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What is the evidence for use of naftidrofuryl in PVD?

Associated tags: Cardiovascular disease, claudication, intermittent claudication, naftidrofuryl, peripheral vascular disease, Raynaud's disease

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Question answered:27/03/09

We searched the NLH Library, TRIP and Medline databases and found naftidrofuryl has been used mainly to treat two conditions: intermitttent claudication and Raynaud's syndrome.

 

There is some evidence to support the use of naftidrofuryl in intermittent claudication but less support for its use in Raynaud’s syndrome.

 

Intermittent claudication

 

The 2006 SIGN guideline on peripheral arterial disease states:

 

Naftidrofuryl is reported to have vasodilator effects. It is thought to act at tissue level improving tissue oxygenation, increasing adenosine triphosphate levels and reducing lactic acid. The drug is given in a dose of 100 mg three times a day initially, increasing to 200 mg three times a day.
There are numerous RCTs evaluating this drug in patients with claudication. A significant number of studies were excluded from consideration because of poor study design (eg lack of intention to treat, non-standard assessment of claudication). Four studies were of sufficient quality to indicate a robust effect. Two used walking distance endpoints although only one used a validated outcome, and two used QoL endpoints. In one study patients who had already undertaken exercise training improved their walking distance by 92% in the naftidrofuryl group compared to 17% in a placebo group. These data are supported by a positive effect on QoL.

 

Patients with intermittent claudication and who have a poor quality of life may be considered for treatment with naftidrofuryl.” [1]

 

The SIGN guideline on peripheral arterial disease, published in 1998, adds:

 

“Naftidrofuryl, 200 mg three times daily, may improve the symptoms of patients suffering moderate disease (claudicant distance less than 500 metres) but it is not known if it has any effect on the outcome of the disease. If naftidrofuryl is prescribed, patients should be reassessed after 3-6 months." [2]

 

A second guideline on peripheral arterial disease issued in 2000 notes:

 

“Naftidrofuryl (200 mg tds may improve symptoms of patients with moderate disease (pain < 500 yds). Drug effectiveness should be assessed at 3 months.” [3]

 

Raynaud’s Syndrome

 

Clinical Evidence has a chapter on Raynaud’s phenomenon which places naftidrofuryl in the category of unknown effectiveness as a treatment:

 

One RCT found that, compared with placebo, naftidrofuryl oxalate reduced the duration and intensity of Raynaud's attacks over 2 months and reduced the impact of attacks on daily activities. However, we were unable to draw a reliable conclusions from this single study.” [4]

 

The PRODIGY guideline on Raynaud’s phenomenon states:

 

“Naftidrofuryl oxalate and inositol nicotinate have been used in Raynaud's phenomenon but are of limited value [Sunderland et al, 1988; SIGN, 1998; Pope, 2006].” [5]

 

Finally, the SIGN guideline on peripheral vascular disease recommends:

 

“The following are recommended for the symptomatic relief of Raynaud.s phenomenon:
§ Nifedipine (30-60 mg daily)
Note: A slow release preparation may lessen side effects
§ Naftidrofuryl (200 mg, three times daily)
§ Inositol nicotinate (1-1.5 g, twice daily).

 

The recommended ordering of treatment is as follows:
1 Nifedipine
2 Naftidrofuryl as first alternative.”
[2]

 

NOTE: In March 2009 the BMJ published "Naftidrofuryl for intermittent claudication: meta-analysis based on individual patient data" (http://www.bmj.com/cgi/content/abstract/338/mar10_1/b603) and this concluded:

 

"This meta-analysis of individual patient data provides evidence that naftidrofuryl has a clinically meaningful effect compared with placebo in improving walking distance in patients with intermittent claudication."

 

References
1. SIGN. The management and diagnosis of peripheral arterial disease. 2006. (http://www.sign.ac.uk/pdf/sign89.pdf ).
2. SIGN. Drug therapy for peripheral arterial disease. 1988. (http://www.sign.ac.uk/pdf/sign27.pdf).
3. SHARP. Peripheral arterial disease. 2000. (http://www.dundee.ac.uk/sharp/arterial.htm).
4. Clinical Evidence. Raynaud’s phenomenon (primary). Literature search to October 2005. (http://www.clinicalevidence.com/ceweb/conditions/msd/1119/1119_I1.jsp)
5. PRODIGY. Raynaud’s phenomenon. May 2006. (http://www.prodigy.nhs.uk/raynauds_phenomenon).


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