ADA: Fish Oil Fails to Reduce CV Event Risk
By*Chris Kaiser, Cardiology Editor, MedPage Today

Published: June 12, 2012

Reviewed*by*Dori F. Zaleznik, MD; Associate Clinical Professor of
Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, BSN,
RN, Nurse Planner


The large ORIGIN trial failed to find differences in mortality or
cardiovascular events in patients with prediabetes or diabetes and high
risk for cardiovascular disease who were taking n-3 fatty acids,
compared with those on placebo.
Note that follow-up was for 6 years.

PHILADELPHIA -- Omega-3 fatty acids did not reduce the rate of
cardiovascular events in high-risk patients with prediabetes or diabetes
followed for half a dozen years, the randomized ORIGIN trial found.

Cardiovascular deaths occurred among 9.1% and 9.3% of those randomized
to n-3 fatty acids or placebo, respectively, Jackie Bosch, MSc, from
McMaster University and Hamilton Health Sciences in Hamilton, Ontario,
and colleagues reported.

Supplementation with fatty acids also did not have a significant impact
on major vascular events (16.5% versus 16.3%) or all-cause death (15.1%
versus 15.4%), Bosch announced here at the annual meeting of the
American Diabetes Association. The study was also simultaneously
published in the New England Journal of Medicine.

Kaplan-Meier curves were virtually indistinguishable between both arms
for:
Death from cardiovascular cause -- HR 0.98, 95% CI 0.87 to 1.10, P=0.72

Composite of myocardial infarction, stroke, or cardiovascular death --
HR 1.01, 95% CI 0.93 to 1.10, P=0.81

All-cause death -- HR 0.98, 95% CI 0.89 to 1.07, P=0.63

Death from arrhythmia -- HR 1.10, 95% CI 0.93 to 1.30, P=0.26

Other outcomes where the n-3 fatty acid intake did not make a difference
included fatal and nonfatal MI, fatal and nonfatal stroke, heart failure
hospitalization, revascularization, limb or digit amputation, and
hospitalization for any cardiovascular cause.

There was minimal difference in blood pressure, heart rate, or
cholesterol of participants except for a significant decrease of 23.5
mg/dL in triglycerides in the group taking the fish oil supplements,
Bosch said during a press briefing.

The ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial,
a double-blind study with a 2-by-2 factorial design, randomized 12,536
patients with type 2 diabetes, impaired fasting glucose, or impaired
glucose tolerance whose mean age was 64 and of whom 35% were women. They
were followed for a mean of 6.2 years.

The part of the trial that investigated the impact of insulin glargine
on cardiovascular outcomes and cancer found no harm or benefit
associated with insulin on these outcomes.

In this current analysis of the influence of omega-3 fatty acids on
cardiovascular risk, the treatment arm took 1 g/day of n-3 fatty acids
(Omacor), which was a combination of eicosapentaenoic acid (EPA) and
docosahexaenoic acid (DHA). The placebo was 1 g/day of olive oil. At the
study's conclusion, researchers had outcomes data on 99% of the
participants.

Compliance with the study drug was high,

Bosch said, with 96%, 92% and 88% taking the drug at 1 year, 4 years,
and at the end of the trial, respectively.

Abdominal discomfort and lower gastrointestinal symptoms were the most
common reasons patients in either arm stopped compliance.

Unlike other previously published trials that found a cardiovascular
benefit from fish oil supplementation, patients in ORIGIN were taking
more cardioprotective drugs, which could have diminished the statistical
power to detect an effect, the researchers noted.

They also stated that patients in other trials were within 3 months of
an MI or had heart failure, and the patient cohort was not confined to
those with abnormal glucose.

The investigators also suggested that the 1 g/day dose of fatty acids
might have been too low, although this dose had previously been
associated with reduced cardiovascular outcomes.

Funding for the study was provided by sanofi-aventis. Study drugs were
provided by Pronova BioPharma Norge.

Bosch reported a relationship with sanofi-aventis. Her co-authors
reported relationships with sanofi-aventis, Eli Lilly, Novo Nordisk,
GlaxoSmithKline, Bayer, Roche, Merck, Novartis, Janssen, Abbott,
AstraZeneca, Boehringer Ingelheim, Amgen, Amylin, and Bristol-Myers
Squibb.

Primary source: New England Journal of Medicine

Source reference:
Bosch J, et al "n-3 fatty acids and cardiovascular outcomes in patients
with dysglycemia: The ORIGIN trial investigators" N Engl J Med 2012;
DOI: 10.1056/NEJMoa1203859.

..
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Donna G.
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1) Rejoice always, Pray continually, Give thanks in all circumstances,
For this is God's will for you in Christ Jesus. ( I Thessalonians
5:16-18 NIV )

2) ANGELS EXIST, but some times, since they don't all have wings, we
call them FRIENDS......

3) Just because you're in pain, doesn't mean you have to be one!