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Eli Lilly

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...
March 14, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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)...
March 10, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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
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...
February 23, 2018: Lancet Diabetes & Endocrinology
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
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...
February 19, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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
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
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
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
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
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)...
December 26, 2017: Modern Rheumatology
Iain Simpson
This industry update covers the period from 1 September through 30 September 2017, and is based on information sourced from company press releases, scientific literature, patents and various news websites. The month saw the US FDA approve three new molecular entities, Aliqopa (copanlisib dihydrochloride) (Bayer Healthcare); Solosec (secnidazole) (Symbiomix Therapeutics) and Verzenio (abemaciclib) (Eli Lilly and Co). Intarcia Therapeutics Inc. has its application for approval of a novel drug device combination of exenatide for the treatment of diabetes rejected by FDA but said that it will work to address the concerns and refile the application...
January 2018: Therapeutic Delivery
Alice B Gottlieb, Brian Kirby, Caitriona Ryan, April N Naegeli, Russel Burge, Alison Potts Bleakman, Milena D Anatchkova, Jennifer Cather
INTRODUCTION: Patient-reported outcome measures (PROs) exist for psoriasis but not genital psoriasis (GenPs). METHODS: This cross-sectional, qualitative study in patients with moderate-to-severe GenPs was conducted to support development of a PRO for measuring the impact of GenPs on sexual activity and to establish content validity. The impacts of GenPs were identified in a literature review. Findings from the literature review were discussed with clinicians, and then patients with GenPs were interviewed...
March 2018: Dermatology and Therapy
Alice B Gottlieb, Brian Kirby, Caitriona Ryan, April N Naegeli, Russel Burge, Alison Potts Bleakman, Milena D Anatchkova, Gil Yosipovitch
INTRODUCTION: Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described. METHODS: In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs...
March 2018: Dermatology and Therapy
Edward Li, Ernesto Lobaina
BACKGROUND: The FDA's extrapolation framework allows for a biosimilar to obtain licensure for indications that were not explicitly studied in the context of a clinical trial by extending conclusions from studies in 1 population to make inferences in other populations. Within routine clinical care, drugs and biologics are routinely used for medically accepted off-label indications. The appropriateness of these products for off-label indications are typically curated by compendia and guidelines, which have established processes and criteria for reviewing and evaluating the evidence to make such determinations...
December 2017: Journal of Managed Care & Specialty Pharmacy
Roy S Herbst, Mary W Redman, Edward S Kim, Thomas J Semrad, Lyudmila Bazhenova, Gregory Masters, Kurt Oettel, Perry Guaglianone, Christopher Reynolds, Anand Karnad, Susanne M Arnold, Marileila Varella-Garcia, James Moon, Philip C Mack, Charles D Blanke, Fred R Hirsch, Karen Kelly, David R Gandara
BACKGROUND: EGFR antibodies have shown promise in patients with advanced non-small-cell lung cancer (NSCLC), particularly with squamous cell histology. We hypothesised that EGFR copy number by fluorescence in-situ hybridisation (FISH) can identify patients most likely to benefit from these drugs combined with chemotherapy and we aimed to explore the activity of cetuximab with chemotherapy in patients with advanced NSCLC who are EGFR FISH-positive. METHODS: We did this open-label, phase 3 study (SWOG S0819) at 277 sites in the USA and Mexico...
January 2018: Lancet Oncology
Mickael Basson, Dionysios Ntais, Ruba Ayyub, Donna Wright, Julia Lowin, Florence Chartier, Stéphane Roze, Kirsi Norrbacka
INTRODUCTION: Dulaglutide is a novel onceweekly administered glucagon-like peptide 1 receptor agonist (GLP-1 RA) for the management of type 2 diabetes mellitus (T2DM). The objective of this analysis was to estimate the cost-effectiveness of dulaglutide 1.5 mg versus exenatide QW for the management of T2DM in France. METHODS: The QuintilesIMS CORE Diabetes Model was used to estimate the expected lifetime direct medical costs and outcomes of T2DM from the perspective of the French National Health Service...
November 13, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Esther S Kim
Abemaciclib (Verzenio™) is an orally administered inhibitor of cyclin-dependent kinases 4 and 6 that is being developed by Eli Lilly and Company. Abemaciclib has been approved in the USA for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with fulvestrant in women with disease progression following endocrine therapy, and as monotherapy in adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting...
December 2017: Drugs
Gary Deed, Gary Kilov, Trisha Dunning, Richard Cutfield, Jane Overland, Ted Wu
INTRODUCTION: Premixed insulin analogs represent an alternative to basal or basal-bolus insulin regimens for the treatment of type 2 diabetes (T2D). "Low-mix" formulations with a low rapid-acting to long-acting analog ratio (e.g., 25/75) are commonly used, but 50/50 formulations (Mix50) may be more appropriate for some patients. We conducted a systematic literature review to assess the efficacy and safety of Mix50, compared with low-mix, basal, or basal-bolus therapy, for insulin initiation and intensification...
December 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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