Progetto GISSI-HF al centro dell'attenzione della cardiologia internazionale

1/09/2008

Domenica 31 Agosto, nella prima Sessione Generale del Congresso dell’European Society of Cardiology, dedicata alle "hot news" della ricerca, ben due delle relazioni principali hanno avuto come protagonisti i risultati del progetto GISSI-HF, che è stato condotto lungo quattro anni dall’o rmai "classico" gruppo GISSI (costituito dall’Associazione Nazionale dei Medici Cardiologi Ospedalieri, ANMCO, dall’Istituto Mario Negri, dal Consorzio Mario Negri Sud). Il progetto era articolato in due trial indipendenti, ma sviluppati insieme grazie a un disegno metodologicamente originale, che avevano come obiettivo la valutazione di due nuovi trattamenti per lo scompenso cardiaco: gli acidi grassi polinsaturi (noti con il loro acronimo n-3 PUFA) e la più recente delle statine (la rosuvastatina).
Probabilmente non c'è modo migliore e più autorevole di riassumere quanto presentato, che quello di riprodurre il comunicato stampa di Lancet che ha pubblicato on line, contestualmente alla presentazione, gli articoli con tutti i risultati dei trial, accompagnati da un editoriale.
 
"RANDOMISED TRIAL SHOWS POLYUNSATURATED FATTY ACIDS REDUCE MORTALITY AND HOSPITAL ADMISSION IN PATIENTS WITH HEART FAILURE, WHILE STATINS SHOW NO EFFECT"
A simple, safe, one-a-day capsule of n-3 polyunsaturated fatty acids (PUFA) can reduce mortality and admission to hospital for cardiovascular reasons in patients with heart failure. These are the conclusions of the first of two Articles based on the GISSI-HF study published early Online and in an upcoming edition of The Lancet. The second Article concludes that statin treatment with rosuvastatin does not affect clinical outcomes in patients with chronic heart failure. Both Articles are being presented at the European Society of Cardiology meeting in Munich.
In the first Article the GISSI-HF investigators discuss the results of a randomised controlled trial from 357 cardiology sites in Italy, which looked at patients with chronic heart disease. Patients received either n-3 PUFA in a capsule once daily (3494 patients) or placebo (3481). 955 patients in the PUFA group (27%) died, compared with 1014 (29%) in the placebo group - meaning a relative risk reduction of 9% in the PUFA group. A higher proportion of patients in the placebo group (2053 / 59%) died or were admitted to hospital for cardiovascular reasons than in the PUFA group (1981 / 57%) a relative reduction of 8% in the PUFA group. In absolute terms, 56 patients needed to be treated with PUFA for just under four years to avoid one death, or 44 patients to avoid one event of either death or admission to hospital for cardiovascular causes. Gastrointestinal disorders were the most frequent adverse reaction, and were experienced by 3% of patients in both groups. The authors conclude: "Our study shows that the long-term administration of 1g per day n-3 PUFA was effective in reducing both all-cause mortality and admissions to hospital for cardiovascular reasons."
The second Article based on GISSI-HF, by the same authors, discusses the results of a randomised controlled trial from the same 357 cardiology sites in Italy, which looked at the effect of the statin drug rosuvastatin in patients with heart failure. Patients received either rosuvastatin 10mg daily (2285 patients) or placebo (2289), and were followed up for a median of nearly four years. The researchers found that 657 patients (29%) died from any cause in the rosuvastatin group, compared with 644 (28%) in the placebo group. Proportions of patients who died or were admitted to hospital for cardiovascular causes were also similar in both groups (1305/57% rosuvastatin versus 1283/56% placebo). Again, gastrointestinal disorders were the most common adverse events in both groups (1% rosuvastatin versus 2% placebo). The authors conclude: "Rosuvastatin 10mg daily did not affect clinical outcomes in patients with chronic heart failure of any cause, in whom the drug seemed to be safe."
In an accompanying Comment, Dr Gregg Fonarow, Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, CA, USA, says: "For n-3 fatty acid supplementation, benefits observed in other populations apply to patients with heart failure. For statins, the benefits, unfortunately, seem not to. Although other promising treatments for heart failure are under investigation, every effort should be made apply those therapies which are evidence-based to all eligible patients with heart failure."
 
 
E’ doveroso commentare che i risultati positivi attenuti con gli n-3 PUFA non solo rappresentano una novità per le potenzialità terapeutiche, ma anche lo sviluppo di una linea di ricerca aperta anni fa con i risultati del GISSI-Prevenzione, che è anche innovativa dal punto di vista dei meccanismi d’azione che sono in un certo senso atipici rispetto ai farmaci tradizionali. Un’ultima - certo non meno rilevante - osservazione: come si può vedere dalla lista degli sponsor indicati su Lancet, lo sviluppo scientifico di questa area farmacologica vede come sostenitori due gruppi industriali italiani.
Non possiamo che augurarci che non solo questo sostegno continui, ma sia un buon indicatore di policy.
 
                                                                                                 
Prof. Silvio Garattini
Direttore
Istituto di Ricerche Farmacologiche Mario Negri
 
Per ulteriori informazioni:
Dr.ssa Maria Grazia FRANZOSI
Capo del Dipartimento di Ricerca Cardiovascolare
franzosi@marionegri.it              
 
Milano, 1 settembre 2008