* Fibrates fail to cut heart risk when added to statins
* Study tests Abbott's TriCor plus statins in diabetics
* TriCor cuts risk in those with higher triglycerides
(Adds FDA plans to review data from trial)
By Bill Berkrot and Debra Sherman
ATLANTA, March 14 Adding a
triglyceride-lowering drug to cholesterol-fighting statins
provided no additional protection from heart attack, stroke and
death from heart disease in patients with Type 2 diabetes,
according to data from a large study.
The study run by the National Institutes of Health, dubbed
Accord, aimed to see if the dual-drug therapy could reduce
cardiovascular events in diabetes patients at particularly high
risk of serious heart problems due to additional risk factors,
such as obesity and high blood pressure.
All subjects in the 5,518-patient trial took Merck & Co's
(MRK.N) cholesterol-reducing Zocor, which is available
generically as simvastatin.
One group also received TriCor, an Abbott Laboratories
(ABT.N) medicine to lower the blood fat triglycerides and raise
good HDL cholesterol. TriCor belongs to a class of drugs called
There was an 8 percent risk reduction from the combination
therapy compared with the statin plus placebo, but researchers
said the result did not approach statistical significance, so
the small difference could have been a fluke.
"Although our analysis suggests that certain patients may
benefit from combination therapy, this study provides important
information that should spare many people with diabetes
unneeded therapy with fibrates," said Dr. Henry Ginsberg, the
study's lead investigator, who presented the data at the
American College of Cardiology scientific meeting in Atlanta.
Analysts have said the study was somewhat stacked against
TriCor, as the median baseline triglyceride level of patients
in the trial -- about 162 -- is well below the level of about
300 at which the drug would typically be prescribed.
"While not without risk, major changes in prescribing
habits post Accord seem unlikely," Cowen and Co analyst Sara
Michelmore said in a note prior to release of the data.
Dr Steven Nissen, a prominent cardiologist with the
Cleveland Clinic, disagreed with that assessment.
"The use of fenofibrates will decline precipitously," he
predicted. "It's another troubling example of a drug that was
approved that didn't work."
The U.S. Food and Drug Administration on Sunday said the
data will undergo close scrutiny.
"The FDA will conduct a thorough review of the primary
Accord data as soon as they become available," said agency
spokeswoman Karen Riley.
MEN MAY HAVE BENEFITED
TriCor and Abbott's newer follow-up fibrate, TriLipix, had
combined sales of $1.34 billion in 2009.
A positive result in this patient population could have
greatly expanded use of fibrates such as TriCor and TriLipix.
As expected, TriCor fared better in a subgroup of patients
with a higher median triglyceride level of 284 and low HDL.
Among those patients -- some 17 percent of participants --
the combination therapy led to about a 30-percent reduction in
the risk of the composite goal of heart attack, stroke and
While the risk reduction in the subgroup was not
technically statistically significant, Ginsberg said he
believed it to be a genuine benefit.
"I do think this is real and supports standard use of the
drug, and possibly some expansion of that use to people whose
triglycerides are over 200, rather than over 300," he said.
Researchers also found that men may have benefited from the
dual therapy, while women appeared to have more heart problems
than those on statins alone. The drug, however, has shown a
benefit in women in previous studies.
"The results of Accord were widely expected and not
surprising given that two-thirds of patients in the trial would
not be treated with fibrates under current guidelines," Eugene
Sun, Abbott's vice president for global pharmaceutical
development, said in a statement.
"The results support how fibrates are used in treatment
The overall result could color perception of a pill
awaiting a U.S. approval decision that combines TriLipix with
AstraZeneca's (AZN.L) powerful statin Crestor. A strong finding
in favor of combination therapy might have raised the profile
of that pill to be marketed under the brand name Certriad.
A second prong of the NIH Accord program tested 4,733
patients with Type 2 diabetes and elevated blood pressure.
It found that more intensive blood pressure lowering
failed to cut the risk of heart attacks, strokes and
cardiovascular death significantly more than the current
standard of care.
There were 208 cardiovascular events in patients whose
systolic blood pressure was reduced to below 120, compared with
237 among patients whose target goal was less than 140 --
results researchers deemed not statistically significant.
Current guidelines recommend that adults with Type 2
diabetes maintain systolic blood pressure -- the top number of
a blood pressure reading -- at less than 130.
The risk of stroke alone was significantly cut by about 40
percent in the intensive treatment group, although the total
numbers were low -- 36 versus 62 in the standard care group.
Researchers also noted higher incidence of complications in
the intensive group, including abnormally high levels of blood
potassium, and some measures of kidney function were worse.
"Both of these studies provide evidence that going beyond
the standard of care provides no substantive additional benefit
in this population of adults with diabetes at especially high
risk of cardiovascular events," said Denise Simons-Morton, the
NIH's Accord project officer.
(Reporting by Bill Berkrot and Debra Sherman; editing by
Paul Simao, Ted Kerr and Gunna Dickson)