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Clinical Therapeutics

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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
#1
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
#2
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
#3
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
#4
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
#5
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
https://www.readbyqxmd.com/read/28781217/impact-of-pharmacist-immunization-authority-on-seasonal-influenza-immunization-rates-across-states
#6
Edward M Drozd, Laura Miller, Michael Johnsrud
PURPOSE: The goal of this study was to investigate the impact on immunization rates of policy changes that allowed pharmacists to administer influenza immunizations across the United States. METHODS: Influenza immunization rates across states were compared before and after policy changes permitting pharmacists to administer influenza immunizations. The study used Behavioral Risk Factor Surveillance System (BRFSS) survey data on influenza immunization rates between 2003 and 2013...
August 3, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28774498/vaccine-hesitancy-where-we-are-and-where-we-are-going
#7
REVIEW
Catherine C McClure, Jessica R Cataldi, Sean T O'Leary
PURPOSE: Vaccines represent one of the most important aspects of pediatric preventive care. However, parents are increasingly questioning the safety of and need for vaccines, and as a result, vaccination rates have fallen to dangerously low levels in certain communities. The effects of vaccine hesitancy are widespread. Community pediatricians who interact regularly with vaccine-hesitant parents report higher levels of burnout and lower levels of job satisfaction. Not surprisingly, vaccine hesitancy has also had direct influence on vaccination rates, which in turn are linked to increased emergency department use, morbidity, and mortality...
July 31, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28760535/a-randomized-phase-i-study-to-assess-the-effect-of-alcohol-on-the-pharmacokinetics-of-an-extended-release-orally-disintegrating-tablet-formulation-of-amphetamine-in-healthy-adults
#8
Jeffrey H Newcorn, Jeffrey G Stark, Sherilyn Adcock, Russ McMahen, Carolyn Sikes
PURPOSE: There is a strong association between attention-deficit/hyperactivity disorder (ADHD) and alcohol abuse, yet no studies have systematically assessed the effect of alcohol on the pharmacokinetics of psychostimulants such as amphetamine (AMP) in vivo. This study evaluated the effects of alcohol on the rate and extent of absorption of Adzenys™ XR-ODT*, a new extended-release orally disintegrating AMP tablet (AMP XR-ODT) for ADHD. METHODS: A Phase I single-dose, open-label study was conducted in 32 healthy adults...
July 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28756883/caspofungin-treatment-for-pulmonary-invasive-fungal-disease-in-hematology-patients-a-retrospective-study-in-a-clinical-practice-setting-in-china
#9
Xiaohui Zhang, Jiong Hu, Yu Hu, He Huang, Jie Jin, Juan Li, Qifa Liu, Zonghong Shao, Jianxiang Wang, Quanshun Wang, Depei Wu, Xiaojun Huang
PURPOSE: Invasive fungal disease (IFD) is a serious complication in patients with hematologic malignancies. Caspofungin is the first approved inhibitor of fungal β-1,3-glucan synthesis. The aim of the present study was to evaluate the effectiveness of caspofungin in the treatment of IFD in patients with hematologic malignancies. METHODS: In this retrospective study, data from the electronic medical records of 1118 inpatients who were admitted to 10 hospitals in China between 2013 and 2014 were analyzed...
July 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28756068/a-phase-ii-randomized-double-blind-multicenter-study-to-evaluate-efficacy-and-safety-of-intravenous-iclaprim-versus-vancomycin-for-the-treatment-of-nosocomial-pneumonia-suspected-or-confirmed-to-be-due-to-gram-positive-pathogens
#10
David B Huang, Thomas M File, Antoni Torres, Andrew F Shorr, Mark H Wilcox, Paul Hadvary, Matthew Dryden, G Ralph Corey
PURPOSE: The primary objective of this Phase II study was to compare the clinical cure rates of 2 iclaprim dosages versus vancomycin in the treatment of patients with nosocomial pneumonia suspected or confirmed to be caused by gram-positive pathogens. METHODS: This study was a double-blind, randomized, multicenter trial. A total of 70 patients were randomized 1:1:1 to receive iclaprim 0.8 mg/kg IV q12h (iclaprim q12h; n = 23), iclaprim 1.2 mg/kg IV q8h (iclaprim q8h; n = 24), or vancomycin 1 g IV q12h (vancomycin; n = 23) for 7 to 14 days...
July 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28756067/pharmacokinetics-dose-proportionality-and-bioavailability-of-bazedoxifene-in-healthy-postmenopausal-women
#11
William McKeand
PURPOSE: Bazedoxifene is a selective estrogen receptor modulator that has estrogen agonist effects on bone and lipid metabolism while having neutral or estrogen antagonist effects on the breast and endometrium. The present report describes findings from 3 Phase I clinical studies that evaluated the single-dose pharmacokinetics (study 1; n = 84), multiple-dose pharmacokinetics (study 2; n = 23), and absolute bioavailability (study 3; n = 18) of bazedoxifene. METHODS: All 3 studies enrolled healthy postmenopausal women who were either naturally postmenopausal or had undergone bilateral oophorectomy at least 6 months before the start of the study...
July 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28756066/prospects-and-challenges-in-the-development-of-a-norovirus-vaccine
#12
REVIEW
Nicolas W Cortes-Penfield, Sasirekha Ramani, Mary K Estes, Robert L Atmar
PURPOSE: Norovirus is the leading cause of acute epidemic gastroenteritis among children under the age of 5 years and adults in the United States and in adults worldwide, accounting for an estimated 20% of episodes of acute gastroenteritis across all ages. No effective vaccine is presently available. This article provides an overview of the current state of norovirus vaccine development, emphasizing barriers and challenges in the development of an effective vaccine, correlates of protection used to assess vaccine efficacy, and the results of clinical trials of the major candidate vaccines...
July 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28756065/relationship-between-atrasentan-concentrations-and-urinary-albumin-to-creatinine-ratio-in-western-and-japanese-patients-with-diabetic-nephropathy
#13
Chih-Wei Lin, Nael M Mostafa, Dennis L Andress, John J Brennan, Cheri E Klein, Walid M Awni
PURPOSE: The objective of the current analyses was to characterize the pharmacokinetic properties of atrasentan and the exposure-response relationships for the efficacy end point, urinary albumin to creatinine ratio (UACR), and the treatment-emergent adverse event, peripheral edema, during 8 or 12 weeks of treatment. METHODS: Results from 3 Phase II, randomized, double-blind, placebo-controlled studies (N = 257) were used for the population pharmacokinetic and exposure-response models...
July 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28754189/progress-and-works-in-progress-update-on-flavivirus-vaccine-development
#14
REVIEW
Matthew H Collins, Stefan W Metz
Most areas of the globe are endemic for at least one flavivirus, putting billions at risk for infection. This diverse group of viral pathogens causes a range of manifestations in humans from asymptomatic infection to hemorrhagic fever to encephalitis to birth defects and even death. Many flaviviruses are transmitted by mosquitos and have expanded in geographic distribution in recent years, with dengue virus being the most prevalent, infecting approximately 400 million people each year. The explosive emergence of Zika virus in Latin America in 2014 refocused international attention on this medically important group of viruses...
July 25, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28751099/efficacy-and-safety-of-delayed-release-dimethyl-fumarate-for-relapsing-remitting-multiple-sclerosis-in-prior-interferon-users-an-integrated-analysis-of-define-and-confirm
#15
Óscar Fernández, Gavin Giovannoni, Robert J Fox, Ralf Gold, J Theodore Phillips, James Potts, Macaulay Okwuokenye, Jing L Marantz
PURPOSE: In Phase III studies (DEFINE [Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS]/CONFIRM [Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis]), delayed-release dimethyl fumarate (DMF) demonstrated significant efficacy and a favorable benefit-risk profile in patients with relapsing-remitting multiple sclerosis (RRMS). Post hoc analyses of integrated data from DEFINE/CONFIRM were conducted to evaluate the effect of DMF in patients previously treated with interferon (IFN) beta...
July 24, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28751098/patient-reported-quality-of-life-and-treatment-satisfaction-in-patients-with-hr-her2-advanced-metastatic-breast-cancer
#16
Robert Wood, Debanjali Mitra, Jonathan de Courcy, Shrividya Iyer
PURPOSE: Globally, around 1.67 million new cases of breast cancer are diagnosed each year, with advanced breast cancer (ABC-Stage III) and metastatic breast cancer (MBC-Stage IV) together accounting for up to 22% of incident cases. Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR(+)/HER2(-)) breast cancer comprises 66% of ABC/MBC. Understanding disease-specific health-related quality of life and patient satisfaction with treatments currently available for HR(+)/HER2(-) ABC/MBC in clinical practice is essential for assessing potential unmet need in this patient population...
July 24, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28751097/corrigendum-to-abstracts-presented-at-eacpt-2017-clin-ther-2017-39-e66
#17
J Gafsi, F Gueyffier, I Marchant
No abstract text is available yet for this article.
July 24, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28751096/vaccines
#18
EDITORIAL
Ravi Jhaveri
No abstract text is available yet for this article.
July 24, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28751095/a-comprehensive-review-of-immunization-practices-in-solid-organ-transplant-and-hematopoietic-stem-cell-transplant-recipients
#19
REVIEW
Pearlie P Chong, Robin K Avery
BACKGROUND: Vaccine-preventable diseases, especially influenza, varicella, herpes zoster, and invasive pneumococcal infections, continue to lead to significant morbidity and mortality in solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients. METHODS: We highlight guideline recommendations for the use of key vaccines in SOT and HSCT recipients and to review the latest evidence and developments in the field. RESULTS: Physicians should vaccinate individuals with end-stage organ disease, as vaccine seroresponse rates are higher pretransplantation...
July 24, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28738991/prophylactic-vaccines-successes-errors-and-complications
#20
EDITORIAL
Richard Shader
No abstract text is available yet for this article.
July 21, 2017: Clinical Therapeutics
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