The Scottish Medicines Consortium has backed the National Health Service use of A.Menarini Pharma’s Nebilet (nebivolol) for the treatment of stable mild and moderate chronic heart failure in patients aged 70 years and over.

A vasodilating beta-blocker, Nebilet has demonstrated its capabilities in treating CHF in two large-scale, placebo-controlled trials, the results of which the SMC took into account when considering the drug’s addition to the NHS treatment menu.

The first trial, called SENIORS 1, is particularly relevant to clinical practice as the median age of participants – 76 – is the median age of CHF patients newly presenting across the UK, the group said. The study involved more than 2,000 patients with CHF, and showed that Nebilet, on top of standard therapy, significantly reduced the composite primary endpoint of death or cardiovascular hospitalisation.

In the second placebo-controlled trial, ENECA2, involving 260 elderly patients, the drug induced a significant improvement in the important cardiovascular marker of left-ventricular ejection fraction.

Cost-effectiveness demonstrated

Furthermore, a spokesperson for the company told PharmaTimes UK News that Nebilet “has demonstrated beneficial cost effectiveness versus all the other beta blockers requested by the SMC.”

Professor Martin Cowie, Chair of Cardiology, Imperial College, London, and Chair of the British Society for Heart Failure, welcomed the SMC’s decision. “There is convincing evidence of the benefits of this therapy for elderly people with heart failure. The challenge is now to ensure that nebivolol is prescribed to such patients so that they can gain the benefits shown in the clinical trials,” he said.

Heart disease and CHF are a major strain on the NHS in Scotland, and the burden looks set to continue to grow over the next two decades, according to research by Stewart et al published in 2003 in the journal Heart. Furthermore, heart failure has a poor prognosis, and about 40% of patients die within one year of diagnosis, and in Scotland, mortality is strikingly high in the older age group, again illustrating the urgent need for effective therapies.