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| FILE - In this Wednesday, May 15, 2013, file photo, a pharmacist works at his desk located next to the prescription pick up counter in New York. New details from two studies reveal more side effects from niacin, a drug that hundreds of thousands of Americans take for cholesterol problems and general heart health. |
New details from two
studies reveal more side effects from niacin, a drug that hundreds of
thousands of Americans take for cholesterol problems and general heart
health. Some prominent doctors say the drug now seems too risky for
routine use.
Niacin is a type of B vitamin
long sold over the counter and in higher prescription doses. Some people
take it alone or with statin medicines such as Lipitor for cholesterol
problems.
Niacin users' main complaint has
been flushing, so drug companies have been testing extended-release and
combining other medicines with it to minimize that problem. Introduced
in the 1950s, the drug hadn't been rigorously tested until recent years
when makers of prescription versions were seeking market approval.
The
two studies were testing prescription versions of niacin, and the
bottom line - that it didn't help prevent heart problems any more than
statins alone do - has already been announced. Some of the side effect
information, including a troubling rise in deaths among niacin users in
one study, also was known but many doctors have been waiting for full
details and verification of the results before drawing firm conclusions
about the drug's safety and effectiveness.
Those details are in this week's New England Journal of Medicine.
The
larger study suggests that "for every 200 people that we treat with
niacin, there is one excess death," plus higher rates of bleeding,
infections and other problems - "a completely unacceptable level" of
harm, said Dr. Donald Lloyd-Jones of Northwestern University in Chicago.
"Niacin should not be used routinely in clinical practice at all."
He
co-led a panel for the American Heart Association and American College
of Cardiology that recently issued new cholesterol treatment guidelines.
The group did not recommend niacin but said it could be considered for
certain patients. If the panel had seen the new results, it "almost
certainly" would have recommended against niacin's routine use,
Lloyd-Jones said.
Heart specialists stress
that patients never should stop taking any medicine without first
talking with their doctors. Many have shied away from niacin since the
initial results came out, but more than 700,000 prescriptions for
various niacin drugs are written each month in the U.S. The top brand is
Niaspan, long sold by Abbott Laboratories and now by AbbVie, which had
nearly $900 million in sales in the U.S. alone last year, according to
IMS Health, a health data firm.
The larger of
the two studies tested Tredaptive - a Merck & Co. combo of niacin
and an anti-flushing medicine - in nearly 26,000 people already taking a
statin. Full results confirm there was a 9 percent increase in the risk
of death for those taking the drug - a result of borderline statistical
significance, meaning the difference could have occurred by chance
alone, but still "of great concern," Lloyd-Jones wrote in a commentary
in the medical journal.
The drug also brought
higher rates of gastrointestinal and muscle problems, infections and
bleeding. More diabetics on the drug lost control of their blood sugar,
and there were more new cases of diabetes among niacin users.
The
initial results in December 2012 led Merck to stop pursuing approval of
Tredaptive in the U.S. and to tell doctors in dozens of countries where
it was sold to stop prescribing it to new patients.
Prompted
by that study, leaders of an earlier one that tested a different niacin
drug, Niaspan, re-examined side effects among their 3,414 participants
and detailed them in a letter in the medical journal.
Besides
more gastrointestinal, blood-sugar and other complications, the new
report details a higher rate of infections and a trend toward higher
rates of serious bleeding.
The consistency of
the results on studies testing multiple types of niacin "leaves little
doubt that this drug provides little if any benefits and imposes serious
side effects," said Yale University cardiologist Dr. Harlan Krumholz.
"It's
an astonishing reversal of fortune" for niacin, one of the very
earliest cholesterol treatments, he said.
"This is a billion-dollar drug
and it never really had the evidence to warrant that sort of
blockbuster status."
The studies were on prescription niacin; risks and benefits of over-the-counter forms are unclear.
Lloyd-Jones
said niacin still may be appropriate for some people with very high
heart risks who cannot take statins, and for people with very high
triglycerides that can't be controlled through other means.
Krumholz said patients should talk with doctors about other treatment options besides niacin.
"This drug can hurt you," he said.
