Steven E. Nissen, MD, MACC

Steven E. Nissen, MD, MACC, is chief academic officer for the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic, as well as the Lewis and Patricia Dickey Chair in Cardiovascular Medicine and professor of medicine at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University School of Medicine. From 2006 to 2019, he served as chair of the Department of Cardiovascular Medicine at Cleveland Clinic. From 2006 to 2007, he served as president of the American College of Cardiology, the professional society representing American cardiologists.

His initial research focused on the application of intravascular ultrasound imaging in the assessment of progression and regression of coronary atherosclerosis, conducting more than a dozen randomized controlled trials, most of which were published in The New England Journal of Medicine or the Journal of the American Medical Association. More recently, he served as study chairman for large global cardiovascular outcomes trials, most studying lipid-modifying therapies. He has directed or is directing clinical trials of several therapies for patients with elevated lipoprotein(a), including studies of pelacarsen, zerlasiran, and lepodisiran. He has also published extensively on the topics of obesity, cardiovascular disease, and drug safety. In 2001, he coauthored the first manuscript (published in the Journal of the American Medical Association) that raised concerns about the cardiovascular safety of rofecoxib, which was withdrawn from the market 3 years later. In 2007, he authored a The New England Journal of Medicine manuscript demonstrating that the widely used diabetes drug rosiglitazone raised the risk of myocardial infarction, eventually leading to the withdrawal of the drug in Europe in 2010 and severe restrictions in the United States. Dr Nissen’s contributions to the scientific literature include 700 journal articles and 60 book chapters. He is coauthor of a book for patients with heart disease, Heart 411, published by Crown Books.

Dr Nissen works closely with pharmaceutical companies on the development of new therapies for cardiovascular disease but maintains a longstanding policy of requiring companies to donate all related honoraria directly to charity so that he receives neither income nor a tax deduction.

He served as a member of the Cardiovascular and Renal Drugs Advisory Panel of US Food and Drug Administration (FDA) for 5 years and as chairman during the final year of his membership. Dr Nissen continues to serve as an advisor to several FDA committees as a “special government employee.” In July 2008, while serving as guest member of the Endocrine and Metabolic Drugs Advisory Committee, he recommended a new approach for the approval of diabetes drugs, which was ultimately adopted by the FDA in December 2008.

Dr Nissen is also known for his role in public policy discussions. He has testified before both the Senate (Health Education and Labor Committee) and the House of Representatives (Energy and Commerce Committee) on FDA policy. He was actively involved in discussions with Congress on the Food and Drug Administration Amendments Act of 2007 that added additional regulatory authority for the agency.

In 2007, TIME magazine selected Dr Nissen as one of the world’s 100 most influential people. Beginning in 2015, he has been named by Thomson Reuters as one of the world’s most highly cited physician-scientists.