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https://www.readbyqxmd.com/read/29752675/estimating-drug-costs-how-do-manufacturer-net-prices-compare-with-other-common-us-price-references
#1
T Joseph Mattingly, Joseph F Levy, Julia F Slejko, Nneka C Onwudiwe, Eleanor M Perfetto
BACKGROUND: Drug costs are frequently estimated in economic analyses using wholesale acquisition cost (WAC), but what is the best approach to develop these estimates? Pharmaceutical manufacturers recently released transparency reports disclosing net price increases after accounting for rebates and other discounts. OBJECTIVE: Our objective was to determine whether manufacturer net prices (MNPs) could approximate the discounted prices observed by the U.S. Department of Veterans Affairs (VA)...
May 12, 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/29744822/study-protocol-for-the-initial-choice-of-dpp-4-inhibitor-in-japanese-patients-with-type-2-diabetes-mellitus-effect-of-linagliptin-on-qol-intel-qol-trial
#2
Tomoya Mita, Toru Hiyoshi, Hidenori Yoshii, Hiroko Chimori, Kazuo Ikeda, Junko Sato, Hirotaka Watada
INTRODUCTION: Consideration of treatment-related quality of life (QOL) is important in diabetes management. However, no studies have compared the influence of dipeptidyl peptidase-4 inhibitors versus metformin on treatment-related QOL when used as first-line therapy in patients with type 2 diabetes mellitus. METHODS: This study is a prospective, randomized, open-label, multicenter, parallel-group, comparative study. Between June 2016 and December 2017, 44 participants who failed to achieve glycemic control despite diet and exercise therapy were recruited at 14 clinics and randomly allocated to linagliptin or metformin therapy...
May 9, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29680881/baricitinib-in-patients-with-rheumatoid-arthritis-and-an-inadequate-response-to-conventional-disease-modifying-antirheumatic-drugs-in-united-states-and-rest-of-world-a-subset-analysis
#3
Alvin F Wells, Maria Greenwald, John D Bradley, Jahangir Alam, Vipin Arora, Cynthia E Kartman
INTRODUCTION: This article evaluates the efficacy and safety of baricitinib 4 mg versus placebo in United States including Puerto Rico (US) and rest of the world (ROW) subpopulations using data pooled from RA-BEAM and RA-BUILD, which enrolled patients with moderate-to-severe adult-onset rheumatoid arthritis (RA). METHODS: In RA-BEAM, patients with an inadequate response (IR) to methotrexate, at least one X-ray erosion, and high sensitivity C-reactive protein (hsCRP) ≥ 6 mg/L were randomized to placebo or orally administered baricitinib 4 mg daily or subcutaneously administered adalimumab 40 mg every other week...
April 21, 2018: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29663262/characteristics-treatment-patterns-and-economic-outcomes-of-patients-initiating-injectable-medications-for-management-of-type-2-diabetes-mellitus-in-japan-results-from-a-retrospective-claims-database-analysis
#4
Shuichi Suzuki, Urvi Desai, Alena Strizek, Jasmina Ivanova, Viviana Garcia-Horton, Zhihong Cai, Luke Schmerold, Xinyue Liu, Magaly Perez-Nieves
INTRODUCTION: This study's objective was to describe characteristics, treatment patterns, and economic outcomes of type 2 diabetes mellitus (T2DM) patients initiating injectable antidiabetic medications in Japan. METHODS: Adults (≥ 18 years) with T2DM, ≥ 2 claims for injectable antidiabetics between 1 August 2011 and 31 July 2015 (first claim = index date), no evidence of type 1 diabetes mellitus, ≤ 1 claim for insulin, no claims for GLP-1RA before index, and continuous enrollment for 6 months before (baseline) and 12 months after index (follow-up) were selected from the Japan Medical Center Database...
April 16, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29649002/jak1-2-inhibition-with-baricitinib-in-the-treatment-of-autoinflammatory-interferonopathies
#5
Gina A Montealegre Sanchez, Adam Reinhardt, Suzanne Ramsey, Helmut Wittkowski, Philip J Hashkes, Yackov Berkun, Susanne Schalm, Sara Murias, Jason A Dare, Diane Brown, Deborah L Stone, Ling Gao, Thomas Klausmeier, Dirk Foell, Adriana A de Jesus, Dawn C Chapelle, Hanna Kim, Samantha Dill, Robert Colbert, Laura Failla, Bahar Kost, Michelle O'Brien, James C Reynolds, Les R Folio, Katherine R Calvo, Scott M Paul, Nargues Weir, Alessandra Brofferio, Ariane Soldatos, Angélique Biancotto, Edward W Cowen, John G Digiovanna, Massimo Gadina, Andrew J Lipton, Colleen Hadigan, Steven M Holland, Joseph Fontana, Ahmad S Alawad, Rebecca J Brown, Kristina I Rother, Theo Heller, Kristina M Brooks, Parag Kumar, Stephen R Brooks, Meryl Waldman, Harsharan K Singh, Volker Nickeleit, Maria Silk, Apurva Prakash, Jonathan M Janes, Seza Ozen, Paul G Wakim, Paul A Brogan, William L Macias, Raphaela Goldbach-Mansky
BACKGROUND: Monogenic Interferon (IFN)-mediated autoinflammatory diseases present in infancy with systemic inflammation, an IFN-response-gene-signature (IRS), inflammatory organ damage and high mortality. We used the janus kinase (JAK) inhibitor baricitinib with IFN-blocking activity in vitro, to ameliorate disease. METHODS: Between October 2011 and February 2017, 10 patients with CANDLE (chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures), 4 with SAVI (Stimulator of IFN genes (STING)-associated vasculopathy with onset in infancy), and 4 patients with other interferonopathies were enrolled in an Expanded Access Program...
April 12, 2018: Journal of Clinical Investigation
https://www.readbyqxmd.com/read/29644618/adherence-to-basal-insulin-therapy-among-people-with-type-2-diabetes-a-retrospective-cohort-study-of-costs-and-patient-outcomes
#6
Magaly Perez-Nieves, Kristina S Boye, Jacek Kiljanski, Dachung Cao, Maureen J Lage
INTRODUCTION: This research compares costs, resource utilization, and complications between adherent and nonadherent patients over the 3-year period post initiation on basal insulin therapy. METHODS: The study utilized the US-based Truven Health MarketScan® Research Databases from 2011 through 2015. Adults aged 18 years or older and identified with type 2 diabetes (T2D) who initiated therapy on basal insulin in 2012 were included. Patients were excluded if they were pregnant, filled their index basal insulin prescription via mail order, or were not continuously insured from 1 year before through 3 years following initiation of treatment with basal insulin...
April 11, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29600503/reproducibility-and-validity-of-a-questionnaire-measuring-treatment-burden-on-patients-with-type-2-diabetes-diabetic-treatment-burden-questionnaire-dtbq
#7
Hitoshi Ishii, Hiroki Shin, Takahiro Tosaki, Tatsuya Haga, Yoshiki Nakajima, Toshihiko Shiraiwa, Nobuaki Watanabe, Miyuki Koizumi, Hiroki Nakajima, Sadanori Okada, Tsuyoshi Mashitani, Takako Mohri, Yasuhiro Akai
INTRODUCTION: To measure the burden of pharmacotherapy on patients with type 2 diabetes mellitus (T2DM), we developed the Diabetes Treatment Burden Questionnaire (DTBQ), a patient-administered questionnaire composed of 18 questions, and evaluated its reproducibility and validity. METHODS: We enrolled 240 patients with T2DM under pharmacotherapy over 20 years of age at seven institutes in Japan. Their physicians filled out report forms on patient backgrounds, and the patients answered both the DTBQ and the Diabetes Treatment Satisfaction Questionnaire (DTSQ)...
March 29, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29574635/relative-contribution-of-fasting-and-postprandial-blood-glucose-in-overall-glycemic-control-post-hoc-analysis-of-a-phase-iv-randomized-trial
#8
Qing Su, Jun Liu, Pengfei Li, Lei Qian, Wenying Yang
INTRODUCTION: Few prospective clinical trials have investigated the role of fasting blood glucose (FBG) and/or postprandial glucose (PPG) in assessing overall glycemic control by using different insulin regimens. In the present post hoc analysis, we assessed the contribution of FBG and/or PPG in overall glycemic control in Chinese patients under insulin treatment. METHODS: CLASSIFY is a phase IV, randomized, open-label, 26-week, parallel-arm, treat-to-target, multinational, controlled study in patients with type 2 diabetes mellitus to compare the efficacy and safety of insulin lispro mix 25 (LM25) and insulin lispro mix 50 (LM50) as starter insulins...
March 24, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29542012/similar-efficacy-and-safety-of-basaglar-%C3%A2-and-lantus-%C3%A2-in-patients-with-type-2-diabetes-in-age-groups-65-years-%C3%A2-65-years-a-post-hoc-analysis-from-the-element-2-study
#9
Robyn K Pollom, Timothy Costigan, Lyndon B Lacaya, Liza L Ilag, Priscilla A Hollander
INTRODUCTION: To compare efficacy and safety of Basaglar® [insulin glargine 100 units/mL; LY insulin glargine (LY IGlar)] to Lantus® [insulin glargine 100 units/mL; SA insulin glargine (SA IGlar)] in older (≥ 65 years) or younger (< 65 years) patients with type 2 diabetes (T2D). METHODS: This subgroup analysis of a phase 3, randomized, double-blind, multinational, 24-week study compared LY IGlar and SA IGlar on several clinical efficacy (change in glycated hemoglobin (A1c), basal insulin dose, weight) and safety outcomes (incidence of adverse events, insulin antibodies, hypoglycemia incidence and rates) in patients either ≥ 65 or < 65 years...
April 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29525885/utilization-patterns-of-glucagon-like-peptide-1-receptor-agonists-in-patients-with-type-2-diabetes-mellitus-in-italy-a-retrospective-cohort-study
#10
Marco Orsini Federici, Janette McQuillan, Giovanni Biricolti, Serena Losi, Jeremie Lebrec, Catrina Richards, Cristiana Miglio, Kirsi Norrbacka
INTRODUCTION: Real-world evidence on glucagon-like peptide-1 receptor agonist (GLP-1 RAs) usage is emerging in different European countries but is lacking in Italy. This retrospective cohort study aimed to describe the real-world drug utilization patterns in patients initiating GLP-1 RAs for treating T2DM in Italy. METHODS: Adults aged ≥ 20 years and with ≥ 1 oral antidiabetic drug (alone or in combination with insulin) other than GLP-1 RAs in the 6 months prior to initiating exenatide twice daily (exBID), exenatide once weekly (exQW), dulaglutide once weekly (DULA), liraglutide once daily (LIRA) or lixisenatide once daily (LIXI) between March and July 2016 were retrospectively identified in the Italian IMS LifeLink™ longitudinal prescriptions database (retail pharmacy data)...
April 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29502174/baricitinib-for-previously-treated-moderate-or-severe-rheumatoid-arthritis-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#11
REVIEW
Shijie Ren, Iñigo Bermejo, Emma Simpson, Ruth Wong, David L Scott, Adam Young, Matt Stevenson
As part of its single technology appraisal process, the National Institute for Health and Care Excellence invited the manufacturer (Eli Lilly) of baricitinib (BARI; Olumiant® ; a Janus kinase inhibitor that is taken orally) to submit evidence of its clinical and cost effectiveness for the treatment of moderate to severe rheumatoid arthritis (RA) after the failure of disease-modifying antirheumatic drugs (DMARDs). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
March 3, 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/29483060/dulaglutide-as-add-on-therapy-to-sglt2-inhibitors-in-patients-with-inadequately-controlled-type-2-diabetes-award-10-a-24-week-randomised-double-blind-placebo-controlled-trial
#12
Bernhard Ludvik, Juan P Frías, Francisco J Tinahones, Julio Wainstein, Honghua Jiang, Kenneth E Robertson, Luis-Emilio García-Pérez, D Bradley Woodward, Zvonko Milicevic
BACKGROUND: Glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose co-transporter-2 (SGLT2) inhibitors improve glycaemic control and reduce bodyweight in patients with type 2 diabetes through different mechanisms. We assessed the safety and efficacy of the addition of the once-weekly GLP-1 receptor agonist dulaglutide to the ongoing treatment regimen in patients whose diabetes is inadequately controlled with SGLT2 inhibitors, with or without metformin. METHODS: AWARD-10 was a phase 3b, double-blind, parallel-arm, placebo-controlled, 24-week study done at 40 clinical sites in Austria, Czech Republic, Germany, Hungary, Israel, Mexico, Spain, and the USA...
May 2018: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29480455/ixekizumab-for-treating-moderate-to-severe-plaque-psoriasis-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#13
REVIEW
Bram L T Ramaekers, Robert F Wolff, Xavier Pouwels, Marije Oosterhoff, Anoukh Van Giessen, Gill Worthy, Caro Noake, Nigel Armstrong, Jos Kleijnen, Manuela A Joore
The National Institute for Health and Care Excellence invited Eli Lilly and Company Ltd, the company manufacturing ixekizumab (tradename Taltz® ), to submit evidence for the clinical and cost effectiveness of ixekizumab. Ixekizumab was compared with tumour necrosis factor-α inhibitors (etanercept, infliximab, adalimumab), ustekinumab, secukinumab, best supportive care and, if non-biological treatment or phototherapy is suitable, also compared with systemic non-biological therapies and phototherapy with ultraviolet B radiation for adults with moderate-to-severe plaque psoriasis...
February 26, 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/29460259/glucagon-like-peptide-1-receptor-agonist-use-and-renal-impairment-a-retrospective-analysis-of-an-electronic-health-records-database-in-the-u-s-population
#14
Kristina S Boye, Fady T Botros, Axel Haupt, Brad Woodward, Maureen J Lage
INTRODUCTION: The study characterizes the use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with type 2 diabetes (T2D) with and without renal impairment and examines the effects of such use on the clinical outcomes of estimated glomerular filtration rate (eGFR) and glycated hemoglobin (A1c). METHODS: Data from the Practice Fusion electronic health records database from 1 January 2012 through 30 April 2015 were used. Adults with T2D who received serum creatinine laboratory tests and initiated therapy with a GLP-1 RA (N = 3225) or other glucose-lowering agent (GLA) (N = 37,074) were included in the analysis...
April 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29436321/effects-of-selective-serotonin-reuptake-inhibitors-on-rating-scale-assessed-suicidality-in-adults-with-depression
#15
Jakob Näslund, Fredrik Hieronymus, Alexander Lisinski, Staffan Nilsson, Elias Eriksson
BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) have been claimed to elicit or aggravate suicidal ideation. Aims To explore the effect of SSRIs on the suicidality item of the Hamilton Rating Scale for Depression (HRSD). METHOD: We undertook a patient-level mega-analysis of adults with depression participating in industry-sponsored studies of sertraline, paroxetine or citalopram, comparing patients on an SSRI (n = 5681) with those on placebo (n = 2581) with respect to HRSD-rated suicidality...
March 2018: British Journal of Psychiatry: the Journal of Mental Science
https://www.readbyqxmd.com/read/29384031/racial-and-ethnic-disparities-in-meeting-mtm-eligibility-criteria-based-on-star-ratings-compared-with-the-medicare-modernization-act
#16
Christina A Spivey, Junling Wang, Yanru Qiao, Ya-Chen Tina Shih, Jim Y Wan, Julie Kuhle, Samuel Dagogo-Jack, William C Cushman, Marie Chisholm-Burns
BACKGROUND: Previous research found racial and ethnic disparities in meeting medication therapy management (MTM) eligibility criteria implemented by the Centers for Medicare & Medicaid Services (CMS) in accordance with the Medicare Modernization Act (MMA). OBJECTIVE: To examine whether alternative MTM eligibility criteria based on the CMS Part D star ratings quality evaluation system can reduce racial and ethnic disparities. METHODS: This study analyzed the Beneficiary Summary File and claims files for Medicare beneficiaries linked to the Area Health Resource File...
February 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29383980/optimizing-anti-vegf-treatment-outcomes-for-patients-with-neovascular-age-related-macular-degeneration
#17
Charles C Wykoff, W Lloyd Clark, Jared S Nielsen, Joel V Brill, Laurence S Greene, Cherilyn L Heggen
BACKGROUND: The introduction of anti-vascular endothelial growth factor (anti-VEGF) drugs to ophthalmology has revolutionized the treatment of neovascular age-related macular degeneration (nAMD). Despite this significant progress, gaps and challenges persist in the diagnosis of nAMD, initiation of treatment, and management of frequent intravitreal injections. Thus, nAMD remains a leading cause of blindness in the United States. OBJECTIVE: To present current knowledge, evidence, and expert perspectives on anti-VEGF therapies in nAMD to support managed care professionals and providers in decision making and collaborative strategies to overcome barriers to optimize anti-VEGF treatment outcomes among nAMD patients...
February 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29365294/trial-of-solanezumab-for-mild-dementia-due-to-alzheimer-s-disease
#18
RANDOMIZED CONTROLLED TRIAL
Lawrence S Honig, Bruno Vellas, Michael Woodward, Mercè Boada, Roger Bullock, Michael Borrie, Klaus Hager, Niels Andreasen, Elio Scarpini, Hong Liu-Seifert, Michael Case, Robert A Dean, Ann Hake, Karen Sundell, Vicki Poole Hoffmann, Christopher Carlson, Rashna Khanna, Mark Mintun, Ronald DeMattos, Katherine J Selzler, Eric Siemers
BACKGROUND: Alzheimer's disease is characterized by amyloid-beta (Aβ) plaques and neurofibrillary tangles. The humanized monoclonal antibody solanezumab was designed to increase the clearance from the brain of soluble Aβ, peptides that may lead to toxic effects in the synapses and precede the deposition of fibrillary amyloid. METHODS: We conducted a double-blind, placebo-controlled, phase 3 trial involving patients with mild dementia due to Alzheimer's disease, defined as a Mini-Mental State Examination (MMSE) score of 20 to 26 (on a scale from 0 to 30, with higher scores indicating better cognition) and with amyloid deposition shown by means of florbetapir positron-emission tomography or Aβ1-42 measurements in cerebrospinal fluid...
January 25, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29290168/the-economic-burden-of-acpa-positive-status-among-patients-with-rheumatoid-arthritis
#19
Jason Shafrin, Mahlet Gizaw Tebeka, Kwanza Price, Chad Patel, Kaleb Michaud
BACKGROUND: Anticitrullinated protein antibodies (ACPAs) are serological biomarkers associated with early, rapidly progressing rheumatoid arthritis (RA), including more severe disease and joint damage. ACPA testing has become a routine tool for RA diagnosis and prognosis. Furthermore, treatment efficacy has been shown to vary by ACPA-positive status. However, it is not clear if the economic burden of patients with RA varies by ACPA status. OBJECTIVE: To determine if the economic burden of RA varies by patient ACPA status...
January 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29278006/relationship-between-disease-activity-and-patient-reported-outcomes-in-rheumatoid-arthritis-post-hoc-analyses-of-overall-and-japanese-results-from-two-phase-3-clinical-trials
#20
Naoki Ishiguro, Maxime Dougados, Zhihong Cai, Baojin Zhu, Masato Ishida, Masayo Sato, Carol Gaich, Amanda Quebe, Ivaylo Stoykov, Yoshiya Tanaka
OBJECTIVE: To examine patient-reported outcomes (PROs) in patients with different rheumatoid arthritis (RA) disease activity levels and identify residual symptoms. METHODS: Post hoc analyses of overall and Japanese data from two randomized controlled trials including RA patients with previous inadequate responses to methotrexate (NCT01710358) or no/minimal previous disease-modifying antirheumatic drug treatment (NCT01711359) (sponsor: Eli Lilly and Company). Week 24 assessments were disease activity (Simplified Disease Activity Index, Disease Activity Score/Disease Activity Score 28 joints-erythrocyte sedimentation rate) and PROs (pain visual analog scale [VAS], morning joint stiffness [MJS], Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue, and Medical Outcomes Study Short Form 36 Health Survey Physical and Mental Component Scores)...
February 2, 2018: Modern Rheumatology
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