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2 G l o b a l C a r d i o V a s c u l a r C l i n i c a l T r i a l i s t s F o r u m GENERAL PRESENTATION Organised in collaboration with the ESC Working Group on Cardiovascular Pharmacology and Drug Therapy and the ESC Working Group on Acute Cardiac Care, CVCT is a meeting specifically and totally dedicated to the discussion of clinical trials in cardiovascular disease. The discussion takes place with a selected audience of opinion leaders, clinical trialists, pharmaceutical industry partners, regulators, investigators and cardiologists. The aims of the meeting are to gather such specialists in order to: Examine the background of knowledge which led to the design of major trials. Identify and understand best evidence from clinical trials. Examine the consequences of trial results on the updating of guidelines. Consider the consequences and relative weight of Evidence based vs Mechanism based and Marketing based medicine. Identify emerging important issues in cardiovascular medicine. Examine opportunities and needs for new trials. Global CVCT Forum constitutes the most comprehensive and authoritative review of current work in the field of cardiovascular trials. CVCT also aims to familiarise practitioners and young investigators with the science of clinical trials from trial protocol design to trial result interpretation. Last but not least, CVCT makes it a priority to foster interaction among all actors in the clinical trial world. Most notably attendance, on special invitation, of regulators as well as of R&D industry doctors makes CVCT a unique and true trial science forum. Pr. Faiez ZANNAD Pr. Bertram PITT F a c u l t y Eric ABADIE, Paris - FRA Aly ELBANAYOSY, Bad Oeynhausen - GER Willibald MAIER, Zurich - SUI Luis RUILOPE, Madrid - ESP Enrico AGABITI-ROSEI, Brescia - ITA Roberto FERRARI, Ferrara - ITA Alan MAISEL, San Diego - USA Roland SCHMIEDER, Erlangen - GER Etienne ALIOT, Nancy - FRA Gerasimos FILIPPATOS, Athens - GRE Jean-Michel MALLION, Grenoble - FRA Peter SLEIGHT, London - GBR Angeles ALONSO, Madrid - ESP Ferenc FOLLATH, Zurich - SUI Doug MANN, Houston - USA Kurt STOSCHITZKY, Graz - AUT Pierre AMARENCO, Paris - FRA Mihai GHEORGHIADE, Chicago - USA Michel MARRE, Paris - FRA Melinda SWANN, London - GBR Ettore AMBROSIONI, Bologna - ITA Daniel GRAS, Nantes - FRA Alexandre MEBAZAA, Paris - FRA Bernard SWYNGHEDAUW, Paris - FRA Dan ATAR, Oslo - NOR Eric de GROOT, Amsterdam - NED Jean-Jacques MERCADIER, Paris - FRA Marja-Riitta TASKINEN, Helsinki - FIN Michel AZIZI, Paris - FRA Steven HAFFNER, San Antonio - USA Dominik MULLER, Berlin - GER Michal TENDERA, Katowice - POL Bernard BÖTTIGER, Heidelberg - GER Daniel HERPIN, Poitiers - FRA Markku NIEMINEN, Helsinki - FIN Christian THUILLEZ, Rouen - FRA Michael BÖHM, Hamburg - GER Luc HITTINGER, Créteil - FRA Daniel O'LEARY, Boston - USA Pierre-Jean TOUBOUL, Paris - FRA Eugene BRAUNWALD, Boston - USA Ake HJALMARSON, Göteborg - SWE John PARISSIS, Athens - GRE Marco TUBARO, Roma - ITA Eric BRUCKERT, Paris - FRA Uta HOPPE, Cologne - GER Terje PEDERSEN, Oslo - NOR Murat TUZCU, Cleveland - USA Dirk BRUTSAERT, Antwerp - BEL Patrick JOURDAIN, Paris - FRA Bertram PITT, Ann Arbor - USA Thomas UNGER, Berlin - GER Phlippe CHEVALIER, Lyon - FRA Stevo JULIUS, Ann Arbor - USA Brian PRICHARD, London - GBR Wiek VAN GILST, Groningen - NED John CLELAND, Hull - GBR Keld KJELDSEN, Copenhagen - DEN Silvia PRIORI, Pavia - ITA Giancarlo VIBERTI, London - GBR Alain COHEN SOLAL, Paris - FRA Alain KRIVITZKY, Paris - FRA Henry PURCELL, London - GBR Adriaan VOORS, Groningen - NED Gilles DAGENAIS, Québec - CAN Stéphane LAURENT, Paris - FRA Knut RASMUSSEN, Tromsø - NOR Kristian WACHTELL, Copenhagen - DEN Nicolas DANCHIN, Paris - FRA Thomas LÜSCHER, Zurich - SUI Andrew RHODES, London - GBR John WARREN, London - GBR Kenneth DICKSTEIN, Stavanger - NOR Aldo MAGGIONI, Florence - ITA Jean RIBSTEIN, Montpellier - FRA Faiez ZANNAD, Nancy - FRA 2-4 th Global CardioVascular Clinical Trialists Forum Cannes 2007

3 SYNOPSIS Scientific program Thursday... 4 Friday... 6 Saturday... 8 Acknowledgements Abstracts Sponsors Posters General Information P r o g r a m a t a g l a n c e Thursday April 26 th, 2007 Friday April 27 th, 2007 Saturday April 28 th, 2007 Consensus Workshop (on invitation only) New Data and Evidence in the Management of Acute Heart Failure since Publication of Guidelines Part An ARB, an ACE Inhibitor or an ARB + an ACE Inhibitor? Coffee Break Coffee Break and visit of the exhibition area Consensus Workshop (on invitation only) New Data and Evidence in the Management of Acute Heart Failure since Publication of Guidelines Part Direct Renin Inhibitors. Where to Fit into the RAAS Inhibition Strategy? Opening Lunch Buffet in the exhibition area Lunch Buffet in the exhibition area Welcome and Introduction European Society of Cardiology Pharmacological Hypotheses which Failed the Clinical Trial Test: Dead Ends or New Opportunities? Coffee Break and visit of the exhibition area Lecture Session Meet & Eat with the Experts (on invitation only) Get with the Guidelines: The Challenges of Implementing Device Trial Results into Daily Practice Beta-Blocker Therapy: From Hypertension to Heart Failure Angiotension Receptor Blockers: From a Single Target to Pleiotropic Effects Efficacy and Protection. New Avenues with Angiotensin Receptor Blockers. Ongoing Trials and Therapies for the Future. The Academic Societies and Working Groups Corner Part Coffee Break and visit of the exhibition area Ongoing Trials and Therapies for the Future. The Academic Societies and Working Groups Corner Part Closing Ceremony Consensus Workshop Part 1 (on invitation only) The Use of Biomarkers and Bio-Imaging in Atherosclerosis Clinical Trials and Clinical Practice From Hypertension to Heart Failure: the Disease Continuum Cardiometabolic Sartans: Killing two Birds with One Stone? Consensus Workshop Part 2 (on invitation only) The Use of Biomarkers and Bio-Imaging in Atherosclerosis Clinical Trials and Clinical Practice From Hypertension to Heart Failure: the Disease Continuum Cardiometabolic Sartans: Killing two Birds with One Stone? European Society of Cardiology Acute Cardiac Care: Recent Developments from Clinical Trials Coffee Break and visit of the exhibition area Slowing Heart Rate: a Therapeutic Goal in Cardiovascular Disease Drugs in, Drugs out: a Glimpse into the Future of the Cardiovascular and Metabolic Risk Lecture Session Simultaneous translation into French SUQUET ROOM MEDITERRANÉE B ROOM MEDITERRANÉE C ROOM Congress Dinner 4 th Global CardioVascular Clinical Trialists Forum Cannes

4 THURSDAY APRIL 26 TH, 2007 SUQUET ROOM CONSENSUS WORKSHOP - Part 1 (by invitation only) NEW DATA AND EVIDENCE IN THE MANAGEMENT OF ACUTE HEART FAILURE SINCE PUBLICATION OF GUIDELINES Chairmen: Kenneth DICKSTEIN, Stavanger - NOR Alexandre MEBAZAA, Paris - FRA Meeting Objective: Review recent trial data and ongoing trials / Practical learnings regarding the treatment of Acute Heart Failure. For each individual therapeutic class: Review of data, Practical use / Implication and Class of recommendation / Level of evidence Individual Presentations (10 minutes duration, followed by 10 minutes of discussion time): Welcome and clarify agenda Melinda SWANN, Reading - GBR Adenosine Receptor 2 Antagonists Adriaan VOORS, Groningen - NED Vasopressin antagonists Mihai GHEORGHIADE, Chicago - USA Cardiac enhancers: levosimendan, dobutamine, milrinone John PARISSIS, Athens - GRE New Vasodilators: BNP analogs ularitide, nesiritide Alexandre MEBAZAA, Paris - FRA New Cardiac SERCA II agents: Istaroxime Gerasimos FILIPPATOS, Athens - GRE Ultrafiltration Equipment Andrew RHODES, London - GBR Portable LV Assisted Devices Aly EL BANAYOSY, Bad Oeynhausen - GER Coffee Break SUQUET ROOM CONSENSUS WORKSHOP - Part 2 (by invitation only) NEW DATA AND EVIDENCE IN THE MANAGEMENT OF ACUTE HEART FAILURE SINCE PUBLICATION OF GUIDELINES PANEL DISCUSSION: PUBLICATION DEVELOPMENT, ACTIONS/ACTIVITIES, TIME-LINES, TASKS Experts Panel: Aly EL BANAYOSY, Bad Oeynhausen - GER Michael BÖHM, Hamburg - GER Kenneth DICKSTEIN, Stavanger - NOR Gerasimos FILIPPATOS, Athens - GRE Mihai GHEORGHIADE, Chicago - USA Alexandre MEBAZAA, Paris - FRA Markku NIEMINEN, Helsinki - FIN John PARISSIS, Athens - GRE Bertram PITT, Ann Arbor - USA Andrew RHODES, London - GBR Adriaan VOORS, Groningen - NED Faiez ZANNAD, Nancy - FRA Opening Lunch Buffet in the exhibition area 4-4 th Global CardioVascular Clinical Trialists Forum Cannes 2007

5 THURSDAY APRIL 26 TH, WELCOME AND INTRODUCTION Course Directors: Bertram PITT, Ann Arbor - USA Faiez ZANNAD, Nancy - FRA EUROPEAN SOCIETY OF CARDIOLOGY Working Group on Cardiovascular Pharmacology and Drug Therapy PHARMACOLOGICAL HYPOTHESES WHICH FAILED THE CLINICAL TRIAL TEST: DEAD ENDS OR NEW OPPORTUNITIES? Chairmen: Dan ATAR, Oslo - NOR Ettore AMBROSIONI, Bologna - ITA Endothelin antagonists in hypertension and heart failure (EARTH, VERITAS) Thomas LÜSCHER, Zurich - SUI Neutral endopeptidases and dual inhibitors in hypertension and heart failure. Did OVERTURE close the door? Ferenc FOLLATH, Zurich - SUI Antiarrhythmic agents for atrial arrhythmias (Amiodarone, Dronedarone and Na current antagonists) Etienne ALIOT, Nancy - FRA Antioxidants and vitamins supplementation in cardiovascular prevention. No hope after HOPE? Knut RASMUSSEN, Tromsø - NOR Coffee Break and visit of the exhibition area SPECIAL GUEST LECTURES Chairmen: Bernard SWYNGHEDAUW, Paris - FRA Faiez ZANNAD, Nancy - FRA Are Heart Failure Trials systolocentric? The Heart Failure continuum paradigm Dirk BRUTSAERT, Antwerp - BEL What's in the Cardiovascular Clinical Trial Pipeline - A Report from the TIMI Study Group Eugene BRAUNWALD, Boston - USA EUROPEAN SOCIETY OF CARDIOLOGY Working Group on Acute Cardiac Care ACUTE CARDIAC CARE: RECENT DEVELOPMENTS FROM CLINICAL TRIALS Chairmen: Gerasimos FILIPPATOS, Athens - GRE Marco TUBARO, Roma - ITA Cardiopulmonary resuscitation: drugs and devices in the new Guidelines Bernard BÖTTIGER, Heidelberg - GER ST elevation myocardial Infarction: advances in pharmacological and interventional strategies Nicolas DANCHIN, Paris - FRA Cholesterol reduction in Intensive Coronary Care Units: data from trials and registries Marco TUBARO, Roma - ITA "The aim of the ESC Working Group on Cardiovascular Pharmacology and Drug Therapy is to improve the safety and effectiveness of the use of drugs in the prevention and treatment of cardiovascular diseases. This Working Group supports clinical trial design, implementation and interpretation of evidence based therapy. New members are more than welcome to join the Working Group and participate to its scientific life. For more information visit the working group web site at 4 th Global CardioVascular Clinical Trialists Forum Cannes

6 FRIDAY APRIL 27 TH, AN ARB, AN ACE INHIBITOR OR AN ARB + AN ACE INHIBITOR? Chairmen: Jean-Michel MALLION, Grenoble - FRA Nicolas DANCHIN, Paris - FRA Similarities and differences among ACE inhibitors and angiotensin receptor blockers The rationale for dual renin angiotensin system inhibition Michel AZIZI, Paris - FRA An ACE inhibitor or an angiotensin receptor blocker? Recent and ongoing trials Gilles DAGENAIS, Québec - CAN An ACE inhibitor plus an angiotensin receptor blocker: update and perspective Rationale and design of ONTARGET Peter SLEIGHT, London - GBR Coffee Break and visit of the exhibition area DIRECT RENIN INHIBITORS. WHERE TO FIT INTO THE RAAS INHIBITION STRATEGY? Chairmen: Michel AZIZI, Paris - FRA Faiez ZANNAD, Nancy - FRA Optimizing pharmacological blockade of the RAAS. Insight from preclinical science Dominik MULLER, Berlin - GER Efficacy and safety of Aliskiren, a novel orally effective renin inhibitor, alone and in combination with other antihypertension agents Roland SCHMIEDER, Erlangen - GER Future perspectives with RAAS blockade. Ongoing trials with Aliskiren (AVOID, ALOFT, AVIATOR) Bertram PITT, Ann Arbor - USA SUQUET ROOM MEET & EAT WITH THE EXPERTS (by invitation or registration only) GET WITH THE GUIDELINES: THE CHALLENGES OF IMPLEMENTING DEVICE TRIAL RESULTS INTO DAILY PRACTICE Chairmen: Daniel GRAS, Nantes - FRA Aldo MAGGIONI, Milano - ITA The heart failure specialist perspective Mihai GHEORGHIADE, Chicago - USA The electrophysiologist perspective Daniel GRAS, Nantes - FRA Device follow up: how to optimize drug treatment post implant Aldo MAGGIONI, Milano - ITA Telemonitoring for the management of the heart failure patient Philippe CHEVALIER, Lyon - FRA MEDITERRANÉE B ROOM MEET & EAT WITH THE EXPERTS (by invitation or registration only) BETA-BLOCKER THERAPY: FROM HYPERTENSION TO HEART FAILURE Chairmen: Alain COHEN SOLAL, Paris - FRA Stéphane LAURENT, Paris - FRA Progression from hypertension to heart failure: identifying mechanisms and therapeutic targets Faiez ZANNAD, Nancy - FRA Nebivolol along the hypertension-heart failure continuum, pharmacological rationale Stéphane LAURENT, Paris - FRA Nebivolol along the hypertension-heart failure continuum, evidence from trials Alain COHEN SOLAL, Paris - FRA With the participation of: Daniel HERPIN, Poitiers - FRA; Alain KRIVITZKY, Paris - FRA; Jean RIBSTEIN, Montpellier - FRA and Kurt STOSCHITZKY, Graz - AUT 6-4 th Global CardioVascular Clinical Trialists Forum Cannes 2007

7 FRIDAY APRIL 27 TH, 2007 MEDITERRANÉE C ROOM MEET & EAT WITH THE EXPERTS (by invitation or registration only) ANGIOTENSIN RECEPTOR BLOCKERS: FROM A SINGLE TARGET TO PLEIOTROPIC EFFECTS Chairmen: Bertram PITT, Ann Arbor - USA Christian THUILLEZ, Rouen - FRA The concept of pleiotropic effects of angiotensin receptor antagonists How pharmacology may help understand the multiple action of a single receptor blockade Christian THUILLEZ, Rouen - FRA Non barometric effects of ARBs. Lessons from LIFE, substudies and other trials Kristian WACHTELL, Copenhagen - DEN Current indications of ARBs, beyond blood pressure lowering Luis RUILOPE, Madrid - ESP Lunch Buffet in the exhibition area EFFICACY AND PROTECTION. NEW AVENUES WITH ANGIOTENSIN RECEPTOR BLOCKERS Chairmen: Roberto FERRARI, Ferrara - ITA Giancarlo VIBERTI, London - GBR Dose effect relationship and differential pharmacology of angiotensin receptor blockers Faiez ZANNAD, Nancy - FRA Effects of ARBs on blood pressure and end organs and their relevance to cardiovascular protection Results of recent trials (EUTOPIA, MORE, VIOS) Enrico AGABITI-ROSEI, Brescia - ITA Ongoing and future trials (ROADMAP, ORIENT, new arterial function and structure studies, Anti-PAF, BNP trial) Stéphane LAURENT, Paris - FRA Coffee Break and visit of the exhibition area SLOWING HEART RATE: A THERAPEUTIC GOAL IN CARDIOVASCULAR DISEASE Chairmen: Faiez ZANNAD, Nancy - FRA Michal TENDERA, Katowice - POL Introduction Faiez ZANNAD, Nancy - FRA Why heart rate should be a therapeutic goal Ake HJALMARSON, Göteborg - SWE Management of stable angina: potential benefits of If Inhibition Henry PURCELL, London - GBR If inhibitors in clinical practice: the German experience Uta HOPPE, Cologne - GER Conclusion Michal TENDERA, Katowice - POL DRUGS IN, DRUGS OUT: A GLIMPSE INTO THE FUTURE OF THE CARDIOVASCULAR AND METABOLIC RISK Chairmen: Steven HAFFNER, San Antonio - USA Michel MARRE, Paris - FRA Endocannabinoid CB1 receptor antagonists in the cardiometabolic risk patients (RIO trials, CRESCENDO, SERENADE) Eric BRUCKERT, Paris - FRA HDL raising drug therapy: unfulfilled needs. What have we learnt from the torcetrapid story? Terje PEDERSEN, Oslo - NOR SPECIAL GUEST LECTURE Chairman: Patrick JOURDAIN, Paris - FRA Using Biomarkers as inclusion criteria and surrogate endpoints in clinical trials Alan MAISEL, San Diego - USA CONGRESS DINNER 4 th Global CardioVascular Clinical Trialists Forum Cannes

8 SATURDAY APRIL 28 TH, ONGOING TRIALS AND THERAPIES FOR THE FUTURE THE ACADEMIC SOCIETIES AND WORKING GROUPS CORNER Chairman: Michal TENDERA, Katowice - POL Part one Atherothrombosis & dyslipidemia Marja-Riitta TASKINEN, Helsinki - FIN Coffee Break and visit of the exhibition area Part two Heart failure Kenneth DICKSTEIN, Stavanger - NOR Arrhythmias Silvia PRIORI, Pavia - ITA Finding a sure path through the jungle of polypharmacy Dan ATAR, Oslo - NOR SUQUET ROOM CONSENSUS WORKSHOP (by invitation or registration only) THE USE OF BIOMARKERS AND BIO-IMAGING IN ATHEROSCLEROSIS CLINICAL TRIALS AND CLINICAL PRACTICE Chairmen: Bertram PITT, Ann Arbor - USA Pierre AMARENCO, Paris - FRA Atherosclerosis biomarkers, CRP and other emerging biomarkers Willibald MAIER, Zurich - SUI Atherosclerosis bio-imaging Intima media thickness (IMT) Pierre-Jean TOUBOUL, Paris - FRA Intravascular ultrasound (IVUS) Murat TUZCU, Cleveland - USA Coffee Break and visit of the exhibition area The use of biomarkers and bio-imaging in clinical trials The investigator viewpoint USA: Doug MANN, Houston - USA EU: Eric de GROOT, Amsterdam - NED The regulator viewpoint EMEA: Eric ABADIE, Paris - FRA Angeles ALONSO, Madrid - ESP The use of biomarkers and bio-imaging in clinical practice: early detection of patients at risk, risk stratification, therapeutic decision making and dose-titration Biomarkers: Terje PEDERSEN, Oslo - NOR Bio-imaging: Daniel O LEARY, Boston - USA Panel Discussion: Setting a roadmap for future work needed in order to validate, if possible, biomarkers and bio-imaging as surrogates to outcomes All speakers Regulators: Eric ABADIE, Paris - FRA John WARREN, London - GBR 8-4 th Global CardioVascular Clinical Trialists Forum Cannes 2007

9 SATURDAY APRIL 28 TH, 2007 MEDITERRANÉE B ROOM CONSENSUS WORKSHOP (by invitation or registration only) FROM HYPERTENSION TO HEART FAILURE: THE DISEASE CONTINUUM Chairmen: Enrico AGABITI-ROSEI, Brescia - ITA Luc HITTINGER, Créteil - FRA How many hypertensive patients will develop heart failure? How many heart failure patients are/ were hypertensive? Insight from epidemiology Faiez ZANNAD, Nancy - FRA Hypertension, cardiovascular remodelling, diastolic and systolic dysfunction and symptomatic heart failure: a single spectrum of heart failure phenotypes Jean-Jacques MERCADIER, Paris - FRA Coffee Break and visit of the exhibition area From blood pressure lowering to heart failure outcome prevention, Candesartan along the hypertension-heart failure continuum Stevo JULIUS, Ann Arbor - USA Brainstorming break-outs: Raising awareness about the hypertension-heart failure continuum Facilitator: Enrico AGABITI-ROSEI, Brescia - ITA Stimulating research on the hypertension-heart failure continuum Facilitator: Aldo MAGGIONI, Florence - ITA MEDITERRANÉE C ROOM CONSENSUS WORKSHOP (by invitation or registration only) CARDIOMETABOLIC SARTANS: KILLING TWO BIRDS WITH ONE STONE? Chairmen: Michel MARRE, Paris - FRA Thomas UNGER, Berlin - GER Risk constellations in patients with the metabolic syndrome: need for multiple action therapeutic strategies Steven HAFFNER, San Antonio - USA Multiple actions of angiotensin receptor blockers in patients with hypertension and insulin resistance Clinically relevant? Michel MARRE, Paris - FRA Coffee Break and visit of the exhibition area How to demonstrate the specific benefit from the PPAR Gamma effects of cardiometabolic sartans? Thomas UNGER, Berlin - GER Board discussion: Possible trial designs to demonstrate additional cardiometabolic actions of telmisartan independent of AT1R blocking actions Are cardiometabolic actions of telmisartan blocked by simultaneous treatment with an inhibitor of PPAR? Does telmisartan reduce the development of diabetes and CVD in insulin resistant patients? Are the beneficial cardiometabolic actions also observed in insulin resistant patients pretreated with maximal doses of other ARBs? Does co-treatment with an activator of PPAR-gamma attenuate the effects of telmisartan in these patients? Closing Ceremony Posters Posters will be exhibited from Thursday April 26 th, 2007 to Saturday April 28 th, 2007 Sponsors, investigators and clinicians are offered a dedicated space at the Poster Area for the presentation of trial related data Design and/or baseline characteristics of ongoing trials Main results and/or results of sub-analyses and ancillary studies Registry data Cost benefit and Health economic analyses 4 th Global CardioVascular Clinical Trialists Forum Cannes

10 SATURDAY APRIL 28 TH, 2007 and SUNDAY APRIL 29 TH, 2007 SECOND ANNUAL MEETING: INTERNATIONAL HEART FAILURE BIOMARKER RESEARCH WORKING GROUP (by invitation only) Chairmen: Kirkwood F. ADAMS, Jr., Chapel Hill - USA Faiez ZANNAD, Nancy - FRA Christopher O'CONNOR, Durham - USA George SOPKO, Washington DC - USA Faculty: Kirkwood F. ADAMS, Jr., Chapel Hill - USA Inder ANAND, Minneapolis - USA Stephan ANKER, Berlin -GER Salvador BORGES-NETO, Durham - USA Robert BOURGE, Birmingham - USA John BURNETT, Rochester - USA François CAMBIEN, Paris - FRA John CLELAND, Hull - GBR Alain COHEN SOLAL, Paris - FRA Anita DESWAL, Houston - USA Kenneth DICKSTEIN, Stavanger - NOR Anna DOMINICZAK, Glasgow - GBR Mike FELKER, Durham - USA Gerasimos FILIPPATOS, Athens - GRE Mihai GHEORGHIADE, Chicago - USA Joshua HARE, Baltimore - USA Luc HITTINGER, Paris - FRA Patrick JOURDAIN, Paris - FRA Peter LIU, Toronto - CAN Aldo MAGGIONI, Florence - ITA Alan MAISEL, San Diego - USA Doug MANN, Houston - USA Harald MISCHAK, Hanover - GER Jagat NARULA, Irvine - USA Christopher O'CONNOR, Durham - USA Howard ROCKMAN, Durham - USA Patrick ROSSIGNOL, Paris - FRA Michael SABOLINSKI (Nitromed) Daniel SARGENT, Rochester Mn - USA Tabassome SIMON, Paris - FRA George SOPKO, NHLBI, Bethesda - USA James UDLESON, Boston - USA Sophie VISVIKIS-SIEST, Nancy - FRA Faiez ZANNAD, Nancy - FRA PROGRAMME HIGHLIGHTS BNP Versus Novel Molecules - Is There a Better Molecular Biomarker for CHF? Does Molecular Imaging Characterize CHF Patients Beyond Molecular Markers? Novel Findings in 'Omic Studies in Clinical Heart Failure Are Biomarkers Only Reliable Surrogates in Non-Approval Trials - Phase II and IV Integration of Biomarkers and Chronic Hemodynamic Monitoring in Guided Therapy Biomarker Based Therapeutics - Better Patient Selection - Better Guided Therapy Clinical and Statistical Approaches to Optimize Predictive Models with Biomarkers Systems Biology: Novel Strategies for Integration of 'Omics in Clinical Research 10-4 th Global CardioVascular Clinical Trialists Forum Cannes 2007

11 ACKNOWLEDGEMENTS 4 th Global CardioVascular Clinical Trialists Forum We would like to thank our major sponsors 4 th Global CardioVascular Clinical Trialists Forum Cannes

12 ABBOTT ASTRAZENECA Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products. The company employs 65,000 people and markets its products in more than 130 countries. Nearly 50 percent of sales are generated outside of the United States. With industry-leading internal research capabilities, Abbott combines science and innovation to develop breakthrough medical technologies that advance patient care. As a leading global health care company, Abbott's commitment to caring goes well beyond patients to the company's employees and the communities it serves. ABBOTT 100 Abbott Park Road Abbott Park, Illinois Ph: (847) AstraZeneca: at the cutting edge of innovation in the health world. AstraZeneca is an Anglo-Swedish pharmaceutical group, born from Zeneca Pharmaceuticals and Astra AB merger in April Ranked 6 th in the world, and 5 th in Europe, AstraZeneca employs 65,000 people across the globe and in 2005 its worldwide turnover reached 23.9 billion dollars. Every day, AstraZeneca invests close to 14 million dollars in research and development and employs 12,000 people throughout the world. In 2005, R&D investment amounted to 3.4 billion dollars, i.e. 14% of group's worldwide turnover. AstraZeneca has thus one of the biggest medical research and development organisations in the world. The group has research centres in Europe, American and Asia and develops multiple partnerships with a high number of players in the medical research field. AstraZeneca works in the areas of gastroenterology, cancerology, cardiology, pain relief and the treatment of pulmonary pathologies and migraines. In France, AstraZeneca ranks 4 th among the pharmaceutical groups with its turnover around 1,2 billion dollars in AstraZeneca's eleven research centres include a research centre based in Reims (France), which specialises in cancer research. Similarly, the AstraZeneca Group has 3 production sites in France, based in Dunkirk, Monts and Reims. AstraZeneca has around 2,700 employees in France. AstraZeneca : à la pointe de l'innovation dans le monde de la santé. AstraZeneca est un groupe pharmaceutique anglo-suédois, issu de la fusion en avril 1999 de Zeneca Pharmaceuticals et d'astra AB. Situé au 6 e rang mondial, au 5 e rang européen, au 4 e rang français, AstraZeneca emploie personnes dans le monde, et a réalisé, en 2005, un chiffre d'affaires mondial de 23.9 milliards de dollars. AstraZeneca investit chaque jour dans le monde près de 14 millions de dollars dans la recherche et le développement et emploie personnes dans le monde entier. Cet investissement en R&D, pour l'année 2005, a représenté 3.4 milliards de dollars soit 14 % du chiffre d'affaires mondial. AstraZeneca a ainsi l'une des organisations de recherche et de développement de médicaments les plus importantes du monde. Des centres de recherche sont installés en Europe, en Amérique et en Asie, développant des partenariats multiples avec de nombreux acteurs de la recherche médicale. AstraZeneca est présent en gastro-entérologie, cancérologie, cardiologie, dans la prise en charge de la douleur, dans le traitement des pathologies pulmonaires et de la migraine. En France, AstraZeneca se situe au 4 e rang des groupes pharmaceutiques, avec un chiffre d'affaires de près de 1,2 milliard d'euros en L'un des onze centres de recherche AstraZeneca, se trouve en France, à Reims. Il est spécialisé dans la recherche en cancérologie. De même le Groupe AstraZeneca dispose en France de 3 sites de production situés à Dunkerque, Monts et Reims. AstraZeneca emploie près de 2700 personnes en France. AstraZeneca 1, place Renault Rueil-Malmaison cedex - France Tél. : +33 (0) Fax : +33 (0) th Global CardioVascular Clinical Trialists Forum Cannes 2007

13 BOEHRINGER INGELHEIM BOSTON SCIENTIFIC The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit Le groupe pharmaceutique Boehringer Ingelheim, dont le siège se situe à Ingelheim en Allemagne, figure parmi les 20 premières entreprises du médicament au monde. Le groupe compte 143 filiales dans 47 pays et près de employés. Cette entreprise indépendante à capitaux privés est engagée depuis 1885 dans la recherche et le développement, la fabrication et la commercialisation de produits d'intérêt thérapeutique majeur à usage humain et vétérinaire. En 2005, Boehringer Ingelheim a enregistré un chiffre d'affaires de 9,5 milliards d'euros et a consacré à la recherche et au développement, près de 20 % du chiffre d'affaires des produits de prescription. For more than 25 years, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. As a market leader in less-invasive medical devices delivering more than 15,000 products to clinicians in over 45 countries, Boston Scientific works every day to build the knowledge, processes and infrastructure it needs to identify opportunities, address new disease areas and support clinicians in advancing the practice of health care around the world. The CRM group of BSC is a leading developer of implantable devices used to treat cardiac arrhythmias, sudden cardiac death, and heart failure. Today, with more than 29,000 employees, revenue of $7.8 billion in 2006, and 26 manufacturing, distribution and technology centers, Boston Scientific remains true to its original mission. For more information, please visit Boston Scientific Guidant Europe NV/SA Park Lane Culliganlaan 2B 1831 Diegem Belgium Tél. : Fax : Si vous souhaitez en savoir davantage sur Boehringer Ingelheim, n'hésitez pas consulter notre site Internet à l'adresse suivante : Boehringer Ingelheim Nadia SPIESS - Frédéric LIEUTAUD 12, rue André Huet BP REIMS Cedex - France Tél. : +33 (0) Fax : +33 (0) th Global CardioVascular Clinical Trialists Forum Cannes

14 DAIICHI-SANKYO IPSEN DAIICHI SANKYO is one of the top 20 leading global pharmaceutical companies with its European Headquarters located in Munich and affiliates in all major European countries. Through the merger of two Japanese pharmaceutical firms DAIICHI SANKYO has strengthened its position as one of the top three pharmaceutical companies in Japan. As Global Pharma Innovator, DAIICHI SANKYO is dedicating huge resources in its research activities in order to ensure the future development of innovative products. Consequently DAIICHI SANKYO is focussed on the development of new, highly effective therapeutic products in the fields of cardiovascular disease, type II diabetes and metabolic syndrome, infectious diseases, cancer, immunology and bone and joint diseases. Through this, DAIICHI SANKYO aims to provide innovative products to physicians and patients. OLMETEC / OLMETEC Plus are DAIICHI SANKYO s leading products line within their cardiovascular portfolio. For further information visit DAIICHI SANKYO EUROPE GmbH Zielstattstr Munich, Germany Tel: Fax: How to recognise a unique pharmaceutical Group? Ipsen is a European pharmaceutical group with over 20 products on the market and a total worldwide staff of 3,800. Its growth model is based on specialised research in targeted disease areas (oncology, endocrinology and neuromuscular disorders) and an active strategy of alliances. The location of its four Research and Development centres (Barcelona, Boston, London, Paris) gives the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. In 2003, Ipsen had a turnover of million, 18.5% of which was reinvested in Research & Development. The 615 people in R&D are dedicated to discovering and developing innovative drugs for patient care. A quoi reconnaît-on un grand laboratoire pharmaceutique? Ipsen est un groupe pharmaceutique européen qui commercialise actuellement plus de 20 médicaments et rassemble collaborateurs dans le monde. Son modèle de croissance repose sur une recherche spécialisée dans des domaines thérapeutiques ciblés (oncologie, endocrinologie et désordres neuromusculaires) et une stratégie d alliances active. La localisation de ses quatre sites de Recherche et Développement (Barcelone, Boston, Londres, Paris) lui permet d être en relation avec les meilleures équipes de la recherche universitaire et d accéder à un personnel de grande qualité. En 2003, le Groupe a réalisé un chiffre d affaires de 737,2 millions d euros, dont 18,5 % ont été investis en Recherche et Développement. Les 615 personnes affectées à la R&D ont pour mission la découverte et le développement de médicaments innovants au service des patients. IPSEN 24, Rue Erlanger PARIS Cedex 16 - France Tél. : +33 (0) Fax : +33 (0) th Global CardioVascular Clinical Trialists Forum Cannes 2007

15 MEDTRONIC NEGMA-LERADS Every five seconds, in more than 120 countries around the world someone's life is improved, enriched and/or extended because of a Medtronic therapy. At CVCT 2007, we invite you discover Medtronic's role as your future partner for device-related scientific collaboration. Join the Meet & Eat with the Experts session on Friday, April 27, 2007 starting at 12:15 for "Get with the guidelines: The challenges of implementing device trial results into daily practice". MEDTRONIC Europe Route du Molliau 31 Case postale CH Tolochenaz Tel: +41 (0) Fax: +41 (0) Founded in 1972, the Negma-Lerads Laboratories are mostly known in France for their medicinal products in angiology, rheumatology and respirology. Today, Negma-Lerads is established in the field of cardiology with the marketing of an original beta-blocker, Nebivolol, available to the medical profession since Its head office is located in the Paris area (Yvelines) and production is divided among two sites: one in Brittany and the other one in The Nivernais. Suppleness and reactivity characterise this human size laboratory, together with a corporate culture mainly oriented towards the quality of service offered to doctors. On an international level, the Negma-Lerads Laboratories have acquired acknowledged expertise thanks to their heavy research and development activity. This activity applies to various fields such as cancerology, with biotechnology-based treatments, and gastroenterology with the particularly promising development of a proton pump inhibitor. NEGMA LERADS Immeuble Strasbourg Avenue de l'europe TOUSSUS LE NOBLE - France Tél. : +33 (0) Fax : +33 (0) th Global CardioVascular Clinical Trialists Forum Cannes

16 NOVARTIS "Caring and Curing" Novartis is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, leading self-medication OTC brands, vaccines and diagnostics. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. Performance. In the global pharmaceutical industry, Novartis is ranked number 6. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Pharmaceuticals gained market share, with sales growth of 10% in USD, driven by the Cardiovascular and Oncology franchises. Approximately USD 4.8 billion was invested in R&D. In France, the Pharma Division of Novartis Pharma S.A.S consists of four business units : Primary Care; Oncology; Ophtalmics; Infectious Diseases, Transplantation & Immunology. Primary Care includes a wide range of products for the treatments of cardiovascular diseases, central nervous system disorders and dermatological conditions. Corporate Citizenship. Novartis tirelessly aspires to responsible global citizenship. In collaboration with the WHO, Novartis provides medicines at cost, or sometimes free, to patients in the developing world afflicted by diseases such as leprosy, malaria and tuberculosis. In 2005, Novartis were able to contribute USD 696 million and reach 6,5 million patients in need through access-to-medicine projects around the world. Since 2001, Novartis France is supporting a new discipline, Proximology, which focuses on the study of relationships between the sick person and their next of kin. This multidisciplinary approach aims to improve knowledge and recognition of the caregiver as a key actor in the therapeutic process. It seeks to evaluate the nature and the limits of the acts of care provided by the patient's family carers from a general care perspective, whatever the chronic pathology may be. MSD SCHERING-PLOUGH MSP Singapore Company, LLC, is a joint venture company formed by Merck & Co. Inc. (New Jersey, USA) and Schering-Plough Corporation (New Jersey, USA) and in partnership, market two products: INEGY and EZETROL. INEGY, through inhibition of cholesterol absorption and production, rovides greater LDL-C cholesterol reduction than single inhibition by a statin alone. EZETROL, when co-administered together with any dose of any statin, provides greater LDL-C efficacy than a statin alone through inhibition of absorption and production of cholesterol. Merck & Co., Inc. One Merck Drive Whitehouse Station New Jersey - USA Schering-Plough Corporation 2000 Galloping Hill Road Kenilworth New Jersey - USA " Caring and Curing " Novartis est un leader mondial dans l'offre de médicaments destinés à préserver la santé, soigner les malades et améliorer le bien-être. Notre objectif est de découvrir, de développer et de commercialiser avec succès des produits innovants pour soigner les patients, soulager la douleur et améliorer la qualité de vie. Situé à Bâle, en Suisse, le Groupe Novartis emploie quelque personnes et déploie ses activités dans plus de 140 pays. Novartis est le seul groupe pharmaceutique à occuper une position de leader à la fois sur le marché des médicaments protégés par brevet et sur celui des génériques. Notre objectif est de renforcer notre portefeuille thérapeutique en investissant dans les plateformes de croissance stratégiques suivantes : les médicaments de pointe, les génériques de haute qualité à faible coût, les grandes marques d'automédication (OTC), les vaccins et les produits de diagnostic. Les trois divisions Pharma, Sandoz et Consumer Health sont représentées en France. La Division Pharma comprend 4 unités d'affaires au sein de Novartis Pharma S.A.S : Médecine générale, Oncologie, Ophtalmologie, Transplantation Immunologie et Maladies infectieuses. L'unité Médecine générale propose une gamme très large de produits pour le traitement des maladies cardiovasculaires, dermatologiques et du système nerveux central. Performance. Novartis se situe au 6ème rang de l'industrie pharmaceutique au plan mondial. En 2005, le Groupe Novartis a réalisé un chiffre d'affaires net de USD 32,2 milliards et un résultat net de USD 6,1 milliards. La division Pharmaceuticals a continué à gagner des parts de marché avec une augmentation du chiffres d'affaires net de 10 % en USD, notamment grâce aux activités oncologie et cardiovasculaire. Le Groupe a investi environ USD 4,8 milliards dans la recherche et le développement (R&D). Citoyenneté d'entreprise. Novartis n'a de cesse d'améliorer sa démarche de responsabilité citoyenne. Novartis est engagé aux côtés de l'organisation Mondiale de la Santé dans des programmes de lutte contre la lèpre, le paludisme et la tuberculose. En 2005, 6,5 millions de patients dans le besoin ont bénéficié des programmes d'accès aux traitements de Novartis, représentant une aide de 696 millions de dollars. Depuis 2001, Novartis soutient une nouvelle aire de recherche, la Proximologie, qui s'intéresse à l'étude des relations entre une personne malade et son entourage. Cette approche pluridisciplinaire vise à améliorer la connaissance et la reconnaissance de l'aidant familial en tant qu'acteur incontournable dans la chaîne du soin. Elle vise à évaluer la nature et les limites de l'acte de soin fourni par les proches du patient à travers une démarche de prise en charge globale, quelle que soit la pathologie. Novartis Pharma S.A.S. 2 et 4, rue Lionel Terray BP Rueil-Malmaison Cedex - France Tél. : +33 (0) Fax : +33 (0) th Global CardioVascular Clinical Trialists Forum Cannes 2007

17 SERVIER Servier is involved in research and development, manufacture and marketing of ethical pharmaceuticals. It is a private, independent pharmaceutical company, led by the founder Dr Jacques Servier. Cardiovascular diseases represent the most important therapeutic area for Servier. Procoralan (ivabradine), the first selective and specific If inhibitor, has received marketing authorization in 27 European countries by the European Agency for the Evaluation of Medicinal Products (EMEA) for the symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm who have a contraindication or intolerance to beta-blockers. Procoralan, the first pure heart rate-lowering agent, was discovered and developed by Servier and represents one of the most important advances in cardiovascular treatment over the last two decades. Other cardiovascular drugs: The ACE inhibitor Coversyl (perindopril) is indicated for the treatment of hypertension, heart failure, and secondary prevention for coronary artery disease. Coversyl's role in preventing cardiovascular morbidity/mortality in different subsets of patients has been largely demonstrated in the PROGRESS, EUROPA, and ASCOT trials. Vastarel MR (trimetazidine), a 3-KAT inhibitor that offers a metabolic approach to the treatment of stable angina, optimizes protection against cardiovascular disease. Le domaine d'activités de SERVIER couvre la recherche, le développement, la fabrication et la vente de médicaments prescrits. C'est une compagnie pharmaceutique privée, indépendante, ayant à sa tête son fondateur, le Dr Servier. Les maladies cardiovasculaires représentent pour Servier le plus important domaine thérapeutique. Procoralan (ivabradine), le premier inhibiteur sélectif et spécifique du courant If a reçu l'autorisation de mise sur le marché dans 27 pays européens par l'emea (European Agency for the Evaluation of Medicinal Products), dans le traitement symptomatique de l'angor stable chez les patients ayant un rythme sinusal et présentant une contre indication ou une intolérance aux beta-bloquants. Procoralan, le premier médicament réduisant de façon exclusive la fréquence cardiaque, a été découvert et développé par Servier et représente l'une des avancées les plus importantes dans le domaine cardiovasculaire de ces vingt dernières années. Autres médicaments de ce domaine : L'inhibiteur d'enzyme de conversion, Coversyl (perindopril) est indiqué dans le traitement de l'hypertension, de l'insuffisance cardiaque et de la prévention secondaire de la maladie coronaire. Le rôle de Coversyl dans la prévention de la morbi-mortalité cardiovasculaire dans différents sous-groupes de patients a été largement démontré dans les études PROGRESS, EUROPA et ASCOT. Vastarel MR (trimetazidine), un inhibiteur 3-KAT doté d'une approche métabolique pour le traitement de l'angor stable, améliore la protection contre les maladies cardiovasculaires. Servier International 192, avenue Charles de Gaulle NEUILLY SUR SEINE CEDEX Tél. : +33 (0) Fax : +33 (0) th Global CardioVascular Clinical Trialists Forum Cannes

18 G E N E R A L I N F O R M A T I O N VENUE OF THE CONGRESS HILTON HOTEL: 50, bd de la Croisette - BP Cannes, France Ph: +33 (0) Fax: +33 (0) Congress welcome desk: Ph: +33 (0) SCIENTIFIC SECRETARIAT LOGISTIC AND TECHNICAL ORGANIZATION Faiez ZANNAD OVERCOME Personal Assistants: Catherine VILLEMAIN - Stéphanie GROJEAN 3-5, bd Paul-Emile Victor CIC - INSERM - CHU de Nancy - Hôpital Jeanne d'arc Neuilly-sur-Seine cedex, France BP Toul cedex, France Ph: +33 (0) Ph: +33 (0) Fax: +33 (0) Fax: +33 (0) REGISTRATION FEE On site registration 750 euros Participant registration fee includes Opening hours of the welcome desk Access to all scientific sessions - Access to the exhibition area Thursday April 26 th, 2007: Congress materials - Lunches on April 26 th and 27 th, 2007 Friday April 27 th, 2007: Daily coffee breaks - Congress dinner on Friday April 27 th, 2007 Saturday April 28 th, 2007: EXHIBITION AREA An exhibition of pharmaceutical firms, technical equipment and a cyberspace theatre will be situated next to the plenary sessions. All coffee breaks and lunches will take place in the exhibition area. ACCREDITATION The 4 th Global CVCT Forum is accredited by the European Board for Accreditation in Cardiology for 12 hours of external CME credits. Each participant should claim only those hours of credit that have actually been spent in the educational activity. EBAC works according to the quality standarts of the European Accreditation Council for Continuing Medical Education (EACCME), which is an institution of the European Union of Medical Specialists (UEMS). In compliance with EBAC/EACCME guidelines, all speakers/chairpersons participating in this programme have disclosed potential conflicts of interest that might cause a bias in the presentations. The Organising Committee is responsible for ensuring that all potential conflicts of interest relevant to the event are declared to the audience prior to the CME activities. OFFICIAL LANGUAGE The official language of the meeting is English. Simultaneous translation into French will be provided for each session in the Theatre. TRANSLATION AIDS The translation aids will be handed out at the welcome desk (These will be given in return for an ID card/passport). TRANSPORTATION On international routes: Discounts registred under GGAIRAFEVENTNEGO On presentation of the original of this document AIR FRANCE offices throughout the World will offer you preferential fares (suject to conditions) from your country of departure # on the regular full fare in business or economy class for your round-trip journey to attend this event. Your nearest Air France office: On the domestic network within metropolitan France: Discounts registred under GGAIRAFGLOBALMEETINGS. This original document will entitle you to a rebate of up 45% (subject to conditions) on the regular full fare in economy class for your round-trip journey on the Air France metropolitan domestic network to attend this event. To book and obtain your electronic ticket within France, contact 3654* or your travel agent in metropolitan France or your Air France office. Your nearest Air France office in France: (* charge for calls: 0,35E/min) Référence to be quoted: AXZE SE Validity from April 20, 2007 to May 4, 2007 Train Vouchers on national railways are at your disposal on request at OVERCOME agency th Global CardioVascular Clinical Trialists Forum Cannes 2007

19 Traitement adjuvant en prévention secondaire de l infarctus du myocarde, en association aux traitements de référence (incluant les statines, les anti-agrégants plaquettaires, les bêtabloquants et les IEC de l angiotensine) OMACOR Prise en charge à 100% dans le cadre de l ALD n 13 (2) - 08/ DÉNOMINATION : OMACOR, capsule molle. COMPOSITION QUALITATIVE ET QUANTITATIVE : Esters éthyliques d acides Oméga-3 à 90 % : 1000 mg comprenant des esters éthyliques d acide eicosapentaénoïque (EPA : 46 %) et d acide docosahexaénoïque (DHA : 38%) : 840 mg contenant comme antioxydant : Alpha Tocophérol : 4 mg pour une capsule molle. Enveloppe de la capsule : gélatine, glycérol, eau purifiée. FORME PHARMACEUTIQUE : capsule molle oblongue en gélatine transparente contenant une huile jaune pale. DONNÉES CLINIQUES : INDICATIONS THÉRAPEUTIQUES : Hypertriglycéridémies : hypertriglycéridémies endogènes, en complément d un régime dont la prescription seule s est révélée insuffisante pour fournir une réponse adéquate : type IV en monothérapie, type IIb/III en association avec les statines, lorsque le contrôle des triglycérides est insuffisant. Post-Infarctus du Myocarde : Traitement adjuvant en prévention secondaire de l infarctus du myocarde, en association aux traitements de référence (incluant les statines, les anti-agrégants plaquettaires, les bêtabloquants et les inhibiteurs de l enzyme de conversion de l angiotensine). POSOLOGIE : Hypertriglycéridémies : la dose quotidienne initiale recommandée est de 2 capsules. En l absence de réponse adéquate, la dose peut être augmentée à 4 capsules par jour (CTJ : 1,93 à 3,87 ; indication non remboursée). Post-Infarctus du Myocarde : Une capsule par jour (CTJ : 0,97 ) ; indication remboursée à 65 %. Il est recommandé d ingérer les capsules au moment des repas afin d éviter les troubles gastro-intestinaux. Interactions avec d autres médicaments et autres formes d interactions* Grossesse et allaitement* Effets indésirables* Surdosage* CONTRE-INDICATIONS : hypersensibilité à l un des composants. Mises en garde et précautions particulières d emploi* : PROPRIÉTÉS PHARMACOLOGIQUES* : Propriétés pharmacodynamiques*. Dans l étude GISSI Prevenzione, patients ayant eu un infarctus du myocarde récent (< 3 mois), et recevant un traitement préventif recommandé associé à un régime méditerranéen, ont été randomisés de façon à recevoir OMACOR (n = 2836), vitamine E (n = 2830), OMACOR + vitamine E (n = 2830) ou pas de traitement (n = 2828). L étude GISSI-Prevenzione est une étude multicentrique, randomisée, en ouvert, réalisée en Italie. Les résultats observés durant les 3,5 ans de suivi avec OMACOR 1 g/jour ont montré une diminution significative du premier critère principal composite incluant la mortalité toutes causes confondues, les infarctus du myocarde non mortels et les accidents vasculaires cérébraux non mortels (diminution du risque relatif de 15 % [2-26], p = 0,0226 chez les patients prenant OMACOR seul par comparaison au groupe contrôle, et de 10 % [1-18], p = 0,0482 chez les patients prenant OMACOR associé ou non à la vitamine E). Une diminution des composants du second critère principal pré-défini incluant la mortalité cardiovasculaire, les infarctus du myocarde non mortels et les accidents vasculaires cérébraux non mortels a été mise en évidence (diminution du risque relatif de 20 % [5-32], p = , chez les patients prenant OMACOR seul par comparaison au groupe contrôle, diminution du risque relatif de 11 % [1-20 %], p= 0,0526, chez les patients prenant OMACOR associé ou non avec la vitamine E). L analyse secondaire de chacun des composants des critères principaux a montré une diminution significative de la mortalité toutes causes confondues et de la mortalité cardiovasculaire, sans toutefois montrer de réduction des événements cardiovasculaires non mortels ou des accidents vasculaires cérébraux mortels ou non mortels. Propriétés pharmacocinétiques* DONNÉES PHARMACEUTIQUES* PRÉSENTATIONS ET NUMÉROS D IDENTIFICATION ADMINISTRATIVE : :28 capsules en flacon (PE). PRIX : OMACOR : 27,06. Remb.Séc. Soc. à 65 % dans la seule indication : traitement adjuvant en prévention secondaire de l infarctus du myocarde, en association aux traitements de référence (incluant les statines, les anti-agrégants plaquettaires, les bêtabloquants et les inhibiteurs de l enzyme de conversion de l angiotensine). - Agréé collect. DATE D APPROBATION/RÉVISION : Octobre PIERRE FABRE MÉDICAMENT Laboratoires PIERRE FABRE 45, Place Abel-Gance, BOULOGNE. - Info. médic. : La Chartreuse, CASTRES CEDEX. Tél. : Pharmacovigilance : Tél. : * Pour une information complète, consultez le dictionnaire Vidal. OMACOR : conditions de prescription et d utilisation. La prescription d OMACOR doit être initiée dans les 3 mois maximum suivant un infarctus du myocarde. OMACOR est un traitement adjuvant. Il n a établi son intérêt qu associé à des médicaments ayant fait la preuve de leur efficacité en monothérapie (bêtabloquants, anti-agrégants plaquettaires) ou ayant conduit à un bénéfice plus important qu OMACOR lorsqu ils étaient prescrits en association (statines). OMACOR n est pas une alternative aux médicaments auxquels il doit être associé et ne doit par conséquent en aucun cas leur être substitué. La poursuite du régime et le respect des règles hygiéno-diététiques restent indispensables (sevrage tabagique, exercice physique, diminution de la consommation de graisses animales ). OMACOR est remboursé à 65 % par la Sécurité Sociale dans la seule indication traitement adjuvant en prévention secondaire de l infarctus du myocarde, en association aux traitements de référence (incluant les statines, les anti-agrégants plaquettaires, les bêtabloquants et les IEC de l angiotensine). Toute autre prescription doit être accompagnée de la mention non remboursable. En l absence de la mention non remboursable, et si les prescriptions s avèrent indûment remboursées, le Laboratoire Pierre Fabre sera redevable des montants correspondants, conformément à la convention qu il a signée avec le comité économique des produits de santé. 1- Groupe italien pour la survie après un infarctus du myocarde. Administration de compléments alimentaires à base d acides gras polyinsaturés n-3 et de vitamine E après un IDM : résultats de l essai Gissi-Prevenzione. The Lancet 1999 ; 354 (9177) : Article L et D du Code de la Sécurité Sociale

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