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https://www.readbyqxmd.com/read/28916371/ramucirumab-plus-docetaxel-versus-placebo-plus-docetaxel-in-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-after-platinum-based-therapy-range-a-randomised-double-blind-phase-3-trial
#1
Daniel P Petrylak, Ronald de Wit, Kim N Chi, Alexandra Drakaki, Cora N Sternberg, Hiroyuki Nishiyama, Daniel Castellano, Syed Hussain, Aude Fléchon, Aristotelis Bamias, Evan Y Yu, Michiel S van der Heijden, Nobuaki Matsubara, Boris Alekseev, Andrea Necchi, Lajos Géczi, Yen-Chuan Ou, Hasan Senol Coskun, Wen-Pin Su, Miriam Hegemann, Ivor J Percent, Jae-Lyun Lee, Marcello Tucci, Andrey Semenov, Fredrik Laestadius, Avivit Peer, Giampaolo Tortora, Sufia Safina, Xavier Garcia Del Muro, Alejo Rodriguez-Vida, Irfan Cicin, Hakan Harputluoglu, Ryan C Widau, Astra M Liepa, Richard A Walgren, Oday Hamid, Annamaria H Zimmermann, Katherine M Bell-McGuinn, Thomas Powles
BACKGROUND: Few treatments with a distinct mechanism of action are available for patients with platinum-refractory advanced or metastatic urothelial carcinoma. We assessed the efficacy and safety of treatment with docetaxel plus either ramucirumab-a human IgG1 VEGFR-2 antagonist-or placebo in this patient population. METHODS: We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy...
September 12, 2017: Lancet
https://www.readbyqxmd.com/read/28914440/olaratumab-in-combination-with-doxorubicin-for-the-treatment-of-advanced-soft-tissue-sarcoma-an-evidence-review-group-perspective-of-a-national-institute-for-health-and-care-excellence-single-technology-appraisal
#2
REVIEW
Irina A Tikhonova, Tracey Jones-Hughes, James Dunham, Fiona C Warren, Sophie Robinson, Peter Stephens, Martin Hoyle
The manufacturer of olaratumab (Lartruvo(®)), Eli Lilly & Company Limited, submitted evidence for the clinical and cost effectiveness of this drug, in combination with doxorubicin, for untreated advanced soft tissue sarcoma (STS) not amenable to surgery or radiotherapy, as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal process. The Peninsula Technology Assessment Group, commissioned to act as the Evidence Review Group (ERG), critically reviewed the company's submission...
September 15, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28904813/seasonal-affective-disorder-and-non-seasonal-affective-disorders-results-from-the-nesda-study
#3
Wim H Winthorst, Annelieke M Roest, Elisabeth H Bos, Ybe Meesters, Brenda W J H Penninx, Willem A Nolen, Peter de Jonge
BACKGROUND: Seasonal affective disorder (SAD) is considered to be a subtype of depression. AIMS: To compare the clinical picture of SAD to non-seasonal affective disorders (non-SADs). METHOD: Diagnoses according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) were established in 2185 participants of the Netherlands Study of Depression and Anxiety. The Seasonal Pattern Assessment Questionnaire was administered to diagnose SAD...
July 2017: BJPsych Open
https://www.readbyqxmd.com/read/28855078/guided-de-escalation-of-antiplatelet-treatment-in-patients-with-acute-coronary-syndrome-undergoing-percutaneous-coronary-intervention-tropical-acs-a-randomised-open-label-multicentre-trial
#4
Dirk Sibbing, Dániel Aradi, Claudius Jacobshagen, Lisa Gross, Dietmar Trenk, Tobias Geisler, Martin Orban, Martin Hadamitzky, Béla Merkely, Róbert Gábor Kiss, András Komócsi, Csaba A Dézsi, Lesca Holdt, Stephan B Felix, Radoslaw Parma, Mariusz Klopotowski, Robert H G Schwinger, Johannes Rieber, Kurt Huber, Franz-Josef Neumann, Lukasz Koltowski, Julinda Mehilli, Zenon Huczek, Steffen Massberg
BACKGROUND: Current guidelines recommend potent platelet inhibition with prasugrel or ticagrelor for 12 months after an acute coronary syndrome managed with percutaneous coronary intervention (PCI). However, the greatest anti-ischaemic benefit of potent antiplatelet drugs over the less potent clopidogrel occurs early, while most excess bleeding events arise during chronic treatment. Hence, a stage-adapted treatment with potent platelet inhibition in the acute phase and de-escalation to clopidogrel in the maintenance phase could be an alternative approach...
August 25, 2017: Lancet
https://www.readbyqxmd.com/read/28846447/stability-of-commercially-available-glucagon-formulation-for-dual-hormone-artificial-pancreas-clinical-use
#5
Nadine Taleb, Adèle Coriati, Christian Khazzaka, Jonathan Bayonne, Virginie Messier, Rémi Rabasa-Lhoret
BACKGROUND: Available glucagon formulations are approved for immediate use after reconstitution for severe hypoglycemia emergency treatment. However, they are used in dual-hormone artificial pancreas (insulin and glucagon) studies through subcutaneous infusion pumps over 24 h. Chemical and physical stability of such glucagon use have not been reported in a comprehensive manner. MATERIALS AND METHODS: Recombinant Glucagon DNA (Eli Lilly) was used. Compatibility and sterility of glucagon delivery through subcutaneous pump systems were verified...
August 28, 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28819835/efficacy-and-safety-of-linagliptin-in-2681-asian-patients-stratified-by-age-obesity-and-renal-function-a-pooled-analysis-of-randomized-clinical-trials
#6
Guang Ning, Tushar Bandgar, Uwe Hehnke, Jisoo Lee, Juliana C N Chan
INTRODUCTION: Asian patients with type 2 diabetes (T2D) are younger, leaner, and more likely to develop renal dysfunction than White populations. In this multiethnic analysis of data from phase 3 trials, we investigated the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in Asians stratified by these subphenotypes. METHODS: Data from randomized, double-blind, placebo-controlled trials evaluating linagliptin (as monotherapy, add-on therapy to metformin ± sulfonylurea, combined with pioglitazone or added to insulin) were pooled with efficacy data from 11 randomized trials of at least 24 weeks and safety data from 15 trials of various durations...
August 17, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28811926/postinjection-delirium-sedation-syndrome-in-patients-with-schizophrenia-receiving-olanzapine-long-acting-injection-results-from-a-large-observational-study
#7
Kristin J Meyers, Himanshu P Upadhyaya, John L Landry, Rashna Chhabra-Khanna, Deborah M Falk, Balasubramanya Seetharama Rao, Meghan E Jones
BACKGROUND: Postinjection delirium/sedation syndrome (PDSS) has been reported uncommonly during treatment with olanzapine long-acting injection (LAI), a sustained-release formulation of olanzapine. AIMS: The primary aim of the study was to estimate the incidence per injection and per patient of PDSS events in adult patients with schizophrenia who were receiving olanzapine LAI in real-world clinical practice. Secondary aims were to further characterise the clinical presentation of PDSS events, to identify potential risk factors associated with PDSS events and to characterise hospitalisations at baseline and post-baseline...
July 2017: BJPsych Open
https://www.readbyqxmd.com/read/28667381/differential-treatment-response-to-insulin-intensification-therapy-a-post-hoc-analysis-of-a-randomized-trial-comparing-premixed-and-basal-bolus-insulin-regimens
#8
Li Xin Shi, Peng Fei Li, Jia Ning Hou
INTRODUCTION: Identification of subgroups of patients that may benefit most from certain treatment is important because individual treatment response varies due to multiple contributing factors. The present study used the subgroup identification based on the differential effect search (SIDES) algorithm to identify subgroups with different treatment responses to insulin intensification therapies. METHODS: This was a post hoc analysis of a 24-week, multicenter, open-label, randomized, parallel study comparing prandial premixed therapy (PPT) to basal-bolus therapy (BBT)...
August 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28666775/effects-of-empagliflozin-on-the-urinary-albumin-to-creatinine-ratio-in-patients-with-type-2-diabetes-and-established-cardiovascular-disease-an-exploratory-analysis-from-the-empa-reg-outcome-randomised-placebo-controlled-trial
#9
David Z I Cherney, Bernard Zinman, Silvio E Inzucchi, Audrey Koitka-Weber, Michaela Mattheus, Maximilian von Eynatten, Christoph Wanner
BACKGROUND: In a pooled analysis of short-term trials, short-term treatment with the sodium-glucose co-transporter-2 (SGLT2) inhibitor empagliflozin reduced albuminuria in patients with type 2 diabetes and prevalent albuminuria. In this exploratory analysis of the EMPA-REG OUTCOME trial, we report the short-term and long-term effects of empagliflozin on albuminuria in patients with type 2 diabetes and established cardiovascular disease, according to patients' baseline albuminuria status...
August 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28656543/ramucirumab-for-treating-advanced-gastric-cancer-or-gastro-oesophageal-junction-adenocarcinoma-previously-treated-with-chemotherapy-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#10
REVIEW
Nasuh C Büyükkaramikli, Hedwig M Blommestein, Rob Riemsma, Nigel Armstrong, Fiona J Clay, Janine Ross, Gill Worthy, Johan Severens, Jos Kleijnen, Maiwenn J Al
The National Institute for Health and Care Excellence (NICE) invited the company that manufactures ramucirumab (Cyramza(®), Eli Lilly and Company) to submit evidence of the clinical and cost effectiveness of the drug administered alone (monotherapy) or with paclitaxel (combination therapy) for treating adults with advanced gastric cancer or gastro-oesophageal junction (GC/GOJ) adenocarcinoma that were previously treated with chemotherapy, as part of the Institute's single technology appraisal (STA) process...
June 27, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28650253/diagnosis-and-treatment-of-osteoporosis-before-and-after-fracture-a-side-by-side-analysis-of-commercially-insured-and-medicare-advantage-osteoporosis-patients
#11
Jessica Weaver, Shiva Sajjan, E Michael Lewiecki, Steven T Harris
BACKGROUND: Although treatment for osteoporosis is recommended by U.S. clinical guidelines, a lack of diagnosis and treatment is common among patients with osteoporotic fractures. OBJECTIVE: To determine the rates of osteoporosis diagnosis and treatment before and after various types of fractures. METHODS: This was a retrospective claims analysis using data from the Humana Medicare Advantage claims (Medicare group) and Optum Insight Clinformatics Data Mart commercial claims (Commercial group)...
July 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28599764/different-insulin-concentrations-in-resuspended-vs-unsuspended-nph-insulin-practical-aspects-of-subcutaneous-injection-in-patients-with-diabetes
#12
P Lucidi, F Porcellati, A Marinelli Andreoli, P Candeloro, P Cioli, G B Bolli, C G Fanelli
AIMS: This study measured the insulin concentration (Ins[C]) of NPH insulin in vials and cartridges from different companies after either resuspension (R+) or not (R-; in the clear/cloudy phases of unsuspended NPH). METHODS: Measurements included Ins[C] in NPH(R+) and in the clear/cloudy phases of NPH(R-), and the time needed to resuspend NPH and time for NPH(R+) to separate again into clear/cloudy parts. RESULTS: In vials of NPH(R+) (assumed to be 100%), Ins[C] in the clear phase of NPH(R-) was<1%, but 230±41% and 234±54% in the cloudy phases of Novo Nordisk and Eli Lilly NPH, respectively...
June 6, 2017: Diabetes & Metabolism
https://www.readbyqxmd.com/read/28593105/photobiomodulation-with-near-infrared-light-helmet-in-a-pilot-placebo-controlled-clinical-trial-in-dementia-patients-testing-memory-and-cognition
#13
Marvin H Berman, James P Halper, Trent W Nichols, H Jarrett, Alan Lundy, Jason H Huang
Alzheimer's disease (AD) is a common, chronic expensive debilitating neurodegenerative disease with no current treatments to prevent the physical deterioration of the brain and the consequent cognitive deficits. The current pathophysiology of Alzheimer's disease is the accumulation of neurofibrillary tangles (NFTs) of hyperphosphorylated tau protein and amyloid-beta (Aβ) plaques. Antibody therapy of Tau and Amyloid beta, vaccines and other methods to decrease Tau and or Amyloid have not been successful after considerable pharmaceutical and biotech efforts...
2017: Journal of neurology and neuroscience
https://www.readbyqxmd.com/read/28579148/effect-of-time-of-administration-of-teriparatide-on-bone-mineral-density-in-glucocorticoid-induced-osteoporosis
#14
Silvina R Mastaglia
Teriparatide (TPTD) (recombinant DNA origin human parathormone [1-34]) is approved for the treatment of glucocorticoid-induced osteoporosis (GIO). There are reports of factors that affect the response to TPTD in GIO treatment. This work describes the case of a 71-yr-old woman diagnosed with lupus nephropathy treated with 40 mg/d of meprednisone, and who suffered multiple vertebral fractures. Despite treatment with a single 5 mg dose of zoledronic acid, the patient continued to have vertebral fractures. Treatment with 20 µg/d of subcutaneous TPTD (PTH1-34, Forteo; Eli Lilly Co...
June 1, 2017: Journal of Clinical Densitometry
https://www.readbyqxmd.com/read/28569042/exposure-response-analysis-of-necitumumab-efficacy-in-squamous-non-small-cell-lung-cancer-patients
#15
E Chigutsa, A J Long, J E Wallin
We sought to describe the exposure-response relationship of necitumumab efficacy in squamous non-small cell lung cancer patients and evaluate intrinsic and extrinsic patient descriptors that may guide dosing. SQUIRE was a phase III study comparing necitumumab in combination with gemcitabine and cisplatin vs. gemcitabine and cisplatin alone in 1,014 patients. An integrated model for tumor size dynamics and overall survival was developed, where reduction in tumor size results in a decrease in survival hazard...
August 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28551073/ixekizumab-for-the-treatment-of-patients-with-active-psoriatic-arthritis-and-an-inadequate-response-to-tumour-necrosis-factor-inhibitors-results-from-the-24-week-randomised-double-blind-placebo-controlled-period-of-the-spirit-p2-phase-3-trial
#16
RANDOMIZED CONTROLLED TRIAL
Peter Nash, Bruce Kirkham, Masato Okada, Proton Rahman, Benard Combe, Gerd-Ruediger Burmester, David H Adams, Lisa Kerr, Chin Lee, Catherine L Shuler, Mark Genovese
BACKGROUND: Patients who have had inadequate response to tumour necrosis factor inhibitors have fewer treatment options and are generally more treatment refractory to subsequent therapeutic interventions than previously untreated patients. We report the efficacy and safety of ixekizumab, a monoclonal antibody that selectively targets interleukin-17A, in patients with active psoriatic arthritis and previous inadequate response to tumour necrosis factor inhibitors. METHODS: In this double-blind, multicentre, randomised, placebo-controlled, phase 3 study (SPIRIT-P2), patients were recruited from 109 centres across ten countries in Asia, Australia, Europe, and North America...
June 10, 2017: Lancet
https://www.readbyqxmd.com/read/28530522/factors-associated-with-adherence-to-and-treatment-duration-of-erlotinib-among-patients-with-non-small-cell-lung-cancer
#17
Lisa M Hess, Anthony Louder, Katherine Winfree, Yajun E Zhu, Ana B Oton, Radhika Nair
BACKGROUND: In lung cancer, there is an increasing number of oral agents available for patients; however, little is known about the factors associated with adherence to and treatment duration on oral medications in non-small cell lung cancer (NSCLC). OBJECTIVE: To evaluate the clinical and demographic factors associated with adherence and treatment discontinuation, respectively, to oral oncolytics among patients with NSCLC. METHODS: A retrospective, claims-based analysis of the Humana Research Database supplemented with medical chart review was conducted among patients with NSCLC who started an oral oncolytic between January 1, 2008, and June 30, 2013...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28530521/the-direct-cost-of-managing-a-rare-disease-assessing-medical-and-pharmacy-costs-associated-with-duchenne-muscular-dystrophy-in-the-united-states
#18
Sarah Thayer, Christopher Bell, Craig M McDonald
BACKGROUND: A Duchenne muscular dystrophy (DMD) cohort was identified using a claims-based algorithm to estimate health care utilization and costs for commercially insured DMD patients in the United States. Previous analyses have used broad diagnosis codes that include a range of muscular dystrophy types as a proxy to estimate the burden of DMD. OBJECTIVE: To estimate DMD-associated resource utilization and costs in a sample of patients identified via a claims-based algorithm using diagnosis codes, pharmacy prescriptions, and procedure codes unique to DMD management based on DMD clinical milestones...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28514624/evacetrapib-and-cardiovascular-outcomes-in-high-risk-vascular-disease
#19
RANDOMIZED CONTROLLED TRIAL
A Michael Lincoff, Stephen J Nicholls, Jeffrey S Riesmeyer, Philip J Barter, H Bryan Brewer, Keith A A Fox, C Michael Gibson, Christopher Granger, Venu Menon, Gilles Montalescot, Daniel Rader, Alan R Tall, Ellen McErlean, Kathy Wolski, Giacomo Ruotolo, Burkhard Vangerow, Govinda Weerakkody, Shaun G Goodman, Diego Conde, Darren K McGuire, Jose C Nicolau, Jose L Leiva-Pons, Yves Pesant, Weimin Li, David Kandath, Simon Kouz, Naeem Tahirkheli, Denise Mason, Steven E Nissen
BACKGROUND: The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease. METHODS: In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease...
May 18, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28507774/footnotes-to-kraepelin-changes-in-the-classification-of-mood-disorders-with-dsm-5
#20
EDITORIAL
Nicola J Kalk, Allan H Young
SUMMARY: Reliable diagnosis of mood disorders continues to pose a challenge. This is surprising because they have been recognised clinically since classical times. Mood disorders are also common: major depressive disorder affects nearly 300 million people worldwide and bipolar affective disorder nearly 60 million and they are a major cause of disability. Nonetheless, the reliability trials of the updated Diagnostic and Statistical Manual, Fifth Edition (DSM-5) found that the reliability of the diagnosis of major depressive disorder was in the 'questionable' range...
May 2017: BJPsych Open
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