Steven Nissen

In November 2013, the FDA lifted its earlier restrictions on rosiglitazone after reviewing the results of the 2009 RECORD clinical trial (a six-year, open label randomized control trial), which failed to show heart infarct risks associated with the drug.

In 2007, the meta-analysis by Nissen and his co-investigator Kathy Wolksi, published in the Journal of the American Medical Association online on October 20, found that the diabetes drug rosiglitazone (Avandia) produced by GlaxoSmithKline carried high cardiovascular risks,. The FDA issued an alert on May 21, 2007, leading to a warning by the Food and Drug Administration and a sales loss of about 75% for the drug. The FDA was not made aware of the Nissen meta-analysis results until the day of its publication. In an editorial written in the Wall Street Journal, former FDA deputy commissioner Scott Gottlieb characterized the failure to inform FDA of the results in advance of publication as "upstage the FDA in an attempt to influence public debate." BioCentury editor Steve Edelson said that congressional staffers but not the FDA had been briefed on the study results in advance.

In 2006, Nissen and his co-investigators reported on The ASTEROID trial (A Study to Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden). The study concluded that intensive use of statins resulting in a decreased LDL and increased HDL can reverse the build-up of plaque in coronary arteries, as measured by IVUS.

A few years later, in 2005, Nissen re-analyzed the data related to the Bristol-Myers Squibb drug Pargluva (muraglitazar), an experimental type 2 diabetes drug. When an U.S. Food and Drug Administration (FDA) advisory panel charged with reviewing the clinical trial data approved the drug, he immediately began an in-depth analysis.

Also in 2005, Nissen published the results of the REVERSAL trial, a head-to-head comparison of the statins atorvastatin (Lipitor) and pravastatin (Pravachol). IVUS images showed that Lipitor had effectively halted the progression of plaque buildup, but coronary disease progressed considerably in those given Pravachol. The study suggested that treatments should aim to lower LDL cholesterol levels as much as possible.

In 2003 Nissen led a Journal of the American Medical Association study, producing evidence that five weekly infusions of ApoA-I Milano/phospholipids complex, a synthetic form of HDL, can possibly remove significant amounts of plaque from coronary arteries. The lipoprotein enhanced the ability of HDL cholesterol to usher fat out of the arteries and into the liver for excretion leading to the purchase of Esperion Therapeutics, the tiny company that had produced recombinant Apo-A1 Milano, by Pfizer for $1.3 billion.

Nissen has led a number of inquiries as to the scientific integrity of many medications currently on the market. Starting with linked COX-2 inhibitors, such as Vioxx (rofecoxib) in 2001, Nissen was one of the first physicians to link it to an increased risk of heart attacks and strokes. Three years later Merck pulled Vioxx from the market when additional studies confirmed that daily, long-term use of the drug could increase the risk of heart attacks and strokes.

Joining Cleveland Clinic in 1992, Nissen served as Vice-Chairman of the Department of Cardiology (1993–2002), Section Head of Clinical Cardiology (1992–2000), and Director of the Coronary Intensive Care Unit (1992–1997). Most recently, he served as Medical Director of the Cleveland Clinic Cardiovascular Coordinating Center (C5), an organization that directs multi-center clinical trials. Nissen still attends in the Cardiac Critical Care Unit periodically throughout the year.

He produced the first images in humans in 1990 and began using IVUS to document the ubiquitous prevalence of coronary artery disease. The technology has been the basis for his research during the last decade and Nissen is currently the principal investigator for several large IVUS atherosclerosis trials.

Steven E. Nissen (born 1948) is an American cardiologist, researcher and patient advocate. He was chairman of cardiovascular medicine at the Cleveland Clinic, in Cleveland, Ohio.