Patients having trouble keeping their cholesterol in check will now get easier access to Merck & Co and Schering Plough’s Ezetrol, after the UK’s cost-effectiveness body issued guidance recommending the drug as a treatment option on the National Health Service.

Specifically, the National Institute for Health and Clinical Excellence recommends Ezetrol (ezetimibe) for patients with hypercholesterolemia who are already on statin therapy, when their levels of cholesterol or low-density lipoprotein cholesterol are not controlled and doctors are considering switching statins.

Importantly, NICE’s Appraisal Committee has also concluded that the option of adding Ezetrol to initial statin therapy is “a cost effective use of NHS resources when compared with switching to an alternative statin.”

Ezetrol, which works by inhibiting the absorption of cholesterol in the gastrointestinal tract and is also sold under the trade name Zetia in certain territories, has been on the UK market since 2003, and recent clinical data has further demonstrated its encouraging efficacy profile in helping to combat heart disease.

Clinical data show benefit
According to the EXPLORER study presented at the World Congress of Cardiology in Barcelona, Spain, last year, adding Ezetrol to AstraZeneca’s Crestor (rosuvastatin) cut levels of C-reactive protein – a marker of inflammation and risk factor for cardiovascular disease – by 46%, compared to a reduction of just 29% with Crestor alone.

Meanwhile, a study of Ezetrol plus the statin simvastatin (which was originally developed by Merck & Co and now available generically in a number of markets including the USA) found that the combination cut CRP by 31%, versus 14% for simvastatin alone.

Likewise, ezetimibe plus simvastatin reduced levels of apolipoprotein B-containing lipoprotein particles such as LDL-c by a greater margin than simvastatin alone; LDL-c was cut 38% with simvastatin but 53% by a combination of the two.

There is an urgent need for new, effective therapies that help fight heart disease by lowering levels of harmful cholesterol. As NICE points out, not only does the UK population have one of the highest average cholesterol concentrations in the world, but around 35% of patients with coronary heart disease are not currently hitting the government targets.

‘Enormous benefit’ to patients
Commenting on the guidance, Michael Livingston, Director of HEART UK, said: “We are delighted with the outcome of this appraisal. Increased prescribing with exetimibe in patients with high cholesterol will be of enormous benefit in preventing premature deaths caused by high cholesterol and coronary heart disease.”

And Dr Stuart Findlay, GP and practice-based commissioning chairman for Durham and Darlington Primary Care Trust, added: “PCTs and practice-based commissioners should now look to increase their prescribing budgets to account for the increased use of ezetimibe,” as “this will help prevent future coronary events…and increase the treatment options available to manage this important risk factor at primary care level.”

The Institute says it expects its guidance to be issued formally in November 2007, at which point “health professionals and the organisations that employ them are expected to take it fully into account when deciding what treatments to give people.”