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Clinical Therapeutics

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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
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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/28189362/patient-centered-outcomes-with-concomitant-use-of-proton-pump-inhibitors-and-other-drugs
#9
REVIEW
Tatyana A Shamliyan, Maria Middleton, Clarissa Borst
PURPOSE: We performed a systematic review of patient-centered outcomes after the concomitant use of proton pump inhibitors (PPIs) and other drugs. METHODS: We searched 4 databases in July 2016 to find studies that reported mortality and morbidity after the concomitant use of PPIs and other drugs. We conducted direct meta-analyses using a random-effects model and graded the quality of evidence according to the Grading of Recommendations Assessment, Development and Evaluation working group approach...
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
#10
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
#11
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
https://www.readbyqxmd.com/read/28187863/a-review-of-the-clinical-efficacy-and-safety-of-insulin-degludec-and-glargine-300-u-ml-in-the-treatment-of-diabetes-mellitus
#12
REVIEW
Vincent C Woo
PURPOSE: The treatment of type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) using insulin is not ideal at this time. Despite advances made with basal insulin analogues, many individuals achieve less than optimal glycemic control or are at risk for hypoglycemia. Currently available basal insulin analogues do not deliver steady, peakless, continuous insulin for >24 hours and are associated with adverse events, including hypoglycemia. The objective of this paper was to review the clinical efficacy and safety of upcoming long-acting insulin analogues such as insulin degludec and insulin glargine 300 U/mL (Gla-300)...
February 7, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28187862/informed-consent-and-assent-in-pediatric-oncology-trials
#13
EDITORIAL
Richard I Shader, Cynthia H Livingston
No abstract text is available yet for this article.
February 7, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28187861/corrigendum-to-demographic-and-clinical-characteristics-of-type-2-diabetes-mellitus-patients-initiating-dipeptidyl-peptidase-4-inhibitors-a-retrospective-study-of-uk-general-practice-clin-ther-2016-8-1825-1832-e15
#14
Abigail Tebboth, Sally Lee, Anna Scowcroft, Paula Bingham-Gardiner, William Spencer, John Bolodeoku, Syed Wasi Hassan
No abstract text is available yet for this article.
February 7, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28185715/effects-of-oral-antidiabetic-drugs-on-changes-in-the-liver-to-spleen-ratio-on-computed-tomography-and-inflammatory-biomarkers-in-patients-with-type-2-diabetes-and-nonalcoholic-fatty-liver-disease
#15
Koichi Yabiku, Akiko Mutoh, Kazufumi Miyagi, Nobuyuki Takasu
PURPOSE: Oral antidiabetic drugs (OADs) such as pioglitazone and metformin have beneficial effects in patients with nonalcoholic steatohepatitis. We prospectively assessed the effects of OADs on nonalcoholic fatty liver disease (NAFLD) in 886 men with type 2 diabetes mellitus and in a murine model of NAFLD. METHODS: Patients were randomized to receive pioglitazone, metformin, sitagliptin, or a non-OAD (control) for 6 months. All the patients received dietary and exercise guidance once a month during this study...
February 6, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28185714/choosing-wisely-the-top-5-recommendations-from-the-italian-panel-of-the-national-guidelines-for-the-management-of-acute-pharyngitis-in-children
#16
Elena Chiappini, Barbara Bortone, Giuseppe Di Mauro, Susanna Esposito, Luisa Galli, Massimo Landi, Andrea Novelli, Paola Marchisio, Gian Luigi Marseglia, Nicola Principi, Maurizio de Martino
PURPOSE: With the aim to reduce waste in the health care system and avoid risks associated with unnecessary treatment, the Italian Panel of the National Guidelines for the Management of Acute Pharyngitis in Children joined the Choosing Wisely initiative. METHODS: An ad hoc Choosing Wisely task force was selected to develop a candidate list of items for the top-5 list on pharyngitis medicine. Through a process of literature review and consensus, the final list of 5 items was chosen...
February 6, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28185713/effects-of-pitavastatin-on-lipid-rich-carotid-plaques-studied-using-high-resolution-magnetic-resonance-imaging
#17
Tao Feng, Xiaoxing Huang, Qundi Liang, Yun Liang, Yong Yuan, Li Feng, Wenjun Wu, Xuehong Xiao, Ying Han
PURPOSE: This study evaluates the effectiveness of pitavastatin in patients with atherosclerosis. METHODS: Sixty patients with atherosclerosis with lipid-rich carotid plaques were included and allocated into low-dose (2 mg/d) and high-dose (4 mg/d) pitavastatin groups with 48 weeks of treatment. Total cholesterol, LDL-C, HDL-C, triglycerides, apolipoprotein A1, apolipoprotein B, lipoprotein (a), and the inflammation-related factors interleukin 6, high-sensitivity C-reactive protein, and homocysteine were determined...
February 6, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28161120/management-of-venetoclax-posaconazole-interaction-in-acute-myeloid-leukemia-patients-evaluation-of-dose-adjustments
#18
Suresh K Agarwal, Courtney D DiNardo, Jalaja Potluri, Martin Dunbar, Hagop M Kantarjian, Rod A Humerickhouse, Shekman L Wong, Rajeev M Menon, Marina Y Konopleva, Ahmed Hamed Salem
PURPOSE: The effect of posaconazole, a strong cytochrome P450 3A (CYP3A) inhibitor and commonly used antifungal agent, on the pharmacokinetic properties of venetoclax, a CYP3A substrate, was evaluated in patients with acute myeloid leukemia to determine the dose adjustments needed to manage this potential interaction. METHODS: Twelve patients received 20- to 200-mg ramp-up treatment with oral venetoclax and 20 mg/m(2) of intravenous decitabine on days 1 through 5, followed by 400 mg of venetoclax alone on days 6 through 20...
February 1, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28161119/monthly-oral-ibandronate-reduces-bone-loss-in-korean-women-with-rheumatoid-arthritis-and-osteopenia-receiving-long-term-glucocorticoids-a-48-week-double-blinded-randomized-placebo-controlled-investigator-initiated-trial
#19
Kichul Shin, Sung-Hwan Park, Won Park, Han Joo Baek, Yun Jong Lee, Seong Wook Kang, Jung-Yoon Choe, Wan-Hee Yoo, Yong-Beom Park, Jung-Soo Song, Seung-Geun Lee, Bin Yoo, Dae-Hyun Yoo, Yeong Wook Song
PURPOSE: Our aim was to investigate the efficacy of monthly oral ibandronate in Korean women with rheumatoid arthritis and reduced bone mineral density (BMD) receiving long-term glucocorticoids. METHODS: Patients (n = 167 women) were randomly assigned (1:1) to receive ibandronate 150 mg or placebo every 4 weeks. Patients had taken glucocorticoid (equivalent of daily prednisolone ≥5 mg) for 3 or more consecutive months before enrollment, and had a lumbar spine 1 to 4 (L1-L4) T-score of < -1...
February 1, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28161118/more-efficient-compliance-with-european-medicines-agency-and-food-and-drug-administration-regulations-for-pediatric-oncology-drug-development-problems-and-solutions
#20
Christopher-Paul Milne
5w?>The morbidity and mortality toll of pediatric cancer affects the public health of children worldwide, but despite the gains in the fight against cancer, more progress needs to take place against this disease, which is a leading cause of death and chronic disability in children. In response, leading regulatory authorities in the developed world have been ratcheting up their efforts to induce the private sector to expand their research and development focus during drug development for adult cancers to include children...
February 1, 2017: Clinical Therapeutics
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