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Clinical Therapeutics

Juliana Meyers, Anushua Sinha, Salome Samant, Sean Candrilli
PURPOSE: Congenital cytomegalovirus (cCMV) infection is the most common congenital infection in the United States; however, limited data exist regarding the economic burden of cCMV disease (cCMVd) among newborns and infants. The purpose of this study was to compare health care resource utilization and costs between infants with cCMVd at birth and during the first year of life versus matched infants without diagnosed cCMVd. METHODS: Retrospective analyses of health insurance claims data from the MarketScan Commercial Claims and Encounters and Multi-State Medicaid databases (January 1, 2011-December 31, 2016) were conducted...
May 15, 2019: Clinical Therapeutics
Sun-Kyeong Park, Sung-Hyun Hong, HyoJin Kim, Sungju Kim, Eui-Kyung Lee
PURPOSE: Sacubitril/valsartan, the first-in-class angiotensin receptor neprilysin inhibitor (ARNI), is a possible treatment option for chronic heart failure patients with reduced ejection fraction (HFrEF). The aim of this study was to estimate the cost-effectiveness of sacubitril/valsartan use in South Korea for treating patients with HFrEF compared with that of enalapril, an angiotensin-converting enzyme inhibitor, and with angiotensin receptor blockers (ARBs). METHODS: A Markov model was designed to estimate the lifetime cost-effectiveness of treatment for patients with HFrEF...
May 14, 2019: Clinical Therapeutics
Hillary H Ward, Emily A Kiernan, Christine L Deschler, Sofia M Murillo, Elizabeth A Karoly, Jennifer E Macfarlan, Matthew M McCambridge, David M Richardson, Richard S Mackenzie, Marna Rayl Greenberg, Jeanne L Jacoby
PURPOSE: The purpose of this study was to investigate potential differences by sex in the demographic and clinical characteristics of patients treated utilizing a sepsis electronic bundle order set. Risk factors for in-hospital mortality were also assessed. METHODS: Data on patients in whom the sepsis order set was initiated in the emergency department over a 16-month period were entered into the hospital database. Data were analyzed for differences by sex in demographic and clinical factors, treatment modalities, and in-hospital mortality...
May 10, 2019: Clinical Therapeutics
K H M Larmené-Beld, J Touwen- Spronk, J Luttjeboer, K Taxis, M J Postma
PURPOSE: Preparation errors occur frequently during conventional preparation of parenteral medication in the clinical environment, causing patient harm and costs for the national health care system. The use of ready-to-administer prefilled sterilized syringes (PFSSs) produced by the hospital pharmacy can reduce preparation errors and the risk of bacteremia from contamination of the intravenous medication. The aim of this research is to compare the total costs of the conventional preparation method (CPM) with the PFSS method...
May 9, 2019: Clinical Therapeutics
Yang Liu, Tingting Qiu, Yan Liu, Jijun Wang, Kai Hu, Fang Bao, Chao Zhang
PURPOSE: The objective of this study was to characterize the population pharmacokinetics of voriconazole and to identify factors that significantly affect pharmacokinetic parameters and to further investigate optimal dosage regimens in Chinese adult patients with hematologic malignancies. METHODS: A prospective population pharmacokinetic analysis was performed on 186 concentration measurements obtained from 41 adult patients with hematologic malignancies. All enrolled patients were treated with voriconazole for diagnosed or suspected invasive fungal diseases...
May 9, 2019: Clinical Therapeutics
Martha R Neagu, Michael A Weinreich, Thao T Doan, Barbara A Hendrickson
This commentary discusses issues particular to drug safety monitoring in prevention trials. Although the general approach to safety assessment applies across all clinical trials, prevention trials pose special challenges given that the patient population is currently asymptomatic or experiencing only mild symptoms of the targeted disease. This sways the risk-benefit analysis balance toward minimal acceptable risk. Definition of the predisease state with validated biomarkers or other assessment tools is essential...
May 8, 2019: Clinical Therapeutics
Robert Wilson, Alison Templeton, Claudia Leemereise, Rhena Eames, Edward Banham-Hall, Edith M Hessel, Anthony Cahn
PURPOSE: Nemiralisib, a phosphoinositide 3-kinase δ inhibitor, is being investigated as an immunomodulatory agent with anti-inflammatory properties in chronic obstructive pulmonary disease. This study evaluated the pharmacokinetic (PK) properties and safety of a new formulation of nemiralisib that contains 0.4% magnesium stearate. METHODS: In this randomized, double-blind, parallel-group study, healthy individuals received a single dose of 500 or 750 μg of nemiralisib administered via the Ellipta dry powder inhaler (DPI) (n = 6 in each treatment group)...
May 7, 2019: Clinical Therapeutics
Nicholas G Kounis, Huali L Ren, Maria Kavalioti, Ioanna Koniari, Theoharis C Theoharides
PURPOSE: To review evidence of hypersensitivity reactions to allergens and/or pathogens transmitted via intimate contact. METHODS: We reviewed PubMed for publications in English between 1980 and 2018 using the terms allergy, drugs, foods, hypersensitivity, intercourse, kissing, Kounis syndrome, mast cells, and semen. FINDINGS: In human RELATIONSHIPS, intimate contact can occasionally have disastrous or even fatal consequences because antigens and pathogens can be transmitted via the oral and vaginal mucosa...
May 7, 2019: Clinical Therapeutics
Malek Okour, Adeep Puri, Geng Chen, Kathleen Port, Alessandro Berni, Sanjeev Khindri, Ian Schneider, David Tenero
PURPOSE: Pulmonary arterial hypertension (PAH) is a life-threatening disease that typically causes shortness of breath and exercise intolerance. Combination therapy with ambrisentan and tadalafil has proven to be more effective at preventing clinical failure events in patients with PAH than either drug alone. The aim of this study was to evaluate the bioequivalence of an ambrisentan/tadalafil fixed-dose combination (FDC) compared with co-administration of the 2 monotherapies. METHODS: This 3-part, randomized, single-dose, open-label crossover study was conducted in healthy volunteers...
May 3, 2019: Clinical Therapeutics
Rosángel Cruz, Lisa Belter, Mike Wasnock, Al Nazarelli, Jill Jarecki
PURPOSE: Patients' perceptions of benefit-risk are essential to informing the regulatory process and the context in which potential therapies are evaluated. To bring this critical information to regulators, Cure SMA launched a first-ever Benefit-Risk Survey for spinal muscular atrophy (SMA) to characterize decision-making and benefit-risk trade-offs in SMA associated with a potential therapy. We hypothesized that risk tolerance would be correlated with SMA type/severity and disease progression...
May 3, 2019: Clinical Therapeutics
Chunxiao Lv, Changxiao Liu, Jia Liu, Ziqiang Li, Xi Du, Yanfen Li, Jinxia Sun, Lanjun Sun, Ruihong Fan, Yuhong Huang
PURPOSE: The combination of warfarin and compound Danshen dripping pill (CDDP) is helpful for patients with both coronary heart disease (CHD) and atrial fibrillation (AF). The main adverse drug reaction of warfarin is bleeding because of its narrow therapeutic index. The safety of a combination therapy with warfarin and CDDP is always a concern. Our previous research showed that the combination of warfarin and CDDP improved the quality of life for patients with both CHD and AF. This study describes the changes in dose and concentration of warfarin necessary and evaluates bleeding risk when warfarin is given concomitantly with CDDP...
April 30, 2019: Clinical Therapeutics
Maria Pia Giannoccaro, Judith Cossins, Kari Sørland, Øystein Fluge, Angela Vincent
PURPOSE: A role for the immune system in causing myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) is long suspected, but few studies have looked for specific autoantibodies that might contribute to the symptoms. Our aim was to look for evidence of antibodies to neuronal proteins in patients with ME/CSF. METHODS: Sera samples from 50 patients and 50 healthy individuals were sent coded to the Neuroimmunology Laboratory in Oxford. Screening for antibody binding to neuronal tissue was performed on brain tissue and neuronal cultures...
April 30, 2019: Clinical Therapeutics
Angela F Jarman, Bryn E Mumma, Sarah M Perman, Pavitra Kotini-Shah, Alyson J McGregor
Sex- and gender-based differences are emerging as clinically significant in the epidemiology and resuscitation of patients with out-of-hospital cardiac arrest (OHCA). Female patients tend to be older, experience arrest in private locations, and have fewer initial shockable rhythms (ventricular fibrillation/ventricular tachycardia). Despite standardized algorithms for the management of OHCA, women are less likely to receive evidence-based interventions, including advanced cardiac life support medications, percutaneous coronary intervention, and targeted temperature management...
April 30, 2019: Clinical Therapeutics
Sarah M Perman, Bonnie J Siry, Adit A Ginde, Anne V Grossestreuer, Benjamin S Abella, Stacie L Daugherty, Edward P Havranek
PURPOSE: Women who experience out-of-hospital cardiac arrest have similar rates of survival to hospital admission as men; however, women are less likely to survive to hospital discharge. We hypothesized that women would have higher rates of "do not attempt resuscitation" (DNAR) orders and that this order would be associated with lower use of aggressive interventions. METHODS: We identified adult hospital admissions with a diagnosis of cardiac arrest (ICD-9 427...
April 30, 2019: Clinical Therapeutics
Marshall V Williams PhD, Brandon Cox, William P Lafuse PhD, Maria Eugenia Ariza
PURPOSE: Neuroinflammation is a common feature in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), affecting 85%-90% of all patients, yet the underlying mechanism or mechanisms responsible for the initiation and/or promotion of this process is largely unknown. Multiple reports, however, have suggested a role for Epstein-Barr virus (EBV), in particular, in ME/CFS, but its potential role, if any, in the neuroinflammatory process has not been addressed. In support of this premise, studies by our group have found that the EBV protein deoxyuridine triphosphate nucleotidohydrolase (dUTPase) induces anxiety and sickness behaviors in female mice...
April 27, 2019: Clinical Therapeutics
Munenobu Kashiwa, Ryo Matsushita
PURPOSE: Clinical trials have shown that the addition of aprepitant (APR) or a phosphorylated prodrug of aprepitant, fosaprepitant (FosAPR) as prophylactic antiemetic therapy consisting of a 5-hydrotryptamine-3 receptor antagonist and dexamethasone is effective in patients receiving highly emetogenic chemotherapy. These combination therapies have been commonly used in Japan. In the present study, we performed a cost-utility analysis of APR and FosAPR in the context of the Japanese medical insurance system, and economic efficiency was compared...
April 26, 2019: Clinical Therapeutics
Richard I Shader
No abstract text is available yet for this article.
April 25, 2019: Clinical Therapeutics
Nanyang Zhang, Wenbing Xu, Shijie Wang, Yan Qiao, Xiaoxiao Zhang
PURPOSE: Chemotherapy-induced alopecia (CIA) is a common and often stressful adverse effect associated with chemotherapy. CIA can cause more psychosocial pressure in patients, including effects on sexuality, self-esteem, and social relationships. We analyzed publicly available data to identify drugs formulated for topical use targeting the relevant CIA molecular pathways by using computational tools. METHODS: The genes associated with CIA were determined by text mining, and the gene ontology of the gene set was studied using the Functional Enrichment analysis tool...
April 25, 2019: Clinical Therapeutics
David B Huang, Stephanie Noviello, Barbara Balser, Amy Scaramucci, G Ralph Corey
PURPOSE: This analysis evaluates the efficacy and safety of iclaprim versus vancomycin for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) in patients who were intravenous drug users (IVDUs). METHODS: A total of 621 patients who were IVDUs from 2 parallel Phase III, double-blind, randomized (1:1), active-controlled, multinational, multicenter trials (REVIVE-1 and REVIVE-2) were analyzed separately and pooled. This post hoc analysis summarizes the efficacy and safety profile of iclaprim 80 mg fixed dose compared with vancomycin 15 mg/kg administered intravenously during 2 h every 12 h for 5-14 days among this population...
April 25, 2019: Clinical Therapeutics
Cinzia Dello Russo, Dimitri Gagliardi, Ronnie Ramlogan, Pierluigi Navarra
Pembrolizumab (MK-3475) is a potent and highly selective humanized monoclonal antibody of the immunoglobulin G4κ class directed against the immune checkpoint programmed cell death protein-1 (PD-1). Binding to PD-1 prevents its interaction with natural ligands and allows for the reactivation of the immune response against cancer cells. The list of approved indications of pembrolizumab is fast expanding, including its use as first-line treatment of metastatic non-small cell lung cancer (NSCLC), which is a complex and evolving disease...
April 25, 2019: Clinical Therapeutics
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