AIM-HIGH study halted prematurely by NIH

The NIH has stopped the AIM-HIGH trial 18 months earlier than planned due to a lack of efficacy in reducing cardiovascular events of a combined treatment of niacin and statin compared with statin alone.

In the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides (AIM-HIGH) trial, 3,414 patients from the United States and Canada with a history of cardiovascular disease were either treated with a combination of a high-dose, extended release niacin and statin or stain therapy alone. Over the study’s 32 months of follow-up, patients who took the combined therapy had increased HDL cholesterol and lowered triglyceride levels. Despite this, the combination treatment failed to reduce fatal or non-fatal heart attacks, strokes, revascularization procedures or hospitalizations for acute coronary syndrome.

The FDA, in an official statement released in an email, noted that the role niacin may have played in the reported imbalance in ischemic stroke was not yet clear.

“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,” they wrote in the statement. “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.”

The study was funded by NHBLI with additional support from Abbott. The full NIH press release is available here.

Carl J. Pepine, MD

I would hope that this information improves the quality of life for those patients who are repeatedly encouraged to continue to take these preparations despite their very annoying cutaneous side effects.

– Carl J. Pepine, MD

Professor of Medicine
the University of Florida, Gainesville

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