NHLBI stops AIM-HIGH trial

Niacin may not be effective in preventing cardiovascular disease. The National Heart Lung and Blood Institute (NHLBI) has prematurely stopped the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health (AIM-HIGH) clinical trial 18 months earlier than planned. Analysis of the data found that adding high-dose, extended-release niacin to statin treatment in people with heart and vascular disease did not reduce the risk of cardiovascular events. AIM-HIGH participants had well-controlled low-density lipoprotein levels on a statin, however they were at risk of cardiovascular disease due to previous history of cardiovascular disease and a combination of low high-density lipoprotein (HDL) cholesterol and high triglycerides. During the nearly 3 years of the study, patients who took high-dose, extended-release niacin with a statin had increased HDL cholesterol and lower triglyceride levels compared to those who took a statin alone; however, the combination was not effective at reducing fatal or nonfatal heart attacks, strokes, hospitalizations for acute coronary syndrome, or revascularization procedures. There also was a "small and unexplained increase in ischemic stroke rates in the high-dose, extended-release niacin group" that contributed to the decision to halt the trial. Termination of the AIM-HIGH trial was announced by press release from the NHLBI on May 26.