-- At an 8 a.m. EST press conference today at the American Heart
Association meeting, UB professor of medicine William E. Boden, MD,
discusses the AIM-HIGH clinical trial, which found that niacin
provides no incremental benefit to patients with atherosclerotic
heart disease, whose levels of LDL cholesterol and non-HDL (which
contributes to plaque in the arteries) were very
-- The study results are applicable only to this narrowly
defined patient population, Boden notes.
-- The results are also being published today as the lead
article in the New England Journal of Medicine.
ORLANDO, Fla. -- In patients whose bad cholesterol is very
well-controlled by statins for a long time period, the addition of
high-dose, extended release niacin did not reduce the risk of
cardiovascular events, including heart attack and stroke.
That is the finding being reported today (Nov. 15) at the
American Heart Association annual meeting by the study's
co-principal investigator, University at Buffalo professor of
medicine William E. Boden, MD; the results are also being published
as the lead article in today's New England Journal of Medicine.
Boden was co-principal investigator, along with Jeffrey
Probstfield, MD, professor of cardiology and medicine at the
University of Washington. Both researchers led the Atherothrombosis
Intervention in Metabolic Syndrome with Low HDL/High Triglycerides:
Impact on Global Health (AIM-HIGH) study.
The trial's purpose was to find out if -- in the setting of
well-treated LDL ("bad" cholesterol levels) and low HDL ("good"
cholesterol levels)/elevated triglycerides -- there was an
incremental benefit of adding extended-release niacin.
Unexpectedly, Boden explains, most patients enrolled in the trial
met existing guideline recommendations for LDL and non-HDL levels,
and therefore would not have been considered candidates for further
Many patients with stable heart and vascular disease are still
at high risk for cardiac death, heart attack or stroke even after
their LDL cholesterol has reached ideal levels -- between 40 and 80
mg/dL on statin therapy. It is believed that this increased
residual risk occurs because they have too little HDL cholesterol
along with high levels of triglycerides.
In the AIM-HIGH study, 1,718 patients received a high-dose
(1,500 to 2,000 mg per day) of extended-release niacin, while 1,696
patients received a placebo.
After two years, HDL and triglyceride levels improved in the
niacin group, with a 25 percent increase in good cholesterol, a 29
percent drop in triglycerides and a further decrease in bad
cholesterol of approximately 12 percent. By contrast, in the
placebo group, there was minimal change, with a 10 percent increase
in good cholesterol and an eight percent drop in triglycerides.
The trial found that adding high-dose, extended-release niacin
to statin treatment in these well-controlled patients with heart
and cardiovascular disease, who had low HDL did not further reduce
the risk of cardiovascular events, including heart attacks and
Because of the lack of benefit, the National Heart, Lung and
Blood Institute, upon the recommendation of its Data Safety
Monitoring Committee, decided to stop the trial 18 months before
its planned completion.
"If you are a patient with stable cardiovascular disease who has
achieved and maintained very low levels of LDL cholesterol on a
statin for a long time period, these research findings indicate the
addition of high-dose niacin does not improve your risk for future
events, and is not needed," explains Boden.
He cautions, however, that these results do not apply to the
majority of patients seen in routine clinical settings, where more
than 80 percent are unable to lower their cholesterol levels to the
degree seen in AIM-HIGH.
"The AIM-HIGH trial was designed to study extended-release
niacin or Niaspan, in a specific, narrowly defined patient
population," says Boden. "That is why the results of AIM-HIGH
cannot be extrapolated to apply to a broader patient population,
especially higher-risk patients admitted for heart attack or acute
coronary syndrome, for example, or those whose LDL, or non-HDL
levels, are not as well-controlled as those in AIM-HIGH, where
prior studies have shown benefit.
"The more relevant observation is that, in this modern era of
statin therapy, we've made profound progress in controlling LDL,"
Boden continues. "However, based on these results, physicians
should not assume that boosting HDL levels with Niaspan is without
In addition to Boden and Probstfield, the members of the Writing
Group that authored the NEJM paper are: Todd Anderson, MD, of the
University of Calgary and Libin Cardiovascular Institute; Bernard
R. Chaitman, MD, St. Louis University; Patrice Desvignes-Nickens,
MD, of the National Institutes of Health; Kent Koprowicz and Ruth
McBride of Axio Research; Koon Teo, PhD, of McMaster University;
and William Weintraub, MD, Christiana Care Health Services.
The University at Buffalo is a premier research-intensive public
university, a flagship institution in the State University of New
York system and its largest and most comprehensive campus. UB's
more than 28,000 students pursue their academic interests through
more than 300 undergraduate, graduate and professional degree
programs. Founded in 1846, the University at Buffalo is a member of
the Association of American Universities.