Pronova's Phase III Heart Failure Study Meets Endpoint
Posted on: Monday, 1 September 2008, 12:00 CDT
Pronova BioPharma ASA has announced that the Phase III outcome trial GISSI-heart failure demonstrated that Omacor reduced mortality and morbidity in patients with congestive heart failure. Both primary endpoints were met in the 7000 patient trial.
The GISSI- heart failure (HF) trial was designed and conducted by the Gruppo Italiano Studio Sopravvivenza Insufficienzia Cardiaca (GISSI) in Italy to investigate the clinical effects of a pharmaceutical prescription omega-3 product in approximately 7000 patients with a clinical diagnosis of heart failure.
The co-primary endpoints of the study were reduction of all-cause mortality, reduction of all-cause mortality or hospitalizations for cardiovascular reasons, and both primary endpoints were met.
The study showed that the long-term administration of 1gm per day of Omacor was effective and safe in reducing both all-cause mortality and hospitalizations for cardiovascular reasons compared to placebo.
Approximately 955 (27%) patients died from any cause in the n-3 PUFA (Omacor) group and 1014 (29%) in the placebo group (relative risk reduction 9%, p=0.041). Approximately, 1981 (57%) patients in the n-3 PUFA group and 2053 (59%) in the placebo group died or were admitted to hospital for cardiovascular reasons (relative risk reduction 8%, p=0.009).
In absolute terms, 56 patients needed to be treated for 3.9 years to avoid one death or 44 patients in the same period of time to avoid one event like death or admission to hospital for cardiovascular reasons. In a per-protocol analysis performed in about 5000 full complier patients, the relative risk of death was reduced by 14% (p 0.004).
Tomas Settevik, CEO of Pronova BioPharma, said: "These latest findings represent an important step forward in the treatment of patients suffering from heart failure. These results underline the potential of Omacor in the treatment of life-threatening cardiovascular diseases."
Source: Datamonitor
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