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Clinical Therapeutics

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https://www.readbyqxmd.com/read/28291581/a-real-world-cost-effectiveness-analysis-of-sevelamer-versus-calcium-acetate-in-korean-dialysis-patients
#1
Jang-Hee Cho, Hye Min Jang, Hee-Yeon Jung, Ji-Young Choi, Sun-Hee Park, Chan-Duck Kim, Chul Woo Yang, Dong-Chan Jin, Yong-Lim Kim
PURPOSE: Sevelamer, a noncalcium phosphate binder, has been shown to attenuate the progression of vascular calcification and improve survival in patients with chronic kidney disease undergoing dialysis compared with calcium-based binders. Using real-world data from a cohort study and the Health Insurance Review and Assessment Service database, we conducted a cost-effectiveness analysis comparing sevelamer with calcium acetate in dialysis patients from the perspective of the National Health Insurance Service in South Korea...
March 10, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28291580/restored-plasma-anandamide-and-endometrial-expression-of-fatty-acid-amide-hydrolase-in-women-with-polycystic-ovary-syndrome-by-the-combination-use-of-diane-35-and-metformin
#2
Na Cui, Xiaoye Feng, Zhiming Zhao, Jie Zhang, Yueming Xu, Luning Wang, Guimin Hao
PURPOSE: Polycystic ovary syndrome (PCOS) is a metabolic and endocrinal disorder affecting a number of women of reproductive age. We aimed to reveal the correlation between the endocannabinoid system and PCOS, which may provide a new therapeutic target for PCOS treatment. METHODS: Serum levels of anandamide and 2-arachidonoylglycerol andexpression of cannabinoid receptors and fatty acid amide hydrolase (FAAH) in the endometrium were compared between women with PCOS and infertile women without PCOS, as well as women with PCOS before and after treatment with Diane-35 and metformin...
March 10, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28285724/frequency-and-impact-of-pharmacist-interventions-in-clinical-trial-patients-with-diabetes
#3
Joe Martinez, Emily Laswell, Stephanie Cailor, Jeb Ballentine
PURPOSE: The objective of this study was to describe the interventions and impact made by pharmacists during clinical trials. METHODS: A specialty contract research organization that used clinical trial research pharmacists to communicate with patients to support clinical trial protocol adherence, retention, and health outcomes performed a retrospective, descriptive analysis of 12 clinical trials that involved 2 noninsulin glucose-lowering medications. Pharmacists called study participants at specific timepoints during the trials as per protocol...
March 9, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28284731/changes-in-asthma-maintenance-therapy-prescribing-patterns-following-the-2006-long-acting-%C3%AE-agonist-fda-drug-warning
#4
Jonathan D Winter, Matthew R Reetz, J William Kerns, Katherine M Winter, Roy T Sabo, Scott D Krugman
PURPOSE: The US Food and Drug Administration issued a boxed warning on all products containing a long-acting β-agonist (LABA) in March 2006, after the findings from a trial suggested an increased risk for death in patients treated with salmeterol monotherapy. Almost nothing is known about the impact of this warning on LABA prescribing patterns or on clinicians' approaches to asthma maintenance therapy. METHODS: A cohort of asthmatic adults on LABA therapy was retrospectively identified from a Baltimore-area Medicaid data warehouse...
March 8, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28258765/current-insights-in-the-placebo-and-nocebo-phenomena
#5
EDITORIAL
Seetal Dodd
No abstract text is available yet for this article.
February 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28256272/placebos-active-placebos-and-clinical-trials
#6
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
February 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28237672/interleukin-10-a-compelling-therapeutic-target-in-patients-with-irritable-bowel-syndrome
#7
REVIEW
Sunil Kumar, Ratnakar Shukla, Prabhat Ranjan, Awanish Kumar
PURPOSE: Pro- and antiinflammatory cytokines are important modulators of the immune response and play a major role in conditions of intestinal inflammation, such as irritable bowel syndrome (IBS). Cytokine production is regulated genetically, and imbalances in cytokine secretion may affect disease susceptibility and clinical outcomes of various conditions. There is a rapidly growing body of evidence to support an etiologic role for gastrointestinal infection and the associated immune activation in the development of postinfectious IBS...
February 23, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28237673/the-placebo-and-nocebo-phenomena-their-clinical-management-and-impact-on-treatment-outcomes
#8
REVIEW
Victor Chavarria, João Vian, Círia Pereira, João Data-Franco, Brisa S Fernandes, Michael Berk, Seetal Dodd
PURPOSE: This overview focuses on placebo and nocebo effects in clinical trials and routine care. Our goal was to propose strategies to improve outcomes in clinical practice, maximizing placebo effects and reducing nocebo effects, as well as managing these phenomena in clinical trials. METHODS: A narrative literature search of PubMed was conducted (January 1980-September 2016). Systematic reviews, randomized controlled trials, observational studies, and case series that had an emphasis on placebo or nocebo effects in clinical practice were included in the qualitative synthesis...
February 22, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28237671/erratum-to-pitavastatin-vs-pravastatin-in-reduction-of-remnant-lipoprotein-cholesterol-in-patients-with-dyslipidemias-clin-ther-2016-39-1250-1251
#9
Leonardo Roever
No abstract text is available yet for this article.
February 22, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28238356/economic-utility-combinatorial-pharmacogenomics-and-medication-cost-savings-for-mental-health-care-in-a-primary-care-setting
#10
Lisa C Brown, Raymond A Lorenz, James Li, Bryan M Dechairo
PURPOSE: This study was an analysis based on a previously completed prospective study investigating medication costs of patients with mental illness guided by using the GeneSight proprietary combinatorial pharmacogenomic (PGx) test. The primary objective of this study was to determine potential cost savings of combinatorial PGx testing over the course of 1 year in patients with mental illness treated by primary care providers (PCPs) and psychiatrists who had switched or added a new psychiatric medication after patients failed to respond to monotherapy...
February 18, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28196623/health-care-utilization-and-direct-costs-in-mild-moderate-and-severe-adult-asthma-a-descriptive-study-using-the-2014-south-korean-health-insurance-database
#11
Yoo Ju Lee, Sun-Hong Kwon, Sung-Hyun Hong, Jin Hyun Nam, Hyun Jin Song, Jong Seop Lee, Eui-Kyung Lee, Ju-Young Shin
PURPOSE: Although asthma exacerbation comprises a large burden of the total asthma-related costs, few studies have examined the frequency and cost of acute exacerbation according to asthma severity. This study investigated asthma-related health care utilization and costs according to the severity of asthma. METHODS: We conducted a descriptive study using the national health insurance claims database between January 1 and December 31, 2014. We included adult patients with asthma (18 years of age and older) who had ≥2 claims with for an asthma diagnosis and were prescribed ≥1 asthma medications...
February 16, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28209373/cost-utility-of-first-line-disease-modifying-treatments-for-relapsing-remitting-multiple-sclerosis
#12
Erkki Soini, Jaana Joutseno, Marja-Liisa Sumelahti
PURPOSE: This study evaluated the cost-effectiveness of first-line treatments of relapsing-remitting multiple sclerosis (RRMS) (dimethyl fumarate [DMF] 240 mg PO BID, teriflunomide 14 mg once daily, glatiramer acetate 20 mg SC once daily, interferon [IFN]-β1a 44 µg TIW, IFN-β1b 250 µg EOD, and IFN-β1a 30 µg IM QW) and best supportive care (BSC) in the health care payer setting in Finland. METHODS: The primary outcome was the modeled incremental cost-effectiveness ratio (ICER; €/quality-adjusted life-year [QALY] gained, 3%/y discounting)...
February 13, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28190600/cost-of-bleeding-related-episodes-in-adult-patients-with-primary-immune-thrombocytopenia-a-population-based-retrospective-cohort-study-of-administrative-claims-data-for-commercial-payers-in-the-united-states
#13
Junji Lin, Xinke Zhang, Xiaoyan Li, David Chandler, Ivy Altomare, Jeffrey S Wasser, Karynsa Cetin
PURPOSE: We estimated the real-world costs of bleeding-related episodes (BREs) in adults with primary immune thrombocytopenia (ITP). METHODS: This retrospective cohort study used the MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases. We identified adult patients diagnosed with primary ITP between 2007 and 2012, defined by at least 2 outpatient claims separated by ≥30 days or 1 inpatient claim (International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code for primary ITP [287...
February 9, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28190599/retrospective-analysis-of-different-treatment-schemes-after-gefitinib-resistance-in-advanced-non-small-cell-lung-cancer
#14
Huijuan Wang, Mina Zhang, Peng Li, Guowei Zhang, Xiangtao Yan, Zhiyong Ma
PURPOSE: The goal of this study was to assess the survival of patients with acquired resistance to gefitinib who underwent different subsequent treatments. METHODS: From September 2007 to July 2014, a total of 103 patients with pathologically confirmed advanced non-small cell lung cancer and acquired resistance to gefitinib were retrospectively analyzed. Fifty-eight (56%) patients received chemotherapy; 36 were treated with chemotherapy and gefitinib continuation (CT + G), and 22 patients received chemotherapy (CT) alone...
February 9, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28190598/lipid-lowering-therapy-in-patients-with-high-cardiovascular-risk-dose-or-combination
#15
Leonardo Roever, Giuseppe Biondi-Zoccai, Sunil V Rao
Cardiovascular disease is the leading cause of death in the world. Dyslipidemia, manifested by elevated low-density lipoprotein cholesterol (LDL-C) levels, is central to the development and progression of atherosclerosis. Dyslipidemia has become a primary target of intervention in strategies for the prevention of cardiovascular events. Therapeutic lifestyle changes, such as increased physical activity, weight loss, smoking cessation, and adoption of a healthier diet, are effectively reducing cardiovascular risk in primary and secondary prevention...
February 9, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28189366/effects-on-spasticity-and-neuropathic-pain-of-an-oral-formulation-of-%C3%AE-9-tetrahydrocannabinol-in-patients-with-progressive-multiple-sclerosis
#16
Guido van Amerongen, Kawita Kanhai, Anne Catrien Baakman, Jules Heuberger, Erica Klaassen, Tim L Beumer, Rob L M Strijers, Joep Killestein, Joop van Gerven, Adam Cohen, Geert Jan Groeneveld
PURPOSE: The aim of the present study was to evaluate the efficacy of an oral formulation of Δ9-tetrahydrocannabinol (ECP002A) in patients with progressive multiple sclerosis (MS). METHODS: This accelerated proof-of-concept study consisted of 2 phases: a crossover challenge (dose-finding) phase and a 4-week, parallel, randomized, placebo-controlled treatment phase. Twenty-four patients with progressive MS and moderate spasticity were enrolled. During the treatment phase, biomarkers for efficacy and secondary pharmacodynamic effects were measured at baseline and after 2 and 4 weeks of treatment...
February 9, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28189364/a-novel-%C3%AF-3-acid-ethyl-ester-formulation-incorporating-advanced-lipid-technologies-tm-alt-%C3%A2-improves-docosahexaenoic-acid-and-eicosapentaenoic-acid-bioavailability-compared-with-lovaza-%C3%A2
#17
Miguel A Lopez-Toledano, Thorsteinn Thorsteinsson, Ahmed Daak, Kevin C Maki, Colleen Johns, Adrian L Rabinowicz, Frederick D Sancilio
PURPOSE: The US Food and Drug Administration has approved several highly purified ω-3 fatty acid prescription drugs for the treatment of severe hypertriglyceridemia. These differ in the amounts and forms of docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA). This study compared the bioavailability of SC401 (1530 mg EPA-ethyl esters [EEs] and DHA-EEs plus Advanced Lipid Technologies(⁎) [ALT(†)], a proprietary lipid-delivery platform to improve absorption), with. Lovaza(‡) (3600 mg ω-3, primarily EPA-EEs and DHA-EEs) under low-fat feeding conditions...
February 9, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28189363/cost-effectiveness-of-pazopanib-versus-sunitinib-as-first-line-treatment-for-locally-advanced-or-metastatic-renal-cell-carcinoma-from-an-italian-national-health-service-perspective
#18
Stefano Capri, Camillo Porta, Thomas E Delea
PURPOSE: A prior randomized controlled trial (COMPARZ [Comparing the Efficacy, Safety and Tolerability of Pazopanib versus Sunitinib]) found non-inferior progression-free survival for pazopanib versus sunitinib as first-line therapy in patients with advanced or metastatic renal cell carcinoma. The present study evaluated the cost-effectiveness of pazopanib versus sunitinib as first-line treatment for patients with metastatic renal cell carcinoma from an Italian National Health Service perspective...
February 9, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28189361/phase-i-randomized-placebo-controlled-double-blind-study-of-the-safety-and-tolerability-of-bremelanotide-coadministered-with-ethanol-in-healthy-male-and-female-participants
#19
Anita H Clayton, Johna Lucas, Leonard R DeRogatis, Robert Jordan
PURPOSE: This was a Phase I study to evaluate the safety, tolerability, and hemodynamic and pharmacokinetic effects of bremelanotide (BMT) coadministered with ethanol to healthy male and female participants. METHODS: This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study. Individuals meeting the inclusion/exclusion criteria received BMT or placebo with or without ethanol at the research facility for 7 consecutive days. Participants were randomized to receive 1 of 6 treatment paths; each participant received single intranasal doses of BMT (20 mg) or placebo on days 1, 4, and 7, with or without oral ethanol (0...
February 9, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28189365/bioequivalence-demonstration-for-%C3%AE-3-acid-ethyl-ester-formulations-rationale-for-modification-of-current-guidance
#20
Kevin C Maki, Colleen Johns, William S Harris, Mark Puder, Steven D Freedman, Thorsteinn Thorsteinsson, Ahmed Daak, Adrian L Rabinowicz, Frederick D Sancilio
The US Food and Drug Administration (FDA) draft guidance for establishing bioequivalence (BE) of ω-3 acid ethyl esters (containing both eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] as ethyl esters), used to treat severe hypertriglyceridemia, recommends the conduct of 2 studies: one with participants in the fasting state and one with participants in the fed state. For the fasting study, the primary measures of BE are baseline-adjusted EPA and DHA levels in total plasma lipids. For the fed study, the primary measures of BE are EPA and DHA ethyl esters in plasma...
February 8, 2017: Clinical Therapeutics
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