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Ironwood Highlights Breadth of Gout Research with Presentations at the American College of Rheumatology 2016 Annual MeetingIronwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced a series of oral and poster presentations to be presented at the upcoming American College of Rheumatology (ACR) Annual Meeting in Washington, D.C. from November 11 to 16, 2016. The poster presentations include data from two lesinurad extension studies that enrolled patients from the pivotal Phase III CLEAR1, CLEAR2 and CRYSTAL trials, as well as a pooled analysis of renal safety from pivotal Phase III and extension studies of lesinurad, and an integrated safety study of lesinurad's three pivotal trials and extension studies. Results from the CLEAR1 pivotal trial were published in the August 2016 issue of Arthritis & Rheumatology. Other presentations will address the potential long-term health consequences of gout with respect to such topics as heart failure, cardiometabolic risk, and progression of chronic kidney disease. The titles and scheduled times of the presentations are as follows:
Safety and Efficacy of Lesinurad: Clinical Response of Tophus and Flares to Extended Use of Lesinurad in Combination With a Xanthine Oxidase Inhibitor in Patients With Gout (CLEAR/CRYSTAL Extension) (abstract #209, poster), to be presented during the Metabolic and Crystal Arthropathies Poster Session I: Clinical Practice on Sunday, Nov. 13, 2016, 9:00 a.m. - 11:00 a.m. Eastern Time, by Thomas Bardin, M.D., Lariboisière Hospital, Paris, France. Renal Safety of Lesinurad: A Pooled Analysis of Phase III and Extension Studies (abstract #206, poster), to be presented during the Metabolic and Crystal Arthropathies Poster Session I: Clinical Practice on Sunday, Nov. 13, 2016, 9:00 a.m. - 11:00 a.m. Eastern Time, by Robert Terkeltaub, M.D., University of California, San Diego. Integrated Safety of Lesinurad, A Novel Uric Acid Reabsorption Inhibitor for the Treatment of Gout (abstract #207, poster), to be presented during the Metabolic and Crystal Arthropathies Poster Session I: Clinical Practice on Sunday, Nov. 13, 2016, 9:00 a.m. - 11:00 a.m. Eastern Time, by Michael A. Becker, M.D., University of Chicago.
Potential Long-Term Health Consequences of Gout: Cardiometabolic Risk and Subclinical Urate Deposits in Patients with Symptomatic Hyperuricemia and Metabolic Syndrome (abstract #2293, poster), to be presented during the Innate Immunity and Rheumatic Disease Poster Session II: Epidemiology and Mechanisms of Disease on Tuesday, Nov. 15, 2016, 9:00 a.m.-11:00 a.m. Eastern Time, by Seoyoung C. Kim, M.D., Sc.D., MSCE, Brigham and Women's Hospital and Harvard Medical School. Association of Gout with Risk of Advanced Chronic Kidney Disease (abstract #3188, oral), to be presented during the Epidemiology and Public Health Oral Session III: Psoriatic Arthritis and More on Wednesday, Nov. 16, 2016, 11:00 a.m. - 12:30 p.m. Eastern Time, by Austin Stack, M.D., M.Sc., FRCPI, University Hospital Limerick & Health Research Institute, University of Limerick, Limerick, Ireland.
Disease State and Mechanism of Action Studies: Evidence of Phospho-Degron Regulating Expression of Urate Secretory Transporter ABCG2 (abstract #2274, poster), to be presented during the Metabolic and Crystal Arthropathies Poster Session II: Epidemiology and Mechanisms of Disease on Tuesday, Nov. 15, 2016, 9:00 a.m. - 11:00 a.m. Eastern Time, by Alexis Hofherr, M.D., Ph.D., University of Freiburg Medical Center, Freiburg im Breisgau, Germany. Fructose Amplifies Inflammatory Potential in Human Monocytic Cells Via Reduction of AMP-Activated Protein Kinase Activity (abstract #2268, poster), to be presented during the Innate Immunity and Rheumatic Disease Poster Session II on Tuesday, Nov. 15, 2016, 9:00 a.m. - 11:00 a.m. Eastern Time, by Xihua Cao, Ph.D., Veterans Medical Research Foundation (VMRF), San Diego, California.
Health Economics Studies: Comparing the Burden of Illness of Patients with Tophaceous and Non-Tophaceous Gout in France, Germany, Italy, Spain, UK, and USA (abstract #226, poster), to be presented during the Metabolic and Crystal Arthropathies Poster Session I: Clinical Practice on Sunday, Nov. 13, 2016, 9:00 a.m. - 11:00 a.m. Eastern Time, by Puja Khanna, M.D., M.P.H., University of Michigan. Relationship Between Patient and Disease Factors and Severity of Gout in a Real-World Population (abstract #229, poster), to be presented during the Metabolic and Crystal Arthropathies Poster Session I: Clinical Practice on Sunday, Nov. 13, 2016, 9:00 a.m. - 11:00 a.m. Eastern Time, by Michael Pillinger, M.D., New York University. Health Economics of Uncontrolled Gout in the United States: A Systematic Literature Review (abstract #2241, poster), to be presented during the Health Services Research - Poster Session III on Tuesday, Nov. 15, 2016, 9:00 a.m. - 11:00 a.m. Eastern Time, by Shaum Kabadi, Ph.D., M.P.H., AstraZeneca. Development and Pilot Testing of an Online Educational Tool for Gout Patients - Mygoutcare® (abstract #3130, oral), to be presented during the Metabolic and Crystal Arthropathies Oral Session II: Clinical Practice on Wednesday, Nov. 16, 2016, 9:00 a.m. - 10:30 a.m. Eastern Time, by Puja Khanna, M.D., M.P.H., University of Michigan. Serum Uric Acid Testing Practices Over Five Years Among Incident Gout Cases (abstract #1225, poster), to be presented during the Health Services Research - Poster Session II on Monday, Nov. 14, 2016, 9:00 a.m. - 11:00 a.m. Eastern Time, by Dena Jaffe, Ph.D., Kantar Health, Tel Aviv, Israel.
About Hyperuricemia and Gout Approximately four million patients are treated with a xanthine oxidase inhibitor (XOI), either allopurinol or febuxostat, for gout in the U.S. Of these, an estimated two million patients are uncontrolled and are not achieving target serum uric acid (sUA) levels <6 mg/dL as recommended by the American College of Rheumatology, despite treatment with an XOI alone. These patients continue to suffer from flares despite treatment with an XOI alone, and may face serious long-term consequences that can result from having uncontrolled sUA levels.
About ZURAMPIC® (lesinurad) 200 mg tablets
Contraindications:
Warnings and Precautions:
Adverse Reactions:
Indication and Limitations of Use for ZURAMPIC:
Please see full Prescribing Information, including Boxed WARNING, http://www.azpicentral.com/zurampic/zurampic.pdf.
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