MUNICH, Sept. 2 /CNW/ - ESC Congress 2008 - Presented at the Annual ESC
Congress 2008, Munich, Germany, 31 August 2008 - For the first time, results
from a new landmark trial of purified n-3 polyunsaturated fatty acids (n-3
PUFAs) were presented at one of the worlds' largest cardiology meetings by
Professor Luigi Tavazzi (GISSI-HF): n-3 PUFAs reduced mortality and hospital
admissions for cardiovascular reasons in patients with symptomatic heart
GISSI-HF was a 3.9 year prospective, multicentre, double-blind,
placebo-controlled study in 6,975 patients. At a dose of 1 g daily, n-3 PUFAs
reduced all-cause mortality by 9% (p=0.041) and the combination of all-cause
mortality and admissions to hospital for cardiovascular reasons by 8% (p
equals 0.009), as compared with placebo against a background of optimal
recommended therapy (ORT (ACE-inhibitors, beta-blockers, diuretics, digitalis,
Primary endpoint n-3 PUFAs vs placebo (ORT)
All-cause mortality 9% (p equals 0.041) (*)
All-cause mortality or 8% (p equals 0.009) (*)
admission to hospital for
Secondary endpoint n-3 PUFAs vs placebo (ORT)
Cardiovascular mortality 10% (p equals 0.045) (*)
Cardiovascular mortality or 6% (p equals 0.043) (*)
admission to hospital for heart
failure or for any reason
Admission to hospital for 7% (p equals 0.026) (*)
Sudden cardiac death 7% (p equals 0.333)
Admission to hospital for any 6% (p equals 0.049)
Admission to hospital for 6% (p equals 0.147)
congestive heart failure
Myocardial infarction 18% (p equals 0.121)
Stroke -16% (0.271)
(*) Difference between groups statistically significant (adjusted
analysis; adapted from reference 1)
The GISSI group initiated, designed and conducted the GISSI-HF trial
following positive results of a post-hoc analysis of the GISSI-Prevenzione
trial (see Notes to Editors) which demonstrated that a subgroup of
post-myocardial infarction patients with left ventricular dysfunction had
reduced all-cause mortality and hospitalisations with n-3 PUFAs(2).
The primary objectives of the GISSI-HF trial were to demonstrate whether
n-3 PUFAs or rosuvastatin improved all-cause mortality or hospitalisations for
cardiovascular reasons. Participants were first randomised to receive n-3
PUFAs vs placebo (ORT). A subset of study participants was further randomised
to receive rosuvastatin vs placebo.
GISSI-HF-the second large-scale cardiovascular outcome trial of n-3
PUFAs-also confirmed and further supports the safety of n-3 PUFAs, whose
cardiovascular benefit in post- myocardial infarction patients had been
established by the GISSI-Prevenzione trial (3). Accordingly, current
indications of n-3 PUFAs are secondary prevention in post-myocardial
infarction patients and treatment of hypertriglyceridaemia. Ongoing studies of
n-3 PUFAs in other cardiovascular indications may unveil additional benefits
in patients with cardiovascular diseases.
Professor Clemens Von Schacky, Head of Preventive Cardiology, University
of Munich, Germany, also reviewed the GISSI-HF trial outcomes and presented
the implications of these results for clinical practice during a
Solvay-sponsored symposium at ESC 2008. He commented. "Very recently, we have
seen a number of large outcome trials in congestive heart failure using a
variety of approaches. Unfortunately, these were either neutral or negative.
In sharp contrast, GISSI-HF, a meticulously conducted trial, reported the
safety and efficacy of n-3 PUFAs in this patient population. Thus, evidence
has been provided for guideline committees to add this treatment to the
established therapies of congestive heart failure."
1. GISSI-HF investigators. Effect of n-3 polyunsaturated fatty acids in
patients with chronic heart failure (the GISSI-HF trial): a
randomised, double-blind, placebo-controlled trial Lancet 2008;
Published online August 31st 2008.
2. Marchioli R, Marfisi RM, Borrelli G, Chieffo C, Franzosi MG,
Levantesi G, et al. Efficacy of n-3 polyunsaturated fatty acids
according to clinical characteristics of patients with recent
myocardial infarction: insights from the GISSI-Prevenzione trial.
Journal of Cardiovascular Medicine (Hagerstown, MD) 2007 Sep.8 Suppl
3. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto
Miocardico. Dietary supplementation with n-3 polyunsaturated fatty
acids and vitamin E after myocardial infarction: results of the
GISSI-Prevenzione trial. Lancet 1999 Aug 7;354(9177):447-55.
Notes for Editors
About GISSI and the GISSI-HF Trial
The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto
Miocardico (GISSI), is considered as one of the most important research teams
in the cardiovascular field. The GISSI has produced a series of large-scale
clinical trials (GISSI 1 (http://www.gissi.org/Egissi1/T_Intro.php), GISSI 2
(http://www.gissi.org/Egissi2/T_Intro.php), GISSI 3
(http://www.gissi.org/Egissi3/T_Intro.php), GISSI Prevention
(http://www.gissi.org/Egissip/T_Intro.php)), which have involved more than
60.000 patients with myocardial infarction (AMI).
The rationale for the GISSI-HF(*) trial was based on positive results with
n-3 PUFAs in a subgroup of patients from a previous GISSI- Prevenzione Trial
(GISSI-P) published in The Lancet in 19993, of 11,323 post-myocardial
infarction ((less than)3 months previous) patients who received n-3 PUFAs (1 g
daily), vitamin E, both, or no treatment (control group), in addition to
standard pharmacological treatment and lifestyle advice (approximately 70% of
patients were already consuming fish at least once per week). The total
mortality was reduced by 20%, with a 45% reduction in sudden death in the n-3
PUFAs group. The GISSI-P trial had shown that 1 g n-3 PUFAs could save 5.7
lives per 1,000 treated patients per year. Interestingly, a sub-analysis from
GISSI-P showed that the clinical benefits observed were independent of whether
or not patients were also receiving a statin.
Further information about the GISSI-group can be found at
(*) The Protocol is sponsored by Gruppo di Ricerca GISSI and partially
supported by: AstraZeneca, Societa Prodotti Antibiotici, Sigma Tau, Pfizer.
About heart failure
Heart failure is not a single disease, but instead is the end result of
several cardiac disease processes, and is the principle complication of
virtually all forms of heart disease. In Europe and the United States
altogether, around 10 million people have been diagnosed with chronic heart
failure. It places a huge burden on society and despite major advances in drug
therapy for symptomatic heart failure, during the past two decades,
hospitalisations continue to increase. Therefore, novel and effective
treatment is necessary to fulfil unmet needs in the management of heart
This highly purified n-3 polyunsaturated fatty acid (n-3 PUFA) ethyl
esters 90, marketed by Solvay under the trade name Omacor(R), is already
indicated-as an adjuvant to standard therapies (statins, antiplatelet drugs,
beta-blockers and ACE inhibitors)- in Europe and some Middle East countries
for secondary prevention of myocardial infarction (MI) in post-myocardial
infarction patients and for the treatment of hypertriglyceridaemia in the US,
Europe, Middle East and Asia. This highly purified n-3 polyunsaturated fatty
acid (n-3 PUFA) ethyl esters 90 is the first and only EU- and FDA-approved n-3
PUFAs-derived prescription drug.
Omacor(R) is not currently indicated for the treatment of symptomatic
Further information about Omacor(R) can be found at http://www.Omacor.com
About Solvay Pharmaceuticals
Solvay Pharmaceuticals commercialises Omacor(R) (licensed-in from Pronova
BioPharma) in 35 countries throughout Europe, Asia and the Middle East.
Omacor(R) is the only Omega-3 product approved for secondary prevention in
post-myocardial infarction patients and patients with hypertriglyceriademia.
Omacor(R) contains the highly purified Omega-3 fatty acid (eicosapentaenoic
and docosahexaenoic acids) ethyl esters 90 in a 1g capsule.
Solvay Pharmaceuticals is a research driven group of companies that
constitutes the global pharmaceutical business of the Solvay Group. The
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gastroenterology and men's and women's health. Its 2007 sales were EUR2.6
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