As the European Society of Cardiology congress gets into full swing in Munich, data has been presented by Italian researchers which demonstrates that GlaxoSmithKline and Pronova BioPharma’s fish-oil product Lovaza/Omacor has shown benefits in patients with heart failure, unlike AstraZeneca’s cholesterol-lowering blockbuster Crestor.

GISSI-HF, a 6,975-patient trial designed and conducted by the Gruppo Italiano Studio Sopravvivenza Insufficienzia Cardiaca, revealed that the omega-3-based pill, sold as Lovaza (omega-3-acid ethyl esters) in the USA by GSK, developed and marketed in Europe by Norway’s ProNova as Omacor, and marketed in the UK as Omacor by Solvay Healthcare, lowered heart failure patients' risk of dying by 9% and the risk of hospitalisation (8%) compared to placebo. - were less likely to die or be admitted to hospital when compared with those who took a dummy pill. Lovaza is approved both as an adjunct to diet for the treatment of elevated levels of triglycerides, hypertriglyceridemia and for post-myocardial infarction patients.

The study authors said they have shown that treatment with n-3 polyunsaturated fatty acids “is effective and safe in a large population of patients with heart failure of any cause, who are receiving standard clinical care provided in hospitals and ambulatory facilities in Italy”. They added that “since we invited all cardiology centres operating in Italy to participate in the trial, and most did so, the results indicate what is likely to happen in the real world during the course of several years of polypharmacy care."

GSK acquired the US rights to Lovaza when it bought Reliant Pharmaceuticals for $1.65 billion last November and sales of the pill reached £157 million last year. However analysts say that figure could top £500 million in the next few years as Lovaza is more widely used.

In contrast, GISSI-HF had some bad news for AstraZeneca and Crestor (rosuvastatin). A separate arm of the study noted that 4,574 patients with chronic heart failure were randomised to receive either placebo or rosuvastatin (10mg daily) and were followed for a median of 3.9 years. However, 29% on Crestor died from any cause against 28% on placebo.

Presenting the results, Gianni Tognoni said that the results back up those from the recently-published CORONA study. Because the two studies concur, he said “it is clear that statins cannot be considered to improve clinical outcome in patients with chronic heart failure, of any age, aetiology or systolic function level”.

However, for those with heart failure who are already receiving the drugs, the decision to continue treatment, he said, “should be left to the informed judgement of the physician”. Prof Tognoni stressed that the GISSI-HF results were “neutral rather than negative” and that patients on rosuvastatin did not suffer harm. Safety data were “reassuring”.