Study of Seniors Shows Niacin Too Dangerous for
Routine Cholesterol Therapy
Mainstay drug for many seniors now linked to death
risk, dangerous side effects and no benefits in large study of older
Niacin does not reduce heart attacks or strokes
Niacin linked to increase in death risk, excess bleeding and
Statins remain best choice to reduce heart attack and stroke
July 17, 2014 - After 50 years of being a mainstay
cholesterol therapy for many seniors, niacin should no longer be
prescribed for most patients due to potential increased risk of death,
dangerous side effects and no benefit in reducing heart attacks and
strokes, writes Northwestern Medicine preventive cardiologist Donald
Lloyd-Jones, M.D., in a New England Journal of Medicine
Large New Study
Lloyd-Jones's editorial is based on a large new
study published in the journal that looked at senior adults, ages 50 to
80, with cardiovascular disease who took extended-release niacin
(vitamin B3) and laropiprant (a drug that reduces face flushing caused
by high doses of niacin) to see if it reduced heart attack and stroke
compared to a placebo over four years.
All patients in the trial were already being
treated with a statin medication.
Niacin did not reduce heart attacks and stroke
rates compared with a placebo.
More concerning, niacin was associated with an
increased trend toward death from all causes as well as significant
increases in serious side effects: liver problems, excess infections,
excess bleeding, gout, loss of control of blood sugar for diabetics and
the development of diabetes in people who didn't have it when the study
"There might be one excess death for every 200
people we put on niacin," said Lloyd-Jones, chair of preventive medicine
at Northwestern University Feinberg School of Medicine and Northwestern
Memorial Hospital. "With that kind of signal, this is an unacceptable
therapy for the vast majority of patients."
"For the reduction of heart disease and stroke
risk, statins remain the most important drug-based strategy by far
because of their demonstrated benefit and their good safety profile,"
said Lloyd-Jones, who was a member of the task force that rewrote
cholesterol treatment guidelines in 2013 for the American College of
Cardiology and the American Heart Association.
Niacin should be reserved only for patients at
very high risk for a heart attack and stroke who can't take statins and
for whom there are no other evidence-based options, Lloyd-Jones said.
Niacin raises "good" HDL (high density lipoprotein)
cholesterol levels, and having high HDL levels means a lowered risk for
cardiovascular events. But clinical trials have not shown that niacin
reduced the risk of coronary heart disease or the broader cardiovascular
disease specifically by raising HDL. Niacin also produces a modest
reduction in low-density lipoprotein (LDL cholesterol) and a more
substantial reduction in triglyceride levels, which might be expected to
lower the risk of coronary heart disease, Lloyd-Jones notes in the
But the new study suggests that higher HDL levels
only are a sign of lowered risk for heart attacks and stroke. Raising
HDL levels with niacin does not appear to impact cardiovascular outcomes
nor does lowering triglyceride levels, Lloyd-Jones points out.
"The recent niacin clinical trials offer important
new evidence that raising 'good' cholesterol (HDL) levels on top of
statin therapy does not have the positive outcome that had been hoped
for," said Neil Stone, M.D., the Robert Bonow MD Professor in Cardiology
at Feinberg and a cardiologist at Northwestern Memorial Hospital.
"Lowering 'bad' cholesterol (LDL) with an optimal
intensity of tolerated statins and adherence to healthy lifestyle
changes remains the most effective approach to prevent strokes and heart
attacks for patients at risk of cardiovascular disease."
Stone was chair of the expert panel that wrote
rewrote cholesterol treatment guidelines in 2013 for the American
College of Cardiology and the American Heart Association.