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Clinical Therapeutics

Angela W Dymond, Colin Howes, Christine Pattison, Karen So, Gabriella Mariani, Mark Savage, Stuart Mair, Gill Ford, Paul Martin
PURPOSE: Selumetinib (AZD6244, ARRY-142886), an oral mitogen activated kinase 1/2 inhibitor, is in clinical development for the treatment of a variety of different tumor types. Herein, we report a study that determined the distribution, metabolism, and excretion of selumetinib in healthy male volunteers. METHODS: In this open-label, single-center, Phase I clinical trial, 6 subjects received a single 75-mg dose of [(14)C]-selumetinib. Blood and excreta samples were collected for pharmacokinetic and radiometric analyses...
October 14, 2016: Clinical Therapeutics
Jay M Margolis, Steven Deitelzweig, Jeffrey Kline, Oth Tran, David M Smith, Concetta Crivera, Brahim Bookhart, Jeff Schein
PURPOSE: Using real-world data, this study compares inpatient length of stay (LOS) and costs for patients with a primary diagnosis of pulmonary embolism (PE) initiating treatment with oral anticoagulation with rivaroxaban versus warfarin. METHODS: Hospitalizations from MarketScan's Hospital Drug Database were selected from November 1, 2012, through December 31, 2013, for adults with a primary diagnosis of PE initiating treatment with rivaroxaban or warfarin. Warfarin patients were matched 1:1 to rivaroxaban patients using exact and propensity score matching...
October 14, 2016: Clinical Therapeutics
Nancy J Carballo, Cathy A Alessi, Jennifer L Martin, Michael N Mitchell, Ron D Hays, Nananda Col, Emily S Patterson, Stella Jouldjian, Karen Josephson, Constance H Fung
PURPOSE: Obstructive sleep apnea is a prevalent sleep disorder among older adults. Oral appliances are increasingly prescribed as therapy for obstructive sleep apnea. Adherence to oral appliance therapy is highly variable. Based on value-expectancy theory and other social-psychological theories, adherence to oral appliance therapy may be influenced by patients' perceived effectiveness of the therapy, self-efficacy, and availability of social support. We examined these perceptions among older adults with obstructive sleep apnea who were prescribed oral appliance therapy...
October 14, 2016: Clinical Therapeutics
Camille P Vaughan, Constance H Fung, Alison J Huang, Theodore M Johnson, Alayne D Markland
PURPOSE: Nocturia is associated with poor sleep quality; however, little is known about the relationship between nocturia and sleep quality across different workforce-relevant age groups of adults. This has implications for developing new treatment strategies that are well tolerated across populations. METHODS: We conducted a cross-sectional study involving merged data from the 2005-2006 and 2007-2008 waves of the National Health and Nutrition Examination Survey...
October 14, 2016: Clinical Therapeutics
Todd M Bishop, Kelsey V Simons, Deborah A King, Wilfred R Pigeon
Whether as a standalone disorder or as a symptom associated with existing pathology, the prevalence of sleep disturbance increases with age. Older adults also experience a myriad of risk factors for suicide, including depression, and have elevated rates of suicide. There is now significant evidence linking sleep disturbances to suicidal thoughts and behaviors. The use of pharmacologic means to treat insomnia (e.g., sedative hypnotics) is also commonplace among older cohorts and has been associated with suicide...
October 14, 2016: Clinical Therapeutics
Li Yang, Seng Chuen Tan, Can Chen, Xingzhi Wang, Xinya Li, Xiaoyan Yang
PURPOSE: To conduct a cost-effectiveness analysis study of sevelamer versus calcium-based binders (CBBs) in treating hyperphosphatemia among patients with end-stage renal disease (ESRD) in China. METHODS: A decision-analytic model of a lifetime horizon was used for base case analysis from the payers' perspective. The transition probabilities between different health states were derived from survival analysis. The overall survival of CBBs was derived from the Dialysis Clinical Outcomes Revisited study for up to 44 months and a Weibull regression model was used to extrapolate the overall survival to a lifetime horizon...
October 14, 2016: Clinical Therapeutics
Jennifer L Schroeck, James Ford, Erin L Conway, Kari E Kurtzhalts, Megan E Gee, Krista A Vollmer, Kari A Mergenhagen
PURPOSE: Insomnia is problematic for older adults. After behavioral modifications fail to show adequate response, pharmacologic options are used. The pharmacokinetics of agents used to treat insomnia may be altered. This review focuses on the safety and efficacy of medications used to treat insomnia. METHODS: A literature search of Medline, PubMed, and Embase was conducted (January 1966-June 2016). It included systematic reviews, randomized controlled trials, observational studies, and case series that had an emphasis on insomnia in an older population...
October 14, 2016: Clinical Therapeutics
Sang-Hyun Kim, Sang-Ho Jo, Sang-Cheol Lee, Sung-Yoon Lee, Myung-Ho Yoon, Hyang-Lim Lee, Nae-Hee Lee, Jong-Won Ha, Nam-Ho Lee, Dong-Woon Kim, Gyu-Rok Han, Min-Su Hyon, Deok-Gyu Cho, Chang-Gyu Park, Young-Dae Kim, Gyu-Hyung Ryu, Cheol-Ho Kim, Kee-Sik Kim, Myung-Ho Chung, Sung-Chul Chae, Ki-Bae Seung, Byung-Hee Oh
PURPOSE: A fixed-dose combination of a stain and an antihypertensive drug may be useful for the treatment of patients with hypertension and hyperlipidemia. It may also improve patient drug compliance to help control risk factors of cardiovascular disease. This study was designed to evaluate the blood pressure-lowering and cholesterol-lowering effect of a fixed-dose combination of irbesartan-atorvastatin compared with monotherapy by either agent over an 8-week treatment period. METHODS: Patients with comorbid hypertension and hypercholesterolemia were screened for this randomized, double-blind, Phase III study...
October 11, 2016: Clinical Therapeutics
Peter L Thompson
No abstract text is available yet for this article.
October 10, 2016: Clinical Therapeutics
Luc Dirix, Helen Swaisland, Henk M W Verheul, Sylvie Rottey, Karin Leunen, Guy Jerusalem, Christian Rolfo, Dorte Nielsen, L Rhoda Molife, Rebecca Kristeleit, Judith de Vos-Geelen, Morten Mau-Sørensen, Patricia Soetekouw, Carla van Herpen, Anitra Fielding, Karen So, Wendy Bannister, Ruth Plummer
PURPOSE: The metabolism of olaparib, a potent inhibitor of poly(ADP-ribose) polymerase (PARP) with demonstrated efficacy in patients with BRCA-mutated ovarian cancer, is mediated by cytochrome P450 (CYP) enzymes (predominantly CYP3A4/5). We assessed the potential of a CYP3A4 inhibitor (itraconazole) and inducer (rifampin) to alter the pharmacokinetic (PK) profile of olaparib following single oral tablet doses. METHODS: Two Phase I, open-label, non-randomized trials were conducted in patients with advanced solid tumors...
October 10, 2016: Clinical Therapeutics
Chang Gyu Park, Tae Hun Ahn, Eun Ju Cho, Won Kim, Hyung Seob Kim, Ju Yeong Yang, Jae Geun Ryu, Cheol Ho Kim, Min Soo Hyeon, Seung Je Tak, Se Jung Im, Jong Won Ha, Wook Beom Pyeon, Je Geon Jae, Gyu Rok Han, Jun Hyung Doh, Sang Wook Im, Myeong Muk Lee
PURPOSE: The objective of this study was to evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan (S-AM/TEL) compared with TEL monotherapy in patients with hypertension inadequately controlled by TEL monotherapy. METHODS: this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/TEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy...
October 6, 2016: Clinical Therapeutics
Richard I Shader
No abstract text is available yet for this article.
October 6, 2016: Clinical Therapeutics
Wan-Su Park, Jongtae Lee, Taegon Hong, Gabjin Park, Sunil Youn, Youngwhan Seo, Sanghun Lee, Seunghoon Han
PURPOSE: Fursultiamine and benfotiamine are lipophilic thiamine derivatives used as oral sources of thiamine. Although there are many publications on the pharmacokinetic (PK) properties of thiamine-containing products, no direct comparisons between these agents . We aimed to compare the PK profiles of these lipophilic thiamine derivatives and to compare the extent of the increase in bioavailability to that of naïve thiamine. METHODS: Two randomized, single-dose, 2-way crossover, full PK studies were conducted in healthy Korean male subjects (n = 24 per group)...
October 1, 2016: Clinical Therapeutics
J Stuart Elborn, Anne-Lise Vataire, Ayako Fukushima, Samuel Aballea, Amine Khemiri, Curtis Moore, Goran Medic, Michiel E H Hemels
PURPOSE: In Europe, 4 inhaled antibiotics (tobramycin, colistimethate sodium, aztreonam, and levofloxacin) are currently approved for the treatment of chronic Pseudomonas aeruginosa lung infection in patients with cystic fibrosis (CF). Levofloxacin inhalation solution (LIS) is the most recently approved inhaled antibiotic for adult patients with CF. A systematic literature review and Bayesian network meta-analysis (NMA) was conducted to compare the relative short-term (4 weeks) and long-term (24 weeks) outcomes of these inhaled antibiotics versus LIS...
September 28, 2016: Clinical Therapeutics
Tim Heise, Jens Jordan, Christoph Wanner, Martina Heer, Sreeraj Macha, Michaela Mattheus, Søren S Lund, Hans J Woerle, Uli C Broedl
PURPOSE: Our aim was to investigate the effects of the sodium glucose cotransporter 2 inhibitor empagliflozin on urinary and serum glucose and electrolytes, urinary volume, osmolality, and the renin-angiotensin system in patients with type 2 diabetes. METHODS: In an open-label study, 22 patients receiving metformin (median age 56 years; range 40-65 years) received empagliflozin 25 mg once daily for 5 days. Food, fluid, and sodium intake were standardized for 3 days before and during treatment...
September 28, 2016: Clinical Therapeutics
Ronald Christopher, Mike Morgan, Jim Ferry, Bhaskar Rege, Yong Tang, Allan Kristensen, William Shanahan
PURPOSE: Lorcaserin is a serotonin 2C receptor agonist indicated for chronic weight management as an adjunct to diet and exercise. The initial approved formulation is a 10-mg, immediate-release (IR) tablet for administration BID. These studies investigated the single- and multiple-dose pharmacokinetic properties of a new, recently US Food and Drug Administration-approved, extended-release, 20-mg once-daily formulation. METHODS: We performed 2 separate 2-period, 2-sequence crossover studies in 36 healthy adults: a study comparing the IR formulation to the extended-release formulation under fasting conditions and a study comparing the extended-release formulation under fed and fasted conditions...
September 27, 2016: Clinical Therapeutics
Tyler Albright, Akram Al-Makki, Rabih Kalakeche, Brian Shepler
PURPOSE: The objective of this short review is to evaluate the efficacy of ferric pyrophosphate citrate and to determine its place in therapy based on the current published literature. METHODS: A literature search was conducted and pared down to yield 4 placebo controlled Phase II and III clinically relevant trials. FINDINGS: Ferric pyrophosphate citrate is a new intradialytic iron supplementation product that has been found to reduce the dose of erythropoiesis-stimulating agents and intravenous iron supplementation and to increase serum ferritin concentrations...
September 27, 2016: Clinical Therapeutics
Aarti A Patel, Winnie W Nelson, Jeff Schein
PURPOSE: The purpose of this study is to report on the effect of using CHA2DS2VASc (congestive heart failure, hypertension, age ≥75 years [doubled], type 1 or type 2 diabetes mellitus, stroke or transient ischemic attack or thromboembolism [doubled], vascular disease [prior myocardial infarction, peripheral artery disease, or aortic plaque], age 65-75 years, sex category [female]) rather than CHADS2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke) to determine candidacy for anticoagulant prophylaxis in insured patients with atrial fibrillation (AF)...
September 23, 2016: Clinical Therapeutics
Dagmara Hering, Carl Schultz, Markus P Schlaich
PURPOSE: Resistant hypertension (RH) is a major and growing public health problem. While noncompliance to antihypertensive medication is a major concern in RH patients, it is estimated that even with adequate multi-drug regimens, approximately 10% of patients diagnosed with hypertension fulfill the criteria of true RH. Patients with sustained blood pressure (BP) elevation display high risk for development of target organ damage and associated cardiovascular morbidity and mortality. While optimized pharmacologic therapy, including the use of mineralocorticoid receptor antagonists to guideline-based antihypertensive drug therapy, is effective for improving BP control in this patient cohort, a sizable proportion of RH patients' BP remains uncontrolled, and alternative therapeutic strategies are warranted...
September 23, 2016: Clinical Therapeutics
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