Fish
oil supplements plus statins protect against heart disease
American
Heart Association
DALLAS,
Nov. 14, 2005 – Cholesterol-lowering drugs, combined
with a fatty acid found in fish, packs a one-two punch against
heart attack, angina and other coronary events, according
to a study presented at a late-breaking clinical trials
session at the American Heart Association’s Scientific
Sessions 2005.
“These
results appear to justify the use of fish oil/omega-3 fatty
acids since they can add to the beneficial effects of statins,”
said lead author Mitsuhiro Yokoyama, M.D., Ph.D., chief
of the division of cardiovascular and respiratory medicine
at Kobe University Graduate School of Medicine in Kobe,
Japan.
He presented
the results of Effects of Eicosapentaenoic Acid (EPA) on
Major Cardiovascular Events in Hypercholesterolemic Patients:
The Japan EPA Lipid Intervention Study (JELIS). It’s
the first large-scale, prospective, randomized trial that
combines statins and omega-3 fatty acid therapy. EPA is
one of the major omega-3 fatty acids in fish.
Of 18,645
eligible participants, 9,326 were given 1,800 milligrams
(mg)/day of highly purified EPA capsules. This form of EPA
has been available in Japan since 1990 for treating lipid
abnormalities and peripheral artery disease (atherosclerosis
in the body’s peripheral circulation in the legs).
The
primary endpoint of the study was experiencing any of a
group of outcomes that included sudden cardiac death, heart
attack, unstable angina (sustained chest pain due to the
heart’s oxygen starvation), or undergoing procedures
to reopen blocked arteries, such as angioplasty/stenting
or coronary artery bypass surgery.
After
more than 4.5 years of follow-up, the primary endpoint was
seen in 2.8 percent of patients treated with statins plus
EPA compared to 3.5 percent in the statin-only group, he
said.
“This
represents a 19 percent reduction in risk from EPA plus
statin treatment compared to statin treatment alone,”
Yokayama said.
Researchers
divided patients into two groups: “primary prevention”
which included 14,981 people who had no history of coronary
artery disease (CAD), and a “secondary prevention”
group that included 3,664 subjects who had a history of
CAD.
The
study found that 8.7 percent of statin/EPA-treated patients
in the secondary prevention group experienced one of the
composite outcomes, compared to 10.7 percent of the statin-only
secondary prevention group, again a 19 percent risk reduction
in those getting statin plus EPA. A similar, but insignificant,
trend occurred for the primary prevention analysis: 1.4
percent among those treated with statins/EPA versus 1.7
percent in those treated with statins alone for an 18 percent
reduction in risk.
“The
beneficial effects of EPA plus statins is more convincing
in patients with coronary artery disease, as they are more
prone to have major coronary events, compared to hypercholesterolemic
patients without coronary artery disease,” he said.
“Epidemiological
studies have demonstrated that a diet rich in long-chain
polyunsaturated omega-3 fatty acids, which are abundant
in fish, is protective against death and disability from
coronary heart disease,” Yokoyama said. Other studies
have shown statins to be similarly beneficial, prompting
the current study to investigate whether their benefits
might be additive.
The
Japanese diet is about 40 percent fish, and heart and blood
vessel disease rates are lower in Japan compared to western
countries, he said. But many young Japanese eat diets similar
to those of Western youth; and blood cholesterol levels
among youth in the two countries are also becoming similar
as well. Interestingly, this study found that the benefits
of the combination therapy did not seem to be due to changes
in cholesterol, Yokoyama said. Both combination and statin-only
therapy reduced LDL, the so-called ‘bad’ cholesterol,
by the same amount – 26 percent – yet double
therapy reduced cardiovascular risk, he said. The EPA could
benefit further through multiple mechanisms which might
include anti-thrombotic (preventing blood clotting), anti-inflammatory
or triglyceride-lowering effects, he said.
According
to Robert Eckel, M.D., president of the American Heart Association,
“The JELIS data continue to support the beneficial
effect of omega-3 fatty acids in patients with known coronary
heart disease, and now an effect that extends the benefit
of statins. Moreover, there’s a hint that a similar
benefit may be present in hypercholesterolemic patients
without known coronary heart disease. Yet, an important
consideration is that the dose of omega-3 fatty acids –
1,800 mg a day of highly purified EPA, is more than the
standard over-the-counter supplement. Check with your physician
first.”
Members
of the JELIS steering committee: Mitsuhiro Yokoyama, M.D.;
Hideki Origasa, Ph.D.; Masunori Matsuzaki, M.D.; Yuji Matsuzawa,
M.D.; Yasushi Saito, M.D.; Yuichi Ishikawa, M.D.; Shinichi
Oikawa, M.D.; Jun Sasaki, M.D.; Hitoshi Hishida, M.D.; Hiroshige
Itakura, M.D.; Toru Kita, M.D.; Akira Kitabatake, M.D.;
Noriaki Nakaya, M.D.; Toshiie Sakata, M.D;. Kazuyuki Shimada,
M.D.; and Kunio Shirato, M.D. for the JELIS Investigators,
Japan.
The
JELIS study was funded by Mochida Pharmaceutical Co, Ltd,
Tokyo, Japan and the study was conducted under the responsibility
of independent steering committee.
Statements
and conclusions of study authors that are published in the
American Heart Association scientific journals are solely
those of the study authors and do not necessarily reflect
association policy or position. The American Heart Association
makes no representation or warranty as to their accuracy
or reliability.
NR05--1149
(SS05-LB/Yokoyama, JELIS)
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