Showing papers by "Mariell Jessup published in 2019"
University of Mississippi Medical Center1, Baylor University Medical Center2, Duke University3, Durham University4, Charité5, Veterans Health Administration6, University of California, Los Angeles7, Harvard University8, American Heart Association9, Johns Hopkins University School of Medicine10, Cedars-Sinai Medical Center11, The George Institute for Global Health12, University of Missouri–Kansas City13, Vanderbilt University14, University of Texas Southwestern Medical Center15, Brigham and Women's Hospital16, San Francisco VA Medical Center17, University of California, San Francisco18, Northwestern University19, Food and Drug Administration20
TL;DR: This topic was discussed by researchers, clinicians, industry sponsors, regulators, and representatives from professional societies, who convened on the US Food and Drug Administration campus on March 6, 2019, and this report summarizes these discussions and the key takeaway messages from this meeting.
Abstract: Following regulatory guidance set forth in 2008 by the US Food and Drug Administration for new drugs for type 2 diabetes mellitus, many large randomized, controlled trials have been conducted with the primary goal of assessing the safety of antihyperglycemic medications on the primary end point of major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Heart failure (HF) was not specifically mentioned in the US Food and Drug Administration guidance and therefore it was not a focus of these studies when planned. Several trials subsequently showed the impact of antihyperglycemic drugs on HF outcomes, which were not originally specified as the primary end point of the trials. The most impressive finding has been the substantial and consistent risk reduction in HF hospitalization seen across 4 trials of sodium glucose cotransporter 2 inhibitors. However, to date, these results have not led to regulatory approval of any of these drugs for a HF indication or a recommendation for use by US HF guidelines. It is therefore important to explore to what extent persuasive treatment effects on nonprimary end points can be used to support regulatory claims and guideline recommendations. This topic was discussed by researchers, clinicians, industry sponsors, regulators, and representatives from professional societies, who convened on the US Food and Drug Administration campus on March 6, 2019. This report summarizes these discussions and the key takeaway messages from this meeting.
17 citations
15 citations
TL;DR: This research examines how sex influences biologic drivers, etiologies, background epidemiology, markers of risk, and care quality in HF, and concludes that women are more likely to be diagnosed with heart failure than men.
Abstract: More women than men currently live with heart failure (HF) in the United States [(1)][1]; this imbalance is projected to persist over the next decade [(2)][2]. Sex influences biologic drivers, etiologies, background epidemiology, markers of risk, and care quality in HF. To bolster enrollment of
12 citations
TL;DR: The greatest barriers to research were insufficient site budgets, delay in contracting, inability to find participants meeting trial entry criteria, and unavailability of qualified study coordinators.
Abstract: Objectives: This study sought to determine clinician and scientist involvement in heart failure (HF) clinical research and to describe the challenges of conducting clinical trials in the Un...
6 citations
1 citations