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Clinical Therapeutics

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https://www.readbyqxmd.com/read/28923291/use-of-prohibited-medication-a-potentially-overlooked-confounder-in-clinical-trials-omarigliptin-once-weekly-dpp-4-inhibitor-monotherapy-trial-in-18-to-45-year-olds
#1
Ira Gantz, Liubov Sokolova, Lokesh Jain, Carol Iredale, Edward A O'Neill, Ziwen Wei, Raymond Lam, Shailaja Suryawanshi, Keith D Kaufman, Samuel S Engel, Eseng Lai
PURPOSE: The objective of this clinical trial was to assess the efficacy and safety of omarigliptin monotherapy in young adult patients with type 2 diabetes mellitus (T2DM). Unexpected efficacy results in this trial led to a series of investigations that identified the use of prohibited medication by a substantial number of trial patients. METHODS: Patients with T2DM who were ≥18 to <45 years of age and either drug-naive or not on an antihyperglycemic agent for ≥12 weeks with inadequate glycemic control were randomized in a double-blind manner to receive omarigliptin 25 mg once weekly (n = 102) or placebo once weekly (n = 101) for 24 weeks...
September 15, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28923290/use-of-adult-sensory-panel-to-study-individual-differences-in-the-palatability-of-a-pediatric-hiv-treatment-drug
#2
Julie A Mennella, Phoebe S Mathew, Elizabeth D Lowenthal
PURPOSE: The recommended first-line treatment for young children infected with HIV includes the liquid formulation of the co-formulated protease inhibitors lopinavir/ritonavir (Kaletra(®) [Abbott Laboratories, Chicago, Illinois]). Clinical reports indicate that some children readily accept the taste of Kaletra, whereas others strongly reject it, which can deter therapeutic adherence and outcomes. METHODS: As a proof-of-concept approach, a sensory panel of genotyped adults was used to document the range of individual differences in the taste and palatability (hedonics) of the liquid formulation of Kaletra and other taste stimuli, including common excipients...
September 15, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28919292/treatment-patterns-health-care-resource-utilization-and-spending-in-medicaid-beneficiaries-initiating-second-generation-long-acting-injectable-agents-versus-oral-atypical-antipsychotics
#3
Dominic Pilon, Neeta Tandon, Marie-Hélène Lafeuille, Rhiannon Kamstra, Bruno Emond, Patrick Lefebvre, Kruti Joshi
PURPOSE: Second-generation long-acting injectable therapies (SGA-LAIs) may reduce health care resource utilization (HRU) and health care costs compared with daily oral atypical antipsychotics (OAAs) in patients with schizophrenia due to reduced dosing frequency, delivery/monitoring by a health care provider, and improved adherence. The aim of the present study was to compare treatment patterns, HRU, and Medicaid spending in patients with schizophrenia initiated on SGA-LAIs (overall and according to agent) versus OAAs...
September 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28867430/thoughts-about-journals-altruism-impact-factors-marijuana-and-the-physician-labeling-rule
#4
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
August 31, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28865800/the-role-of-continuing-medical-education-in-increasing-enrollment-in-prescription-drug-monitoring-programs
#5
John T Finnell, Robert K Twillman, Stephanie A Breslan, Jan Schultz, Lyerka Miller
PURPOSE: Opioid diversion, misuse, and abuse are rapidly growing problems in the United States; >60% of all drug overdose deaths involve an opioid. At least 49 states now have fully operational prescription drug monitoring programs (PDMPs) to support legitimate medical use of controlled substances; however, there is considerable underutilization of such programs. METHODS: To increase awareness of PDMPs and their use, a continuing medical education program including 2 webcasts and a series of newsletters was offered to health care providers...
August 30, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28865799/pharmacokinetics-safety-and-tolerability-of-tedizolid-phosphate-after-single-dose-administration-in-healthy-korean-male-subjects
#6
Yun Kim, Anhye Kim, SeungHwan Lee, Sung-Hak Choi, Dae Young Lee, Ji-Su Song, Howard Lee, In-Jin Jang, Kyung-Sang Yu
PURPOSE: Tedizolid phosphate is a next-generation oxazolidinone prodrug that is transformed into the active moiety tedizolid. Its indication is acute bacterial skin and skin structure infections caused by gram-positive species, including methicillin-resistant Staphylococcus aureus. Although tedizolid phosphate has been marketed in Korea, no data on the pharmacokinetic (PK) properties or tolerability of tedizolid phosphate in Korean subjects are available. This study was designed to evaluate the PK properties, oral bioavailability, and tolerability with a single-dose oral and intravenous administration of tedizolid phosphate in healthy Korean male subjects...
August 30, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28863879/vitamin-c-in-clinical-therapeutics
#7
LETTER
Harri Hemilä
No abstract text is available yet for this article.
August 29, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28859928/response-to-the-letter-to-the-editor
#8
LETTER
Richard I Shader
No abstract text is available yet for this article.
August 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28843366/corrigendum-to-knemometry-assessment-of-short-term-growth-in-children-with-asthma-receiving-fluticasone-furoate-for-2-weeks-a-randomized-placebo-controlled-cross-over-trial-clin-ther-2017-39-1191-1199
#9
Ole D Wolthers, Sally Stone, Philippe Bareille, Susan Tomkins, Sanjeev Khindri
No abstract text is available yet for this article.
August 23, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28844318/tolerability-of-the-sq-tree-slit-tablet-in-adults
#10
Anne O Birk, Jens S Andersen, Hanne H Villesen, Maria A Steffensen, Moises A Calderon
PURPOSE: The tree pollen sublingual immunotherapy (SLIT)-tablet (ALK, Denmark) is being developed for the treatment of tree pollen induced allergic rhinitis with or without conjunctivitis. The objective of this Phase I trial was to investigate the tolerability and acceptable dose range of the SQ tree SLIT-tablet in adults with allergic rhinoconjunctivitis. METHODS: The trial was a randomized, double-blind, placebo-controlled, dose escalation Phase I trial that included 70 adults (aged 19-61 years) with birch pollen-induced rhinoconjunctivitis with or without mild to moderate asthma...
August 22, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28827024/gastrointestinal-adverse-events-of-dipeptidyl-peptidase-4-inhibitors-in-type-2-diabetes-a-systematic-review-and-network-meta-analysis
#11
Shanshan Wu, Sanbao Chai, Jun Yang, Ting Cai, Yang Xu, Zhirong Yang, Yuan Zhang, Linong Ji, Feng Sun, Siyan Zhan
PURPOSE: The purpose of this study was to systematically evaluate the effect of dipeptidyl peptidase 4 inhibitors on gastrointestinal adverse events in patients with type 2 diabetes. METHODS: MEDLINE, Embase, the Cochrane Library, and ClinicalTrials.gov were searched from inception through April 28, 2016. Randomized controlled trials that compared dipeptidyl peptidase 4 inhibitor-based therapies with placebo and other hypoglycemic agents in type 2 diabetes were included...
August 18, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28827023/can-saliva-and-plasma-methadone-concentrations-be-used-for-enantioselective-pharmacokinetic-and-pharmacodynamic-studies-in-patients-with-advanced-cancer
#12
Rani George, Alison Haywood, Phillip Good, Stefanie Hennig, Sohil Khan, Ross Norris, Janet Hardy
PURPOSE: Methadone is a potent analgesic used to treat refractory cancer pain. It is administered as a racemic mixture, with the l-enantiomer being primarily a μ-receptor agonist, whereas the d-enantiomer is an N-methyl-d-aspartate antagonist and inhibits serotonin and norepinephrine reuptake. Dose requirements vary greatly among patients to achieve optimal pain control and to avoid the risk of adverse effects. The relationship between plasma and saliva methadone enantiomer concentrations was investigated to determine if saliva could be a substitute for plasma in pharmacodynamic and pharmacokinetic studies for clinical monitoring and dose optimization of methadone in patients with advanced cancer...
August 18, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28823518/rivaroxaban-in-the-treatment-of-picc-associated-upper-extremity-venous-thrombosis
#13
Fenling Fan, Yuliang Zou, Songlin Zhang, Yushun Zhang, Beidi Lan, Qiang Song, Meili Pei, Lu He, Huili Wu, Yajuan Du, Anthony M Dart
PURPOSE: Peripherally inserted central catheters (PICCs) are frequently used for prolonged drug administration, but their use is commonly complicated by the development of upper extremity deep venous thrombosis (UEDVT) requiring anticoagulation. Here, we compared the efficacy and safety profile of rivaroxaban (20 mg/d) with low molecular weight (LMW) heparin and vitamin K antagonists in the treatment of PICC-associated UEDVT. METHODS: Patients (N = 84) with PICC-associated UEDVT were studied...
August 17, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28823517/data-sharing-in-the-pharmaceutical-enterprise-the-genie-s-out-of-the-bottle
#14
Paul Beninger, James Connelly, Chandrasekhar Natarajan
OBJECTIVE: This Commentary shows that the present emphasis on the sharing of data from clinical trials can be extended to the entire pharmaceutical enterprise. METHODS: The authors constructed a Data Sharing Dashboard that shows the relationship between all of the life-cycle domains of the pharmaceutical enterprise from discovery to obsolescence and the domain-bridging disciplines, such as target credentialing, structure-activity relationships, and exposure-effect relationships...
August 17, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28818298/enhancing-the-pediatric-drug-development-framework-to-deliver-better-pediatric-therapies-tomorrow
#15
Christina Bucci-Rechtweg
Health care professionals involved in the clinical management of children have long appreciated the limited number of therapies suitably evaluated for their optimal use in the pediatric population. In the past century, advances in regulatory policy significantly evolved adult drug evaluation. The scarcity of available patient populations, practical complexities of drug development research, and minimal financial returns have hampered pharmaceutical investment in the study of therapies for children. More recently, pediatric policy and legislation in the United States and Europe have instituted a system of obligations and incentives to stimulate investment in pediatric drug development...
August 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28807393/treatment-trends-effectiveness-and-safety-of-statins-on-lipid-goal-attainment-in-chinese-percutaneous-coronary-intervention-patients-a-multicenter-retrospective-cohort-study
#16
Yundai Chen, Dandan Li, Jing Jing, Hongbing Yan, Jinghua Liu, Zhujun Shen, Stefan James, Christoph Varenhorst
PURPOSE: Limited data exist on the use of statins in Chinese patients with coronary artery disease (CAD) treated with percutaneous coronary intervention (PCI). We therefore conducted this study to observe the usage trend and the effectiveness of statins on LDL-C goal attainment and other lipid parameters among PCI-treated patients. METHODS: This multicenter, retrospective, observational, longitudinal cohort study was conducted in PCI-treated patients with CAD between July 1, 2011, and February 28, 2015...
August 11, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28803702/patient-and-physician-reported-satisfaction-with-systemic-lupus-erythematosus-treatment-in-us-clinical-practice
#17
Katie Pascoe, Steve Lobosco, David Bell, Ben Hoskin, David J Chang, Bonnie Pobiner, Sulabha Ramachandran
PURPOSE: This two-part study comprised two descriptive, cross-sectional surveys to evaluate treatment satisfaction among patients with systemic lupus erythematosus (SLE) and their physicians from US clinical practices. The Lupus Plus Project (LPP; part one) involved belimumab-containing regimens; the Disease Specific Program (DSP; part two) included all treatments and was designed to build on the body of evidence from part one. METHODS: The LPP recruited patients receiving belimumab, and comprised 2 paper questionnaires: a patient self-completion questionnaire (PSC) and a patient record form (PRF) completed by the physician...
August 10, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28803122/comparison-of-pharmacokinetics-and-safety-of-a-fixed-dose-combination-of-rosuvastatin-and-ezetimibe-versus-separate-tablets-in-healthy-subjects
#18
Kyoung Lok Min, Min Soo Park, Jina Jung, Min Jung Chang, Choon Ok Kim
PURPOSE: Rosuvastatin and ezetimibe are concomitantly used for dyslipidemia treatment. Compared with separate tablets, fixed-dose combination (FDC) tablets of rosuvastatin/ezetimibe could increase patient compliance. The aim of this study was to compare the pharmacokinetic (PK) profiles of an FDC tablet of rosuvastatin/ezetimibe and co-administration of rosuvastatin and ezetimibe as separate tablets in healthy Korean volunteers. METHODS: This trial was a randomized, open-label, single-dose, 2-way crossover study...
August 9, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28797777/comparison-of-the-efficacy-of-tenofovir-versus-tenofovir-plus-entecavir-in-the-treatment-of-chronic-hepatitis-b-in-patients-with-poor-efficacy-of-entecavir-a-systematic-review-and-meta-analysis
#19
REVIEW
Jun Chen, Shu-Shan Zhao, Xiao-Xiao Liu, Ze-Bing Huang, Yan Huang
PURPOSE: This study aimed to compare the efficacy between tenofovir disoproxil fumarate (TDF) and TDF plus entecavir (ETV) combination therapy in patients with chronic hepatitis B (CHB) with a poor response to ETV. METHODS: We searched the China National Knowledge Infrastructure (CNKI), PubMed, EMBASE, and SCOPE libraries for articles using the keywords chronic hepatitis B virus or CHB or HBV, entecavir or ETV, and tenofovir or TDF. FINDINGS: Five studies (from CNKI and PubMed) with a total of 408 patients met the inclusion criteria: 212 patients in the TDF group and 196 patients in the TDF plus ETV group...
August 7, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28781218/risk-factors-for-nocturnal-hypoglycemia-in-insulin-treated-patients-with-type-2-diabetes-a-secondary-analysis-of-observational-data-derived-from-an-integrated-clinical-trial-database
#20
Jay P Bae, Ran Duan, Haoda Fu, Byron J Hoogwerf
PURPOSE: A trade-off exists in most diabetes therapies between the benefits of good glycemic control and the morbidity of hypoglycemia. Balancing these factors to achieve desired outcomes is a key consideration for personalized diabetes therapy. Hypoglycemia at night (nocturnal hypoglycemia [NH]) is a common but often under-reported problem in insulin-treated patients with type 2 diabetes. To better understand the risk for NH, we pooled data from multiple clinical trials of insulin treatment and specifically examined NH risk factors in relation to glycemic goals...
August 3, 2017: Clinical Therapeutics
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