Presenting the data at yesterday’s Hot Line session, Professor Gianni Tognoni (Consorzio Mario Negri Sud) said that the results back up those from the recently published CORONA study. Because the two major 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.
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”. Nevertheless, discussant Philip Poole-Wilson said that heart failure patients already on the drugs should “probably” have them withdrawn.
The study, which was simultaneously published online by the Lancet, included 4574 patients with chronic heart failure (New York Association class II to IV), irrespective of cause and left ventricular ejection fraction. They were randomised to receive either placebo or rosuvastatin (10 mg daily) and followed for a median of 3.9 years. No differences between the groups were found in the primary endpoints: time to death, or the composite of time to death and admission to hospital for CVD.
Lowered concentrations of LDL and C-reactive protein were found, but these pharmacological effects did not translate into clinical benefit.
Poole-Wilson said that the study had a strong rationale. Observational studies and meta-analyses had predicted a positive outcome: “There were even those who said the CORONA study, and possibly this study, were unethical because it was so obvious that statins would be beneficial. They were wrong, and this is an unexpected result, which
makes us think again. It will have a considerable impact on our thoughts on the pathophysiology of heart failure.
A separate arm of the same study found that a simple fish oil supplement can benefit patients with heart failure. Patients given a supplement of n-3 polyunsaturated fatty acids (n-3 PUFA, 1 g daily) saw an 8% reduction in their relative risk of mortality and admissions to hospital for cardiovascular reasons.
The benefit was moderate and smaller than expected - the study had assumed a 15% reduction in relative risk. However, it was achieved in a population which was already well treated with recommended therapies. In absolute terms, it means that 56 patients need to be treated for 3.9 years to avoid one death.
Presenting the results at yesterday’s Hot Line session, Professor Luigi Tavazzi (Pavia, Italy) said the n-3 PUFA treatment is “moderately effective, safe and cheap, a once-daily administration”.
Discussant Michel Komajda pointed out that the “modest benefit” of supplementation took time to have an effect: mortality curves for treated and placebo groups only started to diverge after two years of follow-up. But he added that the benefit was statistically significant and at present physicians have little further to offer patients with heart failure. “I am sure that those of us who have responsibility for drawing up the next CHF guidelines will pay a lot of attention to the results of this trial,” he said.
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