Charles L. Liss

Vascular Endothelial Growth Factor–B Blockade with CSL346 in Diabetic Kidney Disease

Melisa Cooper, David Z.I. Cherney, Tom Greene, Hiddo J.L. Heerspink et autres

Key Points The vascular endothelial growth factor B inhibitor CSL346 (8 or 16 mg/kg q4w) did not reduce urinary albumin-creatinine ratio at week 16 versus placebo in patients with type 2 diabetes mellitus and diabetic kidney disease. CSL346 was generally well tolerated …

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CSL112 (Apolipoprotein A-I [Human]) Strongly Enhances Plasma Apoa-I and Cholesterol Efflux Capacity in Post-Acute Myocardial Infarction Patients: A PK/PD Substudy of the AEGIS-I Trial

C. Michael Gibson, Syed Hassan A. Kazmi, Serge Korjian, Gerald Chi et autres

INTRODUCTION: Cholesterol efflux capacity (CEC) is impaired following acute myocardial infarction (AMI). CSL112 is an intravenous preparation of human plasma-derived apoA-I formulated with phosphatidylcholine (PC). CSL112 is intended to improve CEC and thereby prevent early recurrent cardiovascular events following AMI. AEGIS-I (ApoA-I …

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Results from a drug utilization study of extended release quetiapine fumarate prescribed by psychiatrists as treatment for major depressive disorder in selected countries in the European Union

Robert S. Brody, Charles L. Liss, Heather Wray, Kari B. Kastango et autres

This multicenter, observational drug utilization (DU) study (NCT01594996) investigated the profile of patients and specialist providers who prescribed extended release quetiapine fumarate (quetiapine XR) for treatment of major depressive disorder (MDD) across five European countries (Germany, Italy, Romania, Spain, and Sweden). A …

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P1106Direct augmentation of cholesterol efflux capacity in AMI patients: a PKPD substudy of AEGIS-I

Michael A. Tortorici, Andreas Gille, Charles L. Liss, Samuel D. Wright et autres

Background: CSL112 is human apolipoprotein A-I (apoA-I), the main functional component of HDL-C. It is in development to reduce the risk of cardiovascular death, myocardial infarction and stroke (ie, MACE) after acute myocardial infarction (AMI). HDL function as assessed by cholesterol efflux …

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Physician Online Survey

Robert S. Brody, Charles L. Liss, Heather Wray, Ramon C Iovin et autres

Effectiveness of a risk-minimization activity involving physician education on metabolic monitoring of patients receiving quetiapine

Robert S. Brody, Charles L. Liss, Heather Wray, Ramon C Iovin et autres

Following Good Pharmacovigilance Practices Module XVI, two complementary studies were performed that included process and outcome measurements of the effectiveness of physician education on metabolic monitoring of patients receiving quetiapine. A multinational survey of 800 European Union physicians was utilized to assess …

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Predictors of the placebo analgesia response - meta-analysis of 9 randomized, double-blind pain studies

Jan Vollert, Märta Segerdahl, Gary Atkinson, Scott F. Marshall et autres

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Antibody persistence ten years after first and second doses of 23-valent pneumococcal polysaccharide vaccine, and immunogenicity and safety of second and third doses in older adults

Daniel M. Musher, Susan B. Manoff, Richard D. McFetridge, Charles L. Liss et autres

In a study of older adults, first and second doses of 23-valent pneumococcal polysaccharide vaccine (PN23) induced IgG increases for all 8 vaccine serotypes tested. Participants (N=143, mean age 76 years) were re-enrolled to study antibody levels after ten years, and safety …

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Safety and Immunogenicity of a Modified Process Hepatitis B Vaccine in Healthy Infants

Timo Vesikari, Jason C. Martin, Charles L. Liss, Vladimír Liška et autres

BACKGROUND: A modified process hepatitis B vaccine (mpHBV) uses higher phosphate content in the manufacturing process relative to the current product, Recombivax-HB. The higher phosphate is thought to improve antigen presentation, and thereby, increase antibody production. The mpHBV was previously shown to …

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Revaccination with a 23‐Valent Pneumococcal Polysaccharide Vaccine Induces Elevated and Persistent Functional Antibody Responses in Adults Aged ⩾65 Years

Susan B. Manoff, Charles L. Liss, Michael J. Caulfield, Rocio D. Marchese et autres

BACKGROUND: Older adults are at high risk of developing invasive pneumococcal disease, but the optimal timing and number of vaccine doses needed to prevent disease among this group are unknown. We compared revaccination with 23-valent pneumococcal polysaccharide vaccine (PN23) with primary vaccination …

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Effectiveness of a Bivalent Haemophilus influenzae Type b–Hepatitis B Vaccine in Preventing Hepatitis B Virus Infection Among Children Born to Hepatitis B e Antigen-Positive Carrier Mothers

Richard R Doherty, Suzanne Marie Garland, Martin R. Wright, Monique Bulotsky et autres

BACKGROUND: This observational study evaluated a modified immunoprophylactic regimen (hepatitis B immune globulin [HBIG]) and a dose of thimerosal-free monovalent hepatitis B (HB) vaccine shortly after birth followed by doses of thimerosal-free bivalent Haemophilus influenzae type b (Hib)-HB vaccine at 2 and …

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Author/Subject Indexes

Julian C. Rosenthal, Françoise Forette, Richard Handfield-Jones, Michel Henry-Amar et autres