An experimental drug that greatly increases levels of "good"
cholesterol has no effect on heart health, a comprehensive clinical trial
found, leaving researchers shocked and disappointed.
It is also a blow to patients who
were hoping for an alternative because they cannot or will not take statins,
which can cut low-density lipoprotein (LDL), or bad cholesterol.
The study involving more than 12,000
patients at high risk for serious cardiovascular problems found that
evacetrapib had no benefits, according to research presented Sunday at the
American College of Cardiology conference in Chicago.
Manufacturer Eli Lilly stopped the
trial in October when the drug was found to be ineffective but now experts have
given a comprehensive explanation of what happened.
Two other drugs in the same class as
evacetrapib, known as CETP inhibitors and designed to raise levels of HDL
cholesterol -- high-density lipoprotein, the "good" type -- have also
failed, presenting experts with a quandary.
"We have a paradox: here we've
got an agent that more than doubles the levels of good cholesterol and lowers
bad cholesterol and yet has no effect on clinical events," said lead
author Professor Stephen Nicholls.
"We were disappointed and
surprised by the results," added Nicholls, of The University of Adelaide
in Australia and cardiologist at Royal Adelaide Hospital.
On average, patients taking
evacetrapib daily for at least 18 months lowered their LDL cholesterol by 37
percent and increased their HDL cholesterol -- high-density lipoprotein, the
"good" type -- by 130 percent compared with patients taking a
placebo.
However, there was no difference
between the two groups in terms of the primary "endpoint" of the
research -- including the amount of time until cardiovascular death, heart
attack, stroke or coronary artery bypass surgery.
"As we close out the trial,
we're trying to understand how a drug that seems to do all the right things in
terms of blood cholesterol levels doesn't then translate into reducing clinical
events," added Nicholls.
Steve Nissen, chairman of
Cardiovascular Medicine at Cleveland Clinic, attempted to put a positive spin
on the disappointing outcome.
"These findings illustrate the
importance of performing large, high-quality outcome trials," he said.
"Just looking at the effects a
therapy has on cholesterol levels doesn't always translate into clinical
benefits."
However, Nicholls cautioned that
evacetrapib could potentially benefit patients with low risk of serious heart
trouble, although that was not part of the study.
The findings could challenge
conventional thinking regarding the benefits of HDL cholesterol in protecting
against cardiovascular problems, he said.
They also suggest that existing
treatments, such as statins, are already so effective that they cannot be improved
upon.
However, some people with high
cholesterol were hoping for an alternative to statins because they complain
about side effects such as muscle pain and weakness.
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