Good morning. Today we are announcing the early stopping of the AIM HIGH trial, which has met its objectives. This major clinical trial studied whether adding high dose, extended- release niacin, under the brand name Niaspan, to statin treatment in individuals with cardiovascular disease would reduce their risk of major cardiovascular events, such as heart attack and stroke.
Medical therapies for cardiovascular disease have made tremendous progress. However, there is still a burden of cardiovascular disease among people whose LDL or “bad” cholesterol is in the desirable range, particularly among those whose HDL or “good” cholesterol and triglycerides remain in undesirable ranges. The participants in the AIM HIGH study meet these criteria. The NHLBI supported this study to test whether raising HDL and lowering triglycerides would reduce the risk of cardiovascular events among patients with this profile.
The study has ended 18 months early because we answered the primary question. While high dose niacin raised participants’ HDL cholesterol and lowered triglycerides, it did not affect the overall rate of cardiovascular events.
There was also an unexplained higher rate of ischemic stroke in the high dose niacin group compared to the group on statins alone. It remains unclear whether this trend arose by chance, but this trend contributed to the Institute’s decision to stop the trial early in the context of lack of efficacy. The overall frequency of stroke was less than 1 percent and previous studies do not suggest that stroke is a potential complication of niacin. The FDA is aware of the findings and plan, and is recommending no change in labeling or practice pending full analysis of the data. The FDA statement on AIM-HIGH is now posted on its website, and we will be linking to it as well.
Over the years, scientists have sought ways to reduce the incidence of cardiovascular events that remains in patients whose LDL cholesterol has been effectively lowered but who still have low HDL cholesterol and high triglycerides. Higher HDL cholesterol is known to be associated with a lower cardiovascular risk, but it has not been clear whether treatments to raise HDL cholesterol in those with low levels would affect the risk. This was the scientific justification for AIM-HIGH, which is a well designed study. Although no clinical benefit was found, the study contributes to our understanding of cholesterol and cardiovascular disease and promises to guide future research efforts. Cardiovascular disease remains a critical public health issue. The NHLBI continues to pursue ways to reduce risk and develop new therapies.
Now that the study has been stopped and participants have been informed, we will begin the important task of analyzing the data in detail. In depth analyses will be presented at a national scientific meeting and in publications in late 2011. Today you will learn the details of AIM-HIGH’s results that led to the decision to stop the trial, as well as insights into the strategy of raising HDL levels to reduce cardiovascular risk.
Our first speaker today will be Dr. William Boden, professor of medicine and preventive medicine at the University of Buffalo School of Medicine and Public Health and co-principal investigator of the AIM-HIGH study. Dr. Boden will discuss the background, rationale, and design of AIM-HIGH. Then Dr. Jeffrey Probstfield, professor of medicine and epidemiology at the University of Washington, Seattle and AIM-HIGH co-principal investigator, will discuss the results. Ruth McBride, co-director of the study’s Data Coordinating Center at Axio Research, in Seattle, Washington, is available to answer questions.
Thank you Dr. Probstfield and Dr. Boden for providing the details and results of this study. In summary, we have stopped the AIM HIGH trial because we answered an important scientific question: although high dose niacin effectively raised the participants’ HDL cholesterol, it did not affect the overall rate of cardiovascular events. The unexplained risk of stroke in the group that took extended-release niacin also contributed to the decision to stop the trial before its planned conclusion. Studies such as these are extremely important to determine whether promising therapies have real world benefit to patients. The results of this study build upon our body of knowledge and, as we analyze the data further, will help guide future research, and provide important evidence for the FDA in making labeling decisions.
Before we take questions, I would like to acknowledge the outstanding work of the principal investigators and staff of the AIM HIGH trial at 90 clinical sites as well as the NHLBI’s project office staff, including Drs. Patrice Desvigne-Nickens, Jerome Fleg and Song Yang. Thank to the DSMB for thoughtful oversight and monitoring. All of these individuals have shown great dedication and commitment to this important research effort. My thanks also go to Abbott Pharmaceuticals for substantial support and drug as we seek an independent investigation of the HDL hypothesis. In addition, we are most grateful to Merck Pharmaceuticals for providing the statins used in the trial.
Most of all, I want to extend the Institute’s deepest appreciation to the 3,414 study participants and the investigators in the U.S. and Canada. Without them, this trial would not have been possible and their efforts have helped us advance our knowledge in the important public health area. Now we will be pleased to take your questions. Please identify yourself and your organization.
Thank you for participating in today’s press briefing. An audio playback of this briefing will be available within two hours of the end of this call. Call 1-800-642-1687 or if you are outside of the U.S. and Canada, call 706-645-9291. The conference ID for both numbers is 6818 2914. A recording of this briefing will also be posted on the NHLBI website, where you will find additional information. The url is www.nhlbi.nih.gov.