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 Guidelines issued last year by the American Heart Association and
the American College of Cardiology asked doctors to assess
individual patients' risk for heart disease over 10 years based on a
complex calculation of risks posed by lifestyle, family history and
other health conditions. Those deemed at sufficient risk would be
prescribed cholesterol-lowering statins.
The recommendation overturned decades of practice in which doctors
screened patients for high cholesterol, then sought to reduce LDL to
a specific level. Many cardiologists criticized the guidelines,
saying they were confusing, and that patients and physicians were
comfortable with measurable goals to reduce the risk of heart
disease, the world's No. 1 killer.
Those opponents got a boost from data released on Monday showing
high-risk patients fared better when their LDL was brought to very
low levels by adding Merck & Co's Zetia to treatment with a statin.
Several prominent heart specialists told Reuters the guidelines
should be changed, with some advocating LDL targets even lower than
previous ones. Many have ignored the year-old recommendations.
"I never really bought the new guidelines," said Dr. Andrew Klaus of
Mount Carmel Health System in Columbus, Ohio. The Zetia trial
“definitely showed that lower is better," he said. "I would predict
the guidelines are going to be rewritten very soon."
The so-called Improve-It trial of Merck's Zetia, unveiled at the
AHA’s annual meeting in Chicago, studied more than 18,000 high-risk
patients. It showed they could further cut heart attacks and strokes
by taking LDL cholesterol from about 70 to around 53.
Dr. Steven Nissen, cardiology chief at the Cleveland Clinic, said
the result "blows up" the prevention guidelines.
"It matters how low you go (with LDL) ... which is why many of us
were so upset about the guidelines," Nissen told Reuters. At a
recent meeting of cardiologists and primary care doctors, Nissen
asked how many had adopted the guidelines.
"Three out of those 300 raised their hand," he said. "Nobody is
using them."
'SCIENTIFIC TOMES'
Millions of Americans at risk of heart disease could be affected by
the outcome of the debate. Some 83.6 million live with some form or
cardiovascular disease or the effects of stroke, according to the
AHA.
By some estimates, the new guidelines would boost the use of
high-potency statins such as AstraZeneca's Crestor and Pfizer Inc's
Lipitor, now available as cheaper generic atorvastatin.
The debate could also affect the future of new medicines from Amgen
Inc and Regeneron Pharmaceuticals Inc that reduce LDL even more
aggressively.
In Reuters interviews with more than a dozen cardiologists attending
the AHA meeting, most said they were wrestling with the guidelines.
AHA and ACC officials have heard the complaints and said the
guidelines are subject to revision based on new scientific data.
"We don't want guidelines that serve as scientific tomes that nobody
finds useful," said Dr. Robert Harrington, an AHA board member. "We
need our guidelines to really help guide practice."
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When a major trial like Improve-It comes out, "AHA absolutely
responds to that," he said.
Dr. Patrick O’Gara, president of the ACC, said the new guidelines
were based on the fact that clinical trials of cholesterol-lowering
statin drugs were not designed to test the effectiveness of specific
cholesterol targets - only the drugs themselves. Doctors following
the guidelines tend to test cholesterol levels far less frequently,
and that has some in the field worried.
"We're still having this back and forth, which seems to represent a
gap between the manner in which trials were designed and the
practical implications," O’Gara said. "I hope we will be able to
strike the right balance in the process."
CLARIFYING THE MESSAGE
Dr. Lori Mosca of New York-Presbyterian Hospital, who helps train
residents, said she is frequently asked how to interpret the
guidelines.
"There is sufficient confusion out there that it's worthy of
clarifying what the message is," she said.
Dr. Matthew Sorrentino, a preventive cardiologist at University of
Chicago Medicine, uses the guidelines. But he said the older targets
- an LDL of 70 for high-risk patients - were easier for doctors and
patients to grasp.
"Almost everybody knew what the LDL target was," he said. "I can see
making the guidelines easier to follow."
Writers of the guidelines, such as Dr. Donald Lloyd-Jones of
Northwestern Medicine in Chicago, defended the scientific rigor
behind them. He said focusing on a cholesterol goal may have led to
undertreatment, perhaps failing to take into account the added risks
from diabetes, obesity or smoking.
A new class of drugs, known as PCSK9 inhibitors, that can lower LDL
by more than 50 percent may increase the pressure for new, even
lower, LDL targets, some doctors said. One from Amgen and another
developed by Regeneron and Sanofi are expected to reach the market
next year and initially be used in patients with extremely high
cholesterol or those who cannot tolerate statins.
"We can't really get away from paying attention to what the LDL is,"
said Dr. Daniel Rader, director of the preventive cardiology program
at the University of Pennsylvania.
(Reporting by Julie Steenhuysen and Bill Berkrot; Editing by Michele
Gershberg and Douglas Royalty)
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