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Applying Decision Analysis to Inform the US Food and Drug Administration's Benefit-Risk Assessment of Ticagrelor for Primary Prevention of Myocardial Infarction or Stroke Based on THEMIS
Circulation. 2021 Aug 24;144(8):655-658. doi: 10.1161/CIRCULATIONAHA.120.053294. Epub 2021 Aug 23.NO ABSTRACTPMID:34424771 | DOI:10.1161/CIRCULATIONAHA.120.053294
Source: Circulation - August 23, 2021 Category: Cardiology Authors: Leila G Lackey Christine E Garnett Fred Senatore Source Type: research

Benefit-Risk Tradeoffs in Assessment of New Drugs and Devices.
Abstract Balancing benefits and risks is a complex task that poses a major challenge, both to the approval of new medicines and devices by regulatory authorities and in therapeutic decision-making in practice. Several analysis methods and visualization tools have been developed to help evaluate and communicate whether the benefit-risk profile is favorable or unfavorable. In this White Paper, we describe approaches to benefit-risk assessment using qualitative approaches such as the Benefit Risk Action Team framework developed by the Pharmaceutical Research and Manufacturers of America, and the Benefit-Risk Framewor...
Source: Circulation - November 17, 2020 Category: Cardiology Authors: Kaul S, Stockbridge N, Butler J Tags: Circulation Source Type: research

Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Critical Evaluation of Clinical and Regulatory Issues.
This report summarizes these discussions and the key takeaway messages from this meeting. PMID: 31841369 [PubMed - in process]
Source: Circulation - December 16, 2019 Category: Cardiology Authors: Butler J, Packer M, Greene SJ, Fiuzat M, Anker SD, Anstrom KJ, Carson PE, Cooper LB, Fonarow GC, Hernandez AF, Januzzi JL, Jessup M, Kalyani RR, Kaul S, Kosiborod M, Lindenfeld J, McGuire DK, Sabatine MS, Solomon SD, Teerlink JR, Vaduganathan M, Yancy CW, Tags: Circulation Source Type: research

Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association.
ular Biology; Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology Abstract Hypertriglyceridemia (triglycerides 200-499 mg/dL) is relatively common in the United States, whereas more severe triglyceride elevations (very high triglycerides, ≥500 mg/dL) are far less frequently observed. Both are becoming increasingly prevalent in the United States and elsewhere, likely driven in large part by growing rates of obesity and diabetes mellitus. In a 2002 American Heart Association scientific stat...
Source: Circulation - August 18, 2019 Category: Cardiology Authors: Skulas-Ray AC, Wilson PWF, Harris WS, Brinton EA, Kris-Etherton PM, Richter CK, Jacobson TA, Engler MB, Miller M, Robinson JG, Blum CB, Rodriguez-Leyva D, de Ferranti SD, Welty FK, American Heart Association Council on Arteriosclerosis, Thrombosis and Vas Tags: Circulation Source Type: research

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
senfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ, Standardized Data Collection for Cardiovascular Trials Initiative (SCTI) Abstract This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the US Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials in...
Source: Circulation - February 27, 2018 Category: Cardiology Authors: Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, R Tags: Circulation Source Type: research