The National Institute for Health and Clinical Excellence (NICE) has issued final guidance recommending naftidrofuryl oxalate as an option for the treatment of people who have intermittent claudication caused by peripheral arterial disease and for whom vasodilator therapy is considered appropriate after taking into account other treatment options.
Peripheral arterial disease is a condition in which there is a blockage or narrowing of the arteries that carry blood to the legs and arms caused mainly by fatty deposits on the arterial walls. Intermittent claudication, and the pain associated with it, is a result of muscles being starved of oxygen. Pain is relieved with rest. As well as having a detrimental impact on quality of life, intermittent claudication also indicates that there is an increased risk of heart attack and stroke. Additionally, people with intermittent claudication are at higher risk of dying from a heart attack or stroke than patients with PAD who do not have symptoms.
Self-help measures, including lifestyle changes such as quitting smoking, taking regular exercise and eating a healthy diet, are the most important components in reducing the chance of developing peripheral arterial disease. However, for some people the severe pain that is often associated with intermittent claudication means that their ability to engage in regular exercise, particularly walking, can be severely limited. Although it does not halt the progress of peripheral arterial disease, naftidrofuryl oxalate has been shown to be the most clinically and cost effective treatment option for people with the condition in terms of improving maximum walking distance.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “We’re pleased to recommend naftidrofuryl oxalate as an option for treating intermittent claudication, a condition that can have a significant impact on an individual’s life, including loss of independence, employment and social activities. Naftidrofuryl oxalate is one of four drugs, often referred to as vasodilators, that NICE assessed as part of this appraisal. Vasodilators relax the smooth muscle in blood vessels, which causes the vessels to dilate and therefore increases blood supply to the muscles. The evidence considered by the Appraisal Committee showed that the others – cilostazol, pentoxifylline and inositol nicotinate – are not as clinically effective compared with placebo as naftidrofuryl oxalate. Only naftidrofuryl oxalate was shown to be a cost-effective treatment option.”
As well as a branded preparation (Praxilene, Merck Serono), naftidrofuryl oxalate is also available as a cheaper, generic preparation; the final guidance recommends that treatment should be started with the least costly preparation. The guidance ‘Cilostazol, naftidrofyryl oxalate, pentoxifylline and inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial disease’ is available here.