitor ritonavir to boost its exposure (BZF961 10, 20, or 50 mg QD or BID)...
September 2, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30185393/troublesome-news-fake-news-biased-and-incomplete-news
#8
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
September 2, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30185392/the-role-of-colchicine-in-acute-coronary-syndromes
#9
REVIEW
Kaivan Vaidya, Gonzalo Martínez, Sanjay Patel
PURPOSE: Because inflammation is a key process implicated in the pathogenesis of atherosclerosis at all stages, including plaque formation, progression, instability, and rupture, and because colchicine has unique anti-inflammatory properties, this review article summarizes the pathophysiologic mechanisms underpinning inflammation in atherosclerosis and acute coronary syndrome (ACS), outlines anti-inflammatory therapeutic approaches that have been tested thus far, and evaluates the evidence supporting the potential role of colchicine in improving outcomes and reducing cardiovascular morbidity and mortality in patients after ACS...
September 2, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30180974/therapeutic-use-of-synthetic-cannabinoids-still-an-open-issue
#10
Maria Antonietta De Luca, Liana Fattore
Cannabis sativa has a long history of use for medical purposes despite marijuana's addictive potential. The discovery of the endogenous cannabinoid system as a neuromodulatory system composed of receptors, endogenous ligands (endocannabinoids), and enzymes responsible for their synthesis and degradation, together with recent advancements in the elucidation of cannabinoid pharmacology, has renewed interest in medicines acting on the endocannabinoid system. Synthetic cannabinoid agonists have been developed and used for treatment of different human pathologic conditions, and promising potent cannabinoid antagonists are currently under clinical evaluation...
September 1, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30173953/altered-pharmacokinetics-in-prolonged-infusions-of-sedatives-and-analgesics-among-adult-critically-ill-patients-a-systematic-review
#11
REVIEW
Andrew H W Tse, Lowell Ling, Anna Lee, Gavin M Joynt
PURPOSE: The pharmacokinetic (PK) parameters of many drugs are altered as a consequence of the pathophysiological changes associated with critical illness. The critically ill population presents challenges when titrating infusions of sedatives and analgesics to maintain optimal sedation and pain levels. This systematic review examined the PK data in critically ill adult patients with prolonged infusions (>24 hours) of commonly used sedatives and analgesics to highlight possible altered PK parameters compared with noncritically ill patients...
August 31, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30170758/effect-of-rifampin-on-the-pharmacokinetics-of-ertugliflozin-in-healthy-subjects
#12
Vikas K Dawra, Vaishali Sahasrabudhe, Yali Liang, Kyle Matschke, Haihong Shi, Anne Hickman, Didier Saur, Steven G Terra, David L Cutler
PURPOSE: Ertugliflozin is a selective sodium glucose cotransporter 2 inhibitor being developed for the treatment of type 2 diabetes mellitus. The primary enzyme involved in the metabolism of ertugliflozin is uridine diphosphate-glucuronosyltransferase (UGT) 1A9, with minor contributions from UGT2B7 and cytochrome P450 (CYP) isoenzymes 3A4, 3A5, and 2C8. Rifampin induces UGT1A9, UGT2B7, CYP3A4, and CYP3A5. Because concurrent induction of these enzymes could affect ertugliflozin exposure, this study assessed the effect of multiple doses of rifampin on the pharmacokinetic properties of single-dose ertugliflozin...
August 28, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30166053/hydralazine-associated-amenorrhea-in-a-premenopausal-patient-with-chronic-kidney-disease-a-case-report-and-review-of-literature
#13
Kwadwo A Yeboah, Amy Allspaw, Akram Al-Makki, Brian M Shepler
PURPOSE: Several antihypertensive medications have been associated with various forms of sexual dysfunction. We present a case report of a premenopausal patient with hydralazine-associated amenorrhea. METHODS: The Naranjo adverse drug reaction probability scale was used to assess causality. We also performed a literature search on PubMed to find publications that report hydralazine-associated amenorrhea. RESULTS: The Naranjo scale generated a score of 6, suggesting a probable relationship between amenorrhea and hydralazine therapy...
August 27, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30153946/corrigendum-to-a-phase-i-single-and-multiple-dose-study-to-evaluate-the-pharmacokinetics-of-elbasvir-and-grazoprevir-in-healthy-chinese-participants-clinical-therapeutics-40-2018-719-732
#14
Tommy Tsang Cheung, Joanne Wing Yan Chiu, Man Fung Yuen, Karen Siu Ling Lam, Bernard Man Yung Cheung, Hwa-Ping Feng, Wendy W Yeh, Jiangdian Wang, Wenting Li, Xu Min Zhao, Zaiqi Wang, Shengmei Mu
No abstract text is available yet for this article.
August 25, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30150077/effectiveness-outcomes-in-patients-with-recurrent-or-refractory-head-and-neck-cancers-retrospective-analysis-of-data-from-a-community-oncology-database
#15
Maxine D Fisher, Ancilla W Fernandes, Temitope O Olufade, Paul J Miller, Mark S Walker, Moon Fenton
PURPOSE: The purpose of this study was to provide an understanding of the effectiveness of existing therapies in patients with advanced head and neck cancer (HNC), particularly in clinical practice. METHODS: Data from the electronic medical records of adult patients diagnosed with locally advanced or metastatic (Stage III-IVc) HNC between January 1, 2007, and October 1, 2015, were retrospectively collected from a network of community oncology practices in the United States...
August 25, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30150078/cannabidiol-for-epilepsy-new-hope-on-the-horizon
#16
REVIEW
Paul E Sanmartin, Kamil Detyniecki
Epilepsy is a common neurologic disorder; it is estimated that ∼50 million people are affected worldwide. About one third of those patients are drug resistant, defined as failure to stop all seizures despite adequate trials of at least 2 appropriate medications. There has been an enormous interest in developing antiepileptic drugs with novel mechanisms of action. This review discusses the evidence supporting the anticonvulsant properties of cannabis in humans, focusing on cannabidiol. We begin by exploring the early and somewhat anecdotal evidence that was recently replaced by high-quality data from randomized controlled studies, which subsequently led to the US Food and Drug Administration approval of a purified cannabidiol extract for the treatment of 2 highly refractory pediatric epilepsy syndromes (Dravet and Lennox-Gastaut)...
August 24, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30146271/pharmacokinetics-and-pharmacodynamics-of-levornidazole-in-patients-with-intra-abdominal-anaerobic-infection
#17
Hailan Wu, Shengxin Xie, Jicheng Yu, Yuancheng Chen, Jufang Wu, Beining Guo, Zhenghai Zhu, Ying Zhou, Zhiqiang Wang, Jing Zhang
PURPOSE: The pharmacokinetic (PK) and pharmacodynamic characteristics of levornidazole were studied in patients with intra-abdominal anaerobic infection to provide the rationale of new clinical dosing regimen of levornidazole. METHODS: A single-center, open, multidose trial was conducted in 16 patients with intra-abdominal anaerobic infection. Patients received levornidazole at 500 mg q12h by intravenous infusion for 3 to 7 days. The plasma samples collected before and after the last dose were analyzed by the LC-MS/MS method to determine the concentration of levornidazole...
August 23, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30145029/health-care-resource-utilization-and-costs-associated-with-transitioning-to-3-month-paliperidone-palmitate-among-us-veterans
#18
Maral DerSarkissian, Patrick Lefebvre, Kruti Joshi, Brianne Brown, Marie-Hélène Lafeuille, Rachel H Bhak, Michael Hellstern, Priyanka Bobbili, Brian Shiner, Antoine C El Khoury, Yinong Young-Xu
PURPOSE: The aim of this article was to describe and compare treatment patterns, health care resource utilization (HRU), and health care costs before and after transition in veterans with schizophrenia who were transitioned from paliperidone palmitate given once monthly (PP1M) to paliperidone palmitate given every 3 months (PP3M) according to prescribing-information guidelines. METHODS: This retrospective, longitudinal study was conducted using electronic health records data from the Veterans Health Administration (VHA)...
August 22, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30126705/lipid-lowering-therapy-and-goal-achievement-in-high-risk-patients-from-french-general-practice
#19
Jean Ferrières, Katherine Gorcyca, Şerban R Iorga, David Ansell, Dylan L Steen
PURPOSE: The goal of this study was to summarize patterns of lipid-lowering therapy (LLT) usage and achievement of guideline-identified lipid goals in a 2015 general practice cohort of French patients with atherosclerotic cardiovascular disease (ASCVD) and/or diabetes mellitus (DM). METHODS: From the IMS Health Real-World Data database, patients aged ≥18years were classified hierarchically into mutually exclusive categories of ASCVD subgroups and DM. LLT use and lipid goal achievement were assessed on the date of lipid measurement...
August 18, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/30126707/pharmacovigilance-an-overview
#20
REVIEW
Paul Beninger
PURPOSE: Pharmacovigilance (PV) is a relatively new discipline in the pharmaceutical industry. Having undergone rapid growth over the past 2 decades, PV now touches many other disciplines in the research and development enterprise. With its growth has come a heightened awareness and interest in the medical community about the roles that PV plays. This article provides insights into the background and inner workings of PV. METHODS: This narrative review covers the core PV activities and other major areas of the pharmaceutical enterprise in which PV makes significant contributions...
August 17, 2018: Clinical Therapeutics
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