National Institute for Health and Clinical Excellence (NICE)
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Draft guidance from NICE offers hope of improved mobility for people with peripheral arterial disease
Draft guidance published today (1 February) by NICE recommends the use of naftidrofuryl oxalate as a treatment option for people who suffer from the painful symptoms of peripheral arterial disease called intermittent claudication.
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. The main cause is atherosclerosis, which is narrowing of the arteries caused by fatty deposits on the arterial walls. 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. 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. Therefore, 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 treatments belonging to the class of vasoactive drugs that NICE is assessing as part of this appraisal. 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not as clinically or cost effective as naftidrofuryl oxalate so they are not recommended as treatment options in the draft guidance. 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preparation (Praxilene, Merck Serono), naftidrofuryl oxalate is also available as a cheaper, generic preparation; the draft guidance recommends that treatment should be started with the least costly preparation.
Dr Carole Longson, NICE Health Technology Evaluation Centre Director, said: "The severe pain on physical exertion associated with intermittent claudication can have a large impact on the quality of life of people with the condition because of the effects of restricted mobility on independence, social life, recreation and work. Although naftidrofuryl oxalate, like all vasoactive drugs, does not halt the progress of peripheral arterial disease or lower the incidence of heart attack or stroke, the independent Appraisal Committee felt that it demonstrated clear benefits in terms of improving maximum walking distance when compared to a placebo and the other drugs being considered as part of this appraisal, and that these benefits make it a cost effective use of NHS resources."
NICE's preliminary guidance is now available for public consultation on the NICE website until 22 February 2011. Feedback received during consultation may result in changes to the preliminary recommendations and will be considered by the Appraisal Committee at their next meeting.
Notes to Editors
About the draft guidance
1. The appraisal consultation document (ACD) will be available on the NICE website from Tuesday 1 February. Consultation will take place between 1 February and 22 February 2011.
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.
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