The trial, called AIM-HIGH, was aimed to see whether individuals with heart and vascular disease might have better outcomes if they added niacin to their statin treatment.
The study involved patients who were at risk of suffering a cardiovascular event, such as a stroke or heart attack, even though their low-density lipoprotein (LDL) levels were well controlled. These patients already had a history of cardiovascular disease, and high LDL and triglyceride levels.
Patients with high triglyceride and low HDL levels are known to have a higher risk of experiencing a cardiovascular event. Whether raising HDL levels might improve their outcomes has never been shown.
The trial, involving 3,414 American and Canadian patients, compared patients on statin therapy alone (1,696) to those on statins plus high-dose extended release niacin (1,718). The niacin patients did eventually have higher HDL cholesterol levels, as well as lower blood levels of triglycerides, compared to the statin-only patients.
However, their risk of having a stroke or a heart attack (fatal or non fatal) remained the same, as was their likelihood of having to be admitted to hospital. The study leaders added that the niacin combination patient's chances of requiring a revascularization procedure remained the same too.
All the study participants had a history of cardiovascular disease and had been taking statins to control their LDL levels before the trial began. They all had low HDL and high triglyceride levels - they had a higher-than-normal risk of experiencing future cardiovascular events.
The trial was to last from 2006 till 2012. Patients were aged 64 years (average). 34% of them had diabetes, more than half of them had had a heart attack before the study, 71% had high blood pressure, 81% had metabolic syndrome, and 92% had coronary artery disease.
Acting NHLBI Director, Susan B. Shurin, M.D., said:
"Seeking new and improved ways to manage cholesterol levels is vital in the battle against cardiovascular disease. This study sought to confirm earlier and smaller studies. Although we did not see the expected clinical benefit, we have answered an important scientific question about treatment for cardiovascular disease. We thank the research volunteers whose participation is key in advancing our knowledge in this critical public health area, and the dedicated investigators who conducted the study."
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