Embargo: September 2, 2008 at 8:30 AM ( Brussels Time )

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 failure1.

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=0.009), as compared with placebo against a background of optimal recommended therapy (ORT [ACE-inhibitors, beta-blockers, diuretics, digitalis, spironolactone]).

Primary endpoint	IMPROVEMENT n-3 PUFAs vs placebo (ORT)
All-cause mortality	9% (p=0.041) *
All-cause mortality or admission to hospital for cardiovascular reasons	8% (p=0.009) *
Secondary endpoint	n-3 PUFAs vs placebo (ORT)
Cardiovascular mortality	10% (p=0.045) *
Cardiovascular mortality or admission to hospital for heart failure or for any reason	6% (p=0.043) *
Admission to hospital for cardiovascular reasons	7% (p=0.026) *
Sudden cardiac death	7% (p=0.333)
Admission to hospital for any reason	6% (p=0.049)
Admission to hospital for congestive heart failure	6% (p=0.147)
Myocardial infarction	18% (p=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-MI patients had been established by the GISSI-Prevenzione trial3. 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”.

References

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 1:S34-7.

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, GISSI 2, GISSI 3, GISSI Prevention), 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 (<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 http://www.gissi.org/.
*The Protocol is sponsored by Gruppo di Ricerca GISSI and partially supported by: AstraZeneca, Società 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 fulfill unmet needs in the management of heart failure.

About Omacor®
This highly purified n-3 polyunsaturated fatty acid (n-3 PUFA) ethyl esters 90, marketed by Solvay under the trade name Omacor®, 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® is not currently indicated for the treatment of symptomatic heart failure.
Further information about Omacor® can be found at http://www.Omacor®.com

About Solvay Pharmaceuticals
SOLVAY PHARMACEUTICALS commercialises Omacor® (licensed-in from Pronova BioPharma) in 35 countries throughout Europe, Asia and the Middle East. Omacor® is the only Omega-3 product approved for secondary prevention in post-myocardial infarction patients and patients with hypertriglyceriademia. Omacor® 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 company seeks to fulfil carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men’s and women’s health. Its 2007 sales were €2.6 billion, and it employs more than 9,000 people worldwide. For more information, visit solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs more than 28,000 people in 50 countries. In 2007, its consolidated sales amounted to €9.6 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE Euronext: SOLB.BE – Bloomberg: SOLB.BB – Reuters: SOLB.BR) is listed on the NYSE Euronext stock exchange in Brussels. Details are available at www.solvay.com.

For further information please contact :

ELSA DELACROIX
Pharmaceutical Communications
SOLVAY PHARMACEUTICALS
Tel: 32 2 509 68 35
Email : elsa.delacroix@solvay.com
Internet: solvaypharmaceuticals.com