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New drugs of 2015

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https://www.readbyqxmd.com/read/28231676/-post-marketing-surveillance-of-tanreqing-injection-in-children-a-real-world-study
#1
X X Li, L Zhuo, Y H Yang, S Y Zhan, S D Zhai
Objective: To evaluate the safety of Tanreqing injection among children in the real world. Methods: A multicenter, large sample, ambispective cohort study, with registration-type clinical safety monitoring. A total of 6 188 inpatients and patients from the emergency units, aged ≤ 14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China, were recruited between January, 2014 and May, 2015. The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection...
February 10, 2017: Zhonghua Liu Xing Bing Xue za Zhi, Zhonghua Liuxingbingxue Zazhi
https://www.readbyqxmd.com/read/28230455/outcomes-of-pharmacy-led-hepatitis-c-direct-acting-antiviral-utilization-management-at-a-veterans-affairs-medical-center
#2
Sendra Yang, Rachel B Britt, Mohamed G Hashem, Jamie N Brown
BACKGROUND: The Veterans Affairs Health (VA) Administration has reported hepatitis C virus (HCV) infection rates among veterans to be twice that of the general U.S population. New HCV direct-acting antiviral (DAA) treatment options offer superior sustained virologic response (SVR) rates, improved side-effect profiles, and shortened treatment courses; yet, these new HCV DAAs are expensive, and utilization management strategies are needed to optimize use and improve clinical outcomes. A VA medical center uses pharmacist-led HCV DAA utilization management strategies that includes clinical guidance, optimizing operational flow, budget tracking and forecasting, and patient outcomes tracking...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28224774/comparison-of-luminex-nxtag-respiratory-pathogen-panel-and-xtag-respiratory-viral-panel-fast-version-2-for-the-detection-of-respiratory-viruses
#3
Chun Kiat Lee, Hong Kai Lee, Christopher Wei Siong Ng, Lily Chiu, Julian Wei Tze Tang, Tze Ping Loh, Evelyn Siew Chuan Koay
Owing to advancements in molecular diagnostics, recent years have seen an increasing number of laboratories adopting respiratory viral panels to detect respiratory pathogens. In December 2015, the NxTAG respiratory pathogen panel (NxTAG RPP) was approved by the United States Food and Drug Administration. We compared the clinical performance of this new assay with that of the xTAG respiratory viral panel (xTAG RVP) FAST v2 using 142 clinical samples and 12 external quality assessment samples. Discordant results were resolved by using a laboratory-developed respiratory viral panel...
May 2017: Annals of Laboratory Medicine
https://www.readbyqxmd.com/read/28222220/meaningful-endpoints-for-therapies-approved-for-hematologic-malignancies
#4
B Douglas Smith, Amy E DeZern, Alex W Bastian, Brian G M Durie
BACKGROUND: Overall survival (OS) is considered the gold standard for determining treatment efficacy in oncology trials, but the relation between treatment and OS can be challenging to assess because of long study durations and the impact of subsequent therapies on outcome. Using OS can be particularly difficult for new therapies in hematologic malignancies (HMs). METHODS: This retrospective analysis was conducted to characterize the primary endpoints used to support US Food and Drug Administration (FDA) approvals for new drug or novel HM indications between January 2002 and July 2015...
February 21, 2017: Cancer
https://www.readbyqxmd.com/read/28219610/bictegravir-versus-dolutegravir-each-with-emtricitabine-and-tenofovir-alafenamide-for-initial-treatment-of-hiv-1-infection-a-randomised-double-blind-phase-2-trial
#5
Paul E Sax, Edwin DeJesus, Gordon Crofoot, Douglas Ward, Paul Benson, Robin Dretler, Anthony Mills, Cynthia Brinson, Julie Peloquin, Xuelian Wei, Kirsten White, Andrew Cheng, Hal Martin, Erin Quirk
BACKGROUND: All recent treatment guidelines recommend integrase strand transfer inhibitors (INSTIs) as components of initial HIV therapy. Bictegravir, a novel, once-daily, unboosted INSTI, showed potent activity in a 10 day monotherapy study and has a high in-vitro resistance barrier. On the basis of these results, we did a phase 2 trial comparing bictegravir with dolutegravir. METHODS: In this randomised, double-blind, phase 2 trial, we recruited previously untreated adults (aged ≥18 years) with HIV-1 infections from 22 outpatient centres in the USA...
February 14, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28212657/pharmacists-views-and-reported-practices-in-relation-to-a-new-generic-drug-substitution-policy-in-lebanon-a-mixed-methods-study
#6
Fadi El-Jardali, Racha Fadlallah, Rami Z Morsi, Nour Hemadi, Mounir Al-Gibbawi, Magda Haj, Suzan Khalil, Youssef Saklawi, Diana Jamal, Elie A Akl
BACKGROUND: Governments in both developed and developing countries have adopted generic drug substitution policies to decrease pharmaceutical expenditures and improve access to medicine. In August 2015, the Ministry of Public Health (MOPH) in Lebanon introduced generic drug substitution and a unified medical prescription form as policy instruments to promote generic drug use. The objective of this exploratory study was to examine the attitudes of community pharmacists and the reported practices in relation to the implementation of the new generic drug substitution policy...
February 17, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/28208889/management-of-pneumonia-and-blood-stream-infections-with-new-antibiotic-adjuvant-entity-ceftriaxone-sulbactam-disodium-edetate-a-novel-way-to-spare-carbapenems
#7
Mohammad Shameem, Mohammad Amin Mir
INTRODUCTION: Nosocomial infections have been considered as a major health problem causing incremental morbidity, mortality and costs of therapy. AIM: This retrospective study was initiated with aim to analyse the comparative efficacy of a novel Antibiotic Adjuvant Entity (AAE), a combination of ceftriaxone + sulbactam + disodium edetate and meropenem in combination with colistin, for the management of Multi Drug Resistant (MDR) nosocomial Gram-negative bacterial infections...
December 2016: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28208874/topical-corticosteroid-misuse-the-scenario-in-patients-attending-a-tertiary-care-hospital-in-new-delhi
#8
Santwana Mahar, Khushbu Mahajan, Swati Agarwal, Hemanta Kumar Kar, Swapan Kumar Bhattacharya
INTRODUCTION: Irrational use of Topical Corticosteroid (TC) is quite common in India due to unrestricted availability and use of TC not only by general public but also by physicians and chemists due to quick relief of symptoms in different dermatological conditions. AIM: The present study was conducted to evaluate and analyse the prevalence of misuse of TC and the causes behind misuse of TC among patients in a dermatology outpatient department in New Delhi. MATERIALS AND METHODS: This was a cross-sectional observational questionnaire based study conducted over a period of 5 months (1(st) June 2015 to 30(th) November 2015)...
December 2016: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28207928/industry-sponsorship-and-research-outcome
#9
REVIEW
Andreas Lundh, Joel Lexchin, Barbara Mintzes, Jeppe B Schroll, Lisa Bero
BACKGROUND: Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical-industry sponsored studies are more often favorable to the sponsor's product compared with studies with other sources of sponsorship. A similar association between sponsorship and outcomes have been found for device studies, but the body of evidence is not as strong as for sponsorship of drug studies...
February 16, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28205262/modern-multiple-myeloma-therapy-deep-sustained-treatment-response-and-good-clinical-outcomes
#10
REVIEW
O Landgren, K Iskander
In the USA at the beginning of this century, the average overall survival in patients with multiple myeloma was about 3 years. Around that time, three drugs (bortezomib, lenalidomide and thalidomide) were introduced for the treatment of multiple myeloma and, in 2012, carfilzomib received accelerated approval by the US Food and Drug Administration (FDA). Driven by access to better drugs, median overall survival in younger patients (aged <50 years) was >10 years by 2014. The FDA approved 14 new drugs for the treatment of cancer in 2015; four of these were approved for the treatment of myeloma (panobinostat, daratumumab, elotuzumab and ixazomib)...
February 16, 2017: Journal of Internal Medicine
https://www.readbyqxmd.com/read/28203341/new-monoclonal-antibodies-on-the-horizon-in-multiple-myeloma
#11
REVIEW
Elizabeth K O'Donnell, Noopur S Raje
Across all cancers, monoclonal antibodies have emerged as a potential strategy for cancer therapy. Monoclonal antibodies target antigens expressed on the surface of cancer cells and accessory cells. This targeted approach uses the host's immune system to promote the killing of cancer cells. Multiple myeloma (MM) is the second most common hematologic malignancy that remains incurable in the majority of patients. The treatment of MM has evolved dramatically over the past decade and continues to evolve with the approval of four new drugs in 2015...
February 2017: Therapeutic Advances in Hematology
https://www.readbyqxmd.com/read/28196207/correlation-of-long-term-results-of-imatinib-in-advanced-gastrointestinal-stromal-tumors-with-next-generation-sequencing-results-analysis-of-phase-3-swog-intergroup-trial-s0033
#12
Michael Heinrich, Cathryn Rankin, Charles D Blanke, George D Demetri, Ernest C Borden, Christopher W Ryan, Margaret von Mehren, Martin E Blackstein, Dennis A Priebat, William D Tap, Robert G Maki, Christopher L Corless, Jonathan A Fletcher, Kouros Owzar, John J Crowley, Robert S Benjamin, Laurence H Baker
Importance: After identification of activating mutations of the KIT gene in gastrointestinal stromal tumor (GIST)-the most common sarcomaof the gastrointestinal tract-a phase 2 study demonstrated efficacy of imatinib mesylate in patients with metastatic GIST harboring a KIT exon 11 mutation. Initial results of long-term follow-up have found a survival benefit in this subgroup of patients. Obective: To assess the long-term survival of patients with GIST who were treated in SWOG study S0033 and to present new molecular data regarding treatment outcomes...
February 9, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28190690/changes-in-veteran-tobacco-use-identified-in-electronic-medical-records
#13
Paul G Barnett, Adam Chow, Nicole E Flores, Scott E Sherman, Sonia A Duffy
INTRODUCTION: Electronic medical records represent a new source of longitudinal data on tobacco use. METHODS: Electronic medical records of the U.S. Department of Veterans Affairs were extracted to find patients' tobacco use status in 2009 and at another assessment 12-24 months later. Records from the year prior to the first assessment were used to determine patient demographics and comorbidities. These data were analyzed in 2015. RESULTS: An annual quit rate of 12...
February 9, 2017: American Journal of Preventive Medicine
https://www.readbyqxmd.com/read/28190578/quarter-dose-quadruple-combination-therapy-for-initial-treatment-of-hypertension-placebo-controlled-crossover-randomised-trial-and-systematic-review
#14
Clara K Chow, Jay Thakkar, Alex Bennett, Graham Hillis, Michael Burke, Tim Usherwood, Kha Vo, Kris Rogers, Emily Atkins, Ruth Webster, Michael Chou, Hakim-Moulay Dehbi, Abdul Salam, Anushka Patel, Bruce Neal, David Peiris, Henry Krum, John Chalmers, Mark Nelson, Christopher M Reid, Mark Woodward, Sarah Hilmer, Simon Thom, Anthony Rodgers
BACKGROUND: Globally, most patients with hypertension are treated with monotherapy, and control rates are poor because monotherapy only reduces blood pressure by around 9/5 mm Hg on average. There is a pressing need for blood pressure-control strategies with improved efficacy and tolerability. We aimed to assess whether ultra-low-dose combination therapy could meet these needs. METHODS: We did a randomised, placebo-controlled, double-blind, crossover trial of a quadpill-a single capsule containing four blood pressure-lowering drugs each at quarter-dose (irbesartan 37·5 mg, amlodipine 1·25 mg, hydrochlorothiazide 6·25 mg, and atenolol 12·5 mg)...
February 9, 2017: Lancet
https://www.readbyqxmd.com/read/28187774/assessing-the-experience-of-using-synthetic-cannabinoids-by-means-of-interpretative-phenomenological-analysis
#15
Szilvia Kassai, Judit Nóra Pintér, József Rácz, Brigitta Böröndi, Tamás Tóth-Karikó, Kitti Kerekes, V Anna Gyarmathy
BACKGROUND: New psychoactive substances (NPS) have been increasingly consumed by people who use drugs in recent years, which pose a new challenge for treatment services. One of the largest groups of NPS is synthetic cannabinoids (SCs), which are intended as a replacement to cannabis. While there is an increasing body of research on the motivation and the effects associated with SC use, little is known about the subjective interpretation of SC use by the people who use drugs themselves...
February 10, 2017: Harm Reduction Journal
https://www.readbyqxmd.com/read/28185990/a-structure-activity-relationship-study-of-abcc2-inhibitors
#16
Gloria Wissel, Feng Deng, Pavel Kudryavtsev, Leo Ghemtio, Peter Wipf, Henri Xhaard, Heidi Kidron
Multidrug resistance associated protein 2 (MRP2/ABCC2) is a membrane transport protein that can potentially affect the disposition of many substrate drugs and their metabolites. Recently, we studied the interaction of a library of 432 compounds with ABCC2, and the structure-activity relationship (SAR) of a subset of 64 compounds divided into four scaffolds (Wissel, G. et al., 2015. Bioorg Med Chem., 23(13), pp.3513-25). We have now expanded this test set by investigating 114 new compounds, of which 71 are representative of the previous four scaffolds and 43 compounds belong to a new scaffold...
February 6, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28182611/use-of-daclatasvir-in-hcv-hiv-coinfected-patients-in-a-real-life-setting
#17
Stefano Bonora, Massimo Puoti
The burden of HIV and HCV coinfection is estimated to affect 5-7 million people worldwide, with approximately 15-30% of people with HIV coinfected with HCV. The first oral direct-acting antivirals have shown to improve the response in patients with HIV/HCV coinfection, and more recently, other direct-acting antivirals that target various stages of the HCV life cycle have been developed, among them daclatasvir. The objective of this article is to examine recent clinical studies investigating the efficacy and safety of daclatasvir in comparison with other antiretroviral drugs, focusing on its efficacy in the coinfected HIV patient and real-life data...
January 2017: AIDS Reviews
https://www.readbyqxmd.com/read/28181668/nsi-189-a-small-molecule-with-neurogenic-properties-exerts-behavioral-and-neurostructural-benefits-in-stroke-rats
#18
Naoki Tajiri, David M Quach, Yuji Kaneko, Stephanie Wu, David Lee, Tina Lam, Ken L Hayama, Thomas G Hazel, Karl Johe, Michael C Wu, Cesar V Borlongan
Enhancing neurogenesis may be a powerful stroke therapy. Here, we tested in a rat model of ischemic stroke the beneficial effects of NSI-189, an orally active, new molecular entity (mol. wt. 366) with enhanced neurogenic activity, and indicated as an anti-depressant drug in a clinical trial (Fava et al., 2015) and being tested in a Phase 2 efficacy trial (ClinicalTrials.gov, 2016) for treatment of major depression. Oral administration of NSI-189 in adult Sprague-Dawley rats starting at 6 hours after middle cerebral artery occlusion, and daily thereafter over the next 12 weeks resulted in significant amelioration of stroke-induced motor and neurological deficits, which was maintained up to 24 weeks post-stroke...
February 9, 2017: Journal of Cellular Physiology
https://www.readbyqxmd.com/read/28178618/medicinal-plants-and-their-isolated-compounds-showing-anti-trichomonas-vaginalis-activity
#19
REVIEW
Mozhgan Mehriardestani, Atousa Aliahmadi, Tayebeh Toliat, Roja Rahimi
Trichomonas vaginalis is a major of non-viral sexually-transmitted infection and an important cause of serious obstetrical and gynecological complications. Treatment options for trichomoniasis are limited to nitroimidazole compounds. The increasing resistance and allergic reactions to nitroimidazole and recurrent trichomoniasis make it essential to identify and develop new drugs against trichomoniasis. Medicinal plants are an important source for discovery of new medications. This review discusses the anti-trichomonas effects of medicinal plants and their chemical constituents to find better options against this pathogenic protozoon...
February 5, 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/28174830/clinical-benefit-price-and-approval-characteristics-of-fda-approved-new-drugs-for-treating-advanced-solid-cancer-2000-2015
#20
A Vivot, J Jacot, J-D Zeitoun, P Ravaud, P Crequit, R Porcher
No abstract text is available yet for this article.
February 8, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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