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Draft guidance from NICE set to ease the pain for people with peripheral arterial disease

Final draft guidance published today (14 April) by NICE confirms its previous positive draft recommendation for naftidrofuryl oxalate as an option to treat people who suffer from 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 in or narrowing of one of the main arteries, most commonly the femoral artery in the thigh, or sometimes the iliac artery in the lower abdomen, that carry blood to the legs and arms. Intermittent claudication is a result of the narrowed arteries not delivering adequate blood to leg muscles and so pain comes from the oxygen starved muscles. As well as having a detrimental impact on quality of life, people with intermittent claudication are at higher risk of dying from a heart attack or stroke than patients with PAD who do not have intermittent claudication.

Naftidrofuryl oxalate is one of four drugs, often referred to as vasodilators, that NICE is assessing 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(Pletal, Otsuka Pharmaceuticals), pentoxifylline (Trental 400, Sanofi-Aventis) and inositol nicotinate(Hepoxal, Genus Phamaceuticals) - 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preparation (Praxilene, Merck Serono), naftidrofuryl oxalate is also available as a cheaper, generic preparation; the draft guidance recommends that treatment should be started with the least costly preparation.

Professor Peter Littlejohns, NICE Clinical and Public Health Director, said: "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 severe peripheral arterial disease and heart disease or a stroke. 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 demonstrate clear benefits for people with the condition in terms of improving maximum walking distance compared to a placebo. We are pleased, therefore, to be able to recommend naftidrofuryl oxalate as a cost effective use of NHS resources."

The final draft guidance is now with consultees, who have the opportunity to appeal against it. NICE has not yet issued final guidance to the NHS.

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Notes to Editors

About the draft guidance

1. The final appraisal determination (FAD) will be available on the NICE website at http://guidance.nice.org.uk/TA/Wave22/8 from Thursday 14 April.

2. Naftidrofuryl oxalate is an oral peripheral vasodilator that selectively blocks vascular and platelet 5-hydroxytryptamine 2 (5-HT2) receptors. It has a UK marketing authorisation for peripheral vascular disorders, including intermittent claudication. Naftidrofuryl oxalate is available as a branded preparation of 100mg capsules at a cost of £8.10 (excl VAT) for a 84-capsule pack. Generic preparations are also available at a cost of £5.30 (excl VAT) for a 100mg 84-capsule pack. The recommended dose is one or two 100mg capsules three times daily. Therefore, for the branded preparation the average monthly cost is £8.80 assuming three 100mg capsules daily or £17.60 assuming six 100mg capsules daily.

3. Cilostazol (Pletal, Otsuka Pharmaceuticals) is an oral phosphodiesterase III inhibitor. Cilostazol is a direct arterial vasodilator and it also inhibits platelet aggregation. Cilostazol has a UK marketing authorisation for the ‘improvement of the maximal and pain-free walking distances in patients with intermittent claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis (peripheral arterial disease Fontaine stage II)'. Cilostazol is available as a 100 mg tablet at a cost of £35.31(excl VAT) for a 56-tablet pack. The recommended dose is 100 mg twice daily. Therefore, the average monthly cost is £38.26.

4. Pentoxifylline (Trental 400, Sanofi-Aventis) is an oral peripheral vasodilator derived from methylxanthine. Pentoxifylline has a UK marketing authorisation for the ‘treatment of peripheral arterial disease, including intermittent claudication and rest pain'. Pentoxifylline is available as a 400 mg tablet at a cost of £19.68 (excl VAT) for a 90-tablet pack. The recommended dose is one tablet three times daily. Therefore, the average monthly cost is £19.90. However, the summary of product characteristics states that two tablets daily may prove sufficient in some patients, particularly for maintenance therapy.

5. Inositol nicotinate (Hepoxal, Genus Phamaceuticals) is available as a 500 mg tablet at a cost of £30.76 for a 100-tablet pack. It is also available as a 750 mg tablet at a cost of £51.03 (excl VAT) for a 112-tablet pack. The recommended dose is 3 g daily (that is, two tablets three times a day), increased to 4 g daily if necessary. The average monthly cost, assuming two 500 mg tablets three times a day, is £56.14.

About NICE

6. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

7. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

8. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

9. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 14 April 2011

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.