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Clinical Therapeutics

Elliot V Hersh, Stacey Secreto, Steven Wang, Helen Giannakopoulos, Mohammad Mousavian, Bret Lesavoy, Matthew C Hutcheson, John T Farrar, Ping Wang, Geraldine Doyle, Stephen A Cooper
PURPOSE: CTY-5339A is an investigational topical anesthetic spray containing 14% benzocaine/2% tetracaine in a metered canister. Each spray delivers ∼0.2 mL of solution. This double-blind, randomized, crossover study compared the local anesthetic effect of CTY-5339A versus 14% benzocaine alone by using 2 quantitative sensory threshold experimental pain paradigms on the maxillary gingiva: pin prick test pain intensity (PPT PI) and heat pain threshold (HPT). METHODS: American Society of Anesthesiology Class 1 and 2 subjects (N = 50) were enrolled in this study...
January 16, 2019: Clinical Therapeutics
Tricia Santos Cavaiola, Yan Kiriakov, Timothy Reid
Type 2 diabetes (T2D) is a progressive disease caused by insulin resistance and associated progressive β-cell functional decline, as well as multiple other related metabolic and pathophysiologic changes. Left unchecked, T2D increases the risk of long-term microvascular and cardiovascular complications and is associated with excess morbidity and mortality. Despite multiple effective options for reducing hyperglycemia, patients are not optimally managed, largely due to delays in appropriate and timely advancement of therapy...
January 14, 2019: Clinical Therapeutics
Adam D Porath, Sharon Clodfelter, Terra Slaton, Brahim K Bookhart, Chris M Kozma, Michelle L Rand, Michael J Bloch
PURPOSE: Renown Health (Reno, Nevada), a large, locally owned, not-for-profit integrated health care network, has developed an institution-wide policy to shift the treatment of deep vein thrombosis (DVT) from a short-acting anticoagulant and vitamin K antagonist to the direct oral anticoagulant rivaroxaban combined with pharmacy-directed follow-up at an outpatient anticoagulation clinic. We examined data on hospitalizations and costs pre-/post-policy change. METHODS: Data were obtained from the electronic health records of adults with newly diagnosed DVT treated at Renown Health...
January 11, 2019: Clinical Therapeutics
Yan-Mei Liu, Peggy Wu, Risa Fukushi, Shunsuke Yamada, Qian Chen
PURPOSE: This open-label, single-dose study evaluated the pharmacokinetic profiles of enzalutamide and its major metabolites and the safety of enzalutamide in healthy, Chinese male volunteers. METHODS: Fourteen volunteers (median age, 28.5 years) received a single oral dose of enzalutamide (160 mg) under fasting conditions on day 1 and were followed for 50 days. Pharmacokinetic profiles were obtained for enzalutamide and its major metabolites, carboxylic acid metabolite (M1; inactive metabolite) and N-desmethyl enzalutamide (M2; active metabolite), on day 1 up to 1176 hours (49 days)...
January 11, 2019: Clinical Therapeutics
Hongfu Cai, Longfeng Zhang, Na Li, Shen Chen, Bin Zheng, Jing Yang, Lizhu Weng, Mao-Bai Liu
PURPOSE: This study aimed to evaluate the cost-effectiveness of osimertinib with gefitinib or erlotinib as first-line and sequential therapy for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) in China. METHODS: The Markov model was used, and the study included 3 health states over a 10-year period. Transition probabilities and safety data were collected from the FLAURA (AZD9291 versus gefitinib or erlotinib in patients with locally advanced or metastatic Non-small Cell Lung Cancer) trial...
January 10, 2019: Clinical Therapeutics
Michael S Broder, Mallik Greene, Tingjian Yan, Eunice Chang, Ann Hartry, Irina Yermilov
PURPOSE: The purpose of this study was to compare medication adherence, health care utilization, and cost among patients receiving adjunctive treatment for major depressive disorder (MDD) with brexpiprazole, quetiapine, or lurasidone. METHODS: Using Truven Health MarketScan® Commercial, Medicaid, and Medicare Supplemental Databases, we identified adults with MDD initiating adjunctive treatment with brexpiprazole, quetiapine, or lurasidone (index atypical antipsychotic [AAP])...
January 4, 2019: Clinical Therapeutics
Ben Hoskin, Benjamin Ortiz, Brandee Paknis, Abhishek Kavati
PURPOSE: Chronic idiopathic urticaria (CIU) is a debilitating skin condition that can profoundly affect patients' quality of life. This study explored the impact of refractory and nonrefractory CIU on patients in the real-world setting in the United States. METHODS: Data were collected from the Adelphi Real World 2015 Urticaria Disease-Specific Programme. Physicians completed patient record forms (PRFs) for 4 consecutive patients consulting with nonrefractory CIU and 6 patients with refractory CIU...
December 31, 2018: Clinical Therapeutics
Richard I Shader
No abstract text is available yet for this article.
December 29, 2018: Clinical Therapeutics
Sophie J Clarke, Stephen Pettit, Joel P Giblett, Tian Zhao, Anna C Kydd, Nicolai J W Albrechtsen, Carolyn F Deacon, Jayan Parameshwar, Stephen P Hoole
PURPOSE: Cardiovascular-safety studies assessing glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase 4 inhibitors have provided inconsistent data on the risk for developing heart failure. Animal studies have shown that GLP-1 is a vasodilator; if confirmed in humans, this may ameliorate heart failure symptoms. METHODS: In a single-center, observational pilot study, we recruited 10 patients with advanced heart failure undergoing right heart catheterization, and we recorded pulmonary hemodynamic measures, including cardiac output calculated by thermodilution and the indirect Fick method before and after a 15-minute continuous infusion of native GLP-1 (7-36) NH2 ...
December 28, 2018: Clinical Therapeutics
Katie Zomorodi, Martin Kankam, Yuan Lu
PURPOSE: Solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects, is currently being evaluated for the reduction of sleepiness and improvement of wakefulness in patients with narcolepsy and obstructive sleep apnea. The purpose of this study was to evaluate the effect of food on the pharmacokinetic (PK) parameters and bioavailability of solriamfetol at the highest intended therapeutic dose in healthy adults and to characterize its renal excretion under fasting conditions...
December 28, 2018: Clinical Therapeutics
Richard I Shader
No abstract text is available yet for this article.
December 28, 2018: Clinical Therapeutics
Peter L Thompson
No abstract text is available yet for this article.
December 26, 2018: Clinical Therapeutics
Carola A Huber, Matthias R Meyer, Jan Steffel, Eva Blozik, Oliver Reich, Thomas Rosemann
PURPOSE: Secondary medication prevention after acute myocardial infarction (MI) is strongly recommended in international guidelines, but actual use, adherence, and outcomes in current clinical practice are largely unknown. Therefore, the aims of this study were to determine the current adherence to medications for secondary prevention after MI and to estimate the association between medication adherence and mortality and major adverse cardiovascular events (MACE) in a large real-world population...
December 24, 2018: Clinical Therapeutics
Stefan Mark Nidorf, Peter Lindsay Thompson
PURPOSE: Colchicine is a widely available, inexpensive drug with a range of antiinflammatory properties that may make it suitable for the secondary prevention of atherosclerosis. This review examines how past and contemporary approaches to antiinflammatory therapy for atherosclerosis have led to a better understanding of the nature of the disease and sets out the reasons why colchicine has the potential to become a cornerstone therapy in its management. METHODS: We performed a literature search using PubMed, the Cochrane library, and clinical trial registries to identify completed and ongoing clinical studies on colchicine in coronary artery disease, and a PubMed search to identify publications on the mechanism of action of colchicine relevant to atherosclerosis...
December 24, 2018: Clinical Therapeutics
Remon Helmy, Samira Scalso de Almeida, Kris Denhaerynck, Lut Berben, Fabienne Dobbels, Cynthia L Russell, Bartira de Aguiar Roza, Sabina De Geest
PURPOSE: To assess and compare the prevalence of medication nonadherence (MNA) (implementation and persistence) to immunosuppressants and co-medications in heart transplant recipients. METHODS: MNA prevalence was assessed using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (self-report) and compared using logistic regression in a 4-continent sample of 1397 heart transplant recipients from 36 heart transplant centers in 11 countries. FINDINGS: MNA was significantly (α = 0...
December 24, 2018: Clinical Therapeutics
Sumeet Panjabi, Karim Iskander
No abstract text is available yet for this article.
December 23, 2018: Clinical Therapeutics
Eric M Maiese, Claire Ainsworth, Jean-Gabriel Le Moine, Outi Ahdesmӓki, Judith Bell, Emma Hawe
No abstract text is available yet for this article.
December 15, 2018: Clinical Therapeutics
Xue-Rong Sun, Shu-Nan He, Zi-Yi Lin, Lei Zhang, Yan-Jiang Wang, Li-Jun Zeng, Liang Shi, Jian-Wei Xuan, Ying Tian, Xin-Chun Yang, Xing-Peng Liu
PURPOSE: The aim of this study was to evaluate the cost-effectiveness of radiofrequency catheter ablation (RFCA) compared with cryoballoon (CB) ablation in the treatment of patients with paroxysmal atrial fibrillation (PAF) from the payer's perspective in China. METHODS: We constructed a cohort model, combining a 12-month decision-tree model with a lifetime Markov state-transition model, in a hypothetical cohort of patients with drug-refractory PAF managed with either RFCA or CB ablation, to compare the cost-effectiveness of the 2 procedures...
December 14, 2018: Clinical Therapeutics
Yong-Soon Cho, Hyeong-Seok Lim, Sungpil Han, Seok Kyu Yoon, Hyungsub Kim, Young Lag Cho, Hee-Sook Nam, Kyun-Seop Bae
PURPOSE: LCB01-0371 is a novel broad-spectrum oxazolidinone antibacterial agent under investigation for the treatment of infection by gram-positive pathogens, including methicillin-resistant Staphylococcus aureus. This study evaluated the safety, tolerability, and pharmacokinetics of LCB01-0371 after a single intravenous (IV) infusion and determined its absolute oral bioavailability at a therapeutic dose of 800 mg. METHODS: This study was conducted in 2 parts. The first part was a single-blind, placebo-controlled, escalating single IV dose study (200, 400, 800, and 1200 mg) of LCB01-0371 via 2 different infusion regimens (250 mL over 60 min or 150 mL over 30 min) in 36 healthy male volunteers...
December 14, 2018: Clinical Therapeutics
Wei Chen, Huiyun Huang, Chuanxin Yang, Xiaoqing Hu, Fang Bao, Hui Jiang
PURPOSE: A prospective, randomized, single-blind, controlled clinical study was designed to evaluate the efficacy and tolerability of preoperative pregabalin on cardiovascular response to laryngoscopy and endotracheal intubation. METHODS: Patients aged 18-60 years with an American Society of Anesthesiologists scale score of I or II were recruited and randomly allocated to receive placebo (control), low-dose (150-mg) pregabalin, or high-dose (300-mg) pregabalin. The medications were orally administered 1 hour before general anesthesia...
December 12, 2018: Clinical Therapeutics
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