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https://www.readbyqxmd.com/read/29779195/efficacy-and-safety-of-alirocumab-in-individuals-with-diabetes-mellitus-pooled-analyses-from-five-placebo-controlled-phase-3-studies
#1
Henry N Ginsberg, Michel Farnier, Jennifer G Robinson, Christopher P Cannon, Naveed Sattar, Marie T Baccara-Dinet, Alexia Letierce, Maja Bujas-Bobanovic, Michael J Louie, Helen M Colhoun
INTRODUCTION: Diabetes mellitus (DM) carries an elevated risk for cardiovascular disease. Here, we assessed alirocumab efficacy and safety in people with/without DM from five placebo-controlled phase 3 studies. METHODS: Data from up to 78 weeks were analyzed in individuals on maximally tolerated background statin. In three studies, alirocumab 75 mg every 2 weeks (Q2W) was increased to 150 mg Q2W at week 12 if week 8 low-density lipoprotein cholesterol (LDL-C) was ≥ 70 mg/dL; two studies used alirocumab 150 mg Q2W throughout...
May 19, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29778606/avatrombopag-before-procedures-reduces-need-for-platelet-transfusion-in-patients-with-chronic-liver-disease-and-thrombocytopenia
#2
Norah Terrault, Yi-Cheng Chen, Namiki Izumi, Zeid Kayali, Paul Mitrut, Won Young Tak, Lee F Allen, Tarek Hassanein
BACKGROUND & AIMS: Patients with thrombocytopenia and chronic liver disease (CLD) may require platelet transfusions before scheduled procedures to decrease risk of bleeding. We performed 2 randomized, placebo-controlled, phase 3 trials in patients with thrombocytopenia and CLD undergoing scheduled procedures to evaluate the safety and efficacy of avatrombopag in increasing platelet counts in this patient population METHODS: In the ADAPT-1 and ADAPT-2 studies, adults with thrombocytopenia and CLD (n=231 and n= 204, respectively) were in 1 of 2 cohorts according to their baseline platelet count (below 40x109 /L or 40-50x109 /L) and within each cohort randomized (2:1) to 5 daily doses of avatrombopag (60 mg if baseline platelet count below 40x109 /L or 40 mg if 40-50x109 /L) or placebo...
May 17, 2018: Gastroenterology
https://www.readbyqxmd.com/read/29778325/tranexamic-acid-for-hyperacute-primary-intracerebral-haemorrhage-tich-2-an-international-randomised-placebo-controlled-phase-3-superiority-trial
#3
Nikola Sprigg, Katie Flaherty, Jason P Appleton, Rustam Al-Shahi Salman, Daniel Bereczki, Maia Beridze, Hanne Christensen, Alfonso Ciccone, Ronan Collins, Anna Czlonkowska, Robert A Dineen, Lelia Duley, Juan Jose Egea-Guerrero, Timothy J England, Kailash Krishnan, Ann Charlotte Laska, Zhe Kang Law, Serefnur Ozturk, Stuart J Pocock, Ian Roberts, Thompson G Robinson, Christine Roffe, David Seiffge, Polly Scutt, Jegan Thanabalan, David Werring, David Whynes, Philip M Bath
BACKGROUND: Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage. METHODS: We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset...
May 15, 2018: Lancet
https://www.readbyqxmd.com/read/29774521/patient-reported-outcomes-of-multiple-myeloma-patients-treated-with-panobinostat-after-%C3%A2-2-lines-of-therapy-based-on-the-international-phase-3-randomized-double-blind-placebo-controlled-panorama-1-trial
#4
Paul G Richardson, Robert L Schlossman, Anuja N Roy, Ashok Panneerselvam, Suddhasatta Acharyya, Monika Sopala, Sagar Lonial
The phase 3 PANORAMA-1 trial led to regulatory approvals of panobinostat (PAN) in combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of multiple myeloma after ≥2 prior regimens, including BTZ and an immunomodulatory drug. Patient-reported outcomes (PROs) were assessed in PANORAMA-1, with data available for 73 patients in the PAN + BTZ + DEX arm and 74 patients in the placebo (PBO) + BTZ + DEX arm. Per the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), global health status/quality of life (QoL) scores initially declined with PAN + BTZ + DEX during the first 24 weeks before approaching baseline scores and remaining steady during the next 24 weeks, with no difference between arms at Week 48...
May 17, 2018: British Journal of Haematology
https://www.readbyqxmd.com/read/29773934/iglarlixi-a-new-once-daily-fixed-ratio-combination-of-basal-insulin-glargine-and-lixisenatide-for-the-management-of-type-2-diabetes
#5
Debbie Hinnen, Jodi Strong
Background: Patients with type 2 diabetes require treatment intensification to maintain glycemic control. Clinician reluctance, patient injection fears, hypoglycemia, weight gain, or other objections may lead to clinical inertia, whereby therapy is not intensified and patients live with uncontrolled hyperglycemia and increased risk for complications. Initiation of injectable therapy with a glucagon-like peptide (GLP)-1 receptor agonist and/or basal insulin is a recommended option for patients with type 2 diabetes inadequately controlled on one or more oral agents...
May 2018: Diabetes Spectrum: a Publication of the American Diabetes Association
https://www.readbyqxmd.com/read/29773717/stk11-lkb1-mutations-and-pd-1-inhibitor-resistance-in-kras-mutant-lung-adenocarcinoma
#6
Ferdinandos Skoulidis, Michael E Goldberg, Danielle M Greenawalt, Matthew D Hellmann, Mark M Awad, Justin F Gainor, Alexa B Schrock, Ryan J Hartmaier, Sally E Trabucco, Laurie Gay, Siraj M Ali, Julia A Elvin, Gaurav Singal, Jeffrey S Ross, David Fabrizio, Peter M Szabo, Han Chang, Ariella Sasson, Sujaya Srinivasan, Stefan Kirov, Joseph Szustakowski, Patrik Vitazka, Robin Edwards, Jose A Bufill, Neelesh Sharma, Sai-Hong I Ou, Nir Peled, David R Spigel, Hira Rizvi, Elizabeth Jimenez Aguilar, Brett W Carter, Jeremy Erasmus, Darragh F Halpenny, Andrew J Plodkowski, Niamh M Long, Mizuki Nishino, Warren L Denning, Ana Galan-Cobo, Haifa Hamdi, Taghreed Hirz, Pan Tong, Jing Wang, Jaime Rodriguez-Canales, Pamela A Villalobos, Edwin R Parra, Neda Kalhor, Lynette M Sholl, Jennifer L Sauter, Achim A Jungbluth, Mari Mino-Kenudson, Roxana Azimi, Yasir Y Elamin, Jianjun Zhang, Giulia C Leonardi, Fei Jiang, Kwok-Kin Wong, J Jack Lee, Vassiliki A Papadimitrakopoulou, Ignacio I Wistuba, Vincent A Miller, Garrett M Frampton, Jedd D Wolchok, Alice T Shaw, Pasi A Jänne, Philip J Stephens, Charles M Rudin, William J Geese, Lee A Albacker, John V Heymach
KRAS is the most common oncogenic driver in lung adenocarcinoma (LUAC). We previously reported that STK11/LKB1 (KL) or TP53 (KP) co-mutations define distinct subgroups of KRAS-mutant LUAC. Here, we examine the efficacy of PD-1 inhibitors in these subgroups. Objective response rates to PD-1 blockade differed significantly among KL (7.4%), KP (35.7%), and K-only (28.6%) subgroups (P<0.001) in the SU2C cohort (174 patients) with KRAS-mutant LUAC and in patients treated with nivolumab in the CheckMate-057 phase 3 trial (0% vs 57...
May 17, 2018: Cancer Discovery
https://www.readbyqxmd.com/read/29773662/validation-of-the-16-gene-recurrence-score-in-patients-with-locoregional-high-risk-renal-cell-carcinoma-from-a-phase-3-trial-of-adjuvant-sunitinib
#7
Brian I Rini, Bernard Escudier, Jean-Francois Martini, Ahmed Magheli, Christer Svedman, Margarita Lopatin, Dejan Knezevic, Audrey D Goddard, Phillip G Febbo, Rachel Li, Xun Lin, Olga Valota, Michael Staehler, Robert J Motzer, Alain Ravaud
PURPOSE: Adjuvant sunitinib prolonged disease-free survival (DFS) (hazard ratio [HR] 0.76) in patients with locoregional high-risk renal cell carcinoma (RCC) in the S-TRAC trial (ClinicalTrials.gov NCT00375674). The 16-gene Recurrence Score (RS) assay was previously developed and validated to estimate risk for disease recurrence in patients with RCC post-nephrectomy. This analysis further validated the prognostic value of RS assay in patients from S-TRAC and explored association of RS results with prediction of sunitinib benefit...
May 17, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29772609/measuring-outcomes-of-digital-technology-assisted-nursing-postpartum-a-randomized-controlled-trial
#8
Deborah E Mccarter, Eugene Demidenko, Mark T Hegel
AIM: To determine if delivering electronic messages from nurses during the first six months postpartum is feasible, acceptable and effective in improving mood and decreasing parenting stress. BACKGROUND: Competing demands during the postpartum hospitalization make focused time for nurses to provide education and support difficult. Unmet needs following discharge may increase the incidence of postpartum depression. Untreated depression negatively affects families, especially for vulnerable women with limited access to health care...
May 17, 2018: Journal of Advanced Nursing
https://www.readbyqxmd.com/read/29771953/mitochondrial-disease-patient-motivations-and-barriers-to-participate-in-clinical-trials
#9
Zarazuela Zolkipli-Cunningham, Rui Xiao, Amy Stoddart, Elizabeth M McCormick, Amy Holberts, Natalie Burrill, Shana McCormack, Lauren Williams, Xiaoyan Wang, John L P Thompson, Marni J Falk
BACKGROUND: Clinical treatment trials are increasingly being designed in primary mitochondrial disease (PMD), a phenotypically and genetically heterogeneous collection of inherited multi- system energy deficiency disorders that lack effective therapy. We sought to identify motivating factors and barriers to clinical trial participation in PMD. METHODS: A survey study was conducted in two independent mitochondrial disease subject cohorts. A discovery cohort invited subjects with well-defined biochemical or molecularly- confirmed PMD followed at a single medical center (CHOP, n = 30/67 (45%) respondents)...
2018: PloS One
https://www.readbyqxmd.com/read/29771789/raltegravir-1200-mg-once-daily-vs-400-mg-twice-daily-with-emtricitabine-and-tenofovir-disoproxil-fumarate-for-previously-untreated-hiv-1-infection-week-96-results-from-oncemrk-a-randomized-double-blind-non-inferiority-trial
#10
Pedro Cahn, Paul E Sax, Kathleen Squires, Jean-Michel Molina, Winai Ratanasuwan, Mohammed Rassool, Mark Bloch, Xia Xu, Yan Zhou, Brenda Homony, Deborah Hepler, Hedy Teppler, George J Hanna, Bach-Yen Nguyen, Wayne Greaves
BACKGROUND: Raltegravir 1200mg (2x600mg tablets) once daily (QD) demonstrated non-inferior efficacy and similar safety to raltegravir 400mg BID at Week 48 of the ONCEMRK trial. Here we report the Week 96 results from this study. METHODS: ONCEMRK is a phase 3, multicenter, double-blind, non-inferiority trial comparing raltegravir 1200mg QD to raltegravir 400mg BID in treatment-naïve HIV-1-infected adults. Participants were assigned (2:1) to raltegravir 2x600mg QD or 400mg BID, both with emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) for 96 weeks...
May 3, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29771694/fostemsavir-a-new-cd4-attachment-inhibitor
#11
Pedro Cahn, Valeria Fink, Patricia Patterson
PURPOSE OF REVIEW: Even in the era of modern HAART, antiretroviral (ARV) failure and emergence of drug resistance is still a problem worldwide. New classes with different mechanisms of action are needed to overcome this challenge. After the integrase inhibitors were launched, more than a decade ago, no new classes were added to the ARV armamentarium. RECENT FINDINGS: Fostemsavir (FTR) is an attachment inhibitor, active regardless of viral tropism, without cross-resistance to any of the existing ARV compounds...
May 15, 2018: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/29770836/characterization-of-bonded-stationary-phase-performance-as-a-function-of-qualitative-and-quantitative-chromatographic-factors-in-chaotropic-chromatography-with-risperidone-and-its-impurities-as-model-substances
#12
Jelena Čolović, Milena Rmandić, Anđelija Malenović
Numerous stationary phases have been developed with the aim to provide desired performances during chromatographic analysis of the basic solutes in their protonated form. In this work, the procedure for the characterization of bonded stationary phase performance, when both qualitative and quantitative chromatographic factors were varied in chaotropic chromatography, was proposed. Risperidone and its three impurities were selected as model substances, while acetonitrile content in the mobile phase (20-30%), the pH of the aqueous phase (3...
May 17, 2018: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/29770225/quality-of-life-of-irradiated-brain-tumor-survivors-treated-with-donepezil-or-placebo-results-of-the-wfu-ccop-research-base-protocol-91105
#13
Michelle J Naughton, L Douglas Case, Ann Peiffer, Michael Chan, Volker Stieber, Dennis Moore, Steven Falchuk, James Piephoff, William Edenfield, Jeffrey Giguere, Monica Loghin, Edward G Shaw, Stephen R Rapp
Background: The health-related quality of life (HRQL) and fatigue of brain cancer survivors treated with donepezil or placebo for cognitive symptoms after radiation therapy were examined. Methods: One hundred ninety-eight patients who completed >30 Gy fractionated whole or partial brain irradiation at least 6 months prior to enrollment were randomized to either placebo or donepezil (5 mg for 6 weeks followed by 10 mg for 18 weeks) in a phase 3 trial. A neurocognitive battery, the Functional Assessment of Cancer Therapy-Brain (FACT-Br) and the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue, was administered at baseline, 12 weeks, and 24 weeks...
May 2018: Neuro-oncology Practice
https://www.readbyqxmd.com/read/29767677/randomized-phase-3-study-of-docetaxel-plus-bavituximab-in-previously-treated-advanced-non-squamous-non-small-cell-lung-cancer
#14
D E Gerber, L Horn, M Boyer, R Sanborn, R Natale, R Palmero, P Bidoli, I Bondarenko, P Germonpre, D Ghizdavescu, A Kotsakis, H Lena, G Losonczy, K Park, W-C Su, M Tang, J Lai, N L Kallinteris, J S Shan, M Reck, D R Spigel
Background: Bavituximab is a monoclonal antibody that targets phosphatidylserine in the presence of β2 glycoprotein 1 (β2GP1) to exert an anti-tumor immune response. This phase 3 trial determined the efficacy of bavituximab combined with docetaxel in patients with previously treated advanced non-small cell lung cancer (NSCLC). Patients and Methods: Key eligibility criteria included advanced non-squamous NSCLC with disease progression after treatment with platinum-based doublet chemotherapy, evidence of disease control after at least two cycles of first-line therapy, presence of measurable disease, ECOG performance status 0 or 1, adequate bone marrow and organ function, and no recent history of clinically significant bleeding...
May 14, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29767445/comparison-of-de-novo-igm-and-igg-anti-hla-dsa-between-belatacept-and-calcineurin-treated-patients-an-analysis-of-the-benefit-and-benefit-ext-trial-cohorts
#15
Matthew J Everly, Mustimbo Roberts, Robert Townsend, Robert A Bray, Howard M Gebel
Preventing conversion of donor-specific anti-HLA antibodies (DSA) from an IgM-to-IgG could a way to prevent chronic rejection. We evaluated whether belatacept-treated patients [belatacept less-intensive (LI) more-intensive (MI) regimens] have a lower rate of conversion than cyclosporine A (CsA) treated patients. We included 330 HLA mismatched patients from two phase-3 trials with either (a) complete donor/recipient HLA-A,-B,-DR, and -DQ loci typing or (b) incomplete HLA typing with IgG DSA detected pre- or post-transplant...
May 16, 2018: American Journal of Transplantation
https://www.readbyqxmd.com/read/29766635/efficacy-and-safety-of-mk-1293-insulin-glargine-compared-with-originator-insulin-glargine-lantus-in-type-1-diabetes-a-randomized-open-label-clinical-trial
#16
Philip D Home, Raymond L H Lam, Wendy L Carofano, Gregory T Golm, Roy Eldor, Michael F Crutchlow, Michael C Marcos, Julio Rosenstock, Priscilla A Hollander, Baptist Gallwitz
AIMS: Comparison of the efficacy and safety of MK-1293 insulin glargine (Mk-Gla; 100 U/ml) with originator insulin glargine, Lantus (Sa-Gla) in people with type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: This phase 3, randomized, active-controlled, open-label, 52-week study enrolled 508 people with T1DM (HbA1c ≤ 11.0%; 97 mmol/mol) taking basal and prandial insulin. Participants were randomized 1:1 to once-daily Mk-Gla (n=245) or Sa-Gla (n=263). Dose titration of basal insulin was by a pre-breakfast plasma glucose dosing algorithm...
May 15, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29766456/prognostic-role-for-the-derived-neutrophil-to-lymphocyte-ratio-in-early-breast-cancer-a-geicam-9906-substudy
#17
A J Templeton, Á Rodríguez-Lescure, A Ruíz, E Alba, L Calvo, M Ruíz-Borrego, A Santaballa, C A Rodríguez, C Crespo, M Ramos, J M Gracia-Marco, A Lluch, I Álvarez, M I Casas, M Sánchez-Aragó, R Caballero, E Carrasco, E Amir, M Martin, A Ocaña
PURPOSE: Elevated markers of host inflammation, a hallmark of cancer, have been associated with worse outcomes in several solid tumors. Here, we explore the prognostic role of the derived neutrophil-to-lymphocyte ratio (dNLR), across different tumor subtypes, in patients with early breast cancer. PATIENTS AND METHODS: This was a retrospective analysis of 1246 patients with lymph node-positive, operable early breast cancer enrolled in the GEICAM/9906 trial, a multicenter randomized phase 3 study evaluating adjuvant chemotherapy...
May 15, 2018: Clinical & Translational Oncology
https://www.readbyqxmd.com/read/29763816/design-of-a-phase-3-trial-of-intracoronary-administration-of-human-adenovirus-5-encoding-human-adenylyl-cyclase-type-6-rt-100-gene-transfer-in-patients-with-heart-failure-with-reduced-left-ventricular-ejection-fraction-the-flourish-clinical-trial
#18
William F Penny, Timothy D Henry, Matthew W Watkins, Amit N Patel, H Kirk Hammond
The prognosis of patients with HFrEF remains poor despite the use of current medical and device therapies. Preclinical studies of HFrEF using IC delivery of RT-100, a replication deficient, E1/E3-deleted human adenovirus 5 encoding human AC6 was associated with favorable effects on LV function and remodeling. A recent multicenter, double-blind, placebo-controlled, phase 2 study demonstrated the safety of IC delivery of RT-100 in HFrEF patients and potential efficacy at the higher doses. This phase 2 dose finding study, which included doses not expected to be effective, identified a potential reduction in congestive heart failure admissions in the AC6-treated group one year after randomization...
April 6, 2018: American Heart Journal
https://www.readbyqxmd.com/read/29762284/hss-dysphagia-and-dysphonia-inventory-hss-ddi-following-anterior-cervical-fusion-patient-derived-validated-condition-specific-patient-reported-outcome-measure-outperforms-existing-indices
#19
Alexander P Hughes, Stephan N Salzmann, Okezie K Aguwa, Courtney Ortiz Miller, Roland Duculan, Jennifer Shue, Frank P Cammisa, Andrew A Sama, Federico P Girardi, Ashutosh Kacker, Carol A Mancuso
BACKGROUND: Dysphagia and dysphonia are common complications after anterior cervical spine surgery; however, reported prevalences vary greatly due to a lack of reliable clinical standards for measuring postoperative swallowing and speech dysfunction. The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) was developed as a patient-derived, patient-reported instrument to measure dysphagia and dysphonia more accurately after anterior cervical spine surgery than existing indices...
May 16, 2018: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/29761615/efficacy-and-safety-of-mk-1293-insulin-glargine-compared-with-originator-insulin-glargine-lantus-in-type-2-diabetes-a-randomized-open-label-clinical-trial
#20
Priscilla A Hollander, Wendy L Carofano, Raymond L H Lam, Gregory T Golm, Roy Eldor, Michael F Crutchlow, Michael C Marcos, Marc S Rendell, Philip D Home, Baptist Gallwitz, Julio Rosenstock
AIMS: To compare the efficacy and safety of MK-1293 insulin glargine (Mk-Gla) and Lantus (Sa-Gla) in people with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: This Phase 3, randomized, active-controlled, open-label, 24-week clinical trial enrolled 531 participants with T2DM (HbA1c ≤11.0%) eligible for or currently taking basal insulin (≥10 U/day). Participants were randomized 1:1 to once-daily Mk-Gla (n=263) or Sa-Gla (n=263). Titration of insulin was guided by a fasting plasma glucose (FPG)-based dosing algorithm...
May 14, 2018: Diabetes, Obesity & Metabolism
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