The NIH has stopped the AIM-HIGH trial 18 months earlier than planned
due to a lack of efficacy in reducing CV 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 CVD were either treated with a combination of a
high-dose, extended release niacin and statin or stain therapy alone. Over the
studys 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
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
Carl J. Pepine
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
Cardiology Today Chief Medical Editor