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U.S. Department of Health and Human Services

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FDA Statement on the AIM-HIGH Trial

[05-26-2011]

The U.S. Food and Drug Administration (FDA) will conduct a comprehensive review of the results from the clinical trial called the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglyceride and Impact on Global Health Outcomes (AIM-HIGH) once they are available. The AIM-HIGH trial studied whether raising high-density lipoprotein (HDL) or "good" cholesterol levels in patients who have a history of cardiovascular disease and well-controlled low-density lipoprotein (LDL) or "bad" cholesterol levels could lower the rate of major adverse cardiovascular events (MACE). In AIM-HIGH, MACE was defined as cardiovascular death, non-fatal heart attack, ischemic stroke, hospitalizations for acute coronary syndrome in which there is insufficient blood flow to the heart, or revascularization procedures to improve blood flow in the arteries of the heart and brain.

In this trial, all study participants were given standard therapy with simvastatin 40 mg per day, and then randomly assigned to receive either extended-release niacin 1500-2000 mg per day or placebo. In the first year of the trial, the simvastatin dose could be adjusted, or a second LDL cholesterol-lowering drug, ezetimibe 10 mg, could be added, to achieve the target LDL-cholesterol goal of 40-80 mg/dL.

The trial was started in September 2005, but was stopped early due to the lack of incremental benefit on cardiovascular risk reduction in the extended-release niacin plus simvastatin treatment group over simvastatin alone. In addition, a small, unexplained, increase in the rate of ischemic stroke was noted in the simvastatin plus extended-release niacin group compared to the simvastatin alone group (28 strokes [1.6%] vs. 12 strokes [0.7%], respectively). Nine of the ischemic strokes in the simvastatin plus extended-release niacin group occurred in participants who had stopped taking their niacin for at least 2 months and up to 4 years before their stroke. Therefore, it is unclear what role, if any, niacin contributed to this imbalance in ischemic stroke.

At this time, FDA has made no new conclusions or recommendations regarding the use of extended-release niacin alone or in combination with simvastatin or other statins. The Agency will conduct a comprehensive review of the AIM-HIGH trial data as soon as they become available to determine their impact on the approved indications for extended-release niacin.

High-dose niacin is a prescription drug that is used along with diet and exercise to manage cholesterol and fat (triglyceride) levels in the blood. It is also indicated as a monotherapy to lower the risk of heart attacks in patients who have had a heart attack and have high cholesterol. High-dose niacin is available as an extended-release tablet under the brand-name Niaspan, and is also available in combination with simvastatin under the brand-name Simcor, and in combination with lovastatin under the brand-name Advicor.

Healthcare professionals should consider the available clinical information on high-dose extended-release niacin and statin drugs when deciding what cholesterol-lowering medication to prescribe.

Patients should not stop taking their current medications without talking to their healthcare professional.

The Agency will update the public with any new recommendations or conclusions when its review of the AIM-HIGH trial data is complete.

The AIM-HIGH trial was funded by the National Heart, Lung, and Blood Institute (NHLBI).  To view the NHLBI's press release, please visit NIH stops clinical trial on combination cholesterol treatment.