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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
#1
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)...
June 30, 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
#2
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...
June 27, 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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
Emmanuel Chigutsa, Amanda J Long, Johan 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 3 study comparing necitumumab in combination with gemcitabine and cisplatin versus gemcitabine and cisplatin alone in 1014 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...
May 31, 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
#9
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
#10
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
#11
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
#12
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
#13
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
https://www.readbyqxmd.com/read/28479233/addition-of-gemcitabine-to-paclitaxel-epirubicin-and-cyclophosphamide-adjuvant-chemotherapy-for-women-with-early-stage-breast-cancer-tango-final-10-year-follow-up-of-an-open-label-randomised-phase-3-trial
#14
Helena M Earl, Louise Hiller, Helen C Howard, Janet A Dunn, Jennie Young, Sarah J Bowden, Michelle McDermaid, Anna K Waterhouse, Gregory Wilson, Rajiv Agrawal, Susan O'Reilly, Angela Bowman, Diana M Ritchie, Andrew Goodman, Tamas Hickish, Karen McAdam, David Cameron, David Dodwell, Daniel W Rea, Carlos Caldas, Elena Provenzano, Jean E Abraham, Peter Canney, John P Crown, M John Kennedy, Robert Coleman, Robert C Leonard, James A Carmichael, Andrew M Wardley, Christopher J Poole
BACKGROUND: The tAnGo trial was designed to investigate the potential role of gemcitabine when added to anthracycline and taxane-containing adjuvant chemotherapy for early breast cancer. When this study was developed, gemcitabine had shown significant activity in metastatic breast cancer, and there was evidence of a favourable interaction with paclitaxel. METHODS: tAnGo was an international, open-label, randomised, phase 3 superiority trial that enrolled women aged 18 years or older with newly diagnosed, early-stage breast cancer who had a definite indication for chemotherapy, any nodal status, any hormone receptor status, Eastern Cooperative Oncology Group performance status of 0-1, and adequate bone marrow, hepatic, and renal function...
June 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28465370/phase-i-dose-escalation-study-of-ramucirumab-in-chinese-patients-with-advanced-solid-tumors
#15
Junning Cao, Dongmei Ji, Zhiyu Chen, Weina Shen, Jin Wang, Baoyue Li, Haidong Chi, Amanda Long, Ling Gao, Jin Li
LESSONS LEARNED: Ramucirumab was well tolerated in Chinese patients with advanced solid tumors, and adverse events were manageable in this study.Pharmacokinetics characteristics in Chinese patients were similar to those in other populations. Immunogenicity was not detected.No efficacy conclusion could be drawn, and further randomized studies are warranted. BACKGROUND: This single-arm, nonrandomized, open-label, dose-escalation, phase I study was designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of ramucirumab in Chinese patients with advanced solid tumors that were resistant to standard therapy or no standard therapy was available...
June 2017: Oncologist
https://www.readbyqxmd.com/read/28448782/amcp-partnership-forum-driving-value-and-outcomes-in-oncology
#16
(no author information available yet)
Innovation in cancer treatment has provided a wealth of recently available therapeutic agents and a healthy drug pipeline that promises to change the way we approach this disease and the lives of those affected in the years to come. However, the majority of these new agents, many of which are targeted to specific genomic features of various tumors, may challenge the health care system's ability to afford cancer care. This innovation drives the need to focus on the value of the treatments provided to patients with cancer and on methods to optimize the efficiency of the dollars we spend, in addition to the clinical value itself...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28448778/economic-impact-of-above-label-dosing-with-etanercept-adalimumab-or-ustekinumab-in-patients-with-psoriasis
#17
Steven R Feldman, Yang Zhao, Huanxue Zhou, Vivian Herrera, Haijun Tian, Yunfeng Li
BACKGROUND: Patients with moderate-to-severe psoriasis may be treated with above-label doses of biologics in an attempt to optimize outcomes. Dose escalation will have an effect on the cost of treatment. OBJECTIVE: To examine costs related to above-label use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis. METHODS: A retrospective study was performed using a large U.S. claims database. Patients were included in the study if they were aged ≥ 18 years with a diagnosis of psoriasis (excluding psoriatic arthritis) and had at least 1 medication fill for etanercept, adalimumab, or ustekinumab between January 1, 2011, and June 30, 2012...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28440680/efficacy-and-safety-of-baricitinib-in-japanese-patients-with-active-rheumatoid-arthritis-a-52-week-randomized-single-blind-extension-study
#18
Yoshiya Tanaka, Taeko Ishii, Zhihong Cai, Douglas Schlichting, Terence Rooney, William Macias
OBJECTIVES: The objective of this study is to evaluate the efficacy and safety of long-term (64 weeks; 52-week extension of a 12-week study) baricitinib treatment in Japanese patients with active rheumatoid arthritis (RA) despite methotrexate therapy. METHODS: Patients (N = 145) with active RA were randomized to placebo, 1mg, 2mg, 4mg, or 8mg baricitinib for the first 12 weeks. During the 52-week extension period, patients on 4mg or 8mg baricitinib remained on the same dose and all other patients were re-randomized to 4mg or 8mg baricitinib...
April 25, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28416195/pitavastatin-versus-pravastatin-in-adults-with-hiv-1-infection-and-dyslipidaemia-intrepid-12-week-and-52-week-results-of-a-phase-4-multicentre-randomised-double-blind-superiority-trial
#19
Judith A Aberg, Craig A Sponseller, Douglas J Ward, Vladimir A Kryzhanovski, Stuart E Campbell, Melanie A Thompson
BACKGROUND: People living with HIV-1 infection are at greater risk for cardiovascular disease than seronegative adults. Treatment of dyslipidaemia with statins has been challenging in people with HIV because of an increased potential for drug interactions due to competing cytochrome P450 metabolism between statins and commonly used antiretroviral agents. Neither pitavastatin nor pravastatin depend on cytochrome P450 for primary metabolism. We aimed to assess the safety and efficacy of pitavastatin versus pravastatin in adults with HIV and dyslipidaemia...
July 2017: Lancet HIV
https://www.readbyqxmd.com/read/28388667/the-effect-of-federal-and-state-off-label-marketing-investigations-on-drug-prescribing-the-case-of-olanzapine
#20
Bo Wang, David M Studdert, Ameet Sarpatwari, Jessica M Franklin, Joan Landon, Aaron S Kesselheim
In the past decade, the federal government has frequently investigated and prosecuted pharmaceutical manufacturers for illegal promotion of drugs for indications not approved by the Food and Drug Administration (FDA) ("off-label" uses). State governments can choose to coordinate with the federal investigation, or pursue their own independent state investigations. One of the largest-ever off-label prosecutions relates to the atypical antipsychotic drug olanzapine (Zyprexa). In a series of settlements between 2008 and 2010, Eli Lilly paid $1...
2017: PloS One
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